chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Cardiomegaly, Chest X-ray abnormal, Confusional state, Electrocardiogram QT prolonged, Electroencephalogram abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 years old male patient. The patient's medical history included myringotomy tubes, strabismus surgery, scholastically delayed with some cognitive issues surrounding speech development and no known allergy. The patient was vaccinated IM into the right arm with lot # (672652/0022AE) dose 3 GARDASIL on 05-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-APR-2012 the patient had a tonic clonic seizure. He was hospitalized and found to have an abnormal EEG. He was now on anti-seizure medication. The following information was obtained through follow-up and/or provided by the government on 03-MAY-2012. Hospital records (date of service) 06-APR-2012 - 07-APR-2012. Diagnostics: seizure, first time episode. Concurrent condition: fell; found in tonic position with disconjugate gaze; unresponsive for 10 minutes; confused postictally for 30 minutes. Admitted overnight. Uneventful hospitalization. Discharge in stable condition to follow up with cardiologist and primary care physician. Labs/diagnostics: White blood cell count 4.4 K/mm3 (L), Neutrophil count 44% (L), lymphocyte count 44% (H). Nuclear magnetic resonance imaging brain: unremarkable. Chest X-ray: suggestive of cardiomegaly. Electroencephalogram: abnormal. Electrocardiogram: slightly prolonged QT interval; left ventricular hypertrophy. The events required to ER visit and hospitalization. The original reporting source was not provided. The VAERS ID # is 453967-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fall, Gaze palsy, Grand mal convulsion, Lymphocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 years old male patient. The patient's medical history included myringotomy tubes, strabismus surgery, scholastically delayed with some cognitive issues surrounding speech development and no known allergy. The patient was vaccinated IM into the right arm with lot # (672652/0022AE) dose 3 GARDASIL on 05-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-APR-2012 the patient had a tonic clonic seizure. He was hospitalized and found to have an abnormal EEG. He was now on anti-seizure medication. The following information was obtained through follow-up and/or provided by the government on 03-MAY-2012. Hospital records (date of service) 06-APR-2012 - 07-APR-2012. Diagnostics: seizure, first time episode. Concurrent condition: fell; found in tonic position with disconjugate gaze; unresponsive for 10 minutes; confused postictally for 30 minutes. Admitted overnight. Uneventful hospitalization. Discharge in stable condition to follow up with cardiologist and primary care physician. Labs/diagnostics: White blood cell count 4.4 K/mm3 (L), Neutrophil count 44% (L), lymphocyte count 44% (H). Nuclear magnetic resonance imaging brain: unremarkable. Chest X-ray: suggestive of cardiomegaly. Electroencephalogram: abnormal. Electrocardiogram: slightly prolonged QT interval; left ventricular hypertrophy. The events required to ER visit and hospitalization. The original reporting source was not provided. The VAERS ID # is 453967-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Postictal state, Unresponsive to stimuli, Ventricular hypertrophy, White blood cell count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 years old male patient. The patient's medical history included myringotomy tubes, strabismus surgery, scholastically delayed with some cognitive issues surrounding speech development and no known allergy. The patient was vaccinated IM into the right arm with lot # (672652/0022AE) dose 3 GARDASIL on 05-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-APR-2012 the patient had a tonic clonic seizure. He was hospitalized and found to have an abnormal EEG. He was now on anti-seizure medication. The following information was obtained through follow-up and/or provided by the government on 03-MAY-2012. Hospital records (date of service) 06-APR-2012 - 07-APR-2012. Diagnostics: seizure, first time episode. Concurrent condition: fell; found in tonic position with disconjugate gaze; unresponsive for 10 minutes; confused postictally for 30 minutes. Admitted overnight. Uneventful hospitalization. Discharge in stable condition to follow up with cardiologist and primary care physician. Labs/diagnostics: White blood cell count 4.4 K/mm3 (L), Neutrophil count 44% (L), lymphocyte count 44% (H). Nuclear magnetic resonance imaging brain: unremarkable. Chest X-ray: suggestive of cardiomegaly. Electroencephalogram: abnormal. Electrocardiogram: slightly prolonged QT interval; left ventricular hypertrophy. The events required to ER visit and hospitalization. The original reporting source was not provided. The VAERS ID # is 453967-1. