chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Viral infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of viral infection in a subject of unspecified age and gender who was vaccinated with hepatitis A vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown). At an unspecified time after vaccination with Hepatitis A vaccine, the subject experienced viral infection. The healthcare professional considered that this was not an adverse reaction as other family members experienced similar symptoms. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of RECOMBIVAX HB in the past (dates unspecified), is now is showing "negative titers". Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient was not yet recovered.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of RECOMBIVAX HB in the past (dates unspecified), and now is showing "negative titers". Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient was not yet recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with primary series of RECOMBIVAX HB in the past (dates unspecified), and is showing "negative titers". Unspecified medical attention was sought. There was no product quality complaint. At the time reporting the patient was not yet recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of RECOMBIVAX HB in the past (dates unspecified), and now is showing "negative titers". Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient was not yet recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patient mention in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of RECOMBIVAX HB in the past (dates unspecified), and now is showing "negative titers". Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient was not yet recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 29 year old female, with no medical history and no allergies, who on 30-OCT-2007 was vaccinated with a dose of RECOMBIVAX HB. There was no concomitant medication. Two days after the patient received RECOMBIVAX HB, on 01-NOV-2007, the patient broke out with a diffuse rash, on both arms. The physician considered the patient's rash to be related to vaccination with RECOMBIVAX HB. On 08-NOV-2007 the rash was described as in the antecubital area of both arms and slightly better than when the rash started. At the time of the report the patient was recovering. It was reported that the patient went to the physician for follow-up. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a female with an allergy to clindamycin and no medical history, who had received three doses of RECOMBIVAX HB in the past, but when a titer was drawn, it was negative. On 08-FEB-2007, 13-APR-2007, and 23-JUN-2007, the patient was vaccinated with additional "booster" doses of RECOMBIVAX HB (Lot# 6533636/1064 and 653268/0223F). There was no concomitant medication. The patient's titer was drawn again, but it was negative. It was reported that the patient saw the physician. The physician reported that the patient had a vaccine failure. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis allergic, Pruritus, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a physician concerning a 29-year-old (also as 24 and a 30 year old) female with no pertinent medical history or allergies who on 30-OCT-2007 (also reported as 05-NOV-2007 on a barely legible form) was vaccinated with her first dose of RECOMBIVAX HB (lot # 652715/0108U). There were no illness at the time of vaccination. No concomitant medications. On 01-NOV-2007 (also reported as the 06-NOV-2007) (24 hours after vaccination) the patient developed a erythemous macular rash over body, itching in her elbow creases and an allergic rash. The physician states there was no reaction at the injection site. The patient sought unspecified medical attention and was treated with BENADRYL and ZYRTEC and improved. No diagnostic labs were performed. On approximately 15-NOV-2007 (last about 2 weeks) the patient recovered. On an unspecified date the patient was seen by an allergist. A product quality complaint was not involved. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Chills, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 37 year old female 10-NOV-2007, received in her left arm a first dose of RECOMBIVAX HB (lot# 656680/0010). Concomitant therapy included tuberculin purified protein derivative (MANTOUX SKIN TEST) administered in her left arm on 08-NOV-2007. On 10-NOV-2007, the developed body aches, chills and a fever (101 degrees Fahrenheit). No medical attention was sought. It was reported that on 11-NOV-2007, the patient had fully recovered. A product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B surface antigen negative
