chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) overseas. The physician reported that the patient had subotimum titers after receiving VARIVAX (Merck), and needed a booster for college. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who on 08-APR-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot number not provided). The physician reported that one week after vaccination on approximately 15-APR-2010 the patient experienced a 2 cm rash with vesicles. At the time of the report the patient had recovered. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date in 2008 was inadvertently vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot# reported as 796). It was reported that the patient was intended to receive ZOSTAVAX (Merck). No adverse symptoms were reported. No further information is available.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 30 year old female patient who on an unspecified date, was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# not reported). A week after her first dose of VARIVAX (Merck), the patient developed chickenpox. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. The physician wanted to assess if the vaccine caused the varicella. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lichen striatus, Skin hyperpigmentation
Clinical narrative: Information has been received from a consumer concerning a 12 month old female with a history of urticaria pigmentosa (at her 3 months of age) and with no drug reactions/allergies, who on an unspecified date was vaccinated intramuscularly with VARIVAX (Merck). On an unspecified date the patient experienced lyken striatus which was a high pigmented area on her right arm. The patient also reported that M-M-R II and VARIVAX (Merck) were injection into her leg, not her arm. The patient did not seek any medical attention and did not perform any laboratory test. No further information is available.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a licensed visiting nurse concerning her 16 year old female grandchildren with allergy to NYQUIL and no medical history who in approximately 31-DEC-2001 ("at the end of December 2001"), was vaccinated with a dose of VARIVAX (Merck). In January 2002, a classmate of the patient was diagnosed with chicken pox and was sent home on the school bus with the entire class. At some unspecified time after the patient's exposure to her classmate, the patient along with "all of the other children on the bus" developed chicken pox. The nurse was concerned about vaccine failure not transmission. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. The nurse also stated that she developed chicken pox after being exposure to the patient (WAES # 1007USA01768). This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male with soybeans and milk allergies, and a history of eczema who on 01-JUL-2010 was vaccinated with VARIVAX (Merck). Subsequently the patient developed red splotches on his arm, leg and hands after administration. The patient was seen by a allergist who did not believe it was due to VARIVAX (Merck). The patient was recovering. No further information is available.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 20 year old female with no routine medications and slight allergy to dust otherwise no know allergies who on 12-MAR-1996 was vaccinated with the first dose of VARIVAX (Merck) (Lot# 608586/0413B, therapy dose, route and site unknown) and on 18-OCT-2007 received the second dose of VARIVAX (Merck) (Lot# 658572/1257U, therapy dose, route and site unknown). On approximately 08-JUL-2010 the patient experienced break through chicken pox. She had similar lesions a few days after her sister. She was not seen by the doctor. No treatment required. At the time of this report, the patient was doing better. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a licensed visiting nurse concerning herself whose grandchild in approximately 31-DEC-2001 ("at the end of December 2001"), was vaccinated with a dose of VARIVAX (Merck). In January 2002, a classmate of her grandchild was diagnosed with chicken pox and was sent home on the school bus with the entire class. At some unspecified time after the grandchild exposure to her classmate, the grandchild developed chicken pox (WAES # 1007USA01674). The patient stated that she developed chicken pox after being exposure to her grandchild. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a now 62 year old female who was vaccinated with a dose of VARIVAX (Merck) (lot # 662447/1548X) instead of ZOSTAVAX (Merck) in December. No adverse effects were reported. Follow-up information received from a medical assistant stated that the patient was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) on 03-DEC-2009. The bottles did not look like and the boxes were different. It was reported that it was not the packaging but human error on her part. This is one of several reports received from the same source. Additional information is not expected.
