chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 05-JUN-2002 was vaccinated with the first dose of VARIVAX (Merck) and on 15-JUL-2008 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 659942/1797U). The registered nurse reported that on 21-JUN-2009, the patient had numerous scattered and crushed vesicles mainly on her legs. The patient also had some on her left anterior shoulder, trunk and upper arm. Some lesions were vesicular. The patient was receiving topical symptomatic relief. At the time of the report, the patient had not recovered. The patient sought medical attention at the physician's office. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Sudden death
Clinical narrative: Sudden unexplained death on 5/17/10.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Eye rolling
Clinical narrative: Lightheaded, eyes rolled but didn't pass out.
Age: 4.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site urticaria
Clinical narrative: Mom telephoned with in 24 hours after receiving PCV13 developed 3 hives near injection site, resolved on their own - no BENADRYL given.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Varicella, Varicella post vaccine
Clinical narrative: Focal erythema at injection site and mild diffuse varicella eruption.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Dizziness, Pyrexia
Clinical narrative: Fever 102.3F, dizziness. Treatment- monitor temperature and within 1 hrs had dropped to 101.3.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1), IPV, TDAP, TYP, YF
Symptoms: Dyspnoea, Lymphadenopathy
Clinical narrative: Neck glands began swelling and she felt like she could not breathe. Mother called pmd and he advised to give Benadryl. Mother called me 5/18 and pmd advised her to give Zyrtec in am and Benadryl in pm and gave Epi Pen just in case. Doing better now, glands still swollen.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Nodule on extremity
Clinical narrative: Golf ball size knot remained in right arm for 6 months - monitored.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site atrophy, Nuclear magnetic resonance imaging
Clinical narrative: H1N1 Vaccine was administrated on 11/9/2009. About two months later, left upper arm distal end of the deltoid shown muscle and fat tissue atrophy. Gradually, the above-mentioned atrophy became more apparent. Ortho consultation is in progress.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Paralysis
Clinical narrative: Pain in extremities, numbness, tingling, paralysis.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Body temperature increased, Chills, Fatigue
Clinical narrative: She received Tdap and the next morning had headache, tired, nausea, stomach ache, and chills.  Her temperature was 100 degrees at 10 AM and we called her Dr.; she took an Advil and temp went to 99.6 degrees. She was unable to do anything for 2 days and had the headache for over 3 days.  Fatigue continued for 2 days.  Headache was severe the first day and lessened but continued during the first 3 days.  The temperature, nausea and stomach ache was only on 5-4-2010.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea
Clinical narrative: She received Tdap and the next morning had headache, tired, nausea, stomach ache, and chills.  Her temperature was 100 degrees at 10 AM and we called her Dr.; she took an Advil and temp went to 99.6 degrees. She was unable to do anything for 2 days and had the headache for over 3 days.  Fatigue continued for 2 days.  Headache was severe the first day and lessened but continued during the first 3 days.  The temperature, nausea and stomach ache was only on 5-4-2010.
Age: 0.36
Sex: M
Vaccine: DPP, PNC, RV5
Symptoms: Blood culture negative, Cranial nerve disorder, Culture urine negative, Decreased appetite, Full blood count normal
Clinical narrative: Child developed fussiness around stooling immediately after exam and decreased po intake immediately after 4 month vaccines/4 month well child exam.  He was seen in clinic a few times for this and was told he had a viral illness.  No fever, no vomiting, no rash, no diarrhea, stooling normally, no rhinorrhea, no cough. He had a normal CBC, negative blood and urine cultures. The fussiness and anorexia resolved about 7- days after vaccines.  9 days after 4 mo vaccines the patient developed strabismus with bilateral CN VI palsies that are improving with patching prescribed by ophthalmology.  Brain MRI with and without contrast was normal.
Age: 0.36
Sex: M
Vaccine: DPP, PNC, RV5
Symptoms: Hypophagia, Irritability, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Strabismus
Clinical narrative: Child developed fussiness around stooling immediately after exam and decreased po intake immediately after 4 month vaccines/4 month well child exam.  He was seen in clinic a few times for this and was told he had a viral illness.  No fever, no vomiting, no rash, no diarrhea, stooling normally, no rhinorrhea, no cough. He had a normal CBC, negative blood and urine cultures. The fussiness and anorexia resolved about 7- days after vaccines.  9 days after 4 mo vaccines the patient developed strabismus with bilateral CN VI palsies that are improving with patching prescribed by ophthalmology.  Brain MRI with and without contrast was normal.
