chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Protein total increased, Tremor
Clinical narrative: Multiple health problems following receipt of anthrax vaccines December 1998 through January 1999; chronology of symptom onset as follows:  2001 - Bilateral arm paresthesias, hand numbness, neck pain, headaches.  2006 - Joint pain, intermittent diarrhea, fatigue.  2007 - Leg paresthesias, muscle spasms, hand tremors, depression, short term memory loss, hair loss.  2008 - Low back pain.
Age: 0.3
Sex: M
Vaccine: DT, HIBV, IPV, PNC
Symptoms: Eczema
Clinical narrative: Red eczematous rash on back flared since getting shots mostly on right thigh where PT -> HIB were given
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: significant swelling, warmth, induration at site.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Death, General physical health deterioration
Clinical narrative: information is a verbal report from spouse, onset of illness 32 days after vaccination, treated by primary care MD, thought he had a virus, became blind by 11/21/07, continued deterioration to death. Autospy preformed: found patient had a demylinating process as cause of death.  05/27/08 Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy limited to examination of brain).  Report also states clinical hx of acute respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar lavage 1/14/08.  Other contributing conditions included: acute aggressive multifocal demyelinating disease w/white matter lesions multiple areas of the brain including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema.  9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure; dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records reveal patient experienced re-admission for brain biopsy which revealed acute demyelinating process.  Failed high dose steroids & plasma exchange.  Tx w/mitoxantrone treatment & second course of high dose steroids in ICU.  Mental & respiratory status deteriorated, significant muscle spasms & pain.  Mechanical ventilation.  Brain lesions continued to grow & new lesions appeared.  Developed decerebrate posturing.  Comfort care only decided & transferred to hospital closer to family home.  5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007 FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA x 3 days & blurred vision x 1 day.  Patient had viral infection w/fever approx 10 days prior & still has sore eyes & stiff neck.  Referred to neuro-ophthal.  6/6/08 Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to hospital same day.  Had used Cialis & noted difficulty reading next AM w/HA.  Then developed blurry vision, decreased vision & pain over 3 days.  Exam revealed visual acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve.  Admitted for stat MRI & IV steroids.  No improvement & D/C to home on continued tapering steroids.    7/4/08 Reviewed hospital medical records of 11/30-12/02/2007 which were previously included in clinic records. FINAL DX: bilateral optic neuritis
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt presented with 25x30mm red, hot, raised area on lateral (L) thigh, noted yesterday morning, worsened today; no fever per mother. States pt has had a red "bump" at this site since receiving Varicella injection on 30 Apr 08; pt's sister has had a similar delayed reaction to Varicella vaccine in the past. Mom states she was advised by a phone-advice nurse to place cold packs at the site, which may have contributed to the persistence of vaccine serum / irritation in the local tissue; pt was scratching the site throughout triage and screening today as well. Pt was diagnosed with cellulitis and placed on Cephalexin 250mg x 10 days.
Age: 1.25
Sex: M
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at top of arm where vaccine given
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture negative, Full blood count normal, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Pain and excessive swelling at and near the site of administration. Seen in ER at Hospital. Ultrasound consistent with cellulitis. Pt was admitted x 24 hrs and tx with IV Ancef. Discharged with po Keflex. Signs and symptoms have progressively improved.  8/15/2008 Reviewed hospital medical records of 5/1-5/2/2008. FINAL DX: LUE cellulitis secondary to tetanus shot Records reveal patient experienced increasing inflammation, fever, erythema & pain in LUE x 1 week along w/lymphadenopathy.  Tx w/IV antibiotics
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan
Clinical narrative: Pain and excessive swelling at and near the site of administration. Seen in ER at Hospital. Ultrasound consistent with cellulitis. Pt was admitted x 24 hrs and tx with IV Ancef. Discharged with po Keflex. Signs and symptoms have progressively improved.  8/15/2008 Reviewed hospital medical records of 5/1-5/2/2008. FINAL DX: LUE cellulitis secondary to tetanus shot Records reveal patient experienced increasing inflammation, fever, erythema & pain in LUE x 1 week along w/lymphadenopathy.  Tx w/IV antibiotics
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: On 5/8/08, the patient was seen for left lateral thigh with 10 1/2cm x9 1/2cm area that was red, indurated, slightly warm and painful. Possibly early cellulitis. Treatment included Clindamycin x7 days and Motrin for pain.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Rash macular
