chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Ear infection, Febrile convulsion, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 12 month old son who on 08-APR-2009 was vaccinated with MMR II. Concomitant therapy included amoxicillin and DTaP. On 12-APR-2009 4 days after administration of the vaccine the patient developed low grade fever. On 13-APR-2009 the fifth day the patient experienced a febrile seizure and was examined in the emergency room. The patient was not admitted and was currently being treated with MOTRIN and TYLENOL. The patient received other vaccines the day he received MMR II but it was unknown which vaccines. The patient still had a fever intermittently. At the time of reporting the patient's febrile seizure persisted. Follow-up information has been received from the physician that the patient had the flu and ear infection about 1 week prior to receiving the MMR II vaccination. The physician stated that the patient had a well check-up visit with the physician on 08-APR-2009 and at that visit the patient received the MMR II vaccination along with other concomitant vaccinations (not reported). Two days (previously reported as 5 days after vaccination) after receiving the vaccinations the patient had a febrile seizure and was seen at hospital and not admitted. The physician also reported that she prescribed a stronger antibiotic for the patient at that time. The physician said that it was too early to tell if the patient had recovered. The patient had scheduled appointment for later in the month of April. Follow-up information has been received from a Licensed Practical Nurse that the patient received the MMR II (lot # 661675/1505X) on 08-APR-2009. The patient did not receive any concomitant vaccines on 08-APR-2009. It was reported that the patient received PEDIARIX on 08-OCT-2008. It was reported that after the patient had a febrile seizure he was taken to another hospital (not at the hospital as previous reported). Follow-up information has been received from the physician that the patient with otitis media (OM) and no allergy at the time of vaccination was vaccinated with his first dose of MMR II (lot # 661675/1505X) SQ into his left thigh on 09:27 AM 08-APR-2009. The patient was vaccinated with his first dose of VARIVAX (Merck) (lot # 660669/1381X) SQ into his right thigh on 09:27 08-APR-2009. The patient was vaccinated with his first dose of HAVRIX (lot # 1297X) IM into his right thigh on 09:26 08-APR-2009. The patient was vaccinated with his fourth dose of PREVNAR (lot # D34347) IM into his left thigh on 09:28 08-APR-2009. The patient had febrile seizure and was seen in emergency room. No diagnostic and laboratory test was done. At the time of reporting, the patient had recovered from febrile seizure. Upon internal review, febrile seizure was considered to be an other important medical event. No further information is available.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who on an unknown date, was vaccinated with second dose of VARIVAX (Merck) (lot# not reported). Subsequently the patient experienced warmth, redness and swelling at the injection site. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a female patient who on an unspecified date was vaccinated with a dose of MMR II (dose and Lot # not reported). It was reported that when she was  2 year old she had a seizure after vaccination with MMR II. No outcome was reported. Upon internal review, seizure was determined to be an other important medical event. No further information is available.
Age: 1.77
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter who in August 2006, was vaccinated with MMR II (dose, route and lot number unspecified).  The mother stated "her daughter received a dose of the vaccine in August 2006 and then about a week (approximately in August-2006) after receiving the vaccine, the patient had a febrile seizure that lasted about a minute or less.  The patient did see a physician regarding this but was not hospitalized.  The patient's mother, also reported about a year after receiving a second dose (approximately in 2007) of MMR II (dose, route and lot number unspecified), the patient had another febrile seizure and also her mother reported that the patient had recovered".  Upon internal review, febrile seizure was determined to be an other important medical event.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Apparent death, Idiopathic thrombocytopenic purpura
