chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Drug dispensing error, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who was vaccinated with a dose of VARIVAX (Oka/Merck).  It was reported that the patient was supposed to get ZOSTAVAX (Oka/Merck) and was inadvertently given VARIVAX (Oka/Merck) (MSD) due to dispensing error.  No adverse effect reported.  Follow up information was received on 30-JAN-2009:  the pharmacist stated that the error was made in haste.  It was reported that VARIVAX (Oka/Merck) and ZOSTAVAX (Oka/Merck) looked similar.  It was reported that the pharmacy was more aware of what product they were dispensing.  The patient was fine at the time of the report.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who "one week ago" was vaccinated with a dose of VARIVAX (Oka/Merck). It was reported that on approximately 15-JAN-2009 the patient was given VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck). It was reported that the pharmacy sent the wrong medication to administer to the patient. No adverse reactions reported. Follow up information was received on 28-JAN-2009: the certified medical assistant stated that the mistake was made at the pharmacy. It was reported that the pharmacy gave the male patient (previous gender unspecified) the wrong medicine. It was reported that the VARIVAX (Oka/Merck) and ZOSTAVAX (Oka/Merck) (MSD) come in the same box and are packaged the same way, which causes a lot of confusion. Follow up information was received on 12-FEB-2009 from a certified medical assistant concerning a 74 years old male with acute alcoholic hepatitis, diabetes mellitus, gastritis, duodenitis, hyperlipidemia, obstructive sleep apnea, paralysis agitans patient who on 16-JAN-2009 (previously reported as approximately 15-JAN-2009) was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot #) into his right deltoid at 9:00. There was no adverse event reported. Further information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male patient with no known drug reaction/allergies and no pertinent medical history who on 11-APR-2008 was vaccinated with VARIVAX, 0.5 ml, subcutaneously (Lot # 658593/1329U). There was no concomitant medication. The registered nurse reported that on 21-JAN-2009, the patient experienced developed varicella after administration of the vaccine. He had 50 lesions with a majority on his face and neck. At the time of the report, the patient had not recovered. The patient sought medical attention through telephone. Follow-up information was received from the registered nurse indicating that the patient was a white 6 year old male patient, weighing 45 4/3 pounds and 46 inches in height, with no known drug reaction/allergies and no pertinent medical history, who in the afternoon of 11-APR-2008 was vaccinated with the first dose of VARIVAX (Lot # 658593/1329U), subcutaneously in the left leg. There were no illnesses at the time of vaccination. The registered nurse reported that the patient experienced fever 3 days prior to breaking out. The patient presented lesions on mouth, check, nose, neck and trunk. No treatment needed. The patient sought medical attention at the physician's office. At the time of the report, the patient had recovered. No further information is available.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who was intended to receive ZOSTAVAX (Oka/Merck) (MSD), was inadvertently administered VARIVAX (Oka/Merck) (lot# not reported) on an unspecified date. The physician confirmed this was a case of human error and not product confusion. No adverse symptoms reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a male with no pertinent medical history, allergies or drug reactions who on 05-OCT-1998 was vaccinated with VARIVAX (Oka/Merck) (Lot no. 637876/1241H) 0.5 mL, route and site not reported. It was reported by the physician that the patient experienced shingles. On an unknown date, the patient recovered from shingles. Follow up information has been received from a nurse practitioner on 12-MAR-2009. It was reported that the 11 year old student was vaccinated subcutaneously with a one time 0.5 mL dose of VARIVAX (Oka/Merck) at age 1 year. On an unspecified date, the 11 year old was diagnosed with shingles. On an unknown date, the patient had recovered. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old male patient with no pertinent medical history and no known allergies, who on 02-OCT-1996 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot# 617691/0569D) 0.5 ml. Concomitant therapy included MMR II (lot# 618392/0472D). On approximately 09-JAN-2009 the patient developed shingles. In January-2009 the patient recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 5 year old female patient, who on 18-OCT-2007 was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot ####) in her right arm at 13:30. It was reported that the patient experienced fever, arm was very red and swollen, bruised and 5 cm wide, and was described as "huge". It was reported that the patient was still recovering as of 17-JAN-2009. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 year old male with food allergies including peanuts and no past medical history, who on 21-JUL-2001 was vaccinated with a dose of VARIVAX (lot# 638495/1904K) 0.5 mL. The patient was also vaccinated with a dose of MMR II (lot# 635922/0015L) on an unspecified date. The nurse reported that the patient, after receiving VARIVAX, experienced chicken pox. At time of reporting, the patient had recovered. There were no lab diagnostic studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 4 year old female who on an unknown date was vaccinated with a dose of VARIVAX (Oka/Merck). The nurse reported that the patient had shingles reported by another physician (possibly within the last year). The child was healthy, no immunocompromised conditions. She did recover. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (lot# 661008/1317X). Concomitant therapy included measles-mumps-rubella vaccine (MSD) (Lot# 660275/1255X). Patient experienced injection site swelling. The patient sought unspecified medical attention. Follow up information received on 03-Feb-2009 stated that a phone call was received from the medical assistant, he stated that the patient was given VARIVAX (Oka/Merck) (lot# 661008/1317X) and measles - mumps -rubella vaccine (lot # 660275/1255X) on the right thigh. It was also reported that the patient had localized reaction. Follow up information received on 05-MAR-2009 from a registered nurse stated that it was patient with an allergy to penicillin and no illness at time of vaccination, who on 08-Jan-2009 received the first dose of VARIVAX (Oka/Merck) (lot# 661008/1317X) in the right thigh, The patient also received a second dose of MMR II (lot # 66027/1255X) in the right thigh on 08-Jan-2009. On 20-Jan-2009 the patient experienced mild swelling of right thigh. No laboratories studies performed. It was reported that it was patient's first visit. This is one of 2 reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/15/2009. Follow up information was received from a registered nurse. It was reported that a second dose of VARIVAX (Merck) (route and lot number not reported), was given on the patient's left arm three months after the first dose, on 09-APR-2009. No reactions were noted. This is one of 2 reports from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male patient with asthma who on 19-AUG-2002 was vaccinated with one dose of VARIVAX. ON 24-JAN-2009 the patient developed chicken pox. The child has about 100 lesions and fever. At the time of reporting the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of VARIVAX (lot# 661008/1317X). Concomitant therapy included MMR II (lot # 660275/1255X). Patient experienced injection site swelling. The patient sought unspecified medical attention. Follow up information received on 03-FEB-2009 stated that a phone call was received from the medical assistant, he stated that there was no record of the patient, the patient was not documented and no further information was available. This is one of 2 reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male patient who in approximately 2005 was vaccinated with the first dose of VARIVAX (Lot not reported). The patient received the second dose of VARIVAX (Lot not reported) on 28-JAN-2009. After the second dose of VARIVAX was given, the father's patient reported that the child did have chickenpox "last year" (2008). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a public health nurse concerning a 16 year old female child who in 2004 was vaccinated with her first dose of VARIVAX (Merck) in October 2008. The child developed chickenpox in the first week of January of 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed VALTREX. No further information is available.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old male with no pertinent medical history and no drug reactions/allergies on 23-JAN-2009 was vaccinated with the first dose of VARIVAX 0.5ml SQ on the left arm (LOT# 661979/1276X). There was no concomitant medication. On 25-JAN-2009 the patient developed a couple of red raised spots on the left chest. One was about 1 cm and the other was 2 cm. The patient was not recovered from the adverse event. It was reported that the patient sought medical attention: was seen by primary office. Follow up information was received from the registered nurse who reported that the patient on 23-JAN-2009 10:00 AM was vaccinated with the first dose of VARIVAX 0.5 ml SQ on the left arm (LOT# 661979/1276X). On 25-JAN-2009 unspecified time, the patient developed a rash on his abdomen on his left side which was macupapular in nature (2 areas, 1 about 1cm's, 1 about 2cm in diameter) was seen in occupational health. On 30-JAN-2009, the patient came to health