chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a registered nurse concerning two patients who were vaccinated with a dose of VARIVAX. Concomitant therapy included influenza virus vaccine (unspecified). The two patient developed anaphylactic reaction and were both sent to the emergency room for treatment. It was noted that the above information was on a fax that the office received from the another hospital. The two patients not patients from this office. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. The event was considered an other medical event by the reporter. This is one report of several from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of asthma and no drug reactions or allergies who on 15-OCT-2007 was vaccinated with VARIVAX (Oka/Merck) (Lot #658061/1092U). Concomitant therapy included ADVAIR and albuterol. The patient reported that on the "next day", 16-OCT-2007, she had shortness of breath and a small bump at the injection site. The "next day" 17 OCT 2007 that patient had a large, red, hot bump at the injection site. Later that same day the patient reported having trouble breathing, and her arms and legs "felt funny". She was subsequently rushed to the emergency room (ER), where she was administered IV BENADRYL and an aerosol treatment. There was no product quality complaint. Follow up information was received from a registered nurse who reported that the patient received the IV BENADRYL in the ambulance. The patient was not admitted to the hospital, but received unspecified treatment in the emergency room. The nurse reported that the hospital discharge summary stated "allergic reaction". The event of "allergic reaction", requiring intervention enroute to the hospital, was considered as an other medically important event (OME). No further information is expected. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Sensory disturbance
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of asthma and no drug reactions or allergies who on 15-OCT-2007 was vaccinated with VARIVAX (Oka/Merck) (Lot #658061/1092U). Concomitant therapy included ADVAIR and albuterol. The patient reported that on the "next day", 16-OCT-2007, she had shortness of breath and a small bump at the injection site. The "next day" 17 OCT 2007 that patient had a large, red, hot bump at the injection site. Later that same day the patient reported having trouble breathing, and her arms and legs "felt funny". She was subsequently rushed to the emergency room (ER), where she was administered IV BENADRYL and an aerosol treatment. There was no product quality complaint. Follow up information was received from a registered nurse who reported that the patient received the IV BENADRYL in the ambulance. The patient was not admitted to the hospital, but received unspecified treatment in the emergency room. The nurse reported that the hospital discharge summary stated "allergic reaction". The event of "allergic reaction", requiring intervention enroute to the hospital, was considered as an other medically important event (OME). No further information is expected. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Allergy to vaccine, Chest pain, Dyspnoea, Erythema, Feeling abnormal
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of asthma and no drug reactions or allergies who on 15-OCT-2007 was vaccinated with VARIVAX (Oka/Merck) (Lot #658061/1092U). Concomitant therapy included ADVAIR and albuterol. The patient reported that on the "next day", 16-OCT-2007, she had shortness of breath and a small bump at the injection site. The "next day" 17 OCT 2007 that patient had a large, red, hot bump at the injection site. Later that same day the patient reported having trouble breathing, and her arms and legs "felt funny". She was subsequently rushed to the emergency room (ER), where she was administered IV BENADRYL and an aerosol treatment. There was no product quality complaint. Follow up information was received from a registered nurse who reported that the patient received the IV BENADRYL in the ambulance. The patient was not admitted to the hospital, but received unspecified treatment in the emergency room. The nurse reported that the hospital discharge summary stated "allergic reaction". The event of "allergic reaction", requiring intervention enroute to the hospital, was considered as an other medically important event (OME). No further information is expected. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Muscular weakness, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of asthma and no drug reactions or allergies who on 15-OCT-2007 was vaccinated with VARIVAX (Oka/Merck) (Lot #658061/1092U). Concomitant therapy included ADVAIR and albuterol. The patient reported that on the "next day", 16-OCT-2007, she had shortness of breath and a small bump at the injection site. The "next day" 17 OCT 2007 that patient had a large, red, hot bump at the injection site. Later that same day the patient reported having trouble breathing, and her arms and legs "felt funny". She was subsequently rushed to the emergency room (ER), where she was administered IV BENADRYL and an aerosol treatment. There was no product quality complaint. Follow up information was received from a registered nurse who reported that the patient received the IV BENADRYL in the ambulance. The patient was not admitted to the hospital, but received unspecified treatment in the emergency room. The nurse reported that the hospital discharge summary stated "allergic reaction". The event of "allergic reaction", requiring intervention enroute to the hospital, was considered as an other medically important event (OME). No further information is expected. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Peak expiratory flow rate
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of asthma and no drug reactions or allergies who on 15-OCT-2007 was vaccinated with VARIVAX (Oka/Merck) (Lot #658061/1092U). Concomitant therapy included ADVAIR and albuterol. The patient reported that on the "next day", 16-OCT-2007, she had shortness of breath and a small bump at the injection site. The "next day" 17 OCT 2007 that patient had a large, red, hot bump at the injection site. Later that same day the patient reported having trouble breathing, and her arms and legs "felt funny". She was subsequently rushed to the emergency room (ER), where she was administered IV BENADRYL and an aerosol treatment. There was no product quality complaint. Follow up information was received from a registered nurse who reported that the patient received the IV BENADRYL in the ambulance. The patient was not admitted to the hospital, but received unspecified treatment in the emergency room. The nurse reported that the hospital discharge summary stated "allergic reaction". The event of "allergic reaction", requiring intervention enroute to the hospital, was considered as an other medically important event (OME). No further information is expected. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a health care professional from a pediatric office concerning a 15-year-old female with asthma who on 15-OCT-2007 at 16:45 was vaccinated subcutaneously in the right upper arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). There was no illness at the time of vaccination. On 16-OCT-2007, the patient experience/developed a little bump at the injection site and shortness of breath (SOB). On the morning of 17-OCT-2007 the patient woke with her arm red and swollen. It was reported that she called her mother from school due to SOB, weak arms and legs, and "feeling funny". EMS was called, aerosol and IV Benadryl were given. The patient visited the ER and received Solu-Medrol. Oral prednisone, Advair inhaler and Benadryl were prescribed through the ER. Also, 11 cm erythema was reported at the injection site and reported as cellulitis for which the patient received Bactrim. As of 18-OCT-2007, the patient still felt as though she could not breathe. She complained of substernal chest pain. Her peak flow was reported as 250. On examination, per physician, there was no distress, 6"X6" erythema at the injection site, no induration, range of motion was "good", lungs were moving air well, no wheezing was reported. The physician diagnosed with an allergic reaction to varicella virus vaccine live (Oka/Merck). The physician changed Advair inhaler to budesonide (MSD) inhaler, albuterol Q4h, prednisone 40 mg daily for 4 days, Bactrim was discontinued and montelukast sodium (MSD) was started, 10 mg daily. It was reported that the patient recovered on an unspecified date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Sensory disturbance
Clinical narrative: Information has been received from a health care professional from a pediatric office concerning a 15-year-old female with asthma who on 15-OCT-2007 at 16:45 was vaccinated subcutaneously in the right upper arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). There was no illness at the time of vaccination. On 16-OCT-2007, the patient experience/developed a little bump at the injection site and shortness of breath (SOB). On the morning of 17-OCT-2007 the patient woke with her arm red and swollen. It was reported that she called her mother from school due to SOB, weak arms and legs, and "feeling funny". EMS was called, aerosol and IV Benadryl were given. The patient visited the ER and received Solu-Medrol. Oral prednisone, Advair inhaler and Benadryl were prescribed through the ER. Also, 11 cm erythema was reported at the injection site and reported