chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Electrocardiogram normal, Syncope vasovagal
Clinical narrative: Patient had a vasovagal syncopal episode with seizure seconds after receiving the vaccine. Checked blood sugar and BP and EKG and everything looked normal. Observed patient in clinic and no problems after.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Received a Flu shot at pharmacy on October 15th, 2006. Approximately 2 weeks later, I had noticed a tingling sensation I noticed a tingling sensation in my feet and ankles had persisted for 6 weeks. No residual injury noted. Experienced tingling in both feet which had ascended up to my ankles 2 weeks post vaccinated. Sx had resolved December 22nd of same year.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: 7x8 cm slightly rash, erythematous slightly, indurated, pruritic not painful roughly symmetric reaction at injection site and isolated fever? related (afebrile cough from URI).
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Rash erythematous, Urticaria
Clinical narrative: 24 hours after injection was given she developed hives primarily on thigh and buttocks.  Her skin was diffusely erythematous from buttocks to feet, puffy but it spread to knees and thighs though no induration or warmth to skin. Ik was able to arm flat and had joint exam. There were a few urticaria.  No respiration symptoms.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Lichenoid keratosis, Mouth ulceration, Peritonsillar abscess
Clinical narrative: Developed ulcerative lesions in her mouth Aug 06. Treated for peritonsilar abscess with abx. No improvement. Had CT to R10 peritonsilar abscess-negative.  ENT gave dx at Lichen Planus-erosive.  Had tissue bx. Ct and pain report included
Age: 1.48
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: None. Varicella vaccine inadvertently given IM instead of subcutaneous. No actual adverse event occurred.  When I called to discurss the event they said I should report it, but there were no signs or symptoms or problems.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: pt returned to the office on 2/5/07. Pt's parents stated that 2-3 days after the immunization the patient had an itchy rash develop on his left buttock, which turned in to open lesions (pap/vesicles) filled with clear fluid
Age: 2.0
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Pyrexia, Urticaria, White blood cell count
Clinical narrative: 6 cm wheal, fever to 108 lasting 36 hrs
Age: 0.19
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Lethargy, Pyrexia
Clinical narrative: Lethargic and fever x 36 hours.
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: erythema and swelling around injection site of DTap (left thigh) measuring 2 in X 2 in
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Body temperature increased, Culture negative, Psoriasis, Skin lesion, Streptococcal serology negative
Clinical narrative: 8/2/06 104 temperature within a week lesions noted to back, scalp, forehead, ears. Continued to develop new lesions daily. 9/19 Biopsy = Psoriasis. Severe psoriasis from head to toe developed with 1 month of vaccine. Numerous topical med given in addition to UVA light therapy 3 times each week. To date 2/2/07 continues to be severe.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: vaccine given 2/2, the following day noted to have 10 x 10 cm red, indurated area around injection site.  Seen in ER treated, complain itching with Keflex
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying, Screaming
Clinical narrative: 4 month olf woke from nap 4 hours after receiving Pediarix and HIB vaccines.  Proceeded to have screming/crying episode that lasted 3-4 hours.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, Headache, Hydrocephalus, Insomnia, Nasopharyngitis
Clinical narrative: Information has been received from an insurance case manager concerning a 47 year old male with no known allergies and a sinus infection and symptoms related to this infection who on 26 Jun 2006 was vaccinated with a dose of MMR II (lot #647555/0419P) (expiration date 08 Apr 2006). There was no concomitant medication. One month later, on approximately 26 Jul 2006 the patient had massive headaches and other symptoms related to a sinus infection (specific symptoms were unknown). The patient also felt like he had a bad cold. The patient was diagnosed with hydrocephalus. The brain was shunted or drained and there was an over shunting which caused slit ventricles (brain pulling away from the skull). The patient received unspecified treatment to treat the slit ventricles. At the time of the report the patient had not recovered and was still receiving some treatment for the slit ventricles. There were no lab studies performed. The patient still had the headaches and was not able to sleep due to these headaches. It was reported that the patient was taking Ambien to help him sleep. It was reported that a physician other than the treating physician felt that the patient did not have hydrocephalus due to vaccination with MMR II (lot 647555/0419P) although the patient claims he had hydrocephalus from getting MMR II (lot 647555/0419P). The reporter asked for a lot check, a lot check has been requested. There was no product quality complaint involved. Upon internal review the patients hydrocephalus was determined to be an other important medical event. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Shunt malfunction, Sinusitis
Clinical narrative: Information has been received from an insurance case manager concerning a 47 year old male with no known allergies and a sinus infection and symptoms related to this infection who on 26 Jun 2006 was vaccinated with a dose of MMR II (lot #647555/0419P) (expiration date 08 Apr 2006). There was no concomitant medication. One month later, on approximately 26 Jul 2006 the patient had massive headaches and other symptoms related to a sinus infection (specific symptoms were unknown). The patient also felt like he had a bad cold. The patient was diagnosed with hydrocephalus. The brain was shunted or drained and there was an over shunting which caused slit ventricles (brain pulling away from the skull). The patient received unspecified treatment to treat the slit ventricles. At the time of the report the patient had not recovered and was still receiving some treatment for the slit ventricles. There were no lab studies performed. The patient still had the headaches and was not able to sleep due to these headaches. It was reported that the patient was taking Ambien to help him sleep. It was reported that a physician other than the treating physician felt that the patient did not have hydrocephalus due to vaccination with MMR II (lot 647555/0419P) although the patient claims he had hydrocephalus from getting MMR II (lot 647555/0419P). The reporter asked for a lot check, a lot check has been requested. There was no product quality complaint involved. Upon internal review the patients hydrocephalus was determined to be an other important medical event. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Cardiac enzymes, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Patient presented with c/o of chest pain which started on 24 December 2006. The symptoms of pleuritic and positional chest pain continued and on 31December2006 was admitted for observations.  He was evaluated by a cardiologist and was diagnosed with pericarditits related to Smallpox vaccine.  He was discharged on 1Jan2007 with a follow-up on 5January2007. 02/13/07-records received and reviewed for DOS 01/18/07 DC: Pericarditis.
