chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3 inch circular raised red area at (R) thigh.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Bradycardia, Feeling cold, Hyperhidrosis, Hypotension
Clinical narrative: Near syncopal reaction minutes after vaccination.  Hypotensive + bradycardia immediately after near syncopal episode and cool, pale, diaphoretic. Laid down until BP + HR increase soda + crackers provided as he had not eaten.  Reaction like this with blood drawn earlier this year.  Monitored approximately 50 minutes + he left ambulatory with mother.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Pallor, Presyncope
Clinical narrative: Near syncopal reaction minutes after vaccination.  Hypotensive + bradycardia immediately after near syncopal episode and cool, pale, diaphoretic. Laid down until BP + HR increase soda + crackers provided as he had not eaten.  Reaction like this with blood drawn earlier this year.  Monitored approximately 50 minutes + he left ambulatory with mother.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Symptoms, started 11 hours after the injection. Fever 101 deg; shaking chills; no localized reaction; no parathesias. Severe headache.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dyspnoea, Face oedema
Clinical narrative: Facial edema (notable lips & (L) eye), SOB. BENADRYL & SOLUMEDROL given.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Tinnitus
Clinical narrative: 1 hr after receiving Pneumovax & Zostavax, pt began having head fullness/pressure, ears tingling, walk fatigued.  Some lightheadness.  1 wk later still weak.  No fever etc.  No local reaction.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: Vaccine given 6/4/09. Pt developed within 24 hours fever, swelling, chills and generalized hives. She was seen on 6/9/09 when a large erythematous area was noted with swelling and tenderness. She had already been seen at clinic and found to have elevated WBC and had been on Augmentin and Bactrim with no response.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Vaccine given 6/4/09. Pt developed within 24 hours fever, swelling, chills and generalized hives. She was seen on 6/9/09 when a large erythematous area was noted with swelling and tenderness. She had already been seen at clinic and found to have elevated WBC and had been on Augmentin and Bactrim with no response.
Age: 45.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccination LUE with YF Vax 2:30pm 6/15/09 after screening. At approx. 2:35 pt c/o redness, swelling and itching at injection site- 25 mg BENADRYL po. given with 8-12 ounces of H2O. At 2:45 while under observation pt c/o chills, shaky and weakness- 911 called, squad transported to hospital where she was treated and released.
Age: 45.0
Sex: F
Vaccine: YF
Symptoms: Tremor
Clinical narrative: Vaccination LUE with YF Vax 2:30pm 6/15/09 after screening. At approx. 2:35 pt c/o redness, swelling and itching at injection site- 25 mg BENADRYL po. given with 8-12 ounces of H2O. At 2:45 while under observation pt c/o chills, shaky and weakness- 911 called, squad transported to hospital where she was treated and released.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Nodule
Clinical narrative: Swelling, redness at site one day after vaccine administered. Knot under (L) arm two days after.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm - swollen to shoulder & down to end of deltoid muscle observed in office. Dad reported red swollen - req. Abx. therapy.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Non-consummation, Papilloma viral infection, Smear cervix
Clinical narrative: Had PAP at Gyn which came back positive for high risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56 after receiving 3 dose GARDASIL 8/11/06, 1/2207, 6/13/07. Not yet sexually active during immunizations. Will undergo colposcopy.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Flushing, Hyperhidrosis, Hypotonia, Injection site urticaria, Nausea
Clinical narrative: Child became lethargic, flushed, diphoretic and vomited. A 3x4 cm eccentric wheal developed at the left arm site, followed by a wheal at the right arm site and a few urticarial wheals on the trunk. He was afebrile. He improved after receiving 25 mg of oral diphenhydramine.Wheals at the arm injection sites persisted more than 48 hours but the child was well 3 hours after the reaction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Child became lethargic, flushed, diphoretic and vomited. A 3x4 cm eccentric wheal developed at the left arm site, followed by a wheal at the right arm site and a few urticarial wheals on the trunk. He was afebrile. He improved after receiving 25 mg of oral diphenhydramine.Wheals at the arm injection sites persisted more than 48 hours but the child was well 3 hours after the reaction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Flushing, Hyperhidrosis, Injection site urticaria, Lethargy, Urticaria
