chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a school nurse concerning a 10 year old male with no drug reactions or allergies, and with possible learning disability who on 25-AUG-2004 and 30-SEP-2008 was vaccinated with the first and second dose of VARIVAX (Merck) (LOT# not reported), respectively. Now, on 22-MAY-2010 or 23-MAY-2010 the patient experienced itchy rash that may be varicella. There were no diagnostics and labs performed. The patient sought medical attention by telephone call. At this time of reporting, the patient's outcome was unknown. This is the first of three reports concerning the siblings. No further information is available.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Malaise, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) (Lot number not provided). The nurse reported that after 2 weeks after being vaccinated the patient came down with the chickenpox from head to toe. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information has been received from the registered nurse concerning the 29-year-old male patient with no known drug allergies and no illness at the time of vaccination who on 06-MAY-2010 at approximately 14:00 was vaccinated subcutaneously into left side with the second dose (the number of previous dose was reported maybe one) of VARIVAX (Merck) (LOT# 665193/1049Y). The nurse reported that after 2 weeks after being vaccinated, on 20-MAY-2010 at 10:30 AM the patient experienced full body rash (described as red with blisters), malaise and low grade fever. The patient called this Primary Care Provider (PCP) who instructed him to stay at home and use calamine lotion. He was not seen by the physician. On 27-MAY-2010, all lesions scabbed and the patient recovered. Follow-up information indicated that the registered nurse sent the report to us on 28-MAY-2010 and were received it on 02-JUN-2010. No further information is available.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) (Lot number not provided). The nurse reported that after 2 weeks after being vaccinated the patient came down with the chickenpox from head to toe. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information has been received from the registered nurse concerning the 29-year-old male patient with no known drug allergies and no illness at the time of vaccination who on 06-MAY-2010 at approximately 14:00 was vaccinated subcutaneously into left side with the second dose (the number of previous dose was reported maybe one) of VARIVAX (Merck) (LOT# 665193/1049Y). The nurse reported that after 2 weeks after being vaccinated, on 20-MAY-2010 at 10:30 AM the patient experienced full body rash (described as red with blisters), malaise and low grade fever. The patient called this Primary Care Provider (PCP) who instructed him to stay at home and use calamine lotion. He was not seen by the physician. On 27-MAY-2010, all lesions scabbed and the patient recovered. Follow-up information indicated that the registered nurse sent the report to us on 28-MAY-2010 and were received it on 02-JUN-2010. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was "vaccinated with the first dose of VARIVAX (Merck) when they were a child (age unknown). The patient did not receive a booster dose of VARIVAX (Merck). The patient was now a teenage and had shown symptoms of chickenpox." The patient received unspecified medical attention. At the time of the reporting, the patient's status was unknown. Follow up information received from a nurse practitioner concerning a 12 year old male with ZITHROMAX allergy, who 28-JUL-2000 was vaccinated with a dose of VARIVAX (Merck) (lot # 634839/1864J) at another health department. The patient did not receive a booster dose of VARIVAX (Merck). On 24-MAY-2010 the patient was presented to clinic with a rash, his mother was concerned it was chickenpox. The patient was diagnosed with varicella on 25-MAY-2010. There were no labs or diagnostic tests performed. The outcome was unknown. Follow up information had been received from a licensed practical nurse indicating that the patient was not seen in office since 25-MAY-2010. No other information could be provided at this time. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a mother she told the school nurse concerning her child who on an unspecified date was vaccinated with the dose of VARIVAX (Merck) (LOT# not reported). The mother was noted that her child developed chicken pox, in spite of being immunized with VARIVAX (Merck). No further information is available at this time of reporting. This is the second of three reports concerning the siblings. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a mother she told the school nurse concerning her child who on an unspecified date was vaccinated with the dose of VARIVAX (Merck) (LOT# not reported). The mother was noted that the child developed chicken pox, in spite of being immunized with VARIVAX (Merck). No further information is available at this time of reporting. This is the third of three reports concerning the siblings. No further information is available.