chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Convulsion, Face injury, Fall, Gingival injury, Head injury
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no medical history and no drug allergies, who on 19-FEB-2008 was vaccinated with a 0.5mL dose of Gardasil. Concomitant vaccinations included MENACTRA and DTaP. On 19-FEB-2008 the patient fainted, fell off the table, hit her head on the ground, and had a seizure. The patient also had a cut on the bridge of her nose and gums. The patient went to the emergency room and was released the same day. The physician thought the seizure was due to the head trauma. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Laceration, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no medical history and no drug allergies, who on 19-FEB-2008 was vaccinated with a 0.5mL dose of Gardasil. Concomitant vaccinations included MENACTRA and DTaP. On 19-FEB-2008 the patient fainted, fell off the table, hit her head on the ground, and had a seizure. The patient also had a cut on the bridge of her nose and gums. The patient went to the emergency room and was released the same day. The physician thought the seizure was due to the head trauma. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Drug exposure during pregnancy, Kidney infection, Laboratory test, Pyrexia
Clinical narrative: Information has been received from a consumer from Merck Pregnancy Registry for Gardasil concerning her 15 year old daughter with a history of urinary tract infection and kidney infection who in December 2007, was vaccinated with a first dose 0.5 mL of Gardasil (lot # unknown). Concomitant therapy included prenatal vitamins (unspecified), KEFLEX and iron (unspecified). On 31-JAN-2008 the patient developed coughing, severe high fevers, urinary tract infection and kidney infection. On 31-JAN-2008, she was hospitalized for five days. It was reported that she was pregnant for five months. Laboratory tests were performed but not specified. She was recovering. Additional information has been requested.  03/05/2008 MR received for DOS 1/31/2008 to 2/6/2008 with DX:  Intrauterine Pregnancy at 18wks 5 days.  R Acute Pyelonephritis.  Shortened cervix with mild funneling, r/o cervical insufficiency/incompetance.  Teen pregnancy with no prenatal care.  Possible URI.  Electrolyte disturbances (hyponatremia and hypokalemia). Incidental spina bifida occulta C7.  Non-specific anemia, r/o sickle cell anemia. Pt presented to ER with c/o R flank pain and fever/chills x 3 days. Temp 101.6'F. Pt found to be pregnant on exam. Consult for bacteremia.  Improved on IV Rocephin. Cervical cerclage performed on 2/6/08.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a consumer from Merck Pregnancy Registry for Gardasil concerning her 15 year old daughter with a history of urinary tract infection and kidney infection who in December 2007, was vaccinated with a first dose 0.5 mL of Gardasil (lot # unknown). Concomitant therapy included prenatal vitamins (unspecified), KEFLEX and iron (unspecified). On 31-JAN-2008 the patient developed coughing, severe high fevers, urinary tract infection and kidney infection. On 31-JAN-2008, she was hospitalized for five days. It was reported that she was pregnant for five months. Laboratory tests were performed but not specified. She was recovering. Additional information has been requested.  03/05/2008 MR received for DOS 1/31/2008 to 2/6/2008 with DX:  Intrauterine Pregnancy at 18wks 5 days.  R Acute Pyelonephritis.  Shortened cervix with mild funneling, r/o cervical insufficiency/incompetance.  Teen pregnancy with no prenatal care.  Possible URI.  Electrolyte disturbances (hyponatremia and hypokalemia). Incidental spina bifida occulta C7.  Non-specific anemia, r/o sickle cell anemia. Pt presented to ER with c/o R flank pain and fever/chills x 3 days. Temp 101.6'F. Pt found to be pregnant on exam. Consult for bacteremia.  Improved on IV Rocephin. Cervical cerclage performed on 2/6/08.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Food allergy
Clinical narrative: Information has been received from a physician concerning a patient with "allergy to malprotein" who was vaccinated PO with the first 2.0 ml dose of Rotateq (not lot# provided). One to two days after vaccination, the patient experienced a "malprotein allergy." The patient also experienced severe diarrhea and was hospitalized for approximately a week." Subsequently, the patient recovered. It was noted that the patient was not immunized in the specialist's office. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Condition aggravated, Diarrhoea, Food allergy
Clinical narrative: Information has been received from a physician concerning a patient with "allergy to malprotein" who was vaccinated PO with the first 2.0 ml dose of Rotateq (not lot# provided). One to two days after vaccination, the patient experienced a "malprotein allergy." The patient also experienced severe diarrhea and was hospitalized (length of stay unknown). The outcome was unknown. It was noted that the patient was not immunized in the specialist's office. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash generalised
Clinical narrative: Came down with shingles - 30 days hospital turned into heart attack - 30 more days hospital body rash all over - still under treatment 7 months now. Very painful and bleeding. 3/21/08-records received for DOS 8/17-8/19/07-DC DX: herpetic shingles on left lower leg and also on bilateral thighs. Possible allergic reaction to the patient taking herpes zoster vaccine. C/O chest pain and rash. Vaccine administered 2 weeks ago. Burning sensation along chest and lower left leg. Did not feel well and generalized weakness. Presented to ER with burning chest pain, rash all over chest. C/O itchiness and redness.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Blood test, Cardiac operation, Herpes zoster, Myocardial infarction
