chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: I recieved the vaccine at 4:30 pm on 11-23-07 in my left arm.  On 11-25-07 I woke up with a baseball size lump under in my armpit.  The lump was very tender and I was unable to use my arm or to move my arm without pain all day.  My lymph nodes were also swollen and very tender.  This condition has continued and as of this date I am still able to feel a lump in my armpit and I am unable to touch my armpit without pain.  My lymph nodes remain swollen and on 11-26-07 the lymph nodes in my neck were swollen and very tender to touch.  I have been taking tylenol but it does not help the pain.  I also have been taking benedryl to try to decrease the swelling.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Diarrhoea, Dizziness, Fatigue, Feeling hot
Clinical narrative: On 10-14-2007 states she started feeling like she had the flu, achy all over, dizziness, diarrhea, felt clamy then hot, fatigue, stated she felt like her hips did not want to work. Stated that to her knowledge, her temperature was not over 98.8.  These symptoms still continue to present day.  Saw nurse practitioner, on 10-17-2007, 11-13-2007, 11-21-2007 and 11-28-2007.  On 11-21-2007 Labs were ordered and on 11-28-2007 was prescribed Zyrtec 10 mg. and Septra DS.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Gait disturbance, Influenza, Pain, Thyroid function test
Clinical narrative: On 10-14-2007 states she started feeling like she had the flu, achy all over, dizziness, diarrhea, felt clamy then hot, fatigue, stated she felt like her hips did not want to work. Stated that to her knowledge, her temperature was not over 98.8.  These symptoms still continue to present day.  Saw nurse practitioner, on 10-17-2007, 11-13-2007, 11-21-2007 and 11-28-2007.  On 11-21-2007 Labs were ordered and on 11-28-2007 was prescribed Zyrtec 10 mg. and Septra DS.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Syncope, Urticaria
Clinical narrative: Seconds after vaccination with Varivax to the left deltoid, patient stood and collapsed hitting occipital area of head. Immediately awake and cried. Within ~ 1 minute from vaccination, developed urticaria on left forearm and face. no wheezing, no tongue swelling.
Age: 48.0
Sex: U
Vaccine: HEPAB, IPV
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Developed pain and tingling on the right upper arm the next day after receiving vaccine and progressed to numbness and weakness of the right arm over a period of 6 weeks from vaccination date. Patient states that she still is having the pain & numbness up to this time 7 mos later.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Apnoea, Chest X-ray, Crying, Metabolic function test, Pallor
Clinical narrative: My daughter had her 2 month vaccines given at 9:00 a.m. and had been down for her nap at 2:30 p.m. she awoke screaming uncontrollable in the fetal position very tight, then she bacame blue around lips and eyes and stopped breathing for approx 10-15 secs, then turned gray I began back slaps to her back to try and stimulate her back before starting CPR, she then started crying and turned white. She had raccon eyes for a while. We were tranported to the ED by ambulance and spent two nights in the hospital for observation. 1/2/08-records received for DOS 11/27-11/29/07-DC DX: Probably breath holding spell. Awoke screaming from nap, stopped breathing for about ten seconds and turned blue but during the times she was struggling her eyes were open. Continue to have breath holding spells 10 seconds with 1-2 minute recovery time.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Posture abnormal, Screaming
Clinical narrative: My daughter had her 2 month vaccines given at 9:00 a.m. and had been down for her nap at 2:30 p.m. she awoke screaming uncontrollable in the fetal position very tight, then she bacame blue around lips and eyes and stopped breathing for approx 10-15 secs, then turned gray I began back slaps to her back to try and stimulate her back before starting CPR, she then started crying and turned white. She had raccon eyes for a while. We were tranported to the ED by ambulance and spent two nights in the hospital for observation. 1/2/08-records received for DOS 11/27-11/29/07-DC DX: Probably breath holding spell. Awoke screaming from nap, stopped breathing for about ten seconds and turned blue but during the times she was struggling her eyes were open. Continue to have breath holding spells 10 seconds with 1-2 minute recovery time.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient received flu vaccine in thigh on Thursday,   11/8/07, around 3pm.  Friday afternoon, 11/9, he complained that his "feet were itchy".  Saturday morning 11/10 he awoke with fever (101.6 F) headache, and HIVES all over his thighs, calves, ankles, and feet. We were out of town  called our pediatrician who advised giving him oral Benedryl and taking him to an acute care center.  We did so.  Patient responded to the Benedryl (hives began to fade) and Tylenol for headache and fever.  Felt bad for the day.  