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient with no known allergies (NKA) was vaccinated with third dose of ROTATEQ (by mouth, lot # 669996/0326AA, dose unspecified). Suspect therapy given intramuscularly into the left leg included a third dose of RECOMBIVAX HB (lot #669935/1154AA, dose unspecified) on 01-Nov-2011. Concomitant medications included PENTACEL and PREVNAR 13. It was reported that the child was diagnosed with intussusception, hospitalized for 1 night in hospital. The following information was obtained through follow-up and/or provided by the government on 22-May-2012. Hospital records ODS 20-Jan-2012 to 21-Jan-2012. DX: possible intussusception; CC: colicky abdominal pain; bloody stools, vomiting, crying inconsolably. PE: cap refill sluggish. Admitted for observation. Air contrast enema did not find intussusception. DC in stable condition to f/u with PCP. Also lab data on Hospital records as WBC 11.8 K/mm3(N), neuts 54%(L), monos 14%(H). Stool guaiac positive for blood. Air contrast enema: no evidence of intussusception. XR abd: suspicious for intussusception. US abd: alternating circumferential, hyperechoic et hypoechoic rings visualized within the muscle along RUQ-could represent intussusception. The original reporting source was not provided. The VAERS ID number was 455185-1. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast normal, Capillary nail refill test abnormal, Crying
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient with no known allergies (NKA) was vaccinated with third dose of ROTATEQ (by mouth, lot # 669996/0326AA, dose unspecified). Suspect therapy given intramuscularly into the left leg included a third dose of RECOMBIVAX HB (lot #669935/1154AA, dose unspecified) on 01-Nov-2011. Concomitant medications included PENTACEL and PREVNAR 13. It was reported that the child was diagnosed with intussusception, hospitalized for 1 night in hospital. The following information was obtained through follow-up and/or provided by the government on 22-May-2012. Hospital records ODS 20-Jan-2012 to 21-Jan-2012. DX: possible intussusception; CC: colicky abdominal pain; bloody stools, vomiting, crying inconsolably. PE: cap refill sluggish. Admitted for observation. Air contrast enema did not find intussusception. DC in stable condition to f/u with PCP. Also lab data on Hospital records as WBC 11.8 K/mm3(N), neuts 54%(L), monos 14%(H). Stool guaiac positive for blood. Air contrast enema: no evidence of intussusception. XR abd: suspicious for intussusception. US abd: alternating circumferential, hyperechoic et hypoechoic rings visualized within the muscle along RUQ-could represent intussusception. The original reporting source was not provided. The VAERS ID number was 455185-1. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Monocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient with no known allergies (NKA) was vaccinated with third dose of ROTATEQ (by mouth, lot # 669996/0326AA, dose unspecified). Suspect therapy given intramuscularly into the left leg included a third dose of RECOMBIVAX HB (lot #669935/1154AA, dose unspecified) on 01-Nov-2011. Concomitant medications included PENTACEL and PREVNAR 13. It was reported that the child was diagnosed with intussusception, hospitalized for 1 night in hospital. The following information was obtained through follow-up and/or provided by the government on 22-May-2012. Hospital records ODS 20-Jan-2012 to 21-Jan-2012. DX: possible intussusception; CC: colicky abdominal pain; bloody stools, vomiting, crying inconsolably. PE: cap refill sluggish. Admitted for observation. Air contrast enema did not find intussusception. DC in stable condition to f/u with PCP. Also lab data on Hospital records as WBC 11.8 K/mm3(N), neuts 54%(L), monos 14%(H). Stool guaiac positive for blood. Air contrast enema: no evidence of intussusception. XR abd: suspicious for intussusception. US abd: alternating circumferential, hyperechoic et hypoechoic rings visualized within the muscle along RUQ-could represent intussusception. The original reporting source was not provided. The VAERS ID number was 455185-1. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Occult blood positive, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient with no known allergies (NKA) was vaccinated with third dose of ROTATEQ (by mouth, lot # 669996/0326AA, dose unspecified). Suspect therapy given intramuscularly into the left leg included a third dose of RECOMBIVAX HB (lot #669935/1154AA, dose unspecified) on 01-Nov-2011. Concomitant medications included PENTACEL and PREVNAR 13. It was reported that the child was diagnosed with intussusception, hospitalized for 1 night in hospital. The following information was obtained through follow-up and/or provided by the government on 22-May-2012. Hospital records ODS 20-Jan-2012 to 21-Jan-2012. DX: possible intussusception; CC: colicky abdominal pain; bloody stools, vomiting, crying inconsolably. PE: cap refill sluggish. Admitted for observation. Air contrast enema did not find intussusception. DC in stable condition to f/u with PCP. Also lab data on Hospital records as WBC 11.8 K/mm3(N), neuts 54%(L), monos 14%(H). Stool guaiac positive for blood. Air contrast enema: no evidence of intussusception. XR abd: suspicious for intussusception. US abd: alternating circumferential, hyperechoic et hypoechoic rings visualized within the muscle along RUQ-could represent intussusception. The original reporting source was not provided. The VAERS ID number was 455185-1. No further information is available.