Age: 28.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Full blood count, Laboratory test, Pericarditis, Pleuritic pain
Clinical narrative: Patient presented with c/o of chest pain which started on 24 December 2006. The symptoms of pleuritic and positional chest pain continued and on 31December2006 was admitted for observations.  He was evaluated by a cardiologist and was diagnosed with pericarditits related to Smallpox vaccine.  He was discharged on 1Jan2007 with a follow-up on 5January2007. 02/13/07-records received and reviewed for DOS 01/18/07 DC: Pericarditis.
Age: 5.0
Sex: M
Vaccine: HEP, MMR, OPV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt with 3 day historry of rash and tactile fever for 1 day.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV, PNC
Symptoms: Erythema, Irritability, Pyrexia, Rash, Syncope
Clinical narrative: High fever (105.2F), irritable, faint red rash on face
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Breath sounds abnormal, Erythema, Rash, Rash papular, Rash pruritic
Clinical narrative: APPROXIMATELY 22 HOURS AFTER VACCINATION, THE PTS MOTHER NOTED A RASH ON THE PTS LEGS.  INITIALLY THE RASH WAS ITCHY.  We saw the pt in the office about 24 hours after the dose was given and he had scattered approx 5mm red papules on his trunk.  They had white halos surrounding the erythema.  No vesicles or scabs were noted.  No fever.  The child had no further itching.  the child had had a varivax vaccine on 5/14/98 at 12 months of age without any problem.  But I do note in his chart that he was treated for a diagnosis of allergic respiratory symptoms one week after this initial varicella vaccine on 5/21/98.  He was noted to have rhonchi and a pink right TM.  He was treated with rondec syrup and given albuterol syrup prn.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin nodule, Vomiting
Clinical narrative: Patient had red raised lump and vomitting
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, International normalised ratio, Pain, Tenderness
Clinical narrative: Patient developed redness around injection site from the top of the shoulder extending down to the elbow. Area was sore and tender to the touch. Patient complained of pain on 2/7/07.  Area was still sore on 2/8/07 and was noted to have the above mentioned erythema
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: APPPROX. 1 HR. AFTER VACCINE GIVEN, BEGAN EXPERIENCING JOINT PAIN, ESP. IN NECK THAT PROGRESSED TO HER FINGERS, TOES, LOWER BACK, AND KNEES.  THE FOLLOWING DAY BEGAN DIAPHORESING. ONE AND A HALF DAYS LATER, TEMP 100.8 AND COMPLAINS OF STIFFNESS EVERYWHERE.  HAS TAKEN MOTRIN 800 MG. BUT NOT CONSISTENTLY AND APPLIED HEATING PAD TO AFFECTED JOINTS.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood test, Idiopathic thrombocytopenic purpura
Clinical narrative: Diagnosed with ITP (idiopathic thrombolytic purpura) 2/4/2007, 32 days after administration of Varicella and MMR vaccines.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Computerised tomogram, Coordination abnormal, Guillain-Barre syndrome
Clinical narrative: He started out with severe pain in both arms which progressed to pain with numbnes and tingling. We visited the Emergency room 3 times for the umbearable pain.  On 12/3/2006 he became ataxic along with the pain.  He was admitted to the hospital and 3 days later he was unable to take more than one step.  He was very weak and uncoordinated.  He was sent to hospital where more extensive testing could be done.  He worsened until he could not walk at all and could not even feed himself.  He was diagnosed with Gullian Barre' Syndrome.  2/12/07 Received medical records from transfer facility which reveal patient experienced generalized weakness & was admitted 12/6-12/9/06.  Patient had not been feeling well since Thanksgiving starting with shoulder & extremity pain which persisted & was seen in ER several times.  Received bilateral shoulder injections.  Weakness progressed to point of inability to ambulate & was hospitalized at initial hospital.  Dx & tx at transfer hospital.  Neuro consult done.  Tx w/IVIG.  Had persistent HTN despite meds. D/C to home w/continued home PT & neuro f/u.  No EMG/NCS report included with records.  T/C to hospital to request same. FINAL DX: Guillain Barre syndrome; HTN, poorly controlled; & pneumonia.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain
Clinical narrative: He started out with severe pain in both arms which progressed to pain with numbnes and tingling. We visited the Emergency room 3 times for the umbearable pain.  On 12/3/2006 he became ataxic along with the pain.  He was admitted to the hospital and 3 days later he was unable to take more than one step.  He was very weak and uncoordinated.  He was sent to hospital where more extensive testing could be done.  He worsened until he could not walk at all and could not even feed himself.  He was diagnosed with Gullian Barre' Syndrome.  2/12/07 Received medical records from transfer facility which reveal patient experienced generalized weakness & was admitted 12/6-12/9/06.  Patient had not been feeling well since Thanksgiving starting with shoulder & extremity pain which persisted & was seen in ER several times.  Received bilateral shoulder injections.  Weakness progressed to point of inability to ambulate & was hospitalized at initial hospital.  Dx & tx at transfer hospital.  Neuro consult done.  Tx w/IVIG.  Had persistent HTN despite meds. D/C to home w/continued home PT & neuro f/u.  No EMG/NCS report included with records.  T/C to hospital to request same. FINAL DX: Guillain Barre syndrome; HTN, poorly controlled; & pneumonia.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, X-ray
Clinical narrative: He started out with severe pain in both arms which progressed to pain with numbnes and tingling. We visited the Emergency room 3 times for the umbearable pain.  On 12/3/2006 he became ataxic along with the pain.  He was admitted to the hospital and 3 days later he was unable to take more than one step.  He was very weak and uncoordinated.  He was sent to hospital where more extensive testing could be done.  He worsened until he could not walk at all and could not even feed himself.  He was diagnosed with Gullian Barre' Syndrome.  2/12/07 Received medical records from transfer facility which reveal patient experienced generalized weakness & was admitted 12/6-12/9/06.  Patient had not been feeling well since Thanksgiving starting with shoulder & extremity pain which persisted & was seen in ER several times.  Received bilateral shoulder injections.  Weakness progressed to point of inability to ambulate & was hospitalized at initial hospital.  Dx & tx at transfer hospital.  Neuro consult done.  Tx w/IVIG.  Had persistent HTN despite meds. D/C to home w/continued home PT & neuro f/u.  No EMG/NCS report included with records.  T/C to hospital to request same. FINAL DX: Guillain Barre syndrome; HTN, poorly controlled; & pneumonia.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. recieved DTAP and CHICKENPOX in L leg area on 6 Feb. 07. The area is warm to touch and appr. softball size.  no c/o pain with pt. Pt does c/o itching. Pt was seen by provider and given instructions for what to look for in future and to return if condition worsens.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood creatine phosphokinase normal, Injection site discomfort, Swelling
Clinical narrative: Severe discomfort in L deltoid after injection with resultant swelling througout the deltoid, trapezius and rhomboids
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Joint range of motion decreased, Pain, Swelling
Clinical narrative: Severe discomfort in L deltoid after injection with resultant swelling througout the deltoid, trapezius and rhomboids
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient stated deltoid area was painful and the arm was painful to lift up. No redness or swelling just pain
Age: 23.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Headache, Nausea
Clinical narrative: headache and nausea different than usual migraine for 2 wks beginning day after Gardasil vaccine administration
Age: 23.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Headache, Nausea, Sinusitis
Clinical narrative: headache and nausea different than usual migraine for 2 wks beginning day after Gardasil vaccine administration
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Physical examination, Swelling
Clinical narrative: Redness and swelling left uppr arm, pain to left side of ribs.  Vaccine was given 2/1/07 1500 and symptoms started 02/2/07 Treated with Keflex, symptoms resoloved after 2 doses.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Feeling hot, Induration, Swelling
Clinical narrative: Pt had slightly elevated temperature of 101.4.  The left thigh was warm,red,hard and swollen.  Pt was seen by doctor on 02/08/2007.  Pt was doing better and parent was instructed to give pt antibiotics if symptoms persisted.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Clinical narrative: Initial report received on 30 January 2007 from a health care professional. A five-month-old female patient, who was diagnosed with an "URI" (upper respiratory infection) and diarrhea on 22 January 2007, and was being treated with Rondec DM, nystatin, and "Tylenol products", had received, on 29 January 2007 at 16:00 pm, a second, right leg dose of ActHib,  lot number UF085AA (lot number Z1038-2), a second, left leg, intramuscular injection of Daptacel, lot number C2553AA, a second, left leg of IPOL, lot number Z0326-2, and a second, right leg dose of Prevnar (manufacturer reported), lot number B08672K. The route of administration was not reported for the ActHib, IPOL, and Prevnar vaccines. The patient's pediatrician's office was notified by the coroner that the patient had been found dead by the father sometime in the morning, on January 2007. The patient had no history of birth defects or known allergies. She weighed 4 pounds 11 ounces at birth and has a twin sister. Reportedly, the patient had no adverse events with prior vaccinations. She received her last immunizations (vaccine not provided) on 27 November 2006. No other information surrounding the death was available at the time of this report.  4/7/07 Received Autopsy Report which reveals COD as SIDS.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Foetal non-stress test, Gestational diabetes, No adverse effect, Pregnancy