Clinical narrative: Came down with shingles - 30 days hospital turned into heart attack - 30 more days hospital body rash all over - still under treatment 7 months now. Very painful and bleeding. 3/21/08-records received for DOS 8/17-8/19/07-DC DX: herpetic shingles on left lower leg and also on bilateral thighs. Possible allergic reaction to the patient taking herpes zoster vaccine. C/O chest pain and rash. Vaccine administered 2 weeks ago. Burning sensation along chest and lower left leg. Did not feel well and generalized weakness. Presented to ER with burning chest pain, rash all over chest. C/O itchiness and redness.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin haemorrhage, Weight decreased
Clinical narrative: Came down with shingles - 30 days hospital turned into heart attack - 30 more days hospital body rash all over - still under treatment 7 months now. Very painful and bleeding. 3/21/08-records received for DOS 8/17-8/19/07-DC DX: herpetic shingles on left lower leg and also on bilateral thighs. Possible allergic reaction to the patient taking herpes zoster vaccine. C/O chest pain and rash. Vaccine administered 2 weeks ago. Burning sensation along chest and lower left leg. Did not feel well and generalized weakness. Presented to ER with burning chest pain, rash all over chest. C/O itchiness and redness.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypotonia, Hypotonic-hyporesponsive episode, Pallor, Pneumocardiogram, Vomiting
Clinical narrative: Hypotonic, hyporesponsive episode, pallor, emesis, loss of tone ("went limp"). Admitted for observation. 03/13/2008 MR received for DOS 12/18-20/2007 with DX: ALTE.  Mom reports that 2 hrs after immunizations child was crying, became pale and stopped breathing.  Child became dusky a few times, had one episode of diarrhea and vomiting.  PE in ER WNL.
Age: 17.0
Sex: F
Vaccine: MMR, YF
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Five minutes after receiving yellow fever injection, pt. experienced sudden onset of itching & urticaria @ injection site.  Redness also developed @ injection site.  Client remained alert & oriented.  Client denied respiratory problems.  Dr. notified & recommended Benadryl 50 mg IM be administered per office protocol.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: Mother states dgt's right side of face began swelling approx 8pm including jaw and had several welts on face.  Contacted Pediatrician who instructed them to give her Benadryl and call HD next moring.  At the AM call mother stated the swelling was going down, denied any difficulty breathing.  Was to see Physician later that day.  After visiting Physician, RN spoke with the dgt, states Physician felt the swelling was not caused by the shots.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: Allergic reaction.  Hives and swelling.  Goes away with steroid treatment, but returns at completion of steroid.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Malaise
Clinical narrative: Erythema at injection site, headache, malaise.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: ERYTHEMA AT SITE OF INJECTION OF VARICELLA.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Fever of 105 F for 15 days and white blood cell count was as high as a Leukemia patients.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Swelling, Redness and warm to touch.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Muscle spasms, Muscular weakness, Pyrexia
Clinical narrative: Approximately 8 hours after administration of vaccine, patient awoke with fever of 101 accompanied by profound dizziness, muscle weakness and muscle spasm. She reported that she was unable to even hold a glass. Symptoms persisted at the same level for 24 hours then gradually diminished over the next 24 hours. She continued to complain of mild muscle weakness at 96 hours post vaccination but was able to return to work. She spoke with her PCP by phone but was not seen in the office.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Intense soreness at injection site for 2 days after vaccine.  The day after vaccine complaints of fatigue and weakness.  Four days after vaccine noticed red rash about 3 inches below injection site.  Site is warm to touch and tight.  No temperature at time she came to clinic.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Intense soreness at injection site for 2 days after vaccine.  The day after vaccine complaints of fatigue and weakness.  Four days after vaccine noticed red rash about 3 inches below injection site.  Site is warm to touch and tight.  No temperature at time she came to clinic.
Age: 36.0
Sex: F
Vaccine: HIBV
Symptoms: Blood pressure, Chest discomfort, Dyspnoea, Heart rate, Malaise
Clinical narrative: On 2/22/2008 15:20 HB/908228 was given in divided doses in UOQ, IM.  Approximately 5 minutes post injection patient complained of "tingling and not feeling well".  Patient placed on a gurney.  B/P 140/78, Resp. 20 Denied distress.  15:28 Complained of tightness in chest and shortness of breath.  O2 Sat 100%.  Stridor started.  Epi 0.3cc given SQ.  B/P 138/76 HR 113 Reports no change.  Benadryl 50mg IM given in left deltoid.  15:31 No change.  Stridor present.  Epi 0.3cc given SQ.  O2 @3L per nasa; cannula on.  EMS called.  B/P 129/72 HR 119 and increasing up to 130. 1538 EMS here and report given.  Patient transferred to ER.
