chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness
Clinical narrative: Several weeks (end of November) after getting flu vaccine, client began experiencing weakness in legs with numbness in feet and toes.  He began walking with a cane and 2 days later he was in a wheelchair.  Family took client to the ER when he couldn't swallow.  Admitted to hospital on December 3rd, 2007, and diagnosed with Guillian-Barre Syndrome.  He was on life support X 17 days and in ICU X 1 month.  Transferred to rehab center. 5/27/09-records submitted with report-Presented on 12/2/08 with 10 day history of increasing weakness and numbness of feet which made an ascending pattern up entire body. 4 days prior began with feelings of breathlessness and day before presenting to ED C/O trouble with swallowing and muffled speech. Elevated BP on admission 148/99 and subsequent transient increase in BP. Treated with IVIG. Mechanical ventilation required with intubation and subsequent extubation. NG feedings. DX: Guillain-Barre syndrome.  One month hospitalization. Office visit follow up 1/23/09 residual weakness on both sides of face, CN VII focally affected R>L.   6/26/09 Hospital records and DC summary recieved. DOS 12/02/07 to 01/04/08. Assessment: Ascending paralysis, probable Guillain-Barre. Patient presented with ascending numbness and weakness. Nausea and vomitjng. Numbness in feet. Difficulty swallowing liquids. Unable to walk or sit up on his own. DTR's absent. Stregnth diminished upper and lower extremities. Fever, headache. Sedation/Analgesia dependence. Agitation with respiratory distress. Hypertension. IVIG administered. Transferred to rehabilitation facility.  ICD-9 Codes: 357.0, 518.81, V46.11, 707.03, 292.0, 304.01, 112.0, 401.9, 075, 726.87, 041.5, 564.00, 110.5
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Wheelchair user
Clinical narrative: Several weeks (end of November) after getting flu vaccine, client began experiencing weakness in legs with numbness in feet and toes.  He began walking with a cane and 2 days later he was in a wheelchair.  Family took client to the ER when he couldn't swallow.  Admitted to hospital on December 3rd, 2007, and diagnosed with Guillian-Barre Syndrome.  He was on life support X 17 days and in ICU X 1 month.  Transferred to rehab center. 5/27/09-records submitted with report-Presented on 12/2/08 with 10 day history of increasing weakness and numbness of feet which made an ascending pattern up entire body. 4 days prior began with feelings of breathlessness and day before presenting to ED C/O trouble with swallowing and muffled speech. Elevated BP on admission 148/99 and subsequent transient increase in BP. Treated with IVIG. Mechanical ventilation required with intubation and subsequent extubation. NG feedings. DX: Guillain-Barre syndrome.  One month hospitalization. Office visit follow up 1/23/09 residual weakness on both sides of face, CN VII focally affected R>L.   6/26/09 Hospital records and DC summary recieved. DOS 12/02/07 to 01/04/08. Assessment: Ascending paralysis, probable Guillain-Barre. Patient presented with ascending numbness and weakness. Nausea and vomitjng. Numbness in feet. Difficulty swallowing liquids. Unable to walk or sit up on his own. DTR's absent. Stregnth diminished upper and lower extremities. Fever, headache. Sedation/Analgesia dependence. Agitation with respiratory distress. Hypertension. IVIG administered. Transferred to rehabilitation facility.  ICD-9 Codes: 357.0, 518.81, V46.11, 707.03, 292.0, 304.01, 112.0, 401.9, 075, 726.87, 041.5, 564.00, 110.5
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Three days following administration of vaccine, patient with complaints of pruritis, pain, and redness to site.  Denied breathing difficulties.  Six days following administration of vaccine, redness had spread, was warm, and slighly tender.  Patient was treated with Keflex at this time for cellulitis.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Paraesthesia oral
Clinical narrative: tingling of lips and tongue 30 min after injection lasting 30 min
Age: 0.33
Sex: M
Vaccine: IPV, PNC, RV1
Symptoms: Pyrexia, Rash generalised
Clinical narrative: MOTHER REFERS THAT THE NEXT DAY OF VACCINE ADMINISTRATION THE CHILD DEVELOPED A RASH IN THE ENTIRE BODY WITH A SLIGHT FEVER.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Malaise, Syncope