Hives faded in two days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac disorder, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in October 2007 (exact date unknown), was vaccinated (route and site not reported) with the 1st dose of Gardasil (lot # not reported). Three hours post vaccination, the patient passed out and was hospitalized. At the time of this report the patient was still in the hospital based on a cardiac related issue. The cardiologist states that the cardiac issue has nothing to do with the Gardasil the patient received. The physician felt that the patient's passing out and cardiac related issue were considered to be immediately life-threatening. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with three doses of Gardasil (dates not reported). Subsequently the patient was diagnosed with cervical intraepithelial neoplasia II. The patient was treated with a Loop Electrosurgical Excision Procedure. It was reported that the patient was not recovered at the time of this report. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC
Symptoms: Neck injury, Posture abnormal, Torticollis, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of torticollis in a 2-month-old female subject who was vaccinated with Pediarix for prophylaxis. Concurrent vaccination included Haemophilus influenzae type b vaccine (manufacturer unspecified), hepatitis B vaccine recombinant (manufacturer unspecified), inactivated poliomyelitis virus vaccine (manufacturer unspecified) and pneumococcal vaccine (manufacturer unspecified) all given on 2 July 2007, 11 September 2007 and 14 November 2007 with the exception of Haemophilus influenzae type b vaccine which was not given on 14 November 2007. Concurrent medications included Fluoride started sometime between the 2nd and 3rd doses of Pediarix and multivitamin. On 2 July 2007, the subject received the 1st Pediarix vaccination (0.5 ml) at two months of age. Seven days later, on 9 July 2007, the subject experienced torticollis and an episode of vomiting (vomiting at 15:30). The subject was taken to the emergency room and was reportedly hospitalized. She was sent home with a strained neck. Vomiting resolved 9 July 2007 and torticollis was resolved by 11 July 2007. On 11 September 2007, in the morning, the 4 month old subject received 2nd dose of Pediarix (0.5 ml). Seven days later, on 18 September 2007, in the morning, the subject experienced torticollis and vomiting again. The subject was treated with Pedialyte. The events reportedly lasted "hours" and then resolved. Third dose of Pediarix was received by the 6 moth old subject on 14 November 2007 (0.5 ml). Seven days later, on 21 November 2007, the subject developed torticollis in the morning and vomiting. The subject vomited once on the 21st in the afternoon and started again on the 22nd. Vomiting on the 22nd lasted 6 hours and then resolved. Torticollis was unresolved at the time of reporting. The reporter thought that the pertussis may have caused the torticollis, which may have been causing the vomiting. The subject was also reportedly leaning towards the right and favored the right side. On 297 November 2007 a physician reported that the reported events jeopardized the subject or required intervention (disabling was unknown). The doses of Pediarix administered were reportedly 0.5 ml. The events of torticollis were described as a head tilt to the right and vomiting was said to be projectile. The physician reported that all events were possibly related to treatment with Pediarix. The events of torticollis and vomiting continued intermittently for about 48 hours, according to the physicians report, following the 2nd dose of Pediarix and then resolved spontaneously. The physician stated that the same reaction was experienced by the subject exactly seven days after the 4 and 6 month vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling at the injection site in a 18-month-old subject of unspecified gender who was vaccinated with Infanrix for prophylaxis. On an unspecified date the subject received unspecified dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site and injection site discomfort. At the time of reporting the outcome of the events was unspecified. These events occurred in three different subjects. It was reported that one of the subject's arms looked like it could have been drained due to the swelling. The swelling area was also described as similar to the palm of the hand. Follow-up was received from the healthcare professional on 27 November 2007. The subject was a 4 year-old female. On an unspecified date, the subject received a dose of Pediarix ass the 5th "catch-up" dose at an unspecified site of administration. On 30 October 2007, at an unspecified time after administration of Pediarix, the subject experienced injection site swelling, injection site discomfort and cellulitis. The subject was treated with Bactrim and the events improved on 31 October 2007. The healthcare professional considered the events to possibly be related to vaccination with Pediarix. Comment: Cellulitis was assessed as medically serious.