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male patient who on 14-NOV-1996 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided). On 16-APR-2010 the patient received a second dose of VARIVAX (Merck) (Lot # 665969/1447Y), 0.5 mL, SC in the right upper arm. On the same day the patient received a dose of tuberculin purified protein derivative vaccine. It was reported that the patient broke out in chicken pox rash at the injection site. At the time of report, the patient was recovering with no treatment. The patient sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 14 year old student male with allergy to ibuprofen and no history of chickenpox who reported that on 16-APR-2010, the patient was vaccinated with a second dose of VARIVAX (Merck) (Lot # 665969/1447Y), 0.5 mL, SC, in the right upper arm, at 4:00 pm. On 18-APR-2010, the patient developed varicella-like rash at immunization site which was burny and itchy for 2 weeks, and red mark/red area persisted for 1 month. On an unspecified date, the patient recovered from varicella-like rash at immunization site. The registered nurse stated that the patient did not have a recent exposure to chickenpox or herpes zoster and direct fluorescent antibody test and Polymerase Chain Reaction test were not performed. This is one of several reports received from the same source. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male patient in the kindergarten age range who was vaccinated with only one 0.5 ml dose of VARIVAX (Merck) on unspecified date. Within the last 2 weeks, in May 2010 the patient came to the office with case of chickenpox. At the time of the report, the outcome was unknown. Additional information has been requested. This is one of several reports received from the same source.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). It was reported that the patient experienced a case of breakthrough chicken pox after the vaccine was administered. At the time of this report, the patient's outcome was unknown. The patient sought medical attention at the physician's office. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from company representative concerning her 12-month-old son on 26-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) and a dose of MMR II. On 05-JUN-2010 the patient experienced a fever of 102 F. No further information is available at this time of reporting. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a now "9 year old" female patient who in "2001" and in 2007 was vaccinated with the first and the second doses of VARIVAX (Merck), respectively. Subsequently, the patient experienced a mild breakthrough of chicken pox. The pox was on the torso and legs. They were popping out as the patient was in the office. No lot or expiration date was provided. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unspecified. Follow up information has been received from a physician concerning the 10 months old female student with no illness at time of vaccination who on 25-OCT-2001 was vaccinated IM with the first dose of VARIVAX (Merck) on the thigh (lot # 639486/0571L). On 06-JUN-2007 the patient was vaccinated with the second dose of VARIVAX (Merck) on the arm. On 01-JUN-2010 the patient experienced classic case though number of lesions only about 50 (attenuated). On 02-JUN-2010 the patient sought medical attention in office and diagnosed clinically as varicella. There were no relevant diagnostic tests or laboratory data. The status of the patient was unknown. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning current 18 year old male patient with no known medical history and no known drug reactions/allergies who on 15-JUN-1995 was vaccinated with a dose of VARIVAX (Merck) (Lot # 608235/0396B). There was no concomitant medication. The patient was diagnosed with shingles at an unspecified date after receiving VARIVAX (Merck). This occurred at some time in the past, and the patient no longer has shingles. The patient went to an office visit. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 year old male who in 2007 was vaccinated with the second dose of VARIVAX (Merck) injection. On 01-JUN-2010 the patient came into the office and the patient presented with chickenpox. Titer test was performed but the result was unknown. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with asthma who on an unspecified date was vaccinated IM with a dose of VARIVAX (Merck). Concomitant therapy included steroids for asthma control. Subsequently the patient had chicken pox multiple times within the last 5 years. The outbreaks had occurred within the last 1-2 years. The patient sought unspecified medical attention. At the
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Drooling, Headache, VIIth nerve paralysis