Clinical narrative: Child became lethargic, flushed, diphoretic and vomited. A 3x4 cm eccentric wheal developed at the left arm site, followed by a wheal at the right arm site and a few urticarial wheals on the trunk. He was afebrile. He improved after receiving 25 mg of oral diphenhydramine.Wheals at the arm injection sites persisted more than 48 hours but the child was well 3 hours after the reaction.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature decreased, Chills, Sleep disorder, Tremor
Clinical narrative: Twenty-four hours after the PPV vaccine (administered at 2:00 PM Thursday, 6/18 PCT)or Friday, 6/19 around 5:00 PM my temperature dropped perceptably and I began to shiver and shake so much that my teeth chattered.  I immediately went to bed with socks, bathrobe, and knit cap and did not stop shaking for three hours having finally warmed up. I had a slight rise in temperature and slept fitfully through the night.  The next day, 6/20, at 11:30 AM I am  feeling better and capable of writing this note.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Confusional state, Fatigue, Headache
Clinical narrative: Confusion; Severe and continuing headache;  Unusual and continuing sleepiness; Unusual tiredness, weakness (sudden and severe); Severe and continuing vomiting; Moderate pain at injection site; Chills; Body aches
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Somnolence, Vomiting
Clinical narrative: Confusion; Severe and continuing headache;  Unusual and continuing sleepiness; Unusual tiredness, weakness (sudden and severe); Severe and continuing vomiting; Moderate pain at injection site; Chills; Body aches
Sex: U
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Lymphadenopathy, Malaise
Clinical narrative: pain at site, chills, unwell, slightly swollen glands.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Heart rate increased, Pain, Systemic lupus erythematosus
Clinical narrative: I was administered the Anthrax Vaccine the on 2 October 2006 due to the fact I was assigned to a foreign country.  Within 48 hours of receiving the first Anthrax vaccine dose of the series I began experiencing episodes of severe strong and rapid heart beats. This typically happened at night while I was trying to sleep.  Each episode would last for about 10 minutes at a time.  This continued for several months after I received the vaccine.  On 4 May 07 I saw MD about what was happening and he submitted a permanent exemption for me not to receive anymore Anthrax vaccine.  Although the cardiac symptoms I was having caused me the most concern, at the same time I began to experience fatigue and body aches.  These symptoms continued and became progressively more severe.  In March 2009 I was diagnosed with Systemic Lupus (S.L.E.) which I strongly suspect was a result of my receiving the Anthrax vaccine on 2 October 2006. 7/16/09 Brief report with Dx: Systemic Lupus Erythematosus.  No further records available as care was received out of the country.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Bedridden, Fatigue, Headache, Pyrexia
Clinical narrative: Extreme tiredess within 1 hour of vaccine.  Within 2 hours of vaccine, headache and fever of 103 degrees F.  Fever and headache reduced by Motrin (300 mg, 3 children's chewable), but would reoccur as soon as Motrin wore off.  42 hours after vaccine, fever minimal, but headache continues.  Pt. bedridden with tiredness, fever, headaches.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: local exaggerated reaction at site of injection. Red, swelling, temp. 99.9, painful
Age: 0.83
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Injection site rash, Injection site urticaria, Irritability, Pyrexia, Rash erythematous
Clinical narrative: DALLAS RECEIVED HEP B, POLIO, PNEUMOCOCCAL DISEAS, DTAP, AND HIB. THE INJECTIONS WERE GIVEN AT 4 PM ON 6-18-2009, WITH IN 12 HOURS HIS LEGS WERE COVERED WITH RED RASH. WHELPS WERE EVIDENT AT THE SITE OF INJECTION ON BOTH LEGS. WITHIN 24 HOURS RASH WAS HEAD TO TOE. ON THE 21ST OF JUNE RASH IS RAISED. FEVER AND FUSSINESS ALSO OCURRED WHICH IS COMMON WITH ALL IMMUNIZATIONS.
Age: 0.83
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Rash generalised
Clinical narrative: DALLAS RECEIVED HEP B, POLIO, PNEUMOCOCCAL DISEAS, DTAP, AND HIB. THE INJECTIONS WERE GIVEN AT 4 PM ON 6-18-2009, WITH IN 12 HOURS HIS LEGS WERE COVERED WITH RED RASH. WHELPS WERE EVIDENT AT THE SITE OF INJECTION ON BOTH LEGS. WITHIN 24 HOURS RASH WAS HEAD TO TOE. ON THE 21ST OF JUNE RASH IS RAISED. FEVER AND FUSSINESS ALSO OCURRED WHICH IS COMMON WITH ALL IMMUNIZATIONS.
