chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Pain, Pain in extremity, Polymerase chain reaction
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 11 year old male with no pertinent medical history and no allergies who on 18-May-1998 was vaccinated with a dose of VARIVAX (Oka/Merck). There was no concomitant medication. On 10-May-2008 the patient developed symptoms of shingles, left arm pain and a rash. The patient was seen by the physician on 15-May-2008 and the rash was cultured for varicella Zoster virus (VZV) by a polymerase chain reaction (PCR) test. The PCR test results returned with a positive diagnosis on 19-May-2008. No other symptoms were reported. At the time of the report, the patient was recovering from shingles. Follow-up information was received on 24-June-2008 from the R.N. concerning an 11 year old male student with no pre- existing allergies, birth defects or medical conditions who on 18-May-1998 was vaccinated in the right arm with a first dose of VARIVAX (Oka/Merck) (lot #625375/0065H). There was no illness at time of vaccination. On 08-May-2008 the patient developed left forearm pain and new rash on hand and lateral arm. The cluster scabbed vesicles with red base were on left thumb and lateral forearm following C-6 dermatome. The patient also developed body aches for a few days. He had no fever. On 15-May-2008 the patient went to office. A polymerase chain reaction (PCR) test was performed on 19-May-2008 and results revealed "Varicella Zoster confirmation". The patient recovered from the event. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Scab, Viral DNA test positive
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 11 year old male with no pertinent medical history and no allergies who on 18-May-1998 was vaccinated with a dose of VARIVAX (Oka/Merck). There was no concomitant medication. On 10-May-2008 the patient developed symptoms of shingles, left arm pain and a rash. The patient was seen by the physician on 15-May-2008 and the rash was cultured for varicella Zoster virus (VZV) by a polymerase chain reaction (PCR) test. The PCR test results returned with a positive diagnosis on 19-May-2008. No other symptoms were reported. At the time of the report, the patient was recovering from shingles. Follow-up information was received on 24-June-2008 from the R.N. concerning an 11 year old male student with no pre- existing allergies, birth defects or medical conditions who on 18-May-1998 was vaccinated in the right arm with a first dose of VARIVAX (Oka/Merck) (lot #625375/0065H). There was no illness at time of vaccination. On 08-May-2008 the patient developed left forearm pain and new rash on hand and lateral arm. The cluster scabbed vesicles with red base were on left thumb and lateral forearm following C-6 dermatome. The patient also developed body aches for a few days. He had no fever. On 15-May-2008 the patient went to office. A polymerase chain reaction (PCR) test was performed on 19-May-2008 and results revealed "Varicella Zoster confirmation". The patient recovered from the event. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a male who's 5 year old son was vaccinated with VARIVAX (Oka/Merck) on an unspecified date.  Within 2 weeks, the child's father was diagnosed with shingles.  He was not immunocompromised prior to the outbreak.  At the time of reporting, the patient's outcome was unknown.  It was not specified if the patient sought medical attention.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 55 day old patient who on 16-MAY-2008 was vaccinated into the thigh with a dose of VARIVAX vaccine (Oka) (Lot# 659425/1916U). The nurse reported that on 16-MAY-2008 the patient was administered a dose of VARIVAX vaccine (Oka) instead of PREVNAR vaccine. This event was a result of human error, not product confusion. No adverse effect was reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise
Clinical narrative: Information has been received from a physician concerning his 5 year old grandson with a history of eczema (outgrew) and no known allergies who in May 2008, was vaccinated with the first dose of VARIVAX vaccine (Oka). There was no concomitant medication. On an unspecified date the patient was not feeling well. The patient sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 5 year old grandson who was vaccinated with at least one dose of VARIVAX (Merck) on an unspecified date.  He has spent the last 2 weekends with his cousin who had bumps on the bottom of her left foot appeared on 07-APR-2008.  On 09-APR-2007 the same type of bumps his cousin had were noticed on him.  These bumps were on his back, bottom and a couple on the left leg.  The consumer thinks her grandson is on montelukast sodium (MSD) for asthma.  No outcome was reported.  The consumer also reported on her granddaughter and her grandson's father who had a similar problem (refer to WAES number 0804USA02505 and 0805USA04930).  No further information is available.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Initial and follow-up information has been received from a nursing student concerning a 19 month old male with no known drug reaction/allergies or pertinent medical history who on 22-JUL-2003 was vaccinated SQ with her first dose of VARIVAX vaccine (Oka) (lot # 644721/0018N) 0.5 mL into his left upper arm. There was no concomitant medication. The nursing student mentioned that the patient received his first dose of VARIVAX vaccine (Oka) and 2 days after in 24-JUL-2008, developed 1 or 2 lesion (also reported as spots) on his thigh (no adverse) as per the mother's report. No lab diagnostics were performed. The patient did not seek medical attention. On 29-JUL-2003, the patient recovered. There was no product quality complaint. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a 75 year old female who on 16-MAY-2008 was vaccinated with a dose of VARIVAX (Merck) rather than ZOSTAVAX (Merck).  No product confusion, just nursing error.  No problem reported.  Follow-up information was received on 20-JUN-2008 from a health professional concerning a 75 year old female with no pre-existing allergies, birth defects or medical conditions who on 13-MAY-2008 (previously reported as 16-MAY-2008) was vaccinated in the left deltoid with a first dose of VARIVAX (Merck) (Lot #656078/0169U) rather that ZOSTAVAX (Merck).  The patient had no reactions.  On 16-JUN-2008 the patient was vaccinated in the right deltoid with a second dose of ZOSTAVAX (Merck) (Lot #658395/0966U).  There was no illness at the time of vaccination.  Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old male with no pertinent medical history or allergies who on 14-AUG-2006 was vaccinated subcutaneously with 0.5 ml first dose of VARIVAX (Merck) (lot # 653358/0442F).  On 30-JUL-2008 the patient was vaccinated subcutaneously with 0.5 ml second dose of VARIVAX (Merck) (lot # 659845/0270X) in the left thigh.  At the same office visit, the patient also received DTAP in the left thigh.  On 30-JUL-2008 the patient developed red blotches on the left thigh area near the site of vaccination.  On 31-JUL-2008 the left thigh became swollen.  On 31-JUL-2008 the patient was examined by the physician.  No laboratory diagnostics studies were performed.  The patient was prescribed ORAPRED.  No other symptoms or treatment reported.  At the time of the report, the patient was recovering.  At the time of the report, the patient was recovering.  Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 10 year old patient who was vaccinated with a dose of VARIVAX (Merck) and had a chickenpox breakthrough. At the time of report, it was unknown if the patient recovered or not.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 37 year old female who on 28-SEP-1998 was vaccinated with the first dose of VARIVAX (Merck) and on 31-OCT-1998 was vaccinated with the second dose of VARIVAX (Merck). The patient had a negative titer on 16-AUG-2007 (less than 0.91, no units specified). No problems reported. It was not reported if the patient sought medical attention. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old patient who was vaccinated with a dose of VARIVAX (Merck) (dose unspecified) and had a chickenpox breakthrough.  At the time of report, it was unknown if the patient recovered or not.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who on approximately 21-JUL-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot# 659342/1517U) (route and administration site not reported). The patient did not receive other vaccines that day. Within hours of the shot the patient experienced an injection site reaction and swelling at the injection site. The swelling worsened the day after the vaccination. Additional information has been requested. This is one of several reports from the same source.
