chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Retinopathy, Uveitis
Clinical narrative: Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB vaccine, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 22 of 32, a 58 year old male. On an unreported date 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second dose of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 58 year old male on an unspecified date was vaccinated with his third dose of RECOMBIVAX HB vaccine (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of retinopathy. The authors stated the RECOMBIVAX HB vaccine may have possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02346, WAES # 1004USA02348 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Influenza like illness, Lymphadenopathy, Meningitis, Uveitis
Clinical narrative: Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 23 of 32, a 28 year old female. On unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 28 year old female on an unspecified date was vaccinated with the first dose of RECOMBIVAX HB (lot number, route and site not reported). Concomitant therapy included prednisone and diclofenac. Fifteen days after vaccination, the patient developed uveitis. On an unspecified date the patient experienced meningitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of headache, influenza-like symptoms and lymphandenopathy. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02347, WAES # 1004USA02349 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #24 of 32, a 35 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 35 year old female on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02348, WAES # 1004USA02350 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Autoimmune disorder, Uveitis
Clinical narrative: Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received RECOMBIVAX HB vaccine, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 25 of 32, a 17 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second dose of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 17 year old female on an unspecified date was vaccinated with the second dose of RECOMBIVAX HB vaccine (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of autoimmune disorder. The authors stated the RECOMBIVAX HB vaccine may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02349, WAES # 1004USA02351 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 26 of 32, a 15 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 15 year old female on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02350, WAES # 1004USA02352 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Gave Varicella vaccine R arm subq. area red, swollen. 30mm x 30 mm (Quarter size).
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Ankylosing spondylitis, Uveitis
Clinical narrative: Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #27 of 32, a 36 year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 36 year old male on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of ankylosing spondylitis. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02351, WAES # 1004USA02353 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Red raised area about the size of a half dollar.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Arthritis, Injection site reaction, Uveitis
Clinical narrative: Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB vaccine, manufacturer batch number, route and site not reported, on unreported dates. This report concerns patient # 28 of 32, a year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A one year old male on an unspecified date was vaccinated with a dose of RECOMBIVAX HB vaccine (lot number, route and site not reported). There was no concomitant medication. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of arthritis and injection site reaction. The authors stated the RECOMBIVAX HB vaccine may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02352, WAES 1004USA02354 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Nausea, Uveitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 29 of 32, a 26 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 26 year old female on an unspecified date was vaccinated with the first and the second dose of RECOMBIVAX HB (lot number, route and site not reported) respectively. There was no concomitant medication. One day after the first dose and one day after the second dose vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of dizziness, fatigue and nausea. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02353, WAES # 1004USA02355 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 28.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Headache, Lymphadenopathy, Meningitis, Uveitis
Clinical narrative: Information has been received from a published article, title as stated above. This literature case was initially reported to foreign health agency on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 30 of 32, a 28 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccine in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 28 year old female on an unspecified date was vaccinated with the first dose of RECOMBIVAX HB (lot number, route and site not reported). Concomitant therapy included typhoid vaccine (unspecified). One day after vaccination, the patient developed uveitis. On an unspecified date the patient experienced meningitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of headaches and lymphadenopathy. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 TO WAES 1004USA02354, WAES # 1004USA02356 TO WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Blindness, Uveitis
Clinical narrative: Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 31 of 32, a 22 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 22 year old female on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Three days after vaccination, the patient developed uveitis and on an unspecified date the patient also experienced symptoms of severe loss of vision. At the time of the report, the patient outcome was unknown. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02355 and WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Uveitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a published article. This literature case was initially reported on 29-Mar-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 32 of 32, a 20 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 20 year old female on an unspecified date was vaccinated with the second dose and third dose of RECOMBIVAX HB (lot number, route and site not reported) respectively. There was no concomitant medication. Three days after the second dose and four days after the third dose vaccination, the patient developed uveitis. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient outcome was unknown. The patient also experienced symptoms of headache. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES # 1004USA01716, WAES # 1004USA02327 to WAES #1004USA02352, WAES # 1004USA02354 to WAES # 1004USA02356). A copy of the published article is attached as further documentation of the patient's experience.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Tenderness
Clinical narrative: 5x5 cm oval redness & erythema. On L arm where KINRIX & MMR administered no fever, minimal tenderness warm compresses, PO BACTRIM 7.5 ml PO BID.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Oedema peripheral
Clinical narrative: Swollen foot (left) chills will go see the doctor.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: ADACEL administered to a 71 y/o employee.