Clinical narrative: THE PT FAINTED AT A RESTURANT 30-1HOUR AFTER RECEIVING SHOT AND FEELS CHILLS ALL OVER BODY . NOT FEELING WELL
Age: 45.0
Sex: F
Vaccine: ANTH, SMALL
Clinical narrative: Lesions on chest, back, and arms post small pox vaccination on 13 May 09. Followed up with NP on 26 May 09. As of 26 May 09 still has lesions will be following up with MD.  5/29/09 Medical records recieved DOS 5/01/09 to 5/27/09. FINAL DIAGNOSIS: Adverse reaction Post vaccination macular papular lesions on chest, back, arms. 5/27/09 - Returning to active duty, no restrictions.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Laboratory test normal, Pyrexia
Clinical narrative: Fever, crying x 2 days.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal X-ray, Necrotising colitis
Clinical narrative: Necrotizing enterocolitis, symptoms started 24 hrs after Pentacel, Prevnar, Hep B and RotaTec vaccine administration, diagnosis made 3 days after vaccine administartion. Admitted to the hospital on 05-23-09.  6/11/09 Received hospital medical records of 5/23-6/2/2009. FINAL DX: pneumatosis Records reveal patient experienced bloody stools, diarrhea, decreased appetite, decreased activity & fever.  Seen in outlying ER & transferred to higher level of care.  Sugrery, GI consult done.  Tx w/TPN via PICC line, IV antibiotics.  Improved but developed ileus which resolved by d/c to home. 8/21/09 Received ICD9 codes: 58989; 5781; 5131; 75060.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intestinal functional disorder, Pyrexia
Clinical narrative: Necrotizing enterocolitis, symptoms started 24 hrs after Pentacel, Prevnar, Hep B and RotaTec vaccine administration, diagnosis made 3 days after vaccine administartion. Admitted to the hospital on 05-23-09.  6/11/09 Received hospital medical records of 5/23-6/2/2009. FINAL DX: pneumatosis Records reveal patient experienced bloody stools, diarrhea, decreased appetite, decreased activity & fever.  Seen in outlying ER & transferred to higher level of care.  Sugrery, GI consult done.  Tx w/TPN via PICC line, IV antibiotics.  Improved but developed ileus which resolved by d/c to home. 8/21/09 Received ICD9 codes: 58989; 5781; 5131; 75060.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Rash macular
Clinical narrative: blanching macules on trunk, extremeties and face, began on the morning of 5/26/09, worsened as day progressed.  No other cymptoms
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Oral papilloma
Clinical narrative: Patient developed mucosal wart inside lower lip 5 days after receiving second HPV vaccine.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash
Clinical narrative: Pt was taken to facility on 5/21.  Report states patient presented with rash on face, trunk and extremities.  6/9/09 Medical, hospital, DC summary received DOS 5/22/09 to 5/23/09. FINAL DIAGNOSIS: Nonspecific rash Post vaccination: Presented with diffuse erythematous, hive-like rash on face, trunk and extremities. Fussy, crying, difficult to console. Dehydrated. Later maculopapular lesions on face, trunk, extremities.  ICD-9 Codes: 782.1 Non Specif Skin Erup 695.10 Unspecified erythema multiforme 276.51 Dehydration.
Age: 4.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Crying, Nervousness, Pallor, Urinary incontinence
Clinical narrative: After receiving last vaccine MMR noted childs lips pale, no cyanosis observed. Child awake and crying, noted child urinated on self per father and was very scared prior receiving vaccines. Blood pressure 102/67 pulse:100 respirations 22, observed further, no syncope noted. Evaluated by Dr. rule out anxiety, advised parents to observe child and give TYLENOL as needed. Instructed to go to Emergency Room if condition worsens or any changes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Pt reported a swollen arm that subsided 4 days after ZOSTAVAX vaccine was administered. Pt saw PCP were said it may be an allergy. Vaccine administered on May 18, 2009 + Pt reported 08 am ~  may 22/09.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: 5/21/09 developed chickenpox rash - more than 100 lesions
Age: 29.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Rash pruritic
Clinical narrative: 11 days after MMR, developed itch rash on face and trunk. 1 day of headache 8 days after (gone now).
