chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray normal
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Bar virus (EBV) and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A &-haemolytic streptococci (GAS) throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous ROCEPHIN and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and TYLENOL # for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE, and the SAE was not going to be reported to VAERS. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyperaesthesia, Lymphadenitis, Neck pain, Parotid gland enlargement, Photophobia
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Bar virus (EBV) and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A &-haemolytic streptococci (GAS) throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous ROCEPHIN and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and TYLENOL # for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE, and the SAE was not going to be reported to VAERS. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Salivary gland pain, Streptococcal identification test negative, Swelling face, X-ray normal
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Bar virus (EBV) and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A &-haemolytic streptococci (GAS) throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous ROCEPHIN and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and TYLENOL # for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE, and the SAE was not going to be reported to VAERS. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antipsychotic drug level, Blood thyroid stimulating hormone, Drug screen negative, Suicidal ideation
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored manufacturer study. This case involves a 16-year-old female subject, with a history of bipolar disorder, oppositional defiant disorder, attention deficit-hyperactivity disorder, post-traumatic stress disorder due to prior abuse from mother and parent-child relationship problems, who had received a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 04 November 2008. The route and site of administration was not reported. The subject was evaluated at the emergency room on 08 December 2008 for emotional issues with suicidal ideation. A urine drug screen was negative and her TSH level (1.64 mcU/ml) was normal. Serum lithium level was within the therapeutic range (0.6) mEq/L). The subject was admitted for observation and management. Her in-patient stay was for approximately one week. After discharge from the hospital, the subject received individual and family therapy sessions for her current issues on at least the following dates: 17 December 2008, 22 December 2008 and 21 January 2009. The final diagnosis was suicidal ideation. The recovery status of the subject was not reported. Per the reporter, "the SAE was not related to the FLUZONE vaccine and will not be reported to the IRB, or to VAERS." Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antipsychotic drug level, Blood thyroid stimulating hormone normal, Drug screen negative, Emotional disorder, Suicidal ideation
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored manufacturer study. This case involves a 16-year-old female subject, with a history of bipolar disorder, oppositional defiant disorder, attention deficit-hyperactivity disorder, post-traumatic stress disorder due to prior abuse from mother and parent-child relationship problems, who had received a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 04 November 2008. The route and site of administration was not reported. The subject was evaluated at the emergency room on 08 December 2008 for emotional issues with suicidal ideation. A urine drug screen was negative and her TSH level (1.64 mcU/ml) was normal. Serum lithium level was within the therapeutic range (0.6) mEq/L). The subject was admitted for observation and management. Her in-patient stay was for approximately one week. After discharge from the hospital, the subject received individual and family therapy sessions for her current issues on at least the following dates: 17 December 2008, 22 December 2008 and 21 January 2009. The final diagnosis was suicidal ideation. The recovery status of the subject was not reported. Per the reporter, "the SAE was not related to the FLUZONE vaccine and will not be reported to the IRB, or to VAERS." Documents held by sender: None.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cardiac monitoring, Feeling of body temperature change, Malignant hypertension, Tachycardia, Tinnitus
Clinical narrative: This case was received from a health professional on 09 June 2009. A 49-year-old male patient, with a history of seasonal allergies, received an injection of FLUZONE (lot number U1753AA) on 27 October 2005. Two days post-vaccination, on 29 October 2005, he experienced malignant hypertension, tachycardia, "hot and cold" sensations, and ringing in the ears. He was treated with three courses of prednisone, and underwent a full cardiac work-up (results not provided). The "hot and cold" sensation and ringing in the ears remained ongoing. Of note, the patient had also received a flu vaccine (manufacturer and lot number not reported) in January 2005. In addition, this reporter noted that the patient's sister also experienced a similar event after receiving FLUZONE (lot number U1846AA) in 2005. That event is captured in case number 2009-02506.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan vagina abnormal, Urinary tract infection
