chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Rash, Screaming, Social avoidant behaviour, Unresponsive to stimuli
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 18-APR-2007 a 12 month old male patient with a history of roseola and high fever 3 months before he was vaccinated with the first dose of PROQUAD (lot # 656890/0152U), site and route unknown. Concomitant therapy administered on 18-APR-2007 included a third dose of PEDVAXHIB (lot # 654398/078F) and fourth dose of PREVENAR (lot # B0362586). It was reported that the patient developed fever, rash and discomfort immediately after being vaccinated. Within 2 weeks his behavior changed dramatically, his language skills regressed, developed frequent fevers, experienced seizures and loss of eye contact. The patient's medical records from 05-FEB-2007 to October 2008 received from his primary care physician on 04-MAR-2009 indicated that he was seen on 19-OCT-2007 with parental concerns related to his speech development. In addition no real progress since age 1 was found and he did not respond to name when called. More concerns with behaviour were reported on 29-NOV-2007 along with frequent fevers. Episodes of stiffening and unresponsiveness and waking screaming were reported. In December 2007 was diagnosed with autism spectrum disorder. Laboratory tests performed on unspecified dates included "encephalitis", "autism" and "roseola". No further information is available. The original reporting source was not provided. The VAERS ID # is 340268. A standard lot check investigation was performed on 656890/0152U. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Standard lot check investigations were performed on lot # 654398/0784F. All in-process quality checks for the lot number in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Encephalitis
Clinical narrative: Received GARDASIL first injection. 1-week later went to Emergency room with disorientation. Was given IV fluids and released. Next day was found unconscious. Mother called ambulance. Child was then flown from one hospital to another hospital and was hospitalized for approximately 3 weeks. The child recovered from coma after 2 weeks, now suffers a blood clotting disorder and weakness.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Coagulopathy, Coma, Disorientation, Loss of consciousness
Clinical narrative: Received GARDASIL first injection. 1-week later went to Emergency room with disorientation. Was given IV fluids and released. Next day was found unconscious. Mother called ambulance. Child was then flown from one hospital to another hospital and was hospitalized for approximately 3 weeks. The child recovered from coma after 2 weeks, now suffers a blood clotting disorder and weakness.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy, Rash papular
Clinical narrative: 22 y/o male who developed non-tender, non-pruritic papular lesions initially over dorsal surfaces bilateral hands, then over bilateral elbows & forearms, onset approx 15 days following receipt SPV given 4/16/2009;  no mucous membrane, palmar or plantar surface involvement;  no systemic sxs;  Initial dx by PCM 5/7/2009 was dermatitis;  punch biopsy taken;  treated w/ atarax & steroid pulse, with marked improvement over a week.  Co-factors:  AVA#1 given 3/26/2009;  AVA#2 given 4/27/2009;  no known sick contacts, recent travel, insect bites, new drugs, HSV history;  + prior varicella w/ immunity.  Symptoms:  Lesions, papule.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Dermatitis, Rash papular, Skin lesion
Clinical narrative: 22 y/o male who developed non-tender, non-pruritic papular lesions initially over dorsal surfaces bilateral hands, then over bilateral elbows & forearms, onset approx 15 days following receipt SPV given 4/16/2009;  no mucous membrane, palmar or plantar surface involvement;  no systemic sxs;  Initial dx by PCM 5/7/2009 was dermatitis;  punch biopsy taken;  treated w/ atarax & steroid pulse, with marked improvement over a week.  Co-factors:  AVA#1 given 3/26/2009;  AVA#2 given 4/27/2009;  no known sick contacts, recent travel, insect bites, new drugs, HSV history;  + prior varicella w/ immunity.  Symptoms:  Lesions, papule.
Age: 25.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: I had only experienced a short duration of minor pain and redness at injection site each time the vaccine was administered. I was pregnant during my last vaccination on 05/08/2008. On 1/22/2009 I delivered a son at 6 lbs 8 oz. On 1/23/09 physician discovered that son had a right testicular torsion which occurred while in womb because the testicle was already considered dead and he was not experiencing pain. His right testicle had to be removed and the left testicle was stitched into place to prevent future twisting of the left testicle. At the time of vaccination I was unaware I was pregnant. Physician was not informed of this concern due to my pregnancy being transferred to another physician in another state.