Clinical narrative: Information has been received from a physician concerning a female who in approximately 1991 was vaccinated with the complete series of RECOMBIVAX HB. In approximately 2007 the patient's recent titer was performed which was negative. The patient sought medical attention in the physician's office. The patient's status was not recovered. There was product quality complaint. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEP, TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning her 17-year-old son with a penicillin allergy and no other pertinent medical history who in May 2007 was vaccinated with a 5 mcg dose of Recombivax HB (lot# 654436/1106F).  Concomitant vaccination included a dose of diphtheria tetanus booster given on the same day as Recombivax HB.  Within 24 hours of vaccination, in May 2007, the patient experienced a fever of 102 F or 103 F and some myalgia.  Unspecified medical attention was sought but no laboratory or diagnostic tests were performed.  It was reported that the patient recovered within 2 or 3 days after the reaction.  No product quality complaint was involved.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 62 year old male who on 14-FEB-2007, 23-MAR-2007 and 10-AUG-2007 was vaccinated IM with his first, second and third 1.0 ml doses of RECOMBIVAX HB. On 14-SEP-2007 the patient had an anti-HBs antibody titer was less than 5 mIU/ml. On 18-SEP-2007 the patient was administered a booster dose of RECOMBIVAX HB. On 18-OCT-2007 the patient had anti-HBs antibody titers that were less than 5 mIU/ml. It was unknown whether medical attention was sought. The outcome was unknown. there was no product quality complaint. NO further information is available.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Serology negative
Clinical narrative: Information has been received from a 59 year old female physician with multiple sclerosis and no known allergies who in 1992 received her first series of Recombivax HB and a second series in 1999 for a total of 6 doses.  There was no concomitant medication.  On 05-NOV-2007, laboratory studies revealed a negative titer.  It was reported that the patient was seen by a physician for unspecified treatment.  At the time of this report, the patient had not recovered.  A product quality complaint was not reported.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Malaise
Clinical narrative: Information has been received from a consumer concerning a 3 week patient who was vaccinated when the baby was few days old with two doses of Recombivax HB 2 days apart.  It was reported that the baby was not feeling well ever since.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Neurological symptom
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with a dose of RECOMBIVAX HB. On that same day, the patient experienced neurological symptoms. The patient contacted the nurse for medical attention. The outcome was unknown. There was no product quality complaint. This is one of two reports from the same patient. Additional information has been requested. This is in follow-up to report(s) previously submitted on 03/07/2008. Follow-up information indicated that the reporting registered nurse had no information about this patient. Additional follow-up information indicated that the reporting registered nurse was knew nothing about the event and the patient was not a patient of their office. This is one of two reports from the same patient. No further information is available.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody, Hepatitis B antibody abnormal
Clinical narrative: Information has been received from a health professional concerning a 29 year old female "first responder" who on approximately 01-JUN-2007 was vaccinated with Recombivax HB.  Six weeks after a complete vaccination series with Recombivax HB, on 25-JUL-2007, the patient had an anti- HBs titer level of 66mIU/mLl.  Four months later, on 15 NOV 2007, an anti- HBs titer level of 6 mIU/mL  The reporter noted it was unclear if the "first responder" had an earlier vaccination series with Recombivax HB or Hep B vaccine.  It was also unclear as to when the Recombivax HB series started.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Recombivax HB. On an unspecified date following vaccination the patient developed hives. On an unspecified date the patient recovered. A product quality complaint was not involved. No further information is available.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 27-year-old female medical student who was vaccinated with a three dose series of Recombivax HB (manufacturer unknown) while in high school.  When her titer levels were checked (on an unspecified date) she was at zero conversion.  The nurse reported that they restarted the series with the patient and when the patient's titer was checked it was at zero and it was checked again after the second dose with the same results.  It was reported that unspecified medical attention was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Multiple sclerosis, Paraesthesia
Clinical narrative: Information has been received regarding a case in litigation concerning a female who on 10-NOV-1995 was vaccinated with a first dose of Recombivax HB, and a second dose on 08 DEC 1995. On 12-APR-1996 the patient was seen by a physician for complaints of pins and needles in her left foot. On 20 APR 1996 the patient was seen by a physician for complaints that "numbness in her foot had crept up her body into her arm". It was reported that in the opinion of a neurologist that the Recombivax HB had caused the patient's atypical MS. It was noted that the onset of the MS was believed to be four months post vaccination with Recombivax HB. Upon internal review multiple sclerosis was considered to be an other medically important event (OME). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain upper, Hypoaesthesia, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Information has been received regarding a case in litigation concerning a patient on 24-JUN-1996 and 29-JUL-1995 was vaccinated with the first and second dose of Recombivax HB (thimerosal containing). On 30-JUL-1996, the day after he received his second dose, the patient reporting tingling, numbness in his feet, and stomach pains. On 31-JUL-1996, the tingling and numbness spread to his knees and his stomach pain continued. On 01-AUG-1996, this spread to his thighs. By the end of that week, tingling and numbness spread to his hips and stomach pain continued. On 20-AUG-1996, the patient was diagnosed with post-immunization neuropathy. On 25-OCT-1996, a magnetic resonance image found "multiple tiny thigh signal lesions in the periventricular white matter", which suggested multiple sclerosis. Upon internal review, multiple sclerosis was considered to be an other important medical event.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Brachial plexopathy, Erythema, Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Information has been received regarding a case in litigation concerning a female with a history of tendonitis, which had resolved in 1996.  At 60 years of age, while working as a nurse, as part of her employment as a nurse, she was vaccinated with a first dose of Recombivax HB on 27-JUL-1999.  Approximately ten days post vaccination, on 5 JUL 2007, the patient reported pain and discomfort in her shoulder for about three weeks, which restricted her range of motion for about two weeks.  The patient received a second dose of Recombivax HB on 30 AUG 1999.  On the following day, 31 AUG 1999 the patient's left arm was swollen, red and hot.  The patient was subsequently diagnosed by a physical medicine and rehabilitation specialist with a brachial plexitis caused by the vaccine.  It was noted that a claim by the patient of carpal tunnel syndrome was reported as not being supported in her medical records.  Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received regarding a case in litigation concerning a female with a history of tendonitis, which had resolved in 1996.  At 60 years of age, while working as a nurse, as part of her employment as a nurse, she was vaccinated with a first dose of Recombivax HB on 27-JUL-1999.  Approximately ten days post vaccination, on 5 JUL 2007, the patient reported pain and discomfort in her shoulder for about three weeks, which restricted her range of motion for about two weeks.  The patient received a second dose of Recombivax HB on 30 AUG 1999.  On the following day, 31 AUG 1999 the patient's left arm was swollen, red and hot.  The patient was subsequently diagnosed by a physical medicine and rehabilitation specialist with a brachial plexitis caused by the vaccine.  It was noted that a claim by the patient of carpal tunnel syndrome was reported as not being supported in her medical records.  Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with RECOMBIVAX HB (Lot # 655148/0005U), instead of hepatitis A virus vaccine inactivated, who reported this was a "staff error only". The nurse stated "the child has received more than three doses of hepatitis B containing vaccine, but has not experienced any adverse effects".  Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Serology negative
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a three dose series of Recombivax HB in 1998 and a titer in 2007 is negative.  No additional information is available.  Unspecified medical attention was sought in the office.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a female patient who was vaccinated with Recombivax HB. Subsequently the patient developed hives. The patient sought medical attention via telephone. Subsequently, the patient recovered from the hives. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female patient in her 40's who was vaccinated with Recombivax HB (Lot # 655871/0570U) 10mcg IM on 05-SEP-2007.  There was no concomitant medication or pertinent medical history.  Within a few days or a week of the vaccination, the patient developed soreness and aches and pain with range of motion of the injected arm.  The patient sought medical attention at the physician's office and was treated with ibuprofen.  The nurse reported that the patient was improving, but the symptoms continued.  Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Aspartate aminotransferase increased
Clinical narrative: Information has been received from a pharmacist concerning a 20 year old male was vaccinated with two doses of RECOMBIVAX HB. Subsequently the patient had a physical exam and bloodwork drawn revealed an increased serum glutamic oxaloacetic transaminase (SGOT) value. The patient sought unspecified medical attention in the office. The patient's increased SGOT persisted. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Mental disorder
Clinical narrative: Information has been received concerning a case in litigation concerning a female patient who was vaccinated with a dose of Recombivax HB on an unspecified date.  Subsequently, the patient experienced a psychological injury.  No outcome information was reported.  No further information is available.