Clinical narrative: red splotchy rash, nausea/vomiting, headache, dizziness, fever.  OTC Benadryl, topical hydrocortisone cream for rash; continue to follow closely.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: red splotchy rash, nausea/vomiting, headache, dizziness, fever.  OTC Benadryl, topical hydrocortisone cream for rash; continue to follow closely.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Pt received Zostavax 0.65 ml subcutaneously in left arm on March 5, 2008.  Approximately 3 days later she reported mild erythema to shoulder of arm where she received vaccine.   Pt. and Dr. had discussed treatment for possible cellulitis earlier and so non March 8, 2008 pt began emperic treatment of cellulitis with Doxycycline 100 mg.  Pt. reported great improvement after two days of antibiotic, (March 10, 2008)
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Malaise, Pain
Clinical narrative: intense pain at injection site.  Large bump and redness.  Pain up and down arm.  General body pain and general feeling of illness
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site reaction
Clinical narrative: Patient called today to report injection site reaaction.  She reports a red 2 inch raised area (circle) at the site of injection, she does not complain of any pain or itching.  She found this when putting on her deoderant today.  She said it feels a little hard.  Patient was referred to doctor for evaluation.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient called today to report injection site reaaction.  She reports a red 2 inch raised area (circle) at the site of injection, she does not complain of any pain or itching.  She found this when putting on her deoderant today.  She said it feels a little hard.  Patient was referred to doctor for evaluation.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received Zostavax 0.65 ml subcutaneously in left upper arm on 3/7/08.   On 3/9/08 she presented to her LMD with the following HPI extracted from her chart, " Patient comes to the clinic today with possible cellulitis to her left upper arm.  She received a Zostavax two days ago.  She noticed redness and swelling yesterday.  the area is warm and raised.  She denies fever, chills, sweats, or SOB."  Physician actions are as follows: "Assessment  o Cellulitis   (682.9); left upper extremity, site of vaccine- Zostavax Orders  Cephalexin 500 MG Capsule;TAKE 1 CAPSULE EVERY 12 HOURS DAILY; Qty14; R0; Rx. Plan  1. Monitor area  for further signs of infection as discussed.  Increased redness, swelling, pain, fever or yellow green discharge. 2. Follow up as scheduled. Coun/Edu  Patient is encouraged to call with any questions or concerns.
Age: 11.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Skin lesion, Swelling, Tenderness
Clinical narrative: Varicella administered in left upper outer arm - resulting in 3x4 cm tender, raised erythematous lesion; Tripedia administered in right deltoid - resulting in 2x2 tender, raised erythematous lesion
Age: 44.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site pruritus, Reaction to previous exposure to any vaccine, Vaccine positive rechallenge
Clinical narrative: Small reddish lession about 5-6 mm on both sites of immunizations, with a hx of itching on site?.  Hx. of same reaction to flu vaccine administered on 11/2/07, scar present approximatelly 10 mm with no induration or colloid at site.  No other adverse reactions reported from patient.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE KNOWN
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia, Sensation of heaviness
Clinical narrative: RIGHT ARM IS SWOLLEN FROM SHOULDER TO ELBOW, RED FEVERISH ON SITE OF INJECTION, HEAVY FOR LIFTING, CHILD HAD FEVER OF 101, ITCHING ON SITE OF INJECTION. PARENT PLACED COLD PAD ON THE INJECTION SITE THE NIGHT OF VACCINATION.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: NONE KNOWN
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Febrile convulsion, Hypotonia
Clinical narrative: Multiple febrile seizures the day following immunizations.  Seizures, with blank staring and limpness, reportedly lasted 5-15 minutes each. Temp was 102.2 F in ER.  5/19/2008 MR received for DOS 4/9-11/2008 with D/C DX:  Febrile Seizures, most likely viral illness.  Infant transfered from local hospital after presenting with new onset seizures and fever.  he had subsequent episodes in the ER which included shaking of the extremities and eyes rolling back lasting 5-15 minutes.  Infant also had episodes of limpness with staring.  PE  WNL and no further episodes in this facility.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Staring, White blood cell count
Clinical narrative: Multiple febrile seizures the day following immunizations.  Seizures, with blank staring and limpness, reportedly lasted 5-15 minutes each. Temp was 102.2 F in ER.  5/19/2008 MR received for DOS 4/9-11/2008 with D/C DX:  Febrile Seizures, most likely viral illness.  Infant transfered from local hospital after presenting with new onset seizures and fever.  he had subsequent episodes in the ER which included shaking of the extremities and eyes rolling back lasting 5-15 minutes.  Infant also had episodes of limpness with staring.  PE  WNL and no further episodes in this facility.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Much redness and swelling around the site of injections About the size of a baseball.  Hot and sore to touch
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: developed a red area measuring 2inches by 2 1/2 inches at injection site.  Father reported that he noticed it yesterday but area is larger today.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Tenderness, Testicular swelling
Clinical narrative: On 5-7-08 pt was given Pneumovax. Today (5-9-08) presented with 8cm x 8cm erythemic area that was warm to touch and swollen. Pt was complaining of pain and tenderness to touch.
