chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure to communicable disease, Herpes zoster, Viral DNA test negative
Clinical narrative: Information has been received from a registered pharmacist concerning a 33 year old female with diabetes and no known drug allergies who on 23-JUN-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck) (LOT# 658408/1177U). There was no concomitant medication. On 30-JUN-2008 the patient developed zoster. The patient had also been exposed to zoster. Subsequently the patient recovered from zoster. The patient sought medical attention via occupational health department. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 09-JUL-2008. The sample was taken from a vesicular lesion in the mid back. The PCR results for the specimen from the vesicular lesion was negative. The VZV DNA was not amplified and B-globin DNA was amplified. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Fall, Pallor, Syncope, Tremor
Clinical narrative: This serious case was received on 13 May 2009 from a health care professional. A 13 year old patient received MENACTRA (lot number U2870AA) intramuscularly in the right deltoid, HAVRIX (manufacturer GSK, lot number AHAB3334LA) intramuscularly in the left deltoid, GARDASIL (manufacturer Merck, lot number 1130X) intramuscularly in the left deltoid, and VARIVAX (manufacturer Merck, lot number 0228Y) intramuscularly in the right arm on 12 May 2009. On 12 May 2009 post vaccination, the patient fainted in the lobby while leaving the Doctor's office. The patient was unconscious for approximately 2-3 minutes. The patient was observed for an hour in the office. The patient sat in a chair and after 10 minutes the patient " pinked up ". The patient recovered and left the doctor's office in stable condition. List of Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This serious case was received on 13 May 2009 from a health care professional. A 13 year old patient received MENACTRA (lot number U2870AA) intramuscularly in the right deltoid, HAVRIX (manufacturer GSK, lot number AHAB3334LA) intramuscularly in the left deltoid, GARDASIL (manufacturer Merck, lot number 1130X) intramuscularly in the left deltoid, and VARIVAX (manufacturer Merck, lot number 0228Y) intramuscularly in the right arm on 12 May 2009. On 12 May 2009 post vaccination, the patient fainted in the lobby while leaving the Doctor's office. The patient was unconscious for approximately 2-3 minutes. The patient was observed for an hour in the office. The patient sat in a chair and after 10 minutes the patient " pinked up ". The patient recovered and left the doctor's office in stable condition. List of Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: This serious case was received on 13 May 2009 from a health care professional. A 13 year old patient received MENACTRA (lot number U2870AA) intramuscularly in the right deltoid, HAVRIX (manufacturer GSK, lot number AHAB3334LA) intramuscularly in the left deltoid, GARDASIL (manufacturer Merck, lot number 1130X) intramuscularly in the left deltoid, and VARIVAX (manufacturer Merck, lot number 0228Y) intramuscularly in the right arm on 12 May 2009. On 12 May 2009 post vaccination, the patient fainted in the lobby while leaving the Doctor's office. The patient was unconscious for approximately 2-3 minutes. The patient was observed for an hour in the office. The patient sat in a chair and after 10 minutes the patient " pinked up ". The patient recovered and left the doctor's office in stable condition. List of Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Dizziness, Fatigue, Heart rate increased, Nausea, Pain in extremity
Clinical narrative: 05-01-2009 Mom of Pt.  reported child became nauseated & dizzy late pm on 4-30-09 post receiving TDAP on 4/30 - in AM.  Arm very sore" on 5/01 mom also stated increase in heart rate 05-01-09.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Pyrexia, Skin warm
Clinical narrative: 05-01-2009 Mom of Pt.  reported child became nauseated & dizzy late pm on 4-30-09 post receiving TDAP on 4/30 - in AM.  Arm very sore" on 5/01 mom also stated increase in heart rate 05-01-09.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Dizziness, Heart rate increased, Nausea, Pain in extremity
Clinical narrative: 05-01-2009 Mom of Pt.  reported child became nauseated & dizzy late pm on 4-30-09 post receiving TDAP on 4/30 - in AM.  Arm very sore" on 5/01 mom also stated increase in heart rate 05-01-09.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Patient came down with shingles anyway, diagnosed 5/19/09. Rash and blisters on face...lip and below lip and in eye.  Spent $300.00 on vaccine and didn't expect to get the disease 4 months later!