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient came to us for ZOSTAVAX after received other immunizations at a clinic. She reported to us on 5-19-2009 that her left arm was swollen, red, warm and painful from deltoid almost to her wrist.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Patient came to us for ZOSTAVAX after received other immunizations at a clinic. She reported to us on 5-19-2009 that her left arm was swollen, red, warm and painful from deltoid almost to her wrist.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash vesicular
Clinical narrative: Patient came to us for ZOSTAVAX after received other immunizations at a clinic. She reported to us on 5-19-2009 that her left arm was swollen, red, warm and painful from deltoid almost to her wrist.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site rash, Irritability, Rash
Clinical narrative: Approximately five hours after the vaccination my son was unconsolable for an hour and extremely fussy all night. He developed a rash at the injection site which then spread to his legs and torso. It took over 2 mos to clear up.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Chronic fatigue syndrome, Fatigue, Multiple sclerosis
Clinical narrative: memory loss, achy muscles and joint pain. fatigue. Symptoms reflecting M.S. and chronic fatigue syndrome. Symptoms are getting worse over time. I need help!
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia
Clinical narrative: memory loss, achy muscles and joint pain. fatigue. Symptoms reflecting M.S. and chronic fatigue syndrome. Symptoms are getting worse over time. I need help!
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Apnoea, Death, Pulse absent, Respiratory arrest
Clinical narrative: 5/5/09 Pt was brought into ED by EMS. Pt was pulseless and apneic. Pronounced dead in ED. History was that pt was put on sofa for a nap at 7 AM. At 915, EMS was called because pt was not breathing. Pt in foster care. Coroner's case. Possible SIDS.   9/4/09 Coroner's Investigative Report DOS 5/5/09. Decedent found on stomach, not breathing by parent. Parent called 9-1-1 and started CPR.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated. 9/9/09 Rheumatology consultant records received DOS 1/5/05 to 6/17/09. Assessment: Rheumatoid arthritis, uncontrolled anxiety. Patient presented with pain in (L) shoulder, (L) knee, hands and feet. Unable to lift (L) arm above head. Swelling in hands, nodules. Multiple joint swelling. Fatigue, weight loss, inability to function. Wrist pain. 'Hole in back of mouth'. Nausea, vomiting, dizzy, and sick. Left-sided chest pain. Lightheaded. Synovitis multiple joints. H. Pylori and diverticulosis. Vision and dental concerns.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture negative, Culture urine negative, Diarrhoea, Hypophagia, Lethargy
Clinical narrative: Fever to 103; diarrhea; lethargy; decrease oral intake. Hospitalized x 2 days.  6/2/09 ED and inpatient records received DOS 5/14/09 to 5/16/09. FINAL DIAGNOSIS: Fever with no source, diarrhea. Post vaccination patient presented with fever and diarrhea.  ICD-9 Codes: 78060 Fever unspecified, 78791 Diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia, Rotavirus test positive
Clinical narrative: Fever to 103; diarrhea; lethargy; decrease oral intake. Hospitalized x 2 days.  6/2/09 ED and inpatient records received DOS 5/14/09 to 5/16/09. FINAL DIAGNOSIS: Fever with no source, diarrhea. Post vaccination patient presented with fever and diarrhea.  ICD-9 Codes: 78060 Fever unspecified, 78791 Diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal pain upper, Anorexia, Asthenia, Body temperature increased, Diarrhoea
Clinical narrative: Fever to 103; diarrhea; lethargy; decrease oral intake. Hospitalized x 2 days.  6/2/09 ED and inpatient records received DOS 5/14/09 to 5/16/09. FINAL DIAGNOSIS: Fever with no source, diarrhea. Post vaccination patient presented with fever and diarrhea.  ICD-9 Codes: 78060 Fever unspecified, 78791 Diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pallor, Rotavirus test positive, Weight decreased
Clinical narrative: Fever to 103; diarrhea; lethargy; decrease oral intake. Hospitalized x 2 days.  6/2/09 ED and inpatient records received DOS 5/14/09 to 5/16/09. FINAL DIAGNOSIS: Fever with no source, diarrhea. Post vaccination patient presented with fever and diarrhea.  ICD-9 Codes: 78060 Fever unspecified, 78791 Diarrhea.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Weakness and pain in arm. No fever, no redness or swelling at sight of injection but tender to the touch. Weakness and pain lasting 2 days +.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Pyrexia, Skin warm
Clinical narrative: 4-5 inch swelling with hard middle, itchy, very warm, red and fever 99.5 (my temp. usually runs low). Had to go on antibiotics for 3 days. Gradually got worse over 2 days. Fully recovered. Diagnosis Bacteria in system (possibly).
