chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.1
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Autism, Speech disorder developmental
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 4-year-old male subject who was vaccinated with DTaP (SmithKline). A physician or other health care professional has not verified this report. In June 2002 the subject received 1st dose of DTaP (unknown) series. Dates of other vaccinations were not provided. At an unspecified time after vaccination, the mother reported that her son "never talked" but physically never exhibited signs of autism like pounding on the walls or rocking. He would "blurt out one word every six months." January 2007, 4 and one-half years after vaccination with DTaP, the subject was diagnosed with autism. The mother did not have the vaccination record but she believes that he received SmithKline DTaP vaccine. The mother reported that the events were disabling and jeopardized the subject or required intervention. She also believes that the autism is related to one or more of his vaccines but she does not know which vaccine. She also reported that another son developed autism. See GSK number A0721950A for details of this case. At the time of reporting the events were unresolved.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Asthma, Autism, Familial risk factor, Insomnia
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a male subject of unspecified age who was vaccinated with Dtap (SmithKline), PEDVAXHIB, IPOL, HEPTAVAX, PREVNAR. A physician or other health care professional has not verified this report. On 1 August 2001, 15 October 2001 and 15 August 2002 the subject received 1st dose, 2nd dose and 3rd dose of Dtap (unknown). On 1 August 2001 the subject received 2nd dose of PEDVAXHIB (unknown), 2nd dose of IPOL (unknown), 2nd dose of HEPTAVAX (unknown). 3rd dose of PEDVAXHIB (unknown), 3rd dose of PREVNAR (unknown). The reporter indicated that it was documented in the chart that the subject received "Dtp/Dtap by SmithKline." In 2001, at an unspecified time after vaccination with INFANRIX, HEPTAVAX, PEDVAXHIB, IPOL and PREVNAR, as an infant the subject experienced respiratory issues such as colds. The reporter later noted that she was not certain whether the respiratory issues started before or after the dtp/dtap doses. The reporter related the respiratory issues to the subject's formula and changed from milk based formula to soy-based formula which helped the respiratory issues. In 2002, at an unspecified time after vaccinations, the subject was diagnosed with asthma. He was treated with albuterol nebulizer treatments. The respiratory issues and the asthma resolved in 2003. In 2003, approximately two years following vaccinations, the subject began to pound on the walls and have insomnia. The mother believed that these were early signs of autism. On 18 May 2005, approximately four and one half years after the first vaccinations, the subject was diagnosed with autism. She noted that prior to the diagnosis of autism as a toddler, the subject had always talked and over the last 2 years his talking had diminished and his speech had only developed to a certain extent. The subject also experienced a delayed administration and inappropriate schedule of vaccine administered according to the dates provided in the report. At the time of reporting it was noted that the respiratory issues and asthma resolved in September 2003. It was unknown if the insomnia continued. The autism continues. The outcome of the other events were unspecified. The mother considered that the events were disabling and jeopardized the patient or required intervention. The mother also reported that another son developed autism. See GSK A0721937A for details.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Nasopharyngitis, Respiratory disorder, Speech disorder developmental
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a male subject of unspecified age who was vaccinated with Dtap (SmithKline), PEDVAXHIB, IPOL, HEPTAVAX, PREVNAR. A physician or other health care professional has not verified this report. On 1 August 2001, 15 October 2001 and 15 August 2002 the subject received 1st dose, 2nd dose and 3rd dose of Dtap (unknown). On 1 August 2001 the subject received 2nd dose of PEDVAXHIB (unknown), 2nd dose of IPOL (unknown), 2nd dose of HEPTAVAX (unknown). 3rd dose of PEDVAXHIB (unknown), 3rd dose of PREVNAR (unknown). The reporter indicated that it was documented in the chart that the subject received "Dtp/Dtap by SmithKline." In 2001, at an unspecified time after vaccination with INFANRIX, HEPTAVAX, PEDVAXHIB, IPOL and PREVNAR, as an infant the subject experienced respiratory issues such as colds. The reporter later noted that she was not certain whether the respiratory issues started before or after the dtp/dtap doses. The reporter related the respiratory issues to the subject's formula and changed from milk based formula to soy-based formula which helped the respiratory issues. In 2002, at an unspecified time after vaccinations, the subject was diagnosed with asthma. He was treated with albuterol nebulizer treatments. The respiratory issues and the asthma resolved in 2003. In 2003, approximately two years following vaccinations, the subject began to pound on the walls and have insomnia. The mother believed that these were early signs of autism. On 18 May 2005, approximately four and one half years after the first vaccinations, the subject was diagnosed with autism. She noted that prior to the diagnosis of autism as a toddler, the subject had always talked and over the last 2 years his talking had diminished and his speech had only developed to a certain extent. The subject also experienced a delayed administration and inappropriate schedule of vaccine administered according to the dates provided in the report. At the time of reporting it was noted that the respiratory issues and asthma resolved in September 2003. It was unknown if the insomnia continued. The autism continues. The outcome of the other events were unspecified. The mother considered that the events were disabling and jeopardized the patient or required intervention. The mother also reported that another son developed autism. See GSK A0721937A for details.