Age: 0.17
Sex: F
Vaccine: DTAP, PNC
Symptoms: Feeling hot, Hyperhidrosis, Pyrexia
Clinical narrative: Developed fever of 103.4 degrees; hot and sweaty; treated with Children's Tylenol (3 doses given in 4 hour increments) and cool bath.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Patient was keflex and benadryl by attending provider.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Immediately after vaccine administered, guest had seizure lasting 20-30 sec.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV5
Symptoms: Pyrexia
Clinical narrative: FEVER @ 103 FOR THE PAST THREE (3) DAY'S PER MOTHER.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Patient presented vomits, fever and malaise 10 hrs after administration of immunizations for Meningitis, and Hepatits A.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac function test normal, Chest pain, Throat tightness
Clinical narrative: Had yearly physical at provider's office. Approx 25-30 minutes after Varicella vaccination began to have midsternal chest pain and fullness in throat. Ate ice all day to decrease throat sx - then came to ER.  6/02/2008 ER record received for DOS 5/08/2008 with DX: Allergic reaction to vaccination. Pt presented to ER with c/o substernal chest pain which radiated to the jaw and began ~30" after receiving Zostavax. Increased pain on deep breathing but no SOB. Throat feels swollen. PE WNL. Cardiac w/u (-). Tx with solumedrol and Medrol dosepack.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Ataxia, Blood creatine phosphokinase increased, Metabolic acidosis, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis bilateral lower limb. Ataxia, metabolic acidosis.  5/23/08 Reviewed hospital medical records of 4/27-5/1/2008. FINAL DX: mild myositis, possibly secondary to tetanus vaccine; h/o seizure disorder secondary to head injury & possible anxiety disorder. Records reveal patient experienced a finger laceration on 4/26, was seen in ER & received tetanus.  Returned to ER 4/27 due to severe bilateral lower extremity calf pain & weakness.  Tx w/fluids, improved & transfered to inpatient rehab.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pruritus, Rash erythematous, Vomiting
Clinical narrative: After receiving HPV #3, child got navel pierced.  The next day she had nausea, vomiting, light-headedness, dizziness.  Stayed home from school.  Today (5/9/08) noticed a few white spots on her feet-turned to red, spread to legs, hands & arms.  Took Benadryl 5/8/08 for "cold or sinus infection".  Reports itching with rash.  Advised to see a doctor - clinic info given.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dehydration, Headache, Nausea, Pyrexia
Clinical narrative: Within few hours of vaccine, client called with complaint of fever to 101, seen in ER within about 8 hrs, was vomiting, had headache, cough (history of asthma). Was treated for dehydration with IV Tordol for headache, Zofran for nausea, cough medicine, on bedrest for 2 days.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Within few hours of vaccine, client called with complaint of fever to 101, seen in ER within about 8 hrs, was vomiting, had headache, cough (history of asthma). Was treated for dehydration with IV Tordol for headache, Zofran for nausea, cough medicine, on bedrest for 2 days.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure, Heart rate, Syncope
Clinical narrative: Syncope following vaccines. Pt lying down on table - BP 100/68, HR = 72. Pt did not eat or drink before coming to office; gave soda, pretzels - waited for 20 min - resolved, discharged to home.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right deltoid 2 1/2 cm induration, 6 x 6 cm redness. Apply cold compress to right arm
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Feeling abnormal, Full blood count, Pain in extremity
Clinical narrative: Lt arm sore itchy redness 4-28-08 - making her feel weird - disconnected - very tired, felt like vomiting the other day. Redness and swelling now diminished somewhat.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Swelling, Vomiting
Clinical narrative: Lt arm sore itchy redness 4-28-08 - making her feel weird - disconnected - very tired, felt like vomiting the other day. Redness and swelling now diminished somewhat.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Culture, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: (L) arm swollen, erythematous with small blisters somewath tender. Yesterday he had two small, linear vesiculations. Now there are four new linear vesiculation.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: (L) arm swollen, erythematous with small blisters somewath tender. Yesterday he had two small, linear vesiculations. Now there are four new linear vesiculation.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin decreased, Blood bilirubin normal, Faeces pale
Clinical narrative: Pt with acholic stools noted approximately 10 days after vaccines administered at 2 month well check. Liver function tests normal, abd u/s normal. Discussed with ped GI, Dr, who states no further eval necessary. No palpable hepatosplenomegaly; no emesis; normal exam.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Gamma-glutamyltransferase normal, Liver function test normal, Protein total decreased, Ultrasound liver normal
Clinical narrative: Pt with acholic stools noted approximately 10 days after vaccines administered at 2 month well check. Liver function tests normal, abd u/s normal. Discussed with ped GI, Dr, who states no further eval necessary. No palpable hepatosplenomegaly; no emesis; normal exam.
