chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient (gender not specified) who on an unspecified date, was inadvertently vaccinated with VARIVAX vaccine (Oka/Merck) instead of ZOSTAVAX vaccine (Oka/Merck) (MSD) due to physician error. No adverse effect reported. In follow-up information received, it was reported by the registered nurse, that this case was not product confusion. The doctor did not sate the order correctly and clearly. The doctor accepted full responsibility for this event. Since the event, the physician's office's doctor has done additional training to educate the staff on the terminology and confusion with terminology (chickenpox vaccine). They may or may not continue to provide the ZOSTAVAX vaccine (Oka/Merck) (MSD). They are considering leaving this to the primary care physician to avoid problems in the future. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV, TD, VARCEL
Symptoms: Incorrect storage of drug, Nausea, Vomiting
Clinical narrative: Information has been received from an immunization program officer, concerning an unknown number of patients who on an unspecified date, were vaccinated with improperly stored VARIVAX (Merck).  The vaccines were exposed to 8 to 17 degrees F for the past three months.  No adverse effect reported.  In follow-up information received, it was confirmed that the office may not be able to determine if any patients were vaccinated with VARIVAX (Merck) that was stored improperly.  It was explained that the office had not gone back to determine if any patients were vaccinated at the time the temperature excursions appeared to have occurred.  Although the refrigerator seemed to be holding the correct temperature, the officer reported that there may have been a few episodes of slightly variable temperatures.  At the time of reporting, there is no certainty that any patient was involved.  Follow up information has been received from a physician concerning a 72 year old female with penicillin and sulfa allergy, and no illness at time of the vaccination who on 08-JUL-2008 was vaccinated in the physician's office, with the first dose of VARIVAX (Merck) (Lot No 660325/0092X), subcutaneously, in the left deltoid.  On that same day, the patient also received the second dose of POLYVAL (Lot No 1679U), subcutaneous, in the right deltoid, and DECAVAC (Lot No U2287AA), intramuscularly.  The physician reported that the same day (08-JUL-2008) the patient experienced nausea.  The patient experienced vomiting the next day for "several days.  The patient did not seek medical attention.  The patient first contacted the doctor's office by phone on 15-JUL-2008.  The patient recovered spontaneously prior to 15-JUL-2008.  The physician reported that the patient attributes the symptoms to her vaccination.  Follow up information was received from a practice who reported that had no further information and doesn't want to receive any further inquiries.  No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a physician and other health professional concerning a 17 month old (previously reported at 18) female patient with no previous medical history and illness at time of vaccination, who on 10-JUN-2008 was vaccinated with a dose of VARIVAX (lot# 660496/0389X) SQ in the right thigh. On 14-SEP-2008 the patient was diagnosed with shingles, erythematous rash with some clear vesicles in dermatomal pattern on back extended under axilla. On 25-SEP-08, the patient recovered without any signs. No further information is available.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician assistant concerning a 44 year old male who on 05-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # 658587/1520U). On 07-SEP-2008, the patient developed a rash. The patient's rash persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with no previous medical history reported and an allergic reaction to bee sting who on 19-JUN-1997 was vaccinated with the first dose of VARIVAX (Oka/Merck) 0.5 mL subcutaneously in the left arm. On 18-SEP-2008, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot #0956X). There was no concomitant medication. On 18-SEP-2008, the patient developed an immediate injection site reaction, an itchy, red, warm area at the injection site described as a large wheal. The patient was kept in the office for 20 minutes and administered BENADRYL. The patient was recovering when they left the office and has not contacted the office 24 hours after the vaccination. There was no product quality complaint. Additional information is expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Injection site erythema