Clinical narrative: Information has been received from a consumer concerning his brother's "10 years old" daughter who was vaccinated with MMR II "at age 2". "Within hours of getting the vaccine" the patient almost died from idiopathic thrombocytopenic purpura (ITP). The patient was hospitalized for several days. On unspecified date the patient recovered from idiopathic thrombocytopenic purpura. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning two adolescent patients with unspecified drug reactions/allergies and unspecified medical history, who on an unspecified dates were vaccinated SQ with 0.5 ml doses of VARIVAX (Merck) (dose unspecified, lot number: 662578/0048Y). Subsequently, these two patients recently complained of pain at the injection site (date unspecified) bad enough for them to seek medical attention at the doctor's office. It was unspecified if lab studies were performed. At the time of the report the patients recovered on unspecified date. No further information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) and may possible have developed chicken pox. The patient was sent home from school, the nurse also stated that a  parent from school called the office and reported that there were five other cases of chickenpox. This is one report from several from the same source. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: No therapeutic response, Viral test positive
Clinical narrative: Information has been received from a a nurse practitioner concerning a male patient with no pertinent medical history or no know drug allergies, who on an unspecified date was subcutaneously vaccinated with 0.5 ml of the second dose of VARIVAX. There was no concomitant medication. At the time of the reporting the patient had titers low. Follow up has been received from the nurse practitioner who stated that the patient did not have illness at the time of vaccination. It was reported that the patient had negative titers after he received the VARIVAX series (lot number and time not reported). No adverse event was reported. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female patient with no pertinent medical history, who on 09-JAN-2001, was vaccinated with a dose of VARIVAX (Merck) (lot # 635605/1151K) 0.5 ml subcutaneously.  The nurse reported that in approximately May 2009, the patient had a negative varicella titer.  The patient sought medical attention at the office.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 8 year old female patient with no allergies and no medical history who on 13-MAY-2009 was vaccinated SQ with a 0.5 mL second dose of VARIVAX (Merck). On 13-MAY-2009 the patient developed redness, pain and swelling of her arm, at the injection site. Medical attention was sought via telephone call. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a child "under 5 year old" with fever and an ear infection at the time of vaccination, who on an unknown date was vaccinated with 0.5 ml of a dose of MMR II intramuscularly.  In approximately May 2009 (reported as "recently, within the last month"), the patient experienced seizure.  Subsequently, the patient recovered from seizure.  Upon internal review, seizure was considered to be an Other Important Medical Event.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # 663819/0036Y). It was reported that a patient had injection site reactions from VARIVAX (Merck). The patient sought medical attention with an office visit. It was reported that the patient was still recovering at the time of the report. In follow up the nurse reported that an 8 year old female patient was vaccinated with a dose of VARIVAX (Merck) (Lot # 663819/0336Y on 05-MAY-2009 (purchased through the vaccines for Children program). The patient recovered. This is one of several cases from the same source. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N.)concerning an unspecified number of patients who on an unspecified date were vaccinated with a dose of VARIVAX (Merck). It was reported that the patients had an injection site reactions occurring from VARIVAX (Merck). Medical attention was sought via an office visit. In follow up the nurse reported that a 9 year old male patient received from the Vaccines for Children program a dose of VARIVAX (Merck) (lot # 663823/0221Y) on 16-APR-2009. He recovered. This is one of several reports from the same source. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a male who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (lot number, route and site not reported).  The patient developed 50 varicella lesions 2 weeks later after getting vaccination.  The patient had sought unspecified medical attention.  He recovered on the unspecified date.  Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Convulsion, Hypersensitivity, Mental disorder
Clinical narrative: Information has been received from a consumer concerning a 3 year old child who was placed on therapy with MMR II (dose number and vaccination date not reported).  The consumer heard about the patient through her sister about 3 years ago.  Subsequently the patient developed an "allergic reaction" after receiving MMR II.  The patient experienced seizures and a "paralyzed mental state".  It was unknown whether medical attention was sought.  The patient's out come was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a  licensed visiting nurse concerning a patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (lot not reported) and may possible have developed chicken pox. The patient was sent home from school, the nurse also stated that a parent from school called the office and reported that there were five other cases of chickenpox. This is one report from several from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with a history of tuberculosis skin test positive who on 05-FEB-2009 was vaccinated with the second dose of VARIVAX (Merck)  (lot # not reported, 0.5ml, subcutaneous injection) and has failed to seroconvert. Medical attention was sought via an office visit. The patient received her first dose of VARIVAX (Merck) on 28-AUG-1995. Concomitant therapy included isoniazid. Titers were down on an unspecified date (values not reported). No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Viral test
