chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who in approximately August 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#658000/0845U). On 07-AUG-2007, the patient developed injection site pain and swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Varicella zoster serology negative
Clinical narrative: Information has been received from a certified medical assistant concerning a 31 year old female who on 10-OCT-2005 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#649739/0121R). Subsequently, on an unspecified date the patient received a second dose of varicella virus vaccine live (Oka/Merck). The patient had positive titers in 2005, but now the patient presented with low antibody titers. Unspecified medical attention was sought. No adverse events were reported. No further information was provided. There was no product complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient had a low antibody titer following two doses of varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. Antibody titer determination studies were performed, and the results were low. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Hypersensitivity, Swelling face, Throat irritation
Clinical narrative: Information has been received from a physician concerning a 12 year old 25 kg patient who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a dose of Menactra. Subsequently, the patient developed an unspecified allergic reaction. The patient was treated with a one time dose of Orapred 45 mg. No further information was provided. There was no product quality complaint involved. Follow up information has been received from another health care professional concerning this 12 year old male with cellulitis and a latex allergy who was vaccinated SC in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658018/1007U) on 28-AUG-2007. Fifteen minutes after vaccination the patient had facial swelling and throat irritation. Unspecified medical attention was sought. On an unspecified date the patient recovered. There were no adverse events following prior vaccination. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 13 year old male who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy on the same day included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and hepatitis A vaccine (inactive) (VAQTA). Subsequently the patient experienced injection site reaction of swelling and itching that lasted for more than three days. Medical attention was sought. The patient has been recovering. No product quality complaint was involved. This one of two reports from the same source (WAES# 0709USA03804). Further information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Skin swelling
Clinical narrative: Information has been received from a nurse concerning a female who on an unknown date was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657449/0567U). Subsequently, the patient experienced "cellulitis" after getting second dose. The physician was concerned that there might be a problem with the lot number. The patient sought unspecified medical attention. A lot check has been requested. Subsequently, the patient recovered. Follow-up information was received via telephone call from a licensed practical nurse (LPN) who reported that the female patient was between the age of 7-11 years old. She developed "softball sized bumps on her arms" following varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). The patient returned to the office. The physicians office had since switched to using another lot of vaccine and have had no problems. The records of testing prior to release of lot #657449/0597U have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No additional information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a nurse concerning a female who on an unknown date was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). Subsequently, the patient experienced "cellulitis" after getting the second dose. The physician was concerned that there might be a problem with the lot number. The patient sought unspecified medical attention. A lot check has been requested. Subsequently, the patient recovered. Follow-up information was received from a licensed practical nurse who reported a female between the age of ?-11 years old developed softball sized bumps on her arm following vaccination. The patient returned to the office. The physicians office has since switched to using another lot of vaccine and have had no other problems. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No additional information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Rash, Swelling, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 6 year old male with no pertinent medical history, drug reactions or allergies who on 28-AUG-2007 was vaccinated with a "booster shot" of varicella virus vaccine live (Oka/Merck) (Lot # 658413/1025U). There was no concomitant medication. On 28-AUG-2007, the patient experienced severe vomiting, developed a rash and swelling "immediately after he was given varicella virus vaccine live (Oka/Merck)". The patient was treated with Benadryl. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 9 year old female with no pertinent medical history, drug reactions or allergies who on 29-AUG-2007 was vaccinated with a "booster shot" of varicella virus vaccine live (Oka/Merck) (Lot # 658413/1025U). Concomitant therapy included human papillomavirus vaccine (GARDASIL). On 29-AUG-2007 the patient passed out immediately after receiving varicella virus vaccine live (Oka/Merck). There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 9 year old patient who in 1997 was vaccinated with varicella virus vaccine live (Oka/Merck). In May 2007 through 18-JUN-2007, the patient experienced a mild case of chickenpox. The symptoms were mild with a rash on the torso. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 9 year old patient who in 1997 was vaccinated with varicella virus vaccine live (Oka/Merck). In May 2007 through 18-JUN-2007, the patient experienced a mild case of chickenpox. The symptoms were mild, rash on the torso. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 3-year-old patient who at approximately 12-15 months of age, approximately in 2005, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). In August 2007, it was reported that "the patient is experiencing a severe breakthrough of chickenpox". On an unspecified date, the patient was seen at the doctor's office. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 5-year-old female who on 05-JUL-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Her first dose of varicella virus vaccine live (Oka/Merck) was administered at 12-15 months of age in approximately 2003. It is reported that approximately in August 2007, "the patient was experiencing a mild breakthrough of chickenpox" on her trunk and legs. She was seen at the physicians office and given Benadryl to treat the symptoms. The outcome was reported as recovering. No product quality complaint was involved. The physician also reported that the patient's sibling developed chickenpox following vaccine administration (WAES numbers: 0708USA05499). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot number not provided). In August 2007, the patient developed 9X7cm reaction of cellulitis. Unspecified medical attention was sought. The patient was treated with an antibiotic. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction, Nodule
