chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Carbon dioxide abnormal, Chest discomfort, Chest pain, Cytomegalovirus antibody negative, Electrocardiogram
Clinical narrative: The pt received AVA #4 on 8/8/08. On 9/2/08 at 0400 the pt woke with severe substernal chest pain (10/10). The pain was worse lying supine, with deep breaths and activity. The patient was constant but decreased to a 5/10 when sitting up or resting. At 2300 the pt reported to medical. EKG and CXR reported as normal. The pt was Medevac'd and evaluated on 9/3/09. The medical record indicates neg Troponin and D-dimer, EKG: NSR, normal CXR and ECHO wnl (see below). The pt was diagnosed with chest wall pain of non-cardiac origin. On 9/5/09 the pt complained of tightness in his chest that was worse when lying supine and with deep inspiration. The records also indicate that the patient had an URI for 3 days (since 9/2/08). The pt was diagnosed with pleurisy and treated with Toradol and Naprosyn bid. On 9/7/09 the pt was seen for 10/10 chest pain worse with lying supine and deep inspirations; transferred to another facility; diagnosed with Pericarditis; treated with Indocin and Colchicine; and had repeat ECHO (see below). The pt was discharged on 9/10/09 to his duty station. The pt was seen by cardiology on 9/15 and the pt reported intermittent sharp positional chest pain. The pt was placed on light duty for 30 days and instructed to continue the Indocin and Colchicine (Instructed to stop 2 weeks following symptoms resolution). ECHO was repeated (see below). The pt followed up with Cardiology on 10/31/09 and reported occasional chest pain with maximal activity. The pt was returned to full duty without restriction and "worldwide deployable".
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count normal, HIV antibody negative, Herpes simplex serology positive, Musculoskeletal chest pain, Pericarditis
Clinical narrative: The pt received AVA #4 on 8/8/08. On 9/2/08 at 0400 the pt woke with severe substernal chest pain (10/10). The pain was worse lying supine, with deep breaths and activity. The patient was constant but decreased to a 5/10 when sitting up or resting. At 2300 the pt reported to medical. EKG and CXR reported as normal. The pt was Medevac'd and evaluated on 9/3/09. The medical record indicates neg Troponin and D-dimer, EKG: NSR, normal CXR and ECHO wnl (see below). The pt was diagnosed with chest wall pain of non-cardiac origin. On 9/5/09 the pt complained of tightness in his chest that was worse when lying supine and with deep inspiration. The records also indicate that the patient had an URI for 3 days (since 9/2/08). The pt was diagnosed with pleurisy and treated with Toradol and Naprosyn bid. On 9/7/09 the pt was seen for 10/10 chest pain worse with lying supine and deep inspirations; transferred to another facility; diagnosed with Pericarditis; treated with Indocin and Colchicine; and had repeat ECHO (see below). The pt was discharged on 9/10/09 to his duty station. The pt was seen by cardiology on 9/15 and the pt reported intermittent sharp positional chest pain. The pt was placed on light duty for 30 days and instructed to continue the Indocin and Colchicine (Instructed to stop 2 weeks following symptoms resolution). ECHO was repeated (see below). The pt followed up with Cardiology on 10/31/09 and reported occasional chest pain with maximal activity. The pt was returned to full duty without restriction and "worldwide deployable".
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Pleurisy, Protein total decreased, Troponin I, Upper respiratory tract infection
Clinical narrative: The pt received AVA #4 on 8/8/08. On 9/2/08 at 0400 the pt woke with severe substernal chest pain (10/10). The pain was worse lying supine, with deep breaths and activity. The patient was constant but decreased to a 5/10 when sitting up or resting. At 2300 the pt reported to medical. EKG and CXR reported as normal. The pt was Medevac'd and evaluated on 9/3/09. The medical record indicates neg Troponin and D-dimer, EKG: NSR, normal CXR and ECHO wnl (see below). The pt was diagnosed with chest wall pain of non-cardiac origin. On 9/5/09 the pt complained of tightness in his chest that was worse when lying supine and with deep inspiration. The records also indicate that the patient had an URI for 3 days (since 9/2/08). The pt was diagnosed with pleurisy and treated with Toradol and Naprosyn bid. On 9/7/09 the pt was seen for 10/10 chest pain worse with lying supine and deep inspirations; transferred to another facility; diagnosed with Pericarditis; treated with Indocin and Colchicine; and had repeat ECHO (see below). The pt was discharged on 9/10/09 to his duty station. The pt was seen by cardiology on 9/15 and the pt reported intermittent sharp positional chest pain. The pt was placed on light duty for 30 days and instructed to continue the Indocin and Colchicine (Instructed to stop 2 weeks following symptoms resolution). ECHO was repeated (see below). The pt followed up with Cardiology on 10/31/09 and reported occasional chest pain with maximal activity. The pt was returned to full duty without restriction and "worldwide deployable".
