chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
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 female patient who received the first dose of VARIVAX (Merck) on 03-FEB-2005, and received the second dose on 23-MAY-2008. The reporter indicated that the lot numbers were unknown because the vaccines were given in another center. 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 nurse practitioner concerning a patient who in 2003 was vaccinated with VARIVAX (Merck) (lot# not reported). Subsequently the patient experienced an outbreak of chicken pox. The patient was then given another dose of VARIVAX (Merck) (lot# not reported) as a booster (date unspecified). It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 1.45
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a licensed visiting nurse concerning an 18 month old male with reactive airways disease and a history of febrile convulsion in 2008, who on 04-MAR-2009 was vaccinated SC with first 0.5mL dose of VARIVAX (Merck) (lot number 661989/1740X).  Concomitant therapy included Hep A (manufacturer unknown).  On 08-APR-2009 the patient was seen at physicians office and was described as having "mild case" of chickenpox.  No lab studies were performed.  At the time of reporting the patient was recovering from the event.  This is one of two reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a nurse concerning a female who on unspecified date was vaccinated with a of VARIVAX (Merck) 0.5ml (route and lot number was not provided) and GARDASIL (Merck) on the same day. The nurse reported "one day after vaccination" the patient experienced a 103 fever and a localized rash on the arm the VARIVAX (Merck) was given. The patient's outcome was reported as recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash papular, Ulcer
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with juvenile diabetes who on 25-MAR-1998 was vaccinated with a first dose of VARIVAX (Merck). The nurse reported the patient was vaccinated with her second dose of the vaccine on 6-APR-2009 (lot number: 663299/1774X). Subsequently, The nurse reported on 07-APR-2009, the patient experienced swollen, red, hot at the injection site that was "5x4" in size. "The patient also had ulceration as well as other small bumps". The nurse stated the bumps were not vesicles and did not look like shingles or chicken pox. The patient was treated with hot compress and antibiotic treatment. The outcome of the patient was not recovered and sought at the office medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on an unspecified date was vaccinated with VARIVAX (Merck) (lot # not reported).  It was reported that the patient recently received a dose of VARIVAX (Merck) and developed a shingles like rash on her knee.  The patient was seen by the physician.  At the time of reporting, the patient had not recovered.  Additional information is not expected.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old patient who on 03-MAR-2009 was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot# not provided) instead of with a dose of ZOSTAVAX (Merck) (lot# not provided) due to human error. No adverse effect reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a licensed practical nurse concerning her female coworker who on 10-APR-2009 was splashed with VARIVAX (Merck) in her eyes while withdrawing the vaccine.  She felt little burning when some of the liquid had gotten into her eyes.  The patient sought unspecified medical attention. At the time of reporting the patient was recovering.  Information has been received from a licensed practical nurse concerning her female coworker who on 10-APR-2009 was splashed with VARIVAX (Merck) in her eyes while withdrawing the vaccine.  She felt little burning when some of the liquid had gotten into her eyes.  The patient sought unspecified medical attention.  At the time of reporting the patient was recovering.  Follow-up information was received from a licensed visiting nurse concerning a 40 year old patient who is a registered nurse.  It was reported that the registered nurse was drawing up VARIVAX (Merck) upon injection diluent into VARIVAX (Merck) vial and the needle popped of the syringe the contents of the vial sprayed back into her face.  It was reported that the registered nurse's eyes were flushed for 15 minutes.  No laboratory diagnostic studies were performed.  At the time of reporting no serious criteria had been noted and the registered nurse was recovered.  No further information is available.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Drug exposure before pregnancy, Nausea, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from consumer, for VARIVAX (Merck), a Pregnancy Registry product concerning herself, a 35 year old female with a history of fibroid surgery in 2006 who on 10-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck). Lot # not available. On 06-APR-2009, patient was tested positive for pregnancy at physician's office through a urine pregnancy test (LMP: 01-MAR-2009, EDD: 06-DEC-2009). On the same date, the patient reported that she had been experiencing nausea and stomach ache. At the time of reporting the patient's nausea and stomach ache persisted. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old male patient who on an unspecified date was vaccinated with VARIVAX (Merck). It was reported that the patient received 2 doses of VARIVAX (Merck) and he had breakthrough of varicella after receiving the last dose. Lot number not available. The patient's sought medical attention, he went to clinic. At the time of reporting the patient's outcome was unknown. A phone call was received from a woman in a physician's office stating that they did not have any further information to provide regarding this adverse experience. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 6 year old male who on 04-MAR-2009 was vaccinated SC with second 0.5mL dose of VARIVAX (Merck) ( lot number 661989/1740X). On 08-APR-2009 the patient was seen at physician's office and was described as having "mild case" of chickenpox. No lab studies were performed. The patient was being treated with ZOVIRAX. At the time of reporting the patient was recovering from the event. This is one of two reports from the same source. Follow up information has been received from a health professional concerning a 6 year old male with no pertinent medical history reported, no known drug allergies and no illness at the time of vaccination who on 04-MAR-2009 was vaccinated in the right arm with the second dose of VARIVAX (Merck) (lot number 661989/1740X). The health professional reported that on 08-APR-2009 the patient presented to the office with a mild case of varicella. The patient recovered on an unspecified date. No further information is available.