Age: 1.58
Sex: M
Vaccine: DTAP, IPV
Symptoms: Irritability, Lethargy, No reaction on previous exposure to drug, Palpitations, Pyrexia
Clinical narrative: My son had his 4th dose of DTAP and his 3rd of Polio on June 18,2009 at appr. 3:30pm.  He was fine before the shots and the evening after.  First thing in the morning on June 19, 2009 he got up and was burning up and very cranky.  He had a fever of 102.5 right away, I gave him tylenol, it barely reduced his fever even after three hours, then it spiked 103.2 the highest he has ever had, I knew it was from the immunizations. I eventually has to administer childrens motrin because tylenol was'nt bringing it down. I called the drs office three times that day (19th) and let them know.  He had never had a reaction before, he was also very lathargic and his heart was racing in his chest.  They told me to keep giving the meds and cool baths.  As of today he is running low grades and is taking tylenol,(4 days later).  I am concerned about giving any further injections of these.
Age: 1.3
Sex: M
Vaccine: MMR, UNK
Symptoms: Body temperature increased, Pharyngeal erythema, Pyrexia
Clinical narrative: Information has been received from a pediatrician concerning a 15 month old male patient who on 14-APR-2008 was vaccinated with a dose of MMR (lot number, dose, and site not reported) along with several other unspecified vaccinations. On 22-APR-2008, the patient started to have fevers of 103 and 104 degrees with a red throat. The patient sought unspecified medical attention. At the time of the repot, the patient had not recovered. The physician thought it may be a viral infection. There was no product quality complaint. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 1 year old female who on 02-OCT-2008 was vaccinated with the first dose of MMRII.  Suspect therapy included VARIVAX.  After the vaccination, the patient experienced a low grade fever for the first two days and later started experiencing a rash around the trunk area (mostly front, sides and a little bit on the back).  The patient also developed a measles-like rash around the injection site that later spread to the face, forehead and cheeks.  The physician thought the reaction was due to MMRII because of the look of the rash.  The rash started to fade away, however the patient is not yet fully recovered.  No product quality complaint involved.  Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning her 6 year old daughter who was vaccinated with a dose of MMRII (lot number not provided) on an unspecified date.  Subsequently the patient developed seizures 4 to 6 months after getting MMRII.  The reporter did not know how many and what other vaccines were administered on the same day.  The patient did not recover at the time of reporting.  The patient sought unspecified medical attention.  Upon internal review, seizures was determined to be an other important medical event.  No further information is available.
Age: 1.3
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Eye disorder, Facial palsy, Lethargy
Clinical narrative: This case was received from a health professional on 09 June 2009. A 15-month-old male patient, with no reported medical history and no illness at time of vaccination, received his fourth injection of DAPTACEL (lot number C3084AA) on 08 June 2009. Approximately one day post-vaccination, he began experiencing episodes of facial drooping, lethargy, and a "glazed look in his eyes". At the time of the report, he had experienced four episodes, and was seen by his physician on 09 June 2009. The symptoms subsequently resolved. No additional information was reported. Additional documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Electroencephalogram, Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: My daughter had the 3rd shot of GARDASIL on Friday 06/05/2009. On Monday the 8th she started experiencing seizures. She was admitted to the hospital on Tuesday the 9th and kept for observation until the 11th. She has had up to 16 seizures in one day. The hospital released her but she still continues to seize. After doing research on-line I've discovered other have also had seizure activity with the GARDASIL vaccine.  6/29/2009 MR received for DOS 6/9-11/2009 with d/C DX:  Pseudoseizure. 2' dx: Depression.  Anxiety.  L2 fx s/p MVA 3 weeks ago.  Pt presented to ER after several episodes of twitching, shaking arms and legs, myoclonic jerking followed by somnolence/decreased responsiveness/confusion.  Witnessed episode in ED and during EEG, not c/w seizures.  Psych consult done and to continue with previously Rx'd meds. 10/21/09 ICD9 codes: 781.0, 300.00, 311, 493.90, V155.11
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood potassium decreased, Computerised tomogram, Dehydration, Electroencephalogram, Electrolyte imbalance