Age: 2.5
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a office manager concerning a 30 month old female who was vaccinated with the first dose of VARIVAX (Merck) at their one year visit.  The patient just visited the office now 30 months old and has developed shingles.  At the time of the report it was unknown if the patient had recovered from shingles.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Information has been received from a registered nurse concerning one to two female patients between the ages 15 to 18 months out of 20 who were vaccinated with VARIVAX (Merck, lot #659345/1915U). Approximately 13 to 15 days post vaccination, the patients developed red, raised knot at the injection site following vaccination with the same lot numbers. Also refer to WAES #0804USA04795 and 0805USA05445). A lot check has been initiated. Additional information is not expected as the nurse is unable to provide any additional details regarding the three patients. On 05-JUN-2008 lot check results were received. 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 for Biologics Evaluation and Research and was released. No further information is expected.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who on approximately 21-JUL-2008 was vaccinated with a second dose of VARIVAX vaccine (Oka) (route and administration site not reported). Concomitant therapy included other vaccines (unspecified) which were not administered at the same site. Within hours of the shots the patient experienced an injection site reaction and swelling at the injection site. The swelling worsened the day after the vaccination. Additional information has been requested. This is one of several reports from the same source.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 5 year old boy with no pertinent medical history and no history of drug reaction or allergies, weight 43lb, height 44 inches, who on 16-Jun-2004 was vaccinated SQ with the first dose VARIVAX (Merck) (lot number not provided). On 19-May-2008 the patient was vaccinated SQ in the right arm with his second dose of VARIVAX (Merck) (Lot # 660043/1858U). There was no concomitant medication. At the time of injection of the second dose, the patient moved his arm. On 19-MAY-2008 the patient developed edema, redness and pain at injection site in the right arm. On 20-MAY-2008 the patient sought medical attention with a physician office visit. He was seen by the physician when the swelling reportedly increased. After 24 hours, the patient recovered. The reporter stated that she was not sure if the patient had any type of raection after the first dose since that dose was not given at their office. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 10 year old female with no related medical history and drug allergy who was vaccinated her first dose of VARIVAX vaccine (Oka) (lot # was not available) on 30-JUN-1998. On 13-MAY-2008 the patient was subcutaneously vaccinated her second dose of VARIVAX vaccine (Oka) (Lot # 660335/0097X). Subsequently the patient developed redness and pain of the vaccine site. On 14-MAY-2008 the patient was seen by the physician and was diagnosed as cellulitis. The patient started on KEFLEX and didn't improve. On 16-MAY-2008 BACTRIM was added. The symptoms lasted for 7-10 days and subsequently the patient recovered from cellulitis. No further information is available
Age: 1.3
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Information has been received from a physician concerning a 15 month old patient who was vaccinated IM with a first dose of VARIVAX (Merck). At the same visit, the patient was vaccinated with a dose of MMR II. Two days post-vaccination, the patient developed an arthus reaction which lasted approximately 72 hours. Unspecified medical attention was sought. The patient recovered after being treated with antihistamines. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old male who "about one month ago", in April 2008, was vaccinated with the second dose of VARIVAX (Merck) (lot # 660057/1806U) in the office from a state varicella catch up registry. Subsequently the patient developed redness, swelling, erythema, and hardness at the injection site. The reaction site was about the size of a baseball. The patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from medical assistant concerning a 7 year old patient who "about one month ago" in April 2008, was vaccinated with the second dose of VARIVAX (Merck) (lot #660057/1806U) in the office from a state varicella catch up registry. Subsequently the patient developed injection site reaction. The reaction was charactered by redness, swelling, erythema, and hardness at the injection site. The reaction was the size of a baseball. The patient recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a male dentist concerning his female friend who on 08-APR-2008 was vaccinated with VARIVAX (MERCK) instead of ZOSTAVAX (Merck) due to human error.  No adverse effects reported.  The reporting dentist also received VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to human error.  (WAES#:  0804USA04050)  Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Secondary transmission