Age: 0.1
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RVX
Symptoms: Computerised tomogram normal, Convulsion, Laboratory test normal, Sepsis
Clinical narrative: seizure like event on way home from receiving 2 ml vaccine (Rota, DTaP, Prevnar, IPV, Comvax) 12/26/07-records received for DOS 11/17-11/19/07-C/O abnormal movements and fever. Temp 38.4. Eyes deviated right, bilaterally and up. Arms flexed.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Admitted to Hospital for IV Antibiotics for Cellulitis at Site of vaccine. 2/19/08-records received for DOS 11/8-11/9/07-DX DC: cellulitis left ar. Day after receiving vaccine developed itching, swelling, redness and burning at the injection site. Blister like lesion on arm with clear yellowish drainage. Fever, nausea nad malaise.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Bronchoscopy, Collapse of lung
Clinical narrative: Right upper lobe of lung collapsed.  12/7/07 Reviewed hospital medical records which reveal patient experienced 2 week of perisstent nonproductive cough w/intermittent SOB, wheezing & sharp stabbing right neck pain beginning 1 week s/p vax.  Persistent RUL collapse & possible foreign body aspiration which was ruled out.  Admitted 11/14-11/18/2007.  Tx w/antibiotics, PPD & aggressive pulmonary toilet.  Pulmonary consult done.   FINAL DX: no d/c summary available, admit & d/c dates obtained from ROI.  Bronchoscopy revealed asthma w/RUL collapse.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Arthralgia, Discomfort, Pharyngeal oedema, Swollen tongue
Clinical narrative: Had onset of angioedema throat swelling. seen and treated 2 times in ER. 10-16-07. Admitted 10-16-07 x 48 hr Readmitted x 1 to ER again 11-2-07.  12/11/07 Received hospital medical records of 11/2-11/3/2007 patient experienced recurrence of angioedema, tongue swelling, maculopapular rash & blistering of lips when steroids were tapered.  Tx w/IV steroids & admitted overnight for observation after switching to oral steroids. FINAL DX: Allergic reaction.  1/8/08 Received additional hospital medical records for 2 different admissions. 10/16-10/18/2007 patient experienced angioedema w/airway compromise & swelling of tongue & floor of mouth, trouble swallowing, speech difficulty & rash x 4 days.  Seen by pcp earlier on 10/16 & tx w/epi & benadryl.  Sent to ER, treated w/IV steroids & antibiotics & d/c to home.  Returned to ER later same day with same s/s & SOB & difficulty handling oral secretions. Admitted for observation.  Oral surgery consult done.  Laryngeal scoping done & was WNL as swelling resolved.  D/C to home on tapering steroids FINAL DX: angioedema w/airway compromise & swelling of tongue & floor of mouth.  10/19-10/28/2007  patient experienced progressibly worsening SOB, tongue swelling, perioral numbness & paretic erythematous macular papular rash on chest & back angioedema x 1 day.  Tx w/IV steroids, benadryl & admitted.  Exam revealed facial flushing & periorbital edema.  Improved & d/c to home on slow tapering steroids. FINAL DX: angioedema secondary to flu shot, resolved. Annual Follow-up Information 12-DEC-2008: Still residual pain and discomfort in joints. 60 Day Follow-up Information 30-JAN-2008: Still recovering from side effects. Steroid Tx for angioedema/significant myalgias.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Abasia, Asthenia, Blood product transfusion, Electromyogram abnormal, Gait disturbance
Clinical narrative: Vaccines given 10/30/ 48 hours S/P vaccines developed myalgias and difficulty walking - admitted to hospital 11/1, observed - no improvement and amb. 11/6 received w/ RN yet making polyneuropathy c/w dx of Guillain-Barre syndrome. Pt received gammaglobulin x 5d and pt dc'd to rehab (11/13) and later discharged home 11/19 w/ neurologist. 1/2/08-records received for DOS 11/1-11/13/07-DC DX: Guillain-Barre syndrome. C/O weakness, not feeling well, tremors for 2 days prior to admission. Progressively getting worse. Unable to walk at time of admission. Lightheadedness and nausea. Tingling in legs. PE: DTRs present but decreased on right. Macules on abdomen. Treated with IVIG.  This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a physician, concerning a 16 year old (previously reported as 15 year old) female student with no known drug allergies or birth anomalies, who on 30-OCT-2007 was vaccinated with a dose (invalid dose # reported) of GARDASIL (lot # 659437/1266U). There was no illness at the time of vaccination. The physician reported that 48 hours after the vaccination, the patient presented with "symptoms similar to GUILLAIN BARRE syndrome," and went into the hospital. Diagnostic testing was done, and a specialist determined that she did not have GUILLAIN BARRE, but rather a severe case of muscle myalgia. Follow up information from the physician, via the company representative, indicated that on the same day of vaccination with GARDASIL, the patient received a concomitant vaccination of a dose of HAVRIX (lot # AHAVB207BA). The patient, contrary to the above information, was actually diagnosed with GUILLAIN BARRE Syndrome. Additional follow from the physician indicated that the patient's symptoms began on 31-OCT-2007, the day after vaccination, and on 01-NOV-2007, she had difficulty walking and had myalgias. She visited the emergency room and was hospitalized for 19 days (dates not provided). She was evaluated by the infectious disease department, neurology, and had a positive "AMG." Treatment included IV gamma globulin and physical therapy. At the time of this report, the outcome of the event was unknown. The physician considered the event to be serious as disabling/incapacitating and for prolonged hospitalization. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Malaise, Myalgia, Polyneuropathy, Tremor