Clinical narrative: Information has been received from a physician concerning a female adult patient who was vaccinated two doses of with VARIVAX (Merck) (dates, doses and lot # is not reported).  The patient had recent titers which were equivocal.  There were no adverse effects noted.  The patient had sought medical attention in the office.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 12.5 year old granddaughter who was vaccinated with VARIVAX (Merck) and had gotten the chickenpox three times. The patient had sought unknown medical attention. At the time of report the patient's status was recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a patient's granddaughter who was vaccinated with a dose of VARIVAX (Merck) as a child, and developed several very mild cases of chicken pox post vaccination. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 72 year old female patient who on 17-SEP-2009 was mistakenly vaccinated SC by the nurse with 0.5 ml dose of VARIVAX (Merck).  The patient was supposed to receive ZOSTAVAX (Merck).  There were no adverse effects reported.  Follow-up information has been received from a nurse practitioner indicated it was about a male patient.  The nurse would have to call back with any additional information about the medication mistake.  Therefore a message was left for the nurse to return the call about whether or not the VARIVAX (Merck) administration was a case of human error or product confusion.  The health care professional contacted during telephone follow-up could not supply the following information: date of birth, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information.  Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Secondary transmission, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male patient with allergic reaction to antibiotics (name and manufacturer unspecified) who on 15-JAN-1998, when 11 month old, was vaccinated with the first dose of VARIVAX (Merck) (lot number not reported). On 27-SEP-2007 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 658294/1103U). On 23-SEP-2009, when 12 year old, the patient developed mild case on chicken pox. It was also mentioned that week ago the patient was exposed to someone who had chicken pox. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. Follow-up information received from a healthcare professional concerning the 12 year old male patient with allergy to BIAXIN who on 27-SEP-2007, at 16:30 pm was vaccinated IM with the second dose of VARIVAX (Merck) (lot number 658294/1103U). On 23-SEP-2009, at 9:00 am the patient's mother called the office stated that the patient had "chicken pox". The patient had blister like sports on back. The mother described what sounded like chicken pox-also the patient exposed to someone 2 week prior that was diagnosed with chicken pox. The patient was not seen for diagnosis. On 30-SEP-2009 the patient recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning approximately 5 adult patients who were indicated for ZOSTAVAX(Merck) in 2008 and were vaccinated with 2 doses of VARIVAX (Merck)(lot number not reported) mistakenly by the provider. The physician confirmed that he administered VARIVAX (Merck) according to the prescribing information interval. There were no adverse effects reported. Unspecified medical attention was sought. At the time of the report, the outcomes of the patients were not reported. Follow-up information has been received from an office administrator who reported that there were a total of 2 patients who received the wrong vaccine. She reported that she did not have the lot number. The health care professional contacted during telephone follow-up could not supply the following information: patient's name, dates of birth, dates of vaccination/therapy, dose numbers or dates of event. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest pain, Dysphagia, Electrocardiogram, Lip swelling, Lung disorder
Clinical narrative: Information has been received from a medical assistant concerning a 6 year old male patient who on 18-AUG-2009 was vaccinated with the second dose of 0.5ml VARIVAX (Merck) (lot # 664502/0687Y). The expiration date on the vaccine was 15-MAY-2011. There was no concomitant medication. The medical assistant reported that "He was a little bit nervous before the shot, but not abnormally anxious. 