Age: 0.36
Sex: M
Vaccine: DPP, PNC, RV5
Symptoms: Viral infection
Clinical narrative: Child developed fussiness around stooling immediately after exam and decreased po intake immediately after 4 month vaccines/4 month well child exam.  He was seen in clinic a few times for this and was told he had a viral illness.  No fever, no vomiting, no rash, no diarrhea, stooling normally, no rhinorrhea, no cough. He had a normal CBC, negative blood and urine cultures. The fussiness and anorexia resolved about 7- days after vaccines.  9 days after 4 mo vaccines the patient developed strabismus with bilateral CN VI palsies that are improving with patching prescribed by ophthalmology.  Brain MRI with and without contrast was normal.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse practitioner who was working at that office as a nurse concerning a 12 month old patient who was vaccinated with the first dose of VARIVAX (Merck). The child developed a rash at the injection site within minutes of receiving the vaccine. Follow-up information was received from the nurse practitioner who reported that the patient's "3 bumps" resolved by the time the patient left the office after her vaccination. Then the patient's mom called on 06-JUL-2009 and said the patient's "3 bumps" returned over the weekend and were still present as of 06-JUL-2009. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 12 year old patient with no known drug allergies or any pertinent medical history, who on 24-JUN-2009 was vaccinated subcutaneously with 0.5 ml of a dose of VARIVAX (Merck). There was no concomitant medication. On 26-JUN-2009, two days after vaccination, the patient developed redness and warmth at the injection site of the left upper arm. The patient was examined in the office on 06/26/2009 and was diagnosed with cellulitis. The physician prescribed trimethoprim and SEPTRA. At the time of reporting the patient was recovering. The physician was unable to provide the VARIVAX (Merck) lot number, the sterile diluent lot number was 4127X. The physician is concerned that the cellulitis may be related to the sterile diluent and requests a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. (complaint ID 166286). This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Ocular hyperaemia
Clinical narrative: Information has been received from a pharmacist concerning a female with penicillin allergy with no reported medical history who on 29-JUN-2009 was vaccinated with VARIVAX (Merck) (dose, route and lot number not reported).  There was no concomitant medication.  On 30-JUN-2009 the patient experienced coughing and eye afer redness  administration of VARIVAX (Merck).  At the time of the report the outcome of the patient was not recovered.  Laboratory tests were not performed.  The patient sought unspecified medical attention.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a patient who "about 2 weeks ago" on approximately 17-JUN-2009, was vaccinated with VARIVAX (Merck) (Lot # 663818/0593Y).  On approximately 17-JUN-2009, the patient presented with injection site reaction.  The patient had swelling and redness at the injection site about 4 to 5 inches in diameter.  It was reported that the patient was also treated for cellulitis.  The patient sought unspecified medical attention.  After about a week, on approximately 24-JUN-2009, the patient recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure before pregnancy
Clinical narrative: Information has been received for the HPV pregnancy registry, from a 31 year old female patient who on 15-JAN-2009 was vaccinated with a dose of VARIVAX (Merck). It was reported that 1.5 months after vaccination with VARIVAX (Merck), on approximately 01-MAR-2009, the patient became pregnant. The patient stated that her pregnancy is normal, except for a little spotting. On an unknown date an ultrasound was performed; results were not reported. The estimated delivery date is 28-NOV-2009. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash vesicular, Scab
Clinical narrative: Information has been received from a physician concerning a male who two weeks ago was vaccinated with 0.5 mL second dose of VARIVAX, subcutaneously. On 01-JUL-2009 the patient returned to the physician's office because of a varicella-like rash and papules on the face. At the time of this report the patient had not recovered. Follow up information received on 31-JUL-2009 from a health professional indicated that the patient was a 5 year old female with pharyngitis at the time of vaccination and no medical history or drugs allergies, who on 11-JUN-2009 at 09:30 was vaccinated with a second dose of VARIVAX (lot # 661975/0188Y), into the left arm.  On 01-JUL-2009 at 09:00 the patient developed rash-erythematous papules, vesicle, crusted/scabbed erosion (perioral/back). The patient's outcome was not reported. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 19-JUN-2009 was vaccinated with VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously instead of ZOSTAVAX (Merck). No adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Balance disorder, Dizziness, Gait disturbance, Middle ear effusion