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Erythema, Injection site irritation, Injection site pain, Oedema peripheral
Clinical narrative: Pt received injection on 3/18/09. Came in to pharmacy to report on 3/26/09. On 3/18/09 got dark red on left arm to elbow. Pain and burning. About 3/19/09 4-5 am got SOB, she called Medwatch. Went in on Friday to her doctor and got Cephalexin 500 mg qid x 10 days, when came in on 3/26/09 to report to me, arm was clear. Arm also had itchiness.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Pt received injection on 3/18/09. Came in to pharmacy to report on 3/26/09. On 3/18/09 got dark red on left arm to elbow. Pain and burning. About 3/19/09 4-5 am got SOB, she called Medwatch. Went in on Friday to her doctor and got Cephalexin 500 mg qid x 10 days, when came in on 3/26/09 to report to me, arm was clear. Arm also had itchiness.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Dyspnoea, Erythema, Pain, Pruritus
Clinical narrative: Pt received injection on 3/18/09. Came in to pharmacy to report on 3/26/09. On 3/18/09 got dark red on left arm to elbow. Pain and burning. About 3/19/09 4-5 am got SOB, she called Medwatch. Went in on Friday to her doctor and got Cephalexin 500 mg qid x 10 days, when came in on 3/26/09 to report to me, arm was clear. Arm also had itchiness.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Bacterial DNA test, Bronchial obstruction, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: Received GARDASIL vaccine mid Nov 08. Started OCPS 2 weeks later in Dec 08 and then received 2nd GARDASIL vaccine. During this time period she noted lower extremity pain, cough and chest pain treated with antibiotics. Symptoms continued. Feb 09 CTA with pulmonary embolic.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Factor V Leiden mutation, Heart valve incompetence, Pulmonary embolism, Right ventricular dysfunction, X-ray
Clinical narrative: Received GARDASIL vaccine mid Nov 08. Started OCPS 2 weeks later in Dec 08 and then received 2nd GARDASIL vaccine. During this time period she noted lower extremity pain, cough and chest pain treated with antibiotics. Symptoms continued. Feb 09 CTA with pulmonary embolic.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Chest pain, Cough, Factor V Leiden mutation, Pain in extremity, Pulmonary embolism
Clinical narrative: Received GARDASIL vaccine mid Nov 08. Started OCPS 2 weeks later in Dec 08 and then received 2nd GARDASIL vaccine. During this time period she noted lower extremity pain, cough and chest pain treated with antibiotics. Symptoms continued. Feb 09 CTA with pulmonary embolic.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Factor V Leiden mutation, Haematocrit, Unevaluable event
Clinical narrative: Received GARDASIL vaccine mid Nov 08. Started OCPS 2 weeks later in Dec 08 and then received 2nd GARDASIL vaccine. During this time period she noted lower extremity pain, cough and chest pain treated with antibiotics. Symptoms continued. Feb 09 CTA with pulmonary embolic.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: April 7,2009 employee came in to clinic reporting right arm where tdap was adminstired for the last week was red, swollen,and painful at site of injection with tingleing down her arms to fingers for the past week. No signs of reaction at present time. Patient stated took Ibuprofen through out pass week. Recommend ibuprofen prn
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt developed erythrematous local swelling at injection site.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Acute generalised exanthematous pustulosis
Clinical narrative: Non-viral Pustulosis.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood human chorionic gonadotropin, Blood thyroid stimulating hormone, Fatigue, Full blood count, Nausea
Clinical narrative: Nausea, fatigue for one week after vaccine administration. Seen in clinic on 04/14/09. Afebrile, WT 150#, BP 130/67. HEENT-negative, abdomen soft, non-tender, no masses. Patient current on depo provera.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Fatigue, Nausea
Clinical narrative: Nausea, fatigue for one week after vaccine administration. Seen in clinic on 04/14/09. Afebrile, WT 150#, BP 130/67. HEENT-negative, abdomen soft, non-tender, no masses. Patient current on depo provera.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness, swelling around injection site.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, PPV, VARCEL, DTAP, HEP, IPV, MMR, PPV, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, MMR, PPV, VARCEL, DTAP, HEP, IPV, MMR, PPV, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Intensive care