Age: 62.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pneumovax given lft deltoid, pt stated "by that evening my arm was red down to my elbow slightly swollen, hot to the touch.  Next day arm was itchy.  Sx resolved within 48 hr.  No tx given.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Two days after receiving vaccine, patient developed shingles.  Patient has painful, disseminated rash on back and stomach in traditional shingles pattern.  Rash has continued to spread for 5 days without treatment.  Pt treated with acyclovir 800mg po daily x 10 days.
Age: 49.0
Sex: F
Vaccine: MM, RUB
Symptoms: Cough, Dizziness, Heart rate irregular, Wheezing
Clinical narrative: I work at Medical Center and my job required I get the MMR shot even though I had measles as a child. I received the shot at a clinic that was set up for people who needed to get one. By that afternoon after I had recieved the shot my heart was beating irregularly, I was wheezing and coughing. I had some dizziness at work yesterday but just for a short time. I am still wheezing(mostly at night) and coughing all day and night long. I went to the ER at Medical Center today (5-10-08) and the ER doctor gave me a prescription for an Albuteral Inhaler. My breathing and everthing else was fine before I received the shot.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Shaking chills with fever. Pain swelling rt arm. 5/19/2008 MR received for DOS 5/9-11/2008. Pt admitted for syncopal episodes given Pneumovax in hospital. Pt developed a local reaction of pain and swelling of the R thumb with low grade fever. Pt had brief leukopenia and thrombocytopenia ? rxn to Pneumovax. DX: Local reaction to Pneumovax on R upper arm. Low Grade fever.  Thrombocytopenia.  R arm pain. Tx with Levaquin.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blood test, Hypersensitivity, Pyrexia, Urticaria
Clinical narrative: received mmr 1st shot had previous, lost records at dr office(dr parmelee/cozzone) varicella 2, dtp on 5/1 2008.  severe allergic reaction on 5/10/2008.  received epinepherine shot, benadryl and prednisilone?  mercy hosp er scranton ,pa. fever at 7 days then to dr for fever dx. at 10 days 9am smal welts.  at 2pm benadryl 630pm benadryl, at 930 pm severe hives raised on trunk ,legs, genitals  etc.  5/12/2008again hives at 1pm and 6pm both times giving benadryl 12.5cc.    5/13/08 Reviewed ER medical records of 5/11/2008. FINAL ER DX: allergic reaction. Records reveal patient experienced sudden onset of generalized macular red itchy rash.  Tx w/steroids, epi & antihistamine.  Improved & d/c to home.  5/16/08 Reviewed PCP medical records of 5/9-5/12/2008. Records reveal patient w/fever x 2 days, 4x/month.  Patient seen s/p ER visit & was on tapering steroids & antihistamine.   Had few erythematous macules over trunk. FINAL PCP DX: Fever, viral infection & speech/language deficits, urticaria.
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Death, Injury
Clinical narrative: Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB (manufacturer unknown), DTaP, poliovirus vaccine, PedvaxHIB (manufacturer unknown).  Subsequently, the patient experienced alleged injuries and died. The cause of death was unknown.  No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for Gardasil concerning a female (demographics not provided) who on an unspecified date was vaccinated with her first dose of Gardasil (Lot# not reported).  There was no concomitant medication.  The patient reported to the physician that she found out she was pregnant (method of confirmation and date of the confirmation of the pregnancy were not provided) after she received her first dose of Gardasil.  On an unspecified date the patient reported to the physician that she was about 6 weeks pregnant.  Actual date of her last menstrual period was not reported.  It was reported that the patient sought unspecified medical treatment.  No additional information was provided.  Follow up information received from the physician's office stated that the patient terminated her pregnancy on 31-OCT-2007.  Additional details regarding the elective termination were not provided.  Upon internal review, the elective termination was consider an other medical event.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil without incident. On an unspecified date, the patient was vaccinated with the second dose of Gardasil. After the second dose (date unspecified), the patient experienced possible seizures. Unspecified medical attention was sought. Subsequently on an unspecified date, the patient recovered from possible seizures. No product quality complaint was involved. Upon internal review, possible seizures was considered to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received through the Merck Pregnancy Registry from a registered nurse concerning a 25 year old female with a history of a spontaneous abortion at five weeks from her last menstrual period and malignant melanoma at age 19, with a dysplastic nervous system, and an allergy to penicillin and an allergic reaction to CECLOR, who on 16-MAY-2007 was vaccinated IM in the left deltoid with a 0.5 ml first dose of Gardasil (lot # 657736/0389U).  On 16-JUL-2007 the patient was vaccinated IM in the right deltoid with a 0.5 ml second dose of Gardasil (lot # 658100/0525U).  There was no concomitant medication.  Subsequently the patient became pregnant.  