service and stated that he received the Chickenpox vaccine Friday 23-JAN and he noticed a rash on his abdomen Sunday 25-JAN-2009. The patient had a varicella titer drawn last week that showed to immunity. So he received the VARIVAX. The patient denied any other symptoms (no fever, pruritis, etc.) other than a rash on his mid anterior and lateral torso. The patient denied using any new products such as clothing, detergents or lotions and can recall no other possible offending agent. No OTC MEDS requested. The patient was advised to use OTC Benadryl or Cortisone oint PRN and the patient stated did not need anything at this time as he only had rash. It was noted by the health professional at this time that the patient had a 2-3 inch area of dry, red raised 1cm spots on mid anterior abdomen and 1 inch area of same on upper left lateral abdomen. No blisters noted. ALT in skin integrity abdomen R/T rash possibly due to recent VARIVAX. Keep areas clean dry. May use OTC Benadryl or Cortisone oint as instructed. The patient was advised to contact HS if rash increased or new symptom occur. On 30-JAN-2009, the patient reported that his rash was the same except for some mild itching at the lateral site. He reported no other symptoms. Rash appeared same excepted lateral site was a fine papular rash. No drainage. Alteration in skin integrity abdomen related to recent VARIVAX? Continued with OTC cortisone oint PRN. Continue with immunizations/travel health. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 9 year old female who at few years ago was vaccinated injection with VARIVAX (Merck) 0.5ml (LOT# not provided). A few years after receiving VARIVAX (Merck), the patient experienced chicken pox. The patient was not recovered from chicken pox. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of VARIVAX (Merck). Subsequently the patient experienced redness and swelling at the injection site. The patient contacted the office to seek medical attention. This is one of 4 reports from the same source. No further information is available.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with no known allergies or medical history, who on 07-AUG-1997 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (Lot # 623133/0690E) and on 15-JUL-2008 with a second dose of VARIVAX (Merck) (Lot # 661120/0538X) in the right arm and concomitantly on the same date, with Hep A (MSD) (Lot number not provided) on the left arm. The patient developed a hard lump, erythema, and swelling at the injection site on her right arm after administration of her second dose of VARIVAX (Merck) and a dose of Hep A (MSD). The VARIVAX (Merck) was administered in her right arm. The Hep A was administered in her left arm. The patient sought medical attention via telephone. At the time of the report, the patient has not recovered. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old white female who on 25-Aug-2004 was vaccinated SQ with VARIVAX (Oka/Merck) (lot# 64854/0195P), MMR II (MSD), subcutaneous, (Lot# 646886/0949N) and DTAP (Unspecified) IM "reported as manufacturer by Merck" (lot #U272DB). The nurse reported that on 08-Jun-2008 the patient experienced red papules-arms, legs and trunk, less than 50, which was reported by the patient's mother. On 11-Jun-2008 the patient recovered. Additional information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a male patient, who was vaccinated with the first dose of VARIVAX (Oka/Merck) on an unspecified date and received the second dose of VARIVAX (Oka/Merck) (reported as given recently 0488X) in 2008. After receiving the second dose the patient developed injection site reaction, the patient developed redness, warmth and tenderness at the injection site. He was instructed to apply cold compresses to the area. Sought medical attention office visit. Additional information was been requested. The patient's sister also had an adverse experience after vaccination with VARIVAX (Oka/Merck). (WAES # 0807USA04481)
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Dermatitis diaper, Diarrhoea, Irritability, Underdose
Clinical narrative: Information has been received from a medical technician concerning her 18 month old female daughter, with no pertinent medical history and no drug reactions/allergies, who on 16-JUL-2008 was vaccinated with VARIVAX (Merck). There was no concomitant medication. During the administration the child moved, the needle came out of the arm, it was reinserted, the child moved again and about half of the vaccine spilled on the skin. The site was not cleansed but was covered with a band-aid. The following day, on 17-JUL-2008, the patient experienced slight diarrhea with slight diaper rash and was irritable. On 18-JUL-2008, symptoms have resolved. The child is scheduled to have dose at 2 years old. The patient sought medical attention, in office. There was no product quality complaint. No further information is available.
