chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Autoimmune disorder, Back pain, Eye haemorrhage, Headache, Hypertension
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient, with allergic reaction to antibiotics, who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL (lot # 658094/0524U, on 20-SEP-2007 she received the second dose of GARDASIL (lot # 657736/0389U), and on 18-MAR-2008 she received the third dose of GARDASIL (lot # 659964/1978U). The physician reported that the patient experienced "back pain" from the GARDASIL, and on approximately 19-JUL-2007 the patient experienced blood dripping from both eyes (just for one day) and she has been having bad headaches since then. The physician reported that the patient was diagnosed with high blood pressure and an autoimmune disease affecting the large arteries called "TAKAYASU". The physician reported that the patient had been hospitalized for about a week as a result of the condition. Physician recommended Ibuprofen for treatment. The back pain, blood dripping from both eyes, bad headaches, high blood pressure and autoimmune disease affecting the large arteries called "TAKAYASU" were considered immediately life-threatening. On 27-May-2008 a "TB test" was done as a laboratory diagnostic studied (results not provided). The patient had not recovered. According to the physician, the patient has been released from the hospital. The physician is concerned about the "weird" things that she heard are happening to patients around the time of the GARDASIL vaccination. According to the reporting physician, "complications resulting from chronic use of steroids" was considered to be disabling. This is one of two reports from the same source. Additional information has been requested. 1/28/2010 Ongoing treatment of Talemagaen disease.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Takayasu's arteritis, Tuberculin test
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient, with allergic reaction to antibiotics, who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL (lot # 658094/0524U, on 20-SEP-2007 she received the second dose of GARDASIL (lot # 657736/0389U), and on 18-MAR-2008 she received the third dose of GARDASIL (lot # 659964/1978U). The physician reported that the patient experienced "back pain" from the GARDASIL, and on approximately 19-JUL-2007 the patient experienced blood dripping from both eyes (just for one day) and she has been having bad headaches since then. The physician reported that the patient was diagnosed with high blood pressure and an autoimmune disease affecting the large arteries called "TAKAYASU". The physician reported that the patient had been hospitalized for about a week as a result of the condition. Physician recommended Ibuprofen for treatment. The back pain, blood dripping from both eyes, bad headaches, high blood pressure and autoimmune disease affecting the large arteries called "TAKAYASU" were considered immediately life-threatening. On 27-May-2008 a "TB test" was done as a laboratory diagnostic studied (results not provided). The patient had not recovered. According to the physician, the patient has been released from the hospital. The physician is concerned about the "weird" things that she heard are happening to patients around the time of the GARDASIL vaccination. According to the reporting physician, "complications resulting from chronic use of steroids" was considered to be disabling. This is one of two reports from the same source. Additional information has been requested. 1/28/2010 Ongoing treatment of Talemagaen disease.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HBPV, PNC, RV1
Symptoms: Intussusception
Clinical narrative: Intussusception.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HBPV, PNC, RV1
Symptoms: Barium double contrast, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Intussusception.
Age: 28.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Induration, Rash erythematous
Clinical narrative: Diffuse erythematous indurated reaction from shoulder to elbow in the vaccinated arm (lt).  This reaction was mostly resolved within 3 days.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Induration, Rash erythematous
Clinical narrative: Diffuse erythematous indurated reaction from shoulder, mid-way down to elbow.  This reaction was mostly resolved in 3 days.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Pyrexia, Visual acuity reduced
Clinical narrative: Patient appeared to be unable to see during the night two days after receiving the vaccine. She seemed to grope for her mother without seeing her. In the morning, she asked, "What happened to eyes?" She also had fever and cold symptoms for two days.
Age: 1.03
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever started on 11/16/08 101-104 Degrees axt. Rash chest/diaper area. Increased irritability & crankiness.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Drive thru flu clinic - 14 y/o child received adult formulation. No phone number provided, mailed letter to notify.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Drive thru flu clinic, 8 year old child received adult formulation. No phone number provided, mailed letter for patient to call our office to notify.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Drive thru flu clinic -14 y/o child received adult formulation.  No phone number provided.  Mailed letter to pt to call our office to notify
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Headache
Clinical narrative: After 10-15 min, started having chest pains waited 30 ? min, got worse (I had to wait for my ride). Felt like severe indigestion or gallbladder attack which I never had before or since they took back, gave me 2 table spoons MALOX and oxygen, then (left weak kneed had a headache Saturday, slight headache).