5 minutes after vaccination the boy complained of chest pains, a sore throat and said it was hard to swallow. The patient's pulse was 98. The doctor listened to his lungs and the doctor felt that there was a small amount of stress in the lungs. The doctor told him to sit for 5-10 minutes. While sitting, he began vomiting. At the time he did not have shortness of breath, hives or a rash. The office called EMS. When EMS came, the patient was well enough for the mother to drive him to a hospital. When the arrived at the hospital, the hospital nurse said he had minor lip swelling and a rash from head to toe. He received prednisone and a dose of BENADRYL. An electrocardiogram (EKG) was done and he was observed in the emergency room. He was not admitted and he did go home at the night of 18-Aug-2009. On 19-Aug-2009 he was examined at the doctor's office by a different doctor. The patient had a complete exam. The rash was completely gone. There was ho wheezing, the airway was clear and the patient was instructed to finish the prednisone." The patient's adverse events improved after stopping therapy. It's unknown if the patient recovered on 18-AUG-2009 or 19-AUG-2009. It's also reported by a physician that there was no AE after the first shot. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Nervousness, Oropharyngeal pain, Rash generalised, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 6 year old male patient who on 18-AUG-2009 was vaccinated with the second dose of 0.5ml VARIVAX (Merck) (lot # 664502/0687Y). The expiration date on the vaccine was 15-MAY-2011. There was no concomitant medication. The medical assistant reported that "He was a little bit nervous before the shot, but not abnormally anxious. 5 minutes after vaccination the boy complained of chest pains, a sore throat and said it was hard to swallow. The patient's pulse was 98. The doctor listened to his lungs and the doctor felt that there was a small amount of stress in the lungs. The doctor told him to sit for 5-10 minutes. While sitting, he began vomiting. At the time he did not have shortness of breath, hives or a rash. The office called EMS. When EMS came, the patient was well enough for the mother to drive him to a hospital. When the arrived at the hospital, the hospital nurse said he had minor lip swelling and a rash from head to toe. He received prednisone and a dose of BENADRYL. An electrocardiogram (EKG) was done and he was observed in the emergency room. He was not admitted and he did go home at the night of 18-Aug-2009. On 19-Aug-2009 he was examined at the doctor's office by a different doctor. The patient had a complete exam. The rash was completely gone. There was ho wheezing, the airway was clear and the patient was instructed to finish the prednisone." The patient's adverse events improved after stopping therapy. It's unknown if the patient recovered on 18-AUG-2009 or 19-AUG-2009. It's also reported by a physician that there was no AE after the first shot. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Irritability, Rash generalised, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 12 month old male patient with no pertinent medical history and no known allergies who on 17-AUG-2009 was vaccinated SQ with a dose of VARIVAX (Merck) (lot number664721/0859Y). Concomitant vaccine therapy included a dose of MMR II (MSD), ACTHIB (unspecified), pneumococcal conj vaccine (unspecified) all given on 10-AUG-2009 and poliovirus vaccine and VAQTA (unspecified) given on 17-AUG-2009. It was reported that the patient possibly had an allergic reaction. The patient start to be fussy on the night of 18-AUG-2009 and then little spots were developing. It was reported that the patient looked like he had chickenpox from head to toe with papules all over. Medical attention has been sought by phone call and office visit. There were no lab studies performed. The patient was given an antihistamine (unspecified). At the time of the report, the patient had not recovered. Follow-up information has been received from the physician assistant concerning the patient with history of otitis media, bronchiolitis and pneumonia who on 17-AUG-2009 was vaccinated with a dose of VARIVAX (Merck). On 18-AUG-2009 the patient developed rash over entire body. There was no lab studies performed. The patient was ordered BENADRYL. On an unspecified date the patient's rash resolved. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning an 11 year old female patient with no pertinent medical history and no known allergies who on 17-AUG-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (lot number 664507/0689Y). There was no concomitant medication. On 18-AUG-2009 the patient developed a red raised area about 2.5 to 3 inches in size at the injection site. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a nurse concerning a 10 year old male patient with hypersensitivity (dog hair and carpet), seasonal allergies and a history of hyperlipidaemia who on 17-AUG-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (lot number 664507/0689Y).  There was no concomitant medication.  On 18-AUG-2009 the patient developed a red raised area about 2.5 to 3 inches in size at the injection site.