chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash, Skin warm, Swelling
Clinical narrative: PATIENT STATED ARM WAS SWOLLEN, RED, HOT TO TOUCH AND PAINFUL 2 DAYS FOLLOWING ADMINISTRATION. SHE CALLED DR WHO TOLD HER TO REPORT IT TO THE PHARAMCY, SHE WAS NOT SEEN BY DR. PATIENT PRESENTED TO THE PHARMACY 4 DAYS FOLLOWING THE VACCINE WITH ~8 INCH RASH ON UPPER LEFT ARM, ARM SLIGHTLY SWOLLEN, AND PAINFUL. SHE HAD BEEN TAKING CLORTRIMATON.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: PATIENT STATED ARM WAS SWOLLEN, RED, HOT TO TOUCH AND PAINFUL 2 DAYS FOLLOWING ADMINISTRATION. SHE CALLED DR WHO TOLD HER TO REPORT IT TO THE PHARAMCY, SHE WAS NOT SEEN BY DR. PATIENT PRESENTED TO THE PHARMACY 4 DAYS FOLLOWING THE VACCINE WITH ~8 INCH RASH ON UPPER LEFT ARM, ARM SLIGHTLY SWOLLEN, AND PAINFUL. SHE HAD BEEN TAKING CLORTRIMATON.
Age: 50.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: pt had yellow fever vaccine right arm SQ on 8/9/07. Redness and swelling and itching of arm started 8/10/07 in the afternoon.Came to office 8/11/07 c/o redness , warmth,swelling and pruritus on Rt forearm and upper arm for 1day. Denies SOB or dyspnea.   Size:260mm x150mm flat erythematous patches, well delineated redness and swelling.  No pain - just itching.  Red swollen area extends from injection site posterior upper arm, around arm almost to axilla and down 100mm below the elbow.Instructed to take Benadryl or loratadine PO and Benadryl cream to arm to help with itching. Instructed pt and wife - pt is to go to ER if swelling and redness become worse or s/s anaphylaxsis. We will call pt tomorrow Sunday 8/12 to check on condition.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Anger, Depression, Frustration, Sleep disorder, Tension
Clinical narrative: NO SLEEP, ANGER, TENSION, DEPRRESION, FRUSTRATION
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: redness, swelling, blisters, itching, warmth to LUA. had received polio, MMR, Td and varicella vaccine. 2 of the above in each arm. Parents not sure which ones. only new vaccine was varicella. MD tx is Benadryl and antibiotics.
Age: 9.0
Sex: F
Vaccine: HPVX
Symptoms: Blood test, Erythema, Pruritus, Rash
Clinical narrative: Patient has developed spots on her legs that are bothering her , itching and red and not clearing up since she has recieved the Gardasil shots , she is also a heart patient with Truncusaterious Aterious type 1 1/2 with complications & also in remission for Antiphospholipid syndrom.. i dont know if any of these mixed with the Gardasil has made it possible for her to have a reaction but i would appricatiate if you could look into this matter , she does not have the spots anywhere but on her legs and they are getting worse , her doctor as listed above does not seem to be able to find solution to this
Age: 17.0
Sex: M
Vaccine: TTOX
Symptoms: Loss of consciousness, Pallor, Stomach discomfort, Syncope, Visual disturbance
Clinical narrative: Patient was given the meningitis vaccine and about three to four minutes later he collasped on the floor.  He fell against the wall and slid down, face was very very white and pale, so was his lips, he was unconcious until aroused by myself, which took a minuted to do so.  Patient said his stomach started to feel sick and suddenly his eye sight just went black, and then he fell.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Abnormal behaviour, Affect lability, Crying, Pyrexia, Rash morbilliform
Clinical narrative: 1.) High fever, 2.) measle-like rash, also infected 2 year old brother living in same household with the same measle like rash, 3.) severe hives, 4.) behavior changes, since being vaccinated she will not leave mother's side.  She must be with mother at all time.  If separted from mother, she will cry for hours.  Never exhibited behavior like this prior to vaccination.  She is unable to provide a rational explaination for her behavior.     Adverse symptoms 1, and 2 noted above have resolved.  Adverse symptom 3 noted above does return from time to time.  Adverse symptom 4 as noted above continues to be present and seems to be getting worse.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 1.) High fever, 2.) measle-like rash, also infected 2 year old brother living in same household with the same measle like rash, 3.) severe hives, 4.) behavior changes, since being vaccinated she will not leave mother's side.  She must be with mother at all time.  If separted from mother, she will cry for hours.  Never exhibited behavior like this prior to vaccination.  She is unable to provide a rational explaination for her behavior.     Adverse symptoms 1, and 2 noted above have resolved.  Adverse symptom 3 noted above does return from time to time.  Adverse symptom 4 as noted above continues to be present and seems to be getting worse.