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot number not provided). In August 2007, the patient developed a mild localized reaction that was about 1 cm nodule below surface. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 78-year-old female who on 29-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient was given varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse events were reported. The nurse did not feel this was product confusion. A product quality complaint was involved. Additional information has been requested. Follow-up information was received on 10-SEP-2007. Follow-up information was received via a telephone call with a registered nurse who stated that a prescription was written for varicella virus vaccine live (Oka/Merck) for shingles. The pharmacist filled the prescription with varicella vaccine live (Oka/Merck) and then the nurse administered the vaccine. It was reported that the patient had not experienced any untoward effects. The nurse also stated that the patient is considering have the zoster vaccine live (Oka/Merck). No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning an adult female who was vaccinated with two doses of varicella virus vaccine live (Oka/Merck). The patient sought medical attention and had varicella titers drawn for health care employment. The physician reported the results were negative for seroconversion. No other information is available at this time. A product quality complaint was not involved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral DNA test positive
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 25 month old female with no known allergies or pertinent medical history who on 16-AUG-2006 was vaccinated SC in the right thigh with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#652874/0435F). The patient had no rash at the injection site or elsewhere within 42 days of vaccination. On 30-AUG-2007 (also reported as 29-AUG-2007) the patient developed shingles on her right thigh. There were 30-50 vesicular lesions. No other symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint involved. The patient was enrolled in the VZVIP program: the Varicella Zoster Identification Program enables biological samples to be  analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Oka/Merck vaccine VZV strain. A specimen was obtained from a vesicle on the patient's right thigh on 31-AUG-2007. The results were pending. The patient had no recent exposure to chickenpox or herpes zoster, and has never had chickenpox. Subsequently the patient recovered. The sample of the lesion was collected on 31-AUG-2007. The sample was taken from a vesicle on the patient's right thigh. PCR results were provided: the isolated virus was Oka/Merck vaccine strain. Additional information is not expected.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Initial and follow up information has been received from a physician concerning an 8 year old patient who on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot Number 656077/1491F). Subsequently, within two to three days post vaccination, the patient developed a 10 cm area of redness and / or 6 X 6 cm area with a circular pattern with redness, warm to touch and pain. The reaction lasted approximately 1 week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Initial and follow up information has been received from a physician concerning a 10 year old child who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot number 656077/1491F). Subsequently, within two to three days post vaccination, the patient developed a 10 cm area of redness and/ or 6 X 6 cm area with a circular pattern with redness, warm to touch and pain. The reaction lasted approximately 1 week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 15 year old who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot # 654813/1088F). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arms. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 12 year old who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot Number 656260/1502F). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 16 year old who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot Number "657780/06170U"). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 15 year old patient, who on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella vaccine live (Oka/Merck) (Lot number 657751/0779U). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection sit reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 5 year old who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot Number 657404/0592U). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an 11 year old who on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (unknown lot number). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports from the same source.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Exposure to communicable disease, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Initial and follow up information has been received from a consumer concerning a potential varicella outbreak in a 5 year old female child who was vaccinated, on an undisclosed date, with a second dose of varicella virus vaccine live (Oka/Merck). On an unreported date, the child developed a fever of 100 degrees, a sore throat and one pimple/blister on her face, which resolved in three days. The illness was considered mild and treated with Advil and Tylenol for mild fever. The pediatrician of the child asked that the child not be brought into the office, since they felt that he was contagious. The original source of the illness was thought to be a woman in the reporter's neighborhood who had a bad case of shingles and did not restrict her contact with others, however the physician indicated that several cases were seen in the school system prior to the summer break. The product quality complaint unit was not involved. Additional information is not expected. The consumer also provided information regarding other patients' experiences while on treatment with varicella virus vaccine live (WAES #0706USA03851, 0706USA04140, 0706USA04141).