Clinical narrative: My daughter had the 3rd shot of GARDASIL on Friday 06/05/2009. On Monday the 8th she started experiencing seizures. She was admitted to the hospital on Tuesday the 9th and kept for observation until the 11th. She has had up to 16 seizures in one day. The hospital released her but she still continues to seize. After doing research on-line I've discovered other have also had seizure activity with the GARDASIL vaccine.  6/29/2009 MR received for DOS 6/9-11/2009 with d/C DX:  Pseudoseizure. 2' dx: Depression.  Anxiety.  L2 fx s/p MVA 3 weeks ago.  Pt presented to ER after several episodes of twitching, shaking arms and legs, myoclonic jerking followed by somnolence/decreased responsiveness/confusion.  Witnessed episode in ED and during EEG, not c/w seizures.  Psych consult done and to continue with previously Rx'd meds. 10/21/09 ICD9 codes: 781.0, 300.00, 311, 493.90, V155.11
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count, Grand mal convulsion, Muscle twitching, Myoclonus, Nuclear magnetic resonance imaging
Clinical narrative: My daughter had the 3rd shot of GARDASIL on Friday 06/05/2009. On Monday the 8th she started experiencing seizures. She was admitted to the hospital on Tuesday the 9th and kept for observation until the 11th. She has had up to 16 seizures in one day. The hospital released her but she still continues to seize. After doing research on-line I've discovered other have also had seizure activity with the GARDASIL vaccine.  6/29/2009 MR received for DOS 6/9-11/2009 with d/C DX:  Pseudoseizure. 2' dx: Depression.  Anxiety.  L2 fx s/p MVA 3 weeks ago.  Pt presented to ER after several episodes of twitching, shaking arms and legs, myoclonic jerking followed by somnolence/decreased responsiveness/confusion.  Witnessed episode in ED and during EEG, not c/w seizures.  Psych consult done and to continue with previously Rx'd meds. 10/21/09 ICD9 codes: 781.0, 300.00, 311, 493.90, V155.11
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urine analysis
Clinical narrative: My daughter had the 3rd shot of GARDASIL on Friday 06/05/2009. On Monday the 8th she started experiencing seizures. She was admitted to the hospital on Tuesday the 9th and kept for observation until the 11th. She has had up to 16 seizures in one day. The hospital released her but she still continues to seize. After doing research on-line I've discovered other have also had seizure activity with the GARDASIL vaccine.  6/29/2009 MR received for DOS 6/9-11/2009 with d/C DX:  Pseudoseizure. 2' dx: Depression.  Anxiety.  L2 fx s/p MVA 3 weeks ago.  Pt presented to ER after several episodes of twitching, shaking arms and legs, myoclonic jerking followed by somnolence/decreased responsiveness/confusion.  Witnessed episode in ED and during EEG, not c/w seizures.  Psych consult done and to continue with previously Rx'd meds. 10/21/09 ICD9 codes: 781.0, 300.00, 311, 493.90, V155.11
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Encephalitis post varicella, Herpes zoster, Intensive care, Varicella
Clinical narrative: Information has been received from a physician concerning an 82 year old female patient with renal insufficiency, hypertension, coronary artery disease, a history of "diabetes", asthma, and a previous myocardial infarction (MI) who on 09-DEC-2008 was vaccinated subcutaneously in the right arm with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 662860/1617X, expiration date 14-MAY-2010). The physician reported that the patient's husband had shingles and the patient inquired about the vaccine. The physician confirmed that the patient's husband was not vaccinated with ZOSTAVAX (Merck) prior to developing shingles. Shortly after vaccination within 1 week to 1 month the patient developed an illness. The patient experienced shingles after receiving ZOSTAVAX (Merck). The patient was admitted to the hospital on 09-JAN-2009. She was in the ICU and then transferred to the long term unit prior to passing away. The physician explained that the hospital records mention varicella encephalitis, chickenpox complicated with encephalitis. He indicated that shingles was mentioned in the chart once. The physician did not provide a definitive diagnosis or cause of death. Shingles and pass away due to complication from the shingles were considered to be disabling and immediately life-threatening. Upon international review, the patient's varicella encephalitis was considered to be other important medical event. A lot check has been requested. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cardiac monitoring, Feeling of body temperature change, Malignant hypertension, Tachycardia, Tinnitus
Clinical narrative: This case was received from a health professional on 09 June 2009. A 49-year-old male patient, with a history of seasonal allergies, received an injection of FLUZONE SV '2005-'2006 USP (lot number U1753AA) on 27 October 2005. Two days post-vaccination, on 29 October 2005, he experienced malignant hypertension, tachycardia, "hot and cold" sensations, and ringing in the ears. He was treated with three courses of prednisone, and underwent a full cardiac work-up (results not provided). The "hot and cold" sensation and ringing in the ears remained ongoing. Of note, the patient had also received a flu vaccine (manufacturer and lot number not reported) in January 2005. In addition, this reporter noted that the patient's sister also experienced a similar event after receiving FLUZONE (lot number U1846AA) in 2005. That event is captured in case number 2009-02506.