Age: 12.0
Sex: F
Vaccine: DTPHEP, MNQ
Symptoms: Asthenia, Fatigue, Headache, Hypersomnia, Lethargy
Clinical narrative: Lethargic, no energy, achy, sore, tired, headache, slept for 3 days
Age: 12.0
Sex: F
Vaccine: DTPHEP, MNQ
Symptoms: Pain
Clinical narrative: Lethargic, no energy, achy, sore, tired, headache, slept for 3 days
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncopy. Fainting attack after 5-10 min of Menactra and Gardasil vaccination
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depression, Dizziness, Similar reaction on previous exposure to drug
Clinical narrative: Within one week she became very depressed. By April her depression weas so severe she missed about 10 days of school.  She had sadness, anhedonia, no motivation, fatigue, low self esteem, hopelessn, helpless, overwhelmed and some suicidal ideation without plan.  She began therapy with psychologist and symptoms improved significantly.  She received a 2nd injection of Gardasil onMay 25, 2007.  On the very same night she began crying, yelling, became very depressed and had recurrence of suicidal ideation.  She denies ever having an actual plan or intention but did have fantasies of dying.  All her other symptoms of depression also returned..  She also developed a lot of anxiety and concerns and worries about her future.  She was evaluated by me, her psychiatrist on 07/19/07.  She started Lexapro 5mg and her symptoms significantly improved. 8/21/07-records received from consultant for DOS 7/19-8/7/07-one week after vaccine administration C/O depressed. In April missed 10 days of school started therapy. after 2nd vaccine 5/25/07-her behavior angry and within weeks depressed mood again. Positive anxiety regarding college, being away from home and live in a dorm. General worries about how people judge her. Best friend going away. Does not like working. No energy, irritable.DX: R/O depression secondary to gardasil vaccination. R/O Anxiety. Visit on 7/28/07 significant improved mood. REmains nervous about starting college.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Anhedonia, Anxiety, Apathy, Blood aluminium normal
Clinical narrative: Within one week she became very depressed. By April her depression weas so severe she missed about 10 days of school.  She had sadness, anhedonia, no motivation, fatigue, low self esteem, hopelessn, helpless, overwhelmed and some suicidal ideation without plan.  She began therapy with psychologist and symptoms improved significantly.  She received a 2nd injection of Gardasil onMay 25, 2007.  On the very same night she began crying, yelling, became very depressed and had recurrence of suicidal ideation.  She denies ever having an actual plan or intention but did have fantasies of dying.  All her other symptoms of depression also returned..  She also developed a lot of anxiety and concerns and worries about her future.  She was evaluated by me, her psychiatrist on 07/19/07.  She started Lexapro 5mg and her symptoms significantly improved. 8/21/07-records received from consultant for DOS 7/19-8/7/07-one week after vaccine administration C/O depressed. In April missed 10 days of school started therapy. after 2nd vaccine 5/25/07-her behavior angry and within weeks depressed mood again. Positive anxiety regarding college, being away from home and live in a dorm. General worries about how people judge her. Best friend going away. Does not like working. No energy, irritable.DX: R/O depression secondary to gardasil vaccination. R/O Anxiety. Visit on 7/28/07 significant improved mood. REmains nervous about starting college.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Depressed mood, Depression, Fatigue, Full blood count normal
Clinical narrative: Within one week she became very depressed. By April her depression weas so severe she missed about 10 days of school.  She had sadness, anhedonia, no motivation, fatigue, low self esteem, hopelessn, helpless, overwhelmed and some suicidal ideation without plan.  She began therapy with psychologist and symptoms improved significantly.  She received a 2nd injection of Gardasil onMay 25, 2007.  On the very same night she began crying, yelling, became very depressed and had recurrence of suicidal ideation.  She denies ever having an actual plan or intention but did have fantasies of dying.  All her other symptoms of depression also returned..  She also developed a lot of anxiety and concerns and worries about her future.  She was evaluated by me, her psychiatrist on 07/19/07.  She started Lexapro 5mg and her symptoms significantly improved. 8/21/07-records received from consultant for DOS 7/19-8/7/07-one week after vaccine administration C/O depressed. In April missed 10 days of school started therapy. after 2nd vaccine 5/25/07-her behavior angry and within weeks depressed mood again. Positive anxiety regarding college, being away from home and live in a dorm. General worries about how people judge her. Best friend going away. Does not like working. No energy, irritable.DX: R/O depression secondary to gardasil vaccination. R/O Anxiety. Visit on 7/28/07 significant improved mood. REmains nervous about starting college.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test normal, Screaming, Self esteem decreased, Suicidal ideation, Thyroid function test normal
Clinical narrative: Within one week she became very depressed. By April her depression weas so severe she missed about 10 days of school.  She had sadness, anhedonia, no motivation, fatigue, low self esteem, hopelessn, helpless, overwhelmed and some suicidal ideation without plan.  She began therapy with psychologist and symptoms improved significantly.  She received a 2nd injection of Gardasil onMay 25, 2007.  On the very same night she began crying, yelling, became very depressed and had recurrence of suicidal ideation.  She denies ever having an actual plan or intention but did have fantasies of dying.  All her other symptoms of depression also returned..  She also developed a lot of anxiety and concerns and worries about her future.  She was evaluated by me, her psychiatrist on 07/19/07.  She started Lexapro 5mg and her symptoms significantly improved. 8/21/07-records received from consultant for DOS 7/19-8/7/07-one week after vaccine administration C/O depressed. In April missed 10 days of school started therapy. after 2nd vaccine 5/25/07-her behavior angry and within weeks depressed mood again. Positive anxiety regarding college, being away from home and live in a dorm. General worries about how people judge her. Best friend going away. Does not like working. No energy, irritable.DX: R/O depression secondary to gardasil vaccination. R/O Anxiety. Visit on 7/28/07 significant improved mood. REmains nervous about starting college.
