chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood culture negative, Chest X-ray abnormal, Conjunctivitis, Cough, Dehydration
Clinical narrative: Subject is nearly a 6 year old female child who received FluMist through our school-based influenza vaccination program on October 17, 2008. On November 10, 2008 she was seen at the clinic for a 2 day history of fever, rhinorrhea, sore throat and cough. PE was notable for slight erythematous throat without exudates. Chest was clear to auscultation and she was assessed to have an intercurrent viral illness. She was seen in the emergency room on November 11, 2008 for progressive symptoms which now included conjunctivitis, left sided pain, headache, nonbloody and nonbilious emesis, inability to eat without throwing up and decrease urination. PE was remarkable for ill appearing child with moderate dehydration. Her vital signs were Temp 104.3, BP 104/65 Pulse 146 with an oxygen saturation of 92%. Her oral mucosa was dry, chest was clear to auscultation, abdomen was soft and nontendor. Chest X ray revealed a left lower lobe infiltrate. The child had fluid resuscitation and was started on rocephin 75 mg/kg once per day, and was admitted to the hospital. Lab test: Strep screen was reported negative, WBC: 12,000 with 90% PMNs; and urine analysis was unremarkable except for ketones. Blood culture was obtained prior to starting rocephin and it remained sterile. Repeat CXR on Nov 12, 2008 was consistent with a left pleural collection which increased compared to Nov 11 study, a dense LLL consolidation and a small focus in the lingual (left lung). Patient gradually improved and was discharged on November 14, 2008 on omnicef (14 mg/kg twice a day for 10 days). She was seen for a follow-up visit on December 5, 2008. She had done well since discharge except for a slight cough that was resolving. Final diagnosis: Community acquired pneumonia and dehydration. Past Medical History: none. Medication: none. School: kindergarten. Smoke exposure: none. Influenza vaccine: FluMist. Date of Vaccination: 17 Oct 2008. Date of SAE:  November 11, 2008. SAE: Event was serious and not related to FluMist (This SAE was reported to the agency).  12/19/08 Reviewed hospital medical records of 11/11-11/14/2008. FINAL DX: LLL pneumonia Records reveal patient experienced HA, fever, cough, emesis.  Had rhinorrhea, watery eyes, fever, decreased activity, reduced oral intake approx 3-4 days prior to admit & diarrhea x 1 day, left rib/flank pain x 2 days.  Seen by PCP where strep tests neg & dx w/viral illness.  Did not improve, cough worsened & admitted.  Diarrhea & fever continued in hospital.  Gradually improved on antibiotics & d/c to home on continued antibiotics.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Dysuria, Headache, Heart rate increased, Lung infiltration, Mucosal dryness
Clinical narrative: Subject is nearly a 6 year old female child who received FluMist through our school-based influenza vaccination program on October 17, 2008. On November 10, 2008 she was seen at the clinic for a 2 day history of fever, rhinorrhea, sore throat and cough. PE was notable for slight erythematous throat without exudates. Chest was clear to auscultation and she was assessed to have an intercurrent viral illness. She was seen in the emergency room on November 11, 2008 for progressive symptoms which now included conjunctivitis, left sided pain, headache, nonbloody and nonbilious emesis, inability to eat without throwing up and decrease urination. PE was remarkable for ill appearing child with moderate dehydration. Her vital signs were Temp 104.3, BP 104/65 Pulse 146 with an oxygen saturation of 92%. Her oral mucosa was dry, chest was clear to auscultation, abdomen was soft and nontendor. Chest X ray revealed a left lower lobe infiltrate. The child had fluid resuscitation and was started on rocephin 75 mg/kg once per day, and was admitted to the hospital. Lab test: Strep screen was reported negative, WBC: 12,000 with 90% PMNs; and urine analysis was unremarkable except for ketones. Blood culture was obtained prior to starting rocephin and it remained sterile. Repeat CXR on Nov 12, 2008 was consistent with a left pleural collection which increased compared to Nov 11 study, a dense LLL consolidation and a small focus in the lingual (left lung). Patient gradually improved and was discharged on November 14, 2008 on omnicef (14 mg/kg twice a day for 10 days). She was seen for a follow-up visit on December 5, 2008. She had done well since discharge except for a slight cough that was resolving. Final diagnosis: Community acquired pneumonia and dehydration. Past Medical History: none. Medication: none. School: kindergarten. Smoke exposure: none. Influenza vaccine: FluMist. Date of Vaccination: 17 Oct 2008. Date of SAE:  November 11, 2008. SAE: Event was serious and not related to FluMist (This SAE was reported to the agency).  12/19/08 Reviewed hospital medical records of 11/11-11/14/2008. FINAL DX: LLL pneumonia Records reveal patient experienced HA, fever, cough, emesis.  Had rhinorrhea, watery eyes, fever, decreased activity, reduced oral intake approx 3-4 days prior to admit & diarrhea x 1 day, left rib/flank pain x 2 days.  Seen by PCP where strep tests neg & dx w/viral illness.  Did not improve, cough worsened & admitted.  Diarrhea & fever continued in hospital.  Gradually improved on antibiotics & d/c to home on continued antibiotics.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Oxygen saturation decreased, Pharyngeal erythema, Pyrexia, Rhinorrhoea