Age: 36.0
Sex: F
Vaccine: HIBV
Symptoms: Paraesthesia, Stridor
Clinical narrative: On 2/22/2008 15:20 HB/908228 was given in divided doses in UOQ, IM.  Approximately 5 minutes post injection patient complained of "tingling and not feeling well".  Patient placed on a gurney.  B/P 140/78, Resp. 20 Denied distress.  15:28 Complained of tightness in chest and shortness of breath.  O2 Sat 100%.  Stridor started.  Epi 0.3cc given SQ.  B/P 138/76 HR 113 Reports no change.  Benadryl 50mg IM given in left deltoid.  15:31 No change.  Stridor present.  Epi 0.3cc given SQ.  O2 @3L per nasa; cannula on.  EMS called.  B/P 129/72 HR 119 and increasing up to 130. 1538 EMS here and report given.  Patient transferred to ER.
Age: 7.0
Sex: F
Vaccine: DTAP, FLU3, HEP, HEPA, IPV
Symptoms: Urticaria
Clinical narrative: School nurse called 2 days after shots given to report father taking child to doctor due to covered with hives.  Hives first noticed the day after the vaccines were given.  Unable to contact father by phone due to incorrect number on our records.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Fever and redness at injection site, severe arm pain.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Clinical narrative: Seizure on 6-1-2007--anticonvulsant, and seizures 6-8-2007 4/14/08-records received for DOS 7/1/07-seen after 3 short lived episodes of jerking right leg. Alert no loss of consciousnes. Neuro exam, slight head lag when pulled to sitting position. Observed rhythmic movements of right lower extremity, mostly flexion and extension at knee. Impression: Focal seizure.  Follow-up: This patient is seeing another Dr - I have no follow-up information.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Mom noticed a hard spot on left thigh on 2/28/2008.  On 3/01/2008 pt. experienced tenderness and taken to Dr.  Given Ceftriaxone and follow-up on 3-03-2008.  Today left thigh with 4 x 3 cm indurated area with tenderness, not fluctuant.  No culture obtained.  Treated with Bactrim to cover CA-MRSA.  Suspect not all 4 injections were given in left lateral thigh, as listed below.  Will clarify sites and if MMR was IM.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: PATIENT GIVEN PEDIARIX AND IPV.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotension
Clinical narrative: Hypotensive to BP 60/40 + light-headed + dizzy.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood lead, Haemoglobin, Injection site erythema, Injection site swelling
Clinical narrative: Child was administered varicella (SQ) and Hepatitis A (IM) on left Thigh. MA went back to check on Pt. site had swelling and redness.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Rash
Clinical narrative: May 11th 2007 (4 month vac) several days later he got a terrible rash- It was splotchy and several areas of his body. Applied Hydrocortizone cream continuously for approximately 2 months, helped the rash, but didn't prevent it from spreading and did not make it go away.   Again on Feb 13th 2008 in for his (12 month vac) we are seeing the same rash.  It is again splotchy and on different areas of his body.  From what I am reading, this may occur with the varicella vaccination, but this is the first dose he's received, so I believe it is a seperate vaccination to be the cause.
Age: 0.9
Sex: F
Vaccine: DT, FLU3, HEP, HIBV, IPV, PNC
Symptoms: Electroencephalogram normal, Fine motor delay
Clinical narrative: History of seizure like activity age 4 days - negative EEG (hosp).  11/8/07 vaccines given (Pediarix) manufacturer GlaxoSmithKline, lot # AC21B128AB, route/site: IM R ant-lat thigh.  1/11/08 admit seizures (24 hrs) - refer neuro.  1/23/08 vaccines given (DT pediarix), manufacturer GlaxoSmithKline, lot # AC21B128AB, route/site: IM R ant-lat thigh.  At development screening 1/23/08 noted mild right-sided fine motor difference.  1/25/08 seizures (T 101.2).  1/27 hospital after 4 seizures which lasted 2 days.  3/11/08 Reviewed hospital medical records for 1/11-1/12/2008  FINAL DX: none provided Records reveal patient experienced recurring seizure activity 2 mos prior, 3 wks prior to admission & seizures x 4 the day of admission accompanied that day w/fever.   Seizure activity lasting approx 1 min included body spasms, rigidity, diaphoresis, eyes rolling back in head, urinary incontinence, apnea followed by hypotonia & unresponsiveness. Parent noted right sided weakness, dragging left leg & sleep disturbance.  Peds neuro consult done.  No seizure activity while hospitalized.  D/C to home w/peds neuro f/u & antiseizure med if recurs for more than 5 min.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Death
Clinical narrative: Pt died in her sleep 48 hrs after receiving vaccinations.  I do not think related but close time frame with vaccination.  We just wanted to inform you (and family).  Autopsy pending. Final COD:  Mitral Valve Disease. (no autopsy done).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Herpes zoster, Nuclear magnetic resonance imaging