Clinical narrative: Vaccines given 10/30/ 48 hours S/P vaccines developed myalgias and difficulty walking - admitted to hospital 11/1, observed - no improvement and amb. 11/6 received w/ RN yet making polyneuropathy c/w dx of Guillain-Barre syndrome. Pt received gammaglobulin x 5d and pt dc'd to rehab (11/13) and later discharged home 11/19 w/ neurologist. 1/2/08-records received for DOS 11/1-11/13/07-DC DX: Guillain-Barre syndrome. C/O weakness, not feeling well, tremors for 2 days prior to admission. Progressively getting worse. Unable to walk at time of admission. Lightheadedness and nausea. Tingling in legs. PE: DTRs present but decreased on right. Macules on abdomen. Treated with IVIG.  This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a physician, concerning a 16 year old (previously reported as 15 year old) female student with no known drug allergies or birth anomalies, who on 30-OCT-2007 was vaccinated with a dose (invalid dose # reported) of GARDASIL (lot # 659437/1266U). There was no illness at the time of vaccination. The physician reported that 48 hours after the vaccination, the patient presented with "symptoms similar to GUILLAIN BARRE syndrome," and went into the hospital. Diagnostic testing was done, and a specialist determined that she did not have GUILLAIN BARRE, but rather a severe case of muscle myalgia. Follow up information from the physician, via the company representative, indicated that on the same day of vaccination with GARDASIL, the patient received a concomitant vaccination of a dose of HAVRIX (lot # AHAVB207BA). The patient, contrary to the above information, was actually diagnosed with GUILLAIN BARRE Syndrome. Additional follow from the physician indicated that the patient's symptoms began on 31-OCT-2007, the day after vaccination, and on 01-NOV-2007, she had difficulty walking and had myalgias. She visited the emergency room and was hospitalized for 19 days (dates not provided). She was evaluated by the infectious disease department, neurology, and had a positive "AMG." Treatment included IV gamma globulin and physical therapy. At the time of this report, the outcome of the event was unknown. The physician considered the event to be serious as disabling/incapacitating and for prolonged hospitalization. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Guillain-Barre syndrome, Laboratory test abnormal, Myalgia
Clinical narrative: Vaccines given 10/30/ 48 hours S/P vaccines developed myalgias and difficulty walking - admitted to hospital 11/1, observed - no improvement and amb. 11/6 received w/ RN yet making polyneuropathy c/w dx of Guillain-Barre syndrome. Pt received gammaglobulin x 5d and pt dc'd to rehab (11/13) and later discharged home 11/19 w/ neurologist. 1/2/08-records received for DOS 11/1-11/13/07-DC DX: Guillain-Barre syndrome. C/O weakness, not feeling well, tremors for 2 days prior to admission. Progressively getting worse. Unable to walk at time of admission. Lightheadedness and nausea. Tingling in legs. PE: DTRs present but decreased on right. Macules on abdomen. Treated with IVIG.  This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a physician, concerning a 16 year old (previously reported as 15 year old) female student with no known drug allergies or birth anomalies, who on 30-OCT-2007 was vaccinated with a dose (invalid dose # reported) of GARDASIL (lot # 659437/1266U). There was no illness at the time of vaccination. The physician reported that 48 hours after the vaccination, the patient presented with "symptoms similar to GUILLAIN BARRE syndrome," and went into the hospital. Diagnostic testing was done, and a specialist determined that she did not have GUILLAIN BARRE, but rather a severe case of muscle myalgia. Follow up information from the physician, via the company representative, indicated that on the same day of vaccination with GARDASIL, the patient received a concomitant vaccination of a dose of HAVRIX (lot # AHAVB207BA). The patient, contrary to the above information, was actually diagnosed with GUILLAIN BARRE Syndrome. Additional follow from the physician indicated that the patient's symptoms began on 31-OCT-2007, the day after vaccination, and on 01-NOV-2007, she had difficulty walking and had myalgias. She visited the emergency room and was hospitalized for 19 days (dates not provided). She was evaluated by the infectious disease department, neurology, and had a positive "AMG." Treatment included IV gamma globulin and physical therapy. At the time of this report, the outcome of the event was unknown. The physician considered the event to be serious as disabling/incapacitating and for prolonged hospitalization. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Convulsion, Fall, Haematoma, Heart rate normal
Clinical narrative: Syncopal episode, fell face first from exam table. Loc 2 1 min with mild seizure actually prior to coming to vs stable -BP 106/68, pale. Hr WNL Perla hematoma on forehead, bit upper lip and tongue c/o neck pain. Observed x 1 hr 10 min A&O x 3 vs stable
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Neck pain, Pallor, Syncope, Tongue biting
Clinical narrative: Syncopal episode, fell face first from exam table. Loc 2 1 min with mild seizure actually prior to coming to vs stable -BP 106/68, pale. Hr WNL Perla hematoma on forehead, bit upper lip and tongue c/o neck pain. Observed x 1 hr 10 min A&O x 3 vs stable