Clinical narrative: This case was received from a health professional on 10 July 2009, and involves a subject enrolled in an investigator-sponsored study. A 15-year-old female subject, with a history of appendectomy, received an injection of FLUZONE (lot number U2849AC) on 20 November 2008. At the time of vaccination, she was confirmed to be 8 weeks pregnant; date of last menstrual period was 15 September 2008. Prior to vaccination, on 16 November 2008, the subject had presented to the emergency room with complaints of spotting bright red blood and pain on urination. Physical exam revealed suprapubic tenderness and left costal-vertebral tenderness, and urine analysis was consistent with a urinary tract infection. A transvaginal ultrasound revealed a viable fetus with a fetal heart rate of 150 beats per minute. The subject was given the discharge diagnosis of healthy pregnancy with urinary tract infection, and was prescribed antibiotics. She received study vaccine on 20 November 2008. On 17 December 2008, 27 days post-vaccination, the subject presented to the hospital with a three-day history of increasing abdominal cramping and spotting. The subject reported that she had never taken the antibiotics prescribed for her urinary tract infection. A transvaginal ultrasound showed no intrauterine pregnancy. Fluid was noted in the uterus, and tissue was present at os of the cervix. She was discharged home to follow-up with her obstetrician, and final diagnosis was complete spontaneous miscarriage. According to the reporter, the event was not related to FLUZONE. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vaginal haemorrhage
Clinical narrative: This case was received from a health professional on 10 July 2009, and involves a subject enrolled in an investigator-sponsored study. A 15-year-old female subject, with a history of appendectomy, received an injection of FLUZONE (lot number U2849AC) on 20 November 2008. At the time of vaccination, she was confirmed to be 8 weeks pregnant; date of last menstrual period was 15 September 2008. Prior to vaccination, on 16 November 2008, the subject had presented to the emergency room with complaints of spotting bright red blood and pain on urination. Physical exam revealed suprapubic tenderness and left costal-vertebral tenderness, and urine analysis was consistent with a urinary tract infection. A transvaginal ultrasound revealed a viable fetus with a fetal heart rate of 150 beats per minute. The subject was given the discharge diagnosis of healthy pregnancy with urinary tract infection, and was prescribed antibiotics. She received study vaccine on 20 November 2008. On 17 December 2008, 27 days post-vaccination, the subject presented to the hospital with a three-day history of increasing abdominal cramping and spotting. The subject reported that she had never taken the antibiotics prescribed for her urinary tract infection. A transvaginal ultrasound showed no intrauterine pregnancy. Fluid was noted in the uterus, and tissue was present at os of the cervix. She was discharged home to follow-up with her obstetrician, and final diagnosis was complete spontaneous miscarriage. According to the reporter, the event was not related to FLUZONE. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: This case was received from a health professional on 10 July 2009, and involves a subject enrolled in an investigator-sponsored study. A 15-year-old female subject, with a history of appendectomy, received an injection of FLUZONE (lot number U2849AC) on 20 November 2008. At the time of vaccination, she was confirmed to be 8 weeks pregnant; date of last menstrual period was 15 September 2008. Prior to vaccination, on 16 November 2008, the subject had presented to the emergency room with complaints of spotting bright red blood and pain on urination. Physical exam revealed suprapubic tenderness and left costal-vertebral tenderness, and urine analysis was consistent with a urinary tract infection. A transvaginal ultrasound revealed a viable fetus with a fetal heart rate of 150 beats per minute. The subject was given the discharge diagnosis of healthy pregnancy with urinary tract infection, and was prescribed antibiotics. She received study vaccine on 20 November 2008. On 17 December 2008, 27 days post-vaccination, the subject presented to the hospital with a three-day history of increasing abdominal cramping and spotting. The subject reported that she had never taken the antibiotics prescribed for her urinary tract infection. A transvaginal ultrasound showed no intrauterine pregnancy. Fluid was noted in the uterus, and tissue was present at os of the cervix. She was discharged home to follow-up with her obstetrician, and final diagnosis was complete spontaneous miscarriage. According to the reporter, the event was not related to FLUZONE. Documents held by sender: None.