Age: 41.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a nurse practitioner concerning a 41 year old patient who in July 2010 (reported as "12-JUL-2010"), was vaccinated with the first dose of VARIVAX (Merck) (LOT# not reported). In July 2010 (reported as "11 or 12 days after VARIVAX was given"), the patient experienced a rash with vesicles at the injection site. The patient had not recovered yet and no other information was available from the caller. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a now 66 year old patient who was vaccinated with a dose of VARIVAX (Merck) (lot # 662447/1548X) instead of ZOSTAVAX (Merck) in December. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Macule, Papule, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 11 year old male with amoxicillin and CEFZIL allergies who on 21-JUN-2000 was vaccinated with a dose of VARIVAX (Merck), SC and on 03-AUG-2007 with the second dose. There was no concomitant medication. On 16-JUL-2010 the patient broke out in chickenpox. He presented to the office with no fever. He had macules, papules, and vesicles in various stages. The patient was given ZYRTEC, and had not recovered at time of reporting. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information has been received from a Medical Assistant concerning a patient who on 28-JUL-2010 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a kindergarten age patient who on unspecified dates were vaccinated with a dose of VARIVAX (Merck) (lot#s not reported) in the lateral thigh, MMR II (MSD) (lot#s not reported) in the lateral thigh and KINRIX in the deltoid all at the same time. She stated that these are the three standard immunizations given for children of kindergarten age. In the process of trying to narrow down which inoculation was causing the reaction, they moved the injection site of the KINRIX to the deltoid. Subsequently the patient developed cellulitis at the injection site. The office manager stated that it didn't appear that the patient previously reported had a reaction to VARIVAX (Merck), the patient had a reaction to the KINRIX. No medical attention was sought. At the time of this report, the patient had recovered from cellulitis at the injection site. This is one of several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from registered nurse (R.N.) concerning a male child patient who on unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot number unknown). The nurse reported that the child received a booster dose of the vaccine and had chicken pox. At the time of report, the patient's outcome was unknown. The patient sought medical attention at the doctor's office. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 10-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) 1350 unit/0.5ml SC (Lot# 666821/0223Z, site unknown). On 12-AUG-2010, the patient's mother called the physician office to report that her son developed a red hard itchy knot at the injection site that measured 4 inches across. At the time of this report, the patient was recovering. This is the 5th patient in this office who had an adverse event reported for this lot# 666821/0223Z. A lot check investigation has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that lot # 666821/0223Z conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. 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. Follow-up information has been received from the physician concerning the patient with no illness at time of vaccination and no any pre-existing allergies, birth defects or medical conditions who on 10-AUG-2010 at 14:00 was vaccinated at left arm with the second dose of VARIVAX (Merck) (Lot# 666821/0223Z). On 12-AUG-2010 at 10:00 the patient experienced arm red, hot, swollen and 4 inches itchy. On an unspecified date, the patient recovered. No further investigation is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 10-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) 1350 unit/0.5ml SC (Lot# 666821/0223Z, site unknown). On 12-AUG-2010, the patient's mother called the physician office to report that her son developed a red hard itchy knot at the injection site that measured 4 inches across. At the time of this report, the patient was recovering. This is the 5th patient in this office who had an adverse event reported for this lot# 666821/0223Z. A lot check investigation has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that lot # 666821/0223Z conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. 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. Follow-up information has been received from the physician concerning the patient with no illness at time of vaccination and no any pre-existing allergies, birth defects or medical conditions who on 10-AUG-2010 at 14:00 was vaccinated at left arm with the second dose of VARIVAX (Merck) (Lot# 666821/0223Z). On 12-AUG-2010 at 10:00 the patient experienced arm red, hot, swollen and 4 inches itchy. On an unspecified date, the patient recovered. No further investigation is available.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Infection, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history and no known drug allergies who on 21-JUL-2000 was vaccinated with a dose of VARIVAX (Merck) (dose, route, and lot# not reported). There was no concomitant medication. The patient experienced chickenpox a few days after the injection. "It was mild with some vesicles". On an unspecified date, the infection resolved. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to vaccinated person, Pruritus, Varicella
