chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pyrexia, Uveitis
Clinical narrative: Information has been received from a published article, titled as stated above. This literature article was initially reported to a foreign 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 a hepatitis B virus vaccine, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #6 of 32, a 45 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 45 year old female on an unspecified date was vaccinated with her first dose of RECOMBIVAX HB (lot number, route and site not reported). Concomitant therapy included fluoxetine. Two days after the first dose, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of fatigue and pyrexia. 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, 1004USA02328, 1004USA02329, 1004USA02330, WAES # 1004USA02332 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: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 22-APR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 08-MAY-2008 the patient developed a seizure. The patient then received the second dose of GARDASIL (lot# not reported) on 25-JUN-2008 and then was given the third dose of GARDASIL (lot# not reported) on 13-OCT-2009. The physician reported that the patient did not have any experiences after receiving the other doses, but the patient believed they had a seizure because of GARDASIL. At the time of this report, the patient's outcome was unknown. Additional information has been received from the physician concerning the patient who on 22-APR-2008 was vaccinated with first dose of GARDASIL (lot# 660387/1967U). The patient then received the second dose of GARDASIL (lot# 660553/0070X) on 25-JUN-2008 and then was given the third dose of GARDASIL (lot# 660612/0229X) on 13-OCT-2009. The physician reported that the patient did not receive any concomitant vaccinations when she received the GARDASIL vaccinations. The patient's grandmother called the physician on 08-APR-2010 and reported that the patient was experiencing a seizure about once a month. The patient was seeing a neurologist. The physician did not consider the seizures to be disabling or life-threatening and the patient was not hospitalized. Upon internal review, seizure was considered to be an important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a published article, title as
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Optic neuritis, Retinitis, 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 #8 of 32, a 11 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 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. An 11 year old male on an unspecified date was vaccinated with his first 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 patient also experienced symptoms of optic neuritis and retinitis. 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, 1004USA02328, 1004USA02329, 1004USA02330, 1004USA02331, 1004USA02332, WAES # 1004USA02334 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: 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 #9 of 32, a 12 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 on 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 second and third doses. Patient outcome had not been reported. A 12 year old female 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 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 # 1004USA02333, WAES # 1004USA02335 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. 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 #10 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 her first 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 # 1004USA02334, WAES # 1004USA02336 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 11.0
Sex: M
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 #11 of 32, a 11 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. An 11 year old male on an unspecified date was vaccinated with his second dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Two days 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 # 1004USA02335, WAES # 1004USA02337 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, 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 #12 of 32, a 16 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 16 year old female on an unspecified date was vaccinated with the second 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 patient also experienced symptoms of arthritis. 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 # 1004USA02336, WAES # 1004USA02338 to WAES # 1004USA02357).
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: 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 #13 of 32, a 44 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 44 year old female on an unspecified date was vaccinated with the first 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 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 # 104USA02337, WAES # 1004USA02339 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Paralysis, Uveitis
Clinical narrative: Information has been received from a published article. This literature case 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 patient's was 29 years). The patients received RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #14 of 32, a 52 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 52 year old female on an unspecified date was vaccinated with the third dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Five days after vaccination, the patient developed uveitis and also experienced symptoms of paralysis. 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 the experience of an additional 31 patients while on therapy with RECOMBIVAX (WAES #100USA01716, WAES # 1004USA02327 to WAES # 1004USA02338, WAES # 1004USA02340 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: 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 #15 of 32, a 29 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 29 year old male on an unspecified date was vaccinated with the first dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Two days 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 (WAES # 1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02339, WAES # 1004USA02341 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Age: 29.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Arthralgia, Erythema nodosum, Pyrexia, Red blood cell sedimentation rate increased, 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 #16 of 32, a 29 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 29 year old female on an unspecified date was vaccinated with a 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. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of arthralgia, erythema nodosum, elevated sedimentation rate and fever. 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 # 1004USA02340, WAES # 1004USA02342 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: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain. Mother took child to MD on 4/20/10 and was given oral Benadryl and was told to take Tylenol for pain. MD also gave child VZV in the right arm during same appt.