Age: 1.55
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received on 11 September 2009 from a consumer's parent. An 18-month-old male patient who had no concurrent illnesses, and no relevant medical history, had received a dose of Fluzone 2009-2010 on 10 September 2009 at 15:20 hours. That night after receiving the vaccination around 19:00 hours, the patient developed a low-grade fever of  99.1 degrees Fahrenheit. He was given Tylenol around 21:00 hours and at midnight developed a fever again. He was treated with Motrin at around 02:00am. On 11 September 2009, the patient still had a low-grade fever around 99.0 degrees Fahrenheit. At the time of this report, the patient had not recovered. Follow-up information received on 14 September 2009 from the consumer's parent. The patient was evaluated by his physician on 14 September 2009 and the doctor confirmed the patient's symptoms are related to the Fluzone vaccination. The lot number for the Fluzone was reported as U3167FA. On 11 September 2009, the patient did not go to daycare. He still had a low-grade fever and developed coughing, runny nose and stuffy nose. He was treated with Tylenol during the day time. Around 22:00 hours, his body was started shaking and he had a fever of 100.2 degrees Fahrenheit. The patient's physician was contacted and the parent was told to treat him with Tylenol. The patient was administered 0.8mL of Tylenol, but his fever did not decrease at once. At 23:00 pm his fever was 104.0 degrees Fahrenheit. The patient's body was no longer shaking after taking the Tylenol and finally his fever was controlled, but he did not sleep well. On 12 September 2009, the patient still had a low-grade fever in the morning around 99.0 degree Fahrenheit. He was vomited after drinking milk that morning. Since that time, he refused to drink any milk or PediaSure, but was eating and drinking otherwise. At night on 13 September 2009, the patient had a fever again. He was given 0.8mL Tylenol, and he did not sleep well due to a stuffy nose and coughing. On 14 September 2009, the patient had a fever again in the morning and was seen by his physician. The physician confirmed the symptoms were related to the Fluzone vaccination, but were not serious. The patient is ok to return to daycare on 15 September 2009 if he does have any more fever; otherwise, he is to see the physician again. At this time, the patient can have Tylenol. 1.2mL if he has any fever over 100.0 degrees Fahrenheit. Follow-up can be done with the treating physician. Recovery status was not reported. Documents held by sender: None.
Age: 1.55
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Insomnia, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Initial report received on 11 September 2009 from a consumer's parent. An 18-month-old male patient who had no concurrent illnesses, and no relevant medical history, had received a dose of Fluzone 2009-2010 on 10 September 2009 at 15:20 hours. That night after receiving the vaccination around 19:00 hours, the patient developed a low-grade fever of  99.1 degrees Fahrenheit. He was given Tylenol around 21:00 hours and at midnight developed a fever again. He was treated with Motrin at around 02:00am. On 11 September 2009, the patient still had a low-grade fever around 99.0 degrees Fahrenheit. At the time of this report, the patient had not recovered. Follow-up information received on 14 September 2009 from the consumer's parent. The patient was evaluated by his physician on 14 September 2009 and the doctor confirmed the patient's symptoms are related to the Fluzone vaccination. The lot number for the Fluzone was reported as U3167FA. On 11 September 2009, the patient did not go to daycare. He still had a low-grade fever and developed coughing, runny nose and stuffy nose. He was treated with Tylenol during the day time. Around 22:00 hours, his body was started shaking and he had a fever of 100.2 degrees Fahrenheit. The patient's physician was contacted and the parent was told to treat him with Tylenol. The patient was administered 0.8mL of Tylenol, but his fever did not decrease at once. At 23:00 pm his fever was 104.0 degrees Fahrenheit. The patient's body was no longer shaking after taking the Tylenol and finally his fever was controlled, but he did not sleep well. On 12 September 2009, the patient still had a low-grade fever in the morning around 99.0 degree Fahrenheit. He was vomited after drinking milk that morning. Since that time, he refused to drink any milk or PediaSure, but was eating and drinking otherwise. At night on 13 September 2009, the patient had a fever again. He was given 0.8mL Tylenol, and he did not sleep well due to a stuffy nose and coughing. On 14 September 2009, the patient had a fever again in the morning and was seen by his physician. The physician confirmed the symptoms were related to the Fluzone vaccination, but were not serious. The patient is ok to return to daycare on 15 September 2009 if he does have any more fever; otherwise, he is to see the physician again. At this time, the patient can have Tylenol. 1.2mL if he has any fever over 100.0 degrees Fahrenheit. Follow-up can be done with the treating physician. Recovery status was not reported. Documents held by sender: None.