Clinical narrative: See attached; "Patient" received the shingles vaccination on January 7, 2008. Sometime, the following week, she began to experience a tingling sensation beginning with the upper right portion of her face. Over the next week, the tingling and slight lack of feeling to the entire right half of her face, the right side of her tongue and the right side of her bottom lip. The feeling was similar to a novacaine shot which has almost worn off. She also had a mild headache which lasted about three days. Her face hot to her but it wasn't hot to the touch. The only visible symptom was a slight redness which appeared on her right cheek. A week to 10 days later, she called the Hospital.  After describing her symptoms, she was told that the symptoms couldn't be caused by or related to the vaccination. The Center called Dr.'s internist. He gave her the name of a neurologist that he strongly suggested she see for a neurological exam as soon. After a series neurological tests and brain and neck MRI's and MRA's, Dr. concluded that "patient" has a mild case of shingles. Dr. prescribed Neutrontin. As of this date most of the symptoms remain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging brain, Paraesthesia, Paraesthesia oral
Clinical narrative: See attached; "Patient" received the shingles vaccination on January 7, 2008. Sometime, the following week, she began to experience a tingling sensation beginning with the upper right portion of her face. Over the next week, the tingling and slight lack of feeling to the entire right half of her face, the right side of her tongue and the right side of her bottom lip. The feeling was similar to a novacaine shot which has almost worn off. She also had a mild headache which lasted about three days. Her face hot to her but it wasn't hot to the touch. The only visible symptom was a slight redness which appeared on her right cheek. A week to 10 days later, she called the Hospital.  After describing her symptoms, she was told that the symptoms couldn't be caused by or related to the vaccination. The Center called Dr.'s internist. He gave her the name of a neurologist that he strongly suggested she see for a neurological exam as soon. After a series neurological tests and brain and neck MRI's and MRA's, Dr. concluded that "patient" has a mild case of shingles. Dr. prescribed Neutrontin. As of this date most of the symptoms remain.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Pt given 2nd dose of Menactra 6 mths after 1st dose was given. No adverse reactions noted to date.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: For adult use only Influenza Virus Vaccine Fluarix administered
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: For adult use only Influenza Virus Vaccine administered
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Patient given 2nd dose of Menactra 6 months after 1st dose was given.  No adverse reaction noted to date.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Wrong drug administered
Clinical narrative: MMRV was administered in error by Nurse LPN; MA
Age: 69.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Chest discomfort, Dizziness, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Progressed - getting worse day by day:  Started with dizziness next day followed by tightness in chest, then arm swelling especially at injection site - streaking radiating outward.  Getting bigger and bigger, redder and redder, felt raw to the touch.  Doctor notified - got on Benadryl right away, which settled down right away.  Otherwise, patient did not need Prednisone course.
Age: 69.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Progressed - getting worse day by day:  Started with dizziness next day followed by tightness in chest, then arm swelling especially at injection site - streaking radiating outward.  Getting bigger and bigger, redder and redder, felt raw to the touch.  Doctor notified - got on Benadryl right away, which settled down right away.  Otherwise, patient did not need Prednisone course.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Expired drug administered
Clinical narrative: Was administered Hepatitis B vaccine which expired 1/25/08
Age: 19.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Expired drug administered
Clinical narrative: Was administered Hepatitis B vaccine which expired 1/25/08
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: (L) upper extremity swelled to baseball size hrs after injection with erythema then resolved after 2-3 days. Erythema at same spot flared 6 days later after intense itching area. In office today (day 6) was 6.5 cm circum., warm, confluent patent.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cough, Dysphonia, Feeling abnormal, Lower respiratory tract infection, Malaise
Clinical narrative: On the evening of vaccination child developed a hoarse voice progressing to cough and general malaise "feeling bad". On 2-16-08 reported increased hoarseness of voice, "wheezing", cough and fever 101deg - No respiratory distress or change in level of consciousness. On 2-17-08 am feeling better - less wheezing and voice coming back. 2-18-08 fever again 101deg. Seen at clinic on 2-19-08 exam Afebrile, O2 Sat 100% room air, breath sounds clear and productive cough - but improved per "patient". Continued to have cough through week and on 2-22-08 pm developed hives over body which responded to Benadryl. Denied respiratory distress or decreased LOC. Seen 2-26-08 at clinic diagnosed with cough, lower respiratory tract infection. To begin Azithromycin- No respiratory distress, Afebrile, O2 Sat 99%; she continues to have intermittent hives
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Oxygen saturation, Productive cough, Pyrexia, Urticaria, Wheezing