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Two days following pneumonia immunization patient c/o vomiting fever, and reddened area at site of injection.  Seen by MD on 11-13-08 & diagnosed with cellulitis and treated with KEFLEX.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Cough, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Pt c/o fever 102 degrees, H/A, cough, sinus pressure (R) arm sore, red warm to touch over area of injection site- came to office on Monday morning 11/3/08. Evaluated by Doctor - started on course of KEFLEX. Diagnosed with cellulitis.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sinus headache
Clinical narrative: Pt c/o fever 102 degrees, H/A, cough, sinus pressure (R) arm sore, red warm to touch over area of injection site- came to office on Monday morning 11/3/08. Evaluated by Doctor - started on course of KEFLEX. Diagnosed with cellulitis.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Fatigue, itch at injection site, sore, red.  2 cm area erythema at injection site, no induration, no cellulitis - otherwise nl exam.
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Abdominal pain, Abdominal pain upper, Acne, Agitation, Alopecia
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Amblyopia, Amnesia, Anorexia, Anxiety, Aphasia
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Arthralgia, Arthritis, Asthenia, Balance disorder, Blood cholesterol increased
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Blood pressure fluctuation, Bone pain, Burning sensation, Cellulitis, Chest pain
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Chills, Cluster headache, Constipation, Coordination abnormal, Costochondritis
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Cough, Dehydration, Depression, Disturbance in attention, Dry mouth
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Dysarthria, Dyspepsia, Dysphonia, Dyspnoea, Fatigue
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Fungal infection, Gait disturbance, Gastritis, Gastrooesophageal reflux disease, Guillain-Barre syndrome
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Hyperaesthesia, Hyperhidrosis, Hyperventilation, Hypoaesthesia, Influenza like illness
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Joint stiffness, Joint swelling, Keratopathy, Memory impairment, Migraine
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Multiple allergies, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nasopharyngitis
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Nausea, Night sweats, Nuchal rigidity, Osteoarthritis, Pain
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Palpitations, Paraesthesia, Pharyngitis, Photophobia, Pruritus
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Pyrexia, Quadriplegia, Rash, Restless legs syndrome, Rhinitis
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Sinusitis, Suicide attempt, Syncope, Testicular disorder, Tremor
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Urinary retention, Viral infection, Vision blurred, Visual impairment, Vomiting
Clinical narrative: None stated
Age: 48.0
Sex: M
Vaccine: ANTH, HIBV, SMALL, TYP
Symptoms: Weight decreased
Clinical narrative: None stated
Age: 15.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Convulsion, Fatigue, Hypokinesia, Musculoskeletal stiffness
Clinical narrative: >60 seconds seizure. Stiff, unable to move, exhausted.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Irritability, Pruritus, Urticaria, Wheezing
Clinical narrative: Patient received 5th dose of DTaP and started coughing and slight wheezing within 10 minutes. Seemed irritable and started itching intensely within 20 min. Upon arriving home had hives on body and face. Returned to office and BENADRYL & prednisone given.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: (L) Upper arm red, swollen, itchy, low grade FVR yesterday, none today, still using arm/treated with cephalexin.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Dysphonia
Clinical narrative: Hot, sweating, vomiting - diarrhea, chills, crushing pain, fever, dizzy, headache. It lasted three days. Very weak and dizzy for several days. Hoarseness.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Hot, sweating, vomiting - diarrhea, chills, crushing pain, fever, dizzy, headache. It lasted three days. Very weak and dizzy for several days. Hoarseness.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Hot, sweating, vomiting - diarrhea, chills, crushing pain, fever, dizzy, headache. It lasted three days. Very weak and dizzy for several days. Hoarseness.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt to clinic and left deltoid with erythema and slight swelling and warm to touch. Pt states "it doesn't hurt" advised mom to see PMD.