Age: 25.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Drug exposure during pregnancy, Foetal disorder, Injection site erythema, Injection site pain
Clinical narrative: I had only experienced a short duration of minor pain and redness at injection site each time the vaccine was administered. I was pregnant during my last vaccination on 05/08/2008. On 1/22/2009 I delivered a son at 6 lbs 8 oz. On 1/23/09 physician discovered that son had a right testicular torsion which occurred while in womb because the testicle was already considered dead and he was not experiencing pain. His right testicle had to be removed and the left testicle was stitched into place to prevent future twisting of the left testicle. At the time of vaccination I was unaware I was pregnant. Physician was not informed of this concern due to my pregnancy being transferred to another physician in another state.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Death, Vomiting
Clinical narrative: Initial report received from an assistant coroner on 11 May 2009, with additional information received 13 May 2009 from an emergency room health care professional. A 38-year-old male patient had received at 10AM in the hospital emergency room on 04 May 2009, a first intramuscular right deltoid injection of IMOVAX Rabies, lot number 446011A (also reported as 446601A; both lot numbers are invalid sanofi pasteur lot numbers, manufacturer was reported as Novartis). He also received a first right deltoid injection of Imogam Rabies-HT, lot number 26NC8X1 (invalid sanofi pasteur lot number, manufacturer was reported as Talecris). The sites of administration for the IMOVAX Rabies and Imogam Rabies-HT were also reported as "multiple deltoid, thigh, and buttocks". At the time of the report, there was no record of additional series doses and no record of other lot numbers. The patient had been bitten by a bat on their right index finger on the evening of 03 May 2009 and it was reported that the bat appeared to have been sick. It was unknown if the bat had been captured for testing. An unspecified amount of time after receiving the above vaccinations, the patient developed "continuous" vomiting and was subsequently found deceased on 09 May 2009. No additional information was provided at the time of the report. Documents held by sender: None.  8/28/09 Autopsy report. Cause of Death: Fatty liver. Other significant conditions: Chronic alcoholism. Opinion: The decedent has fatty liver changes and Mallory Weiss Syndrome both of which are consistent with chronic alcoholism.   9/1/09 ER records received DOS 5/4/09. Assessment: Bat Bite, Rabies Prone. Presents at ER with two puncture wounds on right index finger. Bitten by bat that looked sick. Imogram Rabies and Imovax rabies vaccine administered.
Age: 76.0
Sex: M
Vaccine: TD
Symptoms: Chills, Injection site cellulitis, Injection site pain, Malaise, Pyrexia
Clinical narrative: Pt s/p TD vaccine 3/1/09, developed fever chills, rigor, malaise, pain @ injection site, admitted to hospital for cellulitis at TD injection site. Treated with Antibiotics.  6/11/09 Received PCP medical records of 3/1-4/12/2009 & hospital d/c summary for 3/2-3/6/2009. FINAL DX: cellulitis injection site left arm Records reveal patient experienced shoulder pain on 3/1 when received vaccine left arm.  Called office 3/2 not feeling well w/chills, rigors, SOB, chest pressure, generalized malaise.  Referred to ER & pt admitted.  Had fever.  Tx w/IV antibioticsCardio & ID consult done.  When seen s/p hospitalization on 4/12 & was improved.  7/13/09 Hospital records received DOS 3/2/09 to 3/6/09. Assessment: arm cellulitis, hypertension, fever, chest tightness. Patient presented with pain in shoulder at deltoid muscle, fever and nonspecific chest tightness, febrile. Mild headache. Left deltoid tenderness, swelling, red. Redness upper lip.  ICD-9 Codes: 038.8, 999.39, 401.9, 272.4, V15.82, E879.8, 786.50
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: 85 yo female presented to the office for routine follow up of chronic medical problems. She had a routine physical examination on 8/8/08 at which time, shingles vaccine was discussed and ordered. Due to back order of vaccine, it was not available until 4/09. In the interim, the patient was diagnosed with metastatic adenocarcinoma, likely pancreatic in origin, and had been started on XELODA by her oncologist in December 2008. When she presented for her follow up, she requested that her shingles vaccine be administered. It was administered by nurse prior to MD entering the room and then pt stated that she read the information given to her by the nurse which stated she should not receive vaccine if on chemotherapy. The patient has had no adverse reaction to the vaccine at this time and her oncologist was notified.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Heart rate increased, Hyperhidrosis, Hypotension
Clinical narrative: 6 hours after - chills - increased pulse - about 15 next 2 days - fever, weakness, sweating.  Also noticed lower blood pressure, about 20 points.  Only took aspirin, symptoms begin to subside on 3rd day.  All items returned to normal in 4 days
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 6 hours after - chills - increased pulse - about 15 next 2 days - fever, weakness, sweating.  Also noticed lower blood pressure, about 20 points.  Only took aspirin, symptoms begin to subside on 3rd day.  All items returned to normal in 4 days
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Irritability
Clinical narrative: R thigh red with bruise @ site of immunization + swelling + erythema. Pt very fussy and difficult to console.