Age: 1.55
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Initial report received on 11 September 2009 from a consumer's parent. An 18-month-old male patient who had no concurrent illnesses, and no relevant medical history, had received a dose of Fluzone 2009-2010 on 10 September 2009 at 15:20 hours. That night after receiving the vaccination around 19:00 hours, the patient developed a low-grade fever of  99.1 degrees Fahrenheit. He was given Tylenol around 21:00 hours and at midnight developed a fever again. He was treated with Motrin at around 02:00am. On 11 September 2009, the patient still had a low-grade fever around 99.0 degrees Fahrenheit. At the time of this report, the patient had not recovered. Follow-up information received on 14 September 2009 from the consumer's parent. The patient was evaluated by his physician on 14 September 2009 and the doctor confirmed the patient's symptoms are related to the Fluzone vaccination. The lot number for the Fluzone was reported as U3167FA. On 11 September 2009, the patient did not go to daycare. He still had a low-grade fever and developed coughing, runny nose and stuffy nose. He was treated with Tylenol during the day time. Around 22:00 hours, his body was started shaking and he had a fever of 100.2 degrees Fahrenheit. The patient's physician was contacted and the parent was told to treat him with Tylenol. The patient was administered 0.8mL of Tylenol, but his fever did not decrease at once. At 23:00 pm his fever was 104.0 degrees Fahrenheit. The patient's body was no longer shaking after taking the Tylenol and finally his fever was controlled, but he did not sleep well. On 12 September 2009, the patient still had a low-grade fever in the morning around 99.0 degree Fahrenheit. He was vomited after drinking milk that morning. Since that time, he refused to drink any milk or PediaSure, but was eating and drinking otherwise. At night on 13 September 2009, the patient had a fever again. He was given 0.8mL Tylenol, and he did not sleep well due to a stuffy nose and coughing. On 14 September 2009, the patient had a fever again in the morning and was seen by his physician. The physician confirmed the symptoms were related to the Fluzone vaccination, but were not serious. The patient is ok to return to daycare on 15 September 2009 if he does have any more fever; otherwise, he is to see the physician again. At this time, the patient can have Tylenol. 1.2mL if he has any fever over 100.0 degrees Fahrenheit. Follow-up can be done with the treating physician. Recovery status was not reported. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness, Injection site reaction, Musculoskeletal stiffness, Mydriasis, No reaction on previous exposure to drug
Clinical narrative: A cluster of seven patients who all received FLUZONE SV 2009-2010 (lot number U3186AA): One patient experienced blurry vision, ringing in ears, and subsequently became pale and unresponsive; the six other patients all experienced localized injection site reactions. Initial report received on 08 September 2009 from a health care professional. An 18 year old female patient, with no medical history and no illness at the time of vaccination, received a first intramuscular injection of FLUZONE SV 2009-2010 (lot number U3186AA) in the right arm on 04 September 2009 at 10:15. The patient had no concomitant medications and no adverse events following prior vaccination. Seven minutes after vaccination, at 10:22, the patient was standing at the check-out window and stated that she couldn't see, her vision blurry and her ears ringing. The patient was asked to sit down and she was given a lollipop since she hadn't eaten breakfast. The patient was talking, and while the physician was examining her, she became pale, unresponsive, her eyes closed, she slumped in her chair and stiffened. Then her eyes opened and her pupils were dilated. Suddenly, the patient became unresponsive again. She then returned to her baseline in less than 30 seconds in total. The patient's outcome was recovered. The same healthcare professional reported the seven events, which are captured in: 2009-03859, 2009-03804, 2009-03805, 2009-03806, 2009-03807, 2009-039808, and 2009-03809.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pallor, Tinnitus, Unresponsive to stimuli, Vision blurred