Clinical narrative: Apnea episodes on day after receiving vaccines requiring transport to PEDS ICU. 05/04/09 - Hospital medical records for 03/17/2007 to 03/23/2007. FINAL DX: apnea and prematurity Records reveal that patient experienced an episode of apnea. On admission the patient received a full septic workup. All labs remained negative or normal through time of discharge.  Although EEG demonstrated a right temporal spike, it was not considered indicative of seizures, however phenobarbital was prescribed to be continued post discharge.  The child remained afebrile. An episode of hypothermia was attributed to the cold MRI suite.  The patient was stable upon discharge and was to be followed up by a pediatrician in one week and a pediatric neurologist in two months.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Rotateq started after 12 weeks.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Full blood count, Injection site macule, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: 03/28/07 Pt. developed red rash all over;itching;14x10 cm red macular rash at injection site on left leg;large erythemous patches on chest, back and abdomen;ears red- given benadryl and clarinex
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Streptococcal identification test negative
Clinical narrative: 03/28/07 Pt. developed red rash all over;itching;14x10 cm red macular rash at injection site on left leg;large erythemous patches on chest, back and abdomen;ears red- given benadryl and clarinex
Age: 1.25
Sex: U
Vaccine: MMR, PNC
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Redness and hives at injection site within 30 minutes of vaccine administration.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Patient isolation, Rash, Rash vesicular, Respiratory disorder
Clinical narrative: On 04/07/09 pt. presented to the office with a rash for 1 day.Exam reveiled approx. 100 vesicular lesions scattered about, primarily on the torso. Mild upper respiratory symptoms.Afebrile.Tx.Aveeno bathes. Benadryl.Tylenol.Isolation.No ASA.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: lightheaded, dizzy, especially when standing up, started within 30 min. of vaccination, lasted about 5 days
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Dysgeusia, Euphoric mood, Palpitations, Parosmia
Clinical narrative: Onset of signs/symptoms approximately one hour following Tdap immunization.  Patient experienced visual disturbances, including blurry vision, Euphoria, Abnormal taste in mouth, abnormal smells, anxiety, feeling as though heart was racing, but normocardic. No treatment necessary.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Onset of signs/symptoms approximately one hour following Tdap immunization.  Patient experienced visual disturbances, including blurry vision, Euphoria, Abnormal taste in mouth, abnormal smells, anxiety, feeling as though heart was racing, but normocardic. No treatment necessary.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: REQUIRED MD VISIT.2 DAYS S/P VACCINE ADMIN OF TDAP, PT SEEN FOR REDNESS/TENDERNESS, GIVEN KEFLEX RX.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, HEPA, MMRV, VARCEL
Symptoms: Anorexia, Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Received call from mom @ 1:29 stating "my son got shots at Southside yesterday now he has a rash all over his body and a fever."  Mom asked what the rash looked like just states "red".  "He keeps scratching", mom asked if she has given any Benadryl and if child is having any trouble breathing.  Mom states " yes I gave Benadryl, no trouble breathing." Asked mom if child still eating and drinking, mom states "not eating but drinking." Mom encouraged to keep child drinking, seek care of primary physician if uncomfortable. Mom was also encouraged to read VIS form as these two symptoms can be mild problems of the MMR vaccine.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area where varicella (RA-SQ) became very reddened, tender and swollen to the size of a silver dollar.  Parent was going to take child to MD for evaluation.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode about 5-10 minutes after receiving Menactra and Gardasil in L arm and TDaP in R.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV1
Symptoms: Rash generalised
Clinical narrative: RASH ALL OVER THE BODY 2 HOURS AFTER VACCINE ADMINISTRATION.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Unintended pregnancy
Clinical narrative: UNPLANNED PREGNANCY
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Urticaria
Clinical narrative: SYSTEMIC URTICARIAL RASH A FEW HOURS AFTER PREVNAR AND PEDIARIX VACCINES.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Red and indurated area on left deltoid at site of Administration approx 4 X 4 inches.  Associated pruritis
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Rash generalised
Clinical narrative: PATIENT REFERS HAVING A RASH ALL OVER THE BODY AND A RED EYE.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Administration site reaction.  2 inch raised welt, red, warm to the touch, painful.  Began 12-18 hours after vaccination, slowly resolved on its own over the course of 2 weeks.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Nausea, Skin discolouration, Vomiting
Clinical narrative: Developed nausea and vomiting after leaving clinic.  Resolved day following injection.  Reported soreness at injection site.  Red skin discoloration 4 x 4 inch in size with multiple interrruptions in distribution.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: Unconsolable crying for several hours continuously.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture
Clinical narrative: Patient developed Guillan Bare syndrome, 4 days after the vaccination.  4/22/09 MR received for DOS 10/29-11/17/2008 with D/C DX:  Guillain-Barre Syndrome.  Non-Hodgkin's Lymphoma controlled with chemotherapy and radiation.  Pancytopenia r/t tx for Hodgkin's Lymphoma.  Pt initially presented to PCP on 10/13/08 with c/o L arm weakness x 8 days. Pt had recently been treated with radiation to the L axilla. Initially thought to be a radiation plexitis. Some improvement in pain level with steroids, none in weakness. Returned 10/28/08 with c/o profound lower and upper extremity weakness.  By 10/29/08 unable to stand or walk.  Admitted after (+) EMG/NCS in office. PE (+) for weakness in upper and lower extremities, areflexia, and brisk knee jerks. Tx with plasmapheresis w/o improvement. Developed bladder retention with Foley cath insertion. Unable to use IVIG due to low IgA level. Some improvement by d/c to rehab on 11/17/08.  4/28/09 Received Neuro consult of 10/13/08-2/19/09. FINAL DX: acute demyelinating inflammatory polyneuropathy, slowly resolving Records reveal patient experienced abrupt onset profound weakness of left arm x 1 wk prior to initial eval & beginning approx 2 days s/p radiation tx.  Tx w/steroids & referred for MRI.  Developed weakness of all 4 extremities within about 2 wks.  Subsequently hospitalized as above for GBS & inpatient rehab.  Returned to Neuro 2/19/09.  Remained areflexic & profoundly weak LUE & LLE.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea
Clinical narrative: Patient experienced 5-6 bouts of diarrhea within 10 months of vaccination.  After she was about 18 mo the bouts of diarrhea seemed to stop.  She was totally breastfed until she was twelve 11 months old, and she was not in any sort of childcare outside of the home, norr was her older sister, yet she kept getting 3-4 day diarrhea viruses.  As of today she has no food allergies, I am convinced it is vaccine related.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of hepatitis A antibody negative in an adult male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates in 2009, the subject received 1st and 2nd doses of TWINRIX. On 11 March 2009 the subject received the 3rd dose of TWINRIX (unknown, standard dosing). The subject received the TWINRIX on a 0, 7 and 21 day schedule. Eleven days after the 3rd dose of TWINRIX, hepatitis A and hepatitis B titers were drawn and were negative. Follow-up information was received from the reporting physician on 07 April 2009. The physician considered that the events could have been associated with lack of efficacy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling at the injection site.  Took BENADRYL and used ice packs.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: None. WNL.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Vaccine given in Left deltoid.  Redness, swelling, warm to touch.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh redness/swelling/tender 4 hours after injection.  TYLENOL/BENADRYL/cool compress resolved in a hour after TYLENOL/BENADRYL
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain in extremity, Pruritus
Clinical narrative: Pt. called @ 11:10 A on 4-13-09 and reports. " I think I have shingles" describes as dime size water blisters to R arm and under R arm, painful. C/O area itchy. Started on 4-9-09. Instructed to use BENADRYL PO or cream for itchiness and see PCP today. Has long health history O2 dependent r/t emphysema. Pt unhappy returned to PCP. Encouraged to do so to get meds, etc. if needed. Follow up - 4-14-09 10:15 AM - saw provider @ Clinic received - Hydrocodone/APAP and ACYCLOVIR for 10 days to return in 10 days to recheck. Reports about 8 blisters largest dime size on hand and then smaller.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt with hot, tender, swollen area right shoulder and fever. Seen 4/9 (2 days after) not on pain/fever meds. Pt returned for PPD reading so its not clear if return visit was required. Patient improved on meds and now resolved.
Age: 4.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Shingles, recurrent area on face,
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: Had IZ on 4-9-09 04-11-09 2/3 of upper thigh around injection site - was red, swollen and child refused to walk. Was not itchy. Was given BENDARYL in ER without any change. Was sent home with antibiotics (KEFLEX and SEPTRA) - Seen again 4-13-09 and much improved.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Hypoaesthesia oral, Rash
Clinical narrative: Peri-oral rash and slight numbness, no swelling of lips or tongues.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 9X9 cm red reaction on L thigh with warmth (no tenderness).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site mass, Injection site rash, Mobility decreased, Pruritus generalised
Clinical narrative: Rash at injection site (large lumps) itchiness all over body, headaches, could not lift arms, aches.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: L arm has rash & VARICELLA appearing rash.