Age: 55.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Amnesia, Anger, Aphasia, Computerised tomogram head, Demyelination
Clinical narrative: The subject identified himself as a cardio-vascular surgeon, 22 years in Army. He was deployed to a foreign country in 1991, at which time he received ANTHRAX vaccine. He remembers diarrhea post vaccination. Immunization records from that time have been lost. He was in a foreign country in 2004. He believes he received the YELLOW FEVER vaccine at that time. He was a surgeon in a Hospital ICU in a foreign country in 2005. The horror of that experience has given him PTSD. In 2008 he was re-mobilized to a foreign country. He received ANTHRAX vaccine once again. The first dose of the second series of ANTHRAX vaccine was given in another state, in 2008, along with about 4-5 other vaccines, including Smallpox, prior to deployment. He remembers 2 weeks of diarrhea and peripheral edema shortly after getting to another foreign country (began about 5 days after 1st shot of second series). He had the same symptoms for 3 days following doses 2 and 3 of the second series of ANTHRAX vaccine, each given in a foreign country. About 4 weeks after the 1st shot of the second series, while he was still in the foreign country, he experienced unexplained lack of concentration, short-term memory loss, missing words, fatigue, lethargy and was very sleepy. He completed approx. 90 days tour the foreign country he injured his hip and was sent to another foreign country for treatment. When he was in the foreign country he reported he had hit his head while in the other foreign country, therefore a CAT scan of the brain was done in that foreign country on March 12, 2009 which was reported to be normal. He was sent to the hospital for continued follow-up of his hip injury and head injury where he was hospitalized for 5 days. On March 24, 2009 he had a brain MRI at the hospital. The brain MRI showed scattered small foci, differential diagnosis including ischemic changes, prior infection, inflammation or demyelinating disease, unlikely to by post-traumatic. The subject reports that the neurologist told him the changes stated above, seen on the MRI, are normal for his age. He was diagnosed with tension headaches. He believes he has post-vaccination encephalomyelitis and reports that he is permanently disabled. He reports that he is very angry. He suffers from afternoon headaches and haziness in mental function. He is currently taking CELEXA and MINIPRESS for his anger and PTSD. His symptoms have improved over the last 9 weeks at the hospital.
Age: 55.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Diarrhoea, Disability, Disturbance in attention, Encephalomyelitis, Fatigue
Clinical narrative: The subject identified himself as a cardio-vascular surgeon, 22 years in Army. He was deployed to a foreign country in 1991, at which time he received ANTHRAX vaccine. He remembers diarrhea post vaccination. Immunization records from that time have been lost. He was in a foreign country in 2004. He believes he received the YELLOW FEVER vaccine at that time. He was a surgeon in a Hospital ICU in a foreign country in 2005. The horror of that experience has given him PTSD. In 2008 he was re-mobilized to a foreign country. He received ANTHRAX vaccine once again. The first dose of the second series of ANTHRAX vaccine was given in another state, in 2008, along with about 4-5 other vaccines, including Smallpox, prior to deployment. He remembers 2 weeks of diarrhea and peripheral edema shortly after getting to another foreign country (began about 5 days after 1st shot of second series). He had the same symptoms for 3 days following doses 2 and 3 of the second series of ANTHRAX vaccine, each given in a foreign country. About 4 weeks after the 1st shot of the second series, while he was still in the foreign country, he experienced unexplained lack of concentration, short-term memory loss, missing words, fatigue, lethargy and was very sleepy. He completed approx. 90 days tour the foreign country he injured his hip and was sent to another foreign country for treatment. When he was in the foreign country he reported he had hit his head while in the other foreign country, therefore a CAT scan of the brain was done in that foreign country on March 12, 2009 which was reported to be normal. He was sent to the hospital for continued follow-up of his hip injury and head injury where he was hospitalized for 5 days. On March 24, 2009 he had a brain MRI at the hospital. The brain MRI showed scattered small foci, differential diagnosis including ischemic changes, prior infection, inflammation or demyelinating disease, unlikely to by post-traumatic. The subject reports that the neurologist told him the changes stated above, seen on the MRI, are normal for his age. He was diagnosed with tension headaches. He believes he has post-vaccination encephalomyelitis and reports that he is permanently disabled. He reports that he is very angry. He suffers from afternoon headaches and haziness in mental function. He is currently taking CELEXA and MINIPRESS for his anger and PTSD. His symptoms have improved over the last 9 weeks at the hospital.
Age: 55.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Feeling abnormal, Head injury, Infection, Inflammation, Injury
Clinical narrative: The subject identified himself as a cardio-vascular surgeon, 22 years in Army. He was deployed to a foreign country in 1991, at which time he received ANTHRAX vaccine. He remembers diarrhea post vaccination. Immunization records from that time have been lost. He was in a foreign country in 2004. He believes he received the YELLOW FEVER vaccine at that time. He was a surgeon in a Hospital ICU in a foreign country in 2005. The horror of that experience has given him PTSD. In 2008 he was re-mobilized to a foreign country. He received ANTHRAX vaccine once again. The first dose of the second series of ANTHRAX vaccine was given in another state, in 2008, along with about 4-5 other vaccines, including Smallpox, prior to deployment. He remembers 2 weeks of diarrhea and peripheral edema shortly after getting to another foreign country (began about 5 days after 1st shot of second series). He had the same symptoms for 3 days following doses 2 and 3 of the second series of ANTHRAX vaccine, each given in a foreign country. About 4 weeks after the 1st shot of the second series, while he was still in the foreign country, he experienced unexplained lack of concentration, short-term memory loss, missing words, fatigue, lethargy and was very sleepy. He completed approx. 90 days tour the foreign country he injured his hip and was sent to another foreign country for treatment. When he was in the foreign country he reported he had hit his head while in the other foreign country, therefore a CAT scan of the brain was done in that foreign country on March 12, 2009 which was reported to be normal. He was sent to the hospital for continued follow-up of his hip injury and head injury where he was hospitalized for 5 days. On March 24, 2009 he had a brain MRI at the hospital. The brain MRI showed scattered small foci, differential diagnosis including ischemic changes, prior infection, inflammation or demyelinating disease, unlikely to by post-traumatic. The subject reports that the neurologist told him the changes stated above, seen on the MRI, are normal for his age. He was diagnosed with tension headaches. He believes he has post-vaccination encephalomyelitis and reports that he is permanently disabled. He reports that he is very angry. He suffers from afternoon headaches and haziness in mental function. He is currently taking CELEXA and MINIPRESS for his anger and PTSD. His symptoms have improved over the last 9 weeks at the hospital.