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: Vesicular rash at injection site, started later same day, mildly painful. In for office visit 10/15/07 3 days later. Grouped dry vesicles. Did not improve with empiric acyclovir.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure, Loss of consciousness, Pallor
Clinical narrative: Patient's brother came into office stating patient had passed out in car - when staff personnel arrived, patient more alert and oriented - pale - brought back to office.  Lying down blood pressure 105/74 x 2 - observed - color good
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Convulsion, Syncope
Clinical narrative: After giving Tdap and Hep A vaccines, patient had syncope, brief seizure activity lasting 3-4 minutes recovered and left clinic with parents. Per call the next morning no further problems
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Candidiasis, Chills, Cough
Clinical narrative: 10-24-07 - teeth cleaned - 2000 mg amoxicillin. 10-25-07 - Headache - fever - tired - weak - cough - temp 103.5. 10-26-07 Above plus hurt - chills - sweats - thrush lasts 10-14 days except cough which lasted about 30 days - no one catches it from me - exact same scenario last year. Amoxicillin 500mg - 3x - 20 days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hyperhidrosis, Pyrexia, Vaccine positive rechallenge
Clinical narrative: 10-24-07 - teeth cleaned - 2000 mg amoxicillin. 10-25-07 - Headache - fever - tired - weak - cough - temp 103.5. 10-26-07 Above plus hurt - chills - sweats - thrush lasts 10-14 days except cough which lasted about 30 days - no one catches it from me - exact same scenario last year. Amoxicillin 500mg - 3x - 20 days.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Pain in extremity
Clinical narrative: Left upper arm, swelling, pain, erythema starting within 2 hours of immunization and continuing to worsen for 48 hrs. Also, lymphadenopathy, left axilla - erythema >6" - treated with antihistamine, NSAIDS, ice improved but not completely resolved at 1 week follow-up
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood thyroid stimulating hormone, Brain natriuretic peptide, C-reactive protein, Cardioactive drug level
Clinical narrative: 1 hour after Flu vaccine-felt cold, hands numb, next few days-fatigue, weakness, malaise, weak-weakness (especially proximal legs and arms).
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling cold, Full blood count, Hypoaesthesia, International normalised ratio
Clinical narrative: 1 hour after Flu vaccine-felt cold, hands numb, next few days-fatigue, weakness, malaise, weak-weakness (especially proximal legs and arms).
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Liver function test, Malaise, Renal function test
Clinical narrative: 1 hour after Flu vaccine-felt cold, hands numb, next few days-fatigue, weakness, malaise, weak-weakness (especially proximal legs and arms).
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Skin warm, Urticaria
Clinical narrative: Pain, swelling site. 7.5 cm weal with eryth and warmth.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Erythema, Slight edema, tender, the erythema ranged in size approx radius 5 in to 16 in treated with Benadryl and ice packs
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Intussusception diagnosed by ultrasound after patient presented with vomiting and bloody stools.  12/04/07 Reviewed vax record which confirms RO dose/lot as reported.  Faxed to CDC. 12/18/07 Reviewed hospital medical records which reveal patient experienced irritability, reduced oral intake, vomiting, abdominal pain & bloody stools.  Taken to ER 11/24/07.  Admitted for observation overnight.  Progressed well & d/c to home. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Body temperature increased, Oedema peripheral, Rash
Clinical narrative: Swelling of arm, rash, and very hot in temperature.  Taking pain killer medication.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Fluid retention, Oedema peripheral, Pain in extremity
Clinical narrative: Right arm swollen and painful starting 10 hours after vaccination. Cortisone injection given by MD, referred to rheumatologist. Fluid removed from both shoulders. Not rheumatoid arthritis, gout or lyme.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Lip swelling, Pharyngeal oedema, Restlessness
Clinical narrative: 45 minutes after vaccination, thought she had an almond stuck in her throat - drank copious amounts of water.  Restless, itchy eyes all night.  Woke up the next morning - eyes, lips and right side of throat swollen.  Benadryl x 24 hrs, no further flu shots (ate almonds with no problem since then).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site swelling, Irritability
Clinical narrative: Patient was fussy in the afternoon following vaccination. Seen in office to recheck; mild swelling in thigh that had Pediarix/HIB. Plan to space out next vaccines.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Local swelling, Lymphadenopathy, Muscle spasms, Sensory disturbance
Clinical narrative: Evening of shot pt developed severe pain at injection site (L) deltoid, swelling soft tissue into (L) neck, (L) supraclavicular lymph node, severe (L) trapezius muscle spasm and sensory abnormalities (L) UE.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Vaccinated 10-09-07.  No symptoms reported at follow-up on 10-16-07.  Rash & itching began 11-18-07.  PCP prescribed acyclovir & hydroxyzine on 11-20-07.  Rash has crusted over.  Still itching at time of report.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Malaise, Pallor, Rash pruritic