Clinical narrative: Subject is nearly a 6 year old female child who received FluMist through our school-based influenza vaccination program on October 17, 2008. On November 10, 2008 she was seen at the clinic for a 2 day history of fever, rhinorrhea, sore throat and cough. PE was notable for slight erythematous throat without exudates. Chest was clear to auscultation and she was assessed to have an intercurrent viral illness. She was seen in the emergency room on November 11, 2008 for progressive symptoms which now included conjunctivitis, left sided pain, headache, nonbloody and nonbilious emesis, inability to eat without throwing up and decrease urination. PE was remarkable for ill appearing child with moderate dehydration. Her vital signs were Temp 104.3, BP 104/65 Pulse 146 with an oxygen saturation of 92%. Her oral mucosa was dry, chest was clear to auscultation, abdomen was soft and nontendor. Chest X ray revealed a left lower lobe infiltrate. The child had fluid resuscitation and was started on rocephin 75 mg/kg once per day, and was admitted to the hospital. Lab test: Strep screen was reported negative, WBC: 12,000 with 90% PMNs; and urine analysis was unremarkable except for ketones. Blood culture was obtained prior to starting rocephin and it remained sterile. Repeat CXR on Nov 12, 2008 was consistent with a left pleural collection which increased compared to Nov 11 study, a dense LLL consolidation and a small focus in the lingual (left lung). Patient gradually improved and was discharged on November 14, 2008 on omnicef (14 mg/kg twice a day for 10 days). She was seen for a follow-up visit on December 5, 2008. She had done well since discharge except for a slight cough that was resolving. Final diagnosis: Community acquired pneumonia and dehydration. Past Medical History: none. Medication: none. School: kindergarten. Smoke exposure: none. Influenza vaccine: FluMist. Date of Vaccination: 17 Oct 2008. Date of SAE:  November 11, 2008. SAE: Event was serious and not related to FluMist (This SAE was reported to the agency).  12/19/08 Reviewed hospital medical records of 11/11-11/14/2008. FINAL DX: LLL pneumonia Records reveal patient experienced HA, fever, cough, emesis.  Had rhinorrhea, watery eyes, fever, decreased activity, reduced oral intake approx 3-4 days prior to admit & diarrhea x 1 day, left rib/flank pain x 2 days.  Seen by PCP where strep tests neg & dx w/viral illness.  Did not improve, cough worsened & admitted.  Diarrhea & fever continued in hospital.  Gradually improved on antibiotics & d/c to home on continued antibiotics.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Urine output decreased, Viral infection, Vomiting
Clinical narrative: Subject is nearly a 6 year old female child who received FluMist through our school-based influenza vaccination program on October 17, 2008. On November 10, 2008 she was seen at the clinic for a 2 day history of fever, rhinorrhea, sore throat and cough. PE was notable for slight erythematous throat without exudates. Chest was clear to auscultation and she was assessed to have an intercurrent viral illness. She was seen in the emergency room on November 11, 2008 for progressive symptoms which now included conjunctivitis, left sided pain, headache, nonbloody and nonbilious emesis, inability to eat without throwing up and decrease urination. PE was remarkable for ill appearing child with moderate dehydration. Her vital signs were Temp 104.3, BP 104/65 Pulse 146 with an oxygen saturation of 92%. Her oral mucosa was dry, chest was clear to auscultation, abdomen was soft and nontendor. Chest X ray revealed a left lower lobe infiltrate. The child had fluid resuscitation and was started on rocephin 75 mg/kg once per day, and was admitted to the hospital. Lab test: Strep screen was reported negative, WBC: 12,000 with 90% PMNs; and urine analysis was unremarkable except for ketones. Blood culture was obtained prior to starting rocephin and it remained sterile. Repeat CXR on Nov 12, 2008 was consistent with a left pleural collection which increased compared to Nov 11 study, a dense LLL consolidation and a small focus in the lingual (left lung). Patient gradually improved and was discharged on November 14, 2008 on omnicef (14 mg/kg twice a day for 10 days). She was seen for a follow-up visit on December 5, 2008. She had done well since discharge except for a slight cough that was resolving. Final diagnosis: Community acquired pneumonia and dehydration. Past Medical History: none. Medication: none. School: kindergarten. Smoke exposure: none. Influenza vaccine: FluMist. Date of Vaccination: 17 Oct 2008. Date of SAE:  November 11, 2008. SAE: Event was serious and not related to FluMist (This SAE was reported to the agency).  12/19/08 Reviewed hospital medical records of 11/11-11/14/2008. FINAL DX: LLL pneumonia Records reveal patient experienced HA, fever, cough, emesis.  Had rhinorrhea, watery eyes, fever, decreased activity, reduced oral intake approx 3-4 days prior to admit & diarrhea x 1 day, left rib/flank pain x 2 days.  Seen by PCP where strep tests neg & dx w/viral illness.  Did not improve, cough worsened & admitted.  Diarrhea & fever continued in hospital.  Gradually improved on antibiotics & d/c to home on continued antibiotics.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dyspnoea, Pyrexia
Clinical narrative: developed fever, mild sob, multiple articular pain the same night
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Vomiting
Clinical narrative: 12 hours after flu shot, child awoke with severe headache, abdominal discomfort, vomited once. No fever, diarrhea, respiratory or local reaction repoerted.  Described head feeling like it would explode & said it was different than the migraine headaches he experiences.  Child received no treatment & was fine after 4 hours.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Rash pruritic, Swelling
Clinical narrative: Patien describes swelling, itchy rash, lumps in her head.