Age: 20.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Dizziness, Dyskinesia, Loss of consciousness, Malaise
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 20 year old male patient with no previous illness or medical history was vaccinated intramuscularly in the left arm with dose 1 of GARDASIL (lot # 672653/1860AA) on 16-MAY-2012. Concomitant vaccines received on the same day included the second dose of MENACTRA (lot # U3905AA) IM in the right arm. There were no other concomitant medications. It was reported that on 16-MAY-2012, within seconds of receiving MENACTRA and then GARDASIL, the patient became lightheaded. He stiffened, lost consciousness and had 5 seconds of jerking movements and stiffening. The patient felt sick, nauseous and weak for the next 30 minutes and then recovered. The original reporting source was not provided. The VAERS ID# is 456158-1. Upon internal review, loss of consciousness was considered an other important medical event. Upon internal review, loss of consciousness was considered an other important medical event. The report was considered not serious, no conditions per agency. No further information is available.
Age: 20.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Musculoskeletal stiffness, Nausea
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 20 year old male patient with no previous illness or medical history was vaccinated intramuscularly in the left arm with dose 1 of GARDASIL (lot # 672653/1860AA) on 16-MAY-2012. Concomitant vaccines received on the same day included the second dose of MENACTRA (lot # U3905AA) IM in the right arm. There were no other concomitant medications. It was reported that on 16-MAY-2012, within seconds of receiving MENACTRA and then GARDASIL, the patient became lightheaded. He stiffened, lost consciousness and had 5 seconds of jerking movements and stiffening. The patient felt sick, nauseous and weak for the next 30 minutes and then recovered. The original reporting source was not provided. The VAERS ID# is 456158-1. Upon internal review, loss of consciousness was considered an other important medical event. Upon internal review, loss of consciousness was considered an other important medical event. The report was considered not serious, no conditions per agency. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 24-MAY-2012, an 18 years old female patient, with no known relevant history, was vaccinated with dose 3 GARDASIL IM in her left arm and dose 2 of (Merck) VARIVAX lot # (670248/0420AA, expiry 13-MAR-2013) SC in the left arm. Concomitant medications included minocycline, vitamins (unspecified), ibuprofen, tretinoin, clindamycin and cyclobenzaprine hydrochloride. On 25-MAY-2012, this morning patient noticed red, raised area on back of left arm (injection site of VARIVAX vaccine) - not painful. The patient was examined at nurse visit and advised to ice area apply either BENADRYL cream, Hydrocortisone cream, or take BENADRYL PO (per Dr) and call the office if it worsened/became painful. Patient outcome was unknown. The original reporting source was unspecified. The VAERS ID # is 456233-1. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 24-MAY-2012, an 18 years old female patient, with no known relevant history, was vaccinated with dose 3 GARDASIL IM in her left arm and dose 2 of (Merck) VARIVAX lot # (670248/0420AA, expiry 13-MAR-2013) SC in the left arm. Concomitant medications included minocycline, vitamins (unspecified), ibuprofen, tretinoin, clindamycin and cyclobenzaprine hydrochloride. On 25-MAY-2012, this morning patient noticed red, raised area on back of left arm (injection site of VARIVAX vaccine) - not painful. The patient was examined at nurse visit and advised to ice area apply either BENADRYL cream, Hydrocortisone cream, or take BENADRYL PO (per Dr) and call the office if it worsened/became painful. Patient outcome was unknown. The original reporting source was unspecified. The VAERS ID # is 456233-1. No further information is available.