Unspecified medical attention was sought.  On 03-AUG-2007 the patient had a positive beta-human chorionic gonadotropin test (unspecified).  Her last menstrual period was 27-JUN-2007.  The estimated date of delivery was 03-APR-2008.  It was reported that the patient had one previous pregnancy and one spontaneous abortion at 5 weeks.  At the time of the report, the outcome of the patient was unknown.  Follow-up information indicated that 39 weeks from her last menstrual period on 27-MAR-2008 the patient gave birth to a male infant.  The infant weighed 7 pounds 6 ounces, was 19.5 inches long, and had an Apgar score of 8/9.  It was reported that the infant was normal, with no complications or abnormalities.  The infant did develop a minimal cleft lip.  Other medications used during the pregnancy were ZITHROMAX for a urinary tract infection, prenatal vitamins, and GYNAZOLE for candida. The reporter considered the minimal cleft lip to be a congenital anomaly.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient, Dizziness
Clinical narrative: Information has been received from a physician concerning a female patient with no known drug allergies and no previous medical history who on an unspecified date was vaccinated at another physicians office with her first dose of GARDASIL (lot #unknown, site and route not reported). There was no concomitant medication. The patient reported to the physician that 3.5 post vaccination, she "felt lightheaded for 5 minutes, experienced dizziness, could not see, and everything turned black for a few seconds. Five minutes after the 1st lightheaded spell went away, it happened again and lasted for 5 minutes." The patient did not seek medical attention. It was reported that on an unspecified date the patient was considered to have recovered from the events. The physician reported that the patient plans to continue further doses of the vaccination. No additional information was reported. Upon internal review, vision loss was considered to be an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient, Dizziness, Headache, Migraine, Sinusitis
Clinical narrative: Information has been received from a physician concerning a 24 year old female with a history of eating disorder, no illness at the time of vaccination who on 29-JAN-2007 was vaccinated with a first dose of GARDASIL (lot # 655617/1447F) in the left deltoid at 3:15 PM. On 25-APR-2007 the patient was vaccinated with a second dose of GARDASIL (lot # 657617/0384U) in the right deltoid at 8:30 AM. On 11-AUG-2007 the patient was vaccinated with a third dose of GARDASIL (lot #658282/0929U) in the left deltoid at 11:10 AM. Concomitant therapy included YAZ. In September 2007, the patient experienced migraine headaches, once a month with loss of vision for 30 minutes followed by 2 to 4 days of headaches and dizziness. The patient has seen the neurologist. The patient had sinusitis at the onset of symptoms in September 2007 which cleared up in 2 months with antibiotics (therapy unspecified). Upon internal review loss of vision is considered to be an Other Medical Event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, X-ray normal
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated with a second dose of ROTATEQ. The infant developed blood in their stool within one week post vaccination. The mother took the infant to the emergency room (ER), given that "the office" was closed. They were met in the ER by the physician. The infant underwent an x-ray, the results of which were negative. The physician diagnosed the condition as hematochezia, etiology unknown. It was noted that although the condition did not resolve, the infant did complete the series. There was no product quality complaint. Upon internal review the event of hematochezia was considered to be a other medically important event (OME). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated with a second dose PO of ROTATEQ. The infant had blood in their stool within one week of receiving the second dose of ROTATEQ. The patient recovered, and subsequently completed the series of ROTATEQ. There was no product quality complaint. Upon internal review the event of blood in stool (hematochezia) was considered a other medically important event (OME). Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5, RV5
Symptoms: Culture stool positive, Dehydration, Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 14 month old white female who on 21-MAR-2007 was vaccinated with ROTATEQ first dose (LOT# 656191/1365F) at the age of 2 months. Subsequent doses of ROTATEQ were given on 30-MAY-2007 (LOT 656383/0235U) at age 4 months and third dose on 18JUL-2007 (LOT # 656705/0241U) age age 6 months. There was no concomitant medication. On 18-APR-2008 the patient developed diarrhea and dehydration and was hospitalized. The patient was hospitalized for three days. The patient had a stool culture which was positive on 19-APR-2008 for rotavirus antigen. On 20-APR-2008 the patient had recovered. Further information received noted that the patient was admitted to the hospital on 17-APR-2008 (previous onset date of event 18-APR-2008) and was treated with IV fluids only. On 20-APR-2008 the patient was discharged from the hospital. On 23-APR-2008 the patient was seen for a well visit in the office and was noted to be fine. The patients appetite was noted as improved. No further information available.