Clinical narrative: Mother related he came home and was very pale and didn't feel well. Developed bumpy, itchy rash on arm where immunization was given. Mom gave him Benadryl and symptoms passed in approx. 4 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Local Site reaction, about The Size of a small orange. Red, Swollen, Hot To Touch, Itchy, by Touch Their is a Nodule, (Large Knot). Onset occurred that evening, was sore. Now just itchy and Red and swollen. Will Take Benadryl and Ibuprofen persists will see MD.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Local Site reaction, about The Size of a small orange. Red, Swollen, Hot To Touch, Itchy, by Touch Their is a Nodule, (Large Knot). Onset occurred that evening, was sore. Now just itchy and Red and swollen. Will Take Benadryl and Ibuprofen persists will see MD.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site mass, Injection site rash
Clinical narrative: After injection, pt had excessive bleeding immediately following along with a 4mm bump. After about 5 min, I noticed a red rash around the injection site. Pt was given 50mg of diphenhydramine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Diarrhoea
Clinical narrative: Inconsolable crying for 5 hours after administration of Predvarix (DTAP/Hep B/IpV) Hib; PCV7, and Rotarvirus vaccine.  Administered vaccine at 10:30 am.  Explosive diarrhea 1 time after Rotavirus vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Arthralgia, Blood glucose normal, Chills, Dizziness, Haematocrit normal
Clinical narrative: Pt. came in for P.E. 11/27/07 - well visit; ILs administered in the morning.  In the evening pt. suddenly felt cold/chills, pain legs/shoulders, dizzy, blurred vision, pain along R wrist.  Took pt. to after hours pediatrics for evaluation.  Vision: 20/16 both eyes; see lab results; vaccine sites were not red, very mild induration; T: 98.6 degrees; SpO2: 98%; Meds: Advil 400 mg.  Still with nausea, decreased appetite, light headed. This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a physician concerning a 14  year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left deltoid with GARDASIL (lot# 659439/1267U). Concomitant therapy included VARIVAX for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included MENACTRA. On the evening of 27-NOV-2007 the patient experienced chills, dizziness, blurred vision and pain in the right wrist. The patient had an emergency pediatric evaluation on 27-NOV-2007 and the results were: vision fine, blood sugar 104, Hemoglobin 17.5 and hematocrit 40%, no fever, no redness and mild induration at the site of vaccination. The patient had taken ADVIL. On 28-NOV-2007 the patient experienced no appetite, lightheaded and nausea with no fever and no local reaction detected. On 10-NOV-2007 the patient was seen in the office with symptoms of headache, nausea and chills. Temporal temperature was 99.2 and blood pressure was "92/44". The left arm had minimal tenderness and right arm was slightly tender where MENACTRA was administered. Subsequently, the patient recovered from chills, dizziness, blurred vision, pain in the right wrist, no appetite, lightheaded, nausea and headache. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site induration, Musculoskeletal pain, Nausea, Vision blurred
Clinical narrative: Pt. came in for P.E. 11/27/07 - well visit; ILs administered in the morning.  In the evening pt. suddenly felt cold/chills, pain legs/shoulders, dizzy, blurred vision, pain along R wrist.  Took pt. to after hours pediatrics for evaluation.  Vision: 20/16 both eyes; see lab results; vaccine sites were not red, very mild induration; T: 98.6 degrees; SpO2: 98%; Meds: Advil 400 mg.  Still with nausea, decreased appetite, light headed. This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a physician concerning a 14  year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left deltoid with GARDASIL (lot# 659439/1267U). Concomitant therapy included VARIVAX for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included MENACTRA. On the evening of 27-NOV-2007 the patient experienced chills, dizziness, blurred vision and pain in the right wrist. The patient had an emergency pediatric evaluation on 27-NOV-2007 and the results were: vision fine, blood sugar 104, Hemoglobin 17.5 and hematocrit 40%, no fever, no redness and mild induration at the site of vaccination. The patient had taken ADVIL. On 28-NOV-2007 the patient experienced no appetite, lightheaded and nausea with no fever and no local reaction detected. On 10-NOV-2007 the patient was seen in the office with symptoms of headache, nausea and chills. Temporal temperature was 99.2 and blood pressure was "92/44". The left arm had minimal tenderness and right arm was slightly tender where MENACTRA was administered. Subsequently, the patient recovered from chills, dizziness, blurred vision, pain in the right wrist, no appetite, lightheaded, nausea and headache. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Soreness in left arm. Pain traveled down left arm to left wrist and hand. Two days later after putting ice on left hand, my hand swelled up.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, High-pitched crying
Clinical narrative: Onset of high pitched inconsolable crying x several hours. No fever. No irritation at injection sites.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Body temperature increased, Stomatitis
Clinical narrative: Temp increased 102 in Day 13 and mild viral stomatitis on trunk on Day 14 after MMR
Age: 4.0
Sex: M
Vaccine: DTP, HEPA, IPV, MMR, VARCEL
Symptoms: Convulsion, Syncope
Clinical narrative: Vogel response, syncope, and possible seizure.