Sex: F
Vaccine: FLU3
Symptoms: Cardiac disorder
Clinical narrative: This case was received from a health care professional on 09 June 2009. A female patient received an injection of FLUZONE SV '2005-'2006 USP (lot number U1846AA) on 17 October 2005. Within a few days of vaccination, she experienced "cardiac like symptoms". No additional information was reported. The reporter in this case also reported that the patient's brother experienced "similar symptoms" after receiving FLUZONE in 2005 (lot number U1753AA). This information is captured in case number 2009-02505.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Gastroenteritis, Helicobacter pylori identification test negative, Influenza serology negative
Clinical narrative: Information has been received from a physician concerning a 6 month old male patient who on 06-JAN-2009 was vaccinated with one dose of ROTATEQ. It was reported that on 09-MAR-2009 the patient was diagnosed with rotavirus. The patient sought medical attention via office visit. The outcome of the patient was unknown. Follow-up information has been from a registered nurse in the physician's office concerning the 18 week old male patient who on 06-JAN-2009 was vaccinated with the first dose of ROTATEQ (lot # 662654/1356X). Vaccine received at the same day included DAPTACEL (lot # C3000AA) into his right thigh, ACTHIB (lot #: UF519AA) into his right thigh, IPOL (lot #: A1229) into his left thigh and PREVNAR (lot #: C45721H) into his right thigh. On 08-MAR-2009 the patient experienced diarrhea and vomiting and was taken to emergency room. The primary diagnoses was acute gastroenteritis. On 08-MAR-2009, stool rotavirus antigen test was performed, which was positive for rotavirus antigen. The patient was hospitalized with rotavirus for 8 days. On 08-MAR-2009, wright stain for white blood cell (WBC) and red blood cell (RBC) on stool was performed, segs, Lymphocytes, eosinophil and red blood cell were not seen. On 08-MAR-2009, other lab test performed included respiratory syncytial virus (RSV) in nasopharyngeal wash negative, influenza A and B antigen in nasal swab negative, stool campylobacter smear negative and stool SHIGA-LIKE toxin assay showed negative for SHGA toxin-producing E. coli. Stool culture was performed on 08-MAR-2009, the result on 10-MAR-2009 revealed normal enteric flora, no salmonella or shigella isolated and no campylobacter isolated. On 13-MAR-2009, stool rotavirus was still positive and stool culture was negative. The patient recovered from rotavirus/acute gastroenteritis. Follow-up information received on 11-JUN-2009 contained the following adverse experience: Upper respiratory infection (08-MAR-2009). Additional information has been requested. All available medical records will be provided upon request.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Respiratory syncytial virus test negative, Rotavirus infection, Rotavirus test positive, Stool analysis normal, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 6 month old male patient who on 06-JAN-2009 was vaccinated with one dose of ROTATEQ. It was reported that on 09-MAR-2009 the patient was diagnosed with rotavirus. The patient sought medical attention via office visit. The outcome of the patient was unknown. Follow-up information has been from a registered nurse in the physician's office concerning the 18 week old male patient who on 06-JAN-2009 was vaccinated with the first dose of ROTATEQ (lot # 662654/1356X). Vaccine received at the same day included DAPTACEL (lot # C3000AA) into his right thigh, ACTHIB (lot #: UF519AA) into his right thigh, IPOL (lot #: A1229) into his left thigh and PREVNAR (lot #: C45721H) into his right thigh. On 08-MAR-2009 the patient experienced diarrhea and vomiting and was taken to emergency room. The primary diagnoses was acute gastroenteritis. On 08-MAR-2009, stool rotavirus antigen test was performed, which was positive for rotavirus antigen. The patient was hospitalized with rotavirus for 8 days. On 08-MAR-2009, wright stain for white blood cell (WBC) and red blood cell (RBC) on stool was performed, segs, Lymphocytes, eosinophil and red blood cell were not seen. On 08-MAR-2009, other lab test performed included respiratory syncytial virus (RSV) in nasopharyngeal wash negative, influenza A and B antigen in nasal swab negative, stool campylobacter smear negative and stool SHIGA-LIKE toxin assay showed negative for SHGA toxin-producing E. coli. Stool culture was performed on 08-MAR-2009, the result on 10-MAR-2009 revealed normal enteric flora, no salmonella or shigella isolated and no campylobacter isolated. On 13-MAR-2009, stool rotavirus was still positive and stool culture was negative. The patient recovered from rotavirus/acute gastroenteritis. Follow-up information received on 11-JUN-2009 contained the following adverse experience: Upper respiratory infection (08-MAR-2009). Additional information has been requested. All available medical records will be provided upon request.