Clinical narrative: Information has been received from a physician assistant (P.A.) concerning a 5 years old patient who reported that she visited her aunt who on 28-JUL-2010 was vaccinated with VARIVAX (Merck) (Lot # 664691/0732Y Exp date 21-MAY-2011) and slept on the same bed as her and developed a mild case of chicken pox on approximately 30-JUL-2010 within a day or so of the visit. The niece has lesions on her back that are itchy. The P.A. reported that on an unspecified date, the patient had been vaccinated. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician assistant indicated that the 5 year old female patient who on 28-JUL-2010 slept with her aunt who on the same day was vaccinated with the first dose of VARIVAX (Merck) (Lot # 664691/0732Y Exp date 21-MAY-2011) SC at right arm. The next morning the 5 year old patient developed chickenpox. This is one of several reports obtained from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female patient with no pertinent medical history and no allergies who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. On 09-AUG-2010 the patient developed chickenpox, with more than 50 spots on her head, abdomen, back and legs. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no pertinent medical history and no drug reactions who on 10-DEC-1997 was vaccinated with the first dose of VARIVAX (Merck). On 04-AUG-2010, the patient received the second dose of VARIVAX (Merck) (SC, lot # 666818/0091Z) into her right arm. There was no concomitant medication. On 06-AUG-2010 the patient presented to the office with a 1 inch erythema at the injection site. The patient had not been seen since. There were no lab diagnostics studies performed. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 12 year old male with asthma and no allergies who on 25-MAY-1999 was vaccinated SQ with the first dose of VARIVAX (Merck), and the second of VARIVAX (Merck) (lot # 666817/0002Z) on 04-AUG-2010 into the left arm. Concomitant therapy included ADVAIR and albuterol. On 06-AUG-2010 the patient presented with a 3 inch reddened, extremely warm, painful area at the site of injection. There were no laboratory studies performed. KEFLEX 500 mg twice a day was prescribed. The patient had not yet been seen for follow-up (also reported the patient sought unspecified medical attention). At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician assistant concerning a 12 month old male who on 15-JAN-1999 was vaccinated with a dose of VARIVAX (Merck) injection. On 17-JAN-1999 the patient experienced a chickenpox like rash about 2 days after vaccination with VARIVAX (Merck). On an unspecified date, the patient recovered from a chickenpox like rash. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning an 11 year old female child with no medical history or allergies who on unspecified dates was vaccinated with two doses of VARIVAX (Merck). There was no concomitant medication. On 10-AUG-2010 the patient experienced chicken pox, with more than 50 spots on her head, abdomen, back and legs. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a male patient who on 09-AUG-2010 was inadvertently vaccinated with a dose of VARIVAX (Merck) (Lot number unknown) instead of the intended ZOSTAVAX (Merck) due to human error. No adverse effect was reported. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a female adolescent patient who within the last two weeks (in August 2010) was vaccinated SC with a dose of VARIVAX (Merck) (lot number not provided). The nurse reported that the patient experienced cellulitis (in August 2010). The nurse reported that the patient required an injectable antibiotic to treat cellulitis. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irrigation, Eye irritation
Clinical narrative: Information has been received from a 34 year old male medical assistant with lupus and no drug reactions or allergies who on 16-AUG-2010, splashed in his eyes an unspecified amount of a dose of VARIVAX (Merck) (Lot#667279/0641Z), when he was drawing up it in the physician's office. Concomitant therapy included vitamins (unspecified). On the same day, after exposure, the patient was experiencing a "burning" sensation in his eyes. It was reported that the patient flushed his eyes with water. No lab tests were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning an approximately 36 month old male patient with penicillin allergy who on 08-MAY-2001, was vaccinated SC with the first 0.5 ml dose of VARIVAX (Merck). In approximately 2003 ("when the patient was 3 years old"), the patient experienced shingles. The patient did not get the second dose of VARIVAX (Merck). The patient had an office visit, and recovered from shingles on an unspecified date. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 11 year old male patient who on 20-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (lot 665967/0224Z). On 21-JUL-2010, one day post vaccination, the patient experienced redness and warmth at the injection site. The patient was treated with prednisone "Z-pak". The office followed-up with the patient on 23-JUL-2010 and he was fine. The nurse also reported that the VARIVAX (Merck) was the only vaccine received given at that particular injection site. The patient sought unspecified medical attention. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin M decreased, Malaise, Pyrexia, Rash vesicular, Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning a 42 year old male patient with no pertinent medical history, drug reactions or allergies who on 11-JUN-2010 was vaccinated SQ with a 0.5 ml first dose of VARIVAX (Merck) (Lot# 665992/1402Y) (Expiration date: unknown). There was no concomitant medication. The physician reported that on 28-JUN-2010 the patient developed 5 to 10 vesicular lesions with central umbilication on both arms, mild malaise and mild to moderate fever after administration of VARIVAX (Merck). The physician also reported that the rash was now spreading to his ankles, face, and lower trunk. No laboratory diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information was received from the physician concerning the male, radiation therapist patient with no illness at time of vaccination who no 11-AUG-2010 had a varicella zoster immune status test which resulted negative, indicating susceptibility to the varicella zoster virus. On the same date, a varicella zoster AB, IgM was performed which result was less than 0.91. There was no immune response with the first dose. The physician offered the second immunization of varicella vaccine. The patient declined the second booster. It was reported that the patient recovered 3 to 4 weeks after one injection. No further information is available.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a "15 year old" male patient who on 02-AUG-2010 was vaccinated with a first dose of VARIVAX (Merck) (route and lot number unspecified). At the next day (on 03-AUG-2010), the patient returned to the office with redness and swelling (unspecified where) and a low grade of fever. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a physician concerning a 15 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) and a dose of MMR II (MSD) (lot# not reported). Subsequently the patient experienced "neurological effects" after receiving VARIVAX (Merck) and MMR II on the same day. At the time of this report, the patient had recovered from neurological effects. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a kindergarten age patient who on unspecified dates were vaccinated with a dose of VARIVAX (Merck) (lot#s not reported) in the lateral thigh, MMR II (lot#s not reported) in the lateral thigh and KINRIX in the deltoid all at the same time. She stated that these are the three standard immunizations given for children of kindergarten age. In the process of trying to narrow down which inoculation was causing the reaction, they moved the injection site of the KINRIX to the deltoid. Subsequently the patient developed cellulitis at the injection site. The office manager stated that it didn't appear that the patient previously reported had a reaction to VARIVAX (Merck), the patient had a reaction to the KINRIX. No medical attention was sought. At the time of this report, the patient had recovered from cellulitis at the injection site. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a kindergarten age patient who on unspecified dates was vaccinated with a dose of VARIVAX (Merck) (lot# not reported). Subsequently the patient developed cellulitis at the injection site after being administered VARIVAX (Merck). No medical attention was sought. At the time of this report, the patient had recovered from cellulitis at the injection site. Follow up information has been received from the office manager who reported that a little girl was given VARIVAX (Merck) in the lateral thigh, MMR II (MSD) (lot#s not reported) in the lateral thigh and KINRIX in the deltoid all at the same time. She stated that these are the three standard immunizations given for children of kindergarten age. In the process of trying to narrow down which inoculation was causing the reaction, they moved the injection site of the KINRIX to the deltoid, and just "last week" a little girl experienced injection site cellulitis in the arm. So the office manager stated that it didn't appear that the patient previously reported had a reaction to VARIVAX (Merck), she had a reaction to the KINRIX. This is one of several reports from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a physician concerning a 4 to 6 year old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) and a dose of MMR II (lot# not reported). Subsequently the patient experienced "neurological effects" after receiving VARIVAX (Merck) and MMR II on the same day. At the time of this report, the patient had recovered from neurological effects. This is one of several reports from the same source. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician's assistant and a medical assistant concerning an 18 month old male patient whose sister developed wild type chicken pox about two weeks ago (on approximately 22-JUL-2010). Eight days ago, on 29-JUL-2009, the patient was vaccinated with a dose of VARIVAX (Merck). One day post vaccination, on 30-JUL-2010, the patient broke out in a chicken pox rash. On 05-AUG-2010, eight days after received the VARIVAX (Merck), the patient was vaccinated with a dose of MMR II. There was no adverse effect noted from the MMR II. At the time of the report, the patient was recovering from chicken pox, there was no fever and crusting scabs. The physician's assistant did not feel that chicken pox was related to VARIVAX (Merck) but the related to the wild type exposure. Additional information has been requested. The patient's twin brother experience has been captured in WAES 1008USA01276.