Age: 55.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Lethargy, Mental disorder, Nuclear magnetic resonance imaging brain abnormal, Oedema peripheral, Post-traumatic stress disorder
Clinical narrative: The subject identified himself as a cardio-vascular surgeon, 22 years in Army. He was deployed to a foreign country in 1991, at which time he received ANTHRAX vaccine. He remembers diarrhea post vaccination. Immunization records from that time have been lost. He was in a foreign country in 2004. He believes he received the YELLOW FEVER vaccine at that time. He was a surgeon in a Hospital ICU in a foreign country in 2005. The horror of that experience has given him PTSD. In 2008 he was re-mobilized to a foreign country. He received ANTHRAX vaccine once again. The first dose of the second series of ANTHRAX vaccine was given in another state, in 2008, along with about 4-5 other vaccines, including Smallpox, prior to deployment. He remembers 2 weeks of diarrhea and peripheral edema shortly after getting to another foreign country (began about 5 days after 1st shot of second series). He had the same symptoms for 3 days following doses 2 and 3 of the second series of ANTHRAX vaccine, each given in a foreign country. About 4 weeks after the 1st shot of the second series, while he was still in the foreign country, he experienced unexplained lack of concentration, short-term memory loss, missing words, fatigue, lethargy and was very sleepy. He completed approx. 90 days tour the foreign country he injured his hip and was sent to another foreign country for treatment. When he was in the foreign country he reported he had hit his head while in the other foreign country, therefore a CAT scan of the brain was done in that foreign country on March 12, 2009 which was reported to be normal. He was sent to the hospital for continued follow-up of his hip injury and head injury where he was hospitalized for 5 days. On March 24, 2009 he had a brain MRI at the hospital. The brain MRI showed scattered small foci, differential diagnosis including ischemic changes, prior infection, inflammation or demyelinating disease, unlikely to by post-traumatic. The subject reports that the neurologist told him the changes stated above, seen on the MRI, are normal for his age. He was diagnosed with tension headaches. He believes he has post-vaccination encephalomyelitis and reports that he is permanently disabled. He reports that he is very angry. He suffers from afternoon headaches and haziness in mental function. He is currently taking CELEXA and MINIPRESS for his anger and PTSD. His symptoms have improved over the last 9 weeks at the hospital.
Age: 55.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Scan brain, Somnolence, Tension headache
Clinical narrative: The subject identified himself as a cardio-vascular surgeon, 22 years in Army. He was deployed to a foreign country in 1991, at which time he received ANTHRAX vaccine. He remembers diarrhea post vaccination. Immunization records from that time have been lost. He was in a foreign country in 2004. He believes he received the YELLOW FEVER vaccine at that time. He was a surgeon in a Hospital ICU in a foreign country in 2005. The horror of that experience has given him PTSD. In 2008 he was re-mobilized to a foreign country. He received ANTHRAX vaccine once again. The first dose of the second series of ANTHRAX vaccine was given in another state, in 2008, along with about 4-5 other vaccines, including Smallpox, prior to deployment. He remembers 2 weeks of diarrhea and peripheral edema shortly after getting to another foreign country (began about 5 days after 1st shot of second series). He had the same symptoms for 3 days following doses 2 and 3 of the second series of ANTHRAX vaccine, each given in a foreign country. About 4 weeks after the 1st shot of the second series, while he was still in the foreign country, he experienced unexplained lack of concentration, short-term memory loss, missing words, fatigue, lethargy and was very sleepy. He completed approx. 90 days tour the foreign country he injured his hip and was sent to another foreign country for treatment. When he was in the foreign country he reported he had hit his head while in the other foreign country, therefore a CAT scan of the brain was done in that foreign country on March 12, 2009 which was reported to be normal. He was sent to the hospital for continued follow-up of his hip injury and head injury where he was hospitalized for 5 days. On March 24, 2009 he had a brain MRI at the hospital. The brain MRI showed scattered small foci, differential diagnosis including ischemic changes, prior infection, inflammation or demyelinating disease, unlikely to by post-traumatic. The subject reports that the neurologist told him the changes stated above, seen on the MRI, are normal for his age. He was diagnosed with tension headaches. He believes he has post-vaccination encephalomyelitis and reports that he is permanently disabled. He reports that he is very angry. He suffers from afternoon headaches and haziness in mental function. He is currently taking CELEXA and MINIPRESS for his anger and PTSD. His symptoms have improved over the last 9 weeks at the hospital.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella zoster virus serology positive