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old male patient who on 06-JAN-2009 was vaccinated with one dose of ROTATEQ. It was reported that on 09-MAR-2009 the patient was diagnosed with rotavirus. The patient sought medical attention via office visit. The outcome of the patient was unknown. Follow-up information has been from a registered nurse in the physician's office concerning the 18 week old male patient who on 06-JAN-2009 was vaccinated with the first dose of ROTATEQ (lot # 662654/1356X). Vaccine received at the same day included DAPTACEL (lot # C3000AA) into his right thigh, ACTHIB (lot #: UF519AA) into his right thigh, IPOL (lot #: A1229) into his left thigh and PREVNAR (lot #: C45721H) into his right thigh. On 08-MAR-2009 the patient experienced diarrhea and vomiting and was taken to emergency room. The primary diagnoses was acute gastroenteritis. On 08-MAR-2009, stool rotavirus antigen test was performed, which was positive for rotavirus antigen. The patient was hospitalized with rotavirus for 8 days. On 08-MAR-2009, wright stain for white blood cell (WBC) and red blood cell (RBC) on stool was performed, segs, Lymphocytes, eosinophil and red blood cell were not seen. On 08-MAR-2009, other lab test performed included respiratory syncytial virus (RSV) in nasopharyngeal wash negative, influenza A and B antigen in nasal swab negative, stool campylobacter smear negative and stool SHIGA-LIKE toxin assay showed negative for SHGA toxin-producing E. coli. Stool culture was performed on 08-MAR-2009, the result on 10-MAR-2009 revealed normal enteric flora, no salmonella or shigella isolated and no campylobacter isolated. On 13-MAR-2009, stool rotavirus was still positive and stool culture was negative. The patient recovered from rotavirus/acute gastroenteritis. Follow-up information received on 11-JUN-2009 contained the following adverse experience: Upper respiratory infection (08-MAR-2009). Additional information has been requested. All available medical records will be provided upon request.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Neonatal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a 17 year old female, for the pregnancy registry for GARDASIL, with asthma and VICODIN allergy, who in January 2008, was vaccinated with the first dose of GARDASIL. On 21-MAR-2008, the patient received the second dose of GARDASIL. Concomitant therapy included albuterol. The patient reported that on 25-MAR-2008, she found out she was pregnant. On an unspecified date, the patient had a pregnancy test that was positive. At the time of the report, the patient was 22 weeks and 4 days gestation. Her LMP was 15-FEB-2008 and EDD 21-NOV-2008. The patient sought medical attention. Follow-up information was received from a nurse who reported that on 17-NOV-2008, the patient had a cesarean section done because her baby was in a breech position. The patient reported the baby's weight at birth was 7 pounds and 13 oz. At the time of the report, the patient reported that she had a six month old "healthy and big" baby who weighed 20+pounds. The patient stated that the baby had asthma, and an inhaler, but that he was doing ok with that; and that the doctors were trying to figure that out, but did not know if he had allergies or not yet. At the time of the report the patient stated that she was feeling better from the cesarean section but still felt a little tender sometimes. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL from a registered nurse concerning a 14 year old female with no pertinent medical history and no history of drug reactions or allergies who on 18-AUG-2008 was vaccinated with the first dose of GARDASIL (lot#: 659653/1448U) 0.5ml IM. There was no concomitant medication. A subsequent pregnancy test on the same day was positive. No problems were reported. The LMP was "3 weeks ago" (on approximately 29-JUL-2008). The EDD is 05-MAY-2009. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse concerning the 14 year old female patient who on an unspecified date had a pregnancy termination. Upon internal review, pregnancy terminated was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Computerised tomogram head, Computerised tomogram normal, Contusion, Dyspnoea
Clinical narrative: Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included "LOLESTRA". The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient's immune system was compromised and believed it was from GARDASIL " The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified)." The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling. Additional information has been requested.  7/24/09 Clinical summary rec'd from PCP including 2 consults-Heme/Onc and Allergy/Asthma. Dx since vaccines: Mononucleosis, infectious. Sinusitis, acute. Viral syndrome.  Weight loss, abnormal. Depression. Splenomegaly. Fatigue.  Bronchitis.  Chest pain. Leg pain.  Seen by allergy/asthma MD 1/26/09 for: Chronic rhinitis with possible allergic trigger, Chronic cough, resolving most likely related to post-nasal drip from rhinitis, possible tongu angioedema vs irritation. Exam WNL. Heme/Onc consult for MTHFR mutation heterozygosity. C/O fatigue, tiredness, arthralgias/myalgias as well abdominal sx.  (+) features of Chronic Fatigue Immune Dysfunction syndrome.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hypophagia, Immobile, Immune system disorder, Infectious mononucleosis