Age: 87.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information has been received from a physician concerning an 87 year old male patient who on 09-APR-2010 was vaccinated SC with a dose of VARIVAX (Merck) (lot number not provided) instead of a dose of ZOSTAVAX (Merck). The physician reported that the office realized the mistake on 04-AUG-2010. No adverse event was reported. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning her friend's child who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). The medical assistant reported that the child got shingles after receiving VARIVAX (Merck). At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Inflammation, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female with no pertinent medical history and no drug reactions/allergies who on 05-AUG-2002 was vaccinated with the first dose of VARIVAX (Merck), and on 03-AUG-2010 was vaccinated subcutaneously with the second 0.5 mL dose of VARIVAX (Merck) (LOT# 666490/1659Y). There was no concomitant medication. On 05-AUG-2010 the patient returned to the office with itchy, hive-like, raised bump centered on the injection site on her (unspecified left or right) arm that was surrounded by a larger area of localized inflammation. Nurse reported that patient was treated with an unspecified dose of BENADRYL, and was asked to return to the practice, if the injection site symptoms did not resolve in the next few days. There was no lab diagnostics studies performed. As of the time of the telephone called on 09-AUG-2010, the patient had not returned to the practice; therefore the practice could not provide any definitive information on the patient's recovery. No further information is available at this time of reporting. Follow-up information has been received from a physician who reported that the 9 year old female student with no illness at time of vaccination who on 03-AUG-2010 at 14:00 was vaccinated subcutaneously at left arm with the second dose of VARIVAX (Merck) (LOT# 666490/1659Y) and at the same time was vaccinated intramuscularly at left arm with the first dose of HAVRIX (LOT# AHAYB362BA). On 04-AUG-2010 the patient experienced exuberant local reactions: warm, slightly tender, with minimal indurations upper posterior 1/2 of upper arm with pruritic urticarial center. The patient required doctor visit. The physician didn't report the patient's outcome at this time. Follow-up information has been received from a physician who reported that the 9 year old patient on 03-AUG-2010 at approximately 14:15 (previously reported as 14:00) was vaccinated subcutaneously at left arm with the second dose of VARIVAX (Merck) (LOT# 666490/1659Y). On 04-AUG-2010 experienced large exuberant local reaction, red, warm, slightly tender with indurations and itching in center at the injection site. No fever or systemic symptoms. Duration was around 3 days. On 10-AUG-2010, the patient recovered. No further information is available.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female with no pertinent medical history and no drug reactions/allergies who on 05-AUG-2002 was vaccinated with the first dose of VARIVAX (Merck), and on 03-AUG-2010 was vaccinated subcutaneously with the second 0.5 mL dose of VARIVAX (Merck) (LOT# 666490/1659Y). There was no concomitant medication. On 05-AUG-2010 the patient returned to the office with itchy, hive-like, raised bump centered on the injection site on her (unspecified left or right) arm that was surrounded by a larger area of localized inflammation. Nurse reported that patient was treated with an unspecified dose of BENADRYL, and was asked to return to the practice, if the injection site symptoms did not resolve in the next few days. There was no lab diagnostics studies performed. As of the time of the telephone called on 09-AUG-2010, the patient had not returned to the practice; therefore the practice could not provide any definitive information on the patient's recovery. No further information is available at this time of reporting. Follow-up information has been received from a physician who reported that the 9 year old female student with no illness at time of vaccination who on 03-AUG-2010 at 14:00 was vaccinated subcutaneously at left arm with the second dose of VARIVAX (Merck) (LOT# 666490/1659Y) and at the same time was vaccinated intramuscularly at left arm with the first dose of HAVRIX (LOT# AHAYB362BA). On 04-AUG-2010 the patient experienced exuberant local reactions: warm, slightly tender, with minimal indurations upper posterior 1/2 of upper arm with pruritic urticarial center. The patient required doctor visit. The physician didn't report the patient's outcome at this time. Follow-up information has been received from a physician who reported that the 9 year old patient on 03-AUG-2010 at approximately 14:15 (previously reported as 14:00) was vaccinated subcutaneously at left arm with the second dose of VARIVAX (Merck) (LOT# 666490/1659Y). On 04-AUG-2010 experienced large exuberant local reaction, red, warm, slightly tender with indurations and itching in center at the injection site. No fever or systemic symptoms. Duration was around 3 days. On 10-AUG-2010, the patient recovered. No further information is available.
