chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella, Varicella post vaccine, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 2 year old female with steroid therapy, absence of corpus callosum and pan-hypopituitarism, developmental delay and hospitalization with no recent exposure to chickenpox or shingles, who on 23-OCT-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (date, dose, site and route not reported).  Concomitant therapy included (LOTRIMIN), hydrocortisone, TYLENOL, pyridoxine and an unspecified inhalant.  On 10-NOV-2008, post-vaccination, the patient developed a vaccine associated rash with no fever, 6 scattered lesion crusted papules type.  At some point the child was hospitalized.  On 11-NOV-2008, a VARICELLA direct fluorescent antibody test was positive.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 13-NOV-2008.  The sample was taken from a papule lesion on an unspecified site.  The PCR results for the specimen from a papule lesion on an unspecified site identified the presence of VZV VACCINE STRAIN.  Additional information was received in the form of medical records on 31-DEC-2008.  The 2 year old female born full term with questionable global developmental delay, who does not walk or talk, vocalizes but no words, went to pediatrician on 22-OCT-2008 and basic workup yielded a sodium level of 168.  Patient was admitted to the hospital on 23-OCT-2008 for a workup.  Patient was otherwise well with only tactile fever over past couple days.  Father of patient thought that urine looked normal but patient urinated in 10 diapers per day (consistent over past 2 months).  Patient was on no medications and father believed behavior was at baseline, not more agitated or cranky.  Emergency dept exam revealed the patient had upper airway congestion.  Medications included: INH 190 mg daily, B6 25 mg PO daily, LOTRIMIN, TYELENOL PRN, hydrocortisone 2.5 mg TID (baseline dose) (5 mg po TID for fever; 7.5 mg po TID for fever >102).  On 23-OCT-2008 patient was vaccinated with VARIVAX (Oka/Merck).  On 10-NOV-2008, the patient developed a rash.  10-NOV-2008 VARICELLA culture was performed and serum VARICELLA ZOSTER virus antibody test was positive.  The patient outcome was not reported.  Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 10 year old female student who on 03-SEP-1999 was vaccinated subcutaneously in her left arm with a second dose of VARIVAX (Oka/Merck) (lot # 661857/1215X).  It was also reported that the patient was administered a second of influenza virus 3v reassortant vaccine live intranasal (cold adapted Ann Arbor master strain) (FLUMIST) (lot # 500544P).  It was unknown if there was any illness at the time of vaccination.  On 06-NOV-2008 the patient experienced swelling and redness at injection site.   At the time of this report, the outcomes were unknown.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Blister, Ear infection, Rash erythematous, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old male patient with no pertinent medical history and known allergies who on 01-OCT-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot # 660944/0512X).  Concomitant therapy included MMR II, PREVNAR and COMVAX received on the same day (01-OCT-2008).  Around 26-DEC-2008 the patient developed a rash described as papular with some vesicles, erythematous on his chest and back.  In the information received on 05-JAN-2009 contained the following adverse experiences: ear infection (in December 2008) and was prescribed antibiotics.  Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse and a medical assistant concerning a 44 month old female who on 03-MAY-2006 was vaccinated with her only dose of VARIVAX (Merck) (lot# not reported) 0.5ml SQ on the right thigh. On 01-JAN-2009 (also reported by the nurse as 06-JAN-2009) the patient experienced chickenpox and she had been on BENADRYL for it. The patient was seen in the office and was started on acyclovir. Lesions were on both sides of the cheek, on the lips, chin, part of the neck, and a couple on the legs. The patient's chickenpox persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who on 09-JUN-1997 was vaccination with the first dose of VARIVAX (Oka/Merck) (lot # not reported).  There was no concomitant medication.  No medical history or drug allergy was reported.  After receiving the second dose of VARIVAX (Oka/Merck) (lot # 662458/1330X), 0.5ml, subcutaneously on 01-DEC-2008, the patient experienced swelling and redness on her arm at the injection site.  The patient sought medical attention by phone call.  At the time of the report, the patient was recovering.  This is one of several reports from the same source.   Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician a 39 year old male with no drug reactions or allergies who on 20-Nov-2008 was vaccinated subcutaneously with a 0.5ml first dose of VARIVAX (Oka/Merck). Concomitant therapy included some unspecified medications. "About 2-3 days ago", on approximately 01-Dec-2008 the patient developed a rash with 6-8 pox on his leg which "looked like chicken pox". The patient went to the office. No laboratory or diagnostic tests were performed. At the time of this report. 