Clinical narrative: A cluster of seven patients who all received FLUZONE SV 2009-2010 (lot number U3186AA): One patient experienced blurry vision, ringing in ears, and subsequently became pale and unresponsive; the six other patients all experienced localized injection site reactions. Initial report received on 08 September 2009 from a health care professional. An 18 year old female patient, with no medical history and no illness at the time of vaccination, received a first intramuscular injection of FLUZONE SV 2009-2010 (lot number U3186AA) in the right arm on 04 September 2009 at 10:15. The patient had no concomitant medications and no adverse events following prior vaccination. Seven minutes after vaccination, at 10:22, the patient was standing at the check-out window and stated that she couldn't see, her vision blurry and her ears ringing. The patient was asked to sit down and she was given a lollipop since she hadn't eaten breakfast. The patient was talking, and while the physician was examining her, she became pale, unresponsive, her eyes closed, she slumped in her chair and stiffened. Then her eyes opened and her pupils were dilated. Suddenly, the patient became unresponsive again. She then returned to her baseline in less than 30 seconds in total. The patient's outcome was recovered. The same healthcare professional reported the seven events, which are captured in: 2009-03859, 2009-03804, 2009-03805, 2009-03806, 2009-03807, 2009-039808, and 2009-03809.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Mydriasis, Pallor, Tinnitus, Unresponsive to stimuli
Clinical narrative: A cluster of seven patients who all received FLUZONE SV 2009-2010 (lot number U3186AA): One patient experienced blurry vision, ringing in ears, and subsequently became pale and unresponsive; the six other patients all experienced localized injection site reactions. Initial report received on 08 September 2009 from a health care professional. An 18 year old female patient, with no medical history and no illness at the time of vaccination, received a first intramuscular injection of FLUZONE SV 2009-2010 (lot number U3186AA) in the right arm on 04 September 2009 at 10:15. The patient had no concomitant medications and no adverse events following prior vaccination. Seven minutes after vaccination, at 10:22, the patient was standing at the check-out window and stated that she couldn't see, her vision blurry and her ears ringing. The patient was asked to sit down and she was given a lollipop since she hadn't eaten breakfast. The patient was talking, and while the physician was examining her, she became pale, unresponsive, her eyes closed, she slumped in her chair and stiffened. Then her eyes opened and her pupils were dilated. Suddenly, the patient became unresponsive again. She then returned to her baseline in less than 30 seconds in total. The patient's outcome was recovered. The same healthcare professional reported the seven events, which are captured in: 2009-03859, 2009-03804, 2009-03805, 2009-03806, 2009-03807, 2009-039808, and 2009-03809.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vision blurred
Clinical narrative: A cluster of seven patients who all received FLUZONE SV 2009-2010 (lot number U3186AA): One patient experienced blurry vision, ringing in ears, and subsequently became pale and unresponsive; the six other patients all experienced localized injection site reactions. Initial report received on 08 September 2009 from a health care professional. An 18 year old female patient, with no medical history and no illness at the time of vaccination, received a first intramuscular injection of FLUZONE SV 2009-2010 (lot number U3186AA) in the right arm on 04 September 2009 at 10:15. The patient had no concomitant medications and no adverse events following prior vaccination. Seven minutes after vaccination, at 10:22, the patient was standing at the check-out window and stated that she couldn't see, her vision blurry and her ears ringing. The patient was asked to sit down and she was given a lollipop since she hadn't eaten breakfast. The patient was talking, and while the physician was examining her, she became pale, unresponsive, her eyes closed, she slumped in her chair and stiffened. Then her eyes opened and her pupils were dilated. Suddenly, the patient became unresponsive again. She then returned to her baseline in less than 30 seconds in total. The patient's outcome was recovered. The same healthcare professional reported the seven events, which are captured in: 2009-03859, 2009-03804, 2009-03805, 2009-03806, 2009-03807, 2009-039808, and 2009-03809.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Gait disturbance, Headache, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: FEVER AFTER IMMUNIZATION. SEVERE HEADACHE AND LEG PAIN. PT WALKING ON TOES. VOMITED LATER.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blood chloride normal, Carbon dioxide abnormal, Headache, Mean cell haemoglobin decreased, Monocyte count increased
Clinical narrative: FEVER AFTER IMMUNIZATION. SEVERE HEADACHE AND LEG PAIN. PT WALKING ON TOES. VOMITED LATER.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pain in extremity, Pyrexia, Red cell distribution width increased, Toe walking, Vomiting
Clinical narrative: FEVER AFTER IMMUNIZATION. SEVERE HEADACHE AND LEG PAIN. PT WALKING ON TOES. VOMITED LATER.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Injection site erythema, Injection site papule, Injection site pruritus