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: clinet c/o fine red rash on both her arms and thighs. Itchy. states started the next day after recieving Tdap.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt developed a rash thought to be Shingles approx 3 weeks s/p Zostavax administration.  Pt treated with valacyclovir.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dizziness, Headache
Clinical narrative: 5 vaccines were administered to this chld. Immediately after the 5th vaccine,  the pt. displayed mild seizure activity lasting about 5 seconds. She awoke immediately. Was alittle dizzy and complained of a headache. She did not sustain any injuries. She layed on an exam table for about 15 minutes and seated for another 10 minutes. The family declined emergency care. Spoke to the childs mother the next day. The child felt well enough to attend school.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Back pain, Body temperature increased, Injection site reaction, Mononucleosis heterophile test negative
Clinical narrative: Received HAV and Depo Provera at doctor visit on a.m. In p.m. state symptoms of back pain, epigastric pain, temp. high 105 degrees ache all over, sore throat. Went to ER. Had test for strep, mono- neg. MD told client she had reaction to HPV.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pain, Streptococcal identification test negative
Clinical narrative: Received HAV and Depo Provera at doctor visit on a.m. In p.m. state symptoms of back pain, epigastric pain, temp. high 105 degrees ache all over, sore throat. Went to ER. Had test for strep, mono- neg. MD told client she had reaction to HPV.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Seen in our office on 5/12/09 for 4 year old boosters.  Two days later developed red, swollen left arm.  Diagnose with cellulits secondary to vaccine administration.  Treated with Augmentin.
Age: 77.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Erythema, Headache, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Next day left deltoid to elbow redness and swelling-fever,headache,and aches all over especially legs-relief with tylenol-denies rash,hives,shortness of breath or chest pain-went to PMD and is improving-encouraged to return to PMD if symptoms worsen or other problems occur.
Age: 77.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Next day left deltoid to elbow redness and swelling-fever,headache,and aches all over especially legs-relief with tylenol-denies rash,hives,shortness of breath or chest pain-went to PMD and is improving-encouraged to return to PMD if symptoms worsen or other problems occur.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Enterococcal infection, Prostatitis
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 1/29/09 with enterococcal prostatitis. Vaccination took place on 4/14/08. According to the physician the relationship is 'None'.  We would be happy to forward the Study's SAE reporting form upon request.  8/7/09 Clinical Research/Hospital records received DOS 2/25/09 to 2/27/09. Assessment: Urinary Tract Infection, bacteremia. Recent hospitalization for pneumonia, enterococcal prostatitis. Placed on antibiotics. Patient now presents with chills, hx of enterococcus bacteremia, maculopapular eruption secondary to drug reaction. Confluent rash more on ankles, wrists, and around neck resembling hives.  ICD-9 Codes: V13.02 history of disorders of the urinary system other, 601.0 acute prostatitis, 995.27 other drug allergy
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Bacteraemia, Urinary tract infection
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 2/25/09 with Urinary tract infection - bacteremia. Vaccination took place on 4/14/08. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received call from Mom 5/21/2009 R/T patients Left thigh. DTaP injection admininstered 5/18/2009.Red feverish area measuring 7 1/2 x 4 1/2 on Left upper thigh. Dr. advised cool pack to area, Zyrtec q d and benadryl as needed.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood chloride decreased, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine increased, Full blood count
Clinical narrative: Pt developed myocarditis. Symptoms developed on  27 April.  Smallpox vaccination given on 19 Apr 09.  5/28/09 Medical records received DOS 4/27/09 to 5/21/09. FINAL DIAGNOSIS: Acute Myocarditis, chest pain, anxiety disorder (NOS). Post vaccination dx of acute myocarditis. Now c/o of periodic episodes of chest pain, pain shoots down left arm, vomiting.  6/12/09 Medical records received DOS 4/27/09 to 6/1/09. FINAL DIAGNOSIS: Myocarditis/pericarditis, anxiety disorder (NOS). Post vaccination c/o chest pain, sharp pain L arm, vomiting. Vaccinia right deltoid normal red reaction. Lightheadedness, headache. Paroxysmal nocturnal dyspnea. Bradycardia. Chest tightness, pressure.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Myocarditis, Myoglobin blood increased, Troponin increased