Clinical narrative: Seriousness criteria Other medically significant. Initial report received from physician on 25 May 2006. A 35 year old pregnant female received the injection of Adacel on 11 Mar 2006. Lot number, route and site of administration was not reported. The patient received the immunization due to having young children at home. The patient has had three full term, viable pregnancies. Last menstrual period was 02 Mar 2006 with expected date of delivery 07 Dec 2006. Per reporter, no adverse event was reported. Follow up information received on 14 Aug 2006 from a health care professional. Adacel, lot number C2384AA, was administered in the left arm. The patient has no past medical problems, but is 35 years old (advanced maternal age). Estimated date of delivery is provided as 06 Dec 2006. Ultrasound, performed on 20 Jul 2006, and nuchal translucency testing, performed on 31 May 2006 were normal. Per the reporter, the patient had not experienced any adverse event. Follow up information received on 25 January 2007. The complete pregnancy report form was received. The patient also received flu vaccine (lot number 69690) on 19 October 2006. she was on prenatal vitamins (for pregnancy, 1/d po) since 1st trimester and insulin (A2 diabetes, 30 UNPH qd) thru 3rd trimester only. The patient did not experience an adverse event. Her current pregnancy history was documented as only advanced maternal age and gestational diabetes. Her pregnancy complication was reported as gestational diabetes. She had an alpha feto protein on 23 June 2006 serologies on 10 May 2006, several fetal non stress tests, several ultrasounds, 1st trimester nuchal screen-all had normal results. There were no complications of labor and/or delivery. The patient gave birth vaginally on 30 November 2006, at 39 gestational weeks, to one male, live child (with no congenial anomaly) who weight 6 lbs 7 oz. A corrective version was created on 05 February 2007 with a latest received date of the previous version (25 January 2007) in order to upgrade the case to serious as based upon the medical information provided on 25 January 2007 (report of gestational diabetes).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Serology normal, Ultrasound scan normal
Clinical narrative: Seriousness criteria Other medically significant. Initial report received from physician on 25 May 2006. A 35 year old pregnant female received the injection of Adacel on 11 Mar 2006. Lot number, route and site of administration was not reported. The patient received the immunization due to having young children at home. The patient has had three full term, viable pregnancies. Last menstrual period was 02 Mar 2006 with expected date of delivery 07 Dec 2006. Per reporter, no adverse event was reported. Follow up information received on 14 Aug 2006 from a health care professional. Adacel, lot number C2384AA, was administered in the left arm. The patient has no past medical problems, but is 35 years old (advanced maternal age). Estimated date of delivery is provided as 06 Dec 2006. Ultrasound, performed on 20 Jul 2006, and nuchal translucency testing, performed on 31 May 2006 were normal. Per the reporter, the patient had not experienced any adverse event. Follow up information received on 25 January 2007. The complete pregnancy report form was received. The patient also received flu vaccine (lot number 69690) on 19 October 2006. she was on prenatal vitamins (for pregnancy, 1/d po) since 1st trimester and insulin (A2 diabetes, 30 UNPH qd) thru 3rd trimester only. The patient did not experience an adverse event. Her current pregnancy history was documented as only advanced maternal age and gestational diabetes. Her pregnancy complication was reported as gestational diabetes. She had an alpha feto protein on 23 June 2006 serologies on 10 May 2006, several fetal non stress tests, several ultrasounds, 1st trimester nuchal screen-all had normal results. There were no complications of labor and/or delivery. The patient gave birth vaginally on 30 November 2006, at 39 gestational weeks, to one male, live child (with no congenial anomaly) who weight 6 lbs 7 oz. A corrective version was created on 05 February 2007 with a latest received date of the previous version (25 January 2007) in order to upgrade the case to serious as based upon the medical information provided on 25 January 2007 (report of gestational diabetes).