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old male patient who on 21-MAY-2010 was vaccinated with a second dose of VARIVAX (Merck) (lot number 665971/1563Y) after antiviral therapy. Concomitant vaccination included a dose of meningococcal vaccine (unspecified). The nurse reported that on 22-MAY-2010 at 22:00 the patient developed headache and was given MOTRIN. At 23:00 the patient developed drooling of saliva and mouth dropping. The patient was taken to the emergency room and was diagnosed with Bell's palsy. The patient was treated with VALTREX and prednisolone but was not admitted to the hospital. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician and a registered nurse concerning a girl who on unspecified dates was vaccinated with her second doses of VARIVAX (Merck) (lot number not reported). On an unspecified date the patient broke out in hives around the injection site. No medical attention was sought. "After a few days", on an unspecified date, the patients recovered. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning a female patient with a history of natural varicella as a child, who was also a physician and the mother of a 14 year old patient who on 14-NOV-1996 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided) and on 16-APR-2010 her son received a second dose of VARIVAX (Merck) (Lot # 665969/1447Y), 0.5 mL, SC in the right upper arm. On the same day the boy received a dose of tuberculin purified protein derivative vaccine. It was reported that the mother contacted the physician's office on 28-MAY-2010 and stated that she now had shingles, which began two weeks after her child was vaccinated with VARIVAX (Merck) (approximately on 30-APR-2010). The patient was treated with acyclovir. Follow-up information was received from the registered nurse who reported that the female patient, who had had a mild case of chickenpox as a child, developed shingles by her C-5 clavicle and up, three weeks post vaccination of her son (approximately on 07-MAY-2010, previously reported as two weeks post son's vaccination). The patient took acyclovir. Shingles rash lasted 2 to 3 weeks and at the time of the report, the patient still had some redness. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Incorrect dose administered, Nasopharyngitis, Pyrexia, Scab
Clinical narrative: Information has been received from a physician concerning a now 18 month male patient with no pertinent medical history who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). During vaccination, the vaccine was splashed because the needle was not firmly attached. The patient received only partial doses of VARIVAX (Merck). Subsequently, about 3-4 weeks later the patient experienced mild cold, fever, cough and 15-20 non-vesicular "dots" scattered over his body. The lesions had crusted over by the time the patient was seen in the office. At this time of reporting, the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Urticaria
Clinical narrative: Information has been received from a physician concerning a now 18 month male patient with no pertinent medical history who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). During vaccination, the vaccine was splashed because the needle was not firmly attached. The patient received only partial doses of VARIVAX (Merck). Subsequently, about 3-4 weeks later the patient experienced mild cold, fever, cough and 15-20 non-vesicular "dots" scattered over his body. The lesions had crusted over by the time the patient was seen in the office. At this time of reporting, the patient was recovering. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Staphylococcal infection, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning her 7 year old daughter who in May 2004, was vaccinated with the first dose of VARIVAX (Merck). Two-three years later, the patient was vaccinated with the second dose of VARIVAX (Merck). After receiving the second dose of VARIVAX (Merck), around 06-MAY-2010 the patient broke out in chickenpox and had a few lesions on her back that eventually turned in to MRSA. The patient went to doctor's office for medical attention. The patient was placed on antibiotics and had since fully recovered. Additional information is not expected.
Age: 1.28
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old female patient with no pertinent medical history and no drug reactions or allergies, who on 07-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot # 668617/1144Z). There was no concomitant medication. The nurse reported that on 20-JAN-2011 the patient developed chicken pox. The patient sought medical attention called office. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the nurse indicating that the patient with none known drug reactions or allergies, on 07-JAN-2011 was vaccinated with a first dose of VARIVAX (Merck) (Lot # 668617/1144Z) in the right leg and a first dose of MMR II (Lot # 666247/0959Z) in the left leg. The patient went to office on 21-JAN-2011 with rash, rash spreading more than on 20-JAN-2011, diagnosed as varicella rash 2 degree to vaccine on 07-JAN-2011. At the time of the report, the patient had recovered. No further information is available.