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site mass
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) and a dose of included ADACEL or a dose of MENACTRA in the same arm. Subsequently, the patient the patient develops a tennis ball size lump at the VARIVAX (Merck) site. The nurse stated that the did not appear to occur when given in separate arm. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 10 year old male with no pertinent medical history and allergy to AUGMENTIN who received subcutaneously into the right deltoid his first and second dose of VARIVAX (Merck) (lot # second dose 663327/0343Y) on 25-JUL-2001 and on 05-JUN-2009 respectively. There was no concomitant medication. The nurse reported that on 05-AUG-2010 the child came in for an office visit with what mom though was "bug bites". The patient was diagnosed with chicken pox and treatment was over the counter oral BENADRYL. On 09-AUG-2010 the child was seen for following follow-up and nurse stated that "the child was much better, he was recovering". Follow-up information has been received from a licensed practical nurse (L.P.N.) who indicated that the patient with unknown illness at time time of vaccination, on 09-AUG-2010 recovered from chicken pox. No relevant laboratory diagnostics studies were performed. No further information is available.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12 year old male patient who had cellulitis prior vaccination who on 05-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 666367/0248Z and expiration date 04-FEB-2012). Concomitant vaccine given on the same day included a dose of MENACTRA. It was reported that on 07-AUG-2010 the patient called to the office to report the injection site reaction with swelling. No hospitalization and no treatment were added. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was not reported. Follow up information has been received via telephone call from a registered nurse concerning a patient who experienced the reaction after the second dose of VARIVAX (Merck). Information on the other vaccinations was not available. This is one of several reports from the same source. The office requested a lot check. A standard lot check investigation has been finalized. 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 available.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician's assistant and a medical assistant concerning an 18 month old male patient whose sister developed wild type chicken pox about two weeks ago (on approximately 22-JUL-2010). Eight days ago, on 29-JUL-2010, the patient was vaccinated with a dose of VARIVAX (Merck). One day post vaccination, on 30-JUL-2010, the patient broke out in a chicken pox rash. On 05-AUG-2010, eight days after received the VARIVAX (Merck), the patient was vaccinated with a dose of MMR vaccine. There was no adverse effect noted from the MMR. At the time of the report, the patient was recovering from chicken pox, there was no fever and crusting scabs. The physician's assistant did not feel that chicken pox was related to VARIVAX (Merck) but the related to the wild type exposure. Additional information has been requested. The patient's twin brother experience has been captured in WAES 1008USA00592.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema, Injection site oedema, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a physician assistant (P.A.) concerning a 16 year old female patient with not pertinent medical history or allergies, who on 28-JUL-2010 was vaccinated with VARIVAX (Merck) (Lot # 664691/0732Y Exp date 21-MAY-2011). There were no concomitant medications. The P.A. reported that a week after she received the first vaccine dose, on 04-AUG-2010, the patient experienced a large red, swollen area of erythema, 5.3cm x 6 cm on the right arm at the injection site. The patient was treated with BENADRYL by mouth and BENADRYL cream applied topically. Then, in the past few days, on an unspecified date, the patient developed 5 lesions that looked like chicken pox on her neck and arm with clear, itchy blisters. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow up information has been received from the physician assistant concerning the 16 year old female patient with no illness at time of vaccination and no known drug allergy who on 28-JUL-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 664691/0732Y) SC at right arm. On 29-JUL-2010 the patient initially developed erythema and edema at injection site. One week later, on approximately 04-AUG-2010 the patient not only had the erythema increased but developed 5 lesions which appeared as chickenpox. The patient recovered on 13-AUG-2010. One month later, on approximately 28-AUG-2010 varicella IgG test titers were negative. This is one of several reports received from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella virus test negative
Clinical narrative: Information has been received from a physician assistant (P.A.) concerning a 16 year old female patient with not pertinent medical history or allergies, who on 28-JUL-2010 was vaccinated with VARIVAX (Merck) (Lot # 664691/0732Y Exp date 21-MAY-2011). There were no concomitant medications. The P.A. reported that a week after she received the first vaccine dose, on 04-AUG-2010, the patient experienced a large red, swollen area of erythema, 5.3cm x 6 cm on the right arm at the injection site. The patient was treated with BENADRYL by mouth and BENADRYL cream applied topically. Then, in the past few days, on an unspecified date, the patient developed 5 lesions that looked like chicken pox on her neck and arm with clear, itchy blisters. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow up information has been received from the physician assistant concerning the 16 year old female patient with no illness at time of vaccination and no known drug allergy who on 28-JUL-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 664691/0732Y) SC at right arm. On 29-JUL-2010 the patient initially developed erythema and edema at injection site. One week later, on approximately 04-AUG-2010 the patient not only had the erythema increased but developed 5 lesions which appeared as chickenpox. The patient recovered on 13-AUG-2010. One month later, on approximately 28-AUG-2010 varicella IgG test titers were negative. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Cellulitis, Inflammation
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on an unspecified date was vaccinated subcutaneously with a second dose of VARIVAX (Merck) (lot # not provided) for prevention of chicken pox. On an unspecified date the patient's arm inflamed with large blisters and cellulitis. Patient sought unspecified medical attention. On 15-FEB-2011, the patient had recovered. Additional information has been requested.