Clinical narrative: Pt developed myocarditis. Symptoms developed on  27 April.  Smallpox vaccination given on 19 Apr 09.  5/28/09 Medical records received DOS 4/27/09 to 5/21/09. FINAL DIAGNOSIS: Acute Myocarditis, chest pain, anxiety disorder (NOS). Post vaccination dx of acute myocarditis. Now c/o of periodic episodes of chest pain, pain shoots down left arm, vomiting.  6/12/09 Medical records received DOS 4/27/09 to 6/1/09. FINAL DIAGNOSIS: Myocarditis/pericarditis, anxiety disorder (NOS). Post vaccination c/o chest pain, sharp pain L arm, vomiting. Vaccinia right deltoid normal red reaction. Lightheadedness, headache. Paroxysmal nocturnal dyspnea. Bradycardia. Chest tightness, pressure.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Bradycardia, Chest discomfort, Chest pain
Clinical narrative: Pt developed myocarditis. Symptoms developed on  27 April.  Smallpox vaccination given on 19 Apr 09.  5/28/09 Medical records received DOS 4/27/09 to 5/21/09. FINAL DIAGNOSIS: Acute Myocarditis, chest pain, anxiety disorder (NOS). Post vaccination dx of acute myocarditis. Now c/o of periodic episodes of chest pain, pain shoots down left arm, vomiting.  6/12/09 Medical records received DOS 4/27/09 to 6/1/09. FINAL DIAGNOSIS: Myocarditis/pericarditis, anxiety disorder (NOS). Post vaccination c/o chest pain, sharp pain L arm, vomiting. Vaccinia right deltoid normal red reaction. Lightheadedness, headache. Paroxysmal nocturnal dyspnea. Bradycardia. Chest tightness, pressure.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dizziness, Dyspnoea paroxysmal nocturnal, Echocardiogram normal, Electrocardiogram ST segment elevation, Headache
Clinical narrative: Pt developed myocarditis. Symptoms developed on  27 April.  Smallpox vaccination given on 19 Apr 09.  5/28/09 Medical records received DOS 4/27/09 to 5/21/09. FINAL DIAGNOSIS: Acute Myocarditis, chest pain, anxiety disorder (NOS). Post vaccination dx of acute myocarditis. Now c/o of periodic episodes of chest pain, pain shoots down left arm, vomiting.  6/12/09 Medical records received DOS 4/27/09 to 6/1/09. FINAL DIAGNOSIS: Myocarditis/pericarditis, anxiety disorder (NOS). Post vaccination c/o chest pain, sharp pain L arm, vomiting. Vaccinia right deltoid normal red reaction. Lightheadedness, headache. Paroxysmal nocturnal dyspnea. Bradycardia. Chest tightness, pressure.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Myocarditis, Myoglobin blood increased, Pain in extremity, Pericarditis, Troponin increased
Clinical narrative: Pt developed myocarditis. Symptoms developed on  27 April.  Smallpox vaccination given on 19 Apr 09.  5/28/09 Medical records received DOS 4/27/09 to 5/21/09. FINAL DIAGNOSIS: Acute Myocarditis, chest pain, anxiety disorder (NOS). Post vaccination dx of acute myocarditis. Now c/o of periodic episodes of chest pain, pain shoots down left arm, vomiting.  6/12/09 Medical records received DOS 4/27/09 to 6/1/09. FINAL DIAGNOSIS: Myocarditis/pericarditis, anxiety disorder (NOS). Post vaccination c/o chest pain, sharp pain L arm, vomiting. Vaccinia right deltoid normal red reaction. Lightheadedness, headache. Paroxysmal nocturnal dyspnea. Bradycardia. Chest tightness, pressure.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Vomiting
Clinical narrative: Pt developed myocarditis. Symptoms developed on  27 April.  Smallpox vaccination given on 19 Apr 09.  5/28/09 Medical records received DOS 4/27/09 to 5/21/09. FINAL DIAGNOSIS: Acute Myocarditis, chest pain, anxiety disorder (NOS). Post vaccination dx of acute myocarditis. Now c/o of periodic episodes of chest pain, pain shoots down left arm, vomiting.  6/12/09 Medical records received DOS 4/27/09 to 6/1/09. FINAL DIAGNOSIS: Myocarditis/pericarditis, anxiety disorder (NOS). Post vaccination c/o chest pain, sharp pain L arm, vomiting. Vaccinia right deltoid normal red reaction. Lightheadedness, headache. Paroxysmal nocturnal dyspnea. Bradycardia. Chest tightness, pressure.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Convulsion, Fall, Muscle twitching, Syncope
Clinical narrative: Administered vaccines at 11:40; promptly fainted; as she fainted she fell from the chair to the floor; had approx 2-3 second duration seizure with twitching of head; first aid administered; VSS with T 97.4 (O); P 82; BP 110/72; notified primary care provider; In speaking with parent who was with the student at time vaccines administered, she indicated that student has history of fainting spells and had not had breakfast.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles - Zoster- Appeared on patient's left arm extending linearly from the left clavicle to the left wrist two weeks after vaccine administration. The vaccine was administered to the thigh.