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 4-5 inch swelling with hard middle, itchy, very warm, red and fever 99.5 (my temp. usually runs low). Had to go on antibiotics for 3 days. Gradually got worse over 2 days. Fully recovered. Diagnosis Bacteria in system (possibly).
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: 8-4-08, received PEDIARIX, HIB and PREVNAR #2, RV5, hives occurred approximately 24 hours after administration. 10-20-08, received PREVNAR # 3. Hives occurred within several hours after administration.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: L upper deltoid with 100 cm of erythema, swelling & warmth  zero damage + tender noted next day really increase later that night.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Soft tissue disorder, Status epilepticus, Ventricular tachycardia
Clinical narrative: Initial report received on 13 May 2009 from a physician. Subject identification number: 1-08-06459. This subject is participating in a study. A 14-year-old previously healthy male subject, who has concurrent medical condition of mild asthma, for which he uses XOPENEX on an as needed basis, had received on 30 November 2008 a dose of FLUZONE, lot number U2803AA. The route and site of administration was not reported. The subject presented with prolonged, generalized new onset of seizure and status epilepticus (onset date not reported) and was hospitalized from 30 November 2008 to 02 December 2008. There was no history of trauma, or substance abuse. Urine drug screen was negative. An MRI with/without contrast on 01 December 2008 revealed no intracranial abnormalities and with abnormal signal in the left middle ear cavity and mastoid region. An EEG was normal without epileptiform discharges. Cerebral spinal fluid Polymerase Chain Reaction was negative for enterovirus and herpes simplex virus. Blood culture was sterile. It was elected to observe the subject without anti-epileptic medication. The subject was discharged on hospital day three. The subject was re-admitted two days later from 04 December 2008 to 06 December 2008 for seizures (onset date not reported). The subject was loaded with fosphenytoin and ATIVAN. Urine drug screen was negative. Head CAT scan did not reveal hemorrhage or other intracranial pathology. A soft tissue density in the left mastoid was observed consistent with cholesteatoma. The subject was discharged home on hospital day three with KEPPRA 300 mg twice a day for prevention of seizures. The subject was re-admitted three days later from 09 December 2008 to 24 December 2008 for seizures (onset not reported). A lumbar puncture test was performed that revealing CSF protein of 50.9 mg/dL and glucose of 71mg/dL, both are within normal values. Urine drug screen was negative, repeat CAT scan of the head did not reveal any new findings, respiratory virus panel was negative and an EEG revealed marked slowing of the background consistent with persistent encephalopathy without accompanying seizure activity. A repeat EEG on 15 December 2008 revealed discharge events indicative of myoclonic seizures. The subject had an EKG that had ventricular tachycardia; however an echocardiogram of the heart was normal. Muscle and skin biopsy of the left thigh was performed to evaluate for progressive myoclonic epilepsy of the Lafora type; however, results of pathology test demonstrated no globules consistent with Lafora. Ophthalmologic examination was unremarkable. The subject was sent home on hospital day 16 on DEPAKOTE 1500 mg twice a day and rectal DIASTAT 17.5 mg for seizures lasting greater than five minutes. The subject's final diagnosis was new onset seizure, status epilepticus, myoclonic epilepsy. Recovery dates were not reported. Per the reporter, "none of the three serious adverse events were related to the he FLUZONE, and the SAEs not going to be reported to the IRB, or to VAERS." Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: woke up and left deltoid dark red, puffy is swollen like a sausage.  Could not lift up arm for four days.  Hot to touch.  Size measured 5-20-09 10 1/2cm (height) by 7cm (width) site still pink and slight warm to touch.  Circle bandaid was used- can still see white circle where bandaid was applied.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood amylase normal, Culture throat negative, Epstein-Barr virus test negative, Eye pain, Facial pain
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Barr virus and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous Rocephin and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and Tylenol # 3 for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE vaccine, and the SAE was not going to be reported to the agency, or VAERS. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymphadenitis, Neck pain, Photophobia, Salivary gland pain, Swelling face
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Barr virus and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous Rocephin and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and Tylenol # 3 for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE vaccine, and the SAE was not going to be reported to the agency, or VAERS. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray normal
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Barr virus and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous Rocephin and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and Tylenol # 3 for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE vaccine, and the SAE was not going to be reported to the agency, or VAERS. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyperaesthesia, Lymphadenitis, Neck pain, Parotid gland enlargement, Photophobia