as cellulitis for which the patient received Bactrim. As of 18-OCT-2007, the patient still felt as though she could not breathe. She complained of substernal chest pain. Her peak flow was reported as 250. On examination, per physician, there was no distress, 6"X6" erythema at the injection site, no induration, range of motion was "good", lungs were moving air well, no wheezing was reported. The physician diagnosed with an allergic reaction to varicella virus vaccine live (Oka/Merck). The physician changed Advair inhaler to budesonide (MSD) inhaler, albuterol Q4h, prednisone 40 mg daily for 4 days, Bactrim was discontinued and montelukast sodium (MSD) was started, 10 mg daily. It was reported that the patient recovered on an unspecified date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Allergy to vaccine, Chest pain, Dyspnoea, Erythema, Feeling abnormal
Clinical narrative: Information has been received from a health care professional from a pediatric office concerning a 15-year-old female with asthma who on 15-OCT-2007 at 16:45 was vaccinated subcutaneously in the right upper arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). There was no illness at the time of vaccination. On 16-OCT-2007, the patient experience/developed a little bump at the injection site and shortness of breath (SOB). On the morning of 17-OCT-2007 the patient woke with her arm red and swollen. It was reported that she called her mother from school due to SOB, weak arms and legs, and "feeling funny". EMS was called, aerosol and IV Benadryl were given. The patient visited the ER and received Solu-Medrol. Oral prednisone, Advair inhaler and Benadryl were prescribed through the ER. Also, 11 cm erythema was reported at the injection site and reported as cellulitis for which the patient received Bactrim. As of 18-OCT-2007, the patient still felt as though she could not breathe. She complained of substernal chest pain. Her peak flow was reported as 250. On examination, per physician, there was no distress, 6"X6" erythema at the injection site, no induration, range of motion was "good", lungs were moving air well, no wheezing was reported. The physician diagnosed with an allergic reaction to varicella virus vaccine live (Oka/Merck). The physician changed Advair inhaler to budesonide (MSD) inhaler, albuterol Q4h, prednisone 40 mg daily for 4 days, Bactrim was discontinued and montelukast sodium (MSD) was started, 10 mg daily. It was reported that the patient recovered on an unspecified date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Muscular weakness, Oedema peripheral
Clinical narrative: Information has been received from a health care professional from a pediatric office concerning a 15-year-old female with asthma who on 15-OCT-2007 at 16:45 was vaccinated subcutaneously in the right upper arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). There was no illness at the time of vaccination. On 16-OCT-2007, the patient experience/developed a little bump at the injection site and shortness of breath (SOB). On the morning of 17-OCT-2007 the patient woke with her arm red and swollen. It was reported that she called her mother from school due to SOB, weak arms and legs, and "feeling funny". EMS was called, aerosol and IV Benadryl were given. The patient visited the ER and received Solu-Medrol. Oral prednisone, Advair inhaler and Benadryl were prescribed through the ER. Also, 11 cm erythema was reported at the injection site and reported as cellulitis for which the patient received Bactrim. As of 18-OCT-2007, the patient still felt as though she could not breathe. She complained of substernal chest pain. Her peak flow was reported as 250. On examination, per physician, there was no distress, 6"X6" erythema at the injection site, no induration, range of motion was "good", lungs were moving air well, no wheezing was reported. The physician diagnosed with an allergic reaction to varicella virus vaccine live (Oka/Merck). The physician changed Advair inhaler to budesonide (MSD) inhaler, albuterol Q4h, prednisone 40 mg daily for 4 days, Bactrim was discontinued and montelukast sodium (MSD) was started, 10 mg daily. It was reported that the patient recovered on an unspecified date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Peak expiratory flow rate