Age: 1.1
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Arthropod bite, Pyrexia, Viral rash
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old male with no relevant medical history and no drug allergy who on 16-JUL-2008 was vaccinated subcutaneously into right arm with 0.5 ml the first dose of VARIVAX (Oka/Merck). Suspect therapy given subcutaneously into the left arm included a first dose of MMR II (Wistar RA 27/3) (MSD). Concomitant therapy subcutaneously into the right arm included the third dose of POLIOVAX (Lot number A0996). Concomitant therapy included tuberculin purified protein derivative. There was no illness at the time of vaccination. 1 to 2 days after the vaccination (on approximately 17-JUL-2008) the patient developed fever. The patient sought medical attention by phone and was seen in the office on 19-JUL-2008. The diagnosis was: mosquito bites, viral exanthema. Therapy was given. No further information is available.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 35 year old female who 15-Mar-2005 was vaccinated with a first dose of VARIVAX (Oka/Merck). On 26-Apr-2005 the patient was vaccinated with a second dose of VARIVAX (Oka/Merck). On an unspecified date VZV antibody titer was preformed and the result indicated it was negative. The event persisted. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a healthcare worker concerning a 19 year old female with no pertinent medical history who on 25-APR-1996 was vaccinated with VARIVAX (Merck). Concomitant therapy included hormonal contraceptives (unspecified). The patient experienced VZV antibody titer was negative. The patient's VZV antibody titer negative persisted. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female teenage patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck). The physician reported that the patient developed shingles 4 times in different areas of the body after receiving the second dose of VARIVAX. The first time that the patient developed shingles was "a couple of days after the 2nd dose of varicella vaccine". The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from an office manager, in physician's office, concerning an office nurse's child who on an unspecified date was vaccinated with VARIVAX (Merck), Lot # not reported. Office manager reported that the child came down with chicken pox after being vaccinated with VARIVAX (Merck). The patient sought medical attention. Follow-up information received from the physician's office indicated they do not know which patient the report is referring to. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site movement impairment, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 8 year old male who on 18-JUN-2008 was vaccinated with the second dose of VARIVAX (Merck). On 19-JUN-2008, the patient developed cellulitis at the injection site. It was also reported that the injection site was very swollen, had a dark a patch on it, and the patient had difficulty moving his arm. This lasted for about two-three days. On approximately 21-JUN-2008, the patient recovered. No further information was provided. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient, who was vaccinated with the first dose of VARIVAX (Merck) on an unspecified date and received the second dose of VARIVAX (Merck) in 2008 (reported as recently) (0488X). After receiving the second dose, the patient developed injection site reaction the patient developed redness, swelling and tenderness at the injection site. The patient's reaction was "worse than her brother". The patient was prescribed antibiotics. Sought medical attention: office visit. Additional information has been requested. The patient's brother also had an adverse experience after vaccination with VARIVAX (Merck). (WAES # 0807USA03815).
Age: 18.0
Sex: F
Vaccine: HPVX, MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Pruritus, Rash papular
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 19-JAN-1998 was vaccinated with the first dose of VARIVAX (Merck). On 03-JUL-2008 at 11:00 AM the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot no. 659935/1900U) into the right arm. At the same time the patient was vaccinated with HPV (MSD), MENACTRA and Tdap. Concomitant therapy included MIRALAX. On 18-JUL-2008 the patient experienced rash. On 21-JUL-2008 the patient was examined in clinic. The patient had no fever. The patient had vesicular and papulovesicular lesions everywhere on scalp, face, trunk and extremities and pruritus. The patient was treated with VALTREX and antihistamines for for pruritus. On 25-JUL-2008 the patient was followed up by phone. The lesions were crusted. No new lesions and no fever. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 23-Jul-2008 was vaccinated with VARIVAX (Oka/Merck). The physician reported that someone in the office gave a patient VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) by mistake. No adverse reaction reported and this was not product confusion. There was no product quality complaint. Follow-up information was received from a medical assistant who reported that the patient is a 66 year old male. She reported that patient was given the wrong vaccine because it was a case of human error and not product confusion and she felt the labeling was clear and sufficient. Additional information has been requested. This is a consolidation of two reports concerning the same patient.