Clinical narrative: On the evening of vaccination child developed a hoarse voice progressing to cough and general malaise "feeling bad". On 2-16-08 reported increased hoarseness of voice, "wheezing", cough and fever 101deg - No respiratory distress or change in level of consciousness. On 2-17-08 am feeling better - less wheezing and voice coming back. 2-18-08 fever again 101deg. Seen at clinic on 2-19-08 exam Afebrile, O2 Sat 100% room air, breath sounds clear and productive cough - but improved per "patient". Continued to have cough through week and on 2-22-08 pm developed hives over body which responded to Benadryl. Denied respiratory distress or decreased LOC. Seen 2-26-08 at clinic diagnosed with cough, lower respiratory tract infection. To begin Azithromycin- No respiratory distress, Afebrile, O2 Sat 99%; she continues to have intermittent hives
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blister, Body temperature increased, Burning sensation
Clinical narrative: 01/18/08 Received the Zoster vaccine. 01/24/08 Painful bump appeared on my left arm, felt light-headed, general malaise. 01/25/08 All muscles and joints sore (as if hit by a Mack truck), 100.6 F, slept all day, sweating a lot. 01/26/08 Still very sore, 100.6 F, slept all day, sweating a lot, took in 2 liters UN electrolyte solution, 5-6 mugs detox tea. 01/27/08 Hardly sore, 100.6 F, slept all day, less sweating. 01/28/08 Soreness gone, 97.6 F, felt quite weak and lightheaded. 01/29/08 Felt weak and lightheaded, showered under supervision, mostly still in bed, developed a cough, sputum clear. 02/11/08 Coughing continuing, sputum clear, intestinal cramping after lunch and evening meal, yellow "baby" stools. 02/14/08 Continued afternoon and evening cramping, bowels more normal, burning on urination with chills. 02/17/08 Burning, itching mini-blisters on L lateral malleolus, continued afternoon and evening cramping. 02/23/08 Noticed miniature scabs on lateral upper thighs, removal of scabs showed chicken pox-like "craters". 02/24/08 Still have low energy and occasional lightheadedness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Dizziness, Dysuria, Faeces pale
Clinical narrative: 01/18/08 Received the Zoster vaccine. 01/24/08 Painful bump appeared on my left arm, felt light-headed, general malaise. 01/25/08 All muscles and joints sore (as if hit by a Mack truck), 100.6 F, slept all day, sweating a lot. 01/26/08 Still very sore, 100.6 F, slept all day, sweating a lot, took in 2 liters UN electrolyte solution, 5-6 mugs detox tea. 01/27/08 Hardly sore, 100.6 F, slept all day, less sweating. 01/28/08 Soreness gone, 97.6 F, felt quite weak and lightheaded. 01/29/08 Felt weak and lightheaded, showered under supervision, mostly still in bed, developed a cough, sputum clear. 02/11/08 Coughing continuing, sputum clear, intestinal cramping after lunch and evening meal, yellow "baby" stools. 02/14/08 Continued afternoon and evening cramping, bowels more normal, burning on urination with chills. 02/17/08 Burning, itching mini-blisters on L lateral malleolus, continued afternoon and evening cramping. 02/23/08 Noticed miniature scabs on lateral upper thighs, removal of scabs showed chicken pox-like "craters". 02/24/08 Still have low energy and occasional lightheadedness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal pain, Hyperhidrosis, Malaise, Myalgia, Pain
Clinical narrative: 01/18/08 Received the Zoster vaccine. 01/24/08 Painful bump appeared on my left arm, felt light-headed, general malaise. 01/25/08 All muscles and joints sore (as if hit by a Mack truck), 100.6 F, slept all day, sweating a lot. 01/26/08 Still very sore, 100.6 F, slept all day, sweating a lot, took in 2 liters UN electrolyte solution, 5-6 mugs detox tea. 01/27/08 Hardly sore, 100.6 F, slept all day, less sweating. 01/28/08 Soreness gone, 97.6 F, felt quite weak and lightheaded. 01/29/08 Felt weak and lightheaded, showered under supervision, mostly still in bed, developed a cough, sputum clear. 02/11/08 Coughing continuing, sputum clear, intestinal cramping after lunch and evening meal, yellow "baby" stools. 02/14/08 Continued afternoon and evening cramping, bowels more normal, burning on urination with chills. 02/17/08 Burning, itching mini-blisters on L lateral malleolus, continued afternoon and evening cramping. 02/23/08 Noticed miniature scabs on lateral upper thighs, removal of scabs showed chicken pox-like "craters". 02/24/08 Still have low energy and occasional lightheadedness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Scab, Skin nodule, Somnolence
Clinical narrative: 01/18/08 Received the Zoster vaccine. 01/24/08 Painful bump appeared on my left arm, felt light-headed, general malaise. 01/25/08 All muscles and joints sore (as if hit by a Mack truck), 100.6 F, slept all day, sweating a lot. 01/26/08 Still very sore, 100.6 F, slept all day, sweating a lot, took in 2 liters UN electrolyte solution, 5-6 mugs detox tea. 01/27/08 Hardly sore, 100.6 F, slept all day, less sweating. 01/28/08 Soreness gone, 97.6 F, felt quite weak and lightheaded. 01/29/08 Felt weak and lightheaded, showered under supervision, mostly still in bed, developed a cough, sputum clear. 02/11/08 Coughing continuing, sputum clear, intestinal cramping after lunch and evening meal, yellow "baby" stools. 02/14/08 Continued afternoon and evening cramping, bowels more normal, burning on urination with chills. 02/17/08 Burning, itching mini-blisters on L lateral malleolus, continued afternoon and evening cramping. 02/23/08 Noticed miniature scabs on lateral upper thighs, removal of scabs showed chicken pox-like "craters". 02/24/08 Still have low energy and occasional lightheadedness.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Hypersensitivity, Oedema peripheral, Pain in extremity