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Barr virus and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous Rocephin and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and Tylenol # 3 for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE vaccine, and the SAE was not going to be reported to the agency, or VAERS. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Salivary gland pain, Streptococcal identification test negative, Swelling face, X-ray normal
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Barr virus and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous Rocephin and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and Tylenol # 3 for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE vaccine, and the SAE was not going to be reported to the agency, or VAERS. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red swollen area on deltoid of right arm. Progressed over 48 hours, at exam, measured 1 1/2 inches circular raised erythema, warm to touch. No streaking or other lesions/illness noted.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antipsychotic drug level, Blood thyroid stimulating hormone, Drug screen negative, Suicidal ideation
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involves a 16-year-old female subject, with a history of bipolar disorder, oppositional defiant disorder, attention deficit-hyperactivity disorder, post-traumatic stress disorder due to prior abuse from mother and parent-child relationship problems, who had received a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 04 November 2008. The route and site of administration was not reported. The subject was evaluated at the emergency room on 08 December 2008 for emotional issues with suicidal ideation. A urine drug screen was negative and her TSH level (1.64 mcU/ml) was normal. Serum lithium level was within the therapeutic range (0.6) mEq/L). The subject was admitted for observation and management. Her in-patient stay was for approximately one week. After discharge from the hospital, the subject received individual and family therapy sessions for her current issues on at least the following dates: 17 December 2008, 22 December 2008 and 21 January 2009. The final diagnosis was suicidal ideation. The recovery status of the subject was not reported. Per the reporter, "the SAE was not related to the FLUZONE vaccine and will not be reported to the agency, or to VAERS." Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antipsychotic drug level, Blood thyroid stimulating hormone normal, Drug screen negative, Emotional disorder, Suicidal ideation
Clinical narrative: Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involves a 16-year-old female subject, with a history of bipolar disorder, oppositional defiant disorder, attention deficit-hyperactivity disorder, post-traumatic stress disorder due to prior abuse from mother and parent-child relationship problems, who had received a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 04 November 2008. The route and site of administration was not reported. The subject was evaluated at the emergency room on 08 December 2008 for emotional issues with suicidal ideation. A urine drug screen was negative and her TSH level (1.64 mcU/ml) was normal. Serum lithium level was within the therapeutic range (0.6) mEq/L). The subject was admitted for observation and management. Her in-patient stay was for approximately one week. After discharge from the hospital, the subject received individual and family therapy sessions for her current issues on at least the following dates: 17 December 2008, 22 December 2008 and 21 January 2009. The final diagnosis was suicidal ideation. The recovery status of the subject was not reported. Per the reporter, "the SAE was not related to the FLUZONE vaccine and will not be reported to the agency, or to VAERS." Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: After vaccine given, pt complained of tingling along anterior medial aspect L upper arm.  Hurt to move arm.  Also complained of "tingling" going down L anterior lower arm + fingers.  Fingers cool.  Gave pt acetaminophen 325mg 2tabs.  Was to return for re check in 1 hour but pt left; Seen 5/18- States symptoms resolved after approximately 24 hrs. By the next day better 5/15
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of erythema and swelling on arm at injection site - 4 1/2 X 6 cm - at 24 hrs post injection LUA.
Age: 25.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: C/o tightness in chest & throat 20 mins after receiving vaccines and ERYTHROMYCIN. Has allergy to CECLOR, was given BENADRYL returned to division.
Age: 22.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Pharyngeal oedema
Clinical narrative: C/o swelling of throat after receiving vaccine and Bicillin, no prior allergy history. Given BENADRYL and observation - return to division.
Sex: U
Vaccine: FLU3, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Electroencephalogram normal, Grand mal convulsion, Lumbar puncture normal
Clinical narrative: Had generalized tonic - clonic seizure 8 hrs after vaccines.  CT, labs EEG normal.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient was administered SMALLPOX vaccine during 1st trimester. Currently in 2nd trimester after learning of pregnancy.