Sex: F
Vaccine: HEP, MMR
Symptoms: Back pain, Dysuria, Multiple sclerosis, Myelitis transverse, Neuropathy peripheral
Clinical narrative: Information has been received regarding a case in litigation for Recombivax HB concerning a female who on 23-MAY-2000 was vaccinated with a dose of Recombivax HB.  Suspect vaccination included a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  Around 10-JUN-2003 the patient developed severe lower back pain and the following day experienced difficulty urinating.  On 20-Jun-2003, she was diagnosed with transverse myelitis, multiple sclerosis and neuropathy, but "different doctors suggested that the patient suffered from different diseases".  Upon internal review, transverse myelitis and multiple sclerosis were considered to be other important medical events.  No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a health professional concerning a patient who on 25-JAN-2006, received his first dose of RECOMBIVAX HB (lot# 651494/0504R). The patient received a second dose on 21-FEB-2006 of RECOMBIVAX HB (lot# 651494/0504R), and his third dose on 26-JUL-2006 (lot#650889/0143R). It was reported that on an unspecified date, that the patient's hepatitis B antibody test was negative. Current patient status was not reported. A product quality complaint was not reported. This is one of three cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a health professional concerning a patient who on 12-APR-2006 received his first dose of Recombivax HB. The patient received a second dose on 19-JUL-2006 of Recombivax HB and the third dose on 19-OCT-2006. It was reported on an unspecified date, that the patient's hepatitis B antibody test was negative. Current patient status was not reported. A product quality complaint was not reported. This is one of three cases from the same source.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female patient in her late 50's who was vaccinated (elsewhere) with a three-dose series of RECOMBIVAX HB. In 2004, she received one additional dose at the reporter's location and developed soreness in the injected arm. The pain perisited for a few months, and the patient sought unspecified medical attention. Subsequently, the patient recovered from the sore arm. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, OPV, DTAP, HIBV, MMR, OPV
Symptoms: Body temperature increased, Deafness
Clinical narrative: This case was received on 01 February 2008 via the scientific literature. Additional information was obtained from the CDC via the VAERS database, under reference number 74150. A four-year-old previously healthy male patient received the following vaccines in April 1995: Tripedia (lot number 4A61075), PedvaxHIB (lot number 0716C), MMRII (lot number 1052A), and Orimune (lot number 0768A). Within two weeks of vaccination, the patient's mother noted a temperature of 100.6 and deterioration in hearing. An evaluation by a otorhinolaryngologist led to the diagnosis of hearing loss. No additional information was available. Follow-up information received on 14 March 2008 from a physician. Per the reporter, he was the author of the publication mentioned above and obtained the case information from VAERS database and other sources. He stated he had no additional information to provide for the patient described in the literature article. No further information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, OPV, DTAP, HIBV, MMR, OPV
Symptoms: Deafness, Pyrexia
Clinical narrative: This case was received on 01 February 2008 via the scientific literature. Additional information was obtained from the CDC via the VAERS database, under reference number 74150. A four-year-old previously healthy male patient received the following vaccines in April 1995: Tripedia (lot number 4A61075), PedvaxHIB (lot number 0716C), MMRII (lot number 1052A), and Orimune (lot number 0768A). Within two weeks of vaccination, the patient's mother noted a temperature of 100.6 and deterioration in hearing. An evaluation by a otorhinolaryngologist led to the diagnosis of hearing loss. No additional information was available. Follow-up information received on 14 March 2008 from a physician. Per the reporter, he was the author of the publication mentioned above and obtained the case information from VAERS database and other sources. He stated he had no additional information to provide for the patient described in the literature article. No further information is expected.
Age: 24.0
Sex: M
Vaccine: FLUN3, FLUN3, MEN
Symptoms: Facial palsy, No therapeutic response
Clinical narrative: 11 days after administration patient started getting right sided facial drooping and numbness, slurring of his speech, and difficulty closing eye completely. DX- Bell's Palsy Tx- Acyclovir 800mg 1 tab daily times 10 days, prednisone 60mg for 3 days then 40mg for 3 days then 20mg for 3 days. Refresh tears and e-mycin ointment. Patching at night.