Clinical narrative: Within 2 hours after shot, headache, dizziness and fever.  Within 12 hours arm painful and swollen.  After headache and fever next 48 hours saw MD and was told allergic reaction to pertussis - antihistamines relieved symptoms.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Within 2 hours after shot, headache, dizziness and fever.  Within 12 hours arm painful and swollen.  After headache and fever next 48 hours saw MD and was told allergic reaction to pertussis - antihistamines relieved symptoms.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Pt with cellulitis overlying injection site, diagnosed about 50 hours after vaccination with influenza and pneumovax.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Vaccine: Zostavax - Merck - given on 2/13/08; According to patient - on 2/15, site was red "rash" and itching. Also somewhat swollen. No allergies to neomycin/gelatin or otherwise. Resolved without problem.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pt c/o pain and limited ROM since about 2 days post injection. Denies swelling or redness at injection site. Pt did see her PA for this.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Oral herpes
Clinical narrative: Developed herpes simplex (cold sore), never have had this before.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Oedema peripheral, Pain, Pruritus
Clinical narrative: -Had vaccine  1 week ago; Redness, swelling and warm to touch. Patient also states itchy, stinging and burning sensation. Treatment ice and Benadryl.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: -Had vaccine  1 week ago; Redness, swelling and warm to touch. Patient also states itchy, stinging and burning sensation. Treatment ice and Benadryl.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, VARCEL
Symptoms: Dizziness, Hyperthermia, Pallor, Tinnitus, Vomiting
Clinical narrative: Patient felt faint, turned pale, became overheated, ears were ringing, vomited a very little bit. I gave her ice packs on the back and chest, fanned her for a short period of time as the began to recover.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: (R) upper arm - red, swollen, bumps
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Pt awoke at 2 AM with swelling and itching on (R) shoulder, arm, and hand. Went to ER, received fluids and Benadryl.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient can't lift left arm above shoulder (Partial loss of motion of left arm). As of 2/28 patient's arm is still painful.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Blood pressure, Body temperature, Heart rate, Penile oedema
Clinical narrative: Has appearance of angio edema localized to phallus/scrotum. Not described with Zostavax, but this only when exposure; HPI: Patient presents today with painless swelling involving scrotum and penis. No pain or tender. Came out of the blue. No recent sexual activity(erectile dysfunction). Has been using prescription antifungal for Dr. to control chronic/recurrent T. cruris; Examination: Male GU Swelling on underside of penis just distal to the tip with an almost edematous, fluid filled appearance to the skin. Similar findings at base of penis/scrotum. No masses. No hernias. L testicle pushed up toward inguinal canal.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Scrotal oedema
Clinical narrative: Has appearance of angio edema localized to phallus/scrotum. Not described with Zostavax, but this only when exposure; HPI: Patient presents today with painless swelling involving scrotum and penis. No pain or tender. Came out of the blue. No recent sexual activity(erectile dysfunction). Has been using prescription antifungal for Dr. to control chronic/recurrent T. cruris; Examination: Male GU Swelling on underside of penis just distal to the tip with an almost edematous, fluid filled appearance to the skin. Similar findings at base of penis/scrotum. No masses. No hernias. L testicle pushed up toward inguinal canal.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Dizziness, Electrocardiogram normal, Full blood count, Metabolic function test
Clinical narrative: After receiving Gardasil #2, Hep A #1 vaccines, pt was placed supine (b/c hx of feeling dizzy after 1st Gardasil). Approx 1 min. after vaccines, pt had 3 second tonic clonic activity of arms and legs with flexion of neck twice. No incontinence. Pt was lucid, AA and ) immediately post-event. Pt felt lightheaded for 30-40 mins. She slowly transitioned from supine to sitting to ambulatory. Exam was non-focal and VS normal. Dx: syncope with seizure.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope, Tonic clonic movements, Vaccine positive rechallenge
Clinical narrative: After receiving Gardasil #2, Hep A #1 vaccines, pt was placed supine (b/c hx of feeling dizzy after 1st Gardasil). Approx 1 min. after vaccines, pt had 3 second tonic clonic activity of arms and legs with flexion of neck twice. No incontinence. Pt was lucid, AA and ) immediately post-event. Pt felt lightheaded for 30-40 mins. She slowly transitioned from supine to sitting to ambulatory. Exam was non-focal and VS normal. Dx: syncope with seizure.