Age: 7.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Injection site warmth, Rash
Clinical narrative: Mom stated patient broke out in a rash on trunk 3 hours post injection.  Mom stated injection site was free from redness or rash but did report warmth at site.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Computerised tomogram normal, Drug screen negative, Electroencephalogram abnormal, Grand mal convulsion, Headache
Clinical narrative: This case was reported by another manufacturer on 06 August 2007 under the reference number WAES 0707USA04022. The following narrative is verbatim from the report: "Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose of Gardasil (lot # unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (MSD) (duration and dose not reported) and Menactra. Other concomitant therapy included Zyrtec-D. On 14-JUL-2007 at 11:30 PM the patient experienced a generalized tonic-clonic seizure at which time she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed axial tomography (CT) test and drug test which were negative. An electroencephalography (EEG) test was also performed which showed minimal abnormalities. There was no family history of seizures and the patient was treated with Ativan, which they believe aborted another possible seizure. It was also reported that the patient was on vacation one week before vaccination on a cruise. At the time of reporting the patient was recovering. Upon internal review generalized tonic-clonic seizure is considered to be an other important medical event. Additional information has been requested."
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by another manufacturer on 06 August 2007 under the reference number WAES 0707USA04022. The following narrative is verbatim from the report: "Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose of Gardasil (lot # unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (MSD) (duration and dose not reported) and Menactra. Other concomitant therapy included Zyrtec-D. On 14-JUL-2007 at 11:30 PM the patient experienced a generalized tonic-clonic seizure at which time she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed axial tomography (CT) test and drug test which were negative. An electroencephalography (EEG) test was also performed which showed minimal abnormalities. There was no family history of seizures and the patient was treated with Ativan, which they believe aborted another possible seizure. It was also reported that the patient was on vacation one week before vaccination on a cruise. At the time of reporting the patient was recovering. Upon internal review generalized tonic-clonic seizure is considered to be an other important medical event. Additional information has been requested."
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Grand mal convulsion, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by another manufacturer on 06 August 2007 under the reference number WAES 0707USA04022. The following narrative is verbatim from the report: "Information has been received from a registered nurse concerning an 18 year old female who on 13-JUL-2007 was vaccinated with a first dose of Gardasil (lot # unknown) IM at 2:30PM. Concomitant therapy also given on 13-JUL-2007 included Vaqta (MSD) (duration and dose not reported) and Menactra. Other concomitant therapy included Zyrtec-D. On 14-JUL-2007 at 11:30 PM the patient experienced a generalized tonic-clonic seizure at which time she was admitted to the ER. Several tests were performed including a magnetic resonance imaging (MRI) and a computed axial tomography (CT) test and drug test which were negative. An electroencephalography (EEG) test was also performed which showed minimal abnormalities. There was no family history of seizures and the patient was treated with Ativan, which they believe aborted another possible seizure. It was also reported that the patient was on vacation one week before vaccination on a cruise. At the time of reporting the patient was recovering. Upon internal review generalized tonic-clonic seizure is considered to be an other important medical event. Additional information has been requested."