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Myalgia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-MAY-2012, an 18 years old male patient with no known allergies, no birth defects was medical history was vaccinated with a third dose of GARDASIL in his left arm. Concomitant vaccination included MENVEO (lot # A11071) in his right arm. On 29-MAY-2012 (also reported as symptoms began a few hours after immunization) the patient experienced elevated temp 99.6, chills, aches and complained joint hurting, sore muscles, hands and knuckles hurt, weakness. No treatment was given. Lab test was not performed. The patient was under observation. Patient outcome was unknown. The original reporting source was not provided. The VAERS ID # is 456618-1. No further information is available.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Pain, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-MAY-2012, an 18 years old male patient with no known allergies, no birth defects was medical history was vaccinated with a third dose of GARDASIL in his left arm. Concomitant vaccination included MENVEO (lot # A11071) in his right arm. On 29-MAY-2012 (also reported as symptoms began a few hours after immunization) the patient experienced elevated temp 99.6, chills, aches and complained joint hurting, sore muscles, hands and knuckles hurt, weakness. No treatment was given. Lab test was not performed. The patient was under observation. Patient outcome was unknown. The original reporting source was not provided. The VAERS ID # is 456618-1. No further information is available.
Age: 22.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dermatitis, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old male patient with no pre-existing illness and no medical history was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 672653/1860AA) in his left arm on 09-MAY-2012. Concomitant therapy included a first dose of MENACTRA (Lot # U4019AA) and a first dose of BOOSTRIX (Lot # AC52B070BA) given intramuscularly in right arm. On 11-MAY-2012 the patient developed dermatitis type rash on left arm within 48 hours of vaccine. It spread from left to right arm and bilateral upper inner thighs and it was itched. Self resolved over 1 week. Treated antihistamines as needed seemed to help. The original reporting source was not provide. The VAERS ID # is 456732-1. No further information is available.
Age: 22.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old male patient with no pre-existing illness and no medical history was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 672653/1860AA) in his left arm on 09-MAY-2012. Concomitant therapy included a first dose of MENACTRA (Lot # U4019AA) and a first dose of BOOSTRIX (Lot # AC52B070BA) given intramuscularly in right arm. On 11-MAY-2012 the patient developed dermatitis type rash on left arm within 48 hours of vaccine. It spread from left to right arm and bilateral upper inner thighs and it was itched. Self resolved over 1 week. Treated antihistamines as needed seemed to help. The original reporting source was not provide. The VAERS ID # is 456732-1. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Discomfort, Dyskinesia, Feeling hot, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the freedom of information Act. A 23 years old female patient was vaccinated IM into left arm with first dose of GARDASIL (lot# 669796/0840AA, expired date 14-OCT-2013) on 01-JUN-2012. No other co-suspects were reported. Concomitant therapy included MICROGESTIN. On 01-JUN-2012 the patient felt hot, uncomfortable, and then weak. The patient stated that her vision was blurry and then lost consciousness. Her body jerked twice and within 30 seconds she awoke feeling nauseated and weak. The outcome of the patient was unknown. On internal review, lost consciousness was determined to be an other important medical event. This report was considered not serious, no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 456735. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the freedom of information Act. A 23 years old female patient was vaccinated IM into left arm with first dose of GARDASIL (lot# 669796/0840AA, expired date 14-OCT-2013) on 01-JUN-2012. No other co-suspects were reported. Concomitant therapy included MICROGESTIN. On 01-JUN-2012 the patient felt hot, uncomfortable, and then weak. The patient stated that her vision was blurry and then lost consciousness. Her body jerked twice and within 30 seconds she awoke feeling nauseated and weak. The outcome of the patient was unknown. On internal review, lost consciousness was determined to be an other important medical event. This report was considered not serious, no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 456735. No further information is available.