Age: 26.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Pain in extremity, Swelling
Clinical narrative: Day after Tdap vaccination, patient presents to clinic with complaints of pain, redness, warmth and swelling to left deltoid.  No other complaints.  Received Td 8/6/07 and Td 10/10/07 with no known prior tetanus vaccination as adult or child.  Patient born non-US.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Injection site sore and swollen.  Lasted a few days per patient.  Patient reports soreness when lifts arm.  (Left deltoid).
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: None - first dose of Rotavirus given after age 12 wks.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Faeces discoloured, Irritability, Pain in extremity, Pyrexia
Clinical narrative: 8/28/07 - Fever 103, fussy, (L) leg painful (3 hrs after Imm. reaction started). 1/31/08 - Fever103 about 3-4 hrs after Pediarix and Imm, fussy x 3 1/2 days. Pt having black stools - bright red skin x 2 days after imm.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Ear infection, Erythema, Photophobia, Pyrexia, Rash
Clinical narrative: Mother states child had possible reaction 3 days after receiving immunizations. Stated rash appeared on feet bilaterally. The following day, erythema appeared, total body, fever, light sensitive. Parent gave child Benadryl - cleared after 4 days. On 2/21/08 , small linear 3 day rash appeared on (R) deltoid followed by full body rash, fever 100.2 axillary. Pt has ear infection per parent.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Mother states child had possible reaction 3 days after receiving immunizations. Stated rash appeared on feet bilaterally. The following day, erythema appeared, total body, fever, light sensitive. Parent gave child Benadryl - cleared after 4 days. On 2/21/08 , small linear 3 day rash appeared on (R) deltoid followed by full body rash, fever 100.2 axillary. Pt has ear infection per parent.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Patient presented in office with approximately 20 lesions.  Rash started 2/27, patient presented on 2/29.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest pain, Chills, Chronic obstructive pulmonary disease, Cough
Clinical narrative: Severe cough, dyspnea, nausea, pains, chills, weakness, dizziness onset within 2 hours of vaccine.  Cough, vomiting, low appetite, fatigue, metal taste, wheezing, burning in chest.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Dizziness, Dysgeusia, Dyspnoea, Fatigue
Clinical narrative: Severe cough, dyspnea, nausea, pains, chills, weakness, dizziness onset within 2 hours of vaccine.  Cough, vomiting, low appetite, fatigue, metal taste, wheezing, burning in chest.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Tobacco user, Vomiting, Wheezing
Clinical narrative: Severe cough, dyspnea, nausea, pains, chills, weakness, dizziness onset within 2 hours of vaccine.  Cough, vomiting, low appetite, fatigue, metal taste, wheezing, burning in chest.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Right thigh swelling/cellulitis
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular, Varicella
Clinical narrative: Patient got Chicken Pox 20-30 papular/vesicles on cheek face and limbs Torso
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Cold sweat, Dizziness, Feeling cold, Feeling hot, Nausea
Clinical narrative: Nauseous, clammy, felt hot, skin cold, dizzy, lightheaded, very pale, shaky
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Tremor
Clinical narrative: Nauseous, clammy, felt hot, skin cold, dizzy, lightheaded, very pale, shaky
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Crying, Irritability, Vomiting
Clinical narrative: Received Pediarix and Prevnar 2/19 in afternoon. Parents gave Tylenol that day. Developed fussiness in late afternoon 2/20. Cried so hard, she vomited. Dozed on and off, but cried a total of 5 hours.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Hyperhidrosis
Clinical narrative: C/o difficulty breathing, SOB; diaphoretic. O2 via N/C at 24m, 1 dose Benadryl 50mg po. Within 20 min, sx's subsided and pt released.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Oedema, Pruritus
Clinical narrative: Patient stated itching approximately 27 hours after vaccine.  Returned to have edema and flushing approximately 5" in diameter from IM site.  Patient denies any pain or discharge.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest pain, Erythema, Rash
Clinical narrative: Patient checked out - went to car with mother. Came back into office about 5 minutes later with c/o chest pain. Provider examined child and could find no basis for chest pain and no relationship to vaccine administration. MOC reports that chest pain continued with exacerbation along with rash and redness face and ears that prompted a visit to an ER later in the day. ER visit reports no sign of rash or redness but Dx: "possible Rxn to vaccine". ER reports also no basis for chest pain and Dx: chest pain; probably not related to vaccine administration.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Had severe pain day of injection - unable to lift arm on own - used other hand to move it.  Significant pain to palpate at site of injection - no redness or hot.  Can not lift arm over head.  Had numbness around tip of deltoid for few days after shot.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Nasopharyngitis, Rash generalised