Age: 47.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Nausea
Clinical narrative: Client states nauseated for about 1 hr about 4 hrs post IMM but thought is was food related.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Pt reports immediate pain/lump/bruising-. States "quarter" size bruising and pain for 2 wks.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None (We gave DTaP instead of Tdap).
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse reaction
Clinical narrative: None known (We gave DTaP instead of Tdap).
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None known (we gave DTaP instead of Tdap)
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None known (We gave DTaP instead of Tdap).
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Swelling, bump was hard on (R) thigh Advised to use ice and Tylenol and to swaddle baby.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Sx: red, tender, warm to touch - redness spread from injection site (deltoid) to elbow. Dx: L arm cellulitis. Tx: Keflex.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Erythema and edema of about 4cm by 2cm on lateral aspect of R arm - not tender.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Oedema, Rash vesicular
Clinical narrative: 9-27-07 patient came in with reaction to 2nd Varicella; Slight tenderness at site with slight erythema, slight edema, afebrile, with approx 10in radius. Treatment; Benadryl and Ice packs. do apply ice pack directly to skin and RTC or call with any problems. 9-27-07 When Pt's mom came back into clinic to check immunization site. Pt's mom now stated that she was not sure if Pt. had had the chicken pox disease or not. Pt's mom led me to believe that Pt. had some chickenpox bumps a few years ago.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pallor
Clinical narrative: Immediately after giving MMR child turned pale on lips, periorally and on his face.  Did not pass out.  Lasted for approximately 30-45 seconds.  No posturing or loss of consciousness.
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling
Clinical narrative: Swollen thigh where shot was administered.  Taken to ER by mother.  ER Doc gave Tylenol & Benadryl.
Age: 6.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: L thigh redness of 1cm diameter & small papular lesion in center.  No fever.  These occurred about 48 hrs after shot.  No treatment.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm swelled from injection site to fingertips. Red. Hot. :for 5 days.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amnesia, Blood test, Computerised tomogram, Confusional state, Convulsion
Clinical narrative: Information has been received from a physician concerning a physician's 17 year old daughter who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st dose of Gardasil (lot # not reported). The physician reported that the patient developed some twitching (not specific) after the 1st dose of Gardasil (lot # not reported). The patient experienced a "grand mal seizure" after being vaccinated intramuscularly (site not reported) with the 2nd dose of Gardasil (date and lot # not reported). The patient was diagnosed with "juvenile myotonic epilepsy" after a 48-hour EEG. The physician reported that the patient will not be receiving the 3rd dose of Gardasil. The patient did received unspecified medical attention and is currently on anti-seizure medication. At the time of this report the patient's outcome is unknown. Upon internal review, the patient's epilepsy was considered an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Hyperhidrosis, Nuclear magnetic resonance imaging, Presyncope, Somnolence
Clinical narrative: Information has been received from a physician concerning a physician's 17 year old daughter who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st dose of Gardasil (lot # not reported). The physician reported that the patient developed some twitching (not specific) after the 1st dose of Gardasil (lot # not reported). The patient experienced a "grand mal seizure" after being vaccinated intramuscularly (site not reported) with the 2nd dose of Gardasil (date and lot # not reported). The patient was diagnosed with "juvenile myotonic epilepsy" after a 48-hour EEG. The physician reported that the patient will not be receiving the 3rd dose of Gardasil. The patient did received unspecified medical attention and is currently on anti-seizure medication. At the time of this report the patient's outcome is unknown. Upon internal review, the patient's epilepsy was considered an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a physician's 17 year old daughter who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st dose of Gardasil (lot # not reported). The physician reported that the patient developed some twitching (not specific) after the 1st dose of Gardasil (lot # not reported). The patient experienced a "grand mal seizure" after being vaccinated intramuscularly (site not reported) with the 2nd dose of Gardasil (date and lot # not reported). The patient was diagnosed with "juvenile myotonic epilepsy" after a 48-hour EEG. The physician reported that the patient will not be receiving the 3rd dose of Gardasil. The patient did received unspecified medical attention and is currently on anti-seizure medication. At the time of this report the patient's outcome is unknown. Upon internal review, the patient's epilepsy was considered an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Muscle twitching, Myoclonic epilepsy