Age: 46.0
Sex: M
Vaccine: PNC, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reports redness at injection site R arm, denies fever, chills.  reports pain 3/0 .  Right arm, deltoid are with redness measuring 130 cm length no cm width.  Warm to touch, no edema noted, no open areas.  Patient afebrile temp 97.6.  Patient reports improvement since yesterday.  NP in to see patient.  Instructed to apply compress, tylenol for pain,   if Sx worsen.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: With erythema and swelling on Rt deltoid site starting 3-31-09
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: 5/15 TC from mom reporting child diagnosed with cellulitis (L) thigh @ Urgent Care on 5-14. Has an approx. 5 inch in diameter area of redness & hardness. MD ordered an antibiotic. 5/19/09 F/U TC, redness & hardness are resolving - ambulating without difficulty, cont. antibiotic.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Pt fainted 10 min. after leaving pharmacy.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Local reaction - pain, erythema started 5/16 - MOTRIN and BENADRYL given.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Body temperature increased, Fatigue, Influenza serology negative, Lymphadenopathy
Clinical narrative: Joint pain and exhaustion started 1st week after vaccine and persist. May 1 started body aches, sore throat, temp 101.8 deg, swollen glands in neck, tonsils, uvula. Aches, sore throat, fever gone May 4. Swollen glands persist of May 19. Seen in ER- cervical adenopathy. Prescribed MEDROL DOSEPAK.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Oropharyngeal swelling, Pain, Tonsillitis
Clinical narrative: Joint pain and exhaustion started 1st week after vaccine and persist. May 1 started body aches, sore throat, temp 101.8 deg, swollen glands in neck, tonsils, uvula. Aches, sore throat, fever gone May 4. Swollen glands persist of May 19. Seen in ER- cervical adenopathy. Prescribed MEDROL DOSEPAK.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Decreased appetite, Headache, Hypophagia, Pain, Pain in extremity
Clinical narrative: 5/12/09 PC received from guardian that child complained of headache leg aches, vomiting x 3 and fever (felt hot to touch) did not check temp after receiving vaccines- 8 hour later- 5/14/09-student had fever body aches x 3 days-no vomiting. 1st day= decreased appetite x 2 day- Eating decreased, Better 3 days after vaccines.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: 5/12/09 PC received from guardian that child complained of headache leg aches, vomiting x 3 and fever (felt hot to touch) did not check temp after receiving vaccines- 8 hour later- 5/14/09-student had fever body aches x 3 days-no vomiting. 1st day= decreased appetite x 2 day- Eating decreased, Better 3 days after vaccines.
Age: 0.28
Sex: M
Vaccine: HPV4, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: This patient was accidently given HPV
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Rash generalised, Varicella
Clinical narrative: Pt. developed 2 cm erythema at local injection site and scattered rash on body consistent with VARICELLA.
Age: 1.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: 1 red spot on belly 5-17-09 in AM, 101.7 fever on 5-17-09 at 8:00 AM TYLENOL was administered, fever went down did not appear again. 7 chicken pox appeared on 5-18-09 at 7:00 has not made a full recovery yet.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling with redness, itchiness over 3/4 of entire surface upper left arm.
Age: 36.0
Sex: F
Vaccine: JEV
Symptoms: Unevaluable event
Clinical narrative: Please see attached encounter
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 26.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: ~ 7-10 vesicles at site of injection of varicella #1 - Occurred ~ 2wks after inj.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 65.0
Sex: M
Vaccine: DT
Symptoms: Full blood count, Myalgia
Clinical narrative: Pt developed diffuse Myalgias approx 12hrs after Pt vaccination given.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Tenderness
Clinical narrative: 3 areas (small) of red flat rash in upper arm; tender to touch; started yesterday.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pustule
Clinical narrative: Pustule at VZV injection site on 5/12/09. No treatment needed.
Age: 1.3
Sex: F
Vaccine: DTAP, PNC
Symptoms: Crying, Injection site erythema, Injection site induration, Pain
Clinical narrative: Local reaction on left and right anterior, upper thigh, 2 inch by 3 inch red, indurated area. Pain eliated due to pt. crying upon touch. No fever. TYLENOL for pain. Ice for pain and or swelling.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Mother called the office at 230 PM on 5/20/09 to report that child broke out in hives all over 10 minutes after she left office yesterday AM She did not call or come back yesterday. She did not give BENADRYL. No respiratory distress. Reported fussiness. Mother states hives are completely gone today.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella vaccine breakthrough. Had VARIVAX-2 doses. Diagnosed with varicella in our office on 5-19-09.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: prevnar was given twice, no adverse reaction noted.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site irritation, Injection site oedema
Clinical narrative: Patient reports a gradual onset of edema and erythema, first to the vaccine site, then spreading to the entire arm. She reports the site was warm to the touch with some burning and itching present. Patient's temperature was 100 degrees Farenheidt throughout the reaction. She was out of town during the time of reaction, but she did call her doctor and took Benadryl and Tylenol, which she said did not seem to help. Patient reports gradual recovery, and now there is redness around the vaccination site, about 3 inches in diameter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Oedema
Clinical narrative: Patient reports a gradual onset of edema and erythema, first to the vaccine site, then spreading to the entire arm. She reports the site was warm to the touch with some burning and itching present. Patient's temperature was 100 degrees Farenheidt throughout the reaction. She was out of town during the time of reaction, but she did call her doctor and took Benadryl and Tylenol, which she said did not seem to help. Patient reports gradual recovery, and now there is redness around the vaccination site, about 3 inches in diameter.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Alopecia, Blood test
Clinical narrative: Severe Hair loss (alopecia) around temples (around ear area, mainly in front) and some hair loss around hair line and crown. Has happened the last 3 years in October-November after administration of the Influenza vaccine (first vaccine in 2006). Noticeable loss each year starting approximately 30 days after administration of vaccines.