Clinical narrative: Information has been received from a health care professional from a pediatric office concerning a 15-year-old female with asthma who on 15-OCT-2007 at 16:45 was vaccinated subcutaneously in the right upper arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). There was no illness at the time of vaccination. On 16-OCT-2007, the patient experience/developed a little bump at the injection site and shortness of breath (SOB). On the morning of 17-OCT-2007 the patient woke with her arm red and swollen. It was reported that she called her mother from school due to SOB, weak arms and legs, and "feeling funny". EMS was called, aerosol and IV Benadryl were given. The patient visited the ER and received Solu-Medrol. Oral prednisone, Advair inhaler and Benadryl were prescribed through the ER. Also, 11 cm erythema was reported at the injection site and reported as cellulitis for which the patient received Bactrim. As of 18-OCT-2007, the patient still felt as though she could not breathe. She complained of substernal chest pain. Her peak flow was reported as 250. On examination, per physician, there was no distress, 6"X6" erythema at the injection site, no induration, range of motion was "good", lungs were moving air well, no wheezing was reported. The physician diagnosed with an allergic reaction to varicella virus vaccine live (Oka/Merck). The physician changed Advair inhaler to budesonide (MSD) inhaler, albuterol Q4h, prednisone 40 mg daily for 4 days, Bactrim was discontinued and montelukast sodium (MSD) was started, 10 mg daily. It was reported that the patient recovered on an unspecified date. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Herpes zoster, Malaise, Pyrexia, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 5 year old female with bilateral sensory-neural hearing loss and a history of neuroblastoma (May 2004; treated with chemotherapy; October 2004 thru November 2004), "rejection" (August 2004), and no known allergies, who was vaccinated with VARIVAX (Oka/Merck). On 11-OCT-2007, she developed malaise and fever with a maximum temperature of 38.7 and was hospitalized with herpes zoster. The herpes zoster dermatone was reported as the right ophthalmic branch of the trigeminal nerve with lesions on her forehead, scalp, and eyelid. Diagnostics included VARIVAX identification scrapings. The samples were collected on 18-OCT-2007 from a vesicle on her right scalp and right forehead (results not reported). Treatment included acyclovir. As of this report, it was reported that she was still recovery. A product quality complaint was not reported. No further was available. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify VZV was present and if is was present to identify if it was associated with the wild type VZV strain or with the Oka/Merck VZV strain. Follow up information indicated that the PCR results from the vesicle on her right scalp and right forehead identified the presence of WT VZV. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blister, Blood immunoglobulin G decreased, CD4 lymphocytes decreased
Clinical narrative: Information has been received concerning a 17 month old male with t-cells, intestinal dysmotility, abnormal IgG levels (not known pre-vaccination), failure to thrive, who on 21-SEP-2007, was vaccinated with VARIVAX. Concomitant vaccination included MMR. On 06-OCT-2007, he had developed 5-6 scattered papules (1-2 vesicles). Diagnostics on 06-Oct-2007 included: blood (CD3-CD4+) helper/inducer T-cell lymphocyte count (29%), serum aspartate aminotransferase test (541), serum alanine aminotransferase test (380), blood helper/inducer cell lymphocyte count (190; 16%), serum immunoglobulin G test 175, and direct fluorescent antibody absorption test (positive) varicella zoster> Subsequently, on 12-OCT-2007, he was hospitalized and therapy with acyclovir was instituted. It was reported that a swab was received 13-Oct-2007, and that the lab had re-read the specimen and reported that the direct fluorescent antibody absorption test was negative for varicella zoster virus. The result of the varicella zoster virus strain identification was vaccine strain. Current patient status was not reported. No product quality complaint was reported. No further information was available. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, T-lymphocyte count abnormal, Varicella zoster serology negative
Clinical narrative: Information has been received concerning a 17 month old male with t-cells, intestinal dysmotility, abnormal IgG levels (not known pre-vaccination), failure to thrive, who on 21-SEP-2007, was vaccinated with VARIVAX. Concomitant vaccination included MMR. On 06-OCT-2007, he had developed 5-6 scattered papules (1-2 vesicles). Diagnostics on 06-Oct-2007 included: blood (CD3-CD4+) helper/inducer T-cell lymphocyte count (29%), serum aspartate aminotransferase test (541), serum alanine aminotransferase test (380), blood helper/inducer cell lymphocyte count (190; 16%), serum immunoglobulin G test 175, and direct fluorescent antibody absorption test (positive) varicella zoster> Subsequently, on 12-OCT-2007, he was hospitalized and therapy with acyclovir was instituted. It was reported that a swab was received 13-Oct-2007, and that the lab had re-read the specimen and reported that the direct fluorescent antibody absorption test was negative for varicella zoster virus. The result of the varicella zoster virus strain identification was vaccine strain. Current patient status was not reported. No product quality complaint was reported. No further information was available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of VARIVAX. On approximately 27-AUG-2007 the patient experienced a bad allergic reaction to the vaccination and was hospitalized. The patient was administered EPINEPHRINE. At the time of the report the patient's status was unknown. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Myelitis transverse