Age: 42.0
Sex: M
Vaccine: YF
Symptoms: Eye swelling, Ocular hyperaemia, Swollen tongue
Clinical narrative: Patient received yellow fever vaccine.  Approximately one hour later patient developed swelling of the tongue.  Patient took Benadryl (PO).  Swelling lasted for approximately 2 hours.  The next morning at approximately 8:30 am, patient ate eggs and his eyes became red and swollen.  Symptoms lasted until 4:30 pm.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: None noted.  Two doses of same antigen given on same day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site oedema, Injection site vesicles, Skin lesion, Skin warm
Clinical narrative: 3/15 right after shot arm turned red and hot to touch.  4 days later she turned cherry red on trunk and arm got bulls eye pattern of blisters, edema at shot site, left thigh developed sm area of shingles type lesions on 3/19/08.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Oedema peripheral
Clinical narrative: Complained of muscle aches right arm, buttocks and right leg beginning around 8/5/07.  Today (8/21) muscle aches have resolved but complained of "swelling" lower right arm below elbow.  Advised to see TND.
Age: 62.0
Sex: F
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Injection site rash, Rash, Skin warm
Clinical narrative: Yellow fever given 3-05-08.  Started Larium tabs 3-7-08 A.M.  Then noticed rash re: 7 pm 3-7-08 at injection site sq left arm.  Saturday 3-8-08 rash started spreading to elbow and under arm.  Fading now 3-10-08.  No fever.  Rash area warm to touch.  Better today 3-10-08.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Alopecia, Ear infection, Ear pain, Hearing impaired, Pyrexia
Clinical narrative: High fever 104.1 (2 days after 12) several days, she complained of her right ear hurting, saw physician 09/08.  Saw doctor "said symptoms likely due to immunizations", treat fever with Tylenol, give her a couple days.  Symptoms became worse, high fever, vomiting, saw physician, treated ear infection with antibiotics.  Since, her hair has been falling out, her hearing seems to be effected by how well she hears things sharply.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Vomiting
Clinical narrative: High fever 104.1 (2 days after 12) several days, she complained of her right ear hurting, saw physician 09/08.  Saw doctor "said symptoms likely due to immunizations", treat fever with Tylenol, give her a couple days.  Symptoms became worse, high fever, vomiting, saw physician, treated ear infection with antibiotics.  Since, her hair has been falling out, her hearing seems to be effected by how well she hears things sharply.
Age: 29.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Wrong drug administered
Clinical narrative: No adverse event - pt was given DTaP and should have received Tdap.  CDC was called 3-13-08.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Right upper arm swollen halfway between shoulder and elbow. 5x7cm area of redness and induration - warm and tender to touch. Mom states temp was 101.2 this AM. Has been giving PO Benadryl and Tylenol. Appt made with pediatrician for this AM.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Right upper arm swollen halfway between shoulder and elbow. 5x7cm area of redness and induration - warm and tender to touch. Mom states temp was 101.2 this AM. Has been giving PO Benadryl and Tylenol. Appt made with pediatrician for this AM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh warm to touch, swollen, erythematous at injection site.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Pt received Varivax on 7/1/99 - noticed rash on trunk morning of 4/11/08. Approx. 15-20 lesions, some beginning to crust over, slightly itchy.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood product transfusion, Feeling cold, Fine motor delay, Guillain-Barre syndrome
Clinical narrative: 3 wk. history of progressive symptoms in arms and legs that started 3-4 wks after receiving flu vaccine Fine motor movements slow. Over last 7-10 days a persistent cold sensation, tingling, and weakness especially in hands. Diagnosis of Guillain Barre by MD. Pts was to received 1gm/kg/day of IVIG. Toward end of 1st infusion she developed headache and fever.  Infusion was discontinued.  Fevere and headache resolved. Given Neurontin 300 mg 1-2 po qhs for extremity pain along with ibuprofen 600 mg po tid x 5 days.  5/20/2008 MR received for OV 11/20/07 and admission DOS 11/29/2007 with DX: Guillain-Barre Syndrome. Aseptic meningitis 2' to IVIG. Dysthesias.  Pt initially presented with c/o weakness in the hands, most notable after running and intermittant numbness. Seen again 11/29/08 with c/o increasing progressive symptoms in pt's arms and now legs. Cramping and clumsiness noted in the hands with persistant cold sensation with tingling. PE (+) for muscle weakness of the bilateral APB, ADM, interossei and toe dorsiflexors.  Diminished reflexes at the biceps, brachial radialis and ankles. Sensory exam impaired to pin prick over fingers and ankles. Temp and vibration also reduced. Tx with IVIgG with development of h/a and fever suspected aseptic meningitis. 6/18/2006 Office records received from 11/12/2008-5/19/2008.  Initially seen with c/o abrupt onset of weakness of the R upper extremity as well as coldness of the extremities.  Unable to grip or start the ignition of her car. Referred to Neurologist. Seen again 2/5/08 with cold sx with recent hx of atypical Guillain Barre syndrome