Age: 1.2
Sex: F
Vaccine: DTAP, FLU3, PNC
Symptoms: Cough, Croup infectious, Dyspnoea, Swelling face, X-ray abnormal
Clinical narrative: 14 month old female was healthy until recent vaccine 11/14/08 at 10:30 AM. They included flu (first time), DTP (4th dose) and PREVNAR (4th dose) im injection. Pt went home took a nap 3 pm and woke up with facial swelling, croupy cough, SOB. Pt brought to ER and given DECADRON AND BENADRYL
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular eruption consistent with attenuated varicella vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Dehydration
Clinical narrative: It was reported that infant was taken to local clinic on 11-14-08 and seen by a private physician. It was reported that the infant had been vomiting and was dehydrated, no fever. Infant was treated and sent home. Infant returned to local ER on 11-15-08 and was transferred to hospital. From there infant was transferred to another hospital.  1/12/09 Death certificate states COD as Liver failure & trisomy 21.  1/12/09 Reviewed hospital medical records of 12/3-12/8/2008. FINAL DX: severe metabolic syndrome including trisomy 21, renal failure, kidney failure, coagulopathy & cerebral edema.   Records reveal patient had steady downhill course after transfer & expired 12/8/08.  Death certificate included w/medical records.   1/7/09 reviewed hospital medical records of 11/16-12/2/2008. FINAL DX: idiopathic fulminant hepatic failure; multiorgan failure including liver & kidney's; encephalopathy; coagulopathy. Records reveal patient experienced vomiting day after vaccinations then irritable & continued vomiting next day & became lethargic.  Family tx w/Tylenol in correct dosing regimen.  Unable to tolerate feedings & taken to outlying hospital ER on 11/14.  Dx w/seizure & glucose of 15.  Tx & transferred to outlying hospital.  Glucose & liver enzymes remained high.  Dx w/fulminant hepatic failure, anemia & coagulopathy.  Tx w/IVF, insulin drip, PRBCs & blood products.  Developed respiratory failure & was intubated.  Transferred to higher level of care.  On admission had anasarca, jaundice & elevated ammonia.  TPN & continuous venovenous hemodialysis started.  GI, metabolic, neuro consults done.  Mitochondrial disorder suspected.  Liver & right thigh muscle biopsy revealed metabolic disorder & necrosis.  Deemed not a candidate for transplant.  Dialysis stopped, extubated & transferred as DNR to hospital closer to family.  12/5/08 Received hospital medical records of 11/16-12/2/08 which consisted only of operative report & labs.  Operative report indicates patient w/fulminant hepatic failure, coagulopathy, renal failure, cerebral edema & gen weakness.  Had open liver biopsy & left thigh muscle biopsy on 11/24/08.  12/2/08 Reviewed hospital medical records of 11/15/2008. FINAL DX: no d/c summary available; H&P states respiratory failure, anemia & severe metabolic acidosis; severe coagulopathy. Records reveal patient experienced projectile vomiting, weakness, lethargy x 4 day.  Seen in outlying ER, dx w/dehydration & tx w/oral rehydration.  Worsened w/increased weakness, diet refusal, moaning & returned to same ER.  Seizure noted in ER at that time secondary to hypoglycemia (BS=15) then rebound hyperglycemia (BS>500).  Transferred to higer level of care for PICU.  Intubated on arrival, pale, tachycardic, chest retractions, abdominal distention & tenderness, decreased BS, NGT w/bloody & coffee grounds aspirate, hypotonia, areflexic.  Transfused PRBCs & FFP.  Tx w/antibiotics.  Transferred to higher level of care.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram, Oxygen saturation, Pharyngeal oedema
Clinical narrative: Received flu shot 10/31/08 at 13:18 hrs. Developed symptoms of throat swelling and difficulty breathing. Treated with ALBUTEROL Nebulizer 2.5 mg in 3 mlns, BENADRYL, 25 mg IVP.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Throat tightness
Clinical narrative: Vaccine given around 5:30PM. Pt wife states, severe cough, tightening of throat by 8:30PM Benadryl taken Sx resolved.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Cerumen impaction, Childhood disintegrative disorder, Ear discomfort, Eating disorder, Eye swelling
Clinical narrative: Following days: Fever, swollen eyes, lethargic (12/24/06) seemed to be getting better. 1/3/07: Wheezing, hives, fever. 1/5/07: Hives worse, wheezing. Lost skills after this. (Stopped eating solids, stopped talking, ultimately dx of Austim & Hypotonia). 01/29/2010 Autism dx, speech loss, sensory problems.   1/19/09 Reviewed PCP medical records which reveal patient was in good health on day of vaccination.   FINAL DX: mixed language delay; autism spectrum disorder RTC 1/3/07 w/rash all over.  Dx w/allergy & hives.  Tx w/antihistamine.  RTC 1/5/07 w/worsening of hives all over & bronchospasm.  Tx w/steroids.  RTC 5/14/07 w/fever, runny nose, cough & sneezing.  Dx w/URI & treated symptomatically.  RTC 6/29/07 w/irritability & pulling at ears.  Parent also expressed concern re speech & hearing.  Referred for speech delay to early intervention program & tx for bilateral OM & otitis externa.  RTC 7/23/07 continuing to pull at ears.  Dx w/cerumen impaction.  Early intervention evaluation done 7/25/07 revealed patient w/non-purposeful speech, not following directions, picky eater, inconsistent eye contact, toe walking & hand flapping.  Referred to ENT for recurrent OM.  Recommended BM & T& adenoidectomy.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Hypotonia, Lethargy, Otitis media, Porphyrins urine increased, Pyrexia