Age: 1.1
Sex: M
Vaccine: FLUX, PNC, VARCEL
Symptoms: Rash papular, Rash pustular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 40 month old male, weight 29.5lb height 35 inches, who on 28-Feb-2006 was vaccinated with VARIVAX (Oka/Merck) (Lot#: 650233/0912R) SQ and (CRM197) PRENVAR (lot#: B08643A) IM and FLUZONE (lot#:B08643A) IM and FLUZONE (lot#: 41804AA) IM. On 23-Jun-2008 the patient developed papular/pustules lesions in trunk, scalp and a few in arms. The patient's outcome was not reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: Information has been received from a physician concerning an 8 year old male with no know allergies who on 01-JUL-2008 at 2 PM was vaccinated subcutaneously with a second dose of VARIVAX (Oka/Merck) (Lot #) in his right deltoid. There was no illness at the time of vaccination. On "30-JUN-2008", in the morning the patient developed local reaction which size was 10 cm times 10 cm. The patient was diagnosed as "cellulitis" and was treated with KEFLEX. At the time of this report, the outcome was known (also reported as the events persisted). Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 9 year old female with no know drug allergies who at 11 AM on 24-JUN-2008 was vaccinated subcutaneously with a second dose of VARIVAX (Oka/Merck) (lot #660277/1893U) in her right deltoid. There was no illness at time of vaccination. In the morning of 25-JUN-2008 the patient experienced local reaction, red area 10 cm times 12 cm in right arm which was diagnosed as cellulitis. KEFLEX was given. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Oka/Merck) over the last six months. The patient developed injection site reaction after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. Follow-up information was received from a registered nurse (R.N.) in the physician's office which reported a 12 month old patient with acoliosis, allergy to "alcohol prep pad", no illness at time of vaccination and no adverse event following prior vaccination who on 05-Feb-1999 was received the first dose of VARIVAX (Oka/Merck) and had shingles after receiving the first dose at 12 months. On 24-Feb-2009 at 4:15 pm the now 11 year old patient was vaccinated SC with the second dose of VARIVAX (Oka/Merck) in the left arm (lot# 662380/1756X). Concomitant therapy at the same time included the first dose of MENACTRA (Lot# U2827CA) given IM into the right thigh and the first dose of BOOSTRIX (lot# AC52BC24DB) given IM into the left thigh. On 25-Feb-2009 in the morning the patient called to the office stating that she experienced swelling with red area at the site of injection on the left arm. The body temperature was 99. On 26-Feb-2009 the patient reported that she still experienced red, hot and itchy with swelling and very tender to touch. The patient's mom was asked to mark borders. On 27-Feb-2009 in the morning the patient's mom called to reported that it was still hot, red (not as/ red) and larger red area on one border, smaller at top border. Office visit was recommended but it was not specified if the patient was seen in the office or not. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Nodule, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a child with no reactions after the first dose of VARIVAX (Oka/Merck) who on approximately 10-JUL-2008, two weeks ago, was vaccinated with the second dose of VARIVAX (Oka/Merck). The patient experienced severe swelling under arm, redness on the arm and nodules. The patient was taken to the emergency room but was not admitted. The patient's severe swelling under arm and redness on the arm and nodules persisted. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Nodule, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a child with no reactions after the first dose of VARIVAX (Oka/Merck) who on approximately 10-JUL-2008, two weeks ago, was vaccinated with the second dose of VARIVAX (Oka/Merck). The patient experienced severe swelling under the arm, redness on the arm and nodules. The patient was taken to the emergency room but was not admitted. The patient's severe swelling under the arm and redness on the arm and nodules persisted. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Oka/Merck) over the last six months. The patient developed injection site reactions after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Nodule, Oedema peripheral, Swelling
Clinical narrative: Information has been received from a physician concerning a child with no reactions after the first dose of VARIVAX (Oka/Merck) who on approximately 10-JUL-2008, two weeks ago, was vaccinated with the second dose of VARIVAX (Oka/Merck). The patient experienced swelling and breathing problems in addition to severe swelling under arm, redness on the arm and nodules. At the time of the report, the patient's adverse experiences persisted. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Crying, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician assistant concerning her approximately 24 month old son with no pertinent medical history nor drug allergies who in approximately 2007 "at 12 months of age" was vaccinated with VARIVAX (Merck) (lot number, dose and therapy route not reported).  There was no concomitant medication.  The reporter mentioned to a representative that the patient developed shingles after receiving VARIVAX (Merck).  On approximately 23-JUL-2008 "two days ago" the patient woke up with 8-10 clusters of lesions on the inside of his thigh.  He had been crying from the pain.  