Age: 20.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Malaise, Myalgia, Rash
Clinical narrative: SICK, RASHES, JOINT PAIN , MUSCLE PAIN,
Age: 20.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Arthralgia, Hypersensitivity, Myalgia, Rash
Clinical narrative: SICK, RASHES, JOINT PAIN , MUSCLE PAIN,
Age: 13.0
Sex: F
Vaccine: HPV4, IPV
Symptoms: Dizziness
Clinical narrative: After receiving vaccinations, patient felt faint lightheaded
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster
Clinical narrative: Exactly 7 days after receiving Zostavax vaccination, client had painful blisters on her scalp and top of the head with severe headaches.  Saw her HCP and was placed on Valtrex and diagnosed as having Shingles.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Complaint of rash and swollen on both thighs after MMR and Varicella vaccines.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Immediate post-injection reaction, Pruritus, Rash, Urticaria
Clinical narrative: Allergic reaction - itching - immediate with hives and rash developing over a 3 day time period.  Treated with 50mg q6h benadryl and 10mg claritin - resolved within 4 days of treatment.
Age: 24.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Patient came in on 8/12/08 for Gardasil and Varivax.  Patient was counseled for pregnancy.  Patient called on 5/21/09 and stated that she had been pregnant on 8/12/08 and did not know it.  She stated she had not missed her period yet when she came in for the vaccinations so she did not think she was pregnant at the time.  She delivered twin boys at on 3/23/09 but her EDC was 4/13/09.  Baby A weighed 5 pounds 10 ounces at birth and Baby B weighed 5 pounds 7 ounces.  Patient took Baby A to pediatrician on 4/27/09 with what she thought was a respiratory illness.  Doctor heard a murmur and upon further evaluation was admitted to hospital and flown to another hospital.  Infant was diagnosed with Total Anomalous Pulmonary Venous Return and had surgery on 4/29/09.  Infant was discharged from the hospital on 5/4/09.  Baby B was found to have an innocent heart murmur.  Patient also has a 5 year old son and 2 year old daughter who are healthy.
Age: 1.75
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient returned to clinic two days post vaccination with a red, slightly swollen area to Right upper arm.  Area is circular in shape and the size of a half dollar.  Patient withdraws arm upon palpation to area.  Instructed to administer Tylenol for discomfort.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Notified Provider pt seen in ER 5/13/09 pm - 30hr after vaccine gen rash + 102 fever. 5/14/09 still has fever + gen rash. Given antibiotics in ER 5/13/2009.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient stated she had localized swelling in left upper arm (injection site) within 24 hours.  Been on 5/15/09 no redness.  C/o pain from left shoulder to elbow.
Age: 1.3
Sex: M
Vaccine: DTAP, HEP, VARCEL
Symptoms: Pyrexia
Clinical narrative: 5/21/09 Fever 101.8, eating ok, not acting sick, no rash, given TYLENOL for fever. Recommended if not better in a few days or if worse to be seen
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: HAVRIX given at about 12:30pm. By 7PM, arm ached - pain in (L) elbow- Daily pain increase in all joints and pain has continued even now.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme 4 days after administration.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Arm pain and tenderness with local swelling at injection site; painful to raise arm.  Tx'd with NSAIDS.  Pt reports had sweats & chills the evening of immunization
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Arm pain and tenderness with local swelling at injection site; painful to raise arm.  Tx'd with NSAIDS.  Pt reports had sweats & chills the evening of immunization
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Urticaria, rash, hives around injection site not sure when it started per patient
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Urticaria, rash, hives around injection site not sure when it started per patient
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: (Rt) deltoid  (+) erythema and edema - warm to touch measuring 3 X 2 inch oval area.