Age: 35.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Borrelia burgdorferi serology positive, Fatigue, Headache
Clinical narrative: Report 2001016628-1 (subsequently assigned GSK reference number A0349688A) describes Lyme disease in a 56-year-old male who reportedly received the complete immunization series of LYMERIX.  This report was received from the vaccinee and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions, and concurrent medications were not provided.  The vaccinee works outdoors.  The vaccinee stated that he received three injections of LYMERIX, with the last dose administered in May 2000.  Exact dates of immunization were not provided.  In early July 2001, approximately 14 months after completing the LYMERIX immunization series, the patient underwent a complete physical.  At that time, he reported to his physician that he had been experiencing fatigue, headaches, and "severe" joint pain, especially in his feet and hands.  The vaccinee requested to be tested for Lyme disease.  He was notified by his physician that an unspecified test for Lyme disease was positive.  Follow up information was received on 03 December 2008 via an interview between the subject and attorney(s).  The subject, who was in his thirties, was vaccinated with LYMERIX on 22 May 1999, 04 December 1999, and 10 July 2000.  In 1999 or 2000, he experienced headaches, neck pain, back pain, knee pain, wrist pain, foot pain, floaters (vision problems), heart palpitations, and ringing in ears.  On unspecified dates, he experienced numbness of the limbs, and shoulder and elbow pain.  Treatment included Tylenol and Ibuprofen.  In 2004 or 2005, he experienced fertility "issues" described as difficulty conceiving.  The subject reported that fertility testing revealed that sperm "morphology was zero", that he was prescribed amino acids, and that his wife conceived twins born in August 2008.  The fertility issues were assessed by GSK to be medically significant.  The events, with the exception of fertility problems, were unresolved at the time of this report.
Age: 35.0
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Infertility male, Lyme disease, Musculoskeletal pain, Myodesopsia
Clinical narrative: Report 2001016628-1 (subsequently assigned GSK reference number A0349688A) describes Lyme disease in a 56-year-old male who reportedly received the complete immunization series of LYMERIX.  This report was received from the vaccinee and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions, and concurrent medications were not provided.  The vaccinee works outdoors.  The vaccinee stated that he received three injections of LYMERIX, with the last dose administered in May 2000.  Exact dates of immunization were not provided.  In early July 2001, approximately 14 months after completing the LYMERIX immunization series, the patient underwent a complete physical.  At that time, he reported to his physician that he had been experiencing fatigue, headaches, and "severe" joint pain, especially in his feet and hands.  The vaccinee requested to be tested for Lyme disease.  He was notified by his physician that an unspecified test for Lyme disease was positive.  Follow up information was received on 03 December 2008 via an interview between the subject and attorney(s).  The subject, who was in his thirties, was vaccinated with LYMERIX on 22 May 1999, 04 December 1999, and 10 July 2000.  In 1999 or 2000, he experienced headaches, neck pain, back pain, knee pain, wrist pain, foot pain, floaters (vision problems), heart palpitations, and ringing in ears.  On unspecified dates, he experienced numbness of the limbs, and shoulder and elbow pain.  Treatment included Tylenol and Ibuprofen.  In 2004 or 2005, he experienced fertility "issues" described as difficulty conceiving.  The subject reported that fertility testing revealed that sperm "morphology was zero", that he was prescribed amino acids, and that his wife conceived twins born in August 2008.  The fertility issues were assessed by GSK to be medically significant.  The events, with the exception of fertility problems, were unresolved at the time of this report.