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: 3 wk. history of progressive symptoms in arms and legs that started 3-4 wks after receiving flu vaccine Fine motor movements slow. Over last 7-10 days a persistent cold sensation, tingling, and weakness especially in hands. Diagnosis of Guillain Barre by MD. Pts was to received 1gm/kg/day of IVIG. Toward end of 1st infusion she developed headache and fever.  Infusion was discontinued.  Fevere and headache resolved. Given Neurontin 300 mg 1-2 po qhs for extremity pain along with ibuprofen 600 mg po tid x 5 days.  5/20/2008 MR received for OV 11/20/07 and admission DOS 11/29/2007 with DX: Guillain-Barre Syndrome. Aseptic meningitis 2' to IVIG. Dysthesias.  Pt initially presented with c/o weakness in the hands, most notable after running and intermittant numbness. Seen again 11/29/08 with c/o increasing progressive symptoms in pt's arms and now legs. Cramping and clumsiness noted in the hands with persistant cold sensation with tingling. PE (+) for muscle weakness of the bilateral APB, ADM, interossei and toe dorsiflexors.  Diminished reflexes at the biceps, brachial radialis and ankles. Sensory exam impaired to pin prick over fingers and ankles. Temp and vibration also reduced. Tx with IVIgG with development of h/a and fever suspected aseptic meningitis. 6/18/2006 Office records received from 11/12/2008-5/19/2008.  Initially seen with c/o abrupt onset of weakness of the R upper extremity as well as coldness of the extremities.  Unable to grip or start the ignition of her car. Referred to Neurologist. Seen again 2/5/08 with cold sx with recent hx of atypical Guillain Barre syndrome
Age: 1.53
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Starting approximately 24 hours after vacination, patient experienced fevers ranging from 101-103.5 that have continued for >72 hrs, requiring ibuprofen to reduce fever and fussiness.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Pain, Rash, Rash erythematous, Rash papular
Clinical narrative: Patient developed fine erythematous papular rash on cheeks after receiving the vaccine.  The rash was pruritic.  She also developed itching of her eyes and body aches.  She says it is at night.  She was already taking OTC antihistamines- Tavist, Claritin and Benadryl.  I treated with Atarax 25mg.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Patient developed fine erythematous papular rash on cheeks after receiving the vaccine.  The rash was pruritic.  She also developed itching of her eyes and body aches.  She says it is at night.  She was already taking OTC antihistamines- Tavist, Claritin and Benadryl.  I treated with Atarax 25mg.
Age: 0.51
Sex: F
Vaccine: PNC, RV5
Symptoms: Tremor
Clinical narrative: Pt was shaking shortly after immunization administered.  No Vomiting, No Fever, Alert and active.
Age: 5.0
Sex: F
Vaccine: DTAP, DTIPV, MMR, OPV
Symptoms: Lethargy, Pallor, Throat irritation, Vomiting
Clinical narrative: PT BECAME PALE, LETHARGIC. VOMITED.  PT STATED THROAT FEELS FUNNY.  EPI PEN JR.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Significant swelling at the site of injection. 5"x4" local reaction with lot of pain Fever up to 101.6 degree Fahrenheit. Treated with Tylenol and Benadryl and Ice pack.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Scratch, Varicella
Clinical narrative: Pt returned to office 3/6/08 with rash of about 24 hrs. Spreading and noted scratching. History of fever 101 and vomiting 2 days earlier. Examining MD noted vesicles with erythemic rash - generalized; Diagnosis clinically of Varicella. Treatments recommended: Benadryl, Tylenol and/or calamine lotion as needed.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt returned to office 3/6/08 with rash of about 24 hrs. Spreading and noted scratching. History of fever 101 and vomiting 2 days earlier. Examining MD noted vesicles with erythemic rash - generalized; Diagnosis clinically of Varicella. Treatments recommended: Benadryl, Tylenol and/or calamine lotion as needed.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Blister, Pyrexia, Rash vesicular, Scab
Clinical narrative: Administered vaccine on 3-17, on 3-29 developed varicella like rash that remained on head, face, arms, neck, torso only. No itching or itchiness at all, no pain at all. Rash persisted despite administration of Benadryl. Developed fever after rash on day 2 of 102. Fever on day three became 103 despite treatment with Motrin and Tylenol. Day 4 he had 105.5 fever again despite treatment with medications. Near no medical facilities, we put him in an ice bath to bring down his fever that would not stop going up. We finally got him to level off at 102.5 for day 5, 6, and 7 with non-stop medications in him. Day 8, 9, 10 fever dropped to 101 and by day 12 was done. Day 14 blister are crusted and healing. Patient has already had chicken pox. We entertained the possibility of a reocurrence however no one he has been to school with or played with has a current or recent outbreak. He has had reactions to DTP and DTap as well.  4/15/08 Reviewed vax record which provides lot # for Hep A as GSK AHAVB216AA.  Office vs of 4/10/08 for rash all over body x 2 weeks, fatigue & fever. No vesicles, now scabbed over.   FINAL DX: varicella post vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Headache, Herpes zoster, Ocular hyperaemia, Sinusitis
Clinical narrative: 4/1/08 had slight headache day of vac. 4/2/08 felt well, 4/3/08 awoke w/ red eye and irritation around eye. Appt w/ PCP DX sinus infection-- was given antibiotic oral and oint for eye.  4/6/08 symptoms worse--went to ER w/ DX shingles. ER MD gave Rx Valtrex.  4/7/08 appt w/ ophthalmologist eye OK, but Rx Valtrex.  4/10/08 SX much better, no PHN.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: States he received the Zostavax vaccine at the pharmacy on 3/25/08.  States he had shingles when he was vaccinated and "should have never received the vaccine".  Had an outbreak of shingles on the right chest and right back.  Outbreak is improving now, and patient now has an order for gabapentin to help with the pain.  Also received acyclovir 800 mg q4h following the immunization. Patient denied having any other immunizations in the month prior to receiving Zostavax.