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dehydration, Diarrhoea, Dizziness, Dyspnoea, Hepatitis C
Clinical narrative: This case was reported by a consumer and described the occurrence of worsening of hepatitis C virus (unspecified manufacturer) plus a separate injection of hepatitis A vaccine (unspecified manufacturer) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included depression, hepatitis C infection and renal surgery. On 06 February 2007, the subject's medical history also included hepatitis B "25 years ago" and the subject reported that she is "now immune". On an unspecified date the subject initiated therapy with (Cymbalta. On an unspecified date before 31 October 2006, the subject initiated therapy with Ribavirin and Peginterferon alfa-2a (Pegasys). On an unspecified date in November 2006, after 4 weeks of treatment with Ribavirin and Pegasys, hepatitis C viral load was 2 million. On an unspecified date in November 2006 after the blood for the hepatitis C virus titer was drawn, the subject received 1st dose of hepatitis B vaccine and 1st dose of hepatitis A vaccine. On 26 January 2007, approximately 2 months 1st doses of hepatitis B vaccine and hepatitis B vaccine and hepatitis A vaccine, the subject  was seen by a physician and a hepatitis C viral, load was 5 million. Therapy with Cymbalta, Ribavirin, and Pegasys was discontinued. Upon discontinuation of Cymbalta, Ribavirin, and Pegasys, on an unspecified date on or after 26 January 2007 and n or before 06 February 2007, the subject experienced diarrhea, dizziness, dehydration, nausea, shortness of breath (exertion) and feeling faint. The consumer considered the events to be disabling. The outcome of the events was unspecified.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hepatitis C virus, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of worsening of hepatitis C virus (unspecified manufacturer) plus a separate injection of hepatitis A vaccine (unspecified manufacturer) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included depression, hepatitis C infection and renal surgery. On 06 February 2007, the subject's medical history also included hepatitis B "25 years ago" and the subject reported that she is "now immune". On an unspecified date the subject initiated therapy with (Cymbalta. On an unspecified date before 31 October 2006, the subject initiated therapy with Ribavirin and Peginterferon alfa-2a (Pegasys). On an unspecified date in November 2006, after 4 weeks of treatment with Ribavirin and Pegasys, hepatitis C viral load was 2 million. On an unspecified date in November 2006 after the blood for the hepatitis C virus titer was drawn, the subject received 1st dose of hepatitis B vaccine and 1st dose of hepatitis A vaccine. On 26 January 2007, approximately 2 months 1st doses of hepatitis B vaccine and hepatitis B vaccine and hepatitis A vaccine, the subject  was seen by a physician and a hepatitis C viral, load was 5 million. Therapy with Cymbalta, Ribavirin, and Pegasys was discontinued. Upon discontinuation of Cymbalta, Ribavirin, and Pegasys, on an unspecified date on or after 26 January 2007 and n or before 06 February 2007, the subject experienced diarrhea, dizziness, dehydration, nausea, shortness of breath (exertion) and feeling faint. The consumer considered the events to be disabling. The outcome of the events was unspecified.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Gait disturbance, Hypokinesia, Muscle atrophy, Muscular weakness
Clinical narrative: A report was received from a company distributor on 30/Jan/2007 concerning a 27-year-old male vaccinee. No details concerning the vaccinees past medical history or concomitant medications were provided. The vaccinee received Fluvirin vaccine on 22/Oct/2003. A few days post vaccination he developed weakness and impaired sensation in the left leg as well as movement and walking difficulties when difficulties when stepping on that leg. The vaccinee was hospitalized for 7 days between 29/Oct/2003 and 04/Nov/2003, where a series of tests and treatments were performed (not specified). The vaccinee was then discharged with follow medical treatment. The vaccinee continues to experiences to experience impaired sensation, muscle atrophy, and limited movement of the left leg. He has difficulty standing continually, lifting heavy weights, performing strenuous physical actions and ascending or descending stairs or inclines. The reporter considers these events therefore, to be serious and disabling. Further information will be sought.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: A report was received from a company distributor on 30/Jan/2007 concerning a 27-year-old male vaccinee. No details concerning the vaccinees past medical history or concomitant medications were provided. The vaccinee received Fluvirin vaccine on 22/Oct/2003. A few days post vaccination he developed weakness and impaired sensation in the left leg as well as movement and walking difficulties when difficulties when stepping on that leg. The vaccinee was hospitalized for 7 days between 29/Oct/2003 and 04/Nov/2003, where a series of tests and treatments were performed (not specified). The vaccinee was then discharged with follow medical treatment. The vaccinee continues to experiences to experience impaired sensation, muscle atrophy, and limited movement of the left leg. He has difficulty standing continually, lifting heavy weights, performing strenuous physical actions and ascending or descending stairs or inclines. The reporter considers these events therefore, to be serious and disabling. Further information will be sought.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Blindness