Age: 35.0
Sex: M
Vaccine: LYME
Symptoms: Neck pain, Pain in extremity, Palpitations, Tinnitus
Clinical narrative: Report 2001016628-1 (subsequently assigned GSK reference number A0349688A) describes Lyme disease in a 56-year-old male who reportedly received the complete immunization series of LYMERIX.  This report was received from the vaccinee and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions, and concurrent medications were not provided.  The vaccinee works outdoors.  The vaccinee stated that he received three injections of LYMERIX, with the last dose administered in May 2000.  Exact dates of immunization were not provided.  In early July 2001, approximately 14 months after completing the LYMERIX immunization series, the patient underwent a complete physical.  At that time, he reported to his physician that he had been experiencing fatigue, headaches, and "severe" joint pain, especially in his feet and hands.  The vaccinee requested to be tested for Lyme disease.  He was notified by his physician that an unspecified test for Lyme disease was positive.  Follow up information was received on 03 December 2008 via an interview between the subject and attorney(s).  The subject, who was in his thirties, was vaccinated with LYMERIX on 22 May 1999, 04 December 1999, and 10 July 2000.  In 1999 or 2000, he experienced headaches, neck pain, back pain, knee pain, wrist pain, foot pain, floaters (vision problems), heart palpitations, and ringing in ears.  On unspecified dates, he experienced numbness of the limbs, and shoulder and elbow pain.  Treatment included Tylenol and Ibuprofen.  In 2004 or 2005, he experienced fertility "issues" described as difficulty conceiving.  The subject reported that fertility testing revealed that sperm "morphology was zero", that he was prescribed amino acids, and that his wife conceived twins born in August 2008.  The fertility issues were assessed by GSK to be medically significant.  The events, with the exception of fertility problems, were unresolved at the time of this report.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Blood creatine phosphokinase normal, Chest X-ray normal, Differential white blood cell count abnormal, Dyspnoea exertional
Clinical narrative: Flu vaccine given on 10/1/08 @ 15:00 pm.  Developed sob on exertion & left scapular back pain within 30 minutes of immunization.  Reported symptoms to supervisor @ 9:00pm.  Ambulance called to transport to local ER.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Laboratory test normal, Musculoskeletal pain, Troponin, White blood cell count increased
Clinical narrative: Flu vaccine given on 10/1/08 @ 15:00 pm.  Developed sob on exertion & left scapular back pain within 30 minutes of immunization.  Reported symptoms to supervisor @ 9:00pm.  Ambulance called to transport to local ER.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder, Nerve injury
Clinical narrative: Autoimmune plexography involving right arm.  Vaccine given in left arm.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder
Clinical narrative: Autoimmune plexography involving right arm.  Vaccine given in left arm.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Breast swelling
Clinical narrative: Bilateral breast swelling 4 hrs post vaccination, slowly improving over next 24 hours.
Age: 1.0
Sex: M
Vaccine: FLU3, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella, Varicella post vaccine
Clinical narrative: Varicella rec.'d, 11/10/08, with influenza, Hep A, MMR, IPV vaccinations. G mother reports 9 days later "chicken pox" with high fever" and "fine rash". Resolved without intervention.
Age: 40.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Mass, Pain
Clinical narrative: (L) Deltoid - very red from (L) deltoid to axillary area lump - 32" c/o pain, red streaks - over area. Medically permanent due to reaction to Anthrax.
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Mass, Pain, Paraesthesia, Skin warm
Clinical narrative: Anthrax given - (R) deltoid. Red /warm, and has a lump - 20 x 25 " - c/o shooting pain and tingling.  Recommend IM next inj.
Age: 6.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Disorientation, Dyspnoea, Hyperhidrosis, Pyrexia, Wheezing
Clinical narrative: Wheezing, SOB, sweating, fever, disoriented, went to ER 12/8/08
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Pain in extremity, Pruritus, Vomiting
Clinical narrative: Received phone call from pt. advising got her flu shot yesterday afternoon. Then midnight itched, feeling bad. Then this morning been throwing up and have a severed headache. Advised her to see her private provider for evaluation. Also arm is sore.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Lymphadenopathy, Rash erythematous, Skin striae
Clinical narrative: Pt c/o soreness at injection site, axilla swollen and red rash.  Red streak 1" wide down arm that spread around to front of arm
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Allergy test, Radioallergosorbent test, Urticaria
Clinical narrative: Pt's mother called office because after about an hour after receiving vaccines, pt broke out in hives.  Pt was brought back into office, given BENADRYL 4ml PO and DECADRON 7mg IM.  Pt was monitored for over one hour and released after hives subsided.  Allergy panels were ordered and we are awaiting results.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Rash macular, Skin lesion
Clinical narrative: PNEUMOVAX injection given 10/6/2008 on 10/8/2008 right arm erythematous macular areas of varying sizes, oval shaped max 3cm. No induration of ecchymosis. Lesions not at site of injection.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Erythemia, swelling 10 x 6cm stating 6 days after.
Age: 38.0
Sex: M
Vaccine: FLUN3, TYP
Symptoms: Erythema, Local reaction, Mass, Skin warm
Clinical narrative: (R) deltoid - warm, red - lump - 30" additional small reddened area / 1" near site. Medically deferred permanently from further Anthrax. Will continue to monitor localized reaction.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPA, SMALL
Symptoms: Erythema, Folliculitis, Rash maculo-papular, Vaccination complication
Clinical narrative: Per dermatologist,  diagnosed with Folliculitis- sterile foliculer based vaccine reaction to smallpox, well described. Patient had asymptomatic red spots on upper trunk 9-10 days after small pox and anthrax shot.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dizziness, Syncope, Syncope vasovagal
Clinical narrative: Pt given immunizations getting up to leave felt faint or fainted. Alert and oriented after 15 seconds.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Initial information was received from a health care professional on 08 August 2008.  A 14 year old male patient with an allergy to AMOXIL received a first dose, intramuscular injection of MENACTRA (U2659AA) in the left deltoid on 05 August 2008.  On 06 August 2008 the patient complained of pain and tenderness in the left axilla with soreness in the entire arm with a 3x3 cm raised red injection site.  He was seen by the doctor on 07 August 2008 regarding the above symptoms.  At the time of the report the patient's recovery status was unknown.  Follow-up information was received 29 September 2008 from a health care professional who reported that the patient had recovered from the event.  No additional information was provided.