Age: 1.12
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Body temperature increased, Pyrexia, Rash erythematous, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 13 month old female with AUGMENTIN allergy and no pertinent medical history reported who on 01-APR-2009, was vaccinated SC in the left upper arm with first 0.5mL dose of VARIVAX (Merck) (lot number 662459/1784X).  There was no concomitant medication.  On 11-APR-2009, the patient developed four lesions on her lower extremity.  Three of the lesions were "red bumps like bites" and one lesion "looks like a popped vesicle".  The four lesions were localized to the calf-area of the right lower leg.  No treatment was prescribed.  No lab studies were performed.  At the time of reporting, patient had not recovered from the events.  The patient sought medical attention by an office visit.  Follow up information was received from a registered nurse concerning a 13 month old female with AUGMENTIN allergy and no illness at the time of vaccination who on 01-APR-2009 in the morning, was vaccinated SC in the left arm with first dose of VARIVAX (Merck) (lot number 662459/178X).  On 10-APR-2009 at 09:31 A.M., the patient developed fever (100F) and had a red raised spot on her back and on the diaper area.  On 13-APR-2009, there was a questionable pox on her leg.  Subsequently, the patient recovered within an unspecified date. No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Information has been received from a certified medical assistant concerning her 32 month old female who on 25-FEB-2009 was vaccinated with a dose of VARIVAX (Merck) 0.5ml (route not reported). There was no concomitant medication. On 15-MAR-2009 the patient experienced macular rash that covered her entire body except for her face and feet. The rash did got away the next day (16-MAR-2009) and the patient recovered. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a registered nurse concerning herself, 49 year old female with no medical history and no known drug allergies who reported some VARIVAX (Merck) (lot # was not available) splashed into her left eye and face on 16-APR-2009. There was no concomitant medication. On 16-APR-2009 the patient's left eye was burning. The patient did not have lab diagnostics studies performed. The patient did not seek medical attention. At time of the report the patient was not recovered. Follow-up information was received from the registered nurse who reported that on 16-APR-2009, a small amount of VARIVAX (Merck) was sprayed onto left side of her face and in left eye as she was drawing up the vaccine. Her eye was irrigated right away. The nurse stated that she had no problem since. At the time of the nurse had recovered. No further information is available.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Ocular hyperaemia, Vision blurred
Clinical narrative: Information has been received from a registered nurse, concerning herself, a 56 year old female with no medical history or drug allergies who reported that on 15-APR-2009 she had either VARIVAX (Merck) or MMR II (MSD) splashed in her eye while working at the pediatrics. She was almost certain that it was VARIVAX (Merck). Concomitant therapy included LEXAPRO, DIOVAN HCT, WELLBUTRIN, ALLEGRA, FLONASE and XANAX. She did not rinse her eye. On 15-APR-2009 her eyes were red, her vision was not clear. Her symptoms were similar to conjunctivitis. The patient did not have lab diagnostics studies performed. The patient did not seek medical attention. At the time of the report on 16-Apr-2009, the patient was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a patient who in April 2009, was vaccinated with a second dose of VARIVAX (Merck). The nurse reported that the patient reported a case of chickenpox this week. The patient did not seek medical attention. At the time of this report the patient had not recovered. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Rash pruritic, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with no pertinent medical history and no known drug allergies who on 27-JAN-1999 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (subcutaneous injection, lot # 628147/1262H).  There was no concomitant medication.  The nurse was reporting that on 05-FEB-1999 the patient developed itchy rash on face, ears, nose, and hands after receiving her first dose of VARIVAX (Merck).  On approximately 01-SEP-2009, the patient had the titer done, but it came back as negative for varicella immunity.  On unspecified date, the patient recovered.  On unspecified date, the patient saw the physician.  Follow up information has been received from a healthcare professional indicated that a 6 year old (previously reported as 5 year old) patient experienced rash on 27-JAN-1999 (previously reported as 05-FEB-1999).  Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 01-SEP-2009 was vaccinated with the first dose of VARIVAX (Merck) (dose, route, and lot# not reported). The nurse was reported that the patient inadvertently received VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD) due to a human error. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, Dependence on enabling machine or device, Myelitis transverse