Age: 37.0
Sex: M
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Fall, Pallor
Clinical narrative: - Layed down for shots - Reports does faint - ask to stay on mat after - finished. He sat up in chair - Became pale - fell to knees & side of chair - pt remained responsive to verbal communication.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Immediate post-injection reaction, Muscle twitching, Staring, Syncope
Clinical narrative: The patient fainted immediately (30 secs) after the vaccine, she twitched for 15-20 secs then staring forwards, and then started crying. PR = 72/min, BP - 90/60 mmHg.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Muscle spasms, Visual impairment
Clinical narrative: 3rd GARDASIL injected into left deltoid. Pt became dizzy, visual disturbances, severe stomach cramps and R hand cramped up and "felt dead" It took 1 hour for patient's hand to uncramp and have feeling in it.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Mydriasis, Pallor, Paraesthesia, Vision blurred
Clinical narrative: The patient turned pale, felt tingling all over, pupil dilated and was blurring over. PR = 80 / mier Bp = 90/60.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Hyperaesthesia, Hypoaesthesia, Oedema peripheral, Pain
Clinical narrative: Right arm is red, swollen, tingling felt in hands and fingers. No fever. Also felt numbness sharp pain when making a fist. No oozing or bleeding present. States skin is very sensitive.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Paraesthesia
Clinical narrative: Right arm is red, swollen, tingling felt in hands and fingers. No fever. Also felt numbness sharp pain when making a fist. No oozing or bleeding present. States skin is very sensitive.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4 inch diameter erythema/induration at site of VARIVAX - Treated with KEFLEX, ibuprofen
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit normal, International normalised ratio increased, Laboratory test normal, Pain in extremity, Prothrombin time prolonged
Clinical narrative: Local pain (L) deltoid area began promptly, pain peaked at the 1-3 wk period gradually improved beginning in May 1 '09.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Glucose tolerance test normal, Skin laceration, Suture insertion, Syncope
Clinical narrative: HPV vaccine number 1 given . Syncope 5 minutes after vaccine. Fell to floor hit head laceration required sutures broken incisor # 1 Rt upper.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Tooth fracture
Clinical narrative: HPV vaccine number 1 given . Syncope 5 minutes after vaccine. Fell to floor hit head laceration required sutures broken incisor # 1 Rt upper.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Skin warm, Urticaria
Clinical narrative: Whelp left upper arm-hot to touch- VARIVAX given 5-13-09. Patient presented with symptoms 5-14-09. Treatment: BENADRYL PRN.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Patient called 2 1/2 hours after shot stating she has what look like broken blood vessels all over her body.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injected limb mobility decreased, Pain in extremity, Pyrexia, Rash
Clinical narrative: I received a PNEUMOVAX shot on Monday afternoon 4/27 and was well until approx. midnight (8hrs after shot). I woke during the night with a very painful, sore arm. I took ALEVE. For the next 2 days the painful arm was so bad, I couldn't lift my arm over head or use it to reach out straight to hold the steering wheel. On the third night I had a 101 degree fever which lasted 8 hrs. Then after the fever, I developed a rush 2 inches below the injection site. It looked like I had been slapped there. My painful arm felt better after 5 days, but it took over a week and a half for it to completely go away. I also had low energy for an entire week. I reported to my doctor. They said to report to  you.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Staring
Clinical narrative: Starring spells X 5 lasting approx 3 seconds, each.
Age: 81.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site erythema, Pain in extremity
Clinical narrative: Patient given varivax 5/8/9.  On 5/14/2009 developed pain left lower extremity.  On exam today findings consistent with shingles in dermatomal distribution left lower extremity.  Several clusters of vesicles.  No lesions elsewhere.  Mild redness at injection site.  No systemic symptoms.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given Approx 6pm on 5/12/09 on 5/13/09 L arm has area 3x3cm redness, swelling.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Musculoskeletal stiffness, Syncope, Tremor
Clinical narrative: Mom called our office on 5-21-09 to report that child received typhoid vaccine at health department 1-2 minutes after vaccine given child fainted. Became "stiff as a board" and  "arms and legs began shaking, revived fairly quickly but was out of it for 1 hour after." Mom attempted to get lot # from health dept. but was unsuccessful also unable to get information from health department it was reported, stated it was an unreportable offense.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration (R) thigh.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Lip swelling, Oedema mouth