Age: 0.5
Sex: F
Vaccine: RV5, RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 14 month old white female who on 21-MAR-2007 was vaccinated with ROTATEQ first dose (LOT# 656191/1365F) at the age of 2 months. Subsequent doses of ROTATEQ were given on 30-MAY-2007 (LOT 656383/0235U) at age 4 months and third dose on 18JUL-2007 (LOT # 656705/0241U) age age 6 months. There was no concomitant medication. On 18-APR-2008 the patient developed diarrhea and dehydration and was hospitalized. The patient was hospitalized for three days. The patient had a stool culture which was positive on 19-APR-2008 for rotavirus antigen. On 20-APR-2008 the patient had recovered. Further information received noted that the patient was admitted to the hospital on 17-APR-2008 (previous onset date of event 18-APR-2008) and was treated with IV fluids only. On 20-APR-2008 the patient was discharged from the hospital. On 23-APR-2008 the patient was seen for a well visit in the office and was noted to be fine. The patients appetite was noted as improved. No further information available.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Faeces discoloured, Haematochezia
Clinical narrative: Information has been received from a consumer concerning her 2 month old child who was vaccinated PO with a 2.0 ml dose of ROTATEQ. The patient experienced "bloody stools" 4 days after receiving the vaccine. She also stated "they changed from yellow to a little green with some blood." It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. Upon internal review, bloody stool was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Cyanosis, Musculoskeletal stiffness, Respiratory arrest
Clinical narrative: Information has been received from a nurse concerning a 12 month old male child who on approximately 01-APR-2008 was vaccinated with VARIVAX (Oka/Merck) (lot # 659726/1772U). It was reported that the patient was at the doctor's office and soon after having blood taken he received the VARIVAX (Oka/Merck) (lot # 659726/1772U) vaccination. Subsequently, after the injection was given the patient stopped breathing, he was stiff, he turned blue; and he was not crying for about 20-30 seconds. It was noted that there were two nurses there, one nurse picked the patient up and started to pat and rub him, while the other nurse also tried to stimulate the patient. The patient finally started crying, and appeared to be fine. It was also reported that the doctor assessed the situation. The patient is due to come back next week for the next set of shots because on that day he was to get some other shots, but they decided to delay them because of the reaction he had. The patient's mother was called later that day and it was reported that "as of right now the child was fine." There was no emergency room visits. Upon internal review "stopped breathing" was determined to be an other important medical event. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Angioedema, Pain in extremity, Pruritus generalised, Wheezing
Clinical narrative: Initial report received on 30 April 2008, and 01 May 2008 from a physician. It was reported a 40-year-old female patient (date of birth reported as 28 August 2007) who had a recent "staph" infection, and who has past medical history of "spring" allergies, allergy to "PCN" (Penicillin) and Keflex, and a history of eczema and allergic rhinitis, had received an intramuscular injection of ADACEL (Lot # C2888AA) on either 16 or 17 April 2008. The site of administration was "unknown." Per the reporter, it was "unknown" if any other vaccinations were received on the same day. Within 24 hours after receiving the ADACEL vaccination, the patient complained of arm pain, and developed generalized pruritus, angioedema, and was wheezing. Reportedly, the patient was evaluated by a physician and treated with Benadryl. At the time of this report, the patient had recovered.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Rash, Rhinorrhoea, Urticaria
Clinical narrative: Mother reports an hour after receiving vaccines, pt. was starting to cough, no obvious resp. distress.  Mother  pt. was exchanging air ok.  Noticed rash over chest, top of head & face.  Describes rash as welts.  She gave pt. some Benadryl.  Also called the ER, but did not take pt. out to ER as logs told.  No need to as long as pt. breathing ok.  Pt. had rash 1 wk later yet with runny nose & seeing a doctor.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: Lg local reaction LA, no fever.  Advised ice/ibuprofen/Benadryl.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure, Dizziness, Heart rate normal, Malaise, Vomiting
Clinical narrative: 10 minutes after pt received vaccines she reported feeling "sick" & "light-headed".  She put head down & elevated her feet.  BP 80/40 pulse 64.  Vomited at 3pm.  Felt better then & BP went back up to 90/60 at 310pm.  Pulse 64.  Wanted to leave by 320pm.  Mother was with her.  She reports patient reacts this way when she is anxious.
Age: 60.0
Sex: M
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Body temperature increased, Chills, Confusional state, Injection site erythema, Injection site induration
Clinical narrative: Chill and fever, temperature 101 F began 1 week after vaccination.  Continued 3 days.  Temperature 102, confused, injection site red, swollen approximately 4" and firm.  Went to ER for evaluation.  States doctor determined symptoms must be due to yellow fever vaccine.  States swelling and redness continued involving upper arm and anterior chest wall.  As of today, (5th day since onset of symptoms), redness and swelling are decreasing, temperature is down 99, and states he is feeling much better.