Age: 0.2
Sex: F
Vaccine: HEP, PNC, RV5
Symptoms: Rash
Clinical narrative: Small rash after receiving Rotavirus vaccine then went away and no distress.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother called 8 days after DTap was given in right thigh to c/o swollen, hot to touch area at site - unrelieved by TYLENOL for age referred to PCP.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chest discomfort, Chest pain, Dyspnoea, Fatigue
Clinical narrative: My daughter is 13 yrs old and has received the gardasil vaccine during which before receiving the 3rd vaccine I was notified that there would be some information broadcasted.  I did decide not to give her the third vaccine due to her having some of the symptoms which included headaches, abdominal pain, nausea, fatigue, shortness of breath, chest pain or tightness, I have taken her to the emergency room twice this month for those symptoms and the physicians are not sure what is happening and say it could be asthma but I am concerned that it is more than that.  Please let me know what else we need to do.  Thank you.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: My daughter is 13 yrs old and has received the gardasil vaccine during which before receiving the 3rd vaccine I was notified that there would be some information broadcasted.  I did decide not to give her the third vaccine due to her having some of the symptoms which included headaches, abdominal pain, nausea, fatigue, shortness of breath, chest pain or tightness, I have taken her to the emergency room twice this month for those symptoms and the physicians are not sure what is happening and say it could be asthma but I am concerned that it is more than that.  Please let me know what else we need to do.  Thank you.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fear, Headache, Injected limb mobility decreased
Clinical narrative: After first dose, there was a very sharp, deep pain at injection site.  When I went to leave office I felt dizzy, nauseous, and vision started blurring and going black.  Nurse brought me back into room and I fainted.  I awoke a few minutes later and vomited.  My vision and steadiness had still not returned for about 30 minutes.  A month later, the arm of the injected site was still sore and a deep muscular ache was constant.  A very sharp pain would be felt if tried to raise my arm higher than horizontally in front of me.  -Parallel to ground. - After two months, I still have discomfort while raising it or moving it up and down, but the pain is less intense.  I feel like after the vaccination, I've had a weaker immune system - more susceptible to illnesses- than I've ever been in the past, and a lack of energy.  I've had an increase of headaches that are reoccurring.  There is still a scar on my arm and a raised bump from the injection. I don not feel safe getting the second or third dose, because I am afraid more serious side effects may likely occur.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Myalgia, Nausea, Scar
Clinical narrative: After first dose, there was a very sharp, deep pain at injection site.  When I went to leave office I felt dizzy, nauseous, and vision started blurring and going black.  Nurse brought me back into room and I fainted.  I awoke a few minutes later and vomited.  My vision and steadiness had still not returned for about 30 minutes.  A month later, the arm of the injected site was still sore and a deep muscular ache was constant.  A very sharp pain would be felt if tried to raise my arm higher than horizontally in front of me.  -Parallel to ground. - After two months, I still have discomfort while raising it or moving it up and down, but the pain is less intense.  I feel like after the vaccination, I've had a weaker immune system - more susceptible to illnesses- than I've ever been in the past, and a lack of energy.  I've had an increase of headaches that are reoccurring.  There is still a scar on my arm and a raised bump from the injection. I don not feel safe getting the second or third dose, because I am afraid more serious side effects may likely occur.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vision blurred, Vomiting
Clinical narrative: After first dose, there was a very sharp, deep pain at injection site.  When I went to leave office I felt dizzy, nauseous, and vision started blurring and going black.  Nurse brought me back into room and I fainted.  I awoke a few minutes later and vomited.  My vision and steadiness had still not returned for about 30 minutes.  A month later, the arm of the injected site was still sore and a deep muscular ache was constant.  A very sharp pain would be felt if tried to raise my arm higher than horizontally in front of me.  -Parallel to ground. - After two months, I still have discomfort while raising it or moving it up and down, but the pain is less intense.  I feel like after the vaccination, I've had a weaker immune system - more susceptible to illnesses- than I've ever been in the past, and a lack of energy.  I've had an increase of headaches that are reoccurring.  There is still a scar on my arm and a raised bump from the injection. I don not feel safe getting the second or third dose, because I am afraid more serious side effects may likely occur.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: After injection at 2:33 pm on the date above, Rainbow began to experience, dizziness, fever, sore throat, severe arm pain.  