Clinical narrative: Information has been received from a health care professional concerning a 14 year old female who on 23-AUG-1999 was vaccinated with the first dose of VARIVAX (Merck), 0.5 mL. On 29-AUG-2007 the patient was vaccinated with the second dose of VARIVAX (Merck). On 19-SEP-2008, the patient was vaccinated with a third dose of VARIVAX (Merck). There was no concomitant medication. On 20-SEP-2008 the patient's mother phoned the office stating that her daughter had redness at the injection site. No treatment required. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a female physician who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) or with ZOSTAVAX (Oka/Merck) (MSD). The pharmacist reported that she is not actively working outside the home but a friend consulted her about transmissibility of Varicella. The pharmacist's friend disclosed her female doctor was vaccinated with VARIVAX, unknown if VARIVAX (Oka/Merck) or ZOSTAVAX (Oka/Merck) (MSD) and had a rash. The physician told this person not to worry she was not contagious. But her friend was not so sure. The patient's outcome was unknown. No further information is available.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 11 year old patient with no pertinent medical history, allergies or drugs reactions, who on 27-JAN-1999 was vaccinated with the first dose of VARIVAX (Oka/Merck) and second dose was received on 07-NOV-2001. On 18-SEP-2008 the patient experienced chickenpox on chest and arms. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a patient who on an unknown date was vaccinated with VARIVAX (Oka/Merck). On an unknown date, the patient developed a breakthrough of chickenpox after getting the VARIVAX (Oka/Merck). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who received the first dose of VARIVAX (Oka/Merck). Subsequently the patient experienced mild chicken pox rash. No additional information. It was unknown whether the patient sought medical attention. No further information is available.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Antibody test negative, Hepatitis B antibody negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female who was vaccinated with 2 doses of of VARIVAX (Oka/Merck) and 3 doses of RECOMBIVAX HB on unspecified dates. Now the patient had low antibody titers to both varicella and hepatitis B. No further information available. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Dermatitis, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 10 year old male with no pertinent medical history or drug reactions/allergies, who on 11-SEP-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 06044 - not valid) IM into his right "ARL". Concomitant vaccination included a second dose of HAVRIX (lot # AHAVB282BH) IM into her left arm. There was no illness at time of vaccination. On 11-SEP-2008 the patient experienced severe dermatitis over entire body with swelling of legs. The patient was treated with 4 mg of dexamethasone and 0.25 unspecified therapy for symptoms described. On 11-SEP-2008 the patient was recovered. No lab tests or diagnostic studies were performed. Further information is not expected.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician and a health care worker concerning a 16 year old male patient who on 02-DEC-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot#661977/1275X). On 04-DEC-2008 the patient experienced cellulitis and was hospitalized. The patient's cellulitis persisted. Patient is still in the hospital as of 05-DEC-2008. It is unknown if the patient had a reaction to the first dose of VARIVAX (Oka/Merck). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Follow-up information was received from a healthcare worker who reported that the patient (weight: 204 pounds, Height 68 inches) with an allergy to penicillin/amoxicillin. The patient developed increase in redness, swelling and warmth at the injection site and was diagnosed with cellulitis on 04-DEC-2008. The patient was treated with cephalexin 500 mg every six hours per ten days with effect. However the patient went to the emergency room and was admitted for two days. The patient recovered on 14-DEC-2008. This is one of two reports received from the same source. No further information is available.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a little over 12 month old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) and a dose of MMR II (Wistar RA 27/3) (MSD). Approximately one month later, the patient developed target lesions in different stages, including papules. There were no vesicles and no mucosal involvement. The lesions resolved within a few days. It was unspecified if the patient sought medical attention or not. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health care worker concerning a 15 month old patient who was vaccinated with a first dose of VARIVAX on an unspecified date. The patient got chickenpox after getting VARIVAX. Unspecified medical attention sought. The patient's outcome was unknown. Medical attention sought. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Information has been received from a medical assistant concerning a three elementary school aged patient about the age of 8 or 9 who received the second dose of VARIVAX (Oka/Merck) (lot# "0996 Y or X") on the same day the patient developed a raised knot, reddened area and about three inches in diameter. The onset of the symptoms was not specified. The symptoms resolved in an unspecified period of time. No other symptoms resolved in an unspecified period of time. No other symptoms or treatment reported. Follow-up Information has been received from a medical assistant who identified one of the patients as a 15 year-old female patient who received the second dose of VARIVAX (Oka/Merck) The medical assistant reported she could not remember any other information on the patient. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Culture wound negative, Erythema, Injection site cellulitis, Rash