Clinical narrative: Following days: Fever, swollen eyes, lethargic (12/24/06) seemed to be getting better. 1/3/07: Wheezing, hives, fever. 1/5/07: Hives worse, wheezing. Lost skills after this. (Stopped eating solids, stopped talking, ultimately dx of Austim & Hypotonia). 01/29/2010 Autism dx, speech loss, sensory problems.   1/19/09 Reviewed PCP medical records which reveal patient was in good health on day of vaccination.   FINAL DX: mixed language delay; autism spectrum disorder RTC 1/3/07 w/rash all over.  Dx w/allergy & hives.  Tx w/antihistamine.  RTC 1/5/07 w/worsening of hives all over & bronchospasm.  Tx w/steroids.  RTC 5/14/07 w/fever, runny nose, cough & sneezing.  Dx w/URI & treated symptomatically.  RTC 6/29/07 w/irritability & pulling at ears.  Parent also expressed concern re speech & hearing.  Referred for speech delay to early intervention program & tx for bilateral OM & otitis externa.  RTC 7/23/07 continuing to pull at ears.  Dx w/cerumen impaction.  Early intervention evaluation done 7/25/07 revealed patient w/non-purposeful speech, not following directions, picky eater, inconsistent eye contact, toe walking & hand flapping.  Referred to ENT for recurrent OM.  Recommended BM & T& adenoidectomy.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Social avoidant behaviour, Speech disorder, Speech disorder developmental, Toe walking, Urticaria
Clinical narrative: Following days: Fever, swollen eyes, lethargic (12/24/06) seemed to be getting better. 1/3/07: Wheezing, hives, fever. 1/5/07: Hives worse, wheezing. Lost skills after this. (Stopped eating solids, stopped talking, ultimately dx of Austim & Hypotonia). 01/29/2010 Autism dx, speech loss, sensory problems.   1/19/09 Reviewed PCP medical records which reveal patient was in good health on day of vaccination.   FINAL DX: mixed language delay; autism spectrum disorder RTC 1/3/07 w/rash all over.  Dx w/allergy & hives.  Tx w/antihistamine.  RTC 1/5/07 w/worsening of hives all over & bronchospasm.  Tx w/steroids.  RTC 5/14/07 w/fever, runny nose, cough & sneezing.  Dx w/URI & treated symptomatically.  RTC 6/29/07 w/irritability & pulling at ears.  Parent also expressed concern re speech & hearing.  Referred for speech delay to early intervention program & tx for bilateral OM & otitis externa.  RTC 7/23/07 continuing to pull at ears.  Dx w/cerumen impaction.  Early intervention evaluation done 7/25/07 revealed patient w/non-purposeful speech, not following directions, picky eater, inconsistent eye contact, toe walking & hand flapping.  Referred to ENT for recurrent OM.  Recommended BM & T& adenoidectomy.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: Following days: Fever, swollen eyes, lethargic (12/24/06) seemed to be getting better. 1/3/07: Wheezing, hives, fever. 1/5/07: Hives worse, wheezing. Lost skills after this. (Stopped eating solids, stopped talking, ultimately dx of Austim & Hypotonia). 01/29/2010 Autism dx, speech loss, sensory problems.   1/19/09 Reviewed PCP medical records which reveal patient was in good health on day of vaccination.   FINAL DX: mixed language delay; autism spectrum disorder RTC 1/3/07 w/rash all over.  Dx w/allergy & hives.  Tx w/antihistamine.  RTC 1/5/07 w/worsening of hives all over & bronchospasm.  Tx w/steroids.  RTC 5/14/07 w/fever, runny nose, cough & sneezing.  Dx w/URI & treated symptomatically.  RTC 6/29/07 w/irritability & pulling at ears.  Parent also expressed concern re speech & hearing.  Referred for speech delay to early intervention program & tx for bilateral OM & otitis externa.  RTC 7/23/07 continuing to pull at ears.  Dx w/cerumen impaction.  Early intervention evaluation done 7/25/07 revealed patient w/non-purposeful speech, not following directions, picky eater, inconsistent eye contact, toe walking & hand flapping.  Referred to ENT for recurrent OM.  Recommended BM & T& adenoidectomy.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Limb discomfort, Oedema peripheral, Pain in extremity
Clinical narrative: Soreness and slight swelling under injection site (L) deltoid. Swelling and slight pain 2 inches above (L) wrist. Discomfort along (L) arm (descending from injection site to (L) wrist).
Age: 0.21
Sex: F
Vaccine: RV5
Symptoms: Asthenia, Depressed level of consciousness, Hyperhidrosis, Hypotonia, Irritability
Clinical narrative: Patient presents in the office today with wheezing. Not really congested today. Mom reminds me that she had a bad reaction after the rotavirus vaccine with becoming weak, pale, diaphoretic, lethargic that evening. At first just fussy and acted like she didn't feel well, wanted to sleep, after a few hours she woke up but then became very limp and almost completely unresponsive. Parents became alarmed and prepared to go to the ER but then the child began to cry and respond to stimuli so they didn't go.