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with VARIVAX, and subsequently developed transverse myelitis. The patient was transferred to a children's rehabilitation facility. The reporting physician noted that the patient's parents had reported "that the physicians thought that it was related to VARIVAX. "The physician noted they have been unable to confirm this. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 46-month-old male with no pertinent medical history or allergies who on 16-APR-2005 was vaccinated in his left thigh with his first dose of VARIVAX (Oka/Merck) (Lot # 648305/0826P). It was unknown if there were any illnesses at the time of vaccination. On 16-APR-2005 concomitant vaccinations included a fourth dose of DTaP 9+ tetanus toxoid (Aventis) (Lot # C2184AA) administered in his left thigh and a third dose of PREVNAR (Wyeth) (Lot # A67185H) administered in his right thigh. On 18-AUG-2007 the patient developed numerous vesicles on his legs and trunk. The patient was prescribed with ZOVIRAX 400 mg three times a day for five days. The patient received from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES#0708USA05829) experienced an adverse event. This is one of several reports received from the same source. Further information is not expected.
Age: 11.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an 11-year-old male with no pertinent medical history or allergies who on 20-FEB-2007 was vaccinated in his left thigh with his first dose of VARIVAX (Oka/Merck) (Lot # 612219/1352D). It was unknown if there were any illnesses at the time of vaccination. On 20-FEB-1997 concomitant vaccination in the right thigh included a first dose of MMR II (Lot # 619799/0997D). On 23-JUL-2007 the patient developed 1 lesion on his abdomen. The patient was treated with ZOVIRAX 800 mg twice a day for 5 days. No diagnostic labs were performed. The patient recovered from the adverse event on 29-AUG-2007. The event was considered to be an other important medical event by the reporter. It was noted that the patient's brother (WAES#0709USA03363) experienced an adverse event. This is one of several reports received from the same source. Further information is not expected.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Ocular hyperaemia, Pharyngolaryngeal pain, Stevens-Johnson syndrome
Clinical narrative: Information has been received from a physician concerning an approximately 25 year old male patient who is a medical student and was vaccinated on 21-SEP-2007 with VARIVAX (Lot #655065/1142F, expiration date 28-SEP-2008).  On 23- or 24-SEP-2007, the patient telephoned the physician and reported that he had developed a sore throat and eye redness.  Initially, it was reported that the patient developed symptoms 10-11 days after receiving VARIVAX.  The patient was hospitalized with a mild-to-moderate case of Stevens-Johnson syndrome.  The physician reported that the patient had fully recovered.  There was no product quality complaint.  Upon internal review Stevens-Johnson syndrome was determined to be an other important medical event.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning his 5 year old daughter who in 2007 was vaccinated with a second VARIVAX (Oka/Merck). The father reported that "the child had absolutely no health problems" until October 2007, when his daughter "began having seizures for no apparent reason" three weeks after receiving the second dose VARIVAX. According to the father, "neurologically she appears to be fine." The father noted that their neurological group "has done every test possible with no negative findings. The neurology group can find nothing abnormal with the child, but she continues to be medicated (not specified) which makes the situation worse." Upon internal review, the reported event, seizures, was determined to be an other important medical event. Follow up from the physician's practice indicated that they did not know what patient this event was in reference to, and were unable to provide additional information. Additional information is not expected.