Clinical narrative: Initial and follow-up information has been received from a physician and a nurse concerning a 5 year old male patient, who on 03-NOV-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot # 661662/1137X) on his right thigh. The physician reported that on 04-NOV-2008, the patient experienced cellulitis on the right thigh. On 05-NOV-2008, the patient was hospitalized. At the time of the initial report the patient had not recovered and was still in the hospital. In follow-up information the nurse reported that the patient was hospitalized from 04-NOV-2008 to 06-NOV-2008. On 04-NOV-2008, the patient was seen in the doctor's office, because of a red, hot and swollen rash on his leg. He was given AUGMENTIN, but the rash continued to spread. He was sent to the emergency room and was admitted because of the speed the rash was spreading. He was given IV antibiotics and cultures were negative for a reaction to varicella. At the time of follow-up report, the patient was at home and doing better. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: Initial and follow-up information has been received from a physician and a nurse concerning a 5 year old male patient, who on 03-NOV-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot # 661662/1137X) on his right thigh. The physician reported that on 04-NOV-2008, the patient experienced cellulitis on the right thigh. On 05-NOV-2008, the patient was hospitalized. At the time of the initial report the patient had not recovered and was still in the hospital. In follow-up information the nurse reported that the patient was hospitalized from 04-NOV-2008 to 06-NOV-2008. On 04-NOV-2008, the patient was seen in the doctor's office, because of a red, hot and swollen rash on his leg. He was given AUGMENTIN, but the rash continued to spread. He was sent to the emergency room and was admitted because of the speed the rash was spreading. He was given IV antibiotics and cultures were negative for a reaction to varicella. At the time of follow-up report, the patient was at home and doing better. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning three patients who between June 2008 and August 2008 were vaccinated with the second dose of VARIVAX (Oka/Merck). The patients developed chickenpox after receiving the second dose of vaccine. No other symptoms and no treatment reported. No other information available. 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. "This is one of several reports provided by the same source". Since the reporter mentioned the other 3 school-aged kids (WAES #0809USA04612). Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: C-reactive protein normal, Chest X-ray normal, Coordination abnormal, Febrile convulsion, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 14 month old female with no drug allergies or reactions a history of reactive airways and frequent rhinitis who on 17-OCT-2008 was vaccinated with the first dose of VARIVAX (Merck). Concomitant therapy included MMR II (dose not reported). Other concomitant medication on that same date included Influenza virus vaccine (manufacturer unspecified). On 18-OCT-2008 the patient developed a low-grade fever, one day after receiving her first dose of MMR II and VARIVAX (Merck) on 17-OCT-2008. On 22-OCT-2008 the patient developed a high fever, vomiting, muscle twitches and a febrile seizure. On 22-OCT-2008 the patient was seen in the office that day, a complete blood count, urinalysis, sed rate, C-reactive protein and chest x-ray were negative. On 24-OCT-2008, the patient's mother sought a second-opinion in a local emergency room. The physician relays a "completed workup" of unspecified tests in the emergency room were negative. On 25-OCT-2008, the patient became afebrile. On 30-Oct-2008 the patient was seen in the office again because of a decrease in hand-eye coordination and episodes of "vacant staring". It is not known if these episodes are seizure. The physician is ordering an electroencephalogram and, possibly, a neurological consult. On 30-OCT-2008 the physician reported that patient was not recovered from febrile seizure, decrease in hand-eye coordination, muscle twitches, vacant staring and vomiting. No further information is available. Upon internal review febrile seizure was considered as an other important medical events. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Laboratory test normal, Muscle twitching, Pyrexia, Red blood cell sedimentation rate normal, Staring
Clinical narrative: Information has been received from a physician concerning a 14 month old female with no drug allergies or reactions a history of reactive airways and frequent rhinitis who on 17-OCT-2008 was vaccinated with the first dose of VARIVAX (Merck). Concomitant therapy included MMR II (dose not reported). Other concomitant medication on that same date included Influenza virus vaccine (manufacturer unspecified). On 18-OCT-2008 the patient developed a low-grade fever, one day after receiving her first dose of MMR II and VARIVAX (Merck) on 17-OCT-2008. On 22-OCT-2008 the patient developed a high fever, vomiting, muscle twitches and a febrile seizure. On 22-OCT-2008 the patient was seen in the office that day, a complete blood count, urinalysis, sed rate, C-reactive protein and chest x-ray were negative. On 24-OCT-2008, the patient's mother sought a second-opinion in a local emergency room. The physician relays a "completed workup" of unspecified tests in the emergency room were negative. On 25-OCT-2008, the patient became afebrile. On 30-Oct-2008 the patient was seen in the office again because of a decrease in hand-eye coordination and episodes of "vacant staring". It is not known if these episodes are seizure. The physician is ordering an electroencephalogram and, possibly, a neurological consult. On 30-OCT-2008 the physician reported that patient was not recovered from febrile seizure, decrease in hand-eye coordination, muscle twitches, vacant staring and vomiting. No further information is available. Upon internal review febrile seizure was considered as an other important medical events. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 month old female with no drug allergies or reactions a history of reactive airways and frequent rhinitis who on 17-OCT-2008 was vaccinated with the first dose of VARIVAX (Merck). Concomitant therapy included MMR II (dose not reported). Other concomitant medication on that same date included Influenza virus vaccine (manufacturer unspecified). On 18-OCT-2008 the patient developed a low-grade fever, one day after receiving her first dose of MMR II and VARIVAX (Merck) on 17-OCT-2008. On 22-OCT-2008 the patient developed a high fever, vomiting, muscle twitches and a febrile seizure. On 22-OCT-2008 the patient was seen in the office that day, a complete blood count, urinalysis, sed rate, C-reactive protein and chest x-ray were negative. On 24-OCT-2008, the patient's mother sought a second-opinion in a local emergency room. The physician relays a "completed workup" of unspecified tests in the emergency room were negative. On 25-OCT-2008, the patient became afebrile. On 30-Oct-2008 the patient was seen in the office again because of a decrease in hand-eye coordination and episodes of "vacant staring". It is not known if these episodes are seizure. The physician is ordering an electroencephalogram and, possibly, a neurological consult. On 30-OCT-2008 the physician reported that patient was not recovered from febrile seizure, decrease in hand-eye coordination, muscle twitches, vacant staring and vomiting. No further information is available. Upon internal review febrile seizure was considered as an other important medical events. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician who heard that an adult female who was vaccinated with VARIVAX (Oka/Merck) (route and site was not reported) experienced Guillain-barre syndrome after receiving the VARIVAX. Guillain-barre syndrome was reported as immediately life-threatening. The patient sought unspecified medical attention. The outcome was unspecified. The physician had no further information to provide. Attempt made to verify the existence of an identifiable patient and reporter was unsuccessful. No further information is available.
Age: 41.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 41 year old female with no pertinent medical history and no known drug reactions or allergies, who on 23-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # 661334/0737X) 0.5 mL, subcutaneously into her left triceps. Concomitant vaccination included a fifth dose of ENGERIX-B (lot # AHABVB584AA) into her left thigh. On 24-SEP-2008 the patient developed an injection site reaction following vaccination with VARIVAX (Merck). The patient had a large raised oval reddened area approximately 6" long to 2" wide, and a swollen area that was 6 inches long (shaped like a cucumber). The oval was mostly below the injection site, but just at the injection site the area was hardened and warm in addition to being swollen and red. Skin area was hot to touch. The patient did not have any fever. Reactions caused a significant discomfort. No fever reported. It was also reported that there was itching at site of injection (also reported as beginning on day 4 on 26-SEP-2008). There were no labs or diagnostic studies performed. The patient sought unspecified medical attention. The patient recovered from the large raised reddened area, significant discomfort, itching at site and area hot to touch on 29-SEP-2008 (previously reported as 28-SEP-2008). The patient also recovered from all the adverse events on 29-SEP-2008. There was no illness at time of vaccination. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 41 year old female with no pertinent medical history and no known drug reactions or allergies, who on 23-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # 661334/0737X) 0.5 mL, subcutaneously into her left triceps. Concomitant vaccination included a fifth dose of ENGERIX-B (lot # AHABVB584AA) into her left thigh. On 24-SEP-2008 the patient developed an injection site reaction following vaccination with VARIVAX (Merck). The patient had a large raised oval reddened area approximately 6" long to 2" wide, and a swollen area that was 6 inches long (shaped like a cucumber). The oval was mostly below the injection site, but just at the injection site the area was hardened and warm in addition to being swollen and red. Skin area was hot to touch. The patient did not have any fever. Reactions caused a significant discomfort. No fever reported. It was also reported that there was itching at site of injection (also reported as beginning on day 4 on 26-SEP-2008). There were no labs or diagnostic studies performed. The patient sought unspecified medical attention. The patient recovered from the large raised reddened area, significant discomfort, itching at site and area hot to touch on 29-SEP-2008 (previously reported as 28-SEP-2008). The patient also recovered from all the adverse events on 29-SEP-2008. There was no illness at time of vaccination. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning a newborn baby (DOB 20-Mar-2008) who was a sibling of a patient vaccinated with VARIVAX (Oka/Merck), developed varicella on 15-APR-2008 and was admitted to the hospital. The physician was not interested in VZVID. Subsequently, the patient  recovered from varicella months ago. It was not reported whether the patient sought medical attention. This was one of two reports from the same source. The other patient was a sibling (WAES # 0810USA01850). On 10-OCT-2008, the physician's MVX stated that the patient's sibling was vaccinated with VARIVAX (Oka/Merck) at the health department. The patient's sibling had just a handful of lesions that were crusting over when this baby was born and his sibling was the presumed contact. Additional information was received from the patient's HCP physician who reported that the 10 days old patient was a sibling of a 19 month old otherwise healthy child who received VARIVAX (Oka/Merck) and subsequently developed a "bunch" of lesions. The newborn patient developed varicella and was hospitalized, treated with ACYCLOVIR. There was no evidence of meningitis. The baby had recovered; he was now approximately 5 months old an otherwise health (no history of immunocompromise). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a dose of VARIVAX (Oka/Merck) subcutaneously. The patient experienced redness and extreme swelling of 5-6 inches in diameter at injection site after administration of vaccine. It was also painful to touch. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician and a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of VARIVEX (Oka/Merck). Subcutaneously. Subsequently, on an unknown date, the patient experienced redness and extreme swelling at injection site after administration of VARIVEX (Oka/Merck). The swelling was so extreme, it expanded to part of patient's chest. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered from redness and extreme swelling at injection site. No additional information is available. Additional information is not expected as the physician requested not to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician who was told by another physician, that a patient who in the past was vaccinated with VARIVAX (Oka/Merck), developed herpes zoster. The date of administration of the vaccine and the onset date of the shingles was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Immunology test abnormal, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 14 month old male with no relevant medical history or allergies who on 19-JUN-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported), a dose of MMR II, a dose of PREVNAR and a dose of hepatitis A virus vaccine (unspecified). On 15-JUL-2008 the patient first developed a few spots and was seen in the office on 22-JUL-2008 with worsening head to toe chickenpox. He was prescribed ZOVIRAX and BENADRYL. At the time of reporting, the patient was recovering from the event. According to the physician, full blown chickenpox was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 month old patient who on 09-SEP-2008 was vaccinated with VARIVAX (Oka/Merck). Vaccination on the same day included MMR II, VAQTA (manufacturer unknown) and PREVNAR. The licensed practical nurse reported a child presented with chicken pox lesions. The licensed nurse stated there were lesions on the child's body and face "but has already been vaccinated with VARIVAX (MSD) and the baby seems happy". At the time of reporting the patient had not recovered. Medical attention was sought: the physician was contacted. There was no product quality complaint. Follow-up received from an office manager indicated that the practice does not have any further information to report.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 24 year old male who on an unspecified date was vaccinated with VARIVAX. About ten days after vaccination, the patient developed generalized, diffuse varicella rash with low grade fever. It was unspecified if patient sought medical attention. At the time of the reporting, the patient had recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Laboratory test, Swollen tongue, Varicella post vaccine
Clinical narrative: Information has been received from a 60 year old female with penicillin allergy and sulfonamide allergy and a history of liver transplant, arthritis and gastrectomy who in  August 2001 was vaccinated with a single dose of VARIVAX (Oka/Merck). Concomitant therapy included anti rejection medication (the name were unspecified). In August 2001, the patient experienced tongue swollen within a couple days of receiving the vaccine. On 31-AUG-2001 the patient was hospitalized and put in isolation and on antibiotics because she had broken out with a case of chicken pox with 20-25 lesions on her body. The patient was released from the hospital on 7-SEP-2001. On 16-SEP-2001 the patient developed an even worse case of chicken pox and herpes zoster and was hospitalized. The lesions were on her left and right side of the stomach, thigh and pubic area. The patient was put back into isolation and put on antibiotics. "A lot of test" and "took pictures" were performed. On 23-SEP-2001 the patient was released from the hospital. On 23-SEP-2001 the patient recovered from chicken pox and herpes zoster. No further information is available.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, VARCEL