Age: 0.21
Sex: F
Vaccine: RV5
Symptoms: Lethargy, Malaise, Pallor, Wheezing
Clinical narrative: Patient presents in the office today with wheezing. Not really congested today. Mom reminds me that she had a bad reaction after the rotavirus vaccine with becoming weak, pale, diaphoretic, lethargic that evening. At first just fussy and acted like she didn't feel well, wanted to sleep, after a few hours she woke up but then became very limp and almost completely unresponsive. Parents became alarmed and prepared to go to the ER but then the child began to cry and respond to stimuli so they didn't go.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Enema administration, Intussusception, Surgery, Ultrasound scan abnormal
Clinical narrative: Information has been received from an investigator concerning a 2 month old male who was vaccinated PO with his first dose of ROTATEQ. This report was part of a post-marketing surveillance program. Seven days after vaccination the patient experienced ileocolic intussusception and was hospitalized for 2 days. Two days prior to admission the patient experienced crampy abdominal pain. Laboratory diagnostic studies included an ultrasonography which verified the ileocolic intussusception. A contrast enema failed to reduce the intussusception, however; it was reduced surgically. The patient was discharged from the hospital on day and the outcome was unknown. At this time, relationship of ileocolic intussusception to study therapy is unknown. Ileocolic intussusception was considered to be an other important medical event (surgery) by the reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Barium double contrast, Diarrhoea, Enema administration, Intussusception
Clinical narrative: Information has been received from an investigator concerning a 6 month old female who was vaccinated PO with her second dose of ROTATEQ. This report was part of a post-marketing surveillance program. The patient experienced ileocecalcolic intussusception at hepatic flexure characterized by sudden onset severe, colicky abdominal pain, yellowish vomiting, loose stool and some lethargy and pallor 53 days after vaccination and was hospitalized for 2 days. Possible complete reduction of the intussusception via air contrast enema was evidenced by dramatic immediate clinical improvement. The patient was discharged on day 2 and the outcome was noted to be recovering. At this time, relationship of ileocecalcolic intussusception to study therapy is unknown. Ileocecalcolic intussusception was considered to be an other important medical event (enema) by the reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Lethargy, Pallor, Vomiting
Clinical narrative: Information has been received from an investigator concerning a 6 month old female who was vaccinated PO with her second dose of ROTATEQ. This report was part of a post-marketing surveillance program. The patient experienced ileocecalcolic intussusception at hepatic flexure characterized by sudden onset severe, colicky abdominal pain, yellowish vomiting, loose stool and some lethargy and pallor 53 days after vaccination and was hospitalized for 2 days. Possible complete reduction of the intussusception via air contrast enema was evidenced by dramatic immediate clinical improvement. The patient was discharged on day 2 and the outcome was noted to be recovering. At this time, relationship of ileocecalcolic intussusception to study therapy is unknown. Ileocecalcolic intussusception was considered to be an other important medical event (enema) by the reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Breech presentation, Caesarean section, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Initial and follow up information has been received from Merck pregnancy registry through a Nurse concerning a 21 year old female with no previous medical history, who on 14-SEP-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL. Concomitant medication included FOCALIN 15 mg QD intermittently just until pregnancy known for ADHD and ZOFRAN 4 mg TID PRN for nausea/vomiting. It was reported that the patient received the vaccination while she was pregnant. Medical attention was sought. In follow up the nurse stated that on 28-May-2008, the patient delivered a normal live born female infant weighing 8 lbs and 9 Oz with an apgar score 9/9. There were no complications or abnormalities and no congenital anomalies. There were no infections or illnesses during pregnancy. It was reported that patient had a caesarean section since the baby was in breech presentation. Pediatric medical records were received and reviewed and the following experience was identified. On 02-JUN-2008 baby came to doctor's office and was found to have jaundice. Baby's bilirubin was 16.7 mg/dL and she needed photo therapy. She was seen on 03-JUN-2008 and it was reported as physiologic jaundice and was admitted to the hospital. On 06-JUN-2008 the baby was seen in the doctor's office for follow up hospitalization for jaundice. It was reported that on examination baby had "?questionable hip dysplasia". A follow up phone call was made to the doctor's office and information was received that the baby was referred to an orthopedist. The nurse reported that as per the doctor's note the baby had an examination with the doctor. It was reported that "physical examination showed the hip to be slightly lax, but there was no evidence of any dislocation and it appeared the hip was tightening". The mother cancelled the follow up visit for the baby with the doctor but reported that the baby was doing well. On 11-JUN-2008 the baby went to the doctor's visit. In the record it was reported that the baby had eye drainage and diarrhea after amoxicillin. The baby was reported to be improving after amoxicillin (date of therapy not reported). It was reported that the baby had poor weight gain. On 18-JUN-2008 the baby visited doctor's office. It was reported that she had positional plagiocephaly. The skull x-ray was negative. On 10-JUL-2008 the baby came to doctor's office. It was reported that the baby was started on 15 mg PREVACID and her plagiocephaly was stable. On 04-AUG-2008 the baby visited the doctor's office for immunization and found to have nasal congestion. Gastro Esophageal Reflux Disease and upper respiratory infection. The outcome was unknown. The baby also had events after she was vaccinated with ROTATEQ (MSD), ACTHIB, PEDIARIX (WAES # 0811USA02267). Upon internal review baby's breech presentation which required a caesarean section delivery was determined to be an other important medical event. Additional information has been requested. All medical records will be provided upon request.