Clinical narrative: Information has been received from a registered nurse concerning her grandson who on unknown date was vaccinated with VARIVAX (Merck) (Lot number was not reported). The patient developed transverse myelitis that had him restricted to a power chair after vaccination. It was unspecified if the patient sought medical attention. At the time of the report, the outcome of the events was unknown. Upon internal review, transverse myelitis was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event, Varicella virus test negative
Clinical narrative: Information has been received from a medical student concerning a 33 year old female patient who was vaccinated with2 doses of VARIVAX (Merck) "at an unknown time in the past". It was reported that the patient has negative varicella titer. The patient sought medical attention in the office. The outcome was reported as not recovered. Additional information has been requested.
Age: 1.55
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Blister, Rash papular, Rash pustular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 19 month old female patient with pertinent medical history unknown who on 10-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) lot number 661869/1010X. Secondary suspect therapy included MMR II (MSD). On 30-AUG-2009 the physician reported that the patient who had received VARIVAX (Merck) developed diffuse lesions on her chest and arms. The physician reported that the patient had 3 large papules and 2 small papules. At the time of this report the patient had not recovered. The patient sought medical attention in the physician office. Follow-up information has been received from the physician who reported that the 21 month year old female patient (previously reported as 19 month year old) with amoxicillin allergy on 10-AUG-2009 was vaccinated with the first dose of MMR II (MSD) subcutaneously at her right lat and with a dose of BOOSTRIX (Lot# AC20B116AB) into her left thigh. There was no illness at the time of vaccination. On 02-SEP-2009 (approximately at 09:00 am) the patient developed vesicular lesions less than 50, 3 larges papules, 2 small pustules and diffusive lesions in chest and arms. On 05-SEP-2009, the patient recovered from vesicular lesions, pustules and diffusive lesions. No further information is available.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Blood pressure increased, Erythema, Induration, Pruritus
Clinical narrative: Information has been received from a 47 year old female patient with antibiotics and mold allergy and seasonal allergies, who on 28-JUL-2009 was holding her granddaughter while she was been vaccinated with a dose of VARIVAX (Merck). On 18-AUG-2009 the patient broke out in approximately 5 itchy blisters on her left leg, then on the top of her left foot and back of her left leg. The blisters started out hard and red under the skin and then swelled and developed into fluid filled blisters. The patient went to the nurse practitioner who diagnosed her with shingles. The patient was treated with generic acyclovir (unspecified) and a "cream" was prescribed. The patient stated that she was then treated with prednisone (unspecified), but it shot up her blood pressure to 218/128, so the patient went to the emergency room on 28-AUG-2009. The patient was not hospitalized but the attending doctor told her that she did not have shingles, since the blisters were not following a nerve route. The patient also mentioned that the attending doctor told her that she did not have chicken pox either, but the same virus as the chickenpox, since this was vaccine related to the her grandchild. On 30-AUG-2009, the patient developed 6 new blisters on her left leg. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Secondary transmission, Swelling
Clinical narrative: Information has been received from a 47 year old female patient with antibiotics and mold allergy and seasonal allergies, who on 28-JUL-2009 was holding her granddaughter while she was been vaccinated with a dose of VARIVAX (Merck). On 18-AUG-2009 the patient broke out in approximately 5 itchy blisters on her left leg, then on the top of her left foot and back of her left leg. The blisters started out hard and red under the skin and then swelled and developed into fluid filled blisters. The patient went to the nurse practitioner who diagnosed her with shingles. The patient was treated with generic acyclovir (unspecified) and a "cream" was prescribed. The patient stated that she was then treated with prednisone (unspecified), but it shot up her blood pressure to 218/128, so the patient went to the emergency room on 28-AUG-2009. The patient was not hospitalized but the attending doctor told her that she did not have shingles, since the blisters were not following a nerve route. The patient also mentioned that the attending doctor told her that she did not have chicken pox either, but the same virus as the chickenpox, since this was vaccine related to the her grandchild. On 30-AUG-2009, the patient developed 6 new blisters on her left leg. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Alpha 1 foetoprotein normal, Assisted delivery, Blood test normal, Complication of pregnancy, No adverse event