Age: 1.01
Sex: M
Vaccine: PNC, PNC13, VARCEL
Symptoms: Eye swelling
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no drug allergies or medical history, who on 24-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot # not provided). On the same day, 24-JAN-2011, the patient was also vaccinated with a dose of PREVNAR 4 and a dose of PREVNAR 13. The next day, on 25-JAN-2011 (also reported as 24-JAN-2011) the patient had a swollen eye. No treatment was given for this adverse event. No lab diagnostics studies performed. Patient did not seek medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information has been received from an office staff person concerning a patient who on an unspecified date came to the office for a ZOSTAVAX (Merck) injection and was inadvertently vaccinated with a 0.5 ml dose of VARIVAX (Merck) instead (route and lot # not reported). No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: MEA, MU, RUB, UNK
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of MERUVAX II (Lot number unspecified). Secondary suspect vaccinations included ATTENUVAX, MUMPSVAX II and other unspecified vaccines (manufacturer unspecified). Subsequently the patient experienced fever and a welt on her arm. At the time of the report the status of the patient was unspecified. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Excoriation, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 9 year old male with no pertinent medical history and no drug allergies, who on 21-JAN-2002 and 28-JAN-2008 was vaccinated with 2 doses of VARIVAX (Merck), SC. There was no concomitant medication. On 08-JUL-2010 the patient broke out in chickenpox. He presented to the physician's office a week later with no fever. He had multiple scabs and areas were excoriated. He was given BENADRYL. There were no labs or diagnostics tests performed. At the time of the reporting, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Varicella virus test negative
Clinical narrative: Information has been received from a pharmacist concerning a female patient in her 20's who was vaccinated with three doses of VARIVAX (Merck) (lot# not reported) respectively in 1995, in 2003 and in 2004. It was reported that the patient did not seroconvert. Titer was negative on two occasions: after the second dose in 2003 and in 2005. No adverse effects were reported. Unspecified medical attention was sought. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old female who on an unspecified date was vaccinated with her second dose (0.5 ml) VARIVAX (Merck) (lot number, route and site not reported). Secondary suspect therapy included VAQTA (manufacturer unknown). The nurse practitioner advised that "the patient received a VAQTA vaccination (manufacturer unknown) and the second dose of VARIVAX (Merck) in the same visit at the same injection site. On 19-JUL-2010 the patient had a reaction which was golf ball size swelling and redness at the injection site." At the time of the report, the outcome was not reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella
Clinical narrative: Information has been received from a physician concerning a 10 year old female who was vaccinated with VARIVAX (Merck), and broke out with a case of chickenpox after being exposed to a peer. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Gaze palsy, Immediate post-injection reaction, Movement disorder, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no known allergies, no concurrent conditions and no pertinent medical history who on 20-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# 657194/0364U). Suspect secondary vaccination administered on the same day included an IM 0.5 ml dose of GARDASIL (lot# 666929/0331Z). It was noted that VARIVAX (Merck) was administered first and GARDASIL last. On 20-JUL-2010, immediately after GARDASIL was administered, the patient, who had been in a sitting position, turned her head, her eyes started to roll, and she had fainting/seizure like activity; body reeling was also reported. The physician stated that there were no tonic/clonic movements and no incontinence. The physician felt that by having the patient lie down, a full blown seizure was prevented. The physician called the event "atypical syncope". No "neuro" consult warranted. The patient sought unspecified medical attention. On an unknown date the patient recovered. No laboratory or diagnostic tests were performed. Upon internal review, "seizure like activity" was considered to be an other important medical event. No further information is available.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician who mentioned that a local pediatrician (name unspecified) had a now around 4 year old patient who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient developed herpes zoster. At the time of reporting, the outcome was unknown. The pediatrician wanted to know if this patient should get a second dose. The patient sought unspecified medical attention. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 21-JUL-2010 was vaccinated SC with a second dose of VARIVAX (Merck) (lot# 666821/0223Z). That same day the patient experienced a large red knot at the injection site. The patient did not seek medical attention. On an unknown date the patient recovered. This is one of several reports received from the same source. The physician expressed concern for this lot. A lot check has been requested. A preliminary lot check investigation was performed. To date our investigation has found that this lot (666821/0223Z) conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX. 