Clinical narrative: ROTATEQ oral vaccine administered. Approx 10 minutes later child's lips noted to be swollen as well as the soft tissue surrounding the lips. Oral mucosa affected only regarding the inside of the lips and only slightly. She recovered spontaneously after 15-20 min observation.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Eye movement disorder, Loss of consciousness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a pharmacist concerning a female in her "early 20s" who on an unspecified date was vaccinated with third dose of GARDASIL (dose, route and lot number not reported). The pharmacist reported that after vaccination, the patient's eyes started to flutter and the patient passed out for four to five minutes. The pharmacist called the emergency medical services, but before they came, the patient had recovered consciousness. The patient was taken to a minor emergency clinic to get checked out. The pharmacist later that same day called to check on the patient and was fine. The patient received the first and second doses of GARDASIL and was fine. The patient recovered from the events on the same day she received the third dose (unspecified date). Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received through a Merck Pregnancy registry from a 38-year-old female with no medical history or allergies who on 16-AUG-2004 was vaccinated with a 0.5 mL dose of VARIVAX (Oka/Merck) (lot # 646135/0848N). Suspect vaccination on the same day included a dose of RECOMBIVAX HB. There was no other concomitant medication. The patient discovered that she was pregnant on 13-SEP-2004. No medical attention was sought. A product quality complaint was not involved. Additional information was received from a nurse in a physician's office who reported on 31-MAR-2005 that the patient was still pregnant and continued to be seen at the practice. Follow-up information was received from a physician's office which indicated that the patient's pregnancy history included three previous pregnancies and three full-term births. No birth defects, stillbirths or miscarriages occurred in any previous pregnancy. The date of the patient's LMP was 12-AUG-2004. Her estimated date of delivery was 19-MAY-2005. Prenatal testing due to "age" included an ultrasound on 07-DEC-2004 which was normal. On 25-MAY-2005, the patient gave birth to a 8 lb. 15 oz. liveborn female infant at 41 weeks from her LMP. There were no congenital anomalies or other complications or abnormalities. There were no complications during pregnancy or labor and delivery. There were no infection, illnesses, or concurrent medical conditions during pregnancy. The infant had no features of congenital varicella zoster syndrome. Additional information was received from the patient. Additional concomitant medication included MICRONOR. She reported that her daughter is now 35 months old and is Rh negative, has a low hemoglobin, is a little anemic, and is neutropenic. Her daughter was diagnosed on 13-APR-2007 with acute lymphocytic leukemia. The mother is Rh positive. It was noted that diagnostic laboratory tests included alpha-fetoprotein and "all pregnancy tests." Follow-up information from the patient indicated no new information. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician and a 35 year old female concerning herself with no pertinent medical history and no known drug reactions/allergies who on 14-JUN-2007 was vaccinated with a dose of VARIVAX. There was no concomitant medication. The patient recently found out that she was pregnant. Her LMP was 20-May-2007 and the estimated due date is 24-FEB-2008. Medical attention was sought. Patient's outcome was unknown. No product quality complaint was involved. This case was part pregnancy registry. Follow-up information has been received from a nurse and the patient's husband. The nurse indicating that the patient delivered the baby in February 2008. However she had no outcome information because the patient was not seen in the office for her post-partum visit. The patient's husband reported that the patient delivered a baby boy. The baby had a rash which was reported to eczema, otherwise was healthy. He stated that the patient had no problems with her pregnancy. This is consolidation of two reports concerning the same patient. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin M increased, Drug exposure during pregnancy, Exposure to communicable disease
Clinical narrative: Information has been received through the pregnancy registry for VARIVAX (Oka/Merck) from a physician's assistant concerning a 34 year old female, who in May 2007, vaccinated with a dose of VARIVAX (Oka/Merck). In May 2007, two weeks after the vaccination the patient became pregnant. Medical attention was sought. It was noted that the patient was exposed to shingles in July 2007 and went on to have an elevated IgM. Follow up information was received from the physician's assistant which reported that the patient delivered in February, 2008. The patient had no problems with the delivery and the baby had no problems either. At the time of the report, the baby was normal and healthy. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the Merck pregnancy registry and from a male consumer concerning his 22 year old wife with no known allergies or pertinent medical history who on 18-JUN-2007 was vaccinated with a dose of VARIVAX (Oka/Merck). Concomitant medication included prenatal vitamin. "About 12 days after vaccination" on approximately 30-JUN-2007 the patient became pregnant. Unspecified medical attention was sought. A urine test was performed. At the time of the report the patient was 6 1/2 weeks pregnant. No further information was provided. There was no product quality complaint involved. Outcome of the pregnancy was received. The patient performed ultrasound at 38 weeks (Approximately Mar 2008). The results confirmed oligohydramnios. On 25-MAR-2008 the patient delivered a normal, healthy male baby weighing 6 pounds 8 OZ. No further information is available.