Age: 24.0
Sex: M
Vaccine: FLUN3, FLUN3, MEN
Symptoms: Dysarthria, Eye disorder, Facial palsy, Full blood count normal, Hypoaesthesia facial
Clinical narrative: 11 days after administration patient started getting right sided facial drooping and numbness, slurring of his speech, and difficulty closing eye completely. DX- Bell's Palsy Tx- Acyclovir 800mg 1 tab daily times 10 days, prednisone 60mg for 3 days then 40mg for 3 days then 20mg for 3 days. Refresh tears and e-mycin ointment. Patching at night.
Age: 24.0
Sex: M
Vaccine: FLUN3, FLUN3, MEN
Symptoms: Laboratory test normal, Liver function test normal, Red blood cell sedimentation rate normal, Syphilis test negative
Clinical narrative: 11 days after administration patient started getting right sided facial drooping and numbness, slurring of his speech, and difficulty closing eye completely. DX- Bell's Palsy Tx- Acyclovir 800mg 1 tab daily times 10 days, prednisone 60mg for 3 days then 40mg for 3 days then 20mg for 3 days. Refresh tears and e-mycin ointment. Patching at night.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA
Symptoms: Biopsy skin, Biopsy skin abnormal, Hyperplasia, Lymphadenectomy, Nodule
Clinical narrative: 10 days after injection of Gardasil developed a supraclavicular lymph node. Received biopsy of same, on 2-8-08.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA
Symptoms: Hyperplasia, Lymphadenopathy
Clinical narrative: 10 days after injection of Gardasil developed a supraclavicular lymph node. Received biopsy of same, on 2-8-08.
Age: 21.0
Sex: M
Vaccine: MEN
Symptoms: Gait disturbance, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 11 March 2008 from a patient.  A 21-year-old male patient reportedly received an injection of Menomune, lot number unknown, in April 1969.  (This product was not licensed by sanofi pasteur until 1981).  Per the reporter, the patient was vaccinated at a military clinic and received approximately six unknown vaccines on that day.  Three to five days post-vaccination, the patient developed a fever of 103.9 degrees Fahrenheit, headache, and rash.  Since that time, the patient has experienced constant stiffness and achiness to the point that he can "barely walk."  At the time of this report, the patient had not recovered.
Age: 21.0
Sex: M
Vaccine: MEN
Symptoms: Rash
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 11 March 2008 from a patient.  A 21-year-old male patient reportedly received an injection of Menomune, lot number unknown, in April 1969.  (This product was not licensed by sanofi pasteur until 1981).  Per the reporter, the patient was vaccinated at a military clinic and received approximately six unknown vaccines on that day.  Three to five days post-vaccination, the patient developed a fever of 103.9 degrees Fahrenheit, headache, and rash.  Since that time, the patient has experienced constant stiffness and achiness to the point that he can "barely walk."  At the time of this report, the patient had not recovered.
Age: 31.0
Sex: F
Vaccine: JEV, RAB, TYP, JEV, RAB
Symptoms: Abdominal pain, Abortion spontaneous, Haemorrhage
Clinical narrative: Initial report received on 11 March 2008 from a health care professional. A 31-year-old female patient, with a history of mitral valve prolapse, had received a second dose, left arm, intramuscular injection of JE-VAX, lot number EJN233B, and a second dose, left deltoid, intramuscular injection of Imovax, lot number A0209-2, both administered on 06 February 2008; and a fourth dose, oral administration of Vivotif, lot number 3001291, on 07 February 2008. The patient also received a left deltoid, intramuscular injection of Adacel, lot number C2864AA.; a left arm, intramuscular injection of IPOL, lot number A0170-2; a left arm, intramuscular injection of MMR vaccine, lot number 1312U; a right deltoid, intramuscular injection of Fluarix, lot number AFLUA303AA; and a right deltoid, intramuscular injection of Twinrix, lot number AHABBLOOA; on 30 January 2008. The patient's last menstrual period was 20 January 2008. Twenty-two days following the 06 February 2008 immunizations (and 29 days following the 30 January 2008 immunizations), the patient developed abdominal cramping and bleeding with "large pieces of tissue." She was examined by an obstetrician and diagnosed with a miscarriage. Relevant diagnostic testing was reported as none. Concomitant medications included vitamins and aspirin. The patient subsequently recovered from the event.