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 was received from the physician concerning a 12 year old female patient with no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions, and no adverse event following prior vaccinations, who at 11:00 am on 20-JUL-2010 (previous reported as 21-JUL-2010) was vaccinated SC with a second dose of VARIVAX (Merck) (lot# 666821/0223Z) in the right arm. On 21-JUL-2010 the patient experienced arm swollen, red, hot, and painful at shot site. On an unknown date the patient recovered. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 5 year old female who with no known drug reactions/allergies and no known medical history who on 08-SEP-2006 was vaccinated with VARIVAX (Merck). On 10-JUN-2010, the patient received another dose of VARIVAX (Merck). There was no concomitant medication. On 10-JUN-2010, after the vaccination, the patient developed a 2 1/2 inch red, warm, raised and swollen area on her left thigh at the injection site. No lab diagnostics studies were performed. At the time of reporting, the patient did not recover from the events. The patient sought medical attention through office visit. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient who suffered from allergies ("very sensitive"), who on 09-JUL-2010 was vaccinated subcutaneously with "one shot" of VARIVAX (Merck) (lot # 666821/0223Z) (getting her one year well child shots). Concomitant therapy included MMR II (MSD), PREVNAR 13 and ACTHIB (MSD). The physician reported that the patient was using VARIVAX (Merck) and experienced large red knots at injection site. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source with the same vaccine lot number. The physician expressed concern for this lot. A lot check has been requested. 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 12 month old female patient with soy, milk and peanut allergies, who on 09-JUL-2010, at 9:15, was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot # 666821/0223Z) into her right thigh, the first dose of MMR II (MSD) (lot#666249/1660Y) SC into the left thigh and the first dose of PREVNAR 13 (lot#E61989) IM into the left thigh. At 9:45, the patient was vaccinated with the fifth dose of ACTHIB (lot# UF817AB) IM into the right thigh. On 10-JUL-2010 the patient developed local reaction: red, hot and swollen at shot site on thigh. At the time of this report, the patient had recovered. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 11 year old male who on unspecified date was vaccinated with a dose of VARIVAX (Merck). On 11-JUN-2010 the patient experienced shingles despite receiving VARIVAX (Merck). No lot number was provided. The patient sought unspecified medical attention. The patient's shingles persisted. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Headache, Pyrexia, Scab
Clinical narrative: Information has been received from a registered nurse concerning a female over 50 years with no drug allergies/reactions who on 25-MAY-2010 was vaccinated SC with a first 0.5mL dose of VARIVAX (Merck) (lot number not reported). The registered nurse stated that recently (in approximately May 2010), the patient called the office to report she had some isolated blisters with some crusting, fever and headache. She had contacted her doctor and was taking antihistamines and oatmeal baths. At the time of the report, the patient had not recovered from the events. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse from a pediatrician's office, concerning a 43 year old patient's mother who on 24-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (lot#: not reported). It was reported that in approximately June 2010, "now" the patient had chickenpox. At the time of the report, the patient had not recovered. Additional information has been received from an office staff member who reported that the patient listed in the adverse event was an adult and not a patient of the office. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a female consumer who on an unspecified day was vaccinated with a dose of VARIVAX (Merck) (Lot#: not reported). On an unspecified date, the consumer developed chicken pox after she was given the VARIVAX (Merck). It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Local reaction
Clinical narrative: Information has been received from a physician concerning an 11 to 12 year old male who on an unspecified date was vaccinated with VARIVAX (Merck) (lot# not reported). Subsequently the patient developed a severe local reaction shortly after receiving vaccination. The injection site had severe edema and redness. The patient was placed on an antibiotic and showed some improvement but the area remained hard and painful, so the antibiotic was switched. The patient also had a fever. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an 11 to 12 year old male who on an unspecified date was vaccinated with VARIVAX (Merck) (lot# not reported). Subsequently the patient developed a severe local reaction shortly after receiving vaccination. The injection site had severe edema and redness. The patient was placed on an antibiotic and showed some improvement but the area remained hard and painful, so the antibiotic was switched. The patient also had a fever. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Back pain