Age: 60.0
Sex: M
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Chill and fever, temperature 101 F began 1 week after vaccination.  Continued 3 days.  Temperature 102, confused, injection site red, swollen approximately 4" and firm.  Went to ER for evaluation.  States doctor determined symptoms must be due to yellow fever vaccine.  States swelling and redness continued involving upper arm and anterior chest wall.  As of today, (5th day since onset of symptoms), redness and swelling are decreasing, temperature is down 99, and states he is feeling much better.
Age: 60.0
Sex: M
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Activities of daily living impaired, Chills, Condition aggravated, Epstein-Barr virus antibody positive, Epstein-Barr virus test positive
Clinical narrative: Chill and fever, temperature 101 F began 1 week after vaccination.  Continued 3 days.  Temperature 102, confused, injection site red, swollen approximately 4" and firm.  Went to ER for evaluation.  States doctor determined symptoms must be due to yellow fever vaccine.  States swelling and redness continued involving upper arm and anterior chest wall.  As of today, (5th day since onset of symptoms), redness and swelling are decreasing, temperature is down 99, and states he is feeling much better.
Age: 60.0
Sex: M
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Mononucleosis syndrome
Clinical narrative: Chill and fever, temperature 101 F began 1 week after vaccination.  Continued 3 days.  Temperature 102, confused, injection site red, swollen approximately 4" and firm.  Went to ER for evaluation.  States doctor determined symptoms must be due to yellow fever vaccine.  States swelling and redness continued involving upper arm and anterior chest wall.  As of today, (5th day since onset of symptoms), redness and swelling are decreasing, temperature is down 99, and states he is feeling much better.
Age: 60.0
Sex: M
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Pyrexia
Clinical narrative: Chill and fever, temperature 101 F began 1 week after vaccination.  Continued 3 days.  Temperature 102, confused, injection site red, swollen approximately 4" and firm.  Went to ER for evaluation.  States doctor determined symptoms must be due to yellow fever vaccine.  States swelling and redness continued involving upper arm and anterior chest wall.  As of today, (5th day since onset of symptoms), redness and swelling are decreasing, temperature is down 99, and states he is feeling much better.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEPA, MMRV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Post vaccine rash (from MMR-V), maculopapular rash all over body - more deuse on chest/abdomen/back.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Presyncope, Rash
Clinical narrative: Received vaccine Wed 4/16/08 2:30 pm.  Developed rash on arms & back in PM 4/17/08.  Also had difficulty breathing.  "I almost passed out".  Seen in ER.  Given a shot of Benadryl & told to use oral Benadryl til rash goes away.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dyskinesia, Erythema, Full blood count normal, Grunting, Laboratory test normal
Clinical narrative: Mother describes 3 episodes each lasting 5-10 seconds of stiffening of arms and legs, jerky movements, grunting, redness in face.  Patient returned to normal after episodes.  Evaluation, including blood work was normal in ER.  Patient afebrile.  Sites post vaccine.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Musculoskeletal stiffness
Clinical narrative: Mother describes 3 episodes each lasting 5-10 seconds of stiffening of arms and legs, jerky movements, grunting, redness in face.  Patient returned to normal after episodes.  Evaluation, including blood work was normal in ER.  Patient afebrile.  Sites post vaccine.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Initial report was received 09 April 2008 from a health care professional.  An 11-year-old female patient with no pre-existing medical conditions, had received an intramuscular left arm injection of Menactra, lot number U2429AA and an intramuscular right arm injection of Havrix, lot number AHAVB214AA (manufactured by GSK) on 08 April 2008 and within 24 hours, experienced tingling in both arms, vomiting and a fever of 100 degrees Fahrenheit.  The patient had no illness at the time of vaccination.  At the time of the report, the patient's recovery status was unknown.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Nervousness, Urticaria
Clinical narrative: 5/2/08 - ate a lot of pizza before coming to the clinic at about 1 pm = received IPV # & DTaP #5 MMR #2, varicella #2, PPD -> went home.  At around 4-5 pm, noted to have some redness on the face -> check his torso -> there were a bit of hives and welts all over -> he was shaking a little bit, respiration problem - not known? -> ambulance called -> seen at ER, given Benadryl shot & steroid -> almost resolved after several hrs.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Joint swelling, Local reaction
Clinical narrative: Patient with large local reaction with knee swelling and large swelling with erythema.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever - started 10 day after immunizations & lasted 4 days.  Rash - started 6 days after immunizations & lasted 6 days.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema
Clinical narrative: 2 mins. after vaccines given Pt's legs becamer erythematous. No swelling or warmth. Pt. was given Benadryl. Redness diminished. After 1/2 hr.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Rash papular