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from Merck pregnancy registry through a Nurse concerning a 21 year old female with no previous medical history, who on 14-SEP-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL. Concomitant medication included FOCALIN 15 mg QD intermittently just until pregnancy known for ADHD and ZOFRAN 4 mg TID PRN for nausea/vomiting. It was reported that the patient received the vaccination while she was pregnant. Medical attention was sought. In follow up the nurse stated that on 28-May-2008, the patient delivered a normal live born female infant weighing 8 lbs and 9 Oz with an apgar score 9/9. There were no complications or abnormalities and no congenital anomalies. There were no infections or illnesses during pregnancy. It was reported that patient had a caesarean section since the baby was in breech presentation. Pediatric medical records were received and reviewed and the following experience was identified. On 02-JUN-2008 baby came to doctor's office and was found to have jaundice. Baby's bilirubin was 16.7 mg/dL and she needed photo therapy. She was seen on 03-JUN-2008 and it was reported as physiologic jaundice and was admitted to the hospital. On 06-JUN-2008 the baby was seen in the doctor's office for follow up hospitalization for jaundice. It was reported that on examination baby had "?questionable hip dysplasia". A follow up phone call was made to the doctor's office and information was received that the baby was referred to an orthopedist. The nurse reported that as per the doctor's note the baby had an examination with the doctor. It was reported that "physical examination showed the hip to be slightly lax, but there was no evidence of any dislocation and it appeared the hip was tightening". The mother cancelled the follow up visit for the baby with the doctor but reported that the baby was doing well. On 11-JUN-2008 the baby went to the doctor's visit. In the record it was reported that the baby had eye drainage and diarrhea after amoxicillin. The baby was reported to be improving after amoxicillin (date of therapy not reported). It was reported that the baby had poor weight gain. On 18-JUN-2008 the baby visited doctor's office. It was reported that she had positional plagiocephaly. The skull x-ray was negative. On 10-JUL-2008 the baby came to doctor's office. It was reported that the baby was started on 15 mg PREVACID and her plagiocephaly was stable. On 04-AUG-2008 the baby visited the doctor's office for immunization and found to have nasal congestion. Gastro Esophageal Reflux Disease and upper respiratory infection. The outcome was unknown. The baby also had events after she was vaccinated with ROTATEQ (MSD), ACTHIB, PEDIARIX (WAES # 0811USA02267). Upon internal review baby's breech presentation which required a caesarean section delivery was determined to be an other important medical event. Additional information has been requested. All medical records will be provided upon request.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who was vaccinated with the second dose of GARDASIL, IM, 0.5ml. Subsequently the patient had a "seizure like" reaction. The patient was "back to normal in 2 to 3 minutes". The patient did not seek medical attention. Upon internal review, patient's "seizure like reaction" was determined to be an other important medical event. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: FLU3
Symptoms: Ketoacidosis, Type 1 diabetes mellitus
Clinical narrative: This serious case was received from a health care professional on 17 November 2008. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 22-month-old male patient received FLUZONE SV (lot number and date of administration not reported). Approximately 48 hours after vaccination, he developed Ketoacidosis, and was subsequently diagnosed with Type I diabetes mellitus. The reporter, a physician who was a friend of the patient's parent, did not have any additional information to provide. Of note, the reporter refused to provide contact information, but did agree to contact the patient's primary care physician directly to obtain additional information. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram, Headache, Pharyngeal oedema, Pruritus
Clinical narrative: Initial information was received on 17 November 2008 from a health care professional. A 47 year old female patient with allergies to penicillin, codeine, DEMEROL, iodine, and bee venom received an intramuscular right deltoid injection of FLUZONE SV 2008-2009 (lot number U2771AA) on 07 November 2008. Three hours post vaccination the patient experienced shortness of breath (SOB), swollen tongue and throat, headache and itching. The patient self treated with EPIPEN and BENADRYL 25 mg. The patient went to the ER and was treated with Prednisone, BENADRYL and a "pain medication" for her headache. The patient had an EKG completed (results not reported). The patient was recovered at the time of the report. List of Documents held by Sender: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Initial information was received on 17 November 2008 from a health care professional. A 47 year old female patient with allergies to penicillin, codeine, DEMEROL, iodine, and bee venom received an intramuscular right deltoid injection of FLUZONE SV 2008-2009 (lot number U2771AA) on 07 November 2008. Three hours post vaccination the patient experienced shortness of breath (SOB), swollen tongue and throat, headache and itching. The patient self treated with EPIPEN and BENADRYL 25 mg. The patient went to the ER and was treated with Prednisone, BENADRYL and a "pain medication" for her headache. The patient had an EKG completed (results not reported). The patient was recovered at the time of the report. List of Documents held by Sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Cardiac disorder, Stent placement