The patient was seen by two physicians, both of whom diagnosed him with shingles.  The patient was prescribed ACYCLOVIR.  As of 25-JUL-2008, the patient was recovering.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Oka/Merck) over the last six months. The patient developed injection site reactions after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated subcutaneously with the second 0.5 ml dose VARIVAX (Oka/Merck) over the last six months. The patient developed injection site reactions after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 23-JUN-1998 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). On 17-JUN-2005 the patient experienced natural chickenpox that they estimated had about 100 pustules over entire body. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of VARIVAX (Oka/Merck). Subsequently the patient experienced redness and swelling at the injection site. The patient contacted the office to seek medical attention. This is one of 4 reports from the same source. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous, Rash macular, Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a female who on 08-JUL-2008 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot # 662294/0715X). On 15-JUL-2008 the patient developed a mild case of chicken pox. The patient's body became itchy with blotches on her legs and red spots on her face. Her chest was itchy but there was no rash on her chest. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 3 year old female who in approximately 2006 (2 years ago) was vaccinated with the first dose of VARIVAX (Oka/Merck). Within one week of receiving the vaccination, the patient experienced 100 lesions of chicken pox on her trunk, arms and face. Subsequently, the patient recovered from chicken pox. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old male with eczema and egg allergy who on 11-JUL-2008 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Oka/Merck) in the right thigh(lot # 659456/1912U). Secondary suspect therapy included MMR II. Other concomitant therapy included PREVNAR and HAVRIX. On 13-JUL-2008 or 14-JUL-2008 the patient developed a rash on his trunk. At the time of this report, the patient's a rash on his trunk persisted. Medical attention was ought via office visit. No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a 14 month old female who on 29-JUN-2005 was vaccinated with a first dose of VARIVAX (Merck) (lot# 648934/0828P) (route and administration site not reported).  On 03-AUG-2005 the patient developed chickenpox.  Subsequently, the patient recovered from chickenpox.  The patient sought medical attention by contacting the office.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning his 4 year old son who "at age of 1", in 2005 was vaccinated with a dose of VARIVAX (Oka/Merck). "Within the past week", in July 2008 the patient experienced shingles. Unspecified medical attention was sought. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old patient who on 19-JUL-2004 was vaccinated with VARIVAX (Oka/Merck). On 14-AUG-2006 the patient developed chickenpox. Subsequently the patient recovered from the chicken pox. The patient was given a second dose of 29-JAN-2008. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an about 7 year old male who on an unspecified date was vaccinated with VARIVAX (Oka/Merck). Subsequently the patient experienced herpes zoster. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Abscess drainage, Injection site erythema, Injection site swelling, Laboratory test abnormal, Skin lesion
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 17 year old female with asthma and no allergy who on 17-JUL-2008 was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot number 660042/1899U) subcutaneously to her right arm and a dose of HAVRIX in the left arm. On 25-AUG-2008, the patient developed red, swollen area on her red right arm at the injection site. The patient went to the doctor's office. ON 28-JUL-2008 the patient developed a 4 and 1/2 by 3 inch area of redness and swelling at the injection site. This area on her arm also contains two draining lesions in the center of redness. Five other lesions were on other unspecified areas of her body. On 29-JUL-2008 the size of redness increased and swelling decreased. Four draining lesions were noted. The primary care physician gave the patient antibiotic and steroids intramuscularly. Oral steroids were also given by PCP. Laboratory test included lesion culture which was no growth. On 30-JUL-2008 the patient's swelling was much improved. On 31-JUL-2008, the swelling resolved and lesions were dry. The patient was seen by PCP, and she no further needed to see PCP unless further issues of concern. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Body temperature, Pyrexia, Skin lesion
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 12 month old male with no relevant medical history or allergies who on 18-JUL-2008, also reported as 10 days ago, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 659457/1913U) subcutaneously in the left arm and a dose of MMR II (lot number 6503X) subcutaneously in the right arm. Concomitant therapy included a dose HAVRIX and a fourth dose of PREVNAR. Subsequently the patient developed vesicles on the body and several lesions on arm and leg. The patient also had a low grade fever (99-100 F). Unspecified medical attention was sought. Subsequently the patient recovered from the events. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: MEN, TTOX, VARCEL