Age: 21.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 21 year old female patient with no medical history. The patient was vaccinated IM on the right arm with lot # (672232/1495AA0 GARDASIL on 21-MAY-2012, Other suspect therapies included hepatitis A virus vaccine (unspecified) (lot # 0447Z) on the left arm on 21-MAY-2012. Concomitant medications included ethinyl estradiol, ORTHO TRI-CYCLEN LO. In the "late evening" of the same day (21-MAY-2012) the patient noted "bumps on her face". She stated "she thought it was acne." She then got additional bumps across her forehead and neck. Patient took antihistamine and symptoms did not progress past this point. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Gaze palsy, Musculoskeletal stiffness, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old male patient with no medical history and with no pre-existing illness was vaccinated intramuscularly with a first dose of GARDASIL (Lot # reported as 0121AE, dose not reported) in his left arm on 01-JUN-2012. Other medications included tuberculin purified protein derivative. On 01-JUN-2012 after receiving vaccine, the patient felt dizzy and to be pale. Suddenly the patient had stiffening of extremities and upward rolling of eyeballs for 30 sec. Vital sign normal. Patient recovered rapidly. Patient placed on bed and observed for about 20 min in the clinic and was also given sips of water. No emergency medication given. Patient sent home feeling better. BP 122/79, P 72, R 22. The original reporting source was not provided. The VAERS ID # 456789-1.
Age: 23.0
Sex: M
Vaccine: HEP, HPV4, MNQ, HPV4
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 years old male patient without medical history and illness at the time of vaccine treated intramuscularly into right arm with two dose of GARDASIL (lot #:670050/1229AA) on 06-JUN-2012. Other concomitant therapies included MENACTRA and HEPATYRIX. The patient became lightheaded, pale, passed out for approx. 45 seconds. BP was 108/67. Pulse rate was 56. At time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required intervention to prevent permanent damage/impairment. No further information is available. The original reporting source was not provided. The VAERS ID # is 456852.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal dreams, Cataplexy, Hallucination, auditory, Hallucination, visual, Muscular weakness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 24 year old female patient was vaccinated intramuscularly in left arm with the third dose of GARDASIL (lot#658560/1062U) on 27-NOV-2007. On 10-DEC-2007, shortly after the last vaccine the patient began experiencing muscle weakness in the face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). The patient also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy had recently been found to be an autoimmune disease sometimes caused by a virus or vaccine. The patient had previous vaccine illness of cataplexy after receiving GARDASIL. The listing indicated that one or more of the events was considered to be disabling. No further information is available. The original reporting source was not provided. The VAERS ID # is 457176-1.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Narcolepsy, Sleep paralysis, Somnolence, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 24 year old female patient was vaccinated intramuscularly in left arm with the third dose of GARDASIL (lot#658560/1062U) on 27-NOV-2007. On 10-DEC-2007, shortly after the last vaccine the patient began experiencing muscle weakness in the face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). The patient also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy had recently been found to be an autoimmune disease sometimes caused by a virus or vaccine. The patient had previous vaccine illness of cataplexy after receiving GARDASIL. The listing indicated that one or more of the events was considered to be disabling. No further information is available. The original reporting source was not provided. The VAERS ID # is 457176-1.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal dreams, Cataplexy, Condition aggravated, Hallucination, auditory, Hallucination, visual
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 24 year old female patient was vaccinated intramuscularly in left arm with the third dose of GARDASIL (lot#658560/1062U) on 27-NOV-2007. On 10-DEC-2007, shortly after the last vaccine the patient began experiencing muscle weakness in the face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). The patient also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy had recently been found to be an autoimmune disease sometimes caused by a virus or vaccine. The patient had previous vaccine illness of cataplexy after receiving GARDASIL. The listing indicated that one or more of the events was considered to be disabling. No further information is available. The original reporting source was not provided. The VAERS ID # is 457176-1.