Age: 44.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Axillary pain, Chills, Injection site pain, Pyrexia
Clinical narrative: A 44 year old male patient with no reported past medical history experienced left deltoid pain extending into the axilla with fever and chills after receiving a first dose injection of MENACTRA (U2657AA) intramuscularly in the right deltoid and a first dose injection  of PNEUMOVAX (03800, manufacturer MERCK) intramuscularly in the left deltoid on 04 August 2008, the morning after received the vaccine, the patient experienced left deltoid pain extending into the left axilla along with a low grade fever of 99.5 and chills. The left deltoid was tender upon palpation. There was no redness or edema. The patient recovered from the events.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site induration, Injection site inflammation, Injection site pain, Injection site reaction, Lymphadenopathy
Clinical narrative: A 19 year old female patient with no past medical history received an intramuscular injection of MENACTRA (lot number U2665AA) in the left deltoid on 29 July 2008, the patient also received MENOMUNE four years prior (lot number not provided).  On 30 July 2008 the patient had a large induration.  "the size of a baseball ", at the left deltoid injection site.  She also had a large amount of lymph node swelling in the left clavicular area.  The patient complained of pain at the injection site.  She was being monitored by her doctor.  She was advised to use an ice pack and IBUPROFEN.  The patient did not recover from the events at the time of the report.  Follow-up information received from a health care professional on 25 August 2008.  It was confirmed that the patient is male, not female.  It was reported that the patient's symptoms of enlarged lymph nodes, injection site reaction and inflammation at site started approximately four to five hours after the MENACTRA vaccine was given on 29 July 2008 at 4:45 PM. The symptoms subsided gradually, lasting three to four days.  The patient had not experienced any adverse events following prior vaccination.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No reaction on previous exposure to drug
Clinical narrative: A 19 year old female patient with no past medical history received an intramuscular injection of MENACTRA (lot number U2665AA) in the left deltoid on 29 July 2008, the patient also received MENOMUNE four years prior (lot number not provided).  On 30 July 2008 the patient had a large induration.  "the size of a baseball ", at the left deltoid injection site.  She also had a large amount of lymph node swelling in the left clavicular area.  The patient complained of pain at the injection site.  She was being monitored by her doctor.  She was advised to use an ice pack and IBUPROFEN.  The patient did not recover from the events at the time of the report.  Follow-up information received from a health care professional on 25 August 2008.  It was confirmed that the patient is male, not female.  It was reported that the patient's symptoms of enlarged lymph nodes, injection site reaction and inflammation at site started approximately four to five hours after the MENACTRA vaccine was given on 29 July 2008 at 4:45 PM. The symptoms subsided gradually, lasting three to four days.  The patient had not experienced any adverse events following prior vaccination.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Bladder disorder, Dysuria, Urinary incontinence, Urine analysis abnormal, Urine protein, quantitative
Clinical narrative: A 14 year old female patient with a medical history of cerebral palsy and allergy to latex received a first injection of MENACTRA (lot number U2329AA) intramuscularly in the left deltoid on 14 February 2008. On 14 February 2008 the patient experienced ongoing bladder issues since she received the injection. The recovery status of the patient was unknown. No additional information was provided. Follow-up information was received from a health care professional on 20 August 2008. It was confirmed that the patient is male not female. On 14 January 2008, the patient experienced "bladder issues". Diagnosis was dysuria. Urinalysis was abnormal. CIPRO 250 mg, one tab twice daily times 10 days was prescribed. the patient was to return if there were concerns or if the condition worsened. Concomitant medications were BENZACLIN, DUAC and doxycycline monohydrate, all acne medications. On 14 February 2008, the patient had no complaints. Urinalysis results were reported as "normal, cloudy with trace protein". MENACTRA was administered on 14 February 2008. No further details concerning a post-vaccination adverse event were reported. Follow-up information was received form a health care professional on 26 September 2008, the reporter indicated that dysuria had been pre-existing in January 2008 and CIPRO was ordered on 14 February 2008 for 10 days. CIPRO stop date should have been 26 January 2008; the patient did not return to the office for the follow-up appointment. The patient had no concerns or complaints of dysuria during the office visit on 14 February 2008; a urinalysis on that date was cloudy with trace protein. The patient was seen twice after the MENACTRA injection and did not complain of any adverse events from the injection. It was reported that on 11 June 2008, the patient's mother asked for "Rx for bladder" but none was given and no tests were performed. It was also reported that on an unspecified date, the patient was referred to a specialist for urinary incontinence and persistent cerebral palsy.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in jaw
Clinical narrative: An 18 year old female patient with a past medical history of Tourette's Syndrome and facial palsy (which occurred as a result of two unknown medications that were given at an unknown time) received a first dose of MENACTRA (lot number 2558AA, lot number provided invalid) intramuscularly in the right deltoid on 14 July 2008. 15 minutes post vaccination, the patient experienced a worsening of left jaw pain when she opened her mouth to talk or eat. Her pain continued. She does not have any prior history of dental issues. Recovery status was unknown. Follow up information was received on 11 August 2008 from a health care professional. The patient received a first dose of MENACTRA (lot number U2558AA). The patient did not have any prior history of jaw pain. After she received the injection, she began with jaw pain. She needed to get her back, left tooth filled and may need a root canal. The patient's father stated that the patient's pain had lessened but was still present. No further information was provided.