Clinical narrative: Information has been received from a physician concerning a male patient who on 29-MAY-2001 was vaccinated with a first dose of VARIVAX (Merck) (lot # not reported) intramuscularly. On approximately 02-JUN-2001 4-5 days post vaccination the child complained of dizziness, staggering and problems with equilibrium. The physician found fluid in the ear and no fever. The physician gave antibiotic and signs and symptoms subsided. In 2001 the patient recovered. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a patient who was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot # 663941/0262Y) instead of ZOSTAVAX (Merck) due to nursing error. No adverse reaction. Follow-up information has been received from the nurse on 10-JUL-2009 who indicated that the label was intact. She said both vaccines were stored in the freezer, one on one side, one on the other. However, the sides were recently switched. She added that the vaccines "sound alike". She suggested making labels totally different colors would be helpful. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 62 year old male patient who on 06-JUL-2009 was vaccinated subcutaneously with one dose of VARIVAX (Merck) (lot # 660339/0487X) instead of ZOSTAVAX (Merck) (MSD) (human error not PQC). No medical attention was sought. No adverse effects reported. Follow-up information has been received from another nurse on 15-JUL-2009 who did not want to be identified and reported that they keep both vaccines in inventory side by side in the freezer, and the nurse just grabbed the wrong one. It was simple human error. There was not anything she could offer or suggest we do differently or better with the labeling or packing of either product. She declined to offer her name or title. Follow-up information has been received from the nurse concerning a 62 year old male patient with no medical history or allergies and no illness at time of vaccination who on 06-JUL-2009 at 11:00 a.m. was vaccinated subcutaneously with the first dose of VARIVAX (Merck) in the left upper arm and on 06-JUL-2009 at 16:00 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (lot # 664320/056Y) in the right upper arm. There were no laboratory studies performed. Addition information is not expected.
Age: 1.28
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 15 month old female with [[name]] white tag on left nipple who on 25-JUN-2009 was vaccinated with her first dose of VARIVAX (lot # 663947/0583Y) SQ into her left thigh. There were no illnesses at the time of vaccination. Concomitant therapy included her fourth dose of PREVNAR (unspecified) (lot # D63486) IM into her left thigh. On 25-JUN-2009 the patient experienced "lower left thigh some redness" and "two [[name]] welts." treatment and shortly after the vaccination. The physician labeled the chart "varicella allergy". No lab test was performed. The outcome of the patient's adverse was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in approximately 1999 (reported as ten year ago) was vaccinated with two dose of VARIVAX (Lot not reported). Subsequently the patient was found to have negative antibody titers. The patient's have negative antibody titers persisted. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Pyrexia, Thirst, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female patient with no drug reactions/allergies and no pertinent medical history who on 01-JUN-2009 was vaccinated SQ with the first 0.5 mL dose of VARIVAX (Merck) (lot #663543/0122Y).   Concomitant vaccines included DTAP, MMR II (MSD) and poliovirus vaccine.  On 01-JUN-2009, the patient experienced vomiting, fever and swollen arms later that night.  Her doctor prescribed her TYLENOL, ordered sips of water and cool compresses to the arms.  Laboratory tests were not performed.  On an unspecified date the patient recovered.  On 30-JUN-2009, the patient received her second 0.5 mL dose of VARIVAX (Merck) (lot # 663543/0122Y), subcutaneous route, and no adverse symptoms were noted.  The patient sought unspecified medical attention.  Follow up information has been received from the licensed practical nurse concerning this 4 year old minor female who on 01-JUN-2009 at 3:59 pm was vaccinated SQ in her left upper arm with the first 0.5 mL dose of VARIVAX (Merck) (lot # 663543/0122Y).  Concomitant vaccines administered on the same day included a fourth dose of DTAP (lot # C3084AA, IM, right deltoid lower arm, at 3:54 pm), a fourth dose of poliovirus vaccine (lot # B0475, IM, right deltoid, at 3:56 pm) and MMR II (MSD) (lot # 663668/ 0114Y, SQ, left lower arm, at 4:01 pm).  On 02-JUN-2009, in the early morning, the patient experienced vomiting, fever, swollen arms and she felt thirsty. The patient was treated with TYLENOL suppository, and on an unknown date the patient recovered.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 15 years old female who was vaccinated subcutaneously with two doses of VARIVAX (Merck). Subsequently the patient experienced chickenpox. There were more than 50 lesions and scattered all over her body. The physician did mention that this incident occurred after an exposure to a girl who had shingles and the two girls shared a sweater. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Information has been received through a voice mail from a physician concerning a 14 year old female who was vaccinated with VARIVAX (Merck).  Concomitant medication included montelukast sodium(MSD), PULMICORT and albuterol.  Subsequently the patient passed out after receiving VARIVAX and then they gave MENACTRA and hepatitis A virus vaccine (unspecified) after she passed out.  The patient was not hospitalized after the event.  The outcome was unknown at the time of report.  Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who on 06-JUL-2009 was vaccinated with the second 0.5 ml dose of VARIVAX (Merck) (subcutaneous injection) (lot # 663541/0335Y) and a dose of MMR II (MSD) (lot#, dose, route not reported).  On 06-JUL-2009 the patient experienced swelling and redness at the injection site as well as hives later that day. The patient was seen in the office on 08-JUL-2009 but it was unknown if therapy was prescribed.  The patient called the office on 09-JUL-2009 and stated the symptoms were getting worse.  No lab diagnostics studies were performed.  At the time of reporting, the patient had not recovered.  The nurse mentioned that 6 other patients, who all received VARIVAX (Merck) as a second dose, had reported similar symptoms.  The nurse was requesting a lot check.  Follow up information has been received from the same nurse concerning a 8-9 year old female patient who on 06-JUL-2009 was vaccinated with the second 0.5 ml dose of VARIVAX (Merck) (subcutaneous injection) (lot # 663541/0335Y).  The nurse confirmed they had had 9 patient who had all the same reaction from VARIVAX (Merck) lot # 663541/0335Y.  All patients were vaccinated "last week" 06-JUL-2009, and experienced different degrees of swelling, redness at injection site, and hives.  She also reported they had not had any ore since then, and all that reacted have recovered.  A lot check has been initiated.  A standard lot check investigation was performed for VARIVAX (Merck) (lot # 663541/0335Y).  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an approximately 12 years old female who was vaccinated with a 0.5ml dose of VARIVAX (Merck) (lot#, route and site of administration not reported) as a baby. In spring 2009, the patient developed chickenpox. Unspecified medical attention was sought. No lab diagnostics studies performed. On an unspecified date the patient recovered. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a now approximately five years old male patient who had an anaphylactic reaction to VARIVAX in the past (date unknown). It's unknown if the patient has sought any medical attention. The patient subsequently experienced anaphylactic reaction while on therapy with MMR II (MSD, WAES0907USA01222). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Back pain, Body temperature increased, Myalgia, Night sweats, No reaction on previous exposure to drug
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 14 year old male who on 06-JUL-2009 was vaccinated with the second booster dose of VARIVAX (Merck) (LOT# not reported). The patient did not have any problems from the first dose. On 07-JUL-2009 the patient developed a fever at 102.5F degree and experienced night sweats, muscle aches and back pain. The patient's sheets have been changed many times because he was sweating so much from the fever. The patient was treated fever using TYLENOL but no effect. The patient was administered IV fluids (unspecified) at emergency room and seen by a pediatrician on unspecified dates. His fever has lasted 4 days and the patient was not recovered at the time of this report. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 14 year old male who on 06-JUL-2009 was vaccinated with the second booster dose of VARIVAX (Merck) (LOT# not reported). The patient did not have any problems from the first dose. On 07-JUL-2009 the patient developed a fever at 102.5F degree and experienced night sweats, muscle aches and back pain. The patient's sheets have been changed many times because he was sweating so much from the fever. The patient was treated fever using TYLENOL but no effect. The patient was administered IV fluids (unspecified) at emergency room and seen by a pediatrician on unspecified dates. His fever has lasted 4 days and the patient was not recovered at the time of this report. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Physician Assistant (P.A.) concerning a 73 year old female patient who on 27-JUL-2009 was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). It was reported that the patient was still in the office and was administered a dose of ZOSTAVAX (Merck) (MSD) subcutaneously prior to being discharged. No adverse reactions noted. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Pruritus, Varicella