Clinical narrative: Red bumps, reddish area 3 in x 4 in pimples - measured by urgent care- Health. Tx - BENADRYL oral- hyrdocortisone topical. Itching at site "Has hx of allergic Rx to Alcohol swabs not this fast usually similar Rx.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Injection site pruritus, Rash erythematous
Clinical narrative: Red bumps, reddish area 3 in x 4 in pimples - measured by urgent care- Health. Tx - BENADRYL oral- hyrdocortisone topical. Itching at site "Has hx of allergic Rx to Alcohol swabs not this fast usually similar Rx.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red bumps, reddish area 3 in x 4 in pimples - measured by urgent care- Health. Tx - BENADRYL oral- hyrdocortisone topical. Itching at site "Has hx of allergic Rx to Alcohol swabs not this fast usually similar Rx.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthenia, Ataxia, Blood creatine phosphokinase increased, Computerised tomogram normal, Confusional state
Clinical narrative: DIZZINESS, SYNCOPE, NEUROLOGICAL DEFICITS.  UNABLE TO BE AROUSED EASILY.  DIDN'T KNOW WHO SHE WAS OR WHERE.  CONFUSED.  PT HOSPITALIZED FOR 1 DAY FOR EVAL.  CONT TO HAVE SEVERE DIZZINESS.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Fibrin D dimer normal, Scan brain, Syncope, White blood cell count normal
Clinical narrative: DIZZINESS, SYNCOPE, NEUROLOGICAL DEFICITS.  UNABLE TO BE AROUSED EASILY.  DIDN'T KNOW WHO SHE WAS OR WHERE.  CONFUSED.  PT HOSPITALIZED FOR 1 DAY FOR EVAL.  CONT TO HAVE SEVERE DIZZINESS.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Computerised tomogram, Confusional state, Depressed level of consciousness, Disorientation, Dizziness
Clinical narrative: DIZZINESS, SYNCOPE, NEUROLOGICAL DEFICITS.  UNABLE TO BE AROUSED EASILY.  DIDN'T KNOW WHO SHE WAS OR WHERE.  CONFUSED.  PT HOSPITALIZED FOR 1 DAY FOR EVAL.  CONT TO HAVE SEVERE DIZZINESS.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: DIZZINESS, SYNCOPE, NEUROLOGICAL DEFICITS.  UNABLE TO BE AROUSED EASILY.  DIDN'T KNOW WHO SHE WAS OR WHERE.  CONFUSED.  PT HOSPITALIZED FOR 1 DAY FOR EVAL.  CONT TO HAVE SEVERE DIZZINESS.
Age: 1.3
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electrocardiogram, Supraventricular tachycardia
Clinical narrative: Supraventricular tachycardia 1 day post seasonal TIV injection. History of one episode of SVT at 3 days of life. See attached case summary. Note- this case been referred to the CISA team.
Age: 1.3
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Supraventricular tachycardia
Clinical narrative: Supraventricular tachycardia 1 day post seasonal TIV injection. History of one episode of SVT at 3 days of life. See attached case summary. Note- this case been referred to the CISA team.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Balance disorder, Disturbance in attention, Dizziness, Drug exposure during pregnancy, Gait disturbance
Clinical narrative: Patient reported dizzy, off balance and bumping into walls. Also reported confusion and difficulty maintaing thinking. 11/16/09 Medical records received for dates 6/19/09 to 11/13/09. Prenatal recs. On 11/13 Pt. presented with c/o disoriented, difficulty walking, after getting H1N1 vax. Pt seen in ER. 25wks pregnant G1P0. EDC: 2/22/10. 11/20/2009 ED records for 11/11/2009, patient with c/o's dizziness, off balance. Labs norm. DC Dx Ataxia
Age: 24.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Balance disorder, Confusional state, Dizziness, Mental impairment
Clinical narrative: Patient reported dizzy, off balance and bumping into walls. Also reported confusion and difficulty maintaing thinking. 11/16/09 Medical records received for dates 6/19/09 to 11/13/09. Prenatal recs. On 11/13 Pt. presented with c/o disoriented, difficulty walking, after getting H1N1 vax. Pt seen in ER. 25wks pregnant G1P0. EDC: 2/22/10. 11/20/2009 ED records for 11/11/2009, patient with c/o's dizziness, off balance. Labs norm. DC Dx Ataxia
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Wheezing
Clinical narrative: Chest tightness, wheezing, runny nose & congestion, headache, muscle aches and fever starting 1 day after nasal spray vaccine administered. Tylenol, Advil and Albuterol.  Not only was there an adverse reaction to this vaccine but there was mis-administration of it.  Due to health issues such as Asthma and Complex Partial Seizures the Nasal Spray Vaccine was not to be used.  Unfortunately, the Nasal Spray  was administered despite the information we provided to the administering powers.  Our consent form clearly stated these health issues and after the fact the Head Nurse admitted she over looked these items on the for during the screening process and that the nurse administering the vaccine also had overlooked them.  Clearly, this is an unacceptable situation and outcome.