Clinical narrative: Initial report was received 18 November 2008 from a health care professional.  A female patient (age and date of birth not reported) with an unknown medical history, had received a dose (administration, route and site not reported) of FLUZONE, lot number U2849AC on 07 November 2008 and an unspecified amount of time later, she developed a cardiac problem which required a stent.  The patient's recovery status was unknown and the reporter had no additional information to provide at the time of the report.  The reporter for this case is the same as case number 2008-03658.  Documents held by sender: None
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abscess drainage, Injection site abscess
Clinical narrative: Initial report was received 18 November 2008 from a health care professional. A 23-year-old female patient with an unknown medical history, had received a first dose intramuscular right deltoid injection of FLUZONE SV 2008-2009, lot number U2749AA and a right deltoid injection (route not reported) of PNEUMOVAX (manufacturer and lot number not reported), on 10 November 2008 and approximately eight hours later, she developed a right deltoid abscess. The patient was hospitalized for two days (dates not reported) and she received corrective treatments with antibiotics (names and routes of administration not reported) and the abscess was drained. The reporter stated the patient's parent called them to report this event. At the time of the report, the patient had not recovered from the event and no further information was provided. Documents held by sender: None
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Back pain, Computerised tomogram, Gait disturbance, Hypoaesthesia, Neck pain
Clinical narrative: Received vaccines on 11-18-08. Thursday 11-20-08, patient started feeling weak with neck and back pain. Legs numb / tingling, trouble walking. ER visit 11-20-08  12/12/2008 Reviewed ER medical records of 11/29/2008. FINAL DX: weakness, malaise, fatigue, dehydration, myalgia, myositis, UTI Records reveal patient experienced nausea, malaise, generalized aching, numbness, tingling, weakness & aching in legs, difficulty walking x 1 day.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Received vaccines on 11-18-08. Thursday 11-20-08, patient started feeling weak with neck and back pain. Legs numb / tingling, trouble walking. ER visit 11-20-08  12/12/2008 Reviewed ER medical records of 11/29/2008. FINAL DX: weakness, malaise, fatigue, dehydration, myalgia, myositis, UTI Records reveal patient experienced nausea, malaise, generalized aching, numbness, tingling, weakness & aching in legs, difficulty walking x 1 day.
Age: 25.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Cellulitis, Jaundice, Laboratory test, Nausea
Clinical narrative: Nausea, vomiting, temp 105 to E.R. & admitted to hospital - Cellulitis of arm, vomiting, jaundice.   12/29/08 MR received for DOS 11/21-24/2008 with d/C DX:  Cellulitis.  Increased liver functions.  Hx of hereditary spherocytosis. Pt presented with c/o chills, rigors, nausea, vomiting and arm pain. PE (+) for fever, dry mucous membranes, scleral icterus, and tnderness, erythema and warmth of the R upper arm.  Tx with abx. Increased LFTs likely 2' to hereditary spherocytosis. Slow improvement in pain and swelling so abx were changed and effective.
Age: 25.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, temp 105 to E.R. & admitted to hospital - Cellulitis of arm, vomiting, jaundice.   12/29/08 MR received for DOS 11/21-24/2008 with d/C DX:  Cellulitis.  Increased liver functions.  Hx of hereditary spherocytosis. Pt presented with c/o chills, rigors, nausea, vomiting and arm pain. PE (+) for fever, dry mucous membranes, scleral icterus, and tnderness, erythema and warmth of the R upper arm.  Tx with abx. Increased LFTs likely 2' to hereditary spherocytosis. Slow improvement in pain and swelling so abx were changed and effective.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Cough, Postnasal drip, Throat irritation
Clinical narrative: Pt noted chest/asthma like Sx. increase PND, slight cough and itchy throat. Pt takes q o wk allergy injections.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Throat irritation
Clinical narrative: Approx 3 hours after injection starting clearing throat action where it seemed to be a constant clearing of throat with irritation.  Medicine taken and within 3 minutes started to note some relief - it continued on thru afternoon but no increase of symptoms.  Started with chills and headache approximately around 3 PM - home at 4 PM, to bed - forcing fluids - ASA and Motrin.  Better in AM - only c/o headache.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site induration, Myalgia
Clinical narrative: Erythema and induration at site that extended to an area of 6 cm X 8cm before resolution began. N & V x1, muscle and joint pain, fever, and chills. Taking CLARITIN & BENADRYL - Erythema resolved, induration 3 1/2 X 4 cm in size.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Erythema and induration at site that extended to an area of 6 cm X 8cm before resolution began. N & V x1, muscle and joint pain, fever, and chills. Taking CLARITIN & BENADRYL - Erythema resolved, induration 3 1/2 X 4 cm in size.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling left arm at injection site.  Advised to apply cool compress and Tylenol PRN.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Reddness and swelling RL and Knot at injection site. Advised to apply cool compress and Tylenol PM.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Patient and mother feel hair loss and thinning are due to GARDASIL vaccine.  Patient uses straightening iron and products and picks hair.  Referred to derm.