Age: 1.24
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Crying, Gaze palsy, Hypotonia, Immediate post-injection reaction
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old female patient who experienced stopped breathing, eyes rolled back, face turned purple, went limp, crying, hives, otitis media, and temperature axillary 98 deg. F. At 15 months of age, the patient received the first dose on 07-Apr-2010. Additional suspect medication included PREVNAR. On 07-Apr-2010, prior to receiving her PREVNAR vaccination, the patient was fussy, but a physical exam was normal and the patient was afebrile. After vaccination, the patient immediately began crying, she stopped breathing, her eyes rolled back into her head, her face turned purple and she went limp in her mother's arms. The nurse blew in the baby's face for several seconds and the patient spontaneously started breathing again. The patient also developed hives and was treated with BENADRYL. The patient was examined and nothing else seemed to be wrong. The hives were resolving by the time the patient was leaving the office. On 08-Apr-2010, the patient was seen for a follow up visit. Her temperature was 98 degrees axillary. That same day the mother reported that the patient's temperature was up to 102.2 degrees. The child was subsequently diagnosed with otitis media. The outcomes for the events of otitis media, crying, fever and eye rolling were not reported. The other events have resolved. No additional information was available at the time of this report.
Age: 1.24
Sex: F
Vaccine: PNC13
Symptoms: Otitis media, Pyrexia, Respiratory arrest, Skin discolouration, Urticaria
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old female patient who experienced stopped breathing, eyes rolled back, face turned purple, went limp, crying, hives, otitis media, and temperature axillary 98 deg. F. At 15 months of age, the patient received the first dose on 07-Apr-2010. Additional suspect medication included PREVNAR. On 07-Apr-2010, prior to receiving her PREVNAR vaccination, the patient was fussy, but a physical exam was normal and the patient was afebrile. After vaccination, the patient immediately began crying, she stopped breathing, her eyes rolled back into her head, her face turned purple and she went limp in her mother's arms. The nurse blew in the baby's face for several seconds and the patient spontaneously started breathing again. The patient also developed hives and was treated with BENADRYL. The patient was examined and nothing else seemed to be wrong. The hives were resolving by the time the patient was leaving the office. On 08-Apr-2010, the patient was seen for a follow up visit. Her temperature was 98 degrees axillary. That same day the mother reported that the patient's temperature was up to 102.2 degrees. The child was subsequently diagnosed with otitis media. The outcomes for the events of otitis media, crying, fever and eye rolling were not reported. The other events have resolved. No additional information was available at the time of this report.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with chronic obstructive pulmonary disease, sodium pentothal allergy, sulfonamide allergy and codeine allergy who on 07-JAN-2008 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Merck) (lot # 656861/0329U). Concomitant therapy included SPIRIVA, ADVAIR and albuterol. In February 2010, the patient was diagnosed with shingles. The patient called the office on 17-FEB-2010 to report she was hospitalized. The patient was discharged and was prescribed acyclovir, hydrocodone and alprazolam. The patient was seen in the office on 13-APR-2010 and was noted to be recovering. Additional information has been requested.
Age: 90.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 90 year old patient who in April 2007, "3 years ago", was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported).  The patient was currently hospitalized with a diagnosis of shingles.  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: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Nodule, Skin warm, Swelling
Clinical narrative: Noticed a hard red knot first about the size of a quarter.  Then, the red place was still hot and as big a tennis ball.
Age: 1.12
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Gait disturbance, Pyrexia
Clinical narrative: fever, joint pain and unwillingness to walk
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pain in extremity, Paraesthesia
Clinical narrative: PAIN TINGLING AND BURNING IN LEFT ARM DISTAL FROM ELBOW TO FINGERS ON THE LATERAL ASPECT. COMES AND GOES. YESTERDAY THERE WAS PAIN AND TINGLING IN HER RIGHT LEG FROM KNEES TO TOES MORE MEDIALLY. IT IS NOT CONTINUOUS OR "SEVERE". SHE WILL BE SEEN BY A NEUROLOGIST. IT IS TOO EARLY FOR ME TO PREDICT A COURSE OR EVEN KNOW FOR SURE IF THIS IS DUE TO THE VACCINE.