Age: 0.16
Sex: F
Vaccine: 6VAX-F, HIBV, PNC, RV5
Symptoms: Bacterial culture negative, Culture stool, Haematochezia
Clinical narrative: TWO DAYS AFTER RECEIVING IMMUNIZATIONS, INCLUDING ROTATEQ, PRESENTED TO OFFICE WITH BLOODY STOOL
Age: 47.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Face oedema, Fatigue, Pain, Productive cough, Pyrexia
Clinical narrative: Patient received vaccination within 3 days began to have low grade fever was assessed by personal physician.  Reported to have low grade fever, achiness and fatigue.  Dr. was concerned that patient may have been having a reaction to Yellow Fever immunization.  1 day later fever appeared to be waning, productive cough developed.  Writer encouraged Primary care MD to perform Influenza culture.  Unsure if that was done.
Age: 0.28
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: ON 04/07/08, THE 2 MONTH IMMUNIZATIONS OF PEDIARIX, PREVNAR, ACT HIB AND ROTATEQ WERE ADMINISTERED TO THIS PATIENT AT HER CURRENT AGE OF 3 1/2 MONTHS. THERE WERE NO ADVERSE EFFECTS NOTED WHILE IN THE OFFICE.  THERE WERE NO PHONE CALLS FROM PARENTS REPORTING PROBLEMS AFTER LEAVING THE OFFICE.  MEDICAL EXAMINER CALLED THIS MORNING (04/11/08) TO MAKE DR. AWARE THAT PATIENT HAD BEEN FOUND UNRESPONSIVE ON MORNING OF 4/11/08.  RESCUE SQUAD WAS UNABLE TO RESCUSITATE THE INFANT.  CASE IS BEING INVESTIGATED BY COUNTY SHERIFF'S OFFICE AND IS MEDICAL EXAMINER'S CASE. AUTOPSY WILL BE DONE. AT PRESENT THE PRESUMED DIAGNOSIS IS SUDDEN INFANT DEATH SYNDROME.  6/27/08 Autopsy states COD as sudden unexplained infant death assoc w/prior sibling death, non-standard bedding & prematurity.  Autopsy states no evidence of trauma, disease or congenital anomaly.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Confusional state, Cough, Nasopharyngitis
Clinical narrative: Student received Tdap with PPD placement on 4/9/2008. At that time she states she had a mild cough and other cold type symptoms. She claims that within a half hour of receiving the vaccine she developed shakes, total body aches and confusion. She was able to drive herself home, took her temperature and it was 102.6. She took Tylenol and went to bed. At 1am she woke up continuing to have the same symptoms, her temperature at that time was 104.9. She did not seek medical care but took more Tylenol. Today student was able to attend school, she continues to feel weak, achy and febrile with her temperature reading 101.3 this am. Student instructed to continue to monitor her health. Take Tylenol or ibuprofen, as needed for fever and other symptoms. If she is not better by Monday, she is to contact me at my work email. VAERS form to be completed.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tremor
Clinical narrative: Student received Tdap with PPD placement on 4/9/2008. At that time she states she had a mild cough and other cold type symptoms. She claims that within a half hour of receiving the vaccine she developed shakes, total body aches and confusion. She was able to drive herself home, took her temperature and it was 102.6. She took Tylenol and went to bed. At 1am she woke up continuing to have the same symptoms, her temperature at that time was 104.9. She did not seek medical care but took more Tylenol. Today student was able to attend school, she continues to feel weak, achy and febrile with her temperature reading 101.3 this am. Student instructed to continue to monitor her health. Take Tylenol or ibuprofen, as needed for fever and other symptoms. If she is not better by Monday, she is to contact me at my work email. VAERS form to be completed.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood creatinine normal, Blood glucose increased, Free prostate-specific antigen increased, Glycosylated haemoglobin increased
Clinical narrative: Zostavax 0.65 mg SC given on 4/4/08.  24 hours later, painful red rash and vesicles on R face, scalp and eye consistent with zoster ophthalmicus. In other words, he developed shingles one day after shingles vaccine given.  No contraindications for vaccine.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic, Pain, Rash erythematous