Clinical narrative: Typical Herpes Zoster - began 5-3-09.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: L thigh rash "hives" x 3 days; improving after 3 days per mother. Rash started 7 days after vaccinations in same place as administered VARIVAX. Mother also notes "hive-like" rash on back that was localized and has resolved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lupus-like syndrome
Clinical narrative: Information has been received from a registered nurse concerning an approximately 14 year old female patient who on 22-AUG-2007, 19-OCT-2007 and 07-MAR-2008 was vaccinated with the series of GARDASIL (lot#: 658556/1060U) of all doses) at another office experienced lupus like symptoms with neurological issues. The patient did see a neurologist. The patient also received MENACTRA and DTAP on 15-AUG-2007 (confirmed different data than initial GARDASIL). Nurse did not wish to be contacted. No further information available at the time of reporting. Upon internal review, lupus like symptoms was determined to be an other important medical event. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with the first dose of GARDASIL IM, 0.5ML on 31-MAY-2008 (lot#: 659441/1446U), the second dose IM, 0.5ML on 26-JAN-2009. After the second dose, the patient developed seizures twice. Concomitant therapy included meningococcal vaccine (manufacturer unknown) and Hep A vaccine (manufacturer unknown). The patient had sought unspecified medical attention. No further information is available at the time of reporting. Upon internal review, Seizures were determined to be an other important medical event. Additional information has been requested.  7/21/09 Medical records received DOS 5/31/08 to 6/27/09. Assessment: Seizures. Parents of patient report several ER visits for seizures.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal growth retardation, Premature labour, Vaginal laceration
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no known medical history, allergies or drug reactions who in March 2007, was vaccinated with the first dose of GARDASIL (lot no. route and site not reported) second dose (lot no. route and site not reported) was given in May 2008. There was no concomitant medication. No adverse effects were reported. Subsequently, she became pregnant. The patient's LMP was in April 2008. On 10-JAN-2008 the patient delivered a baby. No laboratory tests were performed. Follow-up information has been received from a nurse who reported that the patient had received the first and second doses of GARDASIL on 13-MAR-2007 and 17-MAY-2007 at another practice. The nurse confirmed the LMP was in April 2007 and the EDD was 25-JAN-2008. The nurse reported that the patient had come late in her pregnancy at 33 weeks of gestation. The nurse reported that the patient was admitted to the hospital on 12-DEC-2007 for preterm contractions and intrauterine growth restriction (IUGR). The nurse did not know how long hospitalization lasted. The nurse stated that the patient delivered early on 10-JAN-2008. It was a vaginal delivery with repair of a laceration. The patient was discharged from the hospital on 12-JAN-2008 following the birth. The patient did not return for her postpartum visit. The patient was seen in July 2008 for a non-pregnancy issue and her annual exam in December 2008. The nurse reported that the baby "seemed to be doing well", no problems were reported for the baby. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received from a office manager concerning a 4 year old male patient with no pertinent medical history and no known drug allergies/drug reactions who on 12-DEC-2005 was vaccinated with a dose of MMR II (Lot # 649755/0380R). Secondary suspect vaccine given on the same day included VARIVAX (Lot # 646669/0626R). It was reported that a dose of hepatitis B virus vaccine rHBsAg (Lot # 647036/0958P) was administered on 12-JAN-2006. It was reported that on an unspecified date the patient developed an "autism disorder". The patient sought unspecified medical attention. It was reported that the patient had not recovered at the time of the report. Upon internal review "autism disorder" was considered to be an other important medical event. Other vaccines given in the past included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, hepatitis A vaccine (unspecified), Hib conj vaccine (manufacturer unknown), polio vaccine (unspecified), pneumococcal 23v polysaccharide vaccine (manufacturer unknown) and flu vaccine (unspecified). Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Received Menactra on 5/13/09 and developed fever, myalgia, and headache on 5/14/09.  Seen at office and instructed to take ibuprofen.