Clinical narrative: Initial and follow-up information had been received from a physician for the Pregnant Registry for VARIVAX (Merck) concerning a 16 year old female patient with a history of 0 pregnancies and 0 live births who on 08-AUG-2008 was vaccinated subcutaneoulsy with a 0.5ml dose of VARIVAX (Merck) (Lot # 659953/0329X) on the same day the patient was vaccinated with a dose of GARDASIL (lot # 660387/1967U). Concomitant therapy included prenatal vitamins (unspecified), INFANRIX (lot #AC52B027AA), MENACTRA (lot # U2665AA), influenza virus vaccine (unspecified) (lot # U2828AA), and TYLENOL. Subsequently, the patient became pregnant (LMP 27-JUL-2008 and EDD 03-MAY-2009), and on 04-MAY-2009, delivered a normal, healthy male baby weighing 38.95 grams. There were complications during the pregnancy as excessive weight, gestational hypertension and protracted labor required vacuum assist. It was reported that pre-natal blood work had normal results, a pre-natal ultrasound on 30-DEC-2008 showed no abnormalities, and a serum alpha-fetoprotein test (MSAFP) on 04-FEB-2008 was normal. No adverse effects reported. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Pregnancy induced hypertension, Prolonged labour, Ultrasound scan normal, Weight increased
Clinical narrative: Initial and follow-up information had been received from a physician for the Pregnant Registry for VARIVAX (Merck) concerning a 16 year old female patient with a history of 0 pregnancies and 0 live births who on 08-AUG-2008 was vaccinated subcutaneoulsy with a 0.5ml dose of VARIVAX (Merck) (Lot # 659953/0329X) on the same day the patient was vaccinated with a dose of GARDASIL (lot # 660387/1967U). Concomitant therapy included prenatal vitamins (unspecified), INFANRIX (lot #AC52B027AA), MENACTRA (lot # U2665AA), influenza virus vaccine (unspecified) (lot # U2828AA), and TYLENOL. Subsequently, the patient became pregnant (LMP 27-JUL-2008 and EDD 03-MAY-2009), and on 04-MAY-2009, delivered a normal, healthy male baby weighing 38.95 grams. There were complications during the pregnancy as excessive weight, gestational hypertension and protracted labor required vacuum assist. It was reported that pre-natal blood work had normal results, a pre-natal ultrasound on 30-DEC-2008 showed no abnormalities, and a serum alpha-fetoprotein test (MSAFP) on 04-FEB-2008 was normal. No adverse effects reported. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MNQ, VARCEL
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Ultrasound antenatal screen normal
Clinical narrative: Initial and follow-up information has been received from a nurse midwife for the pregnancy registry for VARIVAX (Merck), concerning an 18 year old female with a history of 8 pregnancies and 0 live births who on 03-OCT-2008 was vaccinated with the second dose of VARIVAX (Merck), the third dose of RECOMBIVAX HB (MSD) and the first dose of VAQTA (MSD). Concomitant therapy included MENACTRA and DTaP (unspecified). The patient may have been pregnant at the time of administration (LMP 08-SEP-2008 and EDD 15-JUN-2009 also reported 19-JUN-2009). No adverse reaction reported. No product quality complaint involved. The patient did not seek medical attention. Follow up information has been received from a nurse midwife reported that on 15-JUN-2009 the patient delivered a normal, healthy male baby weighing 8 pounds 7 ounces. Medication taken during pregnancy included PHENERGAN for the treatment of nausea and vomiting on 18-NOV-2008 and FLAGYL for the treatment of Bacterial vaginosis on 10-APR-2009. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Delivery, Drug exposure during pregnancy, Perineal laceration, Ultrasound scan normal
Clinical narrative: Information has been received from a physician through the pregnancy registry for VARICELLA ZOSTER VIRUS CONTAINING VACCINES, concerning a female with morning sickness who in October 2008, was vaccinated with VARIVAX (Merck).  The patient was vaccinated while pregnancy.  LMP: 13-SEP-2008 and EDD: 20-JUN-2009.  On 23-JAN-2009 an ultrasound was performed to check fetal health and was normal.  All telephone attempts to obtain follow-up information has been unsuccessful. Follow up information has been received from a nurse who reported that the primipara female patient had a normal, spontaneous, vaginal delivery on 24-JUN-2009.  The nurse reported that the baby was "perfectly fine", there were no congenital anomalies.  The baby birth weight was 9 lbs 1.4 ounces.  It was reported that the mother had a 3rd degree spontaneous laceration at delivery which had healed.  It was noted that at the time of the report, the patient was returning to the office for her annual examination. No further information is available.