Clinical narrative: Zostavax 0.65 mg SC given on 4/4/08.  24 hours later, painful red rash and vesicles on R face, scalp and eye consistent with zoster ophthalmicus. In other words, he developed shingles one day after shingles vaccine given.  No contraindications for vaccine.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Urticaria, lip swelling, itching -> given Benadryl PO -> resolution of symptoms started within 10 minutes of Benadryl, and complete within 30 minutes.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Chest pain, Dizziness, Electrolyte imbalance, Fatigue
Clinical narrative: Chronic fatigue, chronic headaches, chronic dizzy spells, chest pain, PVC's, fever, muscle aches, mood swings, memory loss, burning sensations on skin, etc. PT suffers from a multitude of other symptoms, but the above are the most predominant.  PT did not seek medical attention until after arriving home from his deployment.  Started having intermittent headaches, but they have been constant since January 26th, 2008 - 2 days after arriving back home.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Mood swings, Myalgia, Pyrexia, Skin burning sensation
Clinical narrative: Chronic fatigue, chronic headaches, chronic dizzy spells, chest pain, PVC's, fever, muscle aches, mood swings, memory loss, burning sensations on skin, etc. PT suffers from a multitude of other symptoms, but the above are the most predominant.  PT did not seek medical attention until after arriving home from his deployment.  Started having intermittent headaches, but they have been constant since January 26th, 2008 - 2 days after arriving back home.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Ventricular extrasystoles
Clinical narrative: Chronic fatigue, chronic headaches, chronic dizzy spells, chest pain, PVC's, fever, muscle aches, mood swings, memory loss, burning sensations on skin, etc. PT suffers from a multitude of other symptoms, but the above are the most predominant.  PT did not seek medical attention until after arriving home from his deployment.  Started having intermittent headaches, but they have been constant since January 26th, 2008 - 2 days after arriving back home.
Age: 0.21
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Meningitis pneumococcal, Pneumococcal bacteraemia, Pyrexia
Clinical narrative: Presented 4/6/08 with fever and subsequently diagnosed with pneumococcal meningitis and bacteremia.  7/11/08 Reviewed hospital medical records of 4/6-4/21/2008. FINAL DX: pneumococcal meningitis & bacteremia Records reveal patient experienced stuffy nose & congestion x 1 wek prior to vaccinations.  Irritable on day of vaccinations then developed fever, reduced oral intake.  Consults by ID.  Intermittent fevers but improved w/neg c/s & improved appetite after 3-4 days.  Tx w/IV antibiotics x 14 days & d/c to home. Annual Follow-up Information 16-APR-2009: Patient transferred to family practise.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Computerised tomogram abnormal, Culture stool negative, Diarrhoea, Irritable bowel syndrome, Pyrexia
Clinical narrative: She developed diarrhea fever 37 hours after the typhoid vaccine. Diarrhea was watery (8-10/24 hours) daily times 4 days. Seen in the emergency room at Homestead Hospital. Admitted on 10-27-07 until 11-1-07, treated with IV Flagyl and Ceftriaxone, IVFs, NPO. CAT. Post infection/Post vaccine Irritable Bowel Syndrome.  4/28/2008 MR received for DOS 10/27-11/01/2008 with D/C DX:  Acute Colitis. S/P Vaccination.  L Adnexal cyst. Gastritis. Pt presented to ER with nausea, abdominal pain, diarrhea, fever, chills and generalized weakness which began 2 days s/p typhoid vax. PE (+) for Mid epigastric tenderness.  Txd with IV abx and symptomatic tx.
Age: 58.0
Sex: F
Vaccine: HEPAB, IPV, PPV, TDAP, TYP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Size of half dollar - redness and heat at injection site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Nausea, Vomiting
Clinical narrative: 4d post injection c/o nausea with vomiting (L) post leg discomfort esp walking.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt called 9 AM on 4/11/08 c/o at 4" circular red, raised, itching vaccine site. Recommended Benadryl and Ibuprofen.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: (L) arm cellulitis after vaccine (Varicella). Redness/immune reaction.
Age: 52.0
Sex: M
Vaccine: YF
Symptoms: Headache, Pyrexia
Clinical narrative: Headache 2 days post Yellow Fever vaccine (3/8/08) until 4/3/08 after he had a fever overnight. They were in a foreign country at the time without a thermometer to measure his fever. (Wife has the same headache.)