Age: 31.0
Sex: F
Vaccine: JEV, RAB, TYP, JEV, RAB
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Initial report received on 11 March 2008 from a health care professional. A 31-year-old female patient, with a history of mitral valve prolapse, had received a second dose, left arm, intramuscular injection of JE-VAX, lot number EJN233B, and a second dose, left deltoid, intramuscular injection of Imovax, lot number A0209-2, both administered on 06 February 2008; and a fourth dose, oral administration of Vivotif, lot number 3001291, on 07 February 2008. The patient also received a left deltoid, intramuscular injection of Adacel, lot number C2864AA.; a left arm, intramuscular injection of IPOL, lot number A0170-2; a left arm, intramuscular injection of MMR vaccine, lot number 1312U; a right deltoid, intramuscular injection of Fluarix, lot number AFLUA303AA; and a right deltoid, intramuscular injection of Twinrix, lot number AHABBLOOA; on 30 January 2008. The patient's last menstrual period was 20 January 2008. Twenty-two days following the 06 February 2008 immunizations (and 29 days following the 30 January 2008 immunizations), the patient developed abdominal cramping and bleeding with "large pieces of tissue." She was examined by an obstetrician and diagnosed with a miscarriage. Relevant diagnostic testing was reported as none. Concomitant medications included vitamins and aspirin. The patient subsequently recovered from the event.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site oedema, Injection site pruritus, Injection site rash
Clinical narrative: At 4" oval of mild edema, rash, itch at injection site.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: TIC received from clients father stating that pt. formed a rash thru the night.  States that she has small red bumps on bilat forearms, hands & L thigh, reports no fever, reports itching.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Bacteria urine identified, Band neutrophil percentage, Basophil count normal
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Basophil percentage, Bilirubin urine, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose increased
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Blood urine absent, CSF culture negative
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: CSF glucose normal, CSF protein normal, CSF white blood cell count negative, Carbon dioxide normal, Chest X-ray normal
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Computerised tomogram normal, Culture urine negative, Eosinophil count normal, Eosinophil percentage
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Glomerular filtration rate normal, Glucose urine absent, Gram stain negative, Granulocyte count increased, Granulocytes abnormal
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Haematocrit normal, Haemoglobin normal, Headache, Injection site rash, Injection site swelling
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Lumbar puncture normal, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Monocyte percentage, Neutrophil percentage increased
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Nitrite urine absent, Pain, Platelet count normal, Protein total normal, Protein urine absent
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Red blood cell count normal, Red blood cells CSF positive, Red blood cells urine, Red cell distribution width normal
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Specific gravity urine normal, Urine ketone body present, Urine leukocyte esterase, Urobilin urine, White blood cell count increased
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: White blood cells urine positive, pH urine normal
Clinical narrative: Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Convulsion
Clinical narrative: Seizure
Age: 55.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ
Symptoms: Erythema, Inappropriate schedule of drug administration, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: 3-5-08; Call from patient to report much itching of left arm.  Was given Hepatitis B and Menactra in left arm yesterday, about 1200.  Itching began about 10 pm last night, no rash or redness noted at site.  "Scratching it doesn't help."  also reports swelling that began about 5 PM, swelling begins at "top of shoulder and goes about 4 inches down my arm".  On questioning she reports pain in left arm at "7" last PM and "5" this AM (0=no pain and 10 is worst imaginable pain).  Denies fever, hives, diff breathing.  Has not done any home care.  Recommended home care of Tylenol/ibuprofen for pain, cold compresses for swelling/itching and Benadryl when home tonight and no longer driving.  3-5-08; 1715; Call to patient to evaluate symptoms at this time.  