Age: 1.67
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site papule
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 month old female with no medical history or drug allergy who on 02-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 662201/1544X), SQ, 0.5ml. There was no concomitant medication. On 16-MAR-2009 the patient developed erythema and duration at the injection site of the left upper arm. The patient was examined in the office on 19-MAR-2009 and no treatment was prescribed. The patient did not have any lab diagnostics study performed. At time of the report the patient was recovering. Follow-up information has been received from the licensed practical nurse concerning the patient was vaccinated in the left arm. On 17-MAR-2009 morning (previous reported as 16-MAR-2009) the patient's skin at vaccine site developed 0.5cm induration, erythema and 2 papules. No further information is available. This is one of several reports received from the same source.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site scab, Injection site vesicles
Clinical narrative: Information has been received from a licensed practical nurse concerning a 28 month old male with autism who on 06-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 662201/1544X), SQ, 0.5ml. There was no concomitant medication. On 16-MAR-2009 the patient experienced vesicular lesions at the injection site of the left upper arm. The patient was examined in the office on 19-MAR-2009 and was prescribed topical antibiotic ointment. At time of the report the patient was recovering. Follow-up information has been received from a licensed practical nurse concerning the patient on 06-MAR-2009 was vaccinated with first dose of VARIVAX (Merck) (lot # 662201/1544X) in left arm, SQ, 0.5ml. On 16-MAR-2009 the patient's skin at site of vaccine 3 blisters with slight scab and faint erythema of 3 cm. Antibiotic ointment was applied to the area. No further information is available. This is one of several reports received from the same source.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Information has been received from a consumer her approximately 5 year old son who was vaccinated with VARIVAX (Merck) in "2000" 0.5 mL. After getting VARIVAX (Merck) the patient developed sudden body pains. The patient sought unspecified medical attention. At the time of reporting, the outcome was not reported. No further information is available.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a physician concerning a 12 or 13 year old female who was vaccinated with a second dose of VARIVAX (Merck) 0.5 mL (lot# 662382/1758X). 5 days after vaccination the patient developed a rash that was raised and looked like dusty cinders". The patient went to a dermatologist for this AE, but the rash cleared up on its own without intervention on unspecified date. It was reported the AE occurred after reintroduction. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a patient who last week on approximately 02-AUG-2009 was vaccinated with one dose of VARIVAX (Merck) (LOT # was not provided) and then experienced a chicken pox outbreak. The outcome of the patient was unknown. It was also unknown that the patient sought medical attention. Follow-up information has been received from the nurse that there was no patient involved and that she was just calling for clarification. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a consumer concerning her son, a 12 year old male with allergies to penicillin and KEFLEX and with no medical history, who on 17-MAR-2009 was vaccinated with the second dose of VARIVAX (Merck), SQ, 0.5ml. There was no concomitant medication. On 18-MAR-2009 the patient developed a swelling "about the size of a dime". On 19-MAR-2009 the patient had a rash on his hand and the swelling was "the size of a golf ball." The reporter brought him to see the doctor and was told that it was just his body reacting to the vaccine. On 20-MAR-2009 the swelling "is about the size of the palm of my hand" and he still had the rash. The patient had no lab diagnostics study performed. At the time of the report the patient was not recovered. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure, Eye discharge
Clinical narrative: Information has been received from a 49 year old female registered nurse with no known allergies and history of cataract surgery performed four years ago who on 28-OCT-2009 was administering MMR II (Lot No. 663798/0357Y) to a patient and the child moved and some of the solution splashed into the nurse's eye. The nurse flushed her eye with cool water. There was a little mucous present. Concomitant medication included SYNTHROID. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was not recovered. This is one of two reports received from the same source. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, No reaction on previous exposure to drug, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no medical history or allergies who on 16-FEB-2009 was vaccinated SC in the right arm with the first dose of VARIVAX (Merck) (lot # 659601/1909U). There was no concomitant medication. The patient was not ill at the time of vaccination and had no prior reactions to prior vaccinations. On 03-MAR-2009 the patient developed 12 to 18 varicella like lesions on the left lower abdomen with erythema and fever. It required a doctor visit and the patient recovered from the symptoms on 06-MAR-2009. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Drug exposure during pregnancy, Measles antibody negative, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician concerning a 32 year old female patient with no pertinent medical history and no known drug reactions or allergies who in June 2009, was vaccinated subcutaneously with a dose of 0.5 ml of MMR II "in another country". There were no concomitant medications. According to the physician her titers were checked when she came to region and her mumps titer was negative. The physician gave her another dose of MMR II on 17-SEP-2009. The physician reported that later it was found that the patient was pregnant at the time of administration. LMP: 28-AUG-2009. EDD: 10-JUN-2010. The patient sought medical attention by an office visit. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with no medical history allergies or drug reactions, who on 15-JUN-2004 was vaccinated with the first dose of VARIVAX (Merck) (Lot no. 648083/0072P) SC and with a dose of MMR (Lot no. 646906/0956N), SC (dose not reported).  On 18-APR-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot no. 659941/1791U) SC and with a dose of MMR (Lot no. 659540/1745U), SC (dose not reported).  Other concomitant therapy included a dose of (Lot no. 495-212) PREVNAR and a dose of (B223AD) HAVRIX.  The nurse reported that on 14-MAR-2009 the patient developed many papules and a few vesicles on trunk, arms and legs.  It was reported that the patient experienced varicella.  The patient was prescribed TYLENOL and BENADRYL.  Subsequently, the patient recovered from varicella.  The patient sought medical attention by a doctor visit.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Cough, Erythema, Headache, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning he 4 year old son with asthma, dermatitis atopic, cow's milk allergy, egg allergy, peanut allergy, allergic reaction to cats, dogs, tree, grass, weeds and mold who on approximately 25-OCT-2006, at the age of 12 months was vaccinated with the first dose of MMR II vaccine. On 02-NOV-2009 afternoon, the patient was vaccinated with the second dose of MMR II vaccine in the upper arm. Secondary suspect vaccination included a dose of AFLURIA (MSD) 2 weeks prior to getting the MMR II vaccine. Concomitant vaccination administered on 02-NOV-2009 included 3 unspecified vaccines. The reporter did not recall the name of the vaccines, but stated that the vaccinations were appropriate for 4 year old age group. 2 vaccinations were given in each arm. Other concomitant therapies included montelukast sodium (MSD), 1 puff of FLOVENT, multivitamin with sodium FLOVENT and PERIACTIN. On 02-NOV-2009, the patient was monitored for approximately 15 minutes post vaccination and then went home. Approximately 45 minutes later at home, the patient's face and ears were red and itchy. The patient developed congestive cough, headache and stomachache. unspecified medical attention was sought. There were no laboratory diagnostic studies performed. the patient was treated with 18.75mg of BENADRYL and 2 puffs of albuterol inhaler. Forty minutes later, the patient had relieved from the reaction. In the evening at 9PM, CLARITIN, 5mg was also given to the patient. By the next morning, the patient fully recovered. The reporter wondered if the vaccination of AFLURIA (MSD) may have contributed to the reaction. Since the patient did not have this type of reaction after the first dose of MMR II vaccine. Follow-up information has been received from a physician concerning a patient with allergic reactions to egg, milk and peanuts and with no illness at the time of vaccination who on 02-NOV-2009 at approximately 3:00PM the patient was vaccinated with the second dose of MMR II vaccine (lot# 664889/0872Y) (rHA) in her right arm. On 02-NOV-2009 at 4:00PM, the patient developed face swelling and itching. The patient did nor seek any medical attention. The patient was given BENADRYL and recovered on 02-NOV-2009. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Information has been received from a nurse practitioner concerning he 4 year old son with asthma, dermatitis atopic, cow's milk allergy, egg allergy, peanut allergy, allergic reaction to cats, dogs, tree, grass, weeds and mold who on approximately 25-OCT-2006, at the age of 12 months was vaccinated with the first dose of MMR II vaccine. On 02-NOV-2009 afternoon, the patient was vaccinated with the second dose of MMR II vaccine in the upper arm. Secondary suspect vaccination included a dose of AFLURIA (MSD) 2 weeks prior to getting the MMR II vaccine. Concomitant vaccination administered on 02-NOV-2009 included 3 unspecified vaccines. The reporter did not recall the name of the vaccines, but stated that the vaccinations were appropriate for 4 year old age group. 