Symptoms: Abdominal pain upper, Hypersensitivity, Oropharyngeal pain, Pyrexia, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with sulfonamide allergy who on 23-JUL-2008 was vaccinated with a dose of VARIVAX (lot number, injection site and route not reported), a dose of Tetanus Toxoid and a dose of Meningococcal vaccine (unspecified) (manufacturer not provided). On 24-JUL-2008 the patient experienced allergic reaction characterized by a 5 inch welt, fever of 101.3 and sore throat. Unspecified medical attention was sought. At the time of reporting, the patient's events persisted. Follow-up information was received from the patient's mother which reported that the welt on the patient's leg went down however she still had a sore throat and a stomach ache. No outcome was reported regarding the patient's fever. Additional information information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a licensed practical nurse and a consumer concerning a 12 year old female twin who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck) and was well tolerated. On 06-AUG-2008, was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 661445/0525x). On 06-AUG-2008, received the fifth dose of ADACEL (Lot # C2995AA), a dose of VAQTA (LOT # AHAVB243AA OKA/MERCK) and a dose of GARDASIL (lot # 659435/1265U OKA/MERCK) and a dose of (LOT # 4254AA MENACTRA). On 07-AUG-2008, the patient experienced redness, itching and swelling at the injection site. The patient may have also experienced fever and/or pain and burning while getting injected with the vaccine. On 09-AUG-2008, the patient recovered. The reporter has requested a lot check due the vaccine. On 09-AUG-2008, the patient recovered. The reporter has requested a lot check due the patients having adverse experiences. The patient sought medical attention by calling the office. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The met the requirements of the government and was released. This is one of several reports provided by the same source. The patient's twin also experienced adverse events (WAES# 0808USA03477). No additional information is expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse and a consumer concerning a 12 year old female twin who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck) and was well tolerated. On 06-AUG-2008, was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 661445/0525x). On 06-AUG-2008, received the fifth dose of ADACEL (Lot # C2995AA), a dose of VAQTA (LOT # AHAVB243AA OKA/MERCK) and a dose of GARDASIL (lot # 659435/1265U OKA/MERCK) and a dose of (LOT # 4254AA MENACTRA). On 07-AUG-2008, the patient experienced redness, itching and swelling at the injection site. The patient may have also experienced fever and/or pain and burning while getting injected with the vaccine. On 09-AUG-2008, the patient recovered. The reporter has requested a lot check due the vaccine. On 09-AUG-2008, the patient recovered. The reporter has requested a lot check due the patients having adverse experiences. The patient sought medical attention by calling the office. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The met the requirements of the government and was released. This is one of several reports provided by the same source. The patient's twin also experienced adverse events (WAES# 0808USA03477). No additional information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 year old female patient who was vaccinated with a second dose of VARIVAX (Oka/Merck) (dose, route, and date not reported) and developed a severe injection site reaction the same day. The patient developed a knot underneath the skin at the injection site and the site was red and warm to the touch. The patient sought unspecified medical attention. There was no fever and the adverse reaction resolved within 48 hours. The patient took over the counter ibuprofen. The patient had no reaction following the first dose of VARIVAX (Oka/Merck). No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning an adult female who on 23-JUL-2008 was vaccinated inadvertently with a dose of VARIVAX (Oka/Merck) instead of a dose of ZOSTAVAX (Oka/Merck). No problems were reported. The healthcare worker confirmed that this was human error and not product confusion. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a licensed practical nurse and a consumer concerning a 11 year old white female twin who on 06-AUG-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 661445/0525X).  On the same day, the patient received a dose of GARDASIL (lot # 659435/1265U), left deltoid, received a dose of VAQTA (lot # AHAVB243AA), the patient was vaccinated also with the fifth dose of ADACEL (lot # C2995AA) and received with a dose of MENACTRA, (lot # 42544AA).  On 07-AUG-2008, the patient experienced redness in left arm, pain and swelling at the injection site.  The patient may have also experienced fever and/or itching and burning while getting injected with the vaccine.  On 09-AUG-2008, the patient recovered.  The reporter has requested a lot check due the patients having adverse experiences.  The patient sought medical attention by calling the office.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question 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 for Biologics Evaluation and Research and was released.  This is one of several reported provided by the same source.  The patient's twin also experienced adverse events.  (WAES# 0808USA03476).  No additional information is expected.