Sex: M
Vaccine: MNQ
Symptoms: Malaise, Pruritus
Clinical narrative: A male patient (age not provided) reported that he had received a shot which I think was MENACTRA..." before taking a trip to Nepal. The patient reported having an unusual amount of itching (site of itching not reported). When he arrived in Nepal, the patient continued to feel ill and he experienced "odd symptoms" (not specified). MENACTRA lot number, date of administration, route/site of administration, event start date (s) and recovery status were not reported.
Age: 19.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, HPV4, MEN, HPV4, MEN
Symptoms: Autopsy, Death, Headache, Malaise
Clinical narrative: Previously healthy 19-year old female college freshman found dead in her dorm bed approximately 10 days after receiving GARDASIL and meningitis immunizations over Thanksgiving break while visiting family in her hometown. She had very recently made a doctor appointment for the afternoon of Mon. 12/08/2008- pending at the time of her death. She did not show up for the appointment, was found in her bed in the dorm room dead with rigor mortis. The reason noted by intake clerk at student health for making a medical appointment was "possible seizure", patient had no prior medical history of epilepsy or any other disorder, was physically fit and on the crew team. She was last seen alive the evening of 12/7/08. She had talked on the phone to her out-of-state boyfriend and chatted with her dorm roommate. She had complained of a headache and not feeling well that day. She went to bed at 10:30 PM. In the AM, her roommate arose and thought patient was still asleep. The roommate left for the day of classes. Patient did not return friends text messages that day, leading to the finding of her body in bed in the dorm room about 5 PM 12/08/08. Preliminary autopsy done 12/09/08 shows no obvious cause of death per family's verbal report to me. Toxicology results are pending, due back in 6 weeks. Patient had no history of substance abuse and is not thought to be a suicide risk. She had been thriving in college and happy. No suspicions of foul play. Patient was a non-smoker. Funeral is planned for Sat 12/13/08. Tragic end for a brilliant and beautiful young woman. Please investigate possible role of GARDASIL and/or menigococcal vaccine in this death. This report submitted by patient's family friend MD, Internal Medicine and Geriatrics. Thank you for your prompt attention to public safety.
Age: 19.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, HPV4, MEN, HPV4, MEN
Symptoms: Death, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Previously healthy 19-year old female college freshman found dead in her dorm bed approximately 10 days after receiving GARDASIL and meningitis immunizations over Thanksgiving break while visiting family in her hometown. She had very recently made a doctor appointment for the afternoon of Mon. 12/08/2008- pending at the time of her death. She did not show up for the appointment, was found in her bed in the dorm room dead with rigor mortis. The reason noted by intake clerk at student health for making a medical appointment was "possible seizure", patient had no prior medical history of epilepsy or any other disorder, was physically fit and on the crew team. She was last seen alive the evening of 12/7/08. She had talked on the phone to her out-of-state boyfriend and chatted with her dorm roommate. She had complained of a headache and not feeling well that day. She went to bed at 10:30 PM. In the AM, her roommate arose and thought patient was still asleep. The roommate left for the day of classes. Patient did not return friends text messages that day, leading to the finding of her body in bed in the dorm room about 5 PM 12/08/08. Preliminary autopsy done 12/09/08 shows no obvious cause of death per family's verbal report to me. Toxicology results are pending, due back in 6 weeks. Patient had no history of substance abuse and is not thought to be a suicide risk. She had been thriving in college and happy. No suspicions of foul play. Patient was a non-smoker. Funeral is planned for Sat 12/13/08. Tragic end for a brilliant and beautiful young woman. Please investigate possible role of GARDASIL and/or menigococcal vaccine in this death. This report submitted by patient's family friend MD, Internal Medicine and Geriatrics. Thank you for your prompt attention to public safety.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: 12 days following patient's 4 mth vaccinations, she developed intussusception and required intestinal surgery.  Dr., pediatrician, also filed a report.  Dr. at Hospital performed the surgery on Nov. 16, 2008.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Gastrointestinal surgery, Intussusception
Clinical narrative: 12 days following patient's 4 mth vaccinations, she developed intussusception and required intestinal surgery.  Dr., pediatrician, also filed a report.  Dr. at Hospital performed the surgery on Nov. 16, 2008.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye swelling, Immediate post-injection reaction, Pruritus, Rash, Sneezing
Clinical narrative: This serious case was received from a health professional on 01 December 2008. A four year-old male patient, with no known allergies and no medical conditions, received the following vaccines on 26 November 2008: a fifth right thigh injection of DAPTACEL (lot number C3000AA); a fourth left thigh injection of IPOL (lot number A1060-2); a left thigh injection of MMR II (Merck, lot number 1011X); and a left thigh injection of VARIVAX (Merck, lot number 0975X). Immediately after vaccination, the patient experienced wheezing, swelling of the eyes, sneezing, a rash, and "itchy feet". He was treated with nebulizer treatments and prednisone, and then sent home. The outcome was unknown. The reporter in this case also reported a similar event in another 4 year-old patient; this event was captured in case number 2008-03837. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: This serious case was received from a health professional on 01 December 2008. A four year-old male patient, with no known allergies and no medical conditions, received the following vaccines on 26 November 2008: a fifth right thigh injection of DAPTACEL (lot number C3000AA); a fourth left thigh injection of IPOL (lot number A1060-2); a left thigh injection of MMR II (Merck, lot number 1011X); and a left thigh injection of VARIVAX (Merck, lot number 0975X). Immediately after vaccination, the patient experienced wheezing, swelling of the eyes, sneezing, a rash, and "itchy feet". He was treated with nebulizer treatments and prednisone, and then sent home. The outcome was unknown. The reporter in this case also reported a similar event in another 4 year-old patient; this event was captured in case number 2008-03837. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Immediate post-injection reaction, Sneezing, Vomiting