Clinical narrative: Information has been received from a physician concerning a 29 year old female patient who on 01-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported).  Four days later, on 05-JUL-2009, the patient started having chickenpox on her knee and neck and as of 13-JUL-2009, the patient continued to develop more vesicles.  At the time of reporting, the patient had not recovered from the event.  The patient sought medical attention by contacting the physician.  Additional information has been received from a physician concerning a 29 year old female patient who had about ten to twenty lesions and it had been two weeks since breaking out and the patient was continuing to break out with new lesions.  The physician reported that the place where the most lesions occurred was at the injection site which has five lesions and was experiencing swelling and pain at the injection site.  The Physician reported that the patient also had a few lesions on her scalp, leg, arm and stomach.  The physician provided the patient with ZYRTEC to help the itching and instructed her to use calamine lotion and another cream (name and manufacturer unspecified) to put at the injection site.  Additional information has been received from a physician concerning a 29 year old healthy female patient who had no known exposures to wild-type VZV.  After vaccination on 01-JUL-2009 with VARIVAX (Merck) the patient broke out into a varicella type rash.  She developed classic vesicles at the injection site and elsewhere on her body, approximately 20 vesicles.  The patient was continuing to develop more vesicles so the health care professional was estimating that the patient had approximately 40 plus vesicles.  The patient had no fever or other complaints, but was concerned that the lesions are still appearing.  At the time of reporting, the patient had not recovered.  If this continues for another couple of days the primary physician may send the patient to a dermatologist and also request an identification whether the lesions are in fact due to vaccine strain.  The physician also discussed possible T cell abnormalities with this patient given the atypical course of the rash.  Follow up information has been received from the physician concerning a 29 year old healthy young female patient who on 01-JUL-2009 was vaccinated with the second dose of VARIVAX (Merck) (Lot : 660336/0108X) subcutaneously in the left deltoid.  On 05-JUL-2009 the patient developed a limited outbreak of chickenpox.  Most pronounced vesicles at the injection site, but had 20-40 vesicles/pox diffusely.  Otherwise the patient felt well, with no fever and no other viral symptoms.  On 20-JUL-2009, all the symptoms resolved without intervention.  Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Blister, Dermatitis contact, Eye swelling, Fatigue
Clinical narrative: Information has been received from a nurse concerning an 8 year old male with asthma and hypersensitivity who on 23-DEC-2002 was vaccinated with the first dose of VARIVAX (Merck) (lot number unknown). On 24-JUL-2009 the patient received the second dose of VARIVAX (Merck) (lot number 663308/0094Y). Concomitant therapy included montelukast sodium (MSD). On 24-JUL-2009 the patient felt "weak, tired and puny" after receiving the second dose. On 27-JUL-2009 the patient  developed a rash from poison ivy contact on his left side of his face and neck. He had periorbital swelling. The rash was described as erythematous clear fluid filled blisters. The patient still felt "puny". At the time of the report the patient had not recovered. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling abnormal, Rash erythematous
Clinical narrative: Information has been received from a nurse concerning an 8 year old male with asthma and hypersensitivity who on 23-DEC-2002 was vaccinated with the first dose of VARIVAX (Merck) (lot number unknown). On 24-JUL-2009 the patient received the second dose of VARIVAX (Merck) (lot number 663308/0094Y). Concomitant therapy included montelukast sodium (MSD). On 24-JUL-2009 the patient felt "weak, tired and puny" after receiving the second dose. On 27-JUL-2009 the patient  developed a rash from poison ivy contact on his left side of his face and neck. He had periorbital swelling. The rash was described as erythematous clear fluid filled blisters. The patient still felt "puny". At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history or allergies who on 04-JUL-2009 ("10 days ago") was vaccinated with VARIVAX (lot#, route and site of administration not reported). The physician reported that the patient developed rash all over her body after receiving the VARIVAX. She called the office for medical attention. No lab diagnostics studies performed. At the time of reporting the patient was not recovered. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 8 year old son with no pertinent medical history and no known allergies who in April 2002 was vaccinated (subcutaneous injection) with a 0.5ml dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. The consumer reported that her son inadvertently received a third dose of VARIVAX (Merck) on 27-JUL-2009. The patient received the second dose of VARIVAX (Merck) in July 2007. The patient woke up in the morning (25-JUL-2009) with a sore arm. The physician's office thought the consumer's son had received only one dose of VARIVAX (Merck) previously. No lab diagnostics study was performed. The patient sought medical attention through a telephone call. At the time of report, the patient was recovering. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Chest pain, Cough, Dyspnoea, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with allergy to animal dander and no medical history who on 18-DEC-2001 was subcutaneously vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# 638249/0426L). On 23-JUL-2009 the patient received the second 0.5ml dose of VARIVAX (Merck) (lot# 663762/0344Y) subcutaneously. There was no concomitant medication. On 23-JUL-2009 the patient experienced an allergic reaction 5 minutes after vaccination. He started sneezing a lot and his one lip became swollen on the way home from the physician's office. The area around the injection site became red and swollen. He also experienced pain in his chest, sore throat, shortness of breath, and coughing. He was examined in the ER room and diagnosed with allergic reaction to vaccine. He was treated with liquid BENADRYL. He was not admitted. No lab diagnostics studies were performed. Subsequently, the patient recovered from allergic reaction to vaccine. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Lip swelling, Oropharyngeal pain, Sneezing
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with allergy to animal dander and no medical history who on 18-DEC-2001 was subcutaneously vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# 638249/0426L). On 23-JUL-2009 the patient received the second 0.5ml dose of VARIVAX (Merck) (lot# 663762/0344Y) subcutaneously. There was no concomitant medication. On 23-JUL-2009 the patient experienced an allergic reaction 5 minutes after vaccination. He started sneezing a lot and his one lip became swollen on the way home from the physician's office. The area around the injection site became red and swollen. He also experienced pain in his chest, sore throat, shortness of breath, and coughing. He was examined in the ER room and diagnosed with allergic reaction to vaccine. He was treated with liquid BENADRYL. He was not admitted. No lab diagnostics studies were performed. Subsequently, the patient recovered from allergic reaction to vaccine. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning his daughter, a 15 month old female who was vaccinated with a dose of VARIVAX (Merck) 2 weeks ago (the reporter thought), on approximately 13-JUL-2009. On approximately 13-JUL-2007 the patient had a disseminated rash on her torso & face, no fever. At the reporting time the patient was acting normal and did not appear sick. The reporter was not even sure if the rash was related to the vaccine. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain of skin, Pyrexia, Rash
Clinical narrative: It was reported in a published article that a 7 year old male experienced fever and severe herpes zoster pain with facial rash and was hospitalized who was vaccinated with VARIVAX (Merck) 6 years previously. The varicella-zoster virus (VZV) vaccine strain may reactivate to cause herpes zoster. Limited data suggest that the risk of herpes zoster in vaccinated children could be lower than in children with naturally acquired varicella. The authors examine incidence trends, risk, and epidemiologic and clinical features of herpes zoster disease among children and adolescents by vaccination status. Population-based active surveillance was conducted among 20 year old residents from 2000 through 2006, structured telephone interviews collected demographic, varicella vaccination and disease histories, and clinical information. From 2000 to 2006, the incidence of herpes zoster among children less than 10 years of age declined by 55%, from 42 cases reported in 2000 (74.8/100,000 persons; 95% confidence interval [95% CI]: 55.3-101.2) to 18 reported in 2006 (933.3/100,000; 95% CI: 20.9-52.8; P less than 0.001). During the same period, the incidence of herpes zoster among 10- to 19-year-old increased by 63%, from 35 cases reported in 2000 (59.5/100,000 persons; 95% CI: 42.7-82.9) to 64 reported in 2006 (96.7/100,000; 95% CI: 75.7-123.6; P less than 0.02). Among children aged less than 10 years, those with a history of varicella vaccination had a 4 to 12 times lower risk for developing herpes zoster compared with children with history of varicella disease. Varicella vaccine substantially decreases the risk of herpes zoster among vaccinated children and its widespread use will likely reduce overall herpes zoster burden. The increase in herpes zoster incidence among 10- to 19-year-olds could be confidently explained and needs to be confirmed from other data sources. The patient was a healthy 7-year-old boy who was vaccinated 6 years previously and had no history of varicella. He was admitted with fever and severe herpes zoster pain with facial rash. Overall, the rate of herpes zoster-related hospitalization per 100,000 population aged, 20 years was 0.6 (95% CI: 0.25-146), and the rate of hospitalization per 1000 herpes zoster cases was 10.9 (95% CI: 4.5-26.2). No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse concerning a adult female who on 24-JUN-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported).  