Age: 40.0
Sex: M
Vaccine: HEPAB, MMR, MNQ, TD, VARCEL
Symptoms: Nerve injury, Pain, X-ray
Clinical narrative: pain started after vaccination, after 2-3 days not better, went to MD, was given Rx to help relax the muscles. Returned to MD after a couple weeks of no improvement, x-ray was done was told the nerve was affected due to the shot. He currently states he has pain night and day all the time.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), TDAP
Symptoms: Ecchymosis, Nodule, Tenderness
Clinical narrative: Firm 3x4cm nodule, tender to touch with surrounding ecchymosis on day 3 after injection. Resolved except for slight tenderness 12 days after injection. Pt tx'd with BENADRYL.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever, temp 101.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Chills, Dizziness, Nausea
Clinical narrative: Onset 6pm 4/20/10 chills, nausea, fever 103, dizziness, brief syncope in bathroom. Severe epigastric pain which lessened by 4/21/10 AM, weak, nausea 4/21/10 fever resolved by 4/21/10 AM.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Syncope
Clinical narrative: Onset 6pm 4/20/10 chills, nausea, fever 103, dizziness, brief syncope in bathroom. Severe epigastric pain which lessened by 4/21/10 AM, weak, nausea 4/21/10 fever resolved by 4/21/10 AM.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Rash macular
Clinical narrative: Shortly after administering immunizations, pt started scratching at left deltoid where shot administered, I checked the site and noticed a reddened splotchy area and both arms, immediately got the doctor, about 2 inches in diameter. No change in status, vital signs stable; lungs/throat continued to be clear. Pt. playful.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left arm bigger than right arm. No redness but warm to touch. No fever 36.7 T. No pain. No complaint from pt.
Age: 56.0
Sex: F
Vaccine: DT, PPV
Symptoms: Dizziness, Nausea, Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: Pt c/o dizziness, hives, nausea, & also c/o arm swelling & soreness which is a normal side effect.  All begin next day.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed left arm swelling, redness and pain starting about 6 hrs after shot. Patient states it was HPV while our records meningococcal. No respiratory symptoms.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Had flu shot on Sep 13, 2009. Had no reaction to the shot at all - called research co & informed about diagnosis of Guillain Barre March 9 started having numbness & tingling in his feet. It progressed up the leg. He went to bed one night and legs felt like they were asleep but he couldn't wake them. He went to the doctor March 12 09 and PCP sent him to the hospital. Diagnosed with Guillain Barre Syndrome - slowly recovering.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Myalgia, Pain in extremity, Pharyngitis, Pyrexia, Streptococcus test negative
Clinical narrative: Fever 103 - 104 for 12 hrs and leg pain, myalgia. Start ibuprofen 100 mg/5mL 10 mL Q6H x 2 days - return if worse. Also pharyngitis.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, X-ray limb abnormal
Clinical narrative: Patient received TD 6/30/09 for health maint. update. She called clinic 8/25/09 stating her arm has been painful since getting the vaccine. She was examined by Dr 11/11/09 - xrays showed minimal degenerative changes left shoulder. Examined by Dr 12/3/09 - advised physical therapy, warm packs and anti-inflammatories. Pt contacted Dr 1/5/2010. Evaluated by neurologist 2/8/10 and p.t. eval 3/10/10.
Age: 1.02
Sex: M
Vaccine: HIBV
Symptoms: Haemoglobin decreased, Hypotonia, Pyrexia, Rhinitis, Rhinorrhoea
Clinical narrative: 3-4 hrs post vaccination fever 100-101 F. Parent gave alternating doses TYLENOL and Ibuprofen q6hr. But fever persisted episodically through Thurs 4/15/10 7pm. 7pm 4/15/10 fever spiked to 104.9F. Parents prepared to take child to Emergency Room (100 miles away). Parents did tepid bath, child limp, staring into space. When takes every bath shaking uncontrollably for several seconds. Fever came down to about 101-102F and gradually decreased to normal temperatures by AM Sat. 4/16/10 then developed runny nose / green nasal discharge.