Clinical narrative: This serious case was received from a health professional on 01 December 2008. A 4 year-old male patient, with no known allergies and no reported medical conditions, received the following vaccines on 18 November 2008: a fifth right thigh injection of DAPTACEL (lot number C3000AA); a fourth left thigh injection of IPOL (lot number A1109); an injection of MMR II (Merck, lot number 1250X); an injection of VARIVAX (Merck, lot number 1009X); and nasal FLUMIST (MedImmune, lot number 500545P). Five minutes after vaccination, the patient began sneezing and vomiting, and experienced shortness of breath. He was given epinephrine in the office, and then sent to the emergency room for observation. He was released the same day; outcome was unknown. The reporter for this case also reported a similar event in another 4-year-old patient; this event is captured in case number 2008-03836. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Menstruation irregular
Clinical narrative: Information has been received from a physical therapist concerning her daughter a 16 year old female with no pertinent medical history reported and no known drug allergies who on 06-NOV-2007 was vaccinated with the first dose of GARDASIL (lot n. 658490/08020), 0.5 mL, intramuscularly. On 08-JAN-2008, the patient was vaccinated with a second dose of GARDASIL (lot n. 658094/0524U). On 22-JUL-2008, the patient was vaccinated with a third dose of GARDASIL (lot n. 660391/0063X). The physical therapist reported that her daughter has had irregular menstrual cycles since administration of her third dose of GARDASIL. Her one and only menstrual period occurred 6 to 7 weeks after receiving her third dose. The patient also experienced injection site soreness on an unspecified date. The patient called to the office. At the same time of reporting the patient had not recovered.  This is one of two reports from the same source. Additional information has been requested
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Coagulopathy, Death, Hypovitaminosis, Liver disorder, Ocular hyperaemia
Clinical narrative: Stopped breathing/death. Blood(redness ) in both eyes, (began 12/15).  2/18/09 Death certificate states COD as hypoxic-ischemic encephalopathy due to whiplash shaking injuries of head & spinal cord.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory arrest
Clinical narrative: Stopped breathing/death. Blood(redness ) in both eyes, (began 12/15).  2/18/09 Death certificate states COD as hypoxic-ischemic encephalopathy due to whiplash shaking injuries of head & spinal cord.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypovitaminosis, Ocular hyperaemia
Clinical narrative: Blood (redness) in both eyes.  01/27/09 Received hospital medical records of 12/19-12/20/2006. FINAL DX: evaluation for nonaccidental trauma Records reveal patient experienced bilateral subconjunctival hemorrhages & cheek abrasion.  Twin sibling expired due to severe brain injury by nonaccidental trauma. Genetics, surgery, ortho & ophtho consult done.  Patient was transferred to hospital closer to home.  CPS & DSS evaluated & placed in foster care.  2/3/09 Received hospital medical records of 12/20-12/22/2006. FINAL DX: Non-accidental trauma Records reveal patient admitted while awaiting placement by DSS.  No new information.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac disorder, Electrocardiogram abnormal, Mitral valve prolapse, Palpitations, X-ray normal
Clinical narrative: Heart problems related to GARDASIL vaccine. My daughter has experienced severe heart palpation's. She has been diagnosed with Mitro Valve Prolapse and struggles with heart palpitations on an ongoing basis. She never had any of these problems prior to her getting the first shot of the vaccine. She is visiting a cardiologist to see what other problems there maybe with her heart. I feels all these symptoms started after her first dose of GARDASIL vaccine. I never made the connections and she has received all three of the series of shots. Until my daughter brought it up in a conversations about a friend of hers at school experienced a similar reaction to her heart after she received the GARDASIL did I finally realize there might be a connection to this drug.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site oedema, Pain
Clinical narrative: Child was given IM Flu vaccination in pediatrician office. Site of injection - right vastus lateralis. Within 12 hrs pt. presented at site of injection erythema, edema/inflammation, localized pain, and low-grade fever - 99. Within 36 hours - symptoms had diffused to about 70% of right thigh. Child was taken to an Urgent Care center - dx with cellulitis; given sulfamethoxazole and trimethoprim.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Child was given IM Flu vaccination in pediatrician office. Site of injection - right vastus lateralis. Within 12 hrs pt. presented at site of injection erythema, edema/inflammation, localized pain, and low-grade fever - 99. Within 36 hours - symptoms had diffused to about 70% of right thigh. Child was taken to an Urgent Care center - dx with cellulitis; given sulfamethoxazole and trimethoprim.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: GARDASIL # 1 given 11/19/08. On 11/21, pruritus and papular red rash. Low grade fever. Have hx. of allergic reaction to PCN, Sulfa, Bee stings and pertussis vaccine.