Symptoms: Anaphylactic reaction, Blood pressure systolic decreased, Dyspnoea, Face oedema, Hypotension
Clinical narrative: Information has been received from a physician concerning a male with positive skin test for egg and soy (physician stated not a clinical allergy to soy) and a history of cleft palate syndrome who on 29-Nov-2006 was vaccinated his first dose of VARIVAX (Oka/Mereck) at the primary health care provider's office. Suspect vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). Post vaccination the patient had an anaphylactic reaction, was treated and monitored and was not hospitalized. Subsequently the patient recovered . On 21-May-2008 at 3 years of age, the patient was vaccinated with his second dose of VARIVAX (Oka/Mereck) at the same primary care provider's office and other vaccines. At 15 minutes post-vaccination, the patient experienced a second occurrence of anaphylactic reaction in the parking lot and was taken back into the doctor's office, treated and taken by ambulance to the hospital. The child was hospitalized for 24 hours and treated with epinephrine, anti-histamines and oral steroids. The child had a follow-up visit with the physician. Subsequently, the patient fully recovered. Follow-up information has been received from a physician concerning an 18 month old male patient who's initial initial episode of anaphylaxis occurred on 29-Nov-2006. During that visit, he had also received PEDIARIX, (Oka/Merck) and influenza vaccine. This was his primary immunization to the VARIVAX (Oka/Merck). He went to develop fitful sneezing, copious rhinorrhea, facial and periorbital edema. He was treated with epinephrine and Benadryl and cleared promptly. He subsequently was skin test positive to egg but had not been skin tested to the individual vaccines. On 21-May-2008 the patient received the second dose of VARIVAX (Oka/Merck). He went on to develop a similar but more severe reaction with copious rhinorrhea, fitful sneezing, generalized urticaria, wheezing and labored breathing. The patient was treated with epinephrine and Benadryl and was transported via 911 to a local emergency room. There he went to develop a late-phase reaction with recurrence of similar symptoms but also had some hypotension with systolic blood dropping into the 50s. The patient received additional emergency care, IV fluids, and recovered with no sequela. Anaphylactic reaction was considered to be immediately life-threatening and another important medical event by the physician. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, VARCEL
Symptoms: Periorbital oedema, Rhinorrhoea, Skin test positive, Sneezing, Urticaria
Clinical narrative: Information has been received from a physician concerning a male with positive skin test for egg and soy (physician stated not a clinical allergy to soy) and a history of cleft palate syndrome who on 29-Nov-2006 was vaccinated his first dose of VARIVAX (Oka/Mereck) at the primary health care provider's office. Suspect vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). Post vaccination the patient had an anaphylactic reaction, was treated and monitored and was not hospitalized. Subsequently the patient recovered . On 21-May-2008 at 3 years of age, the patient was vaccinated with his second dose of VARIVAX (Oka/Mereck) at the same primary care provider's office and other vaccines. At 15 minutes post-vaccination, the patient experienced a second occurrence of anaphylactic reaction in the parking lot and was taken back into the doctor's office, treated and taken by ambulance to the hospital. The child was hospitalized for 24 hours and treated with epinephrine, anti-histamines and oral steroids. The child had a follow-up visit with the physician. Subsequently, the patient fully recovered. Follow-up information has been received from a physician concerning an 18 month old male patient who's initial initial episode of anaphylaxis occurred on 29-Nov-2006. During that visit, he had also received PEDIARIX, (Oka/Merck) and influenza vaccine. This was his primary immunization to the VARIVAX (Oka/Merck). He went to develop fitful sneezing, copious rhinorrhea, facial and periorbital edema. He was treated with epinephrine and Benadryl and cleared promptly. He subsequently was skin test positive to egg but had not been skin tested to the individual vaccines. On 21-May-2008 the patient received the second dose of VARIVAX (Oka/Merck). He went on to develop a similar but more severe reaction with copious rhinorrhea, fitful sneezing, generalized urticaria, wheezing and labored breathing. The patient was treated with epinephrine and Benadryl and was transported via 911 to a local emergency room. There he went to develop a late-phase reaction with recurrence of similar symptoms but also had some hypotension with systolic blood dropping into the 50s. The patient received additional emergency care, IV fluids, and recovered with no sequela. Anaphylactic reaction was considered to be immediately life-threatening and another important medical event by the physician. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, VARCEL