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report, the patient had not recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 22 month old male patient with a history of tick bite, reactive airways disease, and drug reactions or allergies reported as none who on 22-SEP-2008 was vaccinated with a dose of VARIVAX (Merck). There was no concomitant medication. On 30-JUL-2009 the patient experienced chickenpox. Symptoms presented as a "rash all over". The patient was advised to use oatmeal bath, calamine (+) zinc oxide lotion and BENADRYL. The patient sought an unspecified medical attention. The patient was completely recovered on 10-AUG-2009. Follow up information received from a licensed practical nurse indicated that he was a male patient who on 22-SEP-2009 was vaccinated subcutaneously with his first dose of VARIVAX (Merck) in his right arm, suspect therapy included his first dose of MMR II (Lot # 656614/0869U) which was administered subcutaneously in his left arm. There were no illnesses reported at the time of vaccination. Concomitant therapy included HAVRIX received intramuscularly in his right thigh and a fourth dose PREVNAR administered intramuscularly in his left thigh. According to the reporter, the adverse event began on 27-JUL-2009 (previously reported as 30-JUL-2009) as the patient presented to the office/clinic with numerous red bumps. A diagnosis of chickenpox was done at the clinic. The patient recovered on Aug-2009 (previously reported as 10-AUG-2009). There were no laboratories diagnostics studies performed. This is one of four reports from the same source. No further information is available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Rash generalised, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old male at 41 pounds weight and 41.5 inches with no medical history or drugs allergies, who on 08-FEB-2006 was vaccinated in the left with a first dose of VARIVAX (Merck) (646539/0551R).  The same day the patient was vaccinated in the right with a dose of MMR II (lot # 649805/0465R, HSA) and in the left with a dose of DTAP (manufacturer unspecified).  The patient received a second dose of VARIVAX (Merck) (lot # 659433/1919U) on 13-OCT-2008.  Concomitant therapy included montelukast sodium (MSD).  The patient developed chickenpox.  The symptoms presented as a "rash all over" on 24-JUL-2009.  The patient was seen in the office on 28-JUL-2009.  The patient was advised to use oatmeal bath, CALAMINE lotion), BENADRYL and not to attend school.  No laboratories studies performed.  On 18-AUG-2009 the patient was completely recovered at the check up.  Follow up information was received from the nurse stated that the patient did not return for follow up in one week as recommended but did come in 08-AUG-2009 fully recovered (previously reported as 18-AUG-2009).  This is the third of four cases for this reporter.  No further information is available.
Age: 1.21
Sex: F
Vaccine: HBHEPB, HEP, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rhinorrhoea, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26 month old female with allergic rhinitis who on 29-JUL-2008 was vaccinated with a dose of VARIVAX (Merck), lot number 659603/1903U, 0.5 ml, subcutaneously (site not reported). Concomitant therapy included ZYRTEC. It was reported that on 26-JUL-2009 the patient developed chickenpox. The patient presented with rash, no fever and a runny nose. The patient was advised to use oatmeal bath, CALAMINE LOTION and BENADRYL along with no day care. On an unspecified date, the patient completely recovered. Follow up information has been received concerning a 26 month old (also reported as 2 year old) female patient with allergy to ZYRTEC who on 29-JUL-2008 was vaccinated with a first dose of VARIVAX (Merck), subcutaneous - right thigh route, (lot # 659603/1903U); with the third dose of COMVAX (OMPC) (MSD), intramuscular- left thigh route, (lot # 655549/1415F); with the third dose of RECOMBIVAX HB (MSD), intramuscular- left thigh route, (lot # 148F) and with the first dose of MMR II (MSD) subcutaneous - left thigh route, (lot # 658165/0040X). Concomitant therapy included ZYRTEC. On 29-JUL-2009 the patient presented to the clinic and reported rash and red bumps for 3 days (26-JUL-2009). At the time of this report the patient had recovered on an unspecified date. No signed informed consent form reported. This is one of several reports from the same source. No further information is available.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash, Rash erythematous, Rash pustular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 38 month old female patient with amoxicillin allergy, and no other pertinent medical history, who on 03-MAY-2007 was vaccinated with a dose of VARIVAX (Merck) (lot# not provided) as "part of 1 year shots". There was no concomitant medication. On 10-JUL-2009 the patient developed chickenpox, and that same date the patient was seen at the office. No labs diagnostic studies performed. Symptoms presented as rash and red bumps "all over" along with a low grade fever of 99 F. The patient was recommended to use CALAMINE LOTION, oatmeal bath and BENADRYL. The patient was also advised to use contact precautions and follow-up in one week. On 13-JUL-2009 the patient had several lesions with pus. On 12-AUG-2009, the patient no longer had lesions and she had a cough. This is one of several cases reported by the same source. Follow-up information was received from the licensed practical nurse regarding that the 38 month old female (37lb, 381/2 inch) with amoxicillin allergy and reactive airways disease (RAD), who on 03-MAY-2007 was vaccinated with a dose of VARIVAX (Merck) in the same date also received a dose of MMR II (MSD) and VAQTA (Manufacturer unknown). It was reported that on 13-JUL-2009 the patient presented to the office with chickenpox, healing lesions and afebrile. On 13-JUL-2009 (previously reported as 12-AUG-2009) the patient had recovered. It was noted that on 09-AUG-2007 the patient received a fourth dose of DTaP and the fourth dose of Hib (unspecified carrier). Additional information is not expected.