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Chest discomfort, Headache, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Chest tightness, wheezing, runny nose & congestion, headache, muscle aches and fever starting 1 day after nasal spray vaccine administered. Tylenol, Advil and Albuterol.  Not only was there an adverse reaction to this vaccine but there was mis-administration of it.  Due to health issues such as Asthma and Complex Partial Seizures the Nasal Spray Vaccine was not to be used.  Unfortunately, the Nasal Spray  was administered despite the information we provided to the administering powers.  Our consent form clearly stated these health issues and after the fact the Head Nurse admitted she over looked these items on the for during the screening process and that the nurse administering the vaccine also had overlooked them.  Clearly, this is an unacceptable situation and outcome.
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Chest tightness, wheezing, runny nose & congestion, headache, muscle aches and fever starting 1 day after nasal spray vaccine administered. Tylenol, Advil and Albuterol.  Not only was there an adverse reaction to this vaccine but there was mis-administration of it.  Due to health issues such as Asthma and Complex Partial Seizures the Nasal Spray Vaccine was not to be used.  Unfortunately, the Nasal Spray  was administered despite the information we provided to the administering powers.  Our consent form clearly stated these health issues and after the fact the Head Nurse admitted she over looked these items on the for during the screening process and that the nurse administering the vaccine also had overlooked them.  Clearly, this is an unacceptable situation and outcome.
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Abasia, Alanine aminotransferase normal, Areflexia, Aspartate aminotransferase normal, Asthenia
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Ataxia, Back pain, Blood albumin increased, Blood alkaline phosphatase increased, Blood creatine phosphokinase MB increased
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Blood creatine phosphokinase increased, Blood culture negative, Blood immunoglobulin G normal, Borrelia test negative, CSF culture negative
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: CSF test normal, Computerised tomogram normal, Culture urine negative, Electromyogram abnormal, Gait disturbance
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Guillain-Barre syndrome, Headache, Hypokinesia, Immunoglobulin therapy, Lumbar puncture normal
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Muscle spasms, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging normal, Protein total normal
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Sensory loss, Walking aid user
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Asthenia, Pain
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Asthenia, Blood test, Chills, Computerised tomogram, Electrocardiogram
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Fatigue, Headache, Lumbar puncture, Muscle spasms, Muscular weakness
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Abasia, Areflexia, Back pain, Blood product transfusion, Electromyogram abnormal
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 14.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3, FLUX, FLUX(H1N1), FLU3, FLUX(H1N1)
Symptoms: Guillain-Barre syndrome, Headache, Lumbar puncture normal, Muscle spasms, Nuclear magnetic resonance imaging normal
Clinical narrative: Chills, headache, exhaustion, severe muscle spasms in back, loss of strength in legs and control of legs. Fever off and on from 100.8 to 103.8
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Intensive care, Methicillin-resistant staphylococcal aureus test positive, Peritonitis, Pyrexia, Staphylococcal infection
Clinical narrative: Admitted to ICU with high fever protracted vomiting. Found to have MRSA peritonitis. PD cath removed and pt placed on HD, tolerating well.   11/20/09 Medical records received for DOS 10/8-10/28. Final DX; MRSA peritonitis/sepsis/bacteremia associated with peritoneal dialysis  C/O fever and chills. Vomiting, abd pain, Hypotension, anorexia, weakness. Peritoneal catheter infection. Cloudy fluid. +MRSA cx.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Admitted to ICU with high fever protracted vomiting. Found to have MRSA peritonitis. PD cath removed and pt placed on HD, tolerating well.   11/20/09 Medical records received for DOS 10/8-10/28. Final DX; MRSA peritonitis/sepsis/bacteremia associated with peritoneal dialysis  C/O fever and chills. Vomiting, abd pain, Hypotension, anorexia, weakness. Peritoneal catheter infection. Cloudy fluid. +MRSA cx.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Per husband:  Numbness & tingling & body pain sent pt to doctor then hospital.  11/30/09 Medical records received. ED notes for 10/06 .  Final DX: Headache, dehydration C/O L arm, ear and finger numbness.  Tongue and lip numbness. Tingling. 25 weeks pregnant. Headache, intermittent bil abd cramps, nausea.  ICD9 Codes: 784.o, 276.82, V22.2