2 vaccinations were given in each arm. Other concomitant therapies included montelukast sodium (MSD), 1 puff of FLOVENT, multivitamin with sodium FLOVENT and PERIACTIN. On 02-NOV-2009, the patient was monitored for approximately 15 minutes post vaccination and then went home. Approximately 45 minutes later at home, the patient's face and ears were red and itchy. The patient developed congestive cough, headache and stomachache. unspecified medical attention was sought. There were no laboratory diagnostic studies performed. the patient was treated with 18.75mg of BENADRYL and 2 puffs of albuterol inhaler. Forty minutes later, the patient had relieved from the reaction. In the evening at 9PM, CLARITIN, 5mg was also given to the patient. By the next morning, the patient fully recovered. The reporter wondered if the vaccination of AFLURIA (MSD) may have contributed to the reaction. Since the patient did not have this type of reaction after the first dose of MMR II vaccine. Follow-up information has been received from a physician concerning a patient with allergic reactions to egg, milk and peanuts and with no illness at the time of vaccination who on 02-NOV-2009 at approximately 3:00PM the patient was vaccinated with the second dose of MMR II vaccine (lot# 664889/0872Y) (rHA) in her right arm. On 02-NOV-2009 at 4:00PM, the patient developed face swelling and itching. The patient did nor seek any medical attention. The patient was given BENADRYL and recovered on 02-NOV-2009. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a class of 15 students who within the past few weeks were exposed to chickenpox. On an unknown date, each had been vaccinated with one dose VARIVAX (Merck) and all had breakthrough cases of varicella. The nurse practitioner is waiting one more week to see if anyone else in the school district will have breakthrough after having one dose of VARIVAX (Merck). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Age: 1.34
Sex: F
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 16 month old female patient with no allergy to eggs who on 02-SEP-2009 was vaccinated with the first dose of MMR II (lot number, route and site not reported). 10 minutes after vaccination, the patient developed a rash locally at the injection site that was 10 centimeters. The patient had sought unspecified medical attention. At the time of the report, the patient had recovered. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Haematochezia
Clinical narrative: Information has been received from a consumer concerning her nephew who on an unspecified date was vaccinated with a dose of MMR II.  Subsequently, on an unspecified date the patient developed blood stool a month later received the MMR II.  It was unknown if the patient sought medical attention.  At the time of the report, the patient was 4 years old.  The outcome of the event was unknown.  The patient had a twin sister who experienced an AE post vaccination with MMR II (MSD, WAES # 0911USA01595).  Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a physician concerning a cluster of cases in approximately 6-7 boys in one classroom who were approximately 17 years old who on unspecified dates had received 2 doses of MMR II (doses, durations and lot numbers were not reported). The physician reported that he had done some laboratory work to confirm the diagnosis of mumps in a few children. He indicated that he did not find any children who were Immunoglobulin M (IgM) positive for mumps, but most were immunoglobulin G (IgG) positive. The physician said that most children had parotid gland swelling. At the time of the report, the patients' statuses were unknown. The physician also mentioned that he was seeing a fair number of mumps in his community and that there were "a lot" of cases in similar religious communities. 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 from the same source. Additional information had been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Herpes zoster, Rash, Varicella virus test
Clinical narrative: Information has been received from a physician concerning a 10 year old male who in approximately 1999 was vaccinated with a "standard dose" of VARIVAX (Merck) and MMR II (Merck), when he was one year old. On approximately 18-MAR-2009 the patient experienced shingles with multiple painful lesions on his back. The patient's shingles in his back persisted. The patient sought unspecified medical attention. No further information was available. Follow up information has been received from the physician concerning his patient who on approximately 18-APR-1999 was vaccinated with 0.5 mL (standard dose) of VARIVAX (Merck) and MMR II (Merck). The patient was vaccinated at age of 1 year. There were no concomitant medication. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient never had chicken pox. There was not recent exposure to chicken pox or shingles. On 20-MAR-2009, the patient had some redness and his back and arm. On 21-MAR-2009, the patient's parents stated he had vesicles. The patient came into the office on 24-MAR-2009 with a maximum temperature of 99.5. The rash was described as numerous vesicles in T7 dermatome on the R side of back and wrapped around just anterior of mid-axillary line. The patient was started the treatment for the rash. On 25-MAR-2009 a culture was taken and sent the lab on 25-MAR-2009 (results not reported). A direct fluorescent antibody and specimen for PCR were not collected. As of 27-MAR-2009 the patient was not recovered and was currently on treatment. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine VZV strain. The sample of the lesion was collected on 25-MAR-2009. The sample was taken from a vesicular lesion. The PCR results for the specimen from vesicular lesion identified the presence of WT VZV. Additional information is not expected.