Age: 16.0
Sex: F
Vaccine: DPP, VARCEL
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Pharyngitis streptococcal, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Information has been received through the Pregnancy registry from a registered nurse concerning a 16 year old female with no medical history or allergies who on 03-OCT-2007 was vaccinated SQ on right arm with a second dose of VARIVAX (Lot # 658422/1030U). Secondary suspect therapy on the same day included a dose on left arm DTaP (unspecified) (+) Tetanus toxoid. Other concomitant medications included iron (unspecified), calcium (unspecified) and prenatal vitamins (unspecified). A blood test done on 03-OCT-2007 was positive for pregnancy. Ultrasound performed on patient on 12-OCT-2007 showed normal fetal development with a due date of 30-MAR-2008. The patient's LMP was in June 2007. The patient has no previous history of pregnancy of miscarriage. There were no adverse events reported. A product quality complaint was not involved. Follow-up information indicated that on 25-OCT-2007 prenatal testing for MSAFP showed negative screen for the patient (LMP 01-JUN-2007, EDD 30-MAR-2008). It was unknown whether any maternal adverse events occurred. It was also unknown whether the patient was tested for varicella antibodies before vaccination with VZV containing vaccine. Follow-up information was received, which reported that on 03-MAR-2008, the patient had a normal female infant who weighted 5 pounds 8 ounces. No congenital anomalies, complications or abnormalities were reported. There were no features of congenital varicella zoster syndrome on the infant. It was reported that during pregnancy, the patient experienced a strep throat infection. There were no complications during pregnancy or delivery. No further information is available.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 14-year-old female with no pertinent medical history and no drug reactions/allergies who in May 2001, was vaccinated with a 0.5ml dose of VARIVAX (Oka/Merck). There was no concomitant medication. In 2001, 7 days after receiving the vaccine, the patient experienced chickenpox. She was noted to have approximately 10 to 20 lesions. The rash cleared up 21 days after the vaccination. The patient was seen by a nurse or physician at the time. Subsequently, the patient recovered from chickenpox. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 17-MAR-2008 was inadvertently vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck). There was no product confusion involved; the incident was due to human error. The patient did not experienced any know symptoms. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the pharmacist indicated that the patient did not develop any adverse symptoms. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 11 year old male who was vaccinated with VARIVAX (Oka/Merck). The patient reported that the "patient was diagnosed with breakthrough chicken pox after receiving VARIVAX when he was one years old". The patient sought unspecified medical attention. This is one of several reports from the same source. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Information has been received from a physician concerning a 9 year old male who on 21-FEB-2008 was vaccinated (subcutaneous) with a second dose of VARIVAX (Oka/Merck). The physician stated that the patient received his second dose of VARIVAX and on approximately 22-FEB-2008, "less than 24 hours after vaccination", the patient's upper arm became very painful and red. "Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information hs been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Clinical narrative: Information has been received from a health department registered nurse who was told by an unspecified school nurse that a 9 year old male on the morning of 14-APR-2000 was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot number# 632616/1688J) subcutaneous in the right arm. On 11-MAR-2008 the patient developed chickenpox. No specific symptoms or treatment reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from the parent of an approximately 19 month old male patient with a history of seizure who on 13-MAR-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck).  It was reported that the patient also received two other vaccines within the same visit but specifics were unknown.  The patient's parent reported that after receiving the VARIVAX (Oka/Merck), her son developed a fever that lasted about 4-5 days post vaccination.  It was reported that it cleared on its own.  Unspecified medical attention was sought.  There was no product quality complaint.  No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Pyrexia, Rash pustular
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 11 year old female consumer with a history of asthma. Who on 24-NOV-2007 was vaccinated in the left tricep with a second dose of VARIVAX (Oka/Merck) there was no illness at the time of vaccination. First dose of VARIVAX (Oka/Merck) was on 23-SEP-1997. The patient did not have any adverse events following this vaccination. Subsequently, on 22-FEB-2008 the patient's mom reported that she developed approximately 20 pustules and a low grade fever of 99. It was unspecified if medical attention was sought, but there were no lab studies performed. It was reported that on an unspecified date the patient recovered and is doing fine. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a male who on approximately 14-MAR-2008 (reported as on an unspecified date about a week ago), inadvertently received a dose of VARIVAX (Merck) instead of zoster vaccine live (Merck) (MSD).  The patient had no adverse symptoms.  The pharmacist stated that the error was due to product confusion.  There was no product quality complaint.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician's assistant concerning a male who was vaccinated with a first dose of VARIVAX (Oka/Merck). The patient developed ophthalmic shingles during and unspecified time period after the patient received the initial dose of VARIVAX (Oka/Merck). The patient now had no current symptoms or treatment and the outcome was reported as recovered. No product quality complaint was involved. The physician's assistant was not interested in the VZV analysis by Polymerase Chain Reaction because there were no current lesions. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an 89 (also reported as 79 years old) year old retired physician. He reported that he was vaccinated with VARIVAX (Oka/Merck) (route, administration site, lot number not reported) in error instead of ZOSTAVAX (Oka/Merck) on 18-MAR-2008. The reporter felt fine and had no symptoms present at the time of the report. Additional information has been requested.