Age: 39.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Asthma, Condition aggravated
Clinical narrative: Asthma I don't know the date and time of vaccination and asthma,  This is estimate.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Call from Dad today that right thigh where Prevnar 13 was given, is "slightly red and swollen about one inch in diameter"  Dad also states fever of unknown number on 4/20 after shot and was given Motrin.  He states child's activity is normal running on leg and only complains of pain at touch to swollen area.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Adverse event to Lt deltoid: 1/2 dollar size, erythema w/ slight induration, warmth to touch, pt denies pain --- advised pt's father to apply cold ompresses to immz site, ok to give OTC children's acetaminophen per label instructins, prn - ER precautions given.
Sex: M
Vaccine: HEP, HEP
Symptoms: Full blood count normal, Injection site discolouration, Injection site erythema, Injection site exfoliation, Injection site swelling
Clinical narrative: Vaccine administered at 1845.  Noted leg to be red and swollen over night.  By morning, area deeper red/ purple with blisters and sloughing noted.
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site vesicles
Clinical narrative: Vaccine administered at 1845.  Noted leg to be red and swollen over night.  By morning, area deeper red/ purple with blisters and sloughing noted.
Sex: M
Vaccine: HEP, HEP
Symptoms: Chest X-ray, Circumcision, Cyanosis, Full blood count, Injection site discolouration
Clinical narrative: Vaccine administered at 1845.  Noted leg to be red and swollen over night.  By morning, area deeper red/ purple with blisters and sloughing noted.
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Vaccine administered at 1845.  Noted leg to be red and swollen over night.  By morning, area deeper red/ purple with blisters and sloughing noted.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Joint injury, Loss of consciousness, Syncope, Vaccination complication
Clinical narrative: Waited 15 minutes after the vaccine felt fine passed out 3 hrs later at work. Seen in Hospital ED with shoulder injury and dx'ed syncope r/t pertussis. Reported by patient we have not seen any hospital documentation.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Caesarean section, Drug exposure during pregnancy, Premature separation of placenta, Vaginal haemorrhage
Clinical narrative: vaginal bleeding, placental abruption at 30 weeks gestation, emergency cesarean section performed
Age: 1.42
Sex: M
Vaccine: PNC13
Symptoms: Confusional state, Lethargy, Peripheral coldness, Pyrexia, Respiratory rate increased
Clinical narrative: Fever (Rectal 105.4F), mild lethargy, moderate daze/confusion, rapid breathing, cold hands. Treated with Motrin, Tylenol and sponge baths
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Hiccups
Clinical narrative: Coughing and severe Hiccups
Age: 1.31
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Cyanosis, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: high fever (104) Difficulty breathing fast heart beat Cold Hands Cold feet Paleness Blue lips Wheezing red eyes weakness runny nose dizziness
Age: 1.31
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Ocular hyperaemia, Pallor, Peripheral coldness, Pyrexia, Rhinorrhoea
Clinical narrative: high fever (104) Difficulty breathing fast heart beat Cold Hands Cold feet Paleness Blue lips Wheezing red eyes weakness runny nose dizziness
Age: 1.31
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Wheezing
Clinical narrative: high fever (104) Difficulty breathing fast heart beat Cold Hands Cold feet Paleness Blue lips Wheezing red eyes weakness runny nose dizziness
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Condition aggravated, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: IM injection was given to the L deltoid. The day after the injection the arm felt sore, red marks appeared, and some decreased range of motion secondary to soreness.  Pt added that he has HA's usually but they seem a little more intense now; and he also felt warm yesterday with some chills. Denies pruritis, throat swelling, SOB, easy bruising or bleeding, N/V/D, numbness, tingling, weakness, seizures, muscle or joint aches. Denies any type of allergic rxn in the past (No drug allergies listed)
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Skin warm
Clinical narrative: IM injection was given to the L deltoid. The day after the injection the arm felt sore, red marks appeared, and some decreased range of motion secondary to soreness.  Pt added that he has HA's usually but they seem a little more intense now; and he also felt warm yesterday with some chills. Denies pruritis, throat swelling, SOB, easy bruising or bleeding, N/V/D, numbness, tingling, weakness, seizures, muscle or joint aches. Denies any type of allergic rxn in the past (No drug allergies listed)
Age: 80.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Amnesia, Asthenia, Condition aggravated, Decreased appetite, Inappropriate schedule of drug administration
Clinical narrative: lung problems, weakness, loss of eating, loss of weight, sleep disorder, has to use inhaling machine, memory loss,
Age: 80.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lung disorder, Sleep disorder, Weight decreased
Clinical narrative: lung problems, weakness, loss of eating, loss of weight, sleep disorder, has to use inhaling machine, memory loss,
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Epstein-Barr virus test negative, Headache, Influenza serology negative, Pyrexia
Clinical narrative: Fever and headache that would not go away with medication. Dizziness. Given 1000 mg of Tylenol.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Fever and headache that would not go away with medication. Dizziness. Given 1000 mg of Tylenol.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Pt reported only today that after her last vaccines (4) administered that day she developed severe hives over all her body
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, PPV, RV5
Symptoms: Blood test normal, Chest X-ray normal, Cyanosis, Hypotonia, Lethargy
Clinical narrative: Stopped breathing, shock-like state, loss of color pale/blueish in color, went limp, lethargic
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, PPV, RV5
Symptoms: Pallor, Respiratory arrest, Shock
Clinical narrative: Stopped breathing, shock-like state, loss of color pale/blueish in color, went limp, lethargic
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Blood immunoglobulin A increased, Blood immunoglobulin G normal, Blood immunoglobulin M, C-reactive protein increased
Clinical narrative: Pt presented with rash started on left thigh area and then spread to whole of body, not much on face.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Red blood cell sedimentation rate increased
Clinical narrative: Pt presented with rash started on left thigh area and then spread to whole of body, not much on face.