Clinical narrative: Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included "LOLESTRA". The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient's immune system was compromised and believed it was from GARDASIL " The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified)." The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling. Additional information has been requested.  7/24/09 Clinical summary rec'd from PCP including 2 consults-Heme/Onc and Allergy/Asthma. Dx since vaccines: Mononucleosis, infectious. Sinusitis, acute. Viral syndrome.  Weight loss, abnormal. Depression. Splenomegaly. Fatigue.  Bronchitis.  Chest pain. Leg pain.  Seen by allergy/asthma MD 1/26/09 for: Chronic rhinitis with possible allergic trigger, Chronic cough, resolving most likely related to post-nasal drip from rhinitis, possible tongu angioedema vs irritation. Exam WNL. Heme/Onc consult for MTHFR mutation heterozygosity. C/O fatigue, tiredness, arthralgias/myalgias as well abdominal sx.  (+) features of Chronic Fatigue Immune Dysfunction syndrome.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Malaise, Nuclear magnetic resonance imaging normal, Paralysis, Paranasal cyst
Clinical narrative: Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included "LOLESTRA". The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient's immune system was compromised and believed it was from GARDASIL " The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified)." The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling. Additional information has been requested.  7/24/09 Clinical summary rec'd from PCP including 2 consults-Heme/Onc and Allergy/Asthma. Dx since vaccines: Mononucleosis, infectious. Sinusitis, acute. Viral syndrome.  Weight loss, abnormal. Depression. Splenomegaly. Fatigue.  Bronchitis.  Chest pain. Leg pain.  Seen by allergy/asthma MD 1/26/09 for: Chronic rhinitis with possible allergic trigger, Chronic cough, resolving most likely related to post-nasal drip from rhinitis, possible tongu angioedema vs irritation. Exam WNL. Heme/Onc consult for MTHFR mutation heterozygosity. C/O fatigue, tiredness, arthralgias/myalgias as well abdominal sx.  (+) features of Chronic Fatigue Immune Dysfunction syndrome.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Sinusitis, Surgery, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included "LOLESTRA". The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient's immune system was compromised and believed it was from GARDASIL " The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified)." The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling. Additional information has been requested.  7/24/09 Clinical summary rec'd from PCP including 2 consults-Heme/Onc and Allergy/Asthma. Dx since vaccines: Mononucleosis, infectious. Sinusitis, acute. Viral syndrome.  Weight loss, abnormal. Depression. Splenomegaly. Fatigue.  Bronchitis.  Chest pain. Leg pain.  Seen by allergy/asthma MD 1/26/09 for: Chronic rhinitis with possible allergic trigger, Chronic cough, resolving most likely related to post-nasal drip from rhinitis, possible tongu angioedema vs irritation. Exam WNL. Heme/Onc consult for MTHFR mutation heterozygosity. C/O fatigue, tiredness, arthralgias/myalgias as well abdominal sx.  (+) features of Chronic Fatigue Immune Dysfunction syndrome.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site pain, Injection site rash, Injection site warmth, Pain
Clinical narrative: The morning after receiving the vaccine (06/18/2009) she woke up with severe body aches, felt like the flu, and Rt. deltoid warm and tender to the touch. The next day she noticed a raised rash distal to the injection site on the deltoid and still warm to the touch for three days following that. All symptoms gone as of 06/21/2009
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin negative, Computerised tomogram normal, Full blood count normal, Metabolic function test normal, Red blood cell count increased
Clinical narrative: Patient in for doctor's visit and was ordered Gardasil vaccination. Patient received vaccination and was instructed to remain in waiting are for 20 minutes after immunization. Patient was apprehensive from begining and stated that she did not like needles. Patient left immunizations room and went to front desk to make appointment and had a syncope episode at front desk. When called to front desk a provider and staff were tending to patient by placing legs above heart and patient was awake and coherent.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient in for doctor's visit and was ordered Gardasil vaccination. Patient received vaccination and was instructed to remain in waiting are for 20 minutes after immunization. Patient was apprehensive from begining and stated that she did not like needles. Patient left immunizations room and went to front desk to make appointment and had a syncope episode at front desk. When called to front desk a provider and staff were tending to patient by placing legs above heart and patient was awake and coherent.