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Narcolepsy, Sleep paralysis, Somnolence, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 24 year old female patient was vaccinated intramuscularly in left arm with the third dose of GARDASIL (lot#658560/1062U) on 27-NOV-2007. On 10-DEC-2007, shortly after the last vaccine the patient began experiencing muscle weakness in the face and arms/hands after sudden emotion (usually laughter). By 2009, this progressed to full body collapse after trigger of strong emotion (cataplexy). The patient also began experiencing all symptoms of narcolepsy: uncontrollable daytime sleepiness resulting in forced sleep, visual and auditory hallucinations upon waking and sleeping, lucid dreams, and sleep paralysis. Narcolepsy had recently been found to be an autoimmune disease sometimes caused by a virus or vaccine. The patient had previous vaccine illness of cataplexy after receiving GARDASIL. The listing indicated that one or more of the events was considered to be disabling. No further information is available. The original reporting source was not provided. The VAERS ID # is 457176-1.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 11 year old female patient with allergy to OMNICEF, BACTRIM, penicillin, corn, rice, tomatoes, eggs and yeast. On 29-MAY-2012, she was vaccinated with dose 1 GARDASIL (lot # 671463/0359AA 23-JUN-2014) IM at her right arm. Concomitant vaccination on same day included dose 1 of ADACEL (lot # U3561CA) IM at right arm and dose 1 of MENACTRA (lot # U4020AA) IM at left arm. Concomitant medications included MIRALAX, NEXIUM, ATARAX, ZYRTEC, fluticasone propionate, ADVAIR, diazepam, and SINGULAIR. On 29-MAY-2012, the patient's mother called at 2:25 pm and stated the child had rash. Mother was called and left message (urgent for mom to bring child to office at 2:28 pm). It was suspected as allergy to vaccine. Called to mom at 3:30 pm. The mother stated child broke out in hives. The mother gave BENADRYL. Vaccine information Statements (VIS) sheets were given prior to vaccine for reading. Mother said the patient was allergic to yeast. The mother was asked to continue BENADRYL over hours and see sooner if worsened per nurse in am if needed on 30-MAY-2012. Patient outcome was unknown. The original reporting source was not provided. The VAERS ID # is 457207-1. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Allergy to vaccine, Rash, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 11 year old female patient with allergy to OMNICEF, BACTRIM, penicillin, corn, rice, tomatoes, eggs and yeast. On 29-MAY-2012, she was vaccinated with dose 1 GARDASIL (lot # 671463/0359AA 23-JUN-2014) IM at her right arm. Concomitant vaccination on same day included dose 1 of ADACEL (lot # U3561CA) IM at right arm and dose 1 of MENACTRA (lot # U4020AA) IM at left arm. Concomitant medications included MIRALAX, NEXIUM, ATARAX, ZYRTEC, fluticasone propionate, ADVAIR, diazepam, and SINGULAIR. On 29-MAY-2012, the patient's mother called at 2:25 pm and stated the child had rash. Mother was called and left message (urgent for mom to bring child to office at 2:28 pm). It was suspected as allergy to vaccine. Called to mom at 3:30 pm. The mother stated child broke out in hives. The mother gave BENADRYL. Vaccine information Statements (VIS) sheets were given prior to vaccine for reading. Mother said the patient was allergic to yeast. The mother was asked to continue BENADRYL over hours and see sooner if worsened per nurse in am if needed on 30-MAY-2012. Patient outcome was unknown. The original reporting source was not provided. The VAERS ID # is 457207-1. No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Neck pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 10 years old female patient with prophylaxis was vaccinated with lot # (672232/1495AA) GARDASIL in left arm on 12-JUN-2012. No other co-suspects were reported. Concomitant medications included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (diphtheria toxoid (&) pertussis acellular vaccine (unspecified) (&) te) (Lot#C3475AA), MENACTRA (Lot#U4074BA). The patient experienced left sided neck pain which started at midnight on 13-JUN-2012. MOTRIN was ordered on 27-JUL-2012. It was unspecified if the patient had sought medical attention. No further information is available. The original reporting source was not provided.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Extremity contracture, Fall, Loss of consciousness, Staring
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 years old female patient with no medical history and no previous illness was vaccinated IM with the third dose of GARDASIL on 13-JUN-2012 (lot # 672233/1561AA) into the left arm. No other co-suspects were reported. Concomitant medications included: tuberculin purified protein derivative. On 13-JUN-2012, the patient stood up to walk to door and headed to wall, then passed out and falling to floor. The patient was out for 5 to 10 seconds only. The patient lied on floor for 5 to 10 min felt better-sat in chair to check vitals. The patient head fell back, arms contracted and eyes glazed over (? seizures), lasted 10 to 15 seconds. The patient was lied down and taken to ER via ambulance. The patient was alert and awake. At the time of the report, the outcome of passed out, pt. head fell back, arms contracted and eyes glazed over, and falling to door was unknown. Upon internal review, loss of consciousness was considered medically significant. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 457350-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Loss of consciousness, Muscle contractions involuntary, Posture abnormal, Staring