On an unspecified date, the patient has chickenpox.  The patient two days ago had what she thought were bug bites until a ton of these bites showed up.  The patient sought medical attention at office.  No other information is available at the time of this report.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot # 663530/0052Y) instead of ZOSTAVAX (Merck).  This event was a result of human error, not product confusion.  No adverse effects were reported.  At the report time the outcome was unknown.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a company representative concerning her 5 year old daughter with penicillin allergy who was vaccinated with a second 0.5ml dose of VARIVAX (lot#, route and site of administration not reported). On 04-JUL-2009 the patient developed an outbreak of chickenpox with 200 lesions after getting both doses of VARIVAX. Unspecified medical attention was sought. No lab diagnostics studies were performed. At the time of reporting the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pneumonia
Clinical narrative: Information has been received from a Licensed practical Nurse concerning a 44 month old male patient, with no medical history, drug reactions or allergies reported, who on 22-MAY-2001 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck), subcutaneous route in the left upper arm (lot # unknown). There was no concomitant medication. On 23-MAY-2001, the next day following vaccination, the patient experienced pneumonia and was hospitalized. The Licensed practical Nurse reported that the patient was treated with antibiotics. On an unspecified date, a chest x ray was performed with unknown results. The Licensed practical Nurse stated that the patient was released from the hospital on 24-MAY-2001. At the time of the report the patient recovered on an unspecified date. The Licensed practical Nurse stated that the physician decided no to vaccinate the patient with a second dose of VARIVAX (Merck). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old female who 3 years ago, in approximately August 2006, was vaccinated with the only one dose of VARIVAX (Merck). Recently the patient experienced mild case of chicken pox with 6 lesions and one chicken pox developed cellulitis. At the report time the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 year old female patient with no medical history and no drug reactions or allergies who on 21-JAN-2010, was vaccinated with the first SC dose of VARIVAX (Merck) (lot # 665644/1205Y).  There was no concomitant medication.  On an unspecified date, the patient developed red itchy areas surrounding the injection site.  No lab diagnostics studies were performed.  At the time of reporting, the patient was recovering.  The patient sought unspecified medical attention.  The office was requesting a lot check.  A lot check has been initiated.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Information has been received from a physician concerning a 17 month old male with allergies to soy milk, egg white, wheat and ZANTAC who on 15-NOV-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported). On 10-FEB-2005, the patient was vaccinated with the first dose of MMR II (lot # not reported). The patient also received  PREVNAR on 10-FEB-2005. On 06-APR-2005 the patient was diagnosed with idiopathic thrombocytopenic purpura and was hospitalized. The patient was treated with intravenous gammaglobulin. Subsequently, the patient recovered from idiopathic thrombocytopenic purpura and was discharged from the hospital. The reporter considered idiopathic thrombocytopenic purpura to be immediately life-threatening, disabling and an other important medical event. In follow-up the physician reported the patient never had a reaction to VARIVAX (Merck). He was inquiring whether there was any problem with VARIVAX (Merck) and reports of idiopathic thrombocytopenic purpura. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a male who on 27-APR-2004 and 22-MAY-2008 was vaccinated with his first and second dose of VARIVAX (Merck) respectively.  Subsequently the patient was diagnosed with chickenpox on an unspecified date.  The patient had sought medical attention via office visit.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning his 12 month old daughter who was vaccinated with a dose of VARIVAX (Merck) a few weeks ago. The patient was also given six other vaccines along with VARIVAX (Merck). One week after the vaccine being given, the patient developed a zoster like rash on her thigh. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old female patient with no pertinent medical history and no known allergies who on 20-JUL-2009 was vaccinated SQ with a 0.5 ml dose of VARIVAX (Merck) (lot number ___/0265Y). Secondary suspect therapy included MMR II vaccine (MSD, lot number___/0427Y). On 26-JUL-2009 the patient developed rash all over her body. Then the rash disappeared and hives appeared (date unspecified). The patient was treated with BENADRYL (dose and duration not reported). The patient went to the office for medical attention. There was no lab studies performed. At the time of the report, the patient's status was recovering. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female patient between the age of 8-12 years old who on unspecified dates was vaccinated with two doses of VARIVAX (Merck) (lot#s not reported).  On an unspecified date in 2004 the patient came down with full blown chickenpox.  Unspecified medical attention was sought.  At the time of this report, the patient had recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 13 month old patient who on an unspecified date was vaccinated with first dose of VARIVAX (Merck) (dose, route and lot number not reported).  On an unspecified date after being vaccinated, the patient developed zoster.  The physician said that the patient survived without any sequelae.  It was not specified if the patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a dose of VARIVAX (Lot # not reported) instead of ZOSTAVAX. it was stated that the reason was due to human error. The patient sought unknown medical attention. No adverse effect was reported. No other information is available at the time of this report. Follow-up information has been received from the office manager concerning about the female patient. She did not experience any problems and the event was reportedly his staff's error. The "staff member was too busy to look close enough to see they grabbed vaccine". Additional information is not expected.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 18 month old patient who on an unspecified date was vaccinated with first dose of VARIVAX (Merck) (dose, route and lot number not reported). On an unspecified date after being vaccinated, the patient developed zoster. The physician said that the patient survived without any sequelae. It was not specified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male patient between the age of 8-12 years old who on unspecified dates was vaccinated with two doses of VARIVAX (Merck) (lot#s not reported). On an unspecified date in 2004 the patient came down with full blown chickenpox. Unspecified medical attention was sought. At the time of this report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Convulsion, Pyrexia, Speech disorder, Unresponsive to stimuli
Clinical narrative: Information has been received from a mother concerning her 18 months old daughter with no allergies who on an unknown date, was vaccinated with VARIVAX (Merck) (lot# not reported). Secondary suspect therapy included RECOMBIVAX HB (MSD, Lot # not reported). Subsequently the patient experienced seizures when she was only 18 months old. It was reported that the patient "developed a very high fever for up to 105 degree and she was not responding to us so we brought her to the emergency room". The patient was not admitted in the hospital and she was released the same day after her fever was stabilized. It was reported that after seizures, the patient started to show signs of speech problems when she was about 2 to 3 years old and she was enrolled in a special school. At the time of report, on 24-MAR-2009, her daughter, now 6 years old, was fully recovered and had no learning disability issues anymore. She was reading and ahead of her game. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning one of his children who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported).  The physician stated that his child was in a clinical study for VARIVAX (Merck) and had an extreme case of chickenpox following the clinical trial.  It was not specified if the patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Pruritus, Varicella
Clinical narrative: Information has been received from a registered nurse concerning her 5 year old granddaughter with asthma on 16-FEB-2005 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot number 648555/0274P) and on 11-FEB-2009 was vaccinated subcutaneously with an another 0.5ml dose of VARIVAX (Merck) (661269/0787X). Concomitant therapy included FLOVENT. On 28-SEP-2009 the patient had chickenpox like lesions. There were less than 30 lesions that were mainly on the trunk and one lesion in the lower groin and buttock. Initially, the granddaughter experienced periodical itching and a low grade temperature. The lesions had yet to scab over except the ones the granddaughter had been able to reach to scratch. The lesions on the back had not scabbed over. The patient sought medical attention via office visit. No laboratory diagnostic studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old male with no medical history and no allergies who on 14-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (LOT# 662576/0046Y). There was no concomitant medication. The first dose was received at "about 6 years ago" (in approximately 2003). On 15-JUL-2009, the patient experienced redness and swelling at injection site. On 16-JUL-2009, the patient sought medical attention in the office and was prescribed TYLENOL and BENADRYL; no laboratory or diagnostic tests were performed. The patient was recovering at the time of this report. Additional information has been requested.