Sex: F
Vaccine: HEP
Clinical narrative: Patient received a Hepatitis B vaccine on May 18th @ 1:37 PM. She recieved a second dose of the vaccine on May 18th @ 12:45 AM. No known complications at this time.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, C-reactive protein normal, Fall, Full blood count normal, Gait disturbance
Clinical narrative: Patient received the HPV vaccine in the late afternoon of Wednesday, May 6, 2009. Early on Thursday morning she woke up with pain in her right leg which had started during bedtime. She went to school, and there patient experienced severe pain in her right leg accompanied with pain and numbness on her left arm. she said she couldn't move her forearm and her ring and pinky fingers fo a period of about 5 minutes. About an hour later, around 9 to 9:30 a.m. patient had such pain in her right leg that she fell down. That pain was accompanied by spams in her lower leg and in her foot and toes. She could not walk without help and she was taken to the school nurse from where they called patient's mother. Mother picked her up in less than 20 minutes and took her to the ER. No tests (blood nor ultrasound) were performed. She was given Motrin for the pain and was dismissed with instructions to see pediatrician if she  got worse. From Friday through Sunday patient stayed home resting her leg. She had pain on and off and she had difficulty walking most of the weekend. On Monday, May 11, at school, patient's pain got severe again, Mother picked patient up and took her to the pediatrician. Pediatrician ordered blood to be drawn for tests and said she would refer patient to a specialist. On Tuesday, May 12, patient's pain was so severe that she was taken in a wheelchair from the classroom to the nurse's office. Mother picked her up and had to take her home since specialists were not going to see her until the coming week. On Wednesday, May 13, patient had severe pain in the morning while at school, she fell down, Mother picked her up from nurse's office where they had lent her a pair of cruthches to be able to get to the car. Parents called pediatrician to request testing to rule out DVT and parents requested an order for crutches for patient to be able to move around in school. Thursday, May 14, patient was still in pain, and was taken for an ultrasound. No DVT was found. Friday, May 15, patient was able to stay in school with the crutches. Monday, May 18, patient was able to walk most of the day without the crutches. Also, on Monday, May 18, a doctor saw patient. Tuesday, May 19, patient was able to walk without the crutches. Patient still complains on and off of weird feeling in her leg.  6/4/09 Hospital records received DOS 5/7/2009 and 5/18/09. Include bone age radiograph reports fron several prior years. FINAL DIAGNOSIS: Probable post Gardasil vaccination resulting in paresthesias. Post vaccination presents with right knee pain radiating to foot, leg cramps, twisted ankle, left hand tightness, forearm pain, numbness, myalgia, limping, dizziness. Motrin. Tylenol.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Metabolic function test normal, Mobility decreased, Muscle spasms, Pain in extremity
Clinical narrative: Patient received the HPV vaccine in the late afternoon of Wednesday, May 6, 2009. Early on Thursday morning she woke up with pain in her right leg which had started during bedtime. She went to school, and there patient experienced severe pain in her right leg accompanied with pain and numbness on her left arm. she said she couldn't move her forearm and her ring and pinky fingers fo a period of about 5 minutes. About an hour later, around 9 to 9:30 a.m. patient had such pain in her right leg that she fell down. That pain was accompanied by spams in her lower leg and in her foot and toes. She could not walk without help and she was taken to the school nurse from where they called patient's mother. Mother picked her up in less than 20 minutes and took her to the ER. No tests (blood nor ultrasound) were performed. She was given Motrin for the pain and was dismissed with instructions to see pediatrician if she  got worse. From Friday through Sunday patient stayed home resting her leg. She had pain on and off and she had difficulty walking most of the weekend. On Monday, May 11, at school, patient's pain got severe again, Mother picked patient up and took her to the pediatrician. Pediatrician ordered blood to be drawn for tests and said she would refer patient to a specialist. On Tuesday, May 12, patient's pain was so severe that she was taken in a wheelchair from the classroom to the nurse's office. Mother picked her up and had to take her home since specialists were not going to see her until the coming week. On Wednesday, May 13, patient had severe pain in the morning while at school, she fell down, Mother picked her up from nurse's office where they had lent her a pair of cruthches to be able to get to the car. Parents called pediatrician to request testing to rule out DVT and parents requested an order for crutches for patient to be able to move around in school. Thursday, May 14, patient was still in pain, and was taken for an ultrasound. No DVT was found. Friday, May 15, patient was able to stay in school with the crutches. Monday, May 18, patient was able to walk most of the day without the crutches. Also, on Monday, May 18, a doctor saw patient. Tuesday, May 19, patient was able to walk without the crutches. Patient still complains on and off of weird feeling in her leg.  6/4/09 Hospital records received DOS 5/7/2009 and 5/18/09. Include bone age radiograph reports fron several prior years. FINAL DIAGNOSIS: Probable post Gardasil vaccination resulting in paresthesias. Post vaccination presents with right knee pain radiating to foot, leg cramps, twisted ankle, left hand tightness, forearm pain, numbness, myalgia, limping, dizziness. Motrin. Tylenol.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Ultrasound scan normal