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Blood glucose increased, Diabetes mellitus insulin-dependent
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 08-JUN-2007 was vaccinated with a dose of Gardasil (lot # unknown). Concomitant secondary therapy also given on 08-JUN-2007 included VAQTA and Varivax. On 13-JUL-2007 the patient was diagnosed with "new onset type 1 diabetes" Medical attention was sought. On an unspecified date, at a follow-up visit, it was reported that after receiving Gardasil the physician determined this diagnosis. It was reported that at the follow-up visit the patient lost 12 pounds, was lethargic and was urinating frequently. On an unspecified date the patient had a blood glucose test performed and the results had a sugar reading of 977. At the time of reporting the patient had not recovered. Diabetic was considered to be disabling. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Blood glucose increased, Diabetes mellitus insulin-dependent, Lethargy, Pollakiuria, Weight decreased
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 08-JUN-2007 was vaccinated with a dose of Gardasil (lot # unknown). Concomitant secondary therapy also given on 08-JUN-2007 included VAQTA and Varivax. On 13-JUL-2007 the patient was diagnosed with "new onset type 1 diabetes" Medical attention was sought. On an unspecified date, at a follow-up visit, it was reported that after receiving Gardasil the physician determined this diagnosis. It was reported that at the follow-up visit the patient lost 12 pounds, was lethargic and was urinating frequently. On an unspecified date the patient had a blood glucose test performed and the results had a sugar reading of 977. At the time of reporting the patient had not recovered. Diabetic was considered to be disabling. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Asthenia, Blood pressure increased, Hyperhidrosis, Nausea, Pallor
Clinical narrative: After Gardasil vaccination client became pale, c/o weakness, diaphoretic, N/VBP 120/60, symptoms abated BP 102/58
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Vomiting
Clinical narrative: After Gardasil vaccination client became pale, c/o weakness, diaphoretic, N/VBP 120/60, symptoms abated BP 102/58
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Asthenia, Hyperhidrosis, Pallor
Clinical narrative: After Gardasil vaccination client became pale, c/o weakness, diaphoretic, N/VBP 120/60, symptoms abated BP 102/58
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Biopsy intestine, Decreased appetite, Diarrhoea haemorrhagic, Gastroenteritis, Vomiting
Clinical narrative: Patient was given Rotateq 6-29-07 lot # 0409U. Vomiting started July 9 - diarrhea - bloody diarrhea - hospitalized 7/13 - 7/30 at hospital.  8/21/07 Received PCP medical records which reveal patient experienced vomiting x 2 days on office visit of 7/11.  Vax record confirms RO dose & lot #.  Referred to ER.  Admitted 7/13-7/30/07 for persistent vomiting x 4 day w/greenish watery diarrhea w/flecks of blood x 3 days.  GI, Allergy, Metabolic, Neuro & Optho  consult done.  Extensive w/u done.  Will follow up w/allergy, GI & neuro.  Referred for RAST testing & also to case worker for delayed development concerns. FINAL DX: probable allergic enterocolitis.  8/28/07 Hospital med records reviewed which reveal patient admitted 7/13-7/30/07 after experienced vomiting, watery stools w/flecks of blood.  Continued to vomit for several days while hospitalized then developed metabolic acidosis & diarrhea.  Multiple consults done: neuro for head lag, GI surgery, gastroenterology, metabolic consult, allergy, ID & ophthalmology for difficulty tracking.  Multiple formula changes done & patient also received parenteral nutrition due to weight loss.  Improved w/treatment & d/c to home w/close follow up w/pcp & specialists.  FINAL DX: acute gastroenteritis; possible milk allergy; metabolic acidosis, resolved; possible GERD.
Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Biopsy intestine, Diarrhoea, Diarrhoea haemorrhagic, Vomiting
Clinical narrative: Patient was given Rotateq 6-29-07 lot # 0409U. Vomiting started July 9 - diarrhea - bloody diarrhea - hospitalized 7/13 - 7/30 at hospital.  8/21/07 Received PCP medical records which reveal patient experienced vomiting x 2 days on office visit of 7/11.  Vax record confirms RO dose & lot #.  Referred to ER.  Admitted 7/13-7/30/07 for persistent vomiting x 4 day w/greenish watery diarrhea w/flecks of blood x 3 days.  GI, Allergy, Metabolic, Neuro & Optho  consult done.  Extensive w/u done.  Will follow up w/allergy, GI & neuro.  Referred for RAST testing & also to case worker for delayed development concerns. FINAL DX: probable allergic enterocolitis.  8/28/07 Hospital med records reviewed which reveal patient admitted 7/13-7/30/07 after experienced vomiting, watery stools w/flecks of blood.  Continued to vomit for several days while hospitalized then developed metabolic acidosis & diarrhea.  Multiple consults done: neuro for head lag, GI surgery, gastroenterology, metabolic consult, allergy, ID & ophthalmology for difficulty tracking.  Multiple formula changes done & patient also received parenteral nutrition due to weight loss.  Improved w/treatment & d/c to home w/close follow up w/pcp & specialists.  FINAL DX: acute gastroenteritis; possible milk allergy; metabolic acidosis, resolved; possible GERD.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Asthenia, Convulsion, Gaze palsy, Loss of consciousness, Pallor
Clinical narrative: Looked like a vasovagal reaction last 10 minutes was pale, weak. No loc, no sz.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Somnolence, Tremor