Age: 1.02
Sex: M
Vaccine: HIBV
Symptoms: Staring, Tremor
Clinical narrative: 3-4 hrs post vaccination fever 100-101 F. Parent gave alternating doses TYLENOL and Ibuprofen q6hr. But fever persisted episodically through Thurs 4/15/10 7pm. 7pm 4/15/10 fever spiked to 104.9F. Parents prepared to take child to Emergency Room (100 miles away). Parents did tepid bath, child limp, staring into space. When takes every bath shaking uncontrollably for several seconds. Fever came down to about 101-102F and gradually decreased to normal temperatures by AM Sat. 4/16/10 then developed runny nose / green nasal discharge.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Localized erythema 3 X 2 3/4" at injection site within 48 hours of immunization. left arm.  Cont. treatment with CLARITIN.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: PT STATED SHE WOKE UP ON 04/07/2010 AT 7 AM WITH HER ARM SWOLLEN, AND IT WAS SORE.  SHE WENT TO TALK IN CLINIC ON DAY FOUR, DUE TO PROGRESSIVE PAIN AND SWELLING IN THE LEFT ARM.  SHE STATED SHE HAD A FEVER OF 101.3 TO 101.4 PER WALK IN CLINIC NOTE, NO SWEATS OR CHILLS, NO EARACHE, NO EYE DISCHARGE, NO SORE THROAT OR SWELLING OF THE THROAT, NO COUGH OR SHORTNESS OF BREATH.  AREA MEASURED AT WALK IN CLINIC WAS 12X 5 MM OVAL ERYTHEMA, TENDERNESS AND WARMTH.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: PT STATED SHE WOKE UP ON 04/07/2010 AT 7 AM WITH HER ARM SWOLLEN, AND IT WAS SORE.  SHE WENT TO TALK IN CLINIC ON DAY FOUR, DUE TO PROGRESSIVE PAIN AND SWELLING IN THE LEFT ARM.  SHE STATED SHE HAD A FEVER OF 101.3 TO 101.4 PER WALK IN CLINIC NOTE, NO SWEATS OR CHILLS, NO EARACHE, NO EYE DISCHARGE, NO SORE THROAT OR SWELLING OF THE THROAT, NO COUGH OR SHORTNESS OF BREATH.  AREA MEASURED AT WALK IN CLINIC WAS 12X 5 MM OVAL ERYTHEMA, TENDERNESS AND WARMTH.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Back pain, Chest discomfort, Chills, Dizziness
Clinical narrative: Patient woke up with pleuritic chest and back pain, shortness of breath, chills, temp 98-99 degrees F, body aches, sore arms bilaterally, "dizzy", mild rhinorrhea, "weak", chest tightness.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Pain, Pain in extremity, Pleuritic pain, Rhinorrhoea
Clinical narrative: Patient woke up with pleuritic chest and back pain, shortness of breath, chills, temp 98-99 degrees F, body aches, sore arms bilaterally, "dizzy", mild rhinorrhea, "weak", chest tightness.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Gaze palsy, Musculoskeletal stiffness, Presyncope, Tremor
Clinical narrative: I gave PT her first Gardasil injection, explained the risks and told her it our office polices for her to stay 20 mins after injection, she agreed. gave injection to LT buttocks she rolled over and her eyes rolled to back of her head, tightening her whole body and then a slight shake. I called out for DRs because they where closer to room. We watched patient for an hour. The Doctors explained that it was not a drug reaction, but overly excited reaction (Vasovagal). Patient was fine.
Age: 51.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: On Friday 4-9-10, patient noted neck stiffness and swollen lymph node below right earlobe. No fever or chills, but slight neck stiffness only. On 4-21-10, she presented with only the swollen lymph node below her right ear lobe.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: R LEG SWOLLEN AND RED (4X3CM) TENDER TO TOUCH.  PT TREATED WITH KEFLEX 125/5 QID, COMING BK TO OFFICE ON 04-23-2010 FOR A RE CK.  SPOKE TO G-MA, SHE STATES ITS DOING BETTER--CMA
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MM, PNC, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: High Fever and irritability
Age: 17.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling at injection site. 6cm X 2cm. Some itching. Instructions given to apply cold compress for swelling, return to office if swelling worsens or persist.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Crying
Clinical narrative: inconsolable crying for 3 1/2 hours, treated with infant Tylenol
Age: 1.22
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Pharyngeal erythema, Rash maculo-papular
Clinical narrative: Diffuse maculo-papular rash over entire body and face, mostly truncal, but also on extremities and palms and soles.  Also eyelids, lips, labia.  Not in mouth.  Red throat.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site has a bruise around it. Below the injection site is a large, hot, red, tender area. It's swollen to the size of an egg over the course of the day.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Foetal heart rate abnormal, Intra-abdominal pressure increased, Premature separation of placenta
Clinical narrative: Pressure in abdomen, went to er and found out my baby had no heartbeat.  Placenta Abruption.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Extreme swelling of his right upper leg (more than double regular size); below the shot area including the knee and above the knee. Area is warm and red. Mild fever.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: 2 1/2 inch by 1 inch knot red, hot to touch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Dyspnoea, Erythema, Local reaction, Skin warm, Stridor