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 38 month old female patient with amoxicillin allergy, and no other pertinent medical history, who on 03-MAY-2007 was vaccinated with a dose of VARIVAX (Merck) (lot# not provided) as "part of 1 year shots". There was no concomitant medication. On 10-JUL-2009 the patient developed chickenpox, and that same date the patient was seen at the office. No labs diagnostic studies performed. Symptoms presented as rash and red bumps "all over" along with a low grade fever of 99 F. The patient was recommended to use CALAMINE LOTION, oatmeal bath and BENADRYL. The patient was also advised to use contact precautions and follow-up in one week. On 13-JUL-2009 the patient had several lesions with pus. On 12-AUG-2009, the patient no longer had lesions and she had a cough. This is one of several cases reported by the same source. Follow-up information was received from the licensed practical nurse regarding that the 38 month old female (37lb, 381/2 inch) with amoxicillin allergy and reactive airways disease (RAD), who on 03-MAY-2007 was vaccinated with a dose of VARIVAX (Merck) in the same date also received a dose of MMR II (MSD) and VAQTA (Manufacturer unknown). It was reported that on 13-JUL-2009 the patient presented to the office with chickenpox, healing lesions and afebrile. On 13-JUL-2009 (previously reported as 12-AUG-2009) the patient had recovered. It was noted that on 09-AUG-2007 the patient received a fourth dose of DTaP and the fourth dose of Hib (unspecified carrier). Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Skin lesion
Clinical narrative: Information has been received from a nurse concerning a 4 year old male with AMOXIL allergy who on 31-JUL-2009 was vaccinated with a dose of VARIVAX (Merck).  Concomitant vaccinations included DTAP, POLIO virus vaccine and MMR.  On 20-AUG-2009 the patient developed maculopapular rash after receiving VARIVAX (Merck).  The patient had 5-6 lesions on his abdomen, arm, and hip.  At the time of reporting, the patient had not recovered.  The patient called the nurse.  Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Breast feeding, Drug exposure during pregnancy, Injection site haematoma
Clinical narrative: Information has been received from Merck Pregnancy Registry for VARIVAX (Merck) from a nurse practitioner concerning a 29 year old nursing mother with pertinent medical history reported as none and drug reactions or allergies reported as none who on 08-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously.  On 18-AUG-2009 she received second dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously.  There was no concomitant medication.  On 31-MAY-2009 the patient had a healthy infant.  The patient was examined in the office on 20-AUG-2009 and was found to have a small Hematoma at the injection site of the left upper arm.  There were no laboratories diagnostics studies performed.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 11 year old female patient who on unspecified date was vaccinated with a second dose of VARIVAX (Merck) (route and lot number: 664719/0804Y).  The nurse reported that "the patient developed a very large area of swelling and pain at the injection site after the patient received the second dose of the vaccine".  At the time of the report the outcome of the patient was unknown.  The patient sought unspecified medical attention by phone call.  All telephone attempts to contact the reporter have been unsuccessful.  This is one of several reports received from the same source.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number 664719/0804Y were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blood test, Convulsion, Dyskinesia, Electroencephalogram, Gaze palsy
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old male patient who on 11-MAY-2009 was vaccinated with a second dose of MMR II (lot # 663519/1771X ) 0.5ml, subcutaneously. Concomitant therapy also given on 11-MAY-2009, included tuberculin purified protein derivative (manufacturer unknown), DAPTACEL and POLIOVAX (manufacturer unknown). After he got the three other shots and before he got MMR II "seemed fine and was standing" On 11-MAY-2009 right after given MMR II "his head leaned over to the side like he had passed out". The nurse grabbed him and he started having "seizure like movements". Oxygen was administered as an intervention to prevent serious criteria. The office called 911, and he was transported to the emergency room but was not admitted. He was still having "seizure like movements" when he was taken from the office. There