Clinical narrative: Small papular on both arms, trunk and legs - resolved by now soreness and swelling on the shot area L deltoid 05/07/2008.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red around injection site, warm to touch.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red around inj. site, warm to the touch
Age: 1.12
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Cellulitis, Induration, Pyrexia, Swelling
Clinical narrative: Pt developed fever 103.3 swollen, indurated area on upper Rt arm. Taken to Urgent Care on 4/26/08 diagnosed with cellulitis. Placed on Cephalexin for 7 days. Marked improvement within 48 hrs of medication being started.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever to 103 F starting 4 days after vaccine administration and vomiting.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Headache, Musculoskeletal pain, Radiculitis brachial
Clinical narrative: C/O intense pain to shoulders and arm, headaches and muscle spasms. Went to Dr who diagnosed it as brachial neuritis and gave her pain meds - will be going back to Dr for f/u.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Hypersensitivity, Loss of consciousness, Vomiting
Clinical narrative: Patient reported that she had fainted in the past with injections.  Immediately after receiving TWINRIX patient became dizzy and passed out.  Patient was non-responsive for 15-30 seconds.  After awakening patient began to vomit and continued to do so for 20 minutes.  No shortness of breath.  At 1815, blood pressure 124/60, pulse 72 regular.  Patient offered ambulance, declined, desired to go home.  Left with husband - walked to car.  On 5/1/08, patient reports she called MD and he told her she had a "severe allergic reaction to injection" and not to get another.  Feeling better.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, warmth, beginning approx. 24 hours after administration of Varicella vaccine.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pyrexia
Clinical narrative: Fever 102.2 within 24 hours after receiving anthrax vaccine dose #5. Some erythema noted and referred for evaluation.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS&SWELLING FROM THE SHOULDER TO ELBOW. REDNESS ALMOST COMPLETE CIRCUMFERENCE OF ARM. LT DELTOID 1 1/4 CM LARGER THAN RT DELTOID.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient received Zostavax on 5/7/08. Late Friday(5/9/08) she noticed a large red sore itchy area at the injection site.She also had chilling, headache and nausea. This lasted approximately 24 hrs. Today (5/12/08) the redness is decreasing in size and she does not have any other symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient received Zostavax on 5/7/08. Late Friday(5/9/08) she noticed a large red sore itchy area at the injection site.She also had chilling, headache and nausea. This lasted approximately 24 hrs. Today (5/12/08) the redness is decreasing in size and she does not have any other symptoms.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Give 3rd dose of Hep A and 4th dose of Gardisil. Last facility in record dated 3/31 showed student due for both.  Asked if she had received any "shots"/immunizations anywhere else - replied "no" so I gave both.  When I went to facility, discovered she had been given both doses at HD 4/3!  Incident report done, patient checked X3. Supervising MD notified 5/6
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased
Clinical narrative: Temp 99.5-100.5 from 5/1/08 through 5/5/08
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest discomfort, Chest pain, Headache, Injection site erythema
Clinical narrative: Got shot on Friday about 9:30 am and symptoms began Saturday around noon on Saturday. Pt. had been shoveling dirt and cleaning house Friday night and Saturday morning. Headache, back above shoulder blades hurt very bad. Site was red, swollen and tender to the touch. Chest is hurting a bit, tightness. Did not feel as if needed to see an MD about it. Monday morning redness and heat has gone down but swelling is still present.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Got shot on Friday about 9:30 am and symptoms began Saturday around noon on Saturday. Pt. had been shoveling dirt and cleaning house Friday night and Saturday morning. Headache, back above shoulder blades hurt very bad. Site was red, swollen and tender to the touch. Chest is hurting a bit, tightness. Did not feel as if needed to see an MD about it. Monday morning redness and heat has gone down but swelling is still present.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Abnormal behaviour, Crying, Erythema, Food intolerance, Gastrointestinal disorder
Clinical narrative: Within 1 hour of receiving the Hib vaccine, our son clenched both arms in front of him, head got completely red and body shook and he was groaning for apprx 30 seconds. His eyes appeared vacant. The right side of his body was tense on 3 occasions. He stopped using his right hand, clubbed things he used to grab with left hand, stopped smiling, laughing, clapping and waving. He did not recognize/respond to his parents the next morning,stopped responding to pain, the list goes on. He cried and screamed throughout the night for the first week and we now observe absent seizures. He has continued to display behavior completely uncharacteristic to himself and can no longer eat the foods he once ate with no reactions.