Clinical narrative: Information has been received from a physician concerning his 25 year old wife with no pertinent medical history or drug/allergies reactions, who on 24-JAN-2011 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) in one deltoid area and also was vaccinated subcutaneously with a 0.5 ml dose of MMR II (MSD), in the other deltoid area. There was no concomitant medication. Physician reported that "today" (On 25-JAN-2011) his wife experienced pain in the center of her upper back along the trapezius muscle. Physician mentioned that his wife is afebrile and she is not experiencing any injection site pain. He also mentioned that his wife did carry groceries "yesterday" (on 24-JAN-10) which may have contributed to this pain. Treatment therapy for the adverse event included TYLENOL. No lab diagnostic studies were performed. At the time of the report patient's pain in the center of her upper back along the trapezius muscle persisted. The patient sought for medical attention by speaking with the physician. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site mass, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a physician concerning a 24 month old female patient who on 23-JUL-2010 was vaccinated subcutaneously with the "first shot" of VARIVAX (Merck) (lot # 666821/0223Z). Concomitant therapy included MMR II (MSD), ROCEPHIN and an unspecified steroid "shot". The physician reported that the patient was using VARIVAX (Merck) and experienced a large red knot at injection site. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source with the same vaccine lot number. The physician expressed concern for this lot. A preliminary lot check investigation was performed. To date our investigation has found that this lot 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 who reported that the 24 month old patient with sinusitis and wheezing at the time of vaccination and an allergy to AMRIX on 23-JUL-2010 at 11:30 am was vaccinated subcutaneously into the right thigh with the first dose of VARIVAX (Merck) (lot # 666821/0223Z). On the same day, the patient was vaccinated subcutaneously into the left thigh with the first dose of MMR II (Lot # 666293/1740Y). The physician reported that on 24-JUL-2010 the patient developed a local reaction, red, swollen and hot thigh. On an unspecified date, the patient had recovered. No further information is expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who 9 years ago in January 2002, was vaccinated with a dose of VARIVAX (Merck) (Lot #, expire date and route not reported). Physician stated that on an unspecified date, the patient experienced a full blown case of varicella. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning her 12 year old daughter who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (Lot # and expire date not reported), 0.5 ml, subcutaneously. Registered pharmacist stated that on an unspecified date, her daughter experienced shingles and added that her daughter's shingles cleared up after she was administered acyclovir. The patient sought unspecified medical attention. Follow-up information was received from a physician concerning a female patient with no illness at the time of vaccination who on 03-JUL-2007 was vaccinated with the second dose of VARIVAX (Merck) (Lot # and expire date not reported), 0.5 ml, subcutaneously. Suspect therapy included the second dose of GARDASIL (Lot # and expire date not reported) administered on 27-JUL-2010. Concomitant therapy included the third dose of FLUVIRIN (Lot # and expire date not reported) administered on 22-AUG-2010. The physician stated that on 11-JAN-2011, the patient was diagnosed with shingles/Zoster. In 2011, the patient recovered. There were no laboratory diagnostics studies performed. The patient did not seek medical attention. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old male patient who on 20-JUL-2010 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot# 665967/0224Z). It was unknown if the dose administered was the first or second. Between 20-JUL-2010 and 22-JUL-2010, after receiving VARIVAX (Merck), the patient had a localized reaction which may had been cellulitis. The patient was treated with ZYRTEC OTC, 10 mg, prednisone, 20 mg, BID, and azithromycin. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Dry eye
Clinical narrative: Information has been received from a 27 year old female licensed practical nurse with no pertinent medical history and no drug reactions or allergies who on 03-FEB-2011 got some VARIVAX (Merck) (Lot 668587/1184Z# and expire date not reported) into her eyes as she was administering a dose to a patient. There was no concomitant medication. Licensed practical nurse stated that it was a very small amount, "like a mist". She had finished administering the dose of VARIVAX (Merck) and as she was taking the needle out of patient's arm, "patient jerked little bit and some mists or very small drops got into her eyes". Licensed practical nurse stated that flushed her eyes with water after the incident. Licensed practical nurse felt some dryness in her eyes. No other adverse reactions were reported. No treatment was given to the licensed practical nurse. There were no laboratory diagnostics studies performed. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer, concerning a female claimed that her daughter who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). Subsequently, three months later, the patient experienced chicken pox. At this time of reporting, the patient's outcome was unknown. No further information is available.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Ear pain, Nausea, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 10 year old male son with no allergies and no pertinent medical history who on 05-SEP-2001 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot not reported). There was no concomitant medication. The consumer mentioned that on 28-JAN-2011 her son received VARIVAX (Merck) and had mild case of chickenpox. The consumer's son had mild fever, nausea, ears were achy and throat was sore on one side. The consumer also stated that on 29-JAN-2011 her son had no fever and no other symptoms from the previous day but later that night became a little itchy and there were 10-15 spots. On 30-JAN-2011 the spots got worse and her son had about 50-60 of them. On 03-FEB-2011 the spots are almost crusted. CALAMINE Lotion and BENADRYL were the treatment given for the events. There were no laboratories diagnostics performed. At the time of the report the patient's outcome was recovering. The patient sought medical attention by a doctor's visit. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Scab, Varicella