Age: 1.81
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Herpes zoster, Measles antibody negative, Mumps antibody test negative
Clinical narrative: Information has been received from a consumer concerning her 8 year old daughter with no pertinent medical history and no drug reactions/allergies who in 11-SEP-2000, was vaccinated with one dose of VARIVAX (Merck) (Lot#: not reported). There was no concomitant medication and no lab diagnostics studies were performed. The consumer stated that since 2006 her daughter had had four episodes of shingles. The rash consisted of red, raised lesions and a few blisters distributed around the left mid-torso. The rash resolves within 2 weeks without requiring treatment. The consumer added that her daughter had a negative varicella antibody titer approximately on 28-JUL-2010. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow up information was received from a certified medical assistant who stated that the patient had one non-confirmed case of shingles in June 2006. Follow up information has been received from a physician who reported that the patient had received the first dose of VARIVAX (Merck) only. The patient was diagnosed with shingles in June 2006 and had only few vesicles vs macules, Herpes Simplex Virus (HSV). The patient's mother stated that the patient had had these lesions 3-4x and that "other family members would get similar lesions, even the children that had not received VARIVAX (Merck) at all". MMR and varicella titers were performed showing no immunity to VARIVAX (Merck) or mumps. So likely lesions were not varicella and Enzyme immunoassay (EIA) serology was not very sensitivity for vaccine immunity. Bottom line, likely lesions in past were not varicella and the patient would need second vaccine. Follow up information received from a physician indicated that the patient had a history of negative titers while on prior therapy with MMR II (WAES 1101USA01355). This is one of several reports received from the same source. Additional information is not expected.
Age: 1.81
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella virus test negative
Clinical narrative: Information has been received from a consumer concerning her 8 year old daughter with no pertinent medical history and no drug reactions/allergies who in 11-SEP-2000, was vaccinated with one dose of VARIVAX (Merck) (Lot#: not reported). There was no concomitant medication and no lab diagnostics studies were performed. The consumer stated that since 2006 her daughter had had four episodes of shingles. The rash consisted of red, raised lesions and a few blisters distributed around the left mid-torso. The rash resolves within 2 weeks without requiring treatment. The consumer added that her daughter had a negative varicella antibody titer approximately on 28-JUL-2010. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow up information was received from a certified medical assistant who stated that the patient had one non-confirmed case of shingles in June 2006. Follow up information has been received from a physician who reported that the patient had received the first dose of VARIVAX (Merck) only. The patient was diagnosed with shingles in June 2006 and had only few vesicles vs macules, Herpes Simplex Virus (HSV). The patient's mother stated that the patient had had these lesions 3-4x and that "other family members would get similar lesions, even the children that had not received VARIVAX (Merck) at all". MMR and varicella titers were performed showing no immunity to VARIVAX (Merck) or mumps. So likely lesions were not varicella and Enzyme immunoassay (EIA) serology was not very sensitivity for vaccine immunity. Bottom line, likely lesions in past were not varicella and the patient would need second vaccine. Follow up information received from a physician indicated that the patient had a history of negative titers while on prior therapy with MMR II (WAES 1101USA01355). This is one of several reports received from the same source. Additional information is not expected.