Clinical narrative: Looked like a vasovagal reaction last 10 minutes was pale, weak. No loc, no sz.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Asthenia, Pallor, Syncope vasovagal
Clinical narrative: Looked like a vasovagal reaction last 10 minutes was pale, weak. No loc, no sz.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, PNC, RV5, UNK
Symptoms: Autopsy, Death
Clinical narrative: Information has been received from a physician concerning a 2-month-old male who on 22-JUN-2007 was vaccinated with a 2mL PO dose of Rotateq (Lot # "2028U"). Suspect therapy that day included a dose of HIB conj-hepatitis B vaccine, a dose of PREVNAR, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and a dose of "ITV". On 30-JUN-2007 the patient passed away. CPR was noted. The autopsy medical examiner gave verbal to the mother stating that no cause has been determined. At the time of the report, the physician still did not have the autopsy report. No further information was provided. There was no product quality complaint. The event was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician's wife concerning a 16 year old female who in November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included influenza virus vaccine (unspecified). Ten minutes after receiving the vaccination, the patient experienced a one minute seizure. The patient was sent to the emergency room and diagnosed with seizure disorder. Subsequently, the patient recovered from the seizure. She has since had a second and third dose of Gardasil and did not experience any seizure activities after those doses. Upon internal review, seizure disorder was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Loss of consciousness, Urticaria
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a non-pregnant, 18 year old female patient, who on 16-APR-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not provided). On 16-APR-2007, "shortly after being administered the vaccine" the patient had an anaphylactic reaction, described as, she developed hives down both arms but did not have difficulty breathing; she also passed out. Treatment included Benadryl, and oxygen, and the patient was observed in the office for a "short time" and then went home. The patient then fully recovered (duration not reported). The nurse considered anaphylactic reaction and "passing out" to be serious, as life-threatening and as an important medical event. No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Autopsy, Death
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history or drug allergies who on 21-MAY-2007, was vaccinated IM with a 0.5ml dose of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified) ("MERCET"). On 23-MAY-2007, the patient died suddenly. The cause of death was unknown. Unspecified medical attention was sought. Laboratory diagnostic studies included an autopsy which showed no findings. No product quality complaint was involved. The reporter stated that Gardasil did not cause the patient's death. Additional information is not expected. 7/2/08-records received-Adverse effect of drugs.Toxicology survey findings:urine positive for methadone, benzodiazepines, benzoylecgonine (from cocaine), cannabinoids, nicotine, diphenhydramine and naproxen.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Diarrhoea, Faeces discoloured, Gastroenteritis, Oral intake reduced
Clinical narrative: Information has been received from a registered nurse concerning an 8 week old male, with a weakness in his right arm since birth, who on 12-JUL-2007 was vaccinated with a first dose of Rotateq (Lot # 656384/0237U). Concomitant vaccinee administered on the same day included an intramuscular first dose in the left thigh of Pediarix (Lot # AC218110AB), an intramuscular first dose in the right thigh of ActHib (Lot# UF067AA) and an intramuscular first dose in the right thigh of Prevnar (Lot# B08679D). There was no other concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. That night, on 12-JUL-2007 the patient started with green, watery, non-bloody diarrhea (four stools in the afternoon followed by six episodes in the evening) in the setting of slightly decreased oral intake. The patient was admitted to the hospital on 13-JUL-2007 for diarrhea and fever for observation. The patient was diagnosed with acute gastroenteritis. The patient was given rocephin and oral rehydration therapy. There was minimal diarrhea during hospital admission. The patient had one fever to 38.2 which was treated with Tylenol. The patient had a follow-up visit on 19-JUL-2007 and the diarrhea was resolving. It was reported that the patient recovered on 19-JUL-2007. Additional information has been requested. All available medical records will be provided upon request.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse concerning an 8 week old male, with a weakness in his right arm since birth, who on 12-JUL-2007 was vaccinated with a first dose of Rotateq (Lot # 656384/0237U). Concomitant vaccinee administered on the same day included an intramuscular first dose in the left thigh of Pediarix (Lot # AC218110AB), an intramuscular first dose in the right thigh of ActHib (Lot# UF067AA) and an intramuscular first dose in the right thigh of Prevnar (Lot# B08679D). There was no other concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. That night, on 12-JUL-2007 the patient started with green, watery, non-bloody diarrhea (four stools in the afternoon followed by six episodes in the evening) in the setting of slightly decreased oral intake. The patient was admitted to the hospital on 13-JUL-2007 for diarrhea and fever for observation. The patient was diagnosed with acute gastroenteritis. The patient was given rocephin and oral rehydration therapy. There was minimal diarrhea during hospital admission. The patient had one fever to 38.2 which was treated with Tylenol. The patient had a follow-up visit on 19-JUL-2007 and the diarrhea was resolving. It was reported that the patient recovered on 19-JUL-2007. Additional information has been requested. All available medical records will be provided upon request.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Lip swelling, Pruritus, Tongue disorder, Urticaria, Wheezing