was no information whether or not the seizure like movements stopped and then restarted before he was taken from the office or if they lasted from when they first started until he was taken from the office. Unspecified date the patient recovered. Electroencephalography (EEG) and blood work were performed, results not reported. Follow up information has been received via telephone call from a nurse who indicated the physician had set the patient up with a neurologist to rule out a seizure disorder. The patient had no problems after receiving the first dose of MMR II. Follow up information has received from a health professional concerning a 5 year old male patient with no pertinent medical history and no known drug allergies, who on 11-MAY-2009 was vaccinated with the second dose of MMR II (lot # 663519/1771X ) in the right deltoid, a fifth dose of DAPTACEL (Lot# C3139AA) in the left deltoid and a fourth dose of POLIOVAX (Lot# B0009) in the left deltoid at 2:30 pm. On 11-MAY-2009 after given the last dose of MMR II the patient started shaking, his eyes rolled back, the he started seizuring. The patient required a visit to emergency room/doctor visit. On 11-MAY-2009 the patient recovered. Upon internal review seizure was determined to be an other important medical event. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Immediate post-injection reaction, No reaction on previous exposure to drug, Posture abnormal, Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old male patient who on 11-MAY-2009 was vaccinated with a second dose of MMR II (lot # 663519/1771X ) 0.5ml, subcutaneously. Concomitant therapy also given on 11-MAY-2009, included tuberculin purified protein derivative (manufacturer unknown), DAPTACEL and POLIOVAX (manufacturer unknown). After he got the three other shots and before he got MMR II "seemed fine and was standing" On 11-MAY-2009 right after given MMR II "his head leaned over to the side like he had passed out". The nurse grabbed him and he started having "seizure like movements". Oxygen was administered as an intervention to prevent serious criteria. The office called 911, and he was transported to the emergency room but was not admitted. He was still having "seizure like movements" when he was taken from the office. There was no information whether or not the seizure like movements stopped and then restarted before he was taken from the office or if they lasted from when they first started until he was taken from the office. Unspecified date the patient recovered. Electroencephalography (EEG) and blood work were performed, results not reported. Follow up information has been received via telephone call from a nurse who indicated the physician had set the patient up with a neurologist to rule out a seizure disorder. The patient had no problems after receiving the first dose of MMR II. Follow up information has received from a health professional concerning a 5 year old male patient with no pertinent medical history and no known drug allergies, who on 11-MAY-2009 was vaccinated with the second dose of MMR II (lot # 663519/1771X ) in the right deltoid, a fifth dose of DAPTACEL (Lot# C3139AA) in the left deltoid and a fourth dose of POLIOVAX (Lot# B0009) in the left deltoid at 2:30 pm. On 11-MAY-2009 after given the last dose of MMR II the patient started shaking, his eyes rolled back, the he started seizuring. The patient required a visit to emergency room/doctor visit. On 11-MAY-2009 the patient recovered. Upon internal review seizure was determined to be an other important medical event. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning two patients who on unspecified dates received both doses of VARIVAX (Merck) and they were both exposed to an outbreak situation and both developed a mild case of varicella.  There was no concomitant medication and no pertinent medical history.  The patients saw physician for medical attention.  Follow up information has been received from the physician's office, concerning a male patient who received the first dose of VARIVAX (Merck) on 08-AUG-2002, and received the second dose on 26-SEP-2007.  The reporter indicated that the lot numbers were unknown because the vaccines were given in another center.  Follow up information has been received from a physician concerning a 6 year old male student (also reported as female) who received two doses of VARIVAX (Merck), the first one on 08-AUG-2002, and the second dose on 26-SEP-2007 (SQ, 658430/1183U).  On 20-MAY-2008 the patient had a case of chickenpox.  The chickenpox lasted 4 days with a non complicated course.  The patient recovered on 24-MAY-2009.  This is one of two reports from the same source.  No further information is available.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on 05-SEP-1997 was vaccinated with a first dose of VARIVAX (Merck) and the second dose was administered on 3-OCT-2008 (doses, routes and lot numbers unspecified). On 19-MAY-2009, the patient was diagnosed with shingles. The outcome of the patient was not recovered. The patient sought unspecified medical attention. 