Age: 0.17
Sex: M
Vaccine: 6VAX-F
Symptoms: Emotional distress, Pyrexia, Screaming
Clinical narrative: Screaming controllably, fever, unconsolable
Age: 45.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Chills, Dyspnoea, Headache, Pyrexia, Tremor
Clinical narrative: HA, fever 101.8, shaking chills, mild shortness of breath
Age: 45.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Burning sensation, Chills, Cough, Headache, Malaise
Clinical narrative: HA, fever 101.8, shaking chills, mild shortness of breath
Age: 45.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: HA, fever 101.8, shaking chills, mild shortness of breath
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cold sweat, Immediate post-injection reaction, Pallor, Staring, Syncope
Clinical narrative: Requested the H1N1 Flu vaccine, administered immediately had a blank stare and fainted was slightly responsive after inhalation, of an ammonia inhalant, then fainted again. Was cold and clammy and pale. BP 92/53, Pulse 61. Activated EMS was evaluated by them, signed declination to be taken to hospital.
Age: 0.49
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intestinal ischaemia, Intestinal resection, Intussusception, Surgery
Clinical narrative: Intussusception dx'ed 4/6/10, with 10 cm ischemic bowel removed. Good recovery.
Age: 0.49
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intestinal ischaemia, Intestinal resection, Intussusception
Clinical narrative: Intussusception dx'ed 4/6/10, with 10 cm ischemic bowel removed. Good recovery.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Dyspnoea, Flushing, Urticaria, Wheezing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act concerning a 17 year old female with congenital hydrocephalus and a medical history of 32 week preemie and Vascular shunt who on 04-JAN-2010 was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (lot # 662304/1013Y). Secondary suspect vaccination included second doses of VAQTA, (lot # 665702/1257Y), intramuscularly into the right arm and VARIVAX (Merck) (lot # 665208/1109Y), subcutaneously into the left arm. No concomitant therapy reported. On 04-JAN-2010 the patient experienced cough, dizziness, dry mouth, dyspnoea, flushing, heart rate increased, urticaria and wheezing. The patient became flushed, she complained of difficulty breathing, wheezing and developed hives on trunk and extremities required prolonged observation at physician's office. The patient was given 0.5 mL (1:1,000) epinephrine subcutaneous, BENADRYL 50 mg oral, ORAPRED 60 mg x1 dose. Medical records received from 04-JAN-2010 to 11-JAN-2010 indicated that after vaccination the patient complained of flushing face, dizziness, cough and started to complained of SOB, also experienced wheezing, dry mouth. Then the patient had hives at injection site. Assessment: Chest clear, normal voice (+) hives, HR increased, EPI PEN gave, hives decreased, lungs clear, VSS hives gone, the patient was sent home in stable condition. The listing indicated that one or more of the events was considered to be immediately life-threatening. A lot check has been initiated. The original reporting source was not reported. The VAERS ID number is: 376090-1. A preliminary lot check investigation was performed. To date our investigation has found that the lot 665702/1257Y conformed to quality release parameters and the manufacturing was typical of a lot of VAQTA. 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 662304/1013Y of GARDASIL in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. A standard lot check investigation has been finalized. All in-process quality checks for the lot 665208/1109Y of VARIVAX (Merck) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Cough, Dizziness, Dry mouth, Dyspnoea, Flushing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act concerning a 17 year old female with congenital hydrocephalus and a medical history of 32 week preemie and Vascular shunt who on 04-JAN-2010 was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (lot # 662304/1013Y). Secondary suspect vaccination included second doses of VAQTA, (lot # 665702/1257Y), intramuscularly into the right arm and VARIVAX (Merck) (lot # 665208/1109Y), subcutaneously into the left arm. No concomitant therapy reported. On 04-JAN-2010 the patient experienced cough, dizziness, dry mouth, dyspnoea, flushing, heart rate increased, urticaria and wheezing. The