Today, the next morning, she is weak, tired, and still has sore throat.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: After injection at 2:33 pm on the date above, Rainbow began to experience, dizziness, fever, sore throat, severe arm pain.  Today, the next morning, she is weak, tired, and still has sore throat.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. After receiving the vaccine (date unspecified) the patient experienced a seizure. On an unspecified date, the patient recovered from seizure. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Hypophagia, Intussusception, Laparoscopy, Lethargy, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 06-JAN-2009 a 2 month old male patient was vaccinated with ROTATEQ (Lot # 662396/1268X) orally. Concomitant vaccinations given on the same day included: ACTHIB (Sanofi Pasteur), IPOL (Sanofi Pasteur), PREVNAR (Wyeth) and DAPTACEL (Sanofi Pasteur). Fever, vomiting for 2 days, lethargic, poor PO. Seen in hospital ED 08-FEB-2008. Admitted, had diagnostic laparoscopy with ileocecectomy. Diagnosed with intussusception with perforated colon on 09-FEB-2009. 25-FEB-2009 received hospital medical records of 2/8-16-FEB-2009. Final Diagnostic: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection with primary anastomosis. Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP (urinary output), constipation for 2 days. Had been evaluated in outlying emergency room and had fever, looked unwell and had blood, urine, CSF culture and sensitivity done. Treatment with antibiotics and transferred to higher level of care for pediatric surgery consult. After admitted, had large bloody stool. Progressed well postoperatively and discharged to home with surgery and clinic follow up. Laboratory data done through the ED was unknown at the time of this report. Other laboratory data reported ultrasound of the abdomen was consistent with intussusception. Correction with barium enema was attempted twice and failed. Surgical pathology reported 2 perforations of the ileocecum, adenovirus infection of the small intestine, mucosal ischemic necrosis and acute serositis. It was also reported that the patient appendix with adenovirus infection. The patient required an emergency room visit, prolonged hospitalization and the events were considered to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The original reporting source was not provided. The VAERS ID # 339389. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 06-JAN-2009 a 2 month old male patient was vaccinated with ROTATEQ (Lot # 662396/1268X) orally. Concomitant vaccinations given on the same day included: ACTHIB (Sanofi Pasteur), IPOL (Sanofi Pasteur), PREVNAR (Wyeth) and DAPTACEL (Sanofi Pasteur). Fever, vomiting for 2 days, lethargic, poor PO. Seen in hospital ED 08-FEB-2008. Admitted, had diagnostic laparoscopy with ileocecectomy. Diagnosed with intussusception with perforated colon on 09-FEB-2009. 25-FEB-2009 received hospital medical records of 2/8-16-FEB-2009. Final Diagnostic: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection with primary anastomosis. Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP (urinary output), constipation for 2 days. Had been evaluated in outlying emergency room and had fever, looked unwell and had blood, urine, CSF culture and sensitivity done. Treatment with antibiotics and transferred to higher level of care for pediatric surgery consult. After admitted, had large bloody stool. Progressed well postoperatively and discharged to home with surgery and clinic follow up. Laboratory data done through the ED was unknown at the time of this report. Other laboratory data reported ultrasound of the abdomen was consistent with intussusception. Correction with barium enema was attempted twice and failed. Surgical pathology reported 2 perforations of the ileocecum, adenovirus infection of the small intestine, mucosal ischemic necrosis and acute serositis. It was also reported that the patient appendix with adenovirus infection. The patient required an emergency room visit, prolonged hospitalization and the events were considered to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The original reporting source was not provided. The VAERS ID # 339389. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal pain, Adenovirus infection, Barium enema abnormal, Blood culture, CSF culture
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 06-JAN-2009 a 2 month old male patient was vaccinated with ROTATEQ (Lot # 662396/1268X) orally. Concomitant vaccinations given on the same day included: ACTHIB (Sanofi Pasteur), IPOL (Sanofi Pasteur), PREVNAR (Wyeth) and DAPTACEL (Sanofi Pasteur). Fever, vomiting for 2 days, lethargic, poor PO. Seen in hospital ED 08-FEB-2008. Admitted, had diagnostic laparoscopy with ileocecectomy. Diagnosed with intussusception with perforated colon on 09-FEB-2009. 25-FEB-2009 received hospital medical records of 2/8-16-FEB-2009. Final Diagnostic: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection with primary anastomosis. Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP (urinary output), constipation for 2 days. Had been evaluated in outlying emergency room and had fever, looked unwell and had blood, urine, CSF culture and sensitivity done. Treatment with antibiotics and transferred to higher level of care for pediatric surgery consult. After admitted, had large bloody stool. Progressed well postoperatively and discharged to home with surgery and clinic follow up. Laboratory data done through the ED was unknown at the time of this report. Other laboratory data reported ultrasound of the abdomen was consistent with intussusception. Correction with barium enema was attempted twice and failed. Surgical pathology reported 2 perforations of the ileocecum, adenovirus infection of the small intestine, mucosal ischemic necrosis and acute serositis. It was also reported that the patient appendix with adenovirus infection. The patient required an emergency room visit, prolonged hospitalization and the events were considered to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The original reporting source was not provided. The VAERS ID # 339389. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Constipation, Culture urine, Haematochezia, Hypophagia, Intestinal anastomosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 06-JAN-2009 a 2 month old male patient was vaccinated with ROTATEQ (Lot # 662396/1268X) orally. Concomitant vaccinations given on the same day included: ACTHIB (Sanofi Pasteur), IPOL (Sanofi Pasteur), PREVNAR (Wyeth) and DAPTACEL (Sanofi Pasteur). Fever, vomiting for 2 days, lethargic, poor PO. Seen in hospital ED 08-FEB-2008. Admitted, had diagnostic laparoscopy with ileocecectomy. Diagnosed with intussusception with perforated colon on 09-FEB-2009. 25-FEB-2009 received hospital medical records of 2/8-16-FEB-2009. Final Diagnostic: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection with primary anastomosis. Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP (urinary output), constipation for 2 days. Had been evaluated in outlying emergency room and had fever, looked unwell and had blood, urine, CSF culture and sensitivity done. Treatment with antibiotics and transferred to higher level of care for pediatric surgery consult. After admitted, had large bloody stool. Progressed well postoperatively and discharged to home with surgery and clinic follow up. Laboratory data done through the ED was unknown at the time of this report. Other laboratory data reported ultrasound of the abdomen was consistent with intussusception. Correction with barium enema was attempted twice and failed. Surgical pathology reported 2 perforations of the ileocecum, adenovirus infection of the small intestine, mucosal ischemic necrosis and acute serositis. It was also reported that the patient appendix with adenovirus infection. The patient required an emergency room visit, prolonged hospitalization and the events were considered to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The original reporting source was not provided. The VAERS ID # 339389. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intestinal resection, Intussusception, Ischaemia, Laparoscopy, Laparotomy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 06-JAN-2009 a 2 month old male patient was vaccinated with ROTATEQ (Lot # 662396/1268X) orally. Concomitant vaccinations given on the same day included: ACTHIB (Sanofi Pasteur), IPOL (Sanofi Pasteur), PREVNAR (Wyeth) and DAPTACEL (Sanofi Pasteur). Fever, vomiting for 2 days, lethargic, poor PO. Seen in hospital ED 08-FEB-2008. Admitted, had diagnostic laparoscopy with ileocecectomy. Diagnosed with intussusception with perforated colon on 09-FEB-2009. 25-FEB-2009 received hospital medical records of 2/8-16-FEB-2009. Final Diagnostic: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection with primary anastomosis. Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP (urinary output), constipation for 2 days. Had been evaluated in outlying emergency room and had fever, looked unwell and had blood, urine, CSF culture and sensitivity done. Treatment with antibiotics and transferred to higher level of care for pediatric surgery consult. After admitted, had large bloody stool. Progressed well postoperatively and discharged to home with surgery and clinic follow up. Laboratory data done through the ED was unknown at the time of this report. Other laboratory data reported ultrasound of the abdomen was consistent with intussusception. Correction with barium enema was attempted twice and failed. Surgical pathology reported 2 perforations of the ileocecum, adenovirus infection of the small intestine, mucosal ischemic necrosis and acute serositis. It was also reported that the patient appendix with adenovirus infection. The patient required an emergency room visit, prolonged hospitalization and the events were considered to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The original reporting source was not provided. The VAERS ID # 339389. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Large intestine perforation, Lethargy, Mucosal necrosis, Pyrexia, Serositis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 06-JAN-2009 a 2 month old male patient was vaccinated with ROTATEQ (Lot # 662396/1268X) orally. Concomitant vaccinations given on the same day included: ACTHIB (Sanofi Pasteur), IPOL (Sanofi Pasteur), PREVNAR (Wyeth) and DAPTACEL (Sanofi Pasteur). Fever, vomiting for 2 days, lethargic, poor PO. Seen in hospital ED 08-FEB-2008. Admitted, had diagnostic laparoscopy with ileocecectomy. Diagnosed with intussusception with perforated colon on 09-FEB-2009. 