Age: 52.0
Sex: F
Vaccine: YF
Symptoms: Headache, Pain
Clinical narrative: Headache on top of her head and vice-like pain 3-7/10. Pain sometimes alleviated with Tylenol - onset 2 days post Yellow Fever vaccine (Same as husband) but persists to this day.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt called 4/12/08 approximately 11:30 AM. On Thursday AM, 11/10/08 she noticed a rash at site of injection. By 4/10/08 PM, the rash extended from site of injection to elbow. Rash is red, warm, itchy and painful. Rash stayed same through 4/12/08. On 4/13/08 AM, pt reported rash improving and not painful. 09/24/2008 Information has been received from a physician concerning a 67 year old female with no illness at the time of vaccination, allergies to penicillin and sulfonamides who on 09-APR-2008 was vaccinated with ZOSTAVAX (Oka/Merck) SC in the left arm (Lot #659759/1873U) at 1:30 PM. On 09-APR-2008 at 8:00 PM, the patient noticed a rash at the site of injection. By 10-Apr-2008 PM, the rash extended from the site of the injection to the elbow. The rash was red, warm, itchy, and painful. The rash remained the same through 12-Apr-2008. On 13-Apr-2008, the patient reported that the rash was improving and not painful. Follow up information was received from the physician with no additional information. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Pallor
Clinical narrative: Local blanching redness at deltoid site of injection.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt rec'd imms 3/27/08 and at time denied pregnancy. On 4/10/08 home pregnancy test (+). Pt has no PCP and no OB/GYN MD. Advised husband to find PCP or OB/GYN and have confirmatory blood test for pregnancy.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Rash
Clinical narrative: On 3/31/08 a few hours after receiving the vaccine: cough and nasal congestion worsened, rash appeared on left leg. On 04/01/08: The rash spread to both legs, arms, and torso. On 04/02/08: Pt was sent to see MD for treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Oedema peripheral, Pruritus
Clinical narrative: Pt received vaccine son Wednesday. Thurs. his parent reported that he had (L) arm swelling, itching, and pain at injection site. No N&V, no fever, no constitutional sxs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Large, red, swollen area in (Rt) upper thigh approx 8cm x 8cm, very warm to touch.
Age: 65.0
Sex: F
Vaccine: HEP, TD, TYP
Symptoms: Chills, Culture, Pyrexia
Clinical narrative: 4-7-08 around 7 or 8 pm "felt not so good. Went to bed. 4-8-08 Felt bad - really bad fever up to 100.4. Took Tylenol extra strength with no results. C/O chills and fever. took Vanquish with no relief. 4-9-08 Fever down to 100.2 up to 101 on Thursday. 4-10-08 Went to Walk-In clinic.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Anorexia, Blood test normal, Lethargy, Nausea, Pyrexia
Clinical narrative: Lethargic, nausea, vomiting, glassy eyes, no appetite, fever 102.0. Started 30 min after vaccine. Given Zofran and Levison.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Lethargic, nausea, vomiting, glassy eyes, no appetite, fever 102.0. Started 30 min after vaccine. Given Zofran and Levison.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Varicella
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Erythema, Inflammation, Local reaction
Clinical narrative: Redness, inflammation of (L) upper arm. Localized reaction. Benadryl and Tylenol.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling. Tx - Tylenol/Motrin for pain. Presc for Keflex if worse.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Swelling (L) arm and (L) leg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Redness of skin 24 hours after vaccine given.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema multiforme, Hypersensitivity
Clinical narrative: Erythema multiforme (allergic rash) began 4 days after immunizations; treated with Prelone and Benadryl.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Contusion, Injection site ulcer
Clinical narrative: Donor has approx 4 inch bruise and small decubitus ulcer at injection site.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Local reaction, Malaise, Pain, Petechiae
Clinical narrative: Pt complained of headache, malaise, vomiting, local reaction of heat, swelling, pain. Facial rash of periorbital petechiae.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin warm, Swelling, Vomiting
Clinical narrative: Pt complained of headache, malaise, vomiting, local reaction of heat, swelling, pain. Facial rash of periorbital petechiae.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Blood creatine phosphokinase normal, Blood thyroid stimulating hormone, Chest discomfort, Fatigue, Full blood count
Clinical narrative: 4 hour course: 03/23/08 (onset). Office visit: 04/08/08. 4/11/08 Starting to feel better. Symptoms: fatigue; Generalized myalgias, chest discomfort, low grade fever, jaw (muscle) pain.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Pain in jaw, Pyrexia, Urine analysis normal
Clinical narrative: 4 hour course: 03/23/08 (onset). Office visit: 04/08/08. 4/11/08 Starting to feel better. Symptoms: fatigue; Generalized myalgias, chest discomfort, low grade fever, jaw (muscle) pain.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Body temperature increased, Ear pain, Nuclear magnetic resonance imaging normal, Stress