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: R leg 8cm area of erythema, slight swelling. Slight increase warmth around puncture site.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Eye swelling, Lacrimation increased, Pruritus
Clinical narrative: Itchy, red, watery eyes-eyes swollen shut.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Became deaphortic, dizzy and pallor within 1.25 hours after vaccination. VS normal 20 minutes after event.
Age: 30.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache that has now been present for a week, dizziness, nausea.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Malaise, Pyrexia, Rash
Clinical narrative: Symptoms included extreme fatigue/ malaise that started a few hours after the vaccination; fever of 101 and rash to upper torso started 10/14/2009.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Activities of daily living impaired, Headache, Pain, Rhinalgia, Sinus congestion
Clinical narrative: Severe headache, body aches and sinus congestion with nasal pain. Took three days to recover with school time lost. Very severe headache for 29 hours.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cardiac monitoring, Cough, Dyspnoea, Heart rate increased, Laboratory test
Clinical narrative: Coughing after movement. Weezing, trouble breathing, Lethargy, high heart rate.  11/12/09:  Labs and Diagnostics received for dates of service 11/11/09 to 11/12/09.  Dx:  Pneumonia.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Lethargy, Wheezing, X-ray
Clinical narrative: Coughing after movement. Weezing, trouble breathing, Lethargy, high heart rate.  11/12/09:  Labs and Diagnostics received for dates of service 11/11/09 to 11/12/09.  Dx:  Pneumonia.
Age: 25.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, Achy all over, chills Treated with Tylenol with relief for a couple hours and symptoms returned. Next day began fever 101.1 and nausea with headache arm soreness and achy all over. Treated with Tylenol, fever would go down but then spike back up. Emesis x2.
Age: 25.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Vomiting
Clinical narrative: Headache, Achy all over, chills Treated with Tylenol with relief for a couple hours and symptoms returned. Next day began fever 101.1 and nausea with headache arm soreness and achy all over. Treated with Tylenol, fever would go down but then spike back up. Emesis x2.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Throat irritation
Clinical narrative: Immediately after VARIVAX vaccine pt c/o throat pressure. Resolved within seconds of giving BENADRYL PO.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Unevaluable event
Clinical narrative: 8x8cm red slightly tender area around the left leg. Patient advise to use Benadryl.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site induration
Clinical narrative: Cellulatis, inderation at injection site. Pt came in to be seen 11/08/09.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash, Skin lesion
Clinical narrative: Skin lesions - erythem. papules on upper extremities and torso. Outbreak occurred 3 days ago. Some lesions are already crusted.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Soreness, redness, warmness, itchiness bicep area (away from injection site), of right arm.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Injection site pain, Malaise, Musculoskeletal stiffness
Clinical narrative: Headache (30 min s/a administration), sore- stiff sensation from injection site to L occipital region. Malaise, chills, fever up 102 degrees. s/p 4 hours of administration, weakness palpitations (106 BPM @1355 hrs).
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Palpitations, Pulse pressure decreased, Pyrexia
Clinical narrative: Headache (30 min s/a administration), sore- stiff sensation from injection site to L occipital region. Malaise, chills, fever up 102 degrees. s/p 4 hours of administration, weakness palpitations (106 BPM @1355 hrs).