Clinical narrative: Information has been received from a consumer concerning a 48 year old male with high blood pressure whose 5-year-old son developed bumps on his back, bottom and left leg (WAES #0805USA04691) after receiving VARIVAX vaccine (Merck) on an unspecified date. On 09-APR-2007 bumps were discovered and little bumps were mainly on his back. All the bumps were red but some had "festered and some had not". The consumer did not believe that the 48-year-old patient was vaccinated with VARIVAX vaccine (Merck). Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Rash papular, Rash pustular
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 16 month old male with no known allergies or pertinent medical history who on 08-JAN-2003 was vaccinated SQ with a 0.5ml dose of VARIVAX vaccine (MERCK) (Lot # 643821/0865M). There was no concomitant medication. In February 2003, he had a rash with raised bumps that were not itchy which later subsided. He was not seen in the office. On 22-MAR-2004 he was seen in the office with clusters of vesicles and pustules with yellow fluid on his right hand and arm. He was seen the same day by a dermatologist with a diagnosis of Shingles. The patient was treated with oral acyclovir. The patient has completely healed and there were no isolates to collect for VZVID. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Headache, Oropharyngeal pain, Varicella post vaccine
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 7 year old female, weight 46lb, who on 19-JUL-2001 was vaccinated with the first dose of VARIVAX vaccine (Merck) (lot#: 635792/1893K) and on 04-DEC-2006 at 15:00 was vaccinated with a second dose of VARIVAX vaccine (Merck) in the left arm (lot#: 654748/1060F). The 04-DEC-2008 at 15:00 the patient was also vaccinated with the first dose of HAVRIX vaccine in the left arm. On 27-APR-2008 the patient developed multiple chickenpox lesions on her trunk. On 28-APR-2008 the patient was seen in the physician's office. She also had headache, sore throat and no fever. On approximately 04-May-2008 the patient recovered. The patient was exposed to her grandfather who had a shingles outbreak recently. Her 1 brother and 1 sister also developed chickenpox after vaccination. (WAES#: 0804USA06382 and 0805USA05059).  Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Incorrect route of drug administration, Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 29 year old female who was vaccinated with VARIVAX (Merck). The nurse reported that the patient received VARIVAX (Merck) intradermally. The patient returned to the office the day after the administration of the vaccine with redness at the injection site. The patient was being treated for cellulitis. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician's office staff member concerning her daughter, a 4 year old female who on 16-MAY-2008 was vaccinated subcutaneously with a 0.5 ml second dose of VARIVAX (Merck) (LOT# 660219/0154X or 660289/1997U- the vaccine came from one of two lots, but it was not sure which one was received by the patient). Concomitant therapy included poliovirus vaccine. The patient developed swelling with warmth and redness from shoulder to elbow after receiving VARIVAX (Merck). Two days after vaccination, the patient recovered from the symptoms. The patient did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Abscess
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown). The patient experienced sterile abscess. The outcome was unknown at the time of reporting. The patient's sibling developed an AE after vaccination with VARIVAX (Merck) (WAES# 0804USA03479). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician's office staff member concerning a 4 year old boy who on 22-MAY-2008 was vaccinated with the second dose of VARIVAX (Merck) 0.5ml subcutaneously (lot# was either 660219/0154X or 660280/1997U). The patient developed swelling with warmth and redness from shoulder to elbow after receiving VARIVAX (Merck). Subsequently, the patient recovered. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old female, weight 39lb, height 48.5 inches, who on 05-DEC-2000 was vaccinated with the first dose of VARIVAX vaccine (Merck) and on 23-AUG-2007 at 16:00 was vaccinated with the second dose (also reported as the first dose) of VARIVAX vaccine (Merck) (lot#: 658422/1030U) in the left arm and the first dose of HAVRIX vaccine in the right arm.  The patient was seen in the physician's office on 29-APR-2008. She had chickenpox lesions for 4 days before the appointment. The patient was diagnosed with post vaccine varicella. On approximately 02-May-2008 the patient recovered. The patient was exposed to her grandfather who had a shingles outbreak recently. Her 1 brother and 1 sister also developed chickenpox after vaccination. (WAES#: 0804USA06382 and 0805USA05060). Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician and her first office staff member concerning a 4 year old patient who on 22-MAY-2008 was vaccinated with the second dose of VARIVAX (Merck) 0.5ml subcutaneously (lot# was either 660219/0154X or 660280/1997U). The patient developed swelling with warmth and redness from shoulder to elbow after receiving VARIVAX (Merck). Subsequently, the patient recovered. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician and her office staff member concerning a 4 year old boy who on 22-MAY-2008 was vaccinated with the second dose of VARIVAX (Merck) 0.5ml subcutaneously (lot# was either 660219/0154X or 660280/1997U). The patient developed swelling with warmth and redness from shoulder to elbow after receiving VARIVAX (Merck). Subsequently, the patient recovered. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Syncope, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received through the pregnancy registry from a registered nurse for VARIVAX (Merck) concerning a 20 year old female with no pertinent medical history and drug allergy who on 25-MAR-2008 was vaccinated subcutaneously with VARIVAX (Merck) 0.5 ml (Lot number 659072/1469U) (site not reported). Concomitant therapy included ORTHO TRI-CYCLEN LO. The patient's "urine human chorionic gonadotropin (hCG) level was negative". On 01-APR-2008 the patient fainted on the bus and was seen in the emergency room where it was discovered that she was pregnant. The patient sought medical attention. She was then seen on 15-APR-2008 at the clinic. The reporter mentioned that the patient was planning to terminate the pregnancy (for personal reasons, not related to the vaccine) and was assisted in making the appointment. But to the reporter's knowledge the pregnancy has not been terminated. The reporter mentioned that the patient has been been seen since 15-APR-2008 and probably would not been seen at this clinic again since she has been terminated from the program that she was a part of at the clinical building. Follow up information was received. The patient was no longer receiving care at this center. The reporter did not have any further information regarding health care professional contact information for this patient, for prenatal care or otherwise. The reporter had tried to contact the patient herself several times, unsuccessfully. This case had been lost follow-up.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male with no allergies and with Crohn's disease and who is immunocompromised as a result of taking 6 MP who on 15-MAR-1996 was vaccinated subcutaneous with a first dose of VARIVAX (Merck) and on 28-APR-2008 at 8:45AM was vaccinated subcutaneous in left triceps with the second dose of VARIVAX (Merck) (LOT# 660323/1973U) when the patient came in for routine physical examination. Concomitant therapy included 6 MP. On 29-APR-2008 the patient's father called the physician and stated that the patient became nauseated with abdominal pain and had swelling and tenderness at the injection site. The responsible physician called and spoke with another physician in infectious disease department who stated that the second dose of vaccine administration was fine. On 30-APR-2008 the patient felt better and less abdominal pain. His feeding was much improved. On 21-MAY-2008 the patient recovered from the symptoms. There was no product quality complaint. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Labyrinthitis
Clinical narrative: Information has been received from a registered nurse concerning a female in her 30's year old who on 19-MAY-2008 was vaccinated with a first dose of VARIVAX (Merck). Subsequently the patient developed an inner ear infection. The patient was placed on prednisone 60 mg daily for 5 days beginning on 22-MAY-2008 for the ear infection. On an unspecified date, the patient recovered from inner ear infection and appeared to be fine when she brought her child to the office for pediatric care. The patient sought medical attention. There was no product quality complaint. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Information has been received from a registered nurse concerning one to two male patients between the ages 15 to 18 months out of 20 who were vaccinated with VARIVAX vaccine (Merck, lot #659345/1915U). Approximately 13 to 15 days post vaccination, the patients developed red, raised knot at the injection site following vaccination with the same lot numbers Also refer to WAES # 0804USA04795 and 0805USA04398). A lot check has been initiated. Additional information is not expected as the nurse is unable to provide any additional details regarding the three patients. On 05-JUN-2008 lot check results were received. 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. No further information is expected.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old patient who was vaccinated with a dose of VARIVAX (Merck) (dose unspecified) and had a chickenpox breakthrough. At the time of report, it was unknown if the patient recovered or not.