03-Dec-2008, the outcome was unknown. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old female employee who on 01-DEC-2008 was vaccinated with the first dose of VARIVAX (Lot# 661658/1135X). On 03-DEC-2008 the patient developed swelling and erythema at the injection site. The patient sought medical attention at the employee health. At the time of reporting (04-DEC-2008) the outcome of the patient was unknown. The nurse requested a lot a search of VARIVAX. A standard lot check investigation was performed. All in-process quality checks for the lot number investigation was performed. The testing performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several cases from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Drug exposure during pregnancy, Varicella zoster serology negative
Clinical narrative: Information has been received from a 31 year old female patient for the pregnancy Registry for VARIVAX. Some time in February, 2007 was vaccinated with VARIVAX (Lot and route not reported). Concomitant therapy included vitamins (manufacturer unspecified). And about two weeks later after receiving VARIVAX the patient found out she was pregnant (2007). The patient reported that before receiving VARIVAX she just finished nursering her first child. On 07-NOV-2008 she had her child and her child is healthy. The patient sought medical attention. Additional information has been requested. Follow up information was received from the questionnaire which indicated that the patient was 30 year old female who had one previous pregnancy and full term delivery. In 2006 the patient was treated for varicella antibodies and the result was negative. On 01-FEB-2007 the patient was vaccinated a dose of VARIVAX. Concomitant therapy included prenatal vitamins. The patient's last menstrual period was 10-FEB-2007. On 07-NOV-2007, the patient delivered a normal male baby whose weight was 8 pounds and 4 ounce. It was reported that there were no congenital anomalies or other abnormalities with the infant and no complications during pregnancy, labor/delivery, or illnesses/infections during pregnancy. In approximately 2008 the patient developed acne and was treated with Bactrim, Spironolactone and Azithromycin. At the time of this report, the outcome of acne was unknown.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Varicella post vaccine
Clinical narrative: Initial and follow-up information has been received from a registered nurse who while working part time at a high school heard from an acquaintance at the school that an 11 or 12 year old female patient was vaccinated on an unknown date with a second dose of VARIVAX. "Yesterday" the patient developed a breakthrough of chicken pox that started on injection site and went all the way down her arm. At the time reporting the patient had not recovered. The patient sought unspecified medical attention. The reporter confirmed the event but could not provide any further information. She did not get the name of patient's physician. She stated that she was only mentioning that this had happened and that the report should be coming through. No further information is available.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Varicella post vaccine
Clinical narrative: Information has been received from a physician and a nurse supervisor concerning an 7 year old female with asthma, eczema and allergic rhinitis who on 14-APR-2008 was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck).  Concomitant therapy included ALBUTEROL, ZYRTEC, CLARITIN, MSD and FLOVENT.  On 30-NOV-2008 the patient became sick and developed mild to moderate case of chickenpox breakthrough.  Physician identified that the lesions on the patient's abdomen were chicken pox lesions.  The nurse supervisor reported that lot # was not available because the patient received the VARIVAX from another clinic.  At the time of the report it is unknown if the patient recovered.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 8 year old female patient who on 03-Dec-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot#551977/1275X). On 05-DEC-2008 the patient developed cellulitis. Patient sought medical attention by calling the nurse. At the time of the report the patient had not recovered. Follow-up information received from a licensed practical nurse that reported the patient  weights 81 pounds and is 5 feet 1 inch tall. Second dose of VARIVAX (Oka/Merck) (lot#661977/1275X) was administered subcutaneously on the left arm at 18:00. Unspecified medical attention was sought. Increased redness, edema and warmth at injection site were experienced by the patient on 5-DEC-2008 at 17:50. After patient was diagnosed with cellulitis she was treated with CEPHALEXIN (unspecified) 500 mg every 6 hours for 10 days with effect. Patient recovered on 15-DEC-2008. A standard lot check investigation was performed for lot#661977/1275X. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. This is one of several reports from the same source. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female patient who on 29-OCT-1999 was vaccinated with a dose of VARIVAX (Oka/Merck), lot number 631301/0724J, 0.5 ml, subcutaneous. It was reported that on 04-DEC-2008 the patient developed rash and on 05-DEC-2008 the patient was at physician's office where was diagnosed with chickenpox. The nurse stated that the patient had about 30-30 "water filled blisters" scattered all over her body; patient was recently exposed to her grandfather who has shingles. Patient is recovering. Follow-up information received on 12-JAN-2009. A medical assistant stated that the patient developed "20-30 spots" after exposure to a grandparent with shingles "over weekend". Patient not recovered. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an employee who was vaccinated with the first dose of VARIVAR (Oka/Merck).  The patient may have been vaccinated with lot 661658/1135X and developed swelling and erythema at the injection site after getting the first dose.  At the time of reporting (04-DEC-2008) the outcome of the patient was unknown.  The nurse requested a lot search of VARIVAX (Oka/Merck).  A standard lot check investigation was performed.  All in-process quality checks for the lot number 661658/1135X were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Center of Biologics Evaluation and Research and was released.  This is one of several cases from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female employee who was vaccinated with her second dose of VARIVAX. The patient may have been vaccinated with lot # 61658/1135X. After vaccination, the patient developed swelling, erythema, and fever. The patient sought medical attention at the emergency room. The patient also had a reaction (unspecified) when she received the first dose as well. At the time of reporting (04-DEC-2008) the outcome of the patient was unknown. The nurse requested a lot search of VARIVAX. 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 agency and was released. This is one of several cases from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Information was been received from a medical assistant concerning an approximately 60 year old male patient who on 08-DEC-2008 was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to simple human error. No adverse effects noted. This is one of several reports from the same source. Further information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old female patient who either 2003 or 2004 was vaccinated with the first dose of VARIVAX. In April 2007, the patient was vaccinated with the second dose of VARIVAX. Several days ago, the patient had developed a rash on the back of one leg. The reporter stated that "this is not a reportable adverse event and this could possibly be caused by flea bites". The patient sought medical attention at the office. At the time of reporting the patient was recovering. No further information is available.
Age: 76.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a 76 year old female who on 03-DEC-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) mistakenly instead of ZOSTAVAX (Oka/Merck). It was unknown if the patient sought medical attention. Follow-up information was received on 17-DEC-2008 via phone call from the office manager who confirmed that VARIVAX (Oka/Merck) was given mistakenly instead of ZOSTAVAX (Oka/Merck). The office manager stated that this was a human error. The vaccines were in the freezer and somebody had written on the box "not ZOSTAVAX (Oka/Merck)", but you could not see the "not". The nurse pulled the box thinking that it was ZOSTAVAX (Oka/Merck), but instead it was VARIVAX (Oka/Merck) and did not look at the vial and administered the vaccine. There had not been any adverse events. The lot number of VARIVAX (Oka/Merck) was 661013/0604X. Further information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who on 12-DEC-2008 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (lot #658424/1181U). There was no concomitant medication. It was reported that the patient developed three spots on the left side of her neck on 13-DEC-2008. It was noted that one spot appears like a vesicle while the others just look like red mosquito bites. It was reported that the spots were unchanged since 13-DEC-2008. The patient sought medical attention. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning an 8 year old female who was vaccinated with a first and second dose of VARIVAX (Oka/Merck) (lot # 639435/0789L for dose 1, 654280/1889U for dose 2) in July 2002 and on 24-JUL-2008, respectively.  It was reported that the patient was seen in physician's office on 05-JAN=2008 with a "full blown case of crusted lesions in 3 stages".  The lesions were on patient's face, legs and torso.  As of 06-JAN-2008, the patient was not recovered.  Follow-up information was received which reported that the black female patient who was vaccinated with a first and second dose of VARIVAX (Oka/Merck) (lot # 639435/0789L for dose 1, 654280/1889U for dose 2) SQ into the right arm and the left arm on 07-JAN-2002 and 14-JUL-2008, respectively.  