Symptoms: Vaccine positive rechallenge, Wheezing
Clinical narrative: Information has been received from a physician concerning a male with positive skin test for egg and soy (physician stated not a clinical allergy to soy) and a history of cleft palate syndrome who on 29-Nov-2006 was vaccinated his first dose of VARIVAX (Oka/Mereck) at the primary health care provider's office. Suspect vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). Post vaccination the patient had an anaphylactic reaction, was treated and monitored and was not hospitalized. Subsequently the patient recovered . On 21-May-2008 at 3 years of age, the patient was vaccinated with his second dose of VARIVAX (Oka/Mereck) at the same primary care provider's office and other vaccines. At 15 minutes post-vaccination, the patient experienced a second occurrence of anaphylactic reaction in the parking lot and was taken back into the doctor's office, treated and taken by ambulance to the hospital. The child was hospitalized for 24 hours and treated with epinephrine, anti-histamines and oral steroids. The child had a follow-up visit with the physician. Subsequently, the patient fully recovered. Follow-up information has been received from a physician concerning an 18 month old male patient who's initial initial episode of anaphylaxis occurred on 29-Nov-2006. During that visit, he had also received PEDIARIX, (Oka/Merck) and influenza vaccine. This was his primary immunization to the VARIVAX (Oka/Merck). He went to develop fitful sneezing, copious rhinorrhea, facial and periorbital edema. He was treated with epinephrine and Benadryl and cleared promptly. He subsequently was skin test positive to egg but had not been skin tested to the individual vaccines. On 21-May-2008 the patient received the second dose of VARIVAX (Oka/Merck). He went on to develop a similar but more severe reaction with copious rhinorrhea, fitful sneezing, generalized urticaria, wheezing and labored breathing. The patient was treated with epinephrine and Benadryl and was transported via 911 to a local emergency room. There he went to develop a late-phase reaction with recurrence of similar symptoms but also had some hypotension with systolic blood dropping into the 50s. The patient received additional emergency care, IV fluids, and recovered with no sequela. Anaphylactic reaction was considered to be immediately life-threatening and another important medical event by the physician. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 40 month old boy without medical history and no allergy who on 23-JAN-2007 was vaccinated with VARIVAX (Merck) (Lot# 653971/0796F). There was no concomitant medication. On 20-SEP-2008 the patient experienced chickenpox, and developed 50-60 lesions all over his body. The patient was seen by the physician. There were no lab and diagnostics tests. At the time of reporting, the patient was recovering from the chickenpox. This is one of two cases reported. No further information is available.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 7 year old female who on 03-MAR-2003 was vaccinated SC with VARIVAX (lot number 643529/0598M). Secondary suspect therapy included MMR II and concomitant vaccinations included a dose of ACTHIB. After having VARIVAX, on 24-SEP-2008 the patient developed chickenpox. The patient developed approximately 20 lesions on her face, arm, and trunk. No further information is available. The patient sought medical attention., Follow-up information was received on 29-JAN-2009 from a physician indicating that he did not known who this patient was and could not provide any additional information. Follow-up information was received on 03-FEB-2009 from a nurse indicating that the office had no additional information about the patient. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: MEA, VARCEL
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 13 month old female with no medical history or allergies who on 23-SEP-2008 was vaccinated with a dose of MMR II. Concomitant suspect vaccine therapy included a dose of VARIVAX (MSD). On 01-OCT-2008, the patient developed a mild fever (101.9 F) and diarrhea. The patient was being evaluated by the physician at the time of the time of reporting. No treatment was reported. The outcome was reported as not recovered/not resolved. A product quality complaint was not involved. Follow-up information was received from the physician's office. It was reported that they are not sure who the patient was and that they do not administer the MMR II at their facility. The office requested that they would not like any further contact regarding this adverse experience. Due to the inflammation received in follow-up, VARIVAX was changed to the primary suspect vaccine and MMR II was changed to the secondary suspect vaccine. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to human error. No product confusion. The patient visited the office on unknown date. No adverse effect noted. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no pertinent medical history and no allergies who on 05-MAR-2009 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot# 660668/1380X). Other suspect vaccine received on 05-MAR-2009 included MMR II (Wistar RA 27/3) (lot # 661675/1505X) (rHA). There was no concomitant medication. Within four hours after receiving the vaccinations the patient experienced vomiting and decreased appetite. The patient recovered from vomiting and decreased appetite within 8 hours of vaccination. Lot checks have been requested.  This is in follow-up to report(s) previously submitted on 5/15/2009. Standard lot check investigations were performed. All in-process quality checks for the lot number 660668/1308X and 661675/1505X in question were satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. This is one of several reports from the same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no pertinent medical history and no allergies who on 05-MAR-2009 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot# 660668/1380X). Other suspect vaccine received on 05-MAR-2009 included MMR II (lot# 661675/1505X). There was no concomitant medication. Within four hours after receiving the vaccinations the patient experienced vomiting and decreased appetite. The patient recovered from vomiting and decreased appetite within 8 hours of vaccination. Lot checks have been requested. This is one of several reports from the same source. Additional information has been requested. 6/18/10 Standard lot check investigations were performed. All in-process quality checks for the lot number 660668/1380X and 661675/1505X in question were satisfactory. The lots met the requirements and were released. This is one of several reports from the same source.
Age: 1.2
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction, Rash vesicular, Scab
Clinical narrative: Information has been received from a physician concerning a 14 month old patient who on 02-MAR-2009 was vaccinated with a dose of VARIVAX (dose, route and lot number not provided). Ten days after vaccination on 12-MAR-2009, the patient experienced "a local reaction that looks like zoster". The physician stated there was "two centimeter raised area with brown crusts." The patient had not recovered from the event at the time of the report. The patient sought medical attention by contacting the physician. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a registered pharmacist concerning a 21 year old patient who was vaccinated with one or two doses of VARIVAX (Oka/Merck) (Lot # not reported). The patient was found to have negative antibody titers for varicella. No further information is available.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning a 72 year old male who was supposed to received ZOSTAVAX (Oka/Merck) on 10-MAR-2009 was vaccinated with VARIVAX (Oka/Merck) (lot # 660654/0392X). The patient sought unspecified medical attention. No adverse experience reported. No additional information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This is in follow-up to report(s) previously submitting on 5/15/2009. Information has been received from a pharmacist concerning a child (age unknown) who on an unspecified date was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number not provided). The pharmacist reported that the mother may had developed varicella after her child received the vaccine. The reporter mentioned that the child was breast feeding at the time of transmission. The patient sought unspecified medical attention with a physician. The age of the child that received the VARIVAX (Oka/Merck) was unknown. At the time of the report, the pharmacist was uncertain if physician was interested in Polymerase Chain Reaction (PCR) analysis and he was not sure if positive transmission occurred. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: Information has been received from a bachelor of science in nursing concerning her 5 year old daughter who in 1995 was vaccinated with VARIVAX. In 2000 the patient experienced a severe case of chickenpox. Later the patient experienced shingles. On an unspecified date the patient recovered from chickenpox and shingles. The patient sought unspecified medical attention at the physician's office. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning an 8 year old male with unknown drug reactions, asthma and a history of hives (developed after receiving the 2nd dose of MMR II (WAES# 0903USA03186)) who on 12-MAR-2009 was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot # 661994/1390X). Concomitant therapy included montelukast sodium. On 12-MAR-2009 the patient experienced hives and itching after the vaccination. The patient was given BENADRYL. Patient then started having difficulty breathing. The patient was taken to emergency room and sent home the same day. The patient recovered on an unspecified date. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a bachelor of science in nursing concerning her 1 year old son who in 1998 was vaccinated with VARIVAX (Merck).  In 2000 the patient experienced chickenpox.  The outcome of the patient was unknown.  This is one of several reports from the same source.  Additional information has been requested.