patient became flushed, she complained of difficulty breathing, wheezing and developed hives on trunk and extremities required prolonged observation at physician's office. The patient was given 0.5 mL (1:1,000) epinephrine subcutaneous, BENADRYL 50 mg oral, ORAPRED 60 mg x1 dose. Medical records received from 04-JAN-2010 to 11-JAN-2010 indicated that after vaccination the patient complained of flushing face, dizziness, cough and started to complained of SOB, also experienced wheezing, dry mouth. Then the patient had hives at injection site. Assessment: Chest clear, normal voice (+) hives, HR increased, EPI PEN gave, hives decreased, lungs clear, VSS hives gone, the patient was sent home in stable condition. The listing indicated that one or more of the events was considered to be immediately life-threatening. A lot check has been initiated. The original reporting source was not reported. The VAERS ID number is: 376090-1. A preliminary lot check investigation was performed. To date our investigation has found that the lot 665702/1257Y conformed to quality release parameters and the manufacturing was typical of a lot of VAQTA. 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 662304/1013Y of GARDASIL in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. A standard lot check investigation has been finalized. All in-process quality checks for the lot 665208/1109Y of VARIVAX (Merck) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Heart rate increased, Injection site urticaria, Urticaria, Wheezing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act concerning a 17 year old female with congenital hydrocephalus and a medical history of 32 week preemie and Vascular shunt who on 04-JAN-2010 was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (lot # 662304/1013Y). Secondary suspect vaccination included second doses of VAQTA, (lot # 665702/1257Y), intramuscularly into the right arm and VARIVAX (Merck) (lot # 665208/1109Y), subcutaneously into the left arm. No concomitant therapy reported. On 04-JAN-2010 the patient experienced cough, dizziness, dry mouth, dyspnoea, flushing, heart rate increased, urticaria and wheezing. The patient became flushed, she complained of difficulty breathing, wheezing and developed hives on trunk and extremities required prolonged observation at physician's office. The patient was given 0.5 mL (1:1,000) epinephrine subcutaneous, BENADRYL 50 mg oral, ORAPRED 60 mg x1 dose. Medical records received from 04-JAN-2010 to 11-JAN-2010 indicated that after vaccination the patient complained of flushing face, dizziness, cough and started to complained of SOB, also experienced wheezing, dry mouth. Then the patient had hives at injection site. Assessment: Chest clear, normal voice (+) hives, HR increased, EPI PEN gave, hives decreased, lungs clear, VSS hives gone, the patient was sent home in stable condition. The listing indicated that one or more of the events was considered to be immediately life-threatening. A lot check has been initiated. The original reporting source was not reported. The VAERS ID number is: 376090-1. A preliminary lot check investigation was performed. To date our investigation has found that the lot 665702/1257Y conformed to quality release parameters and the manufacturing was typical of a lot of VAQTA. 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 662304/1013Y of GARDASIL in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. A standard lot check investigation has been finalized. All in-process quality checks for the lot 665208/1109Y of VARIVAX (Merck) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old male patient with no pertinent medical history and no known drug  reactions/allergies who on 09-FEB-2010 was vaccinated with a 0.5 ml SQ dose of ZOSTAVAX (Merck) (lot# 665311/1310Y). There was no concomitant medication. On 18-FEB-2010 the patient saw his physician and was diagnosed with shingles. His shingles outbreak spread to his eye and then to his brain. It was reported that the patient experienced brain swelling. The patient was hospitalized. At the time of the report, the patient had not recovered. The reporting pharmacist considered "shingles outbreak spread to his brain", "shingles outbreak spread to his eye" and "brain swelling" to be immediately life-threatening. A lot check has been initiated. Additional information has been requested. Hospital name was unknown.