Clinical narrative: Gastric problems diarrhea, vomiting, nausea, stomach pain, loss of vision, headache, back pain, sinusitis, migraine, joint pain, lack of sleep, lost weight, skin rash, loss of energy, sexual relationship lack. 02/21/07-records received and reviewed- DX:allergic rhinitis, tobacco use disorder, torticollis, refractive error, pain in joint involving shoulder region, dermatophytosis of groin and perianal area, unspecified gastritis and gastroduodenitis without mention of hemorrhage. Criteria not meet for DX of PTSD but has criteria of depression NOS. MRI right shoulder, posterior capsule thinning and redundancy. no hill sachs or reverse hill sachs evident. small posterior peripheral labral tear. 3/31/2010 Follow up: Still rash in the skin; stomach pain, himpotensia, memory loss and other disease.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Gastric disorder, Headache, Insomnia, Libido decreased
Clinical narrative: Gastric problems diarrhea, vomiting, nausea, stomach pain, loss of vision, headache, back pain, sinusitis, migraine, joint pain, lack of sleep, lost weight, skin rash, loss of energy, sexual relationship lack. 02/21/07-records received and reviewed- DX:allergic rhinitis, tobacco use disorder, torticollis, refractive error, pain in joint involving shoulder region, dermatophytosis of groin and perianal area, unspecified gastritis and gastroduodenitis without mention of hemorrhage. Criteria not meet for DX of PTSD but has criteria of depression NOS. MRI right shoulder, posterior capsule thinning and redundancy. no hill sachs or reverse hill sachs evident. small posterior peripheral labral tear. 3/31/2010 Follow up: Still rash in the skin; stomach pain, himpotensia, memory loss and other disease.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine, Nausea, Rash, Sinusitis, Sleep disorder
Clinical narrative: Gastric problems diarrhea, vomiting, nausea, stomach pain, loss of vision, headache, back pain, sinusitis, migraine, joint pain, lack of sleep, lost weight, skin rash, loss of energy, sexual relationship lack. 02/21/07-records received and reviewed- DX:allergic rhinitis, tobacco use disorder, torticollis, refractive error, pain in joint involving shoulder region, dermatophytosis of groin and perianal area, unspecified gastritis and gastroduodenitis without mention of hemorrhage. Criteria not meet for DX of PTSD but has criteria of depression NOS. MRI right shoulder, posterior capsule thinning and redundancy. no hill sachs or reverse hill sachs evident. small posterior peripheral labral tear. 3/31/2010 Follow up: Still rash in the skin; stomach pain, himpotensia, memory loss and other disease.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Vomiting, Weight decreased
Clinical narrative: Gastric problems diarrhea, vomiting, nausea, stomach pain, loss of vision, headache, back pain, sinusitis, migraine, joint pain, lack of sleep, lost weight, skin rash, loss of energy, sexual relationship lack. 02/21/07-records received and reviewed- DX:allergic rhinitis, tobacco use disorder, torticollis, refractive error, pain in joint involving shoulder region, dermatophytosis of groin and perianal area, unspecified gastritis and gastroduodenitis without mention of hemorrhage. Criteria not meet for DX of PTSD but has criteria of depression NOS. MRI right shoulder, posterior capsule thinning and redundancy. no hill sachs or reverse hill sachs evident. small posterior peripheral labral tear. 3/31/2010 Follow up: Still rash in the skin; stomach pain, himpotensia, memory loss and other disease.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Feeding disorder, Intussusception, Irritability
Clinical narrative: Information has been received from a health professional concerning a 19 week old male, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq vaccine (human-bovine) (lot#"08475 or possibility 08475") on 14-NOV-2006 and 16-JAN-2007, respectively. Concomitant vaccinations administered on 16-JAN-2007 included a dose Pediarix vaccine, a dose of Hib conj vaccine, a dose of Prevnar. Concomitant medication included Axid. On 29-JAN-2007 the patient came into the office cranky and would not take a bottle. The patient was transferred to the hospital on the same day and was admitted for intussusception. At the time of the report the reporter did not have any details about the patient's hospital course or any treatments. No product quality complaint was involved. No other information was provided. Additional information has been requested.   2/9/07 Received info from CDC that patient had symptoms of intermittent pain and lethargy on 1/29/07 with subsequent currant jelly stool.  Barium enema was diagnostic and therapeutic.  Child was observed overnight and discharged.  No specimens available.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Chest X-ray, Computerised tomogram, Convulsion, Laboratory test
Clinical narrative: Infant taken to ER by ENS for seizure activity at home.  Exam, labs and CT of head were done by doctor in the ER.  Infant followed up with doctor and he referred infant to neurologist
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Injection site irritation, Lip exfoliation, Lip swelling, Oedema peripheral