Clinical narrative: Information has been received from a physician concerning a physician's 17 year old daughter who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st dose of Gardasil (lot # not reported). The physician reported that the patient developed some twitching (not specific) after the 1st dose of Gardasil (lot # not reported). The patient experienced a "grand mal seizure" after being vaccinated intramuscularly (site not reported) with the 2nd dose of Gardasil (date and lot # not reported). The patient was diagnosed with "juvenile myotonic epilepsy" after a 48-hour EEG. The physician reported that the patient will not be receiving the 3rd dose of Gardasil. The patient did received unspecified medical attention and is currently on anti-seizure medication. At the time of this report the patient's outcome is unknown. Upon internal review, the patient's epilepsy was considered an other important medical event. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Palpitations
Clinical narrative: Information has been received from a 64 year old female with no drug allergies who on 12-NOV-2007 was vaccinated with a single dose of Zostavax (Oka/Merck) (lot# not specified). On 13-NOV-2007 the patient developed redness, swelling, and warmth at the injection site. The patient also reported a high heart rate and not feeling well. The patient was subsequently hospitalized for 1 night. The patient's outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Information has been received from a 64 year old female with no drug allergies who on 12-NOV-2007 was vaccinated with a single dose of Zostavax (Oka/Merck) (lot# not specified). On 13-NOV-2007 the patient developed redness, swelling, and warmth at the injection site. The patient also reported a high heart rate and not feeling well. The patient was subsequently hospitalized for 1 night. The patient's outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Information has been received from a 64 year old female with no drug allergies who on 12-NOV-2007 was vaccinated with a single dose of Zostavax (Oka/Merck) (lot# not specified). On 13-NOV-2007 the patient developed redness, swelling, and warmth at the injection site. The patient also reported a high heart rate and not feeling well. The patient was subsequently hospitalized for 1 night. The patient's outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia, Blood test, Chest pain, Dyspnoea, Echocardiogram normal
Clinical narrative: Became SOB, Expected Chest pain, Chest Soreness, Abnormal EKG-Abnormal holter monitor with arrhythmia, Sent to cardiologist, Put on Toprol to control fast heart rate.Had Echocardiogram which was normal,Still having SOB with heart racing and feeling tired. Feels not like her self.Very fatigued.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Fatigue, Heart rate increased, Palpitations
Clinical narrative: Became SOB, Expected Chest pain, Chest Soreness, Abnormal EKG-Abnormal holter monitor with arrhythmia, Sent to cardiologist, Put on Toprol to control fast heart rate.Had Echocardiogram which was normal,Still having SOB with heart racing and feeling tired. Feels not like her self.Very fatigued.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Back pain, Blood test, Convulsion, Headache
Clinical narrative: My daughter's first Guardsil shot was Sept 13th. She was out of school Sept 14, Sept 20, Oct 1, Oct 19, w/headache, nausea, weakness.  Oct 24 she had a seizure at school.  I called her doctor they were not that concerned but I brought her to the Doctor the next day becasue i was concerned. Blood work was order and an EEG. My daughter had another seizure/fainted (not a severe as the first seizure)on Nov 8th in school. She failed all her classes her first term.  She was absent 9 times.  Second shot Nov 19th.  She was very sick all week with all of the signs of Guillain-Barre Syndrome. Heavy Head, stiff neck, fever, back pains, muscle pain, weakness.  It was Thanskgiving week so she didn't miss that much school however when school began on Monday, Nov 26th she was in tears trying to get ready.  She was out of school again that day she was too sick to go. I gave her Motrin every 6 hours as nothing else seeemed to help i.e. Advil Tylenol.  I told all of the medical professionals that she had appointments with about receiving this shot but not one of them attributed her sickness/symptoms to the Guardsil shot. No one knew why my daughter was sick until one day a friend said "this all seemed to start with those shots" so I started to research this shot.  This is when I found out about the side effects of Gardasil. Many other young girls have had severe side effects just like my daughter. 12/14/07-records received for DOS 9/13/07-well visit, prescribed birth control pills-9/14/07-C/O blurry vision and does not remember anything till she woke up on floor. Observed to have tremors. Hands felt numb. Tired. Head a small bump. Had migraine last week. In class when event occurred discussing blood and things in science class felt uncomfortable and queasy. Likely syncopal episode, might be vagal in nature. Visit 10/25/07-seizure at school fell to floor after loosing vision. Observed as movements of arms and legs. Another fainting episode on 11/8/07. Parent concerned about 5 hour gap between breakfast and lunch.