Age: 1.6
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: After given 2nd dose of flu vaccine - patient sustained fever and vomiting.  Advised by doc more than likely exposed to illness in office, not vaccine reaction - but will file.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Vaccine given on 11/19/08, on 11/20/08 patient presents with urticaria all over body. No distress.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Noticed itching with redness approx 2" diameter. No treatment, except Cortaid.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: The patient states that she has had continued soreness and aching in the shoulder where she received the flu vaccine.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Mass, Nuclear magnetic resonance imaging abnormal, Swelling
Clinical narrative: Employee developed ovoid mass approximately 7 cms in height an 3 cm in width across mid right clavicle. Received FLUZONE on 12 Nov 2008 at 3:10 P.M. here at work. She noted the swelling the evening of 12 Nov 2008 after throwing a baseball. Was seen by me on 14 Nov 2008 and worked up by the personal physician at
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Cough, Dyspnoea
Clinical narrative: Had shortness of breath and cough 3 hours after flu shot given, then chest pain for about for about an hour later that night.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Sore, itching red mark around needle point. started with the size of a quarter-spreaded all down the arm to maybe approx. 6" long and 3" wide. Very red and hurtful.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chills, Eye irritation, Eye pruritus, Glossodynia
Clinical narrative: 3 Hours after receiving FLUZONE vaccination, experienced sore throat generalized achiness, bad chills, burning, itching eyes, tongue and lips swelled, very painful tongue and lips; finger tips felt like they were burning. Sought medical attention on 11-05-08 started on Prednisone & Benadryl p.o. Able to return to work on 11-06-08. MD recommended "no future flu shots."
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Lip pain, Lip swelling, Oropharyngeal pain, Pain, Swollen tongue
Clinical narrative: 3 Hours after receiving FLUZONE vaccination, experienced sore throat generalized achiness, bad chills, burning, itching eyes, tongue and lips swelled, very painful tongue and lips; finger tips felt like they were burning. Sought medical attention on 11-05-08 started on Prednisone & Benadryl p.o. Able to return to work on 11-06-08. MD recommended "no future flu shots."
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Nausea, Vomiting, White blood cell count increased
Clinical narrative: Nausea, vomiting, temp 105 went to ER for labs, IV fluids, WBC increased 20.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at injection site.  Advised to apply cool compress.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Pyrexia, Tremor
Clinical narrative: Pt started w/ fever-sent home-woke up from nap began shaking and lips appeared blue. Advised probably viral-could be MMR reaction.
Age: 9.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Localized reaction. Injection site redder, inflamed c/o itching at site some tenderness (L) lot Prox OE, 9x10cm area with 5mm induration. Benadryl/Aytec for 5x5.
Age: 9.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Local reaction
Clinical narrative: Localized reaction. Injection site redder, inflamed c/o itching at site some tenderness (L) lot Prox OE, 9x10cm area with 5mm induration. Benadryl/Aytec for 5x5.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Back pain, Balance disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, headache, pain, fatigue, poor balance, gastrointestinal problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, activities of daily living impaired and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that he received the first and second doses of LYMERIX in August 1999 and September 1999. In August 1999 or September 1999, "days or weeks" following vaccination, the subject experienced joint pain in the wrists/ neck/ hip/ back, shooting pains in the leg (possible neuropathy), buttock pain, groin pain, fatigue, and paralysis. He attributed chronic fatigue to "debilitating" pain. He reported that he became paralyzed while walking down stairs and could not move, and one week later experienced a second episode of paralysis. In April 2002, he experienced chest pain (heart, with blocked arteries), and underwent a stress test, cardiac catheterization, and open heart surgery. Treatment included PREVASTATIN, CELEBREX, and VIOXX. The events, with the exception of paralysis and chest pain, were unresolved at the time of this report.