Clinical narrative: Patient received the HPV vaccine in the late afternoon of Wednesday, May 6, 2009. Early on Thursday morning she woke up with pain in her right leg which had started during bedtime. She went to school, and there patient experienced severe pain in her right leg accompanied with pain and numbness on her left arm. she said she couldn't move her forearm and her ring and pinky fingers fo a period of about 5 minutes. About an hour later, around 9 to 9:30 a.m. patient had such pain in her right leg that she fell down. That pain was accompanied by spams in her lower leg and in her foot and toes. She could not walk without help and she was taken to the school nurse from where they called patient's mother. Mother picked her up in less than 20 minutes and took her to the ER. No tests (blood nor ultrasound) were performed. She was given Motrin for the pain and was dismissed with instructions to see pediatrician if she  got worse. From Friday through Sunday patient stayed home resting her leg. She had pain on and off and she had difficulty walking most of the weekend. On Monday, May 11, at school, patient's pain got severe again, Mother picked patient up and took her to the pediatrician. Pediatrician ordered blood to be drawn for tests and said she would refer patient to a specialist. On Tuesday, May 12, patient's pain was so severe that she was taken in a wheelchair from the classroom to the nurse's office. Mother picked her up and had to take her home since specialists were not going to see her until the coming week. On Wednesday, May 13, patient had severe pain in the morning while at school, she fell down, Mother picked her up from nurse's office where they had lent her a pair of cruthches to be able to get to the car. Parents called pediatrician to request testing to rule out DVT and parents requested an order for crutches for patient to be able to move around in school. Thursday, May 14, patient was still in pain, and was taken for an ultrasound. No DVT was found. Friday, May 15, patient was able to stay in school with the crutches. Monday, May 18, patient was able to walk most of the day without the crutches. Also, on Monday, May 18, a doctor saw patient. Tuesday, May 19, patient was able to walk without the crutches. Patient still complains on and off of weird feeling in her leg.  6/4/09 Hospital records received DOS 5/7/2009 and 5/18/09. Include bone age radiograph reports fron several prior years. FINAL DIAGNOSIS: Probable post Gardasil vaccination resulting in paresthesias. Post vaccination presents with right knee pain radiating to foot, leg cramps, twisted ankle, left hand tightness, forearm pain, numbness, myalgia, limping, dizziness. Motrin. Tylenol.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling cold, Nasal congestion, Oropharyngeal pain, Pruritus, Rash
Clinical narrative: 6 days after receiving VZV#2, felt cold and had sore throat, day 8 or 9 post vaccination, noticed rash to back of neck with itching; 15 days post vaccination, increased sore throat and nasal congestion
Age: 2.0
Sex: M
Vaccine: RAB, TYP
Symptoms: Chest X-ray normal, Feeling hot, Heart rate increased, Influenza serology negative, Streptococcal identification test negative
Clinical narrative: Father reports they were awakened in the middle of the night with patient screaming.  When they went to him, he was very hot, then he immediately started vomiting repeatedly.  After they were able to calm him, they checked his temp and found it was 105 degrees.  The vomiting continued and they could not get any fluids or medication into him.  His mother and a friend took him to the ER while dad stayed with the other children.  Patient also had a heart rate over 200.  He was rehydrated in the ER and tested for flu, pneumonia, and strep  all tests were negative.  The mother was told that by eliminating everything else, the ER staff felt this was likely a reaction to the Typhim vaccine received on 5-19-09 in the afternoon around 2 pm.  His fever is resolved now and he is tolerating fluids.  They have not yet tried solid food, so have coached dad on options which he will try soon.  Child had no localized reaction as of 5/20/09 at 10 am.  Dad was very calm and positive.  Child is up and about without limitations.
Age: 2.0
Sex: M
Vaccine: RAB, TYP
Symptoms: Vomiting
Clinical narrative: Father reports they were awakened in the middle of the night with patient screaming.  When they went to him, he was very hot, then he immediately started vomiting repeatedly.  After they were able to calm him, they checked his temp and found it was 105 degrees.  The vomiting continued and they could not get any fluids or medication into him.  His mother and a friend took him to the ER while dad stayed with the other children.  Patient also had a heart rate over 200.  He was rehydrated in the ER and tested for flu, pneumonia, and strep  all tests were negative.  The mother was told that by eliminating everything else, the ER staff felt this was likely a reaction to the Typhim vaccine received on 5-19-09 in the afternoon around 2 pm.  His fever is resolved now and he is tolerating fluids.  They have not yet tried solid food, so have coached dad on options which he will try soon.  Child had no localized reaction as of 5/20/09 at 10 am.  Dad was very calm and positive.  Child is up and about without limitations.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported that child's entire left thigh was reddened, swollen, and warm to touch within 25 hours of receipt of vaccines. Mom gave motrin and benadryl for 2 days at which time the condition resolved. Child was not irritable, feverish, or limited in activity level.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody positive, Antiphospholipid antibodies negative, Arthralgia, Arthritis, Complement factor C3 decreased
Clinical narrative: Had employee PE 11/10/08. Received flu vaccine, TB test and Hep B vaccine 11/10/08 during employee PE. Then was sent to health Dept. for Tdap-ADACEL (11/12/08).  Patient states approximately 2 or 3 days after the immunization experienced Myalgia and arthralgia i.e. severe bilateral hip and knee joint pain. Took Tylenol. Went to employee health dept for treatment 11/19/08 due to pain. Was in orientation to work at Hospital as a nurses' assistant. Had difficulty performing her job duties as this required lifting, bending, etc. She was evaluated in the health clinic, Emergency Dept 12/09/2008 and Walk-In clinic. Required Prednisone to control symptoms. Sent to Allergy dept for evaluation. I am sending her to Rheumatology for further eval. due to a positive ANA. Literature review has produced several case reports of reactive arthritis after a tetanus immunization. Most resolved within a few weeks on NSAIDS. But a couple case reports were found with prolonged arthritis symptoms after a tetanus report. Patient continues in pain. Is on NSAIDS, put on "light duty" so was essentially "let go" at the job (was in orientation to be a Nursing assistant).