Clinical narrative: C/O burning at injection site, fingers tingling and cold and swollen. Approximately 1 hr after the injection c/o lips swollen and numb. The following day c/o lips peeling. Patient saw her physician later in Nov. No concerns or problems noted.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: C/O burning at injection site, fingers tingling and cold and swollen. Approximately 1 hr after the injection c/o lips swollen and numb. The following day c/o lips peeling. Patient saw her physician later in Nov. No concerns or problems noted.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Inflammation
Clinical narrative: Localized erythema, inflammation, induration.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: 1st fever x 2 days (fever max 102), WBC;s 32.3, bands 10, mono 17 crp 19.5 from 10/26/07, 2nd shots given 1/11/07. Fever started 1/11/07 at 1600, fever max 102 WBC's 33.5.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC
Symptoms: No adverse effect
Clinical narrative: No adverse effects
Age: 1.06
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Break out all over body
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cyanosis, Fatigue, Lethargy, Pallor
Clinical narrative: 3 hours later after immunization had episode of paleness and very tired, chills, cold to touch, than became lethargic, blue lips.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: 3 hours later after immunization had episode of paleness and very tired, chills, cold to touch, than became lethargic, blue lips.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Paraesthesia, Skin nodule
Clinical narrative: Red hard area 13 mm W X 7.5 mm high, warm to touch, resolving from larger area reported by mom in AM.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Swelling
Clinical narrative: Swelling arm to elbow
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral, Pain
Clinical narrative: Pt seen 10:30am swelling and pain noted at day care brought in by grandmother, no history available as to when symptom accured. Rt upper arm swollen, erythematous indurated, tender area. Localized cellulitis 2 hours vaccines. TX with Keflex 250mg TID x 10 Days.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Swelling, Tenderness
Clinical narrative: Pt seen 10:30am swelling and pain noted at day care brought in by grandmother, no history available as to when symptom accured. Rt upper arm swollen, erythematous indurated, tender area. Localized cellulitis 2 hours vaccines. TX with Keflex 250mg TID x 10 Days.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed hives on facial cheeks within a few hours of receiving IZ's. As of next day has intermittent hives increasing on arms, legs, chest and face.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Paraesthesia
Clinical narrative: Left arm swollen, red and warm to touch. MD advised pt to ice site and keep elevated when possible. MD explained to pt that it should subside in a few days.
Age: 0.52
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception, Rash, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 7-month-old male with no medical history or allergies who on 10-AUG-2006, 12-OCT-2006 and 14-DEC-2006 was vaccinated PO with the first, second and third doses, respectively of Rotateq vaccine (human-bovine) (lot#s 65424B/0577F and 655484/1032F - administration dates not specified). There was no concomitant therapy. The CMA reported that on 26-JAN-2007, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by Barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. The CMA also considered the patient's rash and ileocolic intussusception to be life-threatening and other important medical events. Additional information has been requested.  2/22/07 Received medical records from hospital which reveal patient experienced acute onset abdominal pain & vomiting.  Hospitalized from 1/26-1/30/07 after being transferred from outlying hospital.  BE done x3 at outlying hospital revealed intussusception but was unreducible & so subsequently transferred to higher level of care for management.  Air enema done at second hospital also unsuccessful at reducing.  Taken emergently to OR for exp lap & reduction w/appendectomy.  Uneventful recovery & was d/c to home to be f/u w/peds surgeon & PCP. FINAL DX: Ileocolic Intussusception, surgically reduced.
Age: 0.52
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a certified medical assistant concerning a 7-month-old male with no medical history or allergies who on 10-AUG-2006, 12-OCT-2006 and 14-DEC-2006 was vaccinated PO with the first, second and third doses, respectively of Rotateq vaccine (human-bovine) (lot#s 65424B/0577F and 655484/1032F - administration dates not specified). There was no concomitant therapy. The CMA reported that on 26-JAN-2007, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by Barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. The CMA also considered the patient's rash and ileocolic intussusception to be life-threatening and other important medical events. Additional information has been requested.  2/22/07 Received medical records from hospital which reveal patient experienced acute onset abdominal pain & vomiting.  Hospitalized from 1/26-1/30/07 after being transferred from outlying hospital.  BE done x3 at outlying hospital revealed intussusception but was unreducible & so subsequently transferred to higher level of care for management.  Air enema done at second hospital also unsuccessful at reducing.  Taken emergently to OR for exp lap & reduction w/appendectomy.  Uneventful recovery & was d/c to home to be f/u w/peds surgeon & PCP. FINAL DX: Ileocolic Intussusception, surgically reduced.