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a woman in a pediatric office concerning a 39-month-old female with no pre-existing allergies, birth defects or medical conditions who on 28-APR-2006 was vaccinated subcutaneously in the left tricep with a dose of varicella virus vaccine live (Oka/Merck) (lot# 652722/1127R). There was no illness at the time of vaccination. On 05-JAN-2008, the patient developed a chickenpox rash "for 2 days"; however, it was reported that the patient recovered on 15-JAN-2008. It was not specified if medical attention was sought. No relevant diagnostic test or laboratory data were performed. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Varicella
Clinical narrative: Information has been received from a health professional concerning a 5 year old male with no known drug allergies and no pertinent medical history who on 06-NOV-2007, was vaccinated with a second 0.5 cc subcutaneous dose of VARIVAX (Oka/Merck) (lot# 658424/1181U).  There was no concomitant medication.  On 30-JAN-2008, the patient, developed breakthrough chickenpox with vesicles on unspecified areas.  No laboratory studies were done.  His vaccination history included on 14-JAN-2004, a first dose of VARIVAX (Oka/Merck).  It was indicated that at the time of this report, the patient was recovering.  A product quality complaint was not reported.  This report is one of two reports from the same source.  Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Serology negative
Clinical narrative: Information has been received from a health care worker concerning a male with no known allergies and no pertinent medical history who on an unspecified date, was vaccinated with VARIVAX (Oka/Merck).  The reporter indicated that that patient's "IgG" and "IgM" titers were negative after receiving a dose of VARIVAX (Oka/Merck).  The patient was seen by the physician.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 06-FEB-2008 was administered varicella vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No symptoms were reported. The physician stated that "this was not production confusion, rather the wrong product was ordered". Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning a female in her 40's who was vaccinated with two doses varicella virus vaccine live (Oka/Merck) and remains VZV seronegative. At the time of the report the patient's status was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who "4 years ago" (2004) was vaccinated with varicella virus vaccine live (Oka/Merck). It was indicated that 1 year ago (2007), the patient developed shingles and recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female who was scheduled to receive ZOSTAVAX (Oka/Merck) inadvertently received VARIVAX (Oka/Merck).  The patient was not experiencing any known symptoms.  A product quality complaint was not reported.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Information has been received from a pharmacist concerning a 64 year old male, weight 118.4 kg, who on the morning of 25-FEB-2008 was scheduled to receive ZOSTAVAX (Oka/Merck) but inadvertently received VARIVAX (Oka/Merck) (MSD) subcutaneously.  The patient was not experiencing any known symptoms.  A product quality complaint was not reported.  Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Malaise, Rash papular, Scab
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 25-JUN-2007 was vaccinated with a second subcutaneous dose in the left arm of VARIVAX (Oka/Merck) (lot#656997/0336U).  On 13-DEC-2007 the patient presented to the physicians office after the previous day (12-DEC-2007) he felt a little sick, and then the patients mother noticed a couple pimply looking lesions on his chest and a few more on his back.  On physical examination the physician indicated that the patient's pharynx was clear.  His skin had a total of 10 to 12 lesions that were very typical for chicken pox.  They were a pink base with a small red papule in the middle with a vesicle in the middle of that.  Some the vesicles were intact.  There was a classic one on the patient's back which had an unroofed vesicle with a tiny scab over top.  The physician's diagnosis was post vaccine chicken pox.  The physician instructed the patient's mother to watch for any signs and symptoms and to report them to the physician in case the physician needed to change his mind about the patient's diagnosis.  The physician felt that this was a case of vaccination failure.  On an unreported date the patient had recovered.  The patient's vaccination history included on 11-JUN-2002, a first dose of VARIVAX (Oka/Merck) (lot number reported as "not legible on patient record").  A product quality complaint was not reported.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Follow-up information received indicated that there was no additional information.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Vaccination failure, Varicella
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 25-JUN-2007 was vaccinated with a second subcutaneous dose in the left arm of VARIVAX (Oka/Merck) (lot#656997/0336U).  On 13-DEC-2007 the patient presented to the physicians office after the previous day (12-DEC-2007) he felt a little sick, and then the patients mother noticed a couple pimply looking lesions on his chest and a few more on his back.  On physical examination the physician indicated that the patient's pharynx was clear.  His skin had a total of 10 to 12 lesions that were very typical for chicken pox.  They were a pink base with a small red papule in the middle with a vesicle in the middle of that.  Some the vesicles were intact.  There was a classic one on the patient's back which had an unroofed vesicle with a tiny scab over top.  The physician's diagnosis was post vaccine chicken pox.  