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 patient who on 19-MAY-2009 was vaccinated with a dose of VARIVAX (Merck) due to an office error.  No adverse reaction reported.  Additional information has been requested.  Follow-up has been received from the physician who stated that there was no adverse effect to reported.  "The patient was fine."  Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Angioedema, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a child patient who was vaccinated with the initial dose of MMR II and developed a rash. The only clue to the age of the child is the child is due for a second dose to enter school. The patient has sought medical attention at office and had recovered from rash (date unspecified). Follow up information has been received from a physician concerning the 6 year old male patient who was vaccinated with MMR II. Subsequently the patient experienced facial angioedema and fever of 102. The patient was taken to the emergency room and was given adrenaline and steroids. Subsequently, the patient recovered on an unspecified date. Upon internal review, facial angioedema requiring adrenaline and steroids was determined to be other important medical event. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a patient who on 19-MAY-2009 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) subcutaneously. It was reported that the patient was supposed to received ZOSTAVAX (Merck) (MSD). It was reported that this was related to human error and not product confusion. No adverse effect reported. Follow up information was received from a registered nurse on 28-MAY-2009. It was reported that the patient was inadvertently given VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). It was a human error. The administrator of the vaccine just grabbed the wrong bottle. The patient was doing fine and would receive ZOSTAVX (Merck) (MSD) sometime next month. Follow up information has been received from a registered nurse. It was reported that the 60 year old female patient with no pertinent medical history, no drug reactions/allergies, no illness at time of vaccination on 19-MAY-2009 was vaccinated subcutaneously in the left deltoid with a dose of VARIVAX (Merck) (Lot # 660495/0431X) in the morning. Concomitant therapy included vitamins (unspecified), baby aspirin, ALEVE, TYLENOL ARTHRITIS PAIN and calcium (unspecified) (+) vitamin D (unspecified). There were no adverse reactions per patient. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Myalgia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 38 year old male who on 04-MAY-2009 was vaccinated with VARIVAX (Merck) (dose, route and lot number unspecified).  The physician reported the patient developed a varicella rash on the face, neck and abdomen, about 18 days after vaccination (approximately 22-MAY-2009).  The patient also had myalgia.  The outcome of the patient was not recovered.  The patient sought medical attention at the physician's office.  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 an elderly patient who on 21-MAY-2009, was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to a human error. No adverse effect reported. Additional information has been requested.
Age: 0.11
Sex: M
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning her son who in April 2007 was vaccinated with the first 0.5 ml dose of MMR II. Concomitant therapy included Hep B (unspecified) (name and manufacturer unknown, but this vaccine had been withdrawn from the market due to side effects). In April 2007, the patient experienced seizures after getting vaccination. The patient had sought medical attention, he saw the physician. At the time of report the patient's status was recovered. Upon internal review, seizures was determined to be an other important medical event. No further information is available.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 4 year old female who on 15-APR-2009 was vaccinated with a dose of VARIVAX (Merck) (lot # 663823/0221Y) through the Vaccines for Children program.  It was reported that the patient had injection site reaction.  The patient recovered.  This is one of several reports from the same source.  No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an adult female patient who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck). It was reported that on an unspecified date, the patient was diagnosed with chickenpox. The patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a dental hygienist concerning a her "11 year old" son who on approximately 20-MAY-2009 was vaccinated with a second dose of VARIVAX (Merck) (Lot # not reported). In the same day he received Tdap in different arm. After got the vaccines he experienced an injection site reaction to both vaccines. The injection sites were swollen (3 inches diameter ball), red and hot to the touch. The patient was told to take BENADRYL and on 26-MAY-2007 the patient had stomach ache. The patient sought unspecified medical attention. The hygienist also mentioned that her son friend's went to the same office and got Tdap and MENACTRA and also had an unspecified reaction to both. There were no laboratories diagnostics studies performed. No further information is available.