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 30 month old male with no other medical problems who on an unspecified date had been vaccinated with a dose of VARIVAX (Merck). The patient's mother reported that the patient developed shingles 5 times within 2 months. One time the lesions were on the patient's eyelid and he was seen by an ophthalmologist. The patient was treated with acyclovir for the treatment of shingles 4 times previously and the lesions went away. No blood studied or cultures were previously done. On an unspecified date the patient developed shingles for the fifth time. This time the lesions were on his face under his eye; from his nose to the outside corner of his eye. The patient was seen in office by the physician. The physician planned to do a CBC and other labs to see what the patient's baseline labs are prior to starting acyclovir for a fifth time. The physician also referred the patient to a Pediatric Infectious Disease group at a university and has an appointment on 28-MAY-2008. At the time of the report the patient had not recovered from the shingles. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 13 year old male who was vaccinated with the second dose of VARIVAX (Merck) (lot# 659726/1772U), standard dose, SQ on his left arm. There was no concomitant medication. Several days after the vaccination the patient developed chickenpox rash on the injection site of his left arm. He also had fever. The rash disappeared within 2 to 3 days after the appearance of rash. On an unspecified date the patient recovered from fever. The patient was seen by the physician. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a medical assistant and physician concerning a 21 year old female with no pertinent medical history and no drug reactions/allergies who on 13-MAY-2008 was vaccinated subcutaneous with a 0.5 ml first dose of VARIVAX (Merck) (LOT # 659425/1916U).  There was no concomitant medication.  The patient developed an injection site reaction 9 days later.  The patient was seen on 23-MAY-2008 when the arm was red, swollen, and hot to touch at the injection site.  There was a large welt at the site.  The patient also had pain at the injection site.  There was no report of fever.  The physician did send the patient to the emergency room for an evaluation, the patient was not admitted.  White blood cell count was done with the result of 7.8.  Subsequently, the patient recovered from the events.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a medical assistant and physician concerning a 21 year old female with no pertinent medical history and no drug reactions/allergies who on 13-MAY-2008 was vaccinated subcutaneous with a 0.5 ml first dose of VARIVAX (Merck) (LOT # 659425/1916U).  There was no concomitant medication.  The patient developed an injection site reaction 9 days later.  The patient was seen on 23-MAY-2008 when the arm was red, swollen, and hot to touch at the injection site.  There was a large welt at the site.  The patient also had pain at the injection site.  There was no report of fever.  The physician did send the patient to the emergency room for an evaluation, the patient was not admitted.  White blood cell count was done with the result of 7.8.  Subsequently, the patient recovered from the events.  Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 13 month old male who on 05-MAY-2008 was vaccinated subcutaneous with his first dose of VARIVAX (Merck) (LOT# 659726/1772U) and MMR II. The patient developed chickenpox rash two weeks after vaccination. The rash appeared all over the body including near the injection site and he had fever. Subsequently, the patient recovered from symptoms. The patient sought medical attention by the physician. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Pyrexia, Sinusitis, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female who on 27-MAY-2008 was intended to receive ZOSTAVAX (Merck) (MSD), but inadvertently was vaccinated with VARIVAX (Merck) 0.5ml SC in the left arm (Lot #: 659212/1507U) due to human error. The reporter confirmed this was not a case of product confusion. Later on the same day, the patient received ZOSTAVAX (Merck) (MSD) 0.5ml SC in the right arm (lot#: 658208/0886U). The patient called a week later. The patient reported that she had no local reaction. But she stated that she had a sinusitis with fever a few days after the vaccination. The sinusitis lasted for a few days and finally the patient recovered. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old boy who on 12-MAY-2008 was vaccinated with the second dose of VARIVAX (Merck) subcutaneously (lot#: 659726/1772U). There was no concomitant medication. Two weeks after vaccination (on 26-MAY-2008) the patient developed chickenpox rash all over the body. But the patient had no fever. As of 27-MAY-2008, the patient recovered. The patient was seen by the physician. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning an about 14 year old male patient who was vaccinated with a dose of VARIVAX (Merck) intramuscularly instead of subcutaneously (lot number and injection site not reported). The medical assistant reported that the patient "had tingling after the shot was given but it went away". It was unknown whether the patient sought any medical attention. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 year old male who was vaccinated with a first dose of VARIVAX (Merck). The patient had a chicken pox outbreak. The patient's chicken pox persisted. The patient sought medical attention, he went to the physician. Additional information has been requested. The patient's sister also had an adverse experience after vaccination with VARIVAX (Merck). (WAES# 0806USA01251).