Clinical narrative: On December 17, 2007, four days after receiving the third Gardasil vaccine patient developed violent tics. She was unable to control the movement of her head and limbs. The tics were proceeded by a low grade temperature, then severe shooting ear pain. The following day she was seen by her pediatrician and a pediatric neurologist. Blood tests and MRI's done. There were no positive findings. She was placed on Klonopin and Tenex. The tics reduced and became more manageable. Due to there being no positive findings she was referred to a psychiatrist who gradually took her off Klonopin (the Tenex has been discontinued) and replaced it with Effexor. The tics were controllable, but not gone. Feb 4, 2008 patient developed a low grade temperature, followed by stabbing ear pain, then the tics resumed. She was seen by her ped and ped neuro. Stress was thought to be the cause. They lasted for four days. Then the tics subsided. The temp, ear pain, and violent tics reappeared on March 10 lasting 9 days. Blood tests were run. There were no positive findings. She was seen by the ped, ped neuro and by an ENT. The ENT believes the ear pain was due to clenching of the jaw. She was placed on a soft food diet for two weeks. On April 7 the tics appeared but not as violently. There was a small temperature but no ear pain.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tic
Clinical narrative: On December 17, 2007, four days after receiving the third Gardasil vaccine patient developed violent tics. She was unable to control the movement of her head and limbs. The tics were proceeded by a low grade temperature, then severe shooting ear pain. The following day she was seen by her pediatrician and a pediatric neurologist. Blood tests and MRI's done. There were no positive findings. She was placed on Klonopin and Tenex. The tics reduced and became more manageable. Due to there being no positive findings she was referred to a psychiatrist who gradually took her off Klonopin (the Tenex has been discontinued) and replaced it with Effexor. The tics were controllable, but not gone. Feb 4, 2008 patient developed a low grade temperature, followed by stabbing ear pain, then the tics resumed. She was seen by her ped and ped neuro. Stress was thought to be the cause. They lasted for four days. Then the tics subsided. The temp, ear pain, and violent tics reappeared on March 10 lasting 9 days. Blood tests were run. There were no positive findings. She was seen by the ped, ped neuro and by an ENT. The ENT believes the ear pain was due to clenching of the jaw. She was placed on a soft food diet for two weeks. On April 7 the tics appeared but not as violently. There was a small temperature but no ear pain.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Herpes zoster, Insomnia, Neuralgia, Pain
Clinical narrative: About a week after receiving the flu shot, I developed a painful rash (shingles), increased blood pressure, and insomnia lasting approximately one year. Prescriptions were given for nerve pain to no avail.  After one year I recovered. I will never get a flu shot again. I have been on high blood pressure medicine since this adverse event.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: About a week after receiving the flu shot, I developed a painful rash (shingles), increased blood pressure, and insomnia lasting approximately one year. Prescriptions were given for nerve pain to no avail.  After one year I recovered. I will never get a flu shot again. I have been on high blood pressure medicine since this adverse event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Rash vesicular
Clinical narrative: Patient developed vesicular rash below injection site of Zostavax. Vaccine given on 4-8-08, SQ rt. upper arm.  Patient developed rash 48 hrs later, 4-10-08. 2 x 2 1/2 inch circular area of vesicular rash on right upper arm only, painful.Patient seen in office on 4-12-08. Given Rx. for Valtrex and Medral Dose pack.  Patient to call office in 72 hrs if not improved.
Age: 18.0
Sex: F
Vaccine: DTAP, HEP, MEN, MMR
Symptoms: Abdominal pain, Abnormal behaviour, Activities of daily living impaired, Dyspnoea, Fatigue
Clinical narrative: Patient is having extreme abdominal pain, longterm extreme low immune health, excessive sinus & lung congestion, difficulty breathing, extreme lethargy & fatigue, causing loss of work as well as excessive time in bed not her normal behavior.
Age: 18.0
Sex: F
Vaccine: DTAP, HEP, MEN, MMR
Symptoms: Immune system disorder, Lethargy, Pulmonary congestion, Sinus congestion
Clinical narrative: Patient is having extreme abdominal pain, longterm extreme low immune health, excessive sinus & lung congestion, difficulty breathing, extreme lethargy & fatigue, causing loss of work as well as excessive time in bed not her normal behavior.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Blood culture, Culture urine, Decreased appetite, Full blood count, Irritability
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week. After a few days, fever, lack of appetite, and irritability began.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week. After a few days, fever, lack of appetite, and irritability began.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Activities of daily living impaired, Anorexia, Blood culture, Culture urine, Full blood count
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week. After a few days, fever, lack of appetite, and irritability began.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Urine analysis
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week. After a few days, fever, lack of appetite, and irritability began.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.  Redness has not gone away for about 8 days.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Large local reaction of erythema, induration, and tenderness at varicella site (8 X 11 cm) and at Tdap site (5 X 3 cm).
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large amount of redness, swelling, pain at the injection site about the size of 9x8 area and is increasing in size as the day's pass.