Clinical narrative: This case was received from a health professional on 30 July 2007. An allergist reported that a 4-year-old patient with a history of allergies to milk, nuts, seeds, peanuts, eggs, and shellfish, had received dose four of Daptacel (lot number not provided, administration date unknown). The patient subsequently developed urticaria, swelling lips, itchy tongue, and slight wheezing, which lasted five hours. The patient was seen by a pediatrician and treated with antihistamines. The reporter did not have any additional information.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Body temperature decreased, Hypotonia, Immunisation reaction, Lethargy, Peripheral coldness
Clinical narrative: This case was reported by a health professional on 31 July 2007. Seriousness criteria: other-medically significant A four-month-old female patient with no reported medical history had received an intramuscular thigh injection of Daptacel (lot number C2569AA, date of vaccination not reported). She subsequently experienced a body temperature of 96 degrees Fahrenheit, cool extremities, and was lethargic. She was taken to the emergency room and treated with intravenous fluids and a warming blanket. She was diagnosed with "pertussis reaction to DTAP, hypotonic response", and later recovered. The reporter did not have any additional information.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Abdominal distension, Scan abdomen abnormal, Ultrasound kidney abnormal
Clinical narrative: This case was unblinded, the patient received Prevnar, Control For Pneumococcal Conjugate Vaccine, 13-Valent. Information regarding Blinded Vaccine For Pneumococcal Conjugate Vaccine, 13-Valent was received from an investigator regarding a 10-month-old male participant in a study who experienced distended abdomen and possible wilms tumor. The participant received the third dose on 05-Apr-2007. On an unspecified date, the physician noted a distended abdomen. An ultrasound of the abdomen on 31-JUL-2007 showed a mass rising from the right kidney. The patient was diagnosed with a possible wilms tumor (nephroblastoma). As of 01-Aug-2007, the patient has not recovered. No additional information was available at the time of this report. Abdomen scan (results: noted a mass rising from the right kidney, possible Wilm's tumor) was done on 31-Jul-2007. The investigator (s) considered nephroblastoma and abdominal distension possibly related to the study product. The medical monitor (s) considered nephroblastoma and abdominal distension not related to the study product.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Kawasaki's disease, Platelet count increased, Red blood cell sedimentation rate increased
Clinical narrative: Diagnosed with Kawasaki Disease 6.15.07 after hospitalization.  09/24/2007 MR received for DOS 6/15-18/2007 for DX of Persistant fever elevated for > than 7 days.  Erythema Multiforme.  Kawasaki Disease. Infant presented with 5 day hx of fever, irritability, rash on arms and legs, exudative pharyngitis Strep (-), and poor po intake with decreased UO. Admitted for dx of Erythema multiforme and dehydration.    Tx with IVIG and ASA.  D/C home afebrile with improved po intake.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Kawasaki's disease
Clinical narrative: Diagnosed with Kawasaki Disease 6.15.07 after hospitalization.  09/24/2007 MR received for DOS 6/15-18/2007 for DX of Persistant fever elevated for > than 7 days.  Erythema Multiforme.  Kawasaki Disease. Infant presented with 5 day hx of fever, irritability, rash on arms and legs, exudative pharyngitis Strep (-), and poor po intake with decreased UO. Admitted for dx of Erythema multiforme and dehydration.    Tx with IVIG and ASA.  D/C home afebrile with improved po intake.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Dyspnoea, Injection site pain
Clinical narrative: Pain in localized area where vaccine was received (left tricep). By next day pain continued in tricep and moved to bicep. Large red, blotchy hives on tricep and bicep - hot to the touch. Chest felt tight, shortness of breath. Low grade fever (100.6). Pain in left side of chest which ran down left arm. Treated at clinic twice, hospitalized. Given prednisone, breathing treatment, Benadryl, pain meds.  9/10/07 Received medical records from 2nd hospital which reveals patient experienced dyspnea, chest pain & hypoxemia.  Admitted from 7/6-7/8/07.  Sent to hospital from current pcp office.  No health problems prior to vax on 6/22 which she received at previous pcp office.  Had redness, swelling & hives on left arm injection site initially then developed pleuritic type chest pain & SOB.  Seen at urgent care center for severe allergic reaction.  Tx w/steroids, antihistamines & neb & released to home. Returned several times to urgent care for same s/s, then to pcp then to outlying ER where she was found to be tachycardic & had DVT of left arm.  