It was report that the patient "break the VARICELLA" in office at 12:00, 05-JAN-2009, and experienced "papules, vesicles and crusted lesion 3 stages suffered over extremities, face and legs".  The patient has recovered within 2 weeks.  No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a healthcare worker concerning a female patient, who on unspecified dates, was vaccinated with two doses of VARIVAX (Oka/Merck). The patient did not seroconvert after administrations of two doses of VARIVAX (Oka/Merck). The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Pruritus, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from a physician and licensed practical nurse concerning a 5 year old female patient who on 25-MAR-2004 was vaccinated with first dose of VARIVAX (Oka/Merck) (Lot # not provided). There was no concomitant medication. In March 2008 (also reported as May 2008), the patient experienced chickenpox. Subsequently, the patient recovered. On 07-JAN-2009, the patient experienced chickenpox again. There were no Laboratory Diagnostics Studies performed. At the time on the report on 07-JAN-2009 patient was not recovered. The patient sought medical attention was seen by the physician. Follow up information has been received from a licensed practical nurse concerning a 5 year old female patient with no pre-existing allergies no birth defects and no medical conditions who on 25-MAR-2009 was vaccinated with first dose of VARIVAX (Oka/Merck) (Lot # not provided) in left thigh. Also on 25-MAR-2004 she received MMR II. Concomitant therapy included HIB (unspecified carrier). On 31-MAY-2008 the patient experienced breakthrough varicella. On 06-JAN-2009 she experienced breakthrough varicella, she developed itch "tear - drop" papules and vesicles on torso, some on face and extremities. On unspecified date the patient was recovered. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 51 year old male patient with Bacitracin and Sulfonamide allergy and no medical history who on 10-Dec-2008 was vaccinated subcutaneously with first 0.5ml dose of VARIVAX (Oka/Merck). There was no concomitant medication. The nurse reported that on 02-Jan-2009 the patient developed chickenpox. The vesicular rash is distributed on his torso, under arms, face, and back of neck. The patient was prescribed oatmeal baths to relieve itchiness. The patient sought medical attention during an office visit. At the time reporting the patient was recovering. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old female twin on 02-JAN-2009 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Oka/Merck) (lot #662455/1329X). There was no concomitant medication. On the same day of the vaccination, 02-JAN-2009, the patient experienced dizziness along with pain and swelling at the injection site after vaccination. The patient called the physician for medical attention. Subsequently, the patient recovered on an unspecified date. Follow-up information was received on 13-JAN-2009. Reporter stated that she was not sure if the patient recovered but noted that the patient had not called for a follow-up visit. This is one of several reports received from the same source. The patient's twin also experienced an adverse experienced following vaccination (WAES # 0901USA01284). Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 24-month-old female who was vaccinated with a 0.5ml dose of VERIVAX (Oka/Merck) (lot # not reported) for prevention of chicken pox. It was reported that the patient experienced shingles after vaccination. The patient sought medical attention. Subsequently, the patient recovered from shingles on an unspecified date. Additional information  been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male child with no pertinent medical history and no drug allergies who on 29-DEC-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # not reported). Subsequently the patient developed a generalized/chickenpox like rash after vaccination. The patient called the office to report the rash on 08-JAN-2009. As of 08-JAN-2009, the patient was not recovered. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse concerning another nurse who in 1990 was vaccinated with VARIVAX (Oka/Merck) (unsure if 1 or 2 doses). And at that time the titer was positive. Recently the nurse was exposed to chickenpox from her husband and had a titer done was negative. Another titer was done which was negative. The nurse never contracted the chickenpox from her husband. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 8 year old female who on 02-JAN-2009 was vaccinated subsequently with a 0.5ml dose of VARIVAX (Oka/Merck) (lot # 662455/1329X). There was no concomitant medication. On the same day of the vaccination, 02-JAN-2009, the patient experienced dizziness along with pain and swelling at the injection site after vaccination. The patient called the physician for medical attention. Subsequently, the patient recovered on an unspecified date. Follow-up information was received on 13-JAN-2009. It was reported the patient was 6 year old. Reporter was not sure if the patient recovered but noted that the patient had not called for a follow-up visit. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old female twin who on 02-Jan-2009 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Oka/Merck) (lot# 662455/1329X). There was no concomitant medication. On the same day of vaccination. 02-Jan-2009, the patient experienced dizziness along with pain and swelling at the injection site after vaccination. The patient called the physician for medical attention. Subsequently, the patient recovered on an unspecified date. Follow-up information was received on 13-Jan-2009. The reporter stated that she was not sure if the patient recovered but noted that the patient had not called for a follow-up visit. This is one of several reports received from the same source. The patient's twin also experienced an adverse experience following vaccination (WAES#0901USA01025). Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Serology negative, Varicella post vaccine
Clinical narrative: Information has been received from a physician and certified medical assistant concerning an 8 year old patient who was vaccinated with two doses of VARICELLA (Oka/Merck) (no lot# provided) 0.5ml. Subsequently the patient developed chicken pox. Patient sought unspecified medical attention. Follow-up information received from a certified medical assistant who mentioned that all the patients that had been involved in the "school outbreak" had serological testing and none of the children had chicken pox; they all had only developed a rash. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health educator concerning a male teenager who on 30-DEC-2008 was vaccinated with VARIVAX (Oka/Merck). Concomitant therapy included MENACTRA. On 11-JAN-2009, 12 days post vaccination with VARIVAX (Oka/Merck), the patient developed redness and swelling at the injection site. The patient had sought medical attention from the school nurse. The patient's redness and swelling at the injection site persisted. No further information is available.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Scab
Clinical narrative: Information has been received from a registered nurse concerning a 43 month old male child who on 05-SEP-2006 was vaccinated subcutaneously in the right arm with a first dose of VARIVAX (Oka/Merck) (Lot #652630/0247F). On 03-JAN-2009 the patient's mother noticed he developed "red areas with white heads" and some had crusted. It was reported that the areas were "already on torso" and the "mid-areas" were near penis and back of the legs. Subsequently, on an unspecified date, the patient had recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Serology negative, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 10 year old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (no lot# provided). Subsequently the patient developed chicken pox. Follow-up information received from a certified medical assistant who mentioned that all the patients that had been involved in the "school outbreak" had serological testing and none of the children had chicken pox: they all had only developed a rash. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning an 8 year old male with no medical history, no known drug allergies who on 18-SEP-2001 was vaccinated 0.5ml SQ with one dose of VARIVAX (Oka/Merck) (lot # 638251/0224L).  There was no concomitant medication.  On 11-JAN-2009 the patient developed "atypical VARICELLA".  The patient had 50 to 80 pruritic lesions on his arms, and ears.  He was still developing additional lesions.  The patient sought medical attention in the office.  The patient's "atypical VARICELLA" persisted.  Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Inflammation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 28 year old female with no allergy who on 22-DEC-2008 was vaccinated with her first dose of VARIVAX (Oka/Merck) (lot# 659723/1659U). On 31-DEC-2008, the patient was seen in the office with swelling and pain at the injection site. The patient was prescribed KEFLEX and ADVIL. In follow-up, the nurse indicated that the patient received the first dose of VARIVAX (Oka/Merck) IM (lot# 659723/1659U) into the deltoid on 22-DEC-2008. She began swelling and "hurting" on 31-DEC-2008 at site of injection. On 02-JAN-2009, the area was tender to touch with 1.5 area of raised, redness, warmth. The patient was prescribed KEFLEX 500mg daily for 7 days on 02-JAN-2009 for inflammatory versus infection. On 09-JAN-2009, the patient recovered. In follow-up, the reporting nurse stated that the patient's adverse events were not serious enough to require medical or surgical intervention to prevent disability or death. None of the experiences should be considered other important medical events, as she misunderstood what this classification meant. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 28 year old female with no allergy who on 22-DEC-2008 was vaccinated with her first dose of VARIVAX (Oka/Merck) (lot# 659723/1659U). On 31-DEC-2008, the patient was seen in the office with swelling and pain at the injection site. The patient was prescribed KEFLEX and ADVIL. In follow-up, the nurse indicated that the patient received the first dose of VARIVAX (Oka/Merck) IM (lot# 659723/1659U) into the deltoid on 22-DEC-2008. She began swelling and "hurting" on 31-DEC-2008 at site of injection. On 02-JAN-2009, the area was tender to touch with 1.5 area of raised, redness, warmth. The patient was prescribed KEFLEX 500mg daily for 7 days on 02-JAN-2009 for inflammatory versus infection. On 09-JAN-2009, the patient recovered. In follow-up, the reporting nurse stated that the patient's adverse events were not serious enough to require medical or surgical intervention to prevent disability or death. None of the experiences should be considered other important medical events, as she misunderstood what this classification meant. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was intended to receive ZOSTAVAX (Oka/Merck), was inadvertently vaccinated S. C with a 0.5 ml dose of VARIVAX (Oka/Merck) on 13-JAN-2009. No problems reported. The nurse practitioner confirmed this was a case of human error and not product confusion. Follow-up information was received from the nursed practitioner who indicated that the patient was inadvertently given VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck). The nurse practitioner grabbed the wrong vaccine and realized it later in the day when she was logging in lot #. The nurse practitioner called the patient and told her what happened. The patient was advised to come back in 28 days to receive ZOSTAVAX (Oka/Merck). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event, Serology negative
Clinical narrative: Information has been received from a nurse concerning a 50 year old female who in 1995 was vaccinated with one dose of VARIVAX (Oka/Merck) (lot# not provided). Subsequently the patient had a negative titer. No adverse effects noted from the negative titer. The patient sought medical attention in the office. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning an unspecified number of patients who on an unspecified date were vaccinated with a dose of VARIVAX (Oka/Merck) instead of a dose of ZOSTAVAX (MSD). No AE was reported. Upon follow-up, the nurse reported that she could not recall the specific number of patients or patient identifiers
Age: 89.0
Sex: M
Vaccine: VARCEL
Symptoms: Biopsy skin abnormal, Serology negative, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 88 year old male who on an unknown date, was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot# not provided). The patient received a titer test which showed that had never had chickenpox. Within a week after vaccination the patient developed full blown chickenpox. He did not have a fever or any other major health risks, but had lesions all over his body and face.  A skin biopsy was performed (result unknown). Subsequently, the patient recovered from full blown chickenpox. Unspecified medical attention was sought. Follow-up information from the physician indicated that the 89 year old (previously reported by the same reporter as 88 year old) patient received his first dose of VARIVAX (Oka/Merck) (lot# 661868/1009X) SQ on 15-DEC-2008. On -05-JAN-2009, the patient developed rash secondary to chickenpox. The skin biopsy was positive for chickenpox. On 14-JAN-2009, the patient recovered from chickenpox. The reporting physician did not consider the chickenpox to be serious. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a school registered nurse who heard of a case concerning a child who was vaccinated with one dose of VARIVAX "as a baby". The child developed shingles "a few years later". The child subsequently fully recovered. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 1.0
Sex: F
Vaccine: FLUN3, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site scab
Clinical narrative: Information has been received from a nurse concerning a 12 month old female who on 22-DEC-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 661006/1321X). Concomitant vaccinations included MMR II and FLUMIST. It was reported that the patient came back to the physician's office on 15-JAN-2009 for an unrelated appointment and told the nurse that immediately after the vaccination, on 22-DEC-2009, the injection site was red, hot and inflamed, and then a day later, on 23-DEC-2008 the injection site was blue. Then 12 days after the vaccination, on 03-JAN-2009 the injection site turned blue a scab formed and the scab was still there on 15-JAN-2009, but there was no pain. No lab tests were performed. As of 15-JAN-2009, the patient was recovering. Follow-up information was received from the physician. On 22-DEC-2008, the patient with no medical history and an drug allergy was vaccinated with a dose of VARIVAX (Oka/Merck) into the left leg and a dose of MMR II into the right leg at 12 month old. There is no illness at time of vaccination. Per patients mother, 12 days later, on 03-JAN-2009 a scab formed at the injection site. The patient was seen on 14-JAN-2009 for an unrelated reason. The scab was still present at that appointment. No other symptoms were present. No lab tests were performed. The physician reported that the patient recovered on an unspecified date. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: FLUN3, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 12 month old female who on 22-DEC-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 661006/1321X). Concomitant vaccinations included MMR II and FLUMIST. It was reported that the patient came back to the physician's office on 15-JAN-2009 for an unrelated appointment and told the nurse that immediately after the vaccination, on 22-DEC-2009, the injection site was red, hot and inflamed, and then a day later, on 23-DEC-2008 the injection site was blue. Then 12 days after the vaccination, on 03-JAN-2009 the injection site turned blue a scab formed and the scab was still there on 15-JAN-2009, but there was no pain. No lab tests were performed. As of 15-JAN-2009, the patient was recovering. Follow-up information was received from the physician. On 22-DEC-2008, the patient with no medical history and an drug allergy was vaccinated with a dose of VARIVAX (Oka/Merck) into the left leg and a dose of MMR II into the right leg at 12 month old. There is no illness at time of vaccination. Per patients mother, 12 days later, on 03-JAN-2009 a scab formed at the injection site. The patient was seen on 14-JAN-2009 for an unrelated reason. The scab was still present at that appointment. No other symptoms were present. No lab tests were performed. The physician reported that the patient recovered on an unspecified date. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Rash maculo-papular, Scab, Scratch
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female patient with no previous medical history reported, who on 04-AUG-2000 was vaccinated with the first dose of VARIVAX 0.5 mL SQ. On 04-APR-2007, the patient was vaccinated with a second dose of VARIVAX (Lot number 656823/0305U) 0.5 mL SQ. There was no concomitant medication. On 15-JAN-2009, the patient developed chickenpox rash after received two doses of VARIVAX. There are 40 lesions on her arm, face and legs. The patient had no fever. The patient's chickenpox rash persisted. The patient sought medical attention, with the physician. Follow up information has been received from a physician concerning a 9 year old female (previously reported as 7 years old) with no pertinent medical history reported, no known allergies and no illness at the time of vaccination, who on 04-AUG-2000 was vaccinated SC with first 0.5mL dose of VARIVAX and on 24-APR-2007, the patient was vaccinated SC with second 0.5mL dose of VARIVAX (Lot number 656823/0305U). There was no concomitant medication. on 16-JAN-2009 the patient was seen at the office and was diagnosed with maculopapular rash on upper extremities, neck and abdomen (previously reported as chickenpox rash). On 17-JAN-2009 the physician called the patient's mother to ask how rash was. The physician reported that the mother told him the rash was fading and there were no new bumps. She also said that a few had a scab from the scratching but that they did not have any drainage and that she had a few marks around her neck, chin, shoulders and panty  line area. The patient recovered from the maculopapular rash on an unknown date. Lab test performed on 16-JAN-2009 included temperature measurement (97.6F Tympanic).
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female patient with no previous medical history reported, who on 04-AUG-2000 was vaccinated with the first dose of VARIVAX 0.5 mL SQ. On 04-APR-2007, the patient was vaccinated with a second dose of VARIVAX (Lot number 656823/0305U) 0.5 mL SQ. There was no concomitant medication. On 15-JAN-2009, the patient developed chickenpox rash after received two doses of VARIVAX. There are 40 lesions on her arm, face and legs. The patient had no fever. The patient's chickenpox rash persisted. The patient sought medical attention, with the physician. Follow up information has been received from a physician concerning a 9 year old female (previously reported as 7 years old) with no pertinent medical history reported, no known allergies and no illness at the time of vaccination, who on 04-AUG-2000 was vaccinated SC with first 0.5mL dose of VARIVAX and on 24-APR-2007, the patient was vaccinated SC with second 0.5mL dose of VARIVAX (Lot number 656823/0305U). There was no concomitant medication. on 16-JAN-2009 the patient was seen at the office and was diagnosed with maculopapular rash on upper extremities, neck and abdomen (previously reported as chickenpox rash). On 17-JAN-2009 the physician called the patient's mother to ask how rash was. The physician reported that the mother told him the rash was fading and there were no new bumps. She also said that a few had a scab from the scratching but that they did not have any drainage and that she had a few marks around her neck, chin, shoulders and panty  line area. The patient recovered from the maculopapular rash on an unknown date. Lab test performed on 16-JAN-2009 included temperature measurement (97.6F Tympanic).