Age: 69.0
Sex: M
Vaccine: RAB
Symptoms: Localised oedema, Rash pruritic, Urticaria
Clinical narrative: Approximately 2 to 4 days after 2nd rabies vaccine, pt developed widespread, wheal-like rash to lower arms, lower legs, back of neck, & upper chest.  Rash was pruritic, worsened by sun exposure, & associated with localized edema. Per pt, denies any systemic symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diet refusal, Irritability, Pyrexia
Clinical narrative: Mother came in 6/22/09 stating that child has been fussy, running a low grade fever and unwilling to take a bottle since vaccines given. No fever today, no sign of redness or swelling at injection sites, remains fussy
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: THERE WERE NO ADVERSE EVENTS THAT WE ARE AWARE OF  THE PATIENT DIED 06/11/09 WITH MEDICAL RESULTS PENDING  I WAS TOLD I NEEDED TO FILL OUT REPORT REGARDLESS OF LACK OF PROOF THAT VACCINATION CONTRIBUTED WITH HIS DEATH.  8/31/09 Autopsy Report received. DOD 6/11/09 Cause of Death: Sudden Infant Death Syndrome (SIDS). Manner of Death: Natural.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Genital lesion, Pruritus, Skin lesion
Clinical narrative: Complaining of lesions on right wrist, hand, and genital region 8 days after small pox inoculation. Instructions on keeping lesions convered, good hand washing, Atarax for itching. 6/26/09 Per reporter, pt scratched and spread skin lesions, seen at ER and PCP dx: vaccine auto inoculation. 8/28/09 ER report received dated 6/20/09 with dx: Vaccinia-auto-innoculation. Vesicular lesions noted on various ares of the body. Tx: Atarax
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented with red, swollen, painful area on arm where vaccine was administered approximately 72 hours after shot was given. We told her to put ice on the area and take some acetaminophen for the pain. She then presented 8 days after the vaccination was administered - the area was still slightly pink in color and painful, but did no longer "feel like a knot". She stated the ice and pain pills had helped.
Age: 24.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Altered state of consciousness, Immediate post-injection reaction
Clinical narrative: Immediately after Pt received second vaccine:  Twinrix, Her head went forward towards knees. Pt was returned to sitting position and regained awareness. States she had not eaten all day- (late afternoon)
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paraesthesia, Skin discolouration, Tenderness, Urticaria
Clinical narrative: patient examined - tender, urticarial type reaction distal to injection site.  Large tender, raised urticaria, with central dusky discoloration on forearm, with satellite urticaria further down the arm..  Has paresthesias in the fingertips, and pain with biceps flexion. No history of egg allergy will report & f/u 1 week
Age: 33.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Chest discomfort, Cough, Dizziness, Malaise, Musculoskeletal stiffness
Clinical narrative: Within about 3-4 hours I had a tight chest and nagging cough when I took a deep breath.  Little dizzy on day 2 and blood spot in my eye (never had that happen before, but I kind of assumed it was related to just coughing at night) and cough got a little worse, but still went for a bike ride, so it wasn't that bad and I assumed it was normal.  By Sunday morning I was definitely sick, felt feverish periodically during the day, and slept most of the day.  Coughing and sore throat. Still a little dizzy and congested today (Monday) with stiff neck and muscles, Monday morning (now). Waiting to start Typhoid oral until I feel better. Just filling this out for the record.  I don't imagine this is a big deal, but will call doctor tomorrow if I'm not feeling better.  I haven't had a cold or flu for almost a year, which is a long time for me so maybe it's just a coincidence that I finally got sick the same time as the vaccines.