Age: 1.9
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 21 month old male who, at 12 months of age, was vaccinated with a dose of VARIVAX (Oka/Merck). Subsequently, the patient developed shingles. The physician was "positive" that it was shingles and it was noted to be around his trunk area nerve track. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a female who on 24-MAR-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # 658587/1520U) instead of ZOSTAVAX (Oka/Merck). It was noted this was not product confusion only human error. VARIVAX (Oka/Merck) was stored at a refrigerator range above the recommended range for at least 168 hours. The patient sought medical attention via the pharmacy. No symptoms or problems noted. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Condition aggravated, Febrile convulsion, Pyrexia
Clinical narrative: Information has been received from a mother concerning her 12 months old son with possibly allergy to eggs and a history of febrile seizures and ear infection who on 16-MAY-2008 was vaccinated injection with VARIVAX (Oka/Merck). Concomitant therapy included ZANTAC and BACTRIM. On 18-MAY-2008 the patient experienced a fever over 100.4 degrees Fahrenheit and also experienced febrile seizure. As of 19-MAY-2008, the patient was recovering from fever and febrile seizure. The patient sought medical attention with a physician office visit. Febrile seizure was considered to be an other important medical event. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Clinical narrative: Information has been received from a mother concerning her 11 year old daughter who"at the age of 1" (approximately 1997), was vaccinated with VARIVAX (Oka/Merck). On 10-Mar-2008, the patient developed a mild case of chicken pox on her back. It was reported that the patient dose not have a physician. On an unspecified date, the patient recovered. It was noted that a day later, on 11-Mar-2008, her sister developed a mild case of chicken pox on her lower abdomen. A product quality complaint was not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) who, on an unspecified date, was vaccinated with a second dose of VARIVAX (Merck). Subsequently, on an unspecified date, the patient developed a small, red rash at the injection site. It was noted that the physician was not aware of any adverse experience with the first injection. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX (Oka/Merck). On an unspecified date the patient developed cellulitis and was hospitalized. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Injection site papule
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, dose and route not provided). It was reported that the patient experienced blister like lesions around the injection site. It is unknown if the date of 17-MAR-2008 is the date of vaccination or the AE onset date. It was unspecified if the patient sought medical attention. The patient's outcome was unknown. There was no product quality complaint. Additional information has been requested. Follow-up information has been received from a nurse concerning a 12 month old female who on 07-MAR-2008 was vaccinated with the right thigh with a first dose of VARIVAX (Oka/Merck) (Lot # 659527/1786U) at 9:45 am. On 07-MAR-2008 at 9:45 am the patient was vaccinated into the left thigh with a third dose of ACTHIB. (Sanofi Pasteur) (Lot #UF297AA). There was no illness at the time of vaccination. On 17-MAR-2008 the patient experienced papules on the right anterior thigh 10 days after VARIVAX (Oka/Merck) was administered in the same location. On an unspecified date the patient recovered. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a health professional concerning a 14 month old 20lb. 15oz. 29 in. female with no known pre-existing allergies, birth defects, or medical conditions, who on 03-MAR-2008 at 11:30 hrs was vaccinated with a first subcutaneous dose in the left thigh of VARIVAX (Merck) (lot# 659932/1790U). There was no reported illness at the time of vaccination. On 11-MAR-2008 at 16:00 hrs, the health professional indicated that the mother reported that the patient had developed a local reaction at the site described as redness, and a lump at the site on the left thigh. It was reported that the patient had hives on the back of right leg, and small areas on arms, and chest, but mostly on the right leg. On 17-MAR-2008, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Laboratory test normal, Pruritus, Rash
Clinical narrative: Information has been received from a consumer concerning her 9 year old granddaughter with no pertinent medical history or drug allergies/reaction who was vaccinated with the first dose and booster dose of VARIVAX (Oka/Merck) on unspecified dates. There was no concomitant medication. On 07-APR-2008 the patient had bumps on the bottom of her left foot appear. On 08-APR-2008 the size of the bumps on the bottom of both feet were the size of a half a dollar and itchy. She also has little bumps (some of them are "pimple like") appeared on the belly and back that are itchy. The patient had blood work done at the physician's office on 09-APR-2008 and the results came back on 10-APR-2008 which stated "it is clear". The physician said "it is not chickenpox-, strep or staph." As of 10-APR-2008, the event persisted. The grandmother considered the event to be disabling as the patient can't walk because of the blisters of the bottom of the feet. The consumer also reported on her grandson (cousin of the patient mentioned above) and the cousin's father who had a similar problem (refer to WAES number 0805USA04691 and 0805USA04930. No further information is available.
Age: 12.0
Sex: F
Vaccine: DTAPHEPBIP, MNQ, VARCEL
Symptoms: Cellulitis, Inappropriate schedule of drug administration, Injection site swelling, Rash
Clinical narrative: Information has been received from a physician concerning a female between 12 and 15 years of age with a history of obesity who was vaccinated SC with a second dose of VARIVAX (Oka/Merck). Concomitant therapy included PEDIARIX and MENACTRA. In approximately February 2008, the patient experienced severe swelling at the injection site and developed a rash that ran down their arm. The patient was diagnosed with cellulitis and was treated with antibiotics. The patient was hospitalized. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.