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash, Varicella post vaccine
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who on 10-MAR-1999 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot# not provided)0. On 14-MAR-1999, "4 days after it was given" the patient had 4 small pox at the injection site. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Biopsy bone marrow normal, Granulocytes abnormal, Neutrophil count decreased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a consumer concerning a her 12 month old son with no pertinent medical history and known drug reactions or allergies who on 11-SEP-2007 was vaccinated with VARIVAX (Oka/Merck) (658021/0827U). Concomitant vaccinations on 11-SEP-2007 include MMR II (lot # 654822/0806F), and HAVRIX on in each thigh. On 15-SEP-2007, 4 days after vaccination (also reported as 01-OCT-2007), the patient developed fever. The fever resolved and he was "fine" for 3 days but then on 08-OCT-2007 he developed a fever of 99F-101F for 3 to 4 days. His fever rose to 104F-105F until 18-OCT-2007. While her son was experiencing fever he was treated with MOTRIN and TYLENOL around the clock. He experienced shaking while he had a fever. Around 19-OCT-2007 he was referred for further investigation. He was examined by Infectious disease, Rheumatology and Hematology Department. Laboratory test revealed: White Blood Cell count was low, bone marrow biopsy was normal, sedimentation rate was high, neutrophil count was very low, Anti-neutrophil antibody (results not reported) and absolute neutrophil count was 78. At the time of the report on 19-JAN-2009 the patient was recovering. Patient sought medical attention at the office visit. No further information is available.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Tremor, White blood cell count decreased
Clinical narrative: Information has been received from a consumer concerning a her 12 month old son with no pertinent medical history and known drug reactions or allergies who on 11-SEP-2007 was vaccinated with VARIVAX (Oka/Merck) (658021/0827U). Concomitant vaccinations on 11-SEP-2007 include MMR II (lot # 654822/0806F), and HAVRIX on in each thigh. On 15-SEP-2007, 4 days after vaccination (also reported as 01-OCT-2007), the patient developed fever. The fever resolved and he was "fine" for 3 days but then on 08-OCT-2007 he developed a fever of 99F-101F for 3 to 4 days. His fever rose to 104F-105F until 18-OCT-2007. While her son was experiencing fever he was treated with MOTRIN and TYLENOL around the clock. He experienced shaking while he had a fever. Around 19-OCT-2007 he was referred for further investigation. He was examined by Infectious disease, Rheumatology and Hematology Department. Laboratory test revealed: White Blood Cell count was low, bone marrow biopsy was normal, sedimentation rate was high, neutrophil count was very low, Anti-neutrophil antibody (results not reported) and absolute neutrophil count was 78. At the time of the report on 19-JAN-2009 the patient was recovering. Patient sought medical attention at the office visit. No further information is available.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a bachelor of sciences in nursing concerning a patient who on an unspecified date was inadvertently vaccinated with VARIVAX instead of ZOSTAVAX due to nursing error. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Fear of needles, Incorrect storage of drug, Pain in extremity
Clinical narrative: Information has been received from a physician concerning her ex-husband who was vaccinated IM with VARIVAX (Oka/Merck) (Lot # 659722/1877U).  Also, the vital had been stored in the refrigerator rather than the freezer for the past 2 months.  The ex-husband text- massaged the physician and said his arm hurt.  The physician said, " This is coming from someone who is afraid to even get blood drawn so I don't think it's anything serious."  The ex-husband's employer required documentation of vaccination or to get titers drawn.  He did not have documentation and was afraid to get blood drawn, so he opted to get vaccinated.  The outcome of adverse event was not reported.  It was reported that the patient sought medical attention: text messaged the physician.  No further information is available.
Age: 27.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dry skin, Erythema, Pruritus, Skin lesion
Clinical narrative: Information has been received from a physician assistant concerning a 27 year old male with amoxicillin allergy who on 13-NOV-2008 was vaccinated with his first dose of VARIVAX (Oka/Merck) (lot number 661641/1152X) 0.5ml SQ into his right deltoid. On an unknown date, after receiving vaccination, the patient developed a single lesion on his inner thigh. The patient called to notify the office of the lesion but was not examined at that time. Follow-up information was received from the physician assistant who indicated that no 13-NOV-2008 the patient also was vaccinated with MMR II (lot number 660019/0503X rHa; route not reported) into his left deltoid. On approximately 16-NOV-2008, 3-4 days after injection the patient developed a single lesion on his left inner thigh with area flat, red, dry and itch. The patient recovered on 21-JAN-2009. The second dose of VARIVAX (Oka/Merck) (lot number, route and site not reported) was administered with no repeat of additional lesions. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Rash
Clinical narrative: Information has been received from a physician concerning a male patient under the age of four years who was vaccinated wit ha dose of VARIVAX at about the age of one year. It was reported that the patient recently, "within the last three days," developed a rash. The patient also had an IGG and IGM of zero. The patient had recovered at the time of the report. The patient was seen in office. This is one of several cases from the same source. Additional information has been requested.