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 years old female patient with no medical history and no previous illness was vaccinated IM with the third dose of GARDASIL on 13-JUN-2012 (lot # 672233/1561AA) into the left arm. No other co-suspects were reported. Concomitant medications included: tuberculin purified protein derivative. On 13-JUN-2012, the patient stood up to walk to door and headed to wall, then passed out and falling to floor. The patient was out for 5 to 10 seconds only. The patient lied on floor for 5 to 10 min felt better-sat in chair to check vitals. The patient head fell back, arms contracted and eyes glazed over (? seizures), lasted 10 to 15 seconds. The patient was lied down and taken to ER via ambulance. The patient was alert and awake. At the time of the report, the outcome of passed out, pt. head fell back, arms contracted and eyes glazed over, and falling to door was unknown. Upon internal review, loss of consciousness was considered medically significant. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 457350-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cyanosis, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with no medical history and no previous illness was vaccinated IM with the second dose of VAQTA (lot # reported as 0325AE) into the right arm. Other suspect vaccines given on the same day included the third IM dose of GARDASIL on 13-JUN-2012 (lot # reported as 1696AA) into the left arm. Concomitant therapies included a tuberculin purified protein derivative (PPD). No concomitant medications were reported. On 13-JUN-2012, the patient was in for routine physical. She had fasted overnight. Immediately after GARDASIL, the patient passed out. Also, it was reported that the patient that the patient experienced cyanosis. This episode had duration of 1 minute. The patient did not remember syncope. No laboratory test was performed. At the time of the report, the outcome of passed out, immediately after HPV injection, mild perioral cyanosis and syncope was unknown. Upon internal review, loss of consciousness was considered medically significant. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457654-1. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Full blood count, Injection site cellulitis, Injection site discharge, Injection site erythema, Injection site pain
Clinical narrative: Localized swelling and edema at site that continued with further swelling, weeping a little at site. Quarter-size area of weeping and vesicle on rt. shoulder, erythema that travels down toward elbow and up to shoulder joint. Cellulitis (see notes)
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site vesicles, Metabolic function test, Skin warm
Clinical narrative: Localized swelling and edema at site that continued with further swelling, weeping a little at site. Quarter-size area of weeping and vesicle on rt. shoulder, erythema that travels down toward elbow and up to shoulder joint. Cellulitis (see notes)
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient was vaccinated IM on the right arm with the second dose of GARDASIL on 26-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 26-MAR-2012 the patient experienced loss of consciousness and fell in the waiting room. The patient regained consciousness and was doing fine. Upon internal review, loss of consciousness was considered medical significant. The original reporting source was not provided. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cellulitis, Chronic obstructive pulmonary disease, Computerised tomogram, Condition aggravated
Clinical narrative: This spontaneous report as received from a consumer refers her a 79 years old mother with colon cancer, chronic obstructive pulmonary disease (COPD), diabetic and allergy to penicillin. The patient was vaccinated with a dose of PNUEMOVAX 23 (lot # reported as 0225AE, Expiration date 2013)(dose and route not reported) on 01-JUN-2012. Other suspect therapies included PLAVIX, budesonide, SYMBICORT and "CLONOPAN". The consumer stated on 01-JUN-2012, her mother developed cellulitis down her arm that was injected with PNEUMOVAX 23. Her arm became swollen and red, she also had to be hospitalized, because her chronic obstructive pulmonary disease (COPD) became worse. Unspecified antibiotics were given as a treatment for adverse events. On unknown date lab diagnostics studies were performed -"blood work, computed tomography (CT scan)". On 17-JUL-2012 the patient recovered. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report as received from a consumer refers her a 79 years old mother with colon cancer, chronic obstructive pulmonary disease (COPD), diabetic and allergy to penicillin. The patient was vaccinated with a dose of PNUEMOVAX 23 (lot # reported as 0225AE, Expiration date 2013)(dose and route not reported) on 01-JUN-2012. Other suspect therapies included PLAVIX, budesonide, SYMBICORT and "CLONOPAN". The consumer stated on 01-JUN-2012, her mother developed cellulitis down her arm that was injected with PNEUMOVAX 23. Her arm became swollen and red, she also had to be hospitalized, because her chronic obstructive pulmonary disease (COPD) became worse. Unspecified antibiotics were given as a treatment for adverse events. On unknown date lab diagnostics studies were performed -"blood work, computed tomography (CT scan)". On 17-JUL-2012 the patient recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Feeling hot