Clinical narrative: Information has been received from a consumer concerning her 10 year old male son with no allergies and no pertinent medical history who on 05-SEP-2001 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot not reported). There was no concomitant medication. The consumer mentioned that on 28-JAN-2011 her son received VARIVAX (Merck) and had mild case of chickenpox. The consumer's son had mild fever, nausea, ears were achy and throat was sore on one side. The consumer also stated that on 29-JAN-2011 her son had no fever and no other symptoms from the previous day but later that night became a little itchy and there were 10-15 spots. On 30-JAN-2011 the spots got worse and her son had about 50-60 of them. On 03-FEB-2011 the spots are almost crusted. CALAMINE Lotion and BENADRYL were the treatment given for the events. There were no laboratories diagnostics performed. At the time of the report the patient's outcome was recovering. The patient sought medical attention by a doctor's visit. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Asthenia, Injection site erythema, Injection site warmth, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old male with autism, behaviour disorder, adopted child, anxiety and impulsive and a history of cardiac murmur (2005) who on 21-NOV-2001 was given the first dose of VARIVAX (Merck) and on 12-AUG-2009 was given the first dose of VAQTA. On 02-JUN-2010 was vaccinated with a second dose of VARIVAX (Merck) (lot # 0064L which is valid for famotidine IV, exp: January 2012) in the left arm and VAQTA (lot # 667827/0416Z, exp: February 2013). Other concomitant therapy included "respivadol", "medferman", lithium and CELEXA. On 04-JUN-2010 the patient experienced large, red, warm area on the left arm at the injection site. Shortly after the patient developed spots all over the body. On "16-APR-2010", the mother reported he was still weak but recovering. On 04-JUN-2010, the patient was given BACTRIM DS. At the time of the report, the patient was recovering. The patient sought medical attention by office visit. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old male patient who on 22-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 666863/0467Z), 0.5 mL (route of administration not reported). Concomitant therapy included BOOSTRIX. It was reported that on 23-JUL-2010 the patient experienced localized reaction, discomfort, swelling, redness at the injection site after receiving VARIVAX (Merck) (unknown whether this was the first or second dose). At the time of this 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 has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site oedema, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 11 year old female who for "school and other requirement", on 01-FEB-2011 was vaccinated SC with the second dose of VARIVAX (Merck) (lot # 668473/1187Z). The patient was also given a dose of ADACEL on the same day. The doses were given in different arms. On 01-FEB-2011 the patient experienced an immediate reaction to the VARIVAX (Merck) at the injection site that looked like hives. The patient was given antihistamine and sent home. On 03-FEB-2011, the patient came back with a reaction to both injection sites. The VARIVAX (Merck) injection site was aggravated and the ADACEL injection site was bright red at that time. The patient was given CLARINEX as treatment. The patient was recovering at the time of this report. Follow up information has been received from the licensed practical nurse reporting that the 11 year old female patient with no pre-existing allergies or medical history or illness at the time of vaccination who on 01-FEB-2011 at 10:00 am was vaccinated SC into right arm with the second dose of VARIVAX (Merck) (lot # 668473/1187Z). The patient experienced swelling/edema immediately around the injection site. Redness/edema > 6 cm persisted one week following. On 11-FEB-2011 the patient recovered from the events. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female patient who on 05-MAY-2010 was vaccinated with the second 0.5mL dose of VARIVAX (Merck) (Lot number 666695/1706Y). Concomitant therapy included a dose of VAQTA (Lot number unknown), a dose of MENACTRA and BOOSTRIX. The nurse stated that the patient had a local reaction to the VARIVAX (Merck) vaccination. Between 05-MAY-2010 and 07-MAY-2010, the injection site was hot, red and raised. At the time of report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Decreased appetite, Lymphadenopathy, Pyrexia, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a medical assistant concerning a 13 month old male patient with no pertinent medical history or drug reactions/allergies who on 12-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 661555/1175Z, expiry date 10-FEB-2012) subcutaneously in the right arm. There was no concomitant medication. On 02-FEB-2011 the patient began to have a fever and loss of appetite. The patient reported to the physician's office on 04-FEB-2011 with a fever of 101.5F. The physician noted "anterior cervical lymph nodes" on the neck were swollen. Also, he noted "4 red popular lesions on the back and that one was vesicular." There were no lab diagnostics studies performed. The patient was treated with TYLENOL. At the time of report the patient's status was not recovered. Additional information has been requested.