Age: 17.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Fatigue, Musculoskeletal stiffness, Nausea, Posture abnormal, Tremor
Clinical narrative: After nurse gave FLUMIST and GARDIASIL, pt's face went blank and pt head deviated to the right, also pt's arms went stiff in extension; hands shook a little, legs extended also & loss of urine onto floor, lasted 30-60 seconds, pt was tired and nauseous afterward. No vomiting.
Age: 17.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Urinary incontinence
Clinical narrative: After nurse gave FLUMIST and GARDIASIL, pt's face went blank and pt head deviated to the right, also pt's arms went stiff in extension; hands shook a little, legs extended also & loss of urine onto floor, lasted 30-60 seconds, pt was tired and nauseous afterward. No vomiting.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Conjunctivitis, Cough, Eye swelling, Oropharyngeal pain
Clinical narrative: Bilateral conjunctivitis, sore throat, non productive cough. chest tightness, slight wheezes, swelling around eyes and body aches. BENADRYL 25mg times one per day, Ibuprofen 200mg times twice per day, no effect.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Wheezing
Clinical narrative: Bilateral conjunctivitis, sore throat, non productive cough. chest tightness, slight wheezes, swelling around eyes and body aches. BENADRYL 25mg times one per day, Ibuprofen 200mg times twice per day, no effect.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Mucous stools
Clinical narrative: Loose mucusy stool go to ROTATEQ vaccine 10/29/08 no fever no Rx.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Mother reported patient had hives/itching about 2hrs. after vaccine administered. Gave 1 tsp of Benadryl with good results. Next day only small area of hives- no itching.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: Severe bilateral hand pain, swelling, right wrist, elbow, foot pain and swelling. Onset 20 hours after 2nd injection in Right elbow. Treated 2-6 hours with MOTRIN x 48 hours.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Dyskinesia, Musculoskeletal pain, Vaccination complication, X-ray normal
Clinical narrative: Patient complaint - pain left shoulder. MD visits - no signs of swelling, erythema. Tenderness. Pain noted with passive abduction, limited active internal rotation. Diagnosis bursitis secondary to flu vaccination treated with KENALOG injection into sub deltoid bursa.
Sex: M
Vaccine: HEPAB
Symptoms: Pain, Rash generalised, Swelling
Clinical narrative: 2 days after TWINRIX # 2, developed rash on hands, arms and legs x 3 days. Swelling/pain x 3 days.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Crying, Pain, Tremor
Clinical narrative: Seemed himself all day. Got home at 5:30 pm. Crying was different, shaking for probably 5 minutes. Seemed like he was in pain. Good eye contact. Fell asleep on car ride home, more snuggly tonight. Appetite good, no vomiting. Was given TYLENOL 0.8 ml at 1pm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Swelling
Clinical narrative: Redness, swelling and large - 2" in diameter - lump.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Antinuclear antibody negative, Borrelia burgdorferi serology negative, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Within one week of immunizations patient developed hip arthralgia, in (R) hip then both, crutches, seen 11/25/08 1st. Referred to Rheumatology at Med. Ctr.  1/21/09 Received Rheumatology clinic records of 12/3/08 FINAL DX: probable conversion reaction Records reveal patient had right hip pain x 3 weeks.  Seen by PCP & in ER for pain.  X-rays were WNL.  Now w/bilateral hip pain & unable to walk w/o crutches.  Sleep was disturbed.  Morning stiffness.  NSAIDS had not helped.  tx w/meds & PT
Age: 1.31
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Child with hive like rash. Started on leg, flu injection was given in and now spread over the rest of child's body.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Crying, Rash generalised, Urticaria
Clinical narrative: Pt given HIB, PREVNAR, PEDIANX, ROTATEQ, influenza @ 13:35.  At 13:46 someone in waiting room said, "that baby's face doesn't look right."  Went to waiting room.  Mom holding infant, infant crying, hives noted on entire face and head.  Mom carried baby to exam room.  Trunks rash; hands, arms, legs, feet bilat right swollen.  Adv mom on potential  reaction.  Infant given 0.1cc BENADRY im @ 13:47.  LP-120 crying no wheezing.  13:53 R-45 hives on forehead only, blow by O2 admin. @ 13:49 P-148, hives on forehead, crying, no wheezing.  EMS arrival 13:52.  Pt to ER via EMS @ 13:55 with mom carrying infant.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Pain, Pyrexia, Rash maculo-papular, Rash vesicular
Clinical narrative: This patient got the VARIVAX vaccine on 5/30/2008. On 06/11/08 in the evening the patient developed a fever, body aches, fatigue and generalized maculopapular vesicular rash.
Age: 50.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pt. received with pneumonia vaccine in (L) deltoid and called back. The rest morning stating she had pain at the site. She was instructed to use TYLENOL and cool compress. Called her 9/18/08 at 8:30 am and pt. reports much less pain. Denies erythema.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: severe local reaction left upper arm.  Symptoms began evening of 11/4/08.  Warm to touch-reddness-swelling of arm above elbow.  Patient referred to urgent care for medical intervention 11/25/08 call to patient.  She recovered from event.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: Right deltoid area with extensive erythema, warmth from shoulder to just above elbow. Tender to palpitation. Pain with ROM (range of motion) of shoulder.