Clinical narrative: Light headed, dizzy, warm abdominal cramping.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Fall, Head injury, Loss of consciousness, Neck pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no known pertinent medical history or previous illness was vaccinated intramuscular into the left arm with first dose of GARDASIL (lot # 671994/1537AA) on 12-MAR-2012. A tuberculin (TB) test was performed. The patient experienced concussion, fall, head injury, loss of consciousness, neck pain, syncope and visual impairment on 12-MAR-2012. Patient had syncopal episode in lobby striking her head on floor and had brief LOC (lever of consciousness). She was transferred to ER (emergency room) due to neck pain/visual disturb. The patient was evaluated and released to home and diagnosed with mild concussion. Episode occurred 10 minutes after injection. The listing indicated that one or more of the events required ER visit but were not serious. Upon internal review, loss of consciousness was considered to be a medically significant event. No further information is available. The original reporting source was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no known pertinent medical history or previous illness was vaccinated intramuscular into the left arm with first dose of GARDASIL (lot # 671994/1537AA) on 12-MAR-2012. A tuberculin (TB) test was performed. The patient experienced concussion, fall, head injury, loss of consciousness, neck pain, syncope and visual impairment on 12-MAR-2012. Patient had syncopal episode in lobby striking her head on floor and had brief LOC (lever of consciousness). She was transferred to ER (emergency room) due to neck pain/visual disturb. The patient was evaluated and released to home and diagnosed with mild concussion. Episode occurred 10 minutes after injection. The listing indicated that one or more of the events required ER visit but were not serious. Upon internal review, loss of consciousness was considered to be a medically significant event. No further information is available. The original reporting source was not provided.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abnormal behaviour, Fall, Pallor, Tremor
Clinical narrative: Pt received MENVEO vaccine in left deltoid. Pt began to turn pale within minutes. Pt began to seize? (eyes open, humming noise, vibrating, slumped over in chair) for about 30 seconds. Once pt placed on floor, she felt much better.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Consciousness fluctuating, Fall, Heart rate decreased, Hyperhidrosis, Pallor
Clinical narrative: After given vaccines. Patient fell from sitting position to laying position unconscious x 1-2 min. Reduced pulse after 2 min. Pt was in and out consciousness became alert after about 5-8 min. 911 was called child was took to ER. Diaphoretic pale.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vaccination complication
Clinical narrative: After given vaccines. Patient fell from sitting position to laying position unconscious x 1-2 min. Reduced pulse after 2 min. Pt was in and out consciousness became alert after about 5-8 min. 911 was called child was took to ER. Diaphoretic pale.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 7-26-12 patient had awaken with a red itchy $.50 piece size area at injection site. Advised BENADRYL and ice to area. Mother called again on 7-27-12 and Dr. said to continue current treatment until size decreases. Mother contacted 7-30-12 and she said there was only slight redness at this time.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, PPV
Symptoms: Erythema, Oedema peripheral, Syncope, Vomiting
Clinical narrative: Red, swollen (R) arm, vomiting, and syncope.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Local reaction, Pain in extremity, Pruritus
Clinical narrative: 7/26 - LA slightly red around inj site of Tdap since then - lacy rash 4" around site w/ small 1" area many 4" down arm (+) itch pain - 5 saw MD 2/28/12 (+) local reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received DTaP (R) thigh 7-26-12; Evening of 7-27-12 redness, swelling, warmth at site of injection. Today induration/erythema 6" x 6" very tender.
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Eye pruritus, Pruritus, Urticaria
Clinical narrative: Eyes felt itchy after dose #1, knees and elbows itchy after dose #3. Hives to trunk and limbs after dose #4, No airway involvement. Symptoms improved with topical BENADRYL cream and 50mg oral dose x one time. Completely resolved after 36 hours.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anti-transglutaminase antibody, Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Bacterial test
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Borrelia test, CSF lymphocyte count increased, CSF myelin basic protein, Computerised tomogram abdomen
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.