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no known allergies and a history of cellulitis in left leg at 6 months old following a vaccination with the third dose of PEDIARIX who on 23-APR-2008 was vaccinated into the left leg with first dose of VARIVAX (Merck) (Lot # 632727/0089K). Vaccines received on the same day included MMR (MSD) and PREVNAR. About a week later, on approximately 04-MAY-2008 the patient developed 2x2 cm raised irregular form mass at injection site. There was no fever, no tenderness, and no illness at the time of vaccination. (Previous reaction in that leg to another vaccine was more severe). On an unspecified date the patient recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot number, injection site and route not reported).  Subsequently the patient experienced post vaccination rash.  A physician sent a sample to the report's lab for PCR testing to determine if the patient's rash was caused by the vaccine strain of VARICELLA or wild type VARICELLA.  The reporter would not disclose what VARICELLA vaccine was used in the patient or any information regarding the patient or the physician.  No further information is available.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning an 18 month old female who on 22-MAY-2008 was vaccinated with VARIVAX (Merck). The physician reported that the patient developed rash at the injection site on the leg for 3 days following vaccination with VARIVAX (Merck). It was not clear if this was the first vaccination with VARIVAX (Merck). On approximately 25-MAY-2008 the patient recovered from rash at the injection site on the leg. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash papular, Rash pustular
Clinical narrative: Information has been received from a physician concerning a 5 year old male with seasonal allergies who on 24-JUN-2004 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (Merck). On 14-MAY-2008 the patient received the second 0.5 ml dose of VARIVAX (Merck) subcutaneously. On the same day the patient also received secondary suspect vaccination of MMR II. Concomitant therapy included DTaP (unspecified) (+) Tetanus toxoid, Poliovirus vaccine and CLARITIN. On 01-JUN-2008 the patient developed quite a few pustules and papules generalized on his body. As the time of the report, no other symptoms noted, no treatment required. The patient's events persisted. The patient's mother contacted the office by phone. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Eczema, Herpes simplex, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 9 year old male who on 06-SEP-1995 was vaccinated with VARIVAX (Merck) (lot # not recorded). In approximately September 2004, "at age 9" the patient was diagnosed with shingles and placed in an oral medication (acyclovir). On 12-OCT-2004 the patient was seen by a dermatologist and was diagnosed with eczema vs recurrent herpes simplex virus and was treated with aquaphor. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash pustular, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse, concerning her 13 year old daughter who on 14-JUL-1995 was vaccinated with the first dose of VARIVAX (Merck), 0.5 ml, subcutaneously. There was no concomitant medication. The nurse reported that her daughter received the first dose of varicella, and now on 28-MAY-2008, 12 years post vaccination, she had chickenpox. The chickenpox started as itching underneath the right breast with a noted red blister with white pustule. By the end of the last night, there were 12 red blisters with white pustules on the chest and back area. At the time of the report the patient had not recovered. The patient did not seek medical attention. Follow-up information was received from the registered nurse, who reported that the chickenpox had a duration of less than 7 days. No further information is available.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician assistant concerning a 30 year old white female with seasonal allergy, chronic sinusitis and anaemia who on 01-AUG-2008 was vaccinated with the first VARIVAX (Merck) 0.5 ml SC in the right arm.  Concomitant therapy included CLARITIN and iron supplements.  There was no illness at time of vaccination.  On 13--AUG-2008 ( also reported as 14-AUG-2008) the patient developed itch red bumps in right upper arm at the injection site, appearance consistent with herpes ZOSTER rash.  No other symptoms or treatment reported.  The patient's event was treated with VALTREX for 7 days as herpes ZOSTER rash.  Before and 6 weeks after vaccination, serum VARICELLA ZOSTER virus antibody test were performed with IgG equivocal.  The patient sought medical attention in the office visit.  On 19-AUG-2008 the patient recovered from VARICELLA like rash at the injection site.