She took ibuprofen and "it was helpful" but has not been able to do any cold compresses or Benadryl since she is still at work.  Reports itching persists and again recommended home care of cold compresses and Benadryl when she arrives home this PM.  3-6-08; 1645; after several calls to/from each other I was able to talk to patient at this time and learned that this AM she had swelling of her left leg, extending to the knee.  The leg swelling is less this afternoon than it was this AM.  She reports that she continues to have swelling of the left arm extending to her elbow with arm hot to touch and redness "because skin is so tight; I am able to see my elbow today".  Also reports no fever and "I feel fine."  Has used ice "most of day" and Benadryl cream on arm and itching has resolved.  Recommended to continue ice for 20 minute periods every 2-3 hours, leg elevation at home, and oral Benadryl after getting home tonight.  Also advised that if any new, changed, or worse symptoms, she should be evaluated at UC, ER, or PCP's office.  3-6-08; 1705; Above symptoms reported to Dr.  Patient notified that she should contact her PCP, or go to a UC or ER for evaluation of new symptoms.  She verbalized good understanding of this instruction.  3-7-08; 1345; Call to patient to evaluate symptoms.  She reports that she did not go to any medical facilities last pm and used ice on swollen areas.  At this time she reports that upper leg swelling is nearly gone and that her left arm is much improved; arm remains warm to touch, and swelling now extends to above elbow.  She also states that she "feels good" and is able to do all ADL's with full range of motion of all extremities.  Advised/requested to call if any new, changed, or worse symptoms and to seek medical care if anything occurs over the weekend.  Good understanding verbalized.  3-14-08 - Pt. has gone on foreign travel; unavailable for further travel.
Age: 55.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ
Symptoms: Pruritus, Skin tightness, Skin warm
Clinical narrative: 3-5-08; Call from patient to report much itching of left arm.  Was given Hepatitis B and Menactra in left arm yesterday, about 1200.  Itching began about 10 pm last night, no rash or redness noted at site.  "Scratching it doesn't help."  also reports swelling that began about 5 PM, swelling begins at "top of shoulder and goes about 4 inches down my arm".  On questioning she reports pain in left arm at "7" last PM and "5" this AM (0=no pain and 10 is worst imaginable pain).  Denies fever, hives, diff breathing.  Has not done any home care.  Recommended home care of Tylenol/ibuprofen for pain, cold compresses for swelling/itching and Benadryl when home tonight and no longer driving.  3-5-08; 1715; Call to patient to evaluate symptoms at this time.  She took ibuprofen and "it was helpful" but has not been able to do any cold compresses or Benadryl since she is still at work.  Reports itching persists and again recommended home care of cold compresses and Benadryl when she arrives home this PM.  3-6-08; 1645; after several calls to/from each other I was able to talk to patient at this time and learned that this AM she had swelling of her left leg, extending to the knee.  The leg swelling is less this afternoon than it was this AM.  She reports that she continues to have swelling of the left arm extending to her elbow with arm hot to touch and redness "because skin is so tight; I am able to see my elbow today".  Also reports no fever and "I feel fine."  Has used ice "most of day" and Benadryl cream on arm and itching has resolved.  Recommended to continue ice for 20 minute periods every 2-3 hours, leg elevation at home, and oral Benadryl after getting home tonight.  Also advised that if any new, changed, or worse symptoms, she should be evaluated at UC, ER, or PCP's office.  3-6-08; 1705; Above symptoms reported to Dr.  Patient notified that she should contact her PCP, or go to a UC or ER for evaluation of new symptoms.  She verbalized good understanding of this instruction.  3-7-08; 1345; Call to patient to evaluate symptoms.  She reports that she did not go to any medical facilities last pm and used ice on swollen areas.  At this time she reports that upper leg swelling is nearly gone and that her left arm is much improved; arm remains warm to touch, and swelling now extends to above elbow.  She also states that she "feels good" and is able to do all ADL's with full range of motion of all extremities.  Advised/requested to call if any new, changed, or worse symptoms and to seek medical care if anything occurs over the weekend.  Good understanding verbalized.  3-14-08 - Pt. has gone on foreign travel; unavailable for further travel.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Tired next am, fever 3/11/08.  Arm swollen, upper L deltoid - warm to touch, painful.