Dx from ER: pulmonary embolism & started on heparin.  Consult by cardio & pulmon.  Based on clinical s/s, continued tx for PE w/Coumadin.  D/C to home & new pcp f/u.  No improvement in s/s while home x 4 days & was admitted to this hospital for additional w/u.  On day of admit, was hypoxemic on RA w/O2 sat of 89%.  Pulmo consult obtained.  Placed on heparin drip.  Still felt that clinically had PE w/emboli too small to be detected.  Hypoxia resolved, had mild residual left chest pain.  D/C to home & pulmon f/u. FINAL DX: dyspnea, hypoxia & pleuritic left side chest pain secondary to PE in spite of negative CT angiogram & VQ scan; recent diagnosis of LUE DVT s/p pneumococcal vax. 9/10/07 Received former pcp medical record of 6/22/07 which reveals patient in office for routine annual exam.  Routine vax questioning revealed never to pneumovax.  Exam revealed slight tightness of chest thought to be allergy related.  Diffuse cervical lymphadenopathy anteriorly bilaterally.  9/17/07 Reviewed initial hospital records of 6/27-7/2/2007 admission which reveal patient experienced SOB, left arm swelling & pleuritic chest pain.  Tx w/anticoagulants, nebs, antihistamine & steroids.  Pulm consult obtained.  OB/GYN consulted for heavy menses & birth control.  Cardio consul for tachycardia.  Improved & d/c to home on continuing anticoagulant & antihistamine. FINAL DX: LUE DVT; allergic reaction; possible PE; hx of polycystic ovarian disease; hypoxia, SOB secondary to PE; pleuritic chest pain secondary to PE. 9/28/07 T/C to provider to request vax lot #.  Provided via phone & VAERS database updated w/same.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Pain in localized area where vaccine was received (left tricep). By next day pain continued in tricep and moved to bicep. Large red, blotchy hives on tricep and bicep - hot to the touch. Chest felt tight, shortness of breath. Low grade fever (100.6). Pain in left side of chest which ran down left arm. Treated at clinic twice, hospitalized. Given prednisone, breathing treatment, Benadryl, pain meds.  9/10/07 Received medical records from 2nd hospital which reveals patient experienced dyspnea, chest pain & hypoxemia.  Admitted from 7/6-7/8/07.  Sent to hospital from current pcp office.  No health problems prior to vax on 6/22 which she received at previous pcp office.  Had redness, swelling & hives on left arm injection site initially then developed pleuritic type chest pain & SOB.  Seen at urgent care center for severe allergic reaction.  Tx w/steroids, antihistamines & neb & released to home. Returned several times to urgent care for same s/s, then to pcp then to outlying ER where she was found to be tachycardic & had DVT of left arm.  Dx from ER: pulmonary embolism & started on heparin.  Consult by cardio & pulmon.  Based on clinical s/s, continued tx for PE w/Coumadin.  D/C to home & new pcp f/u.  No improvement in s/s while home x 4 days & was admitted to this hospital for additional w/u.  On day of admit, was hypoxemic on RA w/O2 sat of 89%.  Pulmo consult obtained.  Placed on heparin drip.  Still felt that clinically had PE w/emboli too small to be detected.  Hypoxia resolved, had mild residual left chest pain.  D/C to home & pulmon f/u. FINAL DX: dyspnea, hypoxia & pleuritic left side chest pain secondary to PE in spite of negative CT angiogram & VQ scan; recent diagnosis of LUE DVT s/p pneumococcal vax. 9/10/07 Received former pcp medical record of 6/22/07 which reveals patient in office for routine annual exam.  Routine vax questioning revealed never to pneumovax.  Exam revealed slight tightness of chest thought to be allergy related.  Diffuse cervical lymphadenopathy anteriorly bilaterally.  9/17/07 Reviewed initial hospital records of 6/27-7/2/2007 admission which reveal patient experienced SOB, left arm swelling & pleuritic chest pain.  Tx w/anticoagulants, nebs, antihistamine & steroids.  Pulm consult obtained.  OB/GYN consulted for heavy menses & birth control.  Cardio consul for tachycardia.  Improved & d/c to home on continuing anticoagulant & antihistamine. FINAL DX: LUE DVT; allergic reaction; possible PE; hx of polycystic ovarian disease; hypoxia, SOB secondary to PE; pleuritic chest pain secondary to PE. 9/28/07 T/C to provider to request vax lot #.  Provided via phone & VAERS database updated w/same.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Lumbar puncture normal, Paraesthesia, Syncope
Clinical narrative: 1 day after Menactra dose (8-2-07) patient complained of vertigo and tingling feet. 2 days after vaccine she had a syncopal event. Admitted for diagnostic studies. 8/27/07-records received for DOS 8/4-8/6/07- DC DX: Depression. Dizziness. Asthma. Presented to ED after syncopal episode. C/O dizziness and tingling of feet for 3 days. Seen in another ED and diagnosed with vertigo. Now C/O feeling her hands heavy and headaches. In ED orthostatic heart rate 90 sitting to 120 while standing. . Upon exit from ER felt acutely dizzy and admitted for observation.  Normal neurological exam. Her symptoms could be explained by a viral illness causing orthostatsis which could also explain her arm and leg tingling. The recent increase in the dose of Prozac is a possible etiology. Possible reaction to vaccine
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Vertigo