25-FEB-2009 received hospital medical records of 2/8-16-FEB-2009. Final Diagnostic: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection with primary anastomosis. Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP (urinary output), constipation for 2 days. Had been evaluated in outlying emergency room and had fever, looked unwell and had blood, urine, CSF culture and sensitivity done. Treatment with antibiotics and transferred to higher level of care for pediatric surgery consult. After admitted, had large bloody stool. Progressed well postoperatively and discharged to home with surgery and clinic follow up. Laboratory data done through the ED was unknown at the time of this report. Other laboratory data reported ultrasound of the abdomen was consistent with intussusception. Correction with barium enema was attempted twice and failed. Surgical pathology reported 2 perforations of the ileocecum, adenovirus infection of the small intestine, mucosal ischemic necrosis and acute serositis. It was also reported that the patient appendix with adenovirus infection. The patient required an emergency room visit, prolonged hospitalization and the events were considered to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The original reporting source was not provided. The VAERS ID # 339389. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Somnolence, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 06-JAN-2009 a 2 month old male patient was vaccinated with ROTATEQ (Lot # 662396/1268X) orally. Concomitant vaccinations given on the same day included: ACTHIB (Sanofi Pasteur), IPOL (Sanofi Pasteur), PREVNAR (Wyeth) and DAPTACEL (Sanofi Pasteur). Fever, vomiting for 2 days, lethargic, poor PO. Seen in hospital ED 08-FEB-2008. Admitted, had diagnostic laparoscopy with ileocecectomy. Diagnosed with intussusception with perforated colon on 09-FEB-2009. 25-FEB-2009 received hospital medical records of 2/8-16-FEB-2009. Final Diagnostic: bowel perforation s/p radiological attempt to reduce intussusception; diagnostic laparoscopy; laparotomy; ileocecal resection with primary anastomosis. Records reveal patient experienced abdominal pain, oral intake reduced, sleepy, emesis, decreased UOP (urinary output), constipation for 2 days. Had been evaluated in outlying emergency room and had fever, looked unwell and had blood, urine, CSF culture and sensitivity done. Treatment with antibiotics and transferred to higher level of care for pediatric surgery consult. After admitted, had large bloody stool. Progressed well postoperatively and discharged to home with surgery and clinic follow up. Laboratory data done through the ED was unknown at the time of this report. Other laboratory data reported ultrasound of the abdomen was consistent with intussusception. Correction with barium enema was attempted twice and failed. Surgical pathology reported 2 perforations of the ileocecum, adenovirus infection of the small intestine, mucosal ischemic necrosis and acute serositis. It was also reported that the patient appendix with adenovirus infection. The patient required an emergency room visit, prolonged hospitalization and the events were considered to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. The original reporting source was not provided. The VAERS ID # 339389. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Blood test, Chest pain, Diarrhoea, Dyspnoea, Haematochezia
Clinical narrative: Information has been received from an agency concerning an 16 year old female patient with a history of anxiety and four years ago was diagnosed as having thrombophilia per mother, and patient medical history showed methylenetetrahydrofolate reductase (MTHFR) mutation, who on 19-NOV-2008, was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) IM into left arm; first dose of MMR II (Lot # 659706/0266X) subcutaneously into the right arm; first dose of MENACTRA (Lot # U2620AA) IM into left arm; first dose of HAVRIX (Lot # AHAVB246AA) IM into right arm; and first dose of BOOSTRIX (Lot # AC52B030AA) IM into the right arm. Concomitant therapy included LOVENOX, SEROQUEL and COUMADIN. The patient had cold symptoms, coughing and nasal congestion. On 24-NOV-2008, the patient complaint of difficulty breathing, chest pains and headache. The patient went to hospital emergency room. The patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis pulmonary embolism. Another emergency visit to hospital on 13-FEB-2009, for symptoms of diarrhea and bloody stools. 25-FEB-2009, records received for date of service 24-NOV-2008 to 28-NOV-2008, diagnosed pulmonary embolism. Patient presented with increasing shortness of breath, worsening cough and chest wall pain for two weeks. Seen in ED 1 week prior with shortness of breath and Chest X-ray determined to be asthma. Chest X-ray, venous blood draw, CAT scan, Nuclear contrast test, and many other test but mother can not remember. Laboratories reported: On admission Chest X-ray revealed increased perihilar marking and CT chest angiogram showed decreased att. The VAERS ID # is 340119. A standard lot check was performed. All in-process quality checks for the lot number 659653/1448U Were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements for the Center and was released. No further information is available.