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on 20-MAY-2008 was vaccinated subcutaneously on her left arm with a second dose of VARIVAX (Merck) (LOT# 659696/1762U). On 22-MAY-2008 48 hours post shot, the patient experienced large welt at injection site and painful. At the time of the report the outcome of the patient was unknown. The patient did not seek medical attention. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant and physician concerning a 10 year old female with no pertinent medical history and no allergies who on 09-MAR-1999 was vaccinated with the first dose of VARIVAX (Merck). On 11-AUG-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 660827/0426X) 0.5 ml IM instead of SQ. There was no concomitant medication. The patient did not have any problem with the first dose. On 11-AUG-2008 the patient experienced redness, swelling, hot and pain at injection site and fever. The patient's redness, swelling, hot and pain at injection site and fever persisted. The patient sought medical attention and called office. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant and physician concerning a 10 year old female with no pertinent medical history and no allergies who on 09-MAR-1999 was vaccinated with the first dose of VARIVAX (Merck). On 11-AUG-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 660827/0426X) 0.5 ml IM instead of SQ. There was no concomitant medication. The patient did not have any problem with the first dose. On 11-AUG-2008 the patient experienced redness, swelling, hot and pain at injection site and fever. The patient's redness, swelling, hot and pain at injection site and fever persisted. The patient sought medical attention and called office. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who in approximately 2007, about one year ago, was vaccinated subcutaneous with a 0.5 ml VARIVAX (Merck). About two weeks post vaccination, the patient developed a mild case of chicken pox. The symptoms included a low fever and about 15 total lesions. At the time of the report, it was unspecified if patient sought medical attention and the patient outcome was unknown. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female who on 02-MAR-2001 was vaccinated subcutaneous with a first dose of VARIVAX (Merck) and on 12-SEP-2007 was vaccinated subcutaneous with the second dose of VARIVAX (Merck) (LOT# 658421/1029U). On 09-MAY-2008 the patient experienced a full blown case of chicken pox. Subsequently, the patient recovered from chicken pox. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 82 year old female patient living in an assisted living residence who on 1:30PM, 15-AUG-2008 was vaccinated with VARIVAX (Merck) via SC in the left arm (lot# 655065/1142F). The patient had inadvertently received VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to a human error. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female with no medical history or allergies who on 21-MAY-2008 at 1120 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) in the left arm(Lot# 660217/0167X). There was no concomitant medication. On 23-MAY-2008, the parent called the office to report that the child had an injection site reaction and was scratching her arm. When seen in the office, the injection site was red, hot and hard with possible cellulitis. An antibiotic was prescribed. The outcome of the events was unknown. The patient was seen in office to sought medical attention. Follow-up information was received concerning the patient was starting scratching the site and it opened and started to drain, arm was red, warm and tender last 1-2 days. Upon assessment doctor of medicine (MD) noted site as red raised, warm lesion with central umbilication. The MD prescribed AUGMENTIN 600mg/5ml x 7 days. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with VARIVAX vaccine (Merck). The physician reported that the office gave a patient VARIVAX vaccine (Merck) when they meant to administer ZOSTAVAX vaccine (Merck). NO AE was reported. It is unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of VARIVAX (Merck) in the past. Five or six weeks ago (on approximately 21-APR-2008), the child had vesicles on the forehead. The child was diagnosed with possible shingles. The outcome of the patient was not reported. The patient sought medical attention by contacting the physician. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Feeling hot, Rash, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 08-APR-2008 was vaccinated subcutaneously in the right thigh with a dose of VARIVAX (Merck) ( Lot # 659357/1567U).  On the same day the patient was also vaccinated with suspect therapy a dose of MMR II (Wistar RA 27/3) (Lot # 657637/1485U).  On 17-APR-2008 the patient felt warm and developed rash, multiple erythema and papules on trunk and back of head.  Subsequently, the patient recovered from feels warm, rash, multiple erythema and papules.  The patient was seen in office.  Additional information is not expected.