Age: 1.11
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Condition aggravated, Influenza like illness, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from a mother concerning her approximately 15 month old daughter who was vaccinated with VARIVAX (Merck) (lot # not reported) about 3 months ago (in approximately December 2008).  About 2 days after vaccination, the patient developed a swollen injection site, fever, flu-like symptoms and malaise.  They were treated with cold compresses to the injection site and TYLENOL.  The symptoms lasted 3 weeks.  Subsequently, the patient recovered from swollen injection site, fever, flu-like symptoms and malaise.  Unspecified medical attention was sought.  It was reported that the patient had had similar reactions to other unspecified vaccinations.  Follow-up information from the physician revealed that the patient was a 13 month old female with benign left breast buds and food intolerance who on 27-OCT-2008 was vaccinated SC with the first dose of VARIVAX (Merck) (lot # 661868/1009X) into the right side.  Concomitant therapy included the first dose of HAVRIX (lot # 18243M).  The physician reported that she was unaware of any adverse advent.  Subsequently, the patient recovered.  The physician considered the events to be non-serious.  Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test, Viral titre decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 43 year old female who was vaccinated with 2 doses of VARIVAX (Merck) as an adult and failed to seroconvert. The patient received her vaccines at the proper schedule but dates unknown. The patient received these when she decided to have children. A recent titer in 2009 showed lack of titer to varicella. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. No further information is available.
Age: 63.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist student concerning a patient who was scheduled to received ZOSTAVAX (Merck) but was inadvertently vaccinated with VARIVAX (Merck) on 26-MAR-2009.  The patient did not experience any known symptoms.  Follow up information was received from a registered nurse per voice mail.  It was reported the 64 year old patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck).  The nurse reported that "it was her carelessness that led to the incorrect vaccine administered and that it would be helpful if the boxes for VARIVAX and ZOSTAVAX were different in color."  Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Nurse Practitioner (N.P) concerning a 3 or 4 patients who on an unspecified date were vaccinated with a dose of VARIVAX (Merck).  It was reported that the patients complained about redness around the injection site.  It was reported that this was something that had not happened in the past.  Follow up information has been received from the nurse practitioner concerning a 9 year old male student with seasonal allergies who on 03-AUG-2009, at 2:15 P.M., was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot # 664712/0799Y) into the left arm.  There was no illness at time of vaccination.  On 04-SEP-2009, at 4:55 P.M., the patient developed injection site red, hot and swollen.  No medical attention was sought.  On an unspecified date, the patient recovered.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse four patients who on unspecified dates was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported).  On unreported dates, after vaccination, the patients experienced local injection site reactions.  No further information was available at the time of this report.  Follow-up information has been received from a nurse concerning a 14 year old female who in the week or so of 24-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (LOT# 664620/0797Y).  "During the week or so of 24-JUL-2009", the patient experienced injection site reactions.  She had recovered at the time of this report.  Follow-up information has been received from a registered nurse concerning the 14 year old female who on 29-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (LOT# 664620/0797Y).  On 31-JUL-2009, the patient experienced local injection site reaction described as swelling and erythema.  The patient had responded to icing and observation.  On an unknown date, the patient recovered.  A lot check has been initiated.  This is one of several reports from the same source.  Additional information has been requested.