The physician instructed the patient's mother to watch for any signs and symptoms and to report them to the physician in case the physician needed to change his mind about the patient's diagnosis.  The physician felt that this was a case of vaccination failure.  On an unreported date the patient had recovered.  The patient's vaccination history included on 11-JUN-2002, a first dose of VARIVAX (Oka/Merck) (lot number reported as "not legible on patient record").  A product quality complaint was not reported.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Follow-up information received indicated that there was no additional information.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 11 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #658059/0838U). Subsequently, the patient experienced abnormal swelling and abnormal redness at injection site. The patient's outcome was not reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 14 year old patient who was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot #658059/0838U).   Subsequently the patient experienced abnormal swelling and abnormal redness at injection site.  The patient's outcome was not reported.  Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old patient who was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot #658059/0383U).  Subsequently the patient experienced abnormal swelling and abnormal redness at injection site.  The patient's outcome was not reported.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacy intern concerning an adult patient that received VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck).  He had received the notification from another office, didn't know exactly what happened, and had little information.  He did not know if it was due to human error.  To his knowledge, the patient did not experience symptoms.  No product quality complaint was reported.  Upon followup, the file on the case was pulled and the reporter stated that no further information was available and she had no way of obtaining additional information".  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old male with a history of respiratory syncytial virus infection (RSV) in which he was hospitalized for on 18-NOV-2006 and discharged on 19-NOV-2006, who on 23-AUG-2007 was vaccinated subcutaneous in the left arm with 0.5 ml dose of VARIVAX (Oka/Merck) (lot # 658177/1012U).  On 05-SEP-2007 the patient developed a few vesicles filled with yellow fluid.  At the time of the report the patient's status was unknown.  The patient's vaccination records indicated the patient received 2 doses of IPOL (07-FEB-2007 and 11-APR-2007), 2 doses of DTP (17-JAN-2007 and 09-MAY-2007) and 2 doses of ACTHIB (2006 and 11-APR-2007).  It was also reported the patient's sibling had an adverse experience WAES # 0708USA04004.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of VARIVAX (Oka/Merck).  Subsequently the patient experienced an injection site reaction.  The patient's sought unspecified medical attention.  The patient's status was reported as "improved after a couple of days".  There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report.  Additional information will be provided if available.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. this is on of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old patient who on 30-AUG-2001 was vaccinated with VARIVAX (Oka/Merck).  On 23-MAR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Age: 0.5
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a county health professional concerning a 6 month old male who on 15-JAN-1998 was vaccinated with VARIVAX (Oka/Merck).  On 24-MAR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old male who on 10-AUG-2004 was vaccinated with varicella virus vaccine live (Oka/Merck). On 26-MAR-2007, the patient developed varicella < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the country health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is on of 28 reports received from the same source. No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning a 9 year old female who on 17-JUL-2000 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-FEB-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.2
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old patient who on 12-Jan-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 12-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). this is one of 28 reports received from the same source. No further information is available.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old male who on 22-JUL-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 08-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old male who on 23-JAN-2002 was vaccinated with VARIVAX (Oka/Merck).  On 26-FEB-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 6 year old male who on 25-OCT-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 26-MAY-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning an 8 year old male who on 29-JUL-1999 was vaccinated with VARIVAX (Oka/Merck).  On 08-APR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a county health registered nurse concerning an 8 year old male who on 02-OCT-2002 was vaccinated with VARIVAX (Oka/Merck).  On 08-APR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 7 year old female who on 12-MAR-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 05-APR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical school nurse concerning a 7 year old female, with no pertinent medical history, drug reactions or allergies, who on 12-MAR-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 06-APR-2007, the patient developed a few spots of chickenpox. At the time of reporting the patient was not recovered. Unspecified medical attention was sought. There was no product quality complaint.