Age: 0.52
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception, Rash, Surgery, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 7-month-old male with no medical history or allergies who on 10-AUG-2006, 12-OCT-2006 and 14-DEC-2006 was vaccinated PO with the first, second and third doses, respectively of Rotateq vaccine (human-bovine) (lot#s 65424B/0577F and 655484/1032F - administration dates not specified). There was no concomitant therapy. The CMA reported that on 26-JAN-2007, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by Barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. The CMA also considered the patient's rash and ileocolic intussusception to be life-threatening and other important medical events. Additional information has been requested.  2/22/07 Received medical records from hospital which reveal patient experienced acute onset abdominal pain & vomiting.  Hospitalized from 1/26-1/30/07 after being transferred from outlying hospital.  BE done x3 at outlying hospital revealed intussusception but was unreducible & so subsequently transferred to higher level of care for management.  Air enema done at second hospital also unsuccessful at reducing.  Taken emergently to OR for exp lap & reduction w/appendectomy.  Uneventful recovery & was d/c to home to be f/u w/peds surgeon & PCP. FINAL DX: Ileocolic Intussusception, surgically reduced.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Lumbar puncture, Pyrexia
Clinical narrative: Initial report received on 31 January 2007, from other manufacturer. A two month old female patient was enrolled in the prophylactic study that was conducted by the other manufacturer. On 11 July 2006, she received ActHib intra muscular, into the thigh (lot number UE864AA which corresponds to lot number Z0404-2), the first dose rotavirus vaccine  (lot number AROTA033A), and Prevnar, intra muscular into the thigh (lot number AZ5969K). The patients medical history included gastrointestinal reflux disease, since 29 June 2006. She was treated with lansoprazole, 15 mg, orally, from 29 June 2006 to 30 June 2006. On 20 July 2006, nine days post vaccinations and 21 days post first dose of lansoprazole, the patient developed viral syndrome. She had fever (of 3839 Celsius degrees) and was hospitalized. The patient was treated with paracetamol and ceftriaxone sodium (3 doses). Relevant tests on 20 July 2006 included negative lumbar puncture and also negative blood and urine cultures (after 40 hours). No details of relevant assessments were available. On 21 July 2006, she received the second dose of ceftriaxone sodium. The patient was discharged from the hospital on 22 July 2006 after the third dose of ceftriaxone sodium. The event resolved on 22 July 2006. The investigator considered that there was a reasonably possibility that the viral syndrome may have been caused by rotavirus vaccine, Pediarix, Act Hib and Prevnar and that the event was possibly due to the medication lansoprazole and the patients medical condition of the gastrointestinal reflux disease. The investigator also replied that although it was possible that the patient's fever was due to the rotavirus vaccine, he believed that the possibility was quite small and more likely attribute to a viral syndrome. The reporting other manufacturer was requesting more information.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Viral infection
Clinical narrative: Initial report received on 31 January 2007, from other manufacturer. A two month old female patient was enrolled in the prophylactic study that was conducted by the other manufacturer. On 11 July 2006, she received ActHib intra muscular, into the thigh (lot number UE864AA which corresponds to lot number Z0404-2), the first dose rotavirus vaccine  (lot number AROTA033A), and Prevnar, intra muscular into the thigh (lot number AZ5969K). The patients medical history included gastrointestinal reflux disease, since 29 June 2006. She was treated with lansoprazole, 15 mg, orally, from 29 June 2006 to 30 June 2006. On 20 July 2006, nine days post vaccinations and 21 days post first dose of lansoprazole, the patient developed viral syndrome. She had fever (of 3839 Celsius degrees) and was hospitalized. The patient was treated with paracetamol and ceftriaxone sodium (3 doses). Relevant tests on 20 July 2006 included negative lumbar puncture and also negative blood and urine cultures (after 40 hours). No details of relevant assessments were available. On 21 July 2006, she received the second dose of ceftriaxone sodium. The patient was discharged from the hospital on 22 July 2006 after the third dose of ceftriaxone sodium. The event resolved on 22 July 2006. The investigator considered that there was a reasonably possibility that the viral syndrome may have been caused by rotavirus vaccine, Pediarix, Act Hib and Prevnar and that the event was possibly due to the medication lansoprazole and the patients medical condition of the gastrointestinal reflux disease. The investigator also replied that although it was possible that the patient's fever was due to the rotavirus vaccine, he believed that the possibility was quite small and more likely attribute to a viral syndrome. The reporting other manufacturer was requesting more information.