Clinical narrative: Patient received MMR on 2/5/08. Developed a rash all over her body. Mother states rash compared to picture of measles rash was the same. Patient also has developed symptoms of a cold therefore this rash may be due to a virus. This rash is a possible reaction.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 15 year old female with no medical history, who on 24-JAN-2008 was vaccinated with a first dose of GARDASIL (Lot# 657737/0522U). There was no concomitant medication. Subsequently, the patient was pregnant. The patient's last menstrual period was 01-JAN-2008 and her estimated delivery date was 07-OCT-2008. No adverse reactions were reported. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow-up information indicated that the patient terminated the pregnancy on an unspecified date. Upon internal review the termination of the pregnancy was considered to be an other important medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 15 year old female with no medical history, who on 24-JAN-2008 was vaccinated with a first dose of GARDASIL (Lot# 657737/0522U). There was no concomitant medication. Subsequently, the patient was pregnant. The patient's last menstrual period was 01-JAN-2008 and her estimated delivery date was 07-OCT-2008. No adverse reactions were reported. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow-up information indicated that the patient terminated the pregnancy on an unspecified date. Upon internal review the termination of the pregnancy was considered to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Drug exposure during pregnancy
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry from a licensed practical nurse concerning an 18 year old female who was vaccinated with GARDASIL. The patient became pregnant after receiving all 3 doses of GARDASIL (dates not specified). The patient's last menstrual period (LMP) was 24-DEC-2007. The estimated date of delivery was 29-SEP-2008. The patient sought medical attention. Follow up information indicated that in February, at 6 or 7 weeks gestation, the patient's pregnancy was aborted. No further was provided. Upon internal review, abortion at "weeks from LMP 6 or 7" was considered to be serious as an other important medical event. This is one several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry from a Registered Nurse concerning a 23 year old female who on 24-APR-2007 was vaccinated with GARDASIL (Lot #654535/0960F). Concomitant vaccinations on 24-APR-2007 included MENACTRA, (manufacturer unspecified) and hepatitis A virus vaccine (manufacturer unspecified). The patient received the second dose of GARDASIL (Lot #657006/0188U) on 18-SEP-2007 and then experienced a miscarriage on 06-JAN-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient's estimated delivery date was 16-APR-2008. The patient became pregnant prior to receiving the second dose. Upon internal review, miscarriage is considered to be an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a third dose of Gardasil (site, route, lot # not reported). The physician reported that the patient received her third dose of Gardasil and couple of weeks later at "end of 2007" she was diagnosed with idiopathic viral syndrome induced thrombocytopenia. She saw a hematologist. At the time of this report she had not fully recovered. No further information was provided. Upon internal review idiopathic viral-syndrome induced thrombocytopenia was determined to be an other important medical event (OME). Additional information has been requested. 4/14/08-records received-seen on 12/27/07-C/O increased bruising over shins, thigh, flank and arm. Rash on shins. One week of gum bleding difficult to control. Awoke once with blood in mouth and had epistaxis once. Menses longer in duration. Tingling before bruises, especially behind knee. Decreased appetite attributed to decreased exercise. Seen on 12/31/07-Idiopathic thrombocytopenia. continues with light menses has not restarted her BCP. Bruising and light gum bleeding. Seen on 2/28/08-Now C/O menometrorrhagia. Missed taking 2 of her BCP. 6/9/08-records received for DOS 5/13/08-seen for gyn exam. denies any irregular bleeding, menses are regular now. Started distance running again, yeast infection recently.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Head injury, Injection site rash, Syncope
Clinical narrative: Information  has been received from a consumer concerning her 13 year old daughter with migraine and seasonal allergies who on 27-FEB-2008 was vaccinated with a first dose 0.5 mL of GARDASIL (lot # unknown). Concomitant therapy included AMERGE and INDERAL. The reporter reported that on 27-FEB-2008 her daughter received the dose of GARDASIL vaccine and within one or two minutes she fainted and hit her head, and had a seizure. She recovered within a short period of time. She also developed a rash around the injection site which lasted about ten minutes. It was reported that on 27-FEB-2008 the patient recovered. Upon internal review seizure was determined to be an other important medical event (OME). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Catatonia, Convulsion, Staring, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 17 year old female with low blood pressure, who on 12-FEB-2008 was vaccinated IM with a 0.5mL first dose of GARDASIL. On 12-FEB-2008 post vaccination the patient "went catatonic" and was "non-responsive." The patient had a glassy stare and was emulating a seizure because her arm was flexing. The patient "came to" after 5 to 10 minutes and stayed at the office for an hour and 45 minutes. The patient was then released. It was reported that the series of vaccination would not be completed. The patient recovered on 12-FEB-2008. No product quality complaint was involved. Upon internal review "emulating a seizure" was considered to be an other important medical event. Additional information has been requested.