Clinical narrative: 1 day after Menactra dose (8-2-07) patient complained of vertigo and tingling feet. 2 days after vaccine she had a syncopal event. Admitted for diagnostic studies. 8/27/07-records received for DOS 8/4-8/6/07- DC DX: Depression. Dizziness. Asthma. Presented to ED after syncopal episode. C/O dizziness and tingling of feet for 3 days. Seen in another ED and diagnosed with vertigo. Now C/O feeling her hands heavy and headaches. In ED orthostatic heart rate 90 sitting to 120 while standing. . Upon exit from ER felt acutely dizzy and admitted for observation.  Normal neurological exam. Her symptoms could be explained by a viral illness causing orthostatsis which could also explain her arm and leg tingling. The recent increase in the dose of Prozac is a possible etiology. Possible reaction to vaccine
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue
Clinical narrative: Pt went to work after receiving the meningococcal vaccine and started getting dizzy and unsteady on feet. Also very tired. Went to the ER and saw Dr the following day. Asthenia.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Erythema, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: 4-24-07 woke up with sore red arm. Unable to move arm. C/O severe pain and swelling at injection site 4/25/07. Face broke out and started having diarrhea. Takes Zelnorm for diarrhea
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Rash
Clinical narrative: 4-24-07 woke up with sore red arm. Unable to move arm. C/O severe pain and swelling at injection site 4/25/07. Face broke out and started having diarrhea. Takes Zelnorm for diarrhea
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cardiac stress test, Electrocardiogram abnormal, Headache, Injected limb mobility decreased
Clinical narrative: Severe headache - lasted to 2-6-07, pain right arm traveled to shoulder and elbow. Injection site red, swollen to armpit. Saturday unable to get out of bed 2-3-07. Sunday 2-4-07 - went to hospital, temp. 103, IV Benadryl. Issued Morphine and pain medication, temp. normal. Unable to move right arm until 2-7-07. March 1, 07 only complaint - muscle soreness in body.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: Severe headache - lasted to 2-6-07, pain right arm traveled to shoulder and elbow. Injection site red, swollen to armpit. Saturday unable to get out of bed 2-3-07. Sunday 2-4-07 - went to hospital, temp. 103, IV Benadryl. Issued Morphine and pain medication, temp. normal. Unable to move right arm until 2-7-07. March 1, 07 only complaint - muscle soreness in body.
Age: 34.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Burning sensation, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: State a few minutes after got MMR and Flu states burning sensation at shoulder and neck and back of neck felt stiff. After 15 minutes pt states burning is now just in shoulder of arm. Neck still a little stiff.
Age: 56.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Body temperature increased, Chronic obstructive pulmonary disease, Hepatic failure, Injection site pain
Clinical narrative: Pt wife called. Pt end stage liver failure C/O rt arm pain today at injection site from Tdap on 1-8-07. States oxycontin and morphine from hospice nurse has not helped. Reports pt running temp 101 F.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: He states that his left arm swelled three times normal after receiving a flu shot. He states that it was so painful that he could not sleep that night. He saw PA the next day and was told it was an allergic reaction. His arm was warm to touch and swollen but not 3 times on 11/28/06
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Mom states child has rash on face, upper extremities, and trunk
Age: 22.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Body temperature increased, Dyspnoea
Clinical narrative: Client reports shortness of breath next day after immunization; elevated temperature about 36 hours after immunization.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Electrocardiogram, Influenza like illness, Oedema peripheral
Clinical narrative: Arm swell with not, flu like symptoms, joint pain
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rash generalised
Clinical narrative: 6-26-06 Pt states "I had fever, body aches, rash all over body, swollen lymph nodes in neck"
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Axillary pain, C-reactive protein increased, Chest X-ray normal, Chest pain, Chills
Clinical narrative: 24 y/o male who received primary SPV L) arm & AVA #1 R) arm on 6/14/2007. 3 days post vaccination, he noticed increasing redness & swelling at SPV site, which progressed to involvement of "whole upper arm" with associated L) axillary tenderness, chills & HA; from 6/18-6/24/2007, he experienced mild DOE, described as "difficulty getting a deep breath" and steady substernal chest pain, described as an "ache" w/intensity up to "5/10", with pain radiating to his L) arm. During this time frame, he also noted L) shoulder & neck discomfort and palpitations described as his "heart pounding hard and fast; SM was admitted to hospital 6/24/2007 & subsequently diagnosed with myocarditis Symptom: Chest Pain Start: 06/18/2007 Comment: substernal Symptom: Dyspnea (shortness of breath) Start: 06/18/2007 Symptoms: Dyspnea on exertion Start: 06/18/2007 Symptoms: Palpitations Start: 06/18/2007 8/23/07-records received vaccinated on 6/14/07- and on 6/17/07-developed gradually worsening dull substernal chest pain without radiation and lasting 5 days continuously developed SOB with pain during inspiration and activity and worse pain laying down. Somewhat relieved with sitting up. 6/24/07-sent to ED diagnosed with vaccinia associated myopericarditis. Continues with residual intermittent complaints of chest pain mostly with exertion. Syncope and C/O fatigue after discharge.