Age: 0.59
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood culture negative, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Full blood count normal
Clinical narrative: Presented via EMS to Emergency Dept on the morning of 08/11/2006 00:57 actively seizing.  Symptoms began 30 minutes prior to arrival to ED.  No fever documented.  Child received Valium en route to ED followed by 3 doses of Ativan for seizure control.  Seizure resolved after 3rd dose of Ativan at 01:37. 7/15/09-records received for DOS 8/11/06-DC DX- Seizures-presented to ED after generalized seizure activity which continued in ED. Ran a fever during day-choking spells prior to seizure. Observed and discharged home.  Follow-up: Pt continues with seizures although controlled with meds (KEPPRA and Valproic acid). She also has developmental delays and attends the steps program. Testing revealed function at a 2yo level (2 yrs behind). It is difficult to determine if some of these problems could be related to premature birth (32 wks gestation), but there is no history of birth depression. Normal MRI.
Age: 0.59
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Metabolic function test normal
Clinical narrative: Presented via EMS to Emergency Dept on the morning of 08/11/2006 00:57 actively seizing.  Symptoms began 30 minutes prior to arrival to ED.  No fever documented.  Child received Valium en route to ED followed by 3 doses of Ativan for seizure control.  Seizure resolved after 3rd dose of Ativan at 01:37. 7/15/09-records received for DOS 8/11/06-DC DX- Seizures-presented to ED after generalized seizure activity which continued in ED. Ran a fever during day-choking spells prior to seizure. Observed and discharged home.  Follow-up: Pt continues with seizures although controlled with meds (KEPPRA and Valproic acid). She also has developmental delays and attends the steps program. Testing revealed function at a 2yo level (2 yrs behind). It is difficult to determine if some of these problems could be related to premature birth (32 wks gestation), but there is no history of birth depression. Normal MRI.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Heart rate decreased, Oral pruritus, Oxygen saturation abnormal
Clinical narrative: Patient received the Typhoid Vaccine 0.5ml IM Left Deltoid at Approximately 8:15am.  Left Health Center approx. 8:30am.  Health Center alerted at 9:30am that patient was experiencign itchy mouth.  Brought to health center.  In no distress. Mouth itchy.  No hive or oral lesion.  No swelling eveident. Lungs clear, no wheezing, no SOB, oxygen saturation 89% pulse 78.  Given Benadryl 50mg liquid PO.  Montiored for two hours post event.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Muscle spasms, Muscle twitching
Clinical narrative: I have random twitches and involuntary muscle movement/spasms in my legs, calves, quads, ankles, feet, and toes and sometimes in my fingers and bottom. The date I've listed below was the 3rd Gardasil shot. The first shot was September 2007. Without looking at the doctor records, I don't have the date, but I remember the month and year. Also, the adverse affect was just sometime in between the first and 2nd shot in 2008  7/1/09 Consultant OB-GYN records received DOS 5/28/09 to 6/9/09. Assessment: Twitches. Twitches in legs and fingers. Concerns about infertility. Anxiety, panic attacks.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: local reaction red, hot and swollen and tender to touch
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling of body temperature change, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: Pt experiencing flu like symptoms with hot/cold, some sweating, nausea and dizziness. Legs hurting.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt experiencing flu like symptoms with hot/cold, some sweating, nausea and dizziness. Legs hurting.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Six days after vaccine administration he presented with widespread urticaria rash.  Of note he also finished a course of Bactrim the day before rash started