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Complement factor C4 decreased, Full blood count normal, Myalgia, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Had employee PE 11/10/08. Received flu vaccine, TB test and Hep B vaccine 11/10/08 during employee PE. Then was sent to health Dept. for Tdap-ADACEL (11/12/08).  Patient states approximately 2 or 3 days after the immunization experienced Myalgia and arthralgia i.e. severe bilateral hip and knee joint pain. Took Tylenol. Went to employee health dept for treatment 11/19/08 due to pain. Was in orientation to work at Hospital as a nurses' assistant. Had difficulty performing her job duties as this required lifting, bending, etc. She was evaluated in the health clinic, Emergency Dept 12/09/2008 and Walk-In clinic. Required Prednisone to control symptoms. Sent to Allergy dept for evaluation. I am sending her to Rheumatology for further eval. due to a positive ANA. Literature review has produced several case reports of reactive arthritis after a tetanus immunization. Most resolved within a few weeks on NSAIDS. But a couple case reports were found with prolonged arthritis symptoms after a tetanus report. Patient continues in pain. Is on NSAIDS, put on "light duty" so was essentially "let go" at the job (was in orientation to be a Nursing assistant).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Had DTaP and IPV vaccines on 4/29/09, came in to office on 5/1/09 with R leg red, swollen, hot and painful to touch.  Diagnosed with cellulitis and treated with Keflex.
Age: 18.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Injection site pain, Nausea
Clinical narrative: Pain at injection site, difficulty breathing and nausea.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Areflexia, Asthenia, Ataxia, Biopsy muscle, Blood folate normal
Clinical narrative: Within a few months of the vaccination on 12/05/06, I became less stable on my feet, and experienced symptoms of neuropathy including foot drop, loss of muscle strength, loss of reflexes, muscle loss, problems with gait, pain and numbness in feet, and now numbness in hands.  I did not seek medical attention immediately, and, at first, attributed symptoms to old age or low back condition.  I eventually saw my family physician in 8/07 to discuss my symptoms which were continuing to get worse.  In 10/08, I was diagnosed with very severe and very chronic neuropathic disease.  Medical records received 10/4/08 to 10/17/08. Assessment: Progessive weakness of lower extremities and foot drop on the right. Patient presents with numbness, muscle spasm, weakness in legs. Paresthesias and muscle wasting from knees to feet. Dorsiflexor weakness right greated that left. Unable to elevate great toe. Weight loss. Follow-up: Loss of feeling, muscle strength in my hands and feet - nearly disabled, and getting worse as the months go on. Walking now with leg braces.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram, Gait disturbance, Gait disturbance, Hypoaesthesia, Muscle atrophy
Clinical narrative: Within a few months of the vaccination on 12/05/06, I became less stable on my feet, and experienced symptoms of neuropathy including foot drop, loss of muscle strength, loss of reflexes, muscle loss, problems with gait, pain and numbness in feet, and now numbness in hands.  I did not seek medical attention immediately, and, at first, attributed symptoms to old age or low back condition.  I eventually saw my family physician in 8/07 to discuss my symptoms which were continuing to get worse.  In 10/08, I was diagnosed with very severe and very chronic neuropathic disease.  Medical records received 10/4/08 to 10/17/08. Assessment: Progessive weakness of lower extremities and foot drop on the right. Patient presents with numbness, muscle spasm, weakness in legs. Paresthesias and muscle wasting from knees to feet. Dorsiflexor weakness right greated that left. Unable to elevate great toe. Weight loss. Follow-up: Loss of feeling, muscle strength in my hands and feet - nearly disabled, and getting worse as the months go on. Walking now with leg braces.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle spasms, Muscular dystrophy, Muscular weakness, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Within a few months of the vaccination on 12/05/06, I became less stable on my feet, and experienced symptoms of neuropathy including foot drop, loss of muscle strength, loss of reflexes, muscle loss, problems with gait, pain and numbness in feet, and now numbness in hands.  I did not seek medical attention immediately, and, at first, attributed symptoms to old age or low back condition.  I eventually saw my family physician in 8/07 to discuss my symptoms which were continuing to get worse.  In 10/08, I was diagnosed with very severe and very chronic neuropathic disease.  Medical records received 10/4/08 to 10/17/08. Assessment: Progessive weakness of lower extremities and foot drop on the right. Patient presents with numbness, muscle spasm, weakness in legs. Paresthesias and muscle wasting from knees to feet. Dorsiflexor weakness right greated that left. Unable to elevate great toe. Weight loss. Follow-up: Loss of feeling, muscle strength in my hands and feet - nearly disabled, and getting worse as the months go on. Walking now with leg braces.