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a female who on 30-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The nurse stated that the patient received a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse symptoms were reported. It was unknown whether medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who in 2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). In 2007, the patient developed chickenpox with lesions all over the body 6 weeks after the second dose. Unspecified medical attention was sought. No lab diagnostic studies were performed. On approximately 24-AUG-2007 the patient recovered. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 30-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The pharmacist ordered zoster vaccine live (Oka/Merck) but was sent varicella virus vaccine live (Oka/Merck) by mistake. He stated the wholesaler ordered the wrong product. The unopened shipment was sent to the physician from the pharmacy. The physician thought that varicella virus vaccine live (Oka/Merck) was the zoster vaccine live (Oka/Merck) so he administered it. This was a medical error not a PQC. No adverse experiences related to this event. It was unknown whether medical attention was sought. The patient's outcome was unknown.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pustular, Varicella
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 07-AUG-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (MSD). On approximately 09-SEP-2007 the patient developed chickenpox. The patient sought medical attention at the physician's office. The patient had large pustules and the physician prescribed acyclovir and cephalexin (Keflex). No labs were performed. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Blister, Erythema, Mass, Rash papular, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 4 year old male child with hemoglobin c trait who on 13-NOV-2003, at 13:40, was vaccinated subcutaneously into the left thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 644796/0336N). Concomitant therapy that same day included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PCV7) (Lot # 492849) administered intramuscularly into the right thigh. There was no illness at the time of vaccination. On 01-AUG-2007 the patient developed bumps on his face and mouth. On 13-Aug-2007 the patient was seen in office. The patient presented with over 50 lesions on body, erythematous papules with overlying vesicles. The patient was afebrile and symptomatic. There were no lab diagnostic tests performed. There were no reported adverse events following prior vaccinations. At the time of reporting the patient was considered recovered, but the recovery was noted to be ongoing. No product quality complaint was involved. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning two male children 4 to 6 years of age who were vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patients experienced redness, pain and swelling at the injection site. Additional information has been requested. This is one of several reports received from the same source.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 2-year-old patient who on approximately 13-AUG-2007 (18 days after the adverse experience) was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). This was the first set of immunizations the child had ever received, the child is from out of the country. On 31-AUG-2007 the patient developed injection site rash. At the time of the report it was unknown if the injection site rash had resolved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 29-month-old white male who on 10-FEB-2006 was vaccinated subcutaneous (lt) with his first dose of varicella virus vaccine live (Oka/Merck) (Lot # 649992/0791R). Concomitant vaccine received on 10-FEB-2006 included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot # B08640A). On 23-JUL-2007 the patient presented during a medical visit with fever and a rash, and was diagnosed with varicella. It was reported contacts at the patient's daycare were also diagnosed with varicella. The patient's symptoms were treated with an unspecified therapy with no complications. At an unspecified date the patient recovered from all adverse events. Follow-up information was received on 19-SEP-2007 via a phone call with the doctor's office. It was reported the patient had chickenpox and his daycare center was positive for other children having chickenpox. The doctor's office does not know how many kids at the daycare center had chickenpox. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Diagnostic procedure, Diarrhoea, Pyrexia, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a male (age not reported) who was vaccinated with the "second dose" of varicella virus vaccine live (Oka/Merck) (lot # not reported). The registered nurse reported that "after receiving the second dose of varicella virus vaccine live (Oka/Merck), the patient developed a small rash on the stomach, which was transient and went away after one day. The patient also had five pox marks on his face and experienced diarrhea and fever". The patient sought unspecified medical attention. The patient's status concerning the five pox marks on his face, diarrhea, and fever was not reported. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a health professional concerning a 4 year old female who on 25-JUL-2007 was vaccinated SC on the right thigh with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657757/0641U). Concomitant therapy included the fourth dose of an IM administration of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot # AC14B046AA) to the right thigh, the fourth dose of a SC administration of poliovirus vaccine (Lot #Z1069) to the left thigh and the second dose of a SC administration of measles-mumps-rubella vaccine (MSD) (Lot# 656038/0204U) to the left thigh. On 27-JUL-2007 the patient experienced right outer thigh with red area at site. The patient's outcome was no reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with varicella virus vaccine live (Oka/Merck). After getting the second dose of the vaccine, the patient developed a red swollen arm. Unspecified medical attention was sought. As of 31-MAY-2007 the outcome was unknown. This is one of several reports received from the same source. Additional information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 9-year-old male who on 18-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot no. 657759/70639U) in the L deltoid. On 20-JUL-2007, the patient developed an injection site rash which was described as red, swollen and painful to touch. The parents of the patient were told to apply ice to treat the rash. 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 pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 657759/0639U). The patient developed an injection site rash which was described as red, swollen and painful to touch. The rash resolved at another follow-up appointment. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: Information has been received from a health care worker in a physician's office concerning a 34 year old female with a codeine allergy an no other medical history who on 05-MAY-2000 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 25-AUG-2007, the patient did not have protective antibodies with an antibody titer that was less than 0.91 for IgG/IgM. Medical attention was sought via contacting the physician. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with no pertinent medical history or drug allergies who on 01-OCT-1998 was vaccinated with his first 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (lot# 626966/1054H) in the left arm. There was no illness at the time of vaccination. There was no concomitant medication. On 04-SEP-2007 the patient experienced an "insect bite-like rash" consisting of 28 lesions on his face, neck, chest, back, and buttocks. Medical attention was sought via physician exam in office. No labs or diagnostic studies were performed. The patient was treated with hydrocortisone (SARNA) lotion, diphenhydramine HCl (BENADRYL) and oatmeal baths. On 10-SEP-2007 the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a medical assistant and a registered nurse concerning a 65 year old male consumer with no known allergies or pertinent medical history who on 06-SEP-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#658005/1006U) instead of zoster vaccine live (Oka/Merck) (MSD). There were no adverse events reported. This was not a product confusion according to the reporter. Medical attention was not sought. No lab studies were performed. The patient was doing fine. The nurse stated that she was advised that the patient would be permitted to receive the correct vaccine 4 weeks from the time of the incorrect vaccination. The doctor phoned the patient to follow up for any adverse reactions and to instruct the patient to make an appointment in 4 weeks for the correct vaccination. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 30-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 657403/0715U). On 02-JUL-2007, the patient developed a golf ball lump around the injection site that was tender. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a male who on 04-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). Reporter indicated it was due to staff error. No further information was provided. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Blood immunoglobulin M increased, Rash, Skin lesion, Varicella
Clinical narrative: Information has been received from a newspaper article titled "Varicella Breaks Out Despite Double Vaccine Doses" from the Family Practice News, July 15, 2007, concerning a child who received a first dose of varicella virus vaccine live (Oka/Merck) on an unspecified date. It is reported that in the fall if 2006, the child had a mild outbreak of varicella, with less than 250 lesions. The rash lasted about 4 days. A positive IgM serum spot test was used as confirmation. It is unspecified if medical attention was sought. The outcome is recovered. Additional information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health nurse concerning a 6 year old male who on 24-OCT-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 10-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 one of 28 reports received from the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a 1-year-old male with no pertinent medical history or allergies who in February 2007, was vaccinated subcutaneous with 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 653434/0563F). There was no concomitant medication. On 03-SEP-2007, the patient developed varicella and had about 10-15 lesions. The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report it was unknown if the patient had recovered. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Skin lesion, Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 13-month-old white female with no pertinent medical history or allergies who on 28-AUG-2007 at 16:40 was vaccinated subcutaneous with her first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 653517/1300F). Concomitant vaccines administered on 28-AUG-2007 included a first intramuscular dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 654379/0706F) administered in the right thigh and a first intramuscular dose of hepatitis A virus vaccine inactivated (MSD) (lot # 656320/1281F) administered in the left thigh. On 06-SEP-2007 at 10:00 (previously reported as "in 2007") the patient developed lesions after vaccination. Also reported as several chickenpox lesions behind her ear and a blister on her arm, as reported by the patient's mother. The patient's mother sought medical attention via a phone call to the physician. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of three reports concerning the same patient. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Information has been received from a physician concerning an 11 year old female consumer who "about one month ago" was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Additional suspect therapy included a second dose of Gardasil (MSD). Other concomitant vaccination may have included Menactra. " Soon after vaccination" the patient developed nausea, dizziness, injection site redness and injection site swelling. The patient was examined by the physician. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a male with no pertinent medical history or allergies who in approximately 1999 (1 year of age) was vaccine subcutaneous with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. At a recent office visit it was mentioned the patient developed breakthrough chickenpox at an unspecified date. No diagnostic labs were performed. Subsequently, the patient recovered from breakthrough chickenpox. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a adult patient who in August 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient inadvertently received varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD) due to human error. A product quality complaint was not involved. Follow-up information was received on 20-SEP-2007 via a telephone call. The physician reported the patient did not experience any adverse event and "is doing fine". This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no pre-existing allergies, or medical conditions who on 29-AUG-2007 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Within four weeks of vaccination with varicella virus vaccine live (Oka/Merck, the patient also received the following vaccinations, on unspecified dates: Hib conj vaccine (unspecified carrier) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/30 (manufacturer unknown). On 07-SEP-2007, the patient developed a fever and a varicella rash. The reporter noted that the patient's mother was 12-16 weeks pregnant at the time. Mother has received Varicella Zoster Immune Globulin (VZIG). The patient was recovered at the time of reporting. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning an 8-year-old female with no pertinent medical history or allergies who in December 2000, was vaccinated subcutaneous with 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 02-SEP-2007 the patient developed varicella and has about 10-15 lesions. The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a 12-year-old female with an allergy to Zithromax and no pertinent medical history who on 12-AUG-2000 was vaccinated subcutaneous with 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Triaminic Syrup and ibuprofen. On 02-SEP-2007, the patient developed varicella and has about 10-20 lesions. The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report the patient status is recovering. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a 7 year old patient with no pertinent medical history and an allergy to penicillin who was vaccinated SQ with 0.5 mL of the second dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 06-SEP-2007, the patient experienced varicella, with about 20 lesions. No lab diagnostic tests were performed. There was no product quality complaint. Medical attention was sought at an office visit. As of 07-SEP-2007, the patient was recovering from varicella. This is one of thirteen reports received from the same source. No further information is available.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Culture negative, Incorrect route of drug administration, Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 5-year-old female with Ventricular septal defect and cerebral palsy who on 04-SEP-2007 (in the AM) was vaccinated intramuscular in the right thigh with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658178/1013U). Concomitant therapy included a dose of Havrix (manufacturer unspecified). There were no illnesses at the time of vaccination. On 05-SEP-2007, post vaccination, the patient developed on her right leg at the injection site large big bullous 2.5 X 2.5 cm (size of a small donut), with small bullae surrounding (previously described as "with blisters around it") that was fluid filled. There was also a large area of redness and warmth 5 X 5 cm also present at the site of injection and the patient experienced leg pain. The patient was referred to an infectious disease doctor for follow-up. On 06-SEP-2007, anaerobic and aerobic cultures of the bullous fluid were cultured and drained the results showed no growth. The patient was being treated with Clomacin. On the 10-Sep-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 5-year-old female with Ventricular septal defect and cerebral palsy who on 04-SEP-2007 (in the AM) was vaccinated intramuscular in the right thigh with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658178/1013U). Concomitant therapy included a dose of Havrix (manufacturer unspecified). There were no illnesses at the time of vaccination. On 05-SEP-2007, post vaccination, the patient developed on her right leg at the injection site large big bullous 2.5 X 2.5 cm (size of a small donut), with small bullae surrounding (previously described as "with blisters around it") that was fluid filled. There was also a large area of redness and warmth 5 X 5 cm also present at the site of injection and the patient experienced leg pain. The patient was referred to an infectious disease doctor for follow-up. On 06-SEP-2007, anaerobic and aerobic cultures of the bullous fluid were cultured and drained the results showed no growth. The patient was being treated with Clomacin. On the 10-Sep-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.