Age: 18.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting, headache, fever of 102'.  Lasted for 24 hrs.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Rec'd Zostavax at 1330 3/19/2008. Thirty hours later (20 March 2000 hours) noticed intense itching left anterior/lateral abdominal wall at approx T10 level, and twelve associated raised welts which then blurred together by 0800 3/21/2008. Associated painful burning. No associated fever, no local reaction at injection site. Presumed to be zoster. Called internist and obtained a script via telephone for Valtrex 1.0 Gram to be taken three times a day for 7 days, and began taking 3/21/2008 at 1400 hours. Saw Dr. at outpatient facility on 3/24/2008 and he confirmed zoster and documented it in the medical record. Used topical calamine lotion from day 3 through 12 while active blisters noted. As of this date the pain and itching have subsided and the "rash" is fading. I believe the vaccine precipitated the zoster I have experienced.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Rec'd Zostavax at 1330 3/19/2008. Thirty hours later (20 March 2000 hours) noticed intense itching left anterior/lateral abdominal wall at approx T10 level, and twelve associated raised welts which then blurred together by 0800 3/21/2008. Associated painful burning. No associated fever, no local reaction at injection site. Presumed to be zoster. Called internist and obtained a script via telephone for Valtrex 1.0 Gram to be taken three times a day for 7 days, and began taking 3/21/2008 at 1400 hours. Saw Dr. at outpatient facility on 3/24/2008 and he confirmed zoster and documented it in the medical record. Used topical calamine lotion from day 3 through 12 while active blisters noted. As of this date the pain and itching have subsided and the "rash" is fading. I believe the vaccine precipitated the zoster I have experienced.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Basal ganglia infarction, Grand mal convulsion, Laboratory test normal
Clinical narrative: Day after vaccination infant had a generalized tonic-clonic seizure.  Recovered spontaneously and completely. Had another generalized seizure 4/12/08 and admitted for further evaluation. CT, LP, chemistries normal. Evaluation proceeds; is still hosptialized.  4/22/2008 ER record received for DOS 3/28/2008 with DX: Seizure, presenting to ER post-ictal.  Infant found in crib staring with arms and legs shaking.  Unresponsive to parent.  Shaking continued 5-10 minutes.  PE WNL except T=100.1'F.  5/12/2008 MR received for DOS 4/13-15/2008 with Final DX: Seizure. Infant presented to ER with 2nd generalized seizure in 3 weeks. Admitted for w/u.  PE (+) for somnolence alternating with irritability, otherwise WNL. Pt had no subsequent seizures and remained afebrile. Follow-up: Continues to have a seizure disorder. Neurodevelopmental status, otherwise, appears to be normal.
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Rash generalised
Clinical narrative: Red dots started forming on hands, arms and face.  Later in the day the red dots had covered her entire body with multiple areas that the dots were severe.  The lesions were very itchy and inflamed.
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Erythema, Inflammation, Pruritus, Rash generalised
Clinical narrative: Red dots started forming on hands, arms and face.  Later in the day the red dots had covered her entire body with multiple areas that the dots were severe.  The lesions were very itchy and inflamed.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Full blood count, Lymphadenitis
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter with no known drug allergies and no medical history reported, who on 04-SEP-2007 was vaccinated intramuscularly with the second dose of Gardasil. Concomitant therapy included ACCUTANE. On 05-SEP-2007, the patient developed acute abdominal pain "within 24 hours of the vaccination," and was hospitalized for three days. The patient was diagnosed with mesenteric lymphadenitis and was treated with antibiotics and pain medications. Diagnostic laboratory studies performed, with no results reported, included: complete blood cell count, urine test, x-ray and computed axial tomography. On 09-SEP-2007 the patient recovered and was released from the hospital. No product quality complaint was involved. Mesenteric lymphadenitis was considered to be disabling and an other important medical event. Additional information has been requested.  5/2/08 Reviewed hospital medical records of 9/7-9/8/07. FINAL DX: non provided, no d/c summary available. Records reveal patient experienced fever, generalized body aches & achy abdominal pain x 1 day, worse on deep inspiration, better if lying down.  Exam revealed tenderness RUQ & RLQ.  Admitted for observation.  GYN & surgical consults done.  D/C to home.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old female who was vaccinated IM with the first dose of GARDASIL (lot# not reported). Subsequently the patient started convulsing and fainted after administration. The patient recovered from her convulsions and from having fainted. After internal review, convulsion was considered to be an other important medical event. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: RV5
Symptoms: Culture stool positive, Rotavirus infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old patient who was vaccinated with the first, second and third doses of Rotateq.  Subsequently the patient experienced rotavirus.  The patient sought medical attention by an emergency room visit and was subsequently hospitalized.  The hospital cultured and documented rotavirus.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, DTPHIB, HEP, HIBV, PNC, RV5
Symptoms: Respiratory syncytial virus infection, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on approximately 12-MAR-2008, was vaccinated PO with his first 2.0 ml dose of ROTATEQ.  On approximately 13-MAR-2008 the day after the vaccine was administered, the patient experienced vomiting.  On approximately 14-MAR-2008 the patient was diagnosed with RSV and was hospitalized for approximately 1 week.  The outcome was unknown.  There was no product quality complaint.  The events were also considered to be other important medical events by the physician.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5, DTPHIB, HEP, HIBV, PNC, RV5
Symptoms: Apnoea, Caffeine consumption, Intensive care, Laboratory test normal, Oxygen supplementation
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on approximately 12-MAR-2008, was vaccinated PO with his first 2.0 ml dose of ROTATEQ.  On approximately 13-MAR-2008 the day after the vaccine was administered, the patient experienced vomiting.  On approximately 14-MAR-2008 the patient was diagnosed with RSV and was hospitalized for approximately 1 week.  The outcome was unknown.  There was no product quality complaint.  The events were also considered to be other important medical events by the physician.  Additional information has been requested.