Age: 0.1
Sex: F
Vaccine: DTP, IPV
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: No adverse effects; Examined by Dr.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Left arm, upper, red, swollen; Treated for cellulitis (Keflex 250/5 1 tsp qid x 10d)
Age: 32.0
Sex: F
Vaccine: MMR, TD
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: Pt states he has she has numbness R arm from deltoid area up to neck and from deltoid area to wrist.  Pt advised to seek medical attention now, from Dr. or other provider.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Blood uric acid increased, Carpal tunnel syndrome, Depression, Erectile dysfunction
Clinical narrative: Erectile Disorder, High Blood Pressure, Sleep Apnea, Obstructive, Sleeping Disorder, Herniated Nucleus Pulpous with Myelopathy, Radiculopathy, Discogenic Syndrome, Osteo arthritis- poly joint, Carpal tunel, Palindromic Rheumatism (knee/patella/tibia/ fibula), Sinusitis, gastritis, Depression and Anxiety; High levels of uric acid
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Gastritis, Hypertension, Intervertebral disc disorder, Intervertebral disc protrusion, Myelopathy
Clinical narrative: Erectile Disorder, High Blood Pressure, Sleep Apnea, Obstructive, Sleeping Disorder, Herniated Nucleus Pulpous with Myelopathy, Radiculopathy, Discogenic Syndrome, Osteo arthritis- poly joint, Carpal tunel, Palindromic Rheumatism (knee/patella/tibia/ fibula), Sinusitis, gastritis, Depression and Anxiety; High levels of uric acid
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Osteoarthritis, Palindromic rheumatism, Radiculopathy, Sinusitis, Sleep apnoea syndrome
Clinical narrative: Erectile Disorder, High Blood Pressure, Sleep Apnea, Obstructive, Sleeping Disorder, Herniated Nucleus Pulpous with Myelopathy, Radiculopathy, Discogenic Syndrome, Osteo arthritis- poly joint, Carpal tunel, Palindromic Rheumatism (knee/patella/tibia/ fibula), Sinusitis, gastritis, Depression and Anxiety; High levels of uric acid
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: Erectile Disorder, High Blood Pressure, Sleep Apnea, Obstructive, Sleeping Disorder, Herniated Nucleus Pulpous with Myelopathy, Radiculopathy, Discogenic Syndrome, Osteo arthritis- poly joint, Carpal tunel, Palindromic Rheumatism (knee/patella/tibia/ fibula), Sinusitis, gastritis, Depression and Anxiety; High levels of uric acid
Sex: U
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling and itching of right thigh with both vaccines given in thigh
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Mother reports "golf ball size" lump in left deltoid area where Hep A #1 was given on 3/11/08-Area is hard and sore to touch, warm and red; swelling began on 3/13/08. No other problems reported.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Mother reports "golf ball size" lump in left deltoid area where Hep A #1 was given on 3/11/08-Area is hard and sore to touch, warm and red; swelling began on 3/13/08. No other problems reported.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Malaise, Pruritus, Swelling face, Throat irritation
Clinical narrative: Teacher was given the vaccine on Friday 3/7/08 at 3:00pm by late Friday night to early Saturday morning teacher awoke not feeling well had a very itchy throat.  By late Saturday early Sunday the right side of her face was red puffy and itchy.  On Monday morning I saw the teacher she told be about the the symptoms/ reaction she had over the weekend.  I observed a red splotch in my opinion a hive on her face under her right eye.  She stated that the splotch itched.  I spoke with her at the end of the day she stated that the swelling was getting better, but she was still very itchy.  I advised her to take some Benadryl once she got home.  I spoke with the teacher again on Tuesday she stated that the Benadryl had helped and the red spot was gone.  I spoke with the health dept. about the possible reaction and they advised against future inoculation.