Clinical narrative: Mother noted approx 1-2 hrs after vaccine hives on legs / increased work of breathing and mild stridor. Local reaction persisted through clinic visit 4/19 - red/warm/swollen.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Swelling, Urticaria
Clinical narrative: Mother noted approx 1-2 hrs after vaccine hives on legs / increased work of breathing and mild stridor. Local reaction persisted through clinic visit 4/19 - red/warm/swollen.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Hyperventilation
Clinical narrative: On 4/16/10 pt received ADACEL, MENACTRA and GARDASIL, went home 2 Hrs later, she felt severe muscle body ache area UE, LE, trunk and chest and back. She complains of short of breath, tingling sensation of chest and back. She felt weakness of UE and LE. Not paralysis, No fever, she felt difficulty of breathing and tends to hyperventilate.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Muscular weakness, Myalgia, Pain, Paraesthesia
Clinical narrative: On 4/16/10 pt received ADACEL, MENACTRA and GARDASIL, went home 2 Hrs later, she felt severe muscle body ache area UE, LE, trunk and chest and back. She complains of short of breath, tingling sensation of chest and back. She felt weakness of UE and LE. Not paralysis, No fever, she felt difficulty of breathing and tends to hyperventilate.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Rash macular, Skin discomfort, Urticaria
Clinical narrative: Patient received 1st dose of HPV. That night developed hives all over body - itchy & uncomfortable. BENADRYL given with some relief. After 2 weeks pt still has off & on splotchy skin - hive like reaction. Seems to flare up with exercise or in eve.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye swelling, Hypersensitivity, Lip swelling, Oedema peripheral, Pain
Clinical narrative: Patient received 1st dose of HPV. That night developed hives all over body - itchy & uncomfortable. BENADRYL given with some relief. After 2 weeks pt still has off & on splotchy skin - hive like reaction. Seems to flare up with exercise or in eve.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Rash macular, Swelling face, Tenderness, Urticaria
Clinical narrative: Patient received 1st dose of HPV. That night developed hives all over body - itchy & uncomfortable. BENADRYL given with some relief. After 2 weeks pt still has off & on splotchy skin - hive like reaction. Seems to flare up with exercise or in eve.
Age: 1.47
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Pt had temp of 104.4 & febrile seizures.  Went to ER for treatment.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal X-ray, Intussusception, Ultrasound abdomen
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act concerning a 2 month old female with no medical history or previous illness who 19-JAN-2010 was orally vaccinated with a dose of ROTATEQ (lot # 664688/1182Y). Secondary suspect vaccination given on the same date included a dose of RECOMBIVAX HB (lot # "12504"), intramuscularly. Concomitant vaccination given on the same date included doses of PREVNAR (lot # D78697) and PENTACEL (lot # C3385AA), both were given intramuscularly. On 24-JAN-2010 the patient experienced intussusception and vomiting. Ileocolic intussusception - reduced 24-JAN-2010, 15-FEB-2010 and 09-MAR-2010, 10-MAR-2010. Hospital records were received on 24-JAN-2010; diagnosis was intussusception. On 15-FEB-2010 the patient had an abnormal abdominal ultrasound. On an unspecified date the patient recovered from vomiting. Assessment: successful reduction of an ileocolic intussusception via air enema. The patient required an emergency room visit. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was not provided: The VAERS ID # is: 380355-1. A standard lot check has been finalized. All in-process quality checks for the lot number 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 for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Barium double contrast, Enema administration, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act concerning a 2 month old female with no medical history or previous illness who 19-JAN-2010 was orally vaccinated with a dose of ROTATEQ (lot # 664688/1182Y). Secondary suspect vaccination given on the same date included a dose of RECOMBIVAX HB (lot # "12504"), intramuscularly. Concomitant vaccination given on the same date included doses of PREVNAR (lot # D78697) and PENTACEL (lot # C3385AA), both were given intramuscularly. On 24-JAN-2010 the patient experienced intussusception and vomiting. Ileocolic intussusception - reduced 24-JAN-2010, 15-FEB-2010 and 09-MAR-2010, 10-MAR-2010. Hospital records were received on 24-JAN-2010; diagnosis was intussusception. On 15-FEB-2010 the patient had an abnormal abdominal ultrasound. On an unspecified date the patient recovered from vomiting. Assessment: successful reduction of an ileocolic intussusception via air enema. The patient required an emergency room visit. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was not provided: The VAERS ID # is: 380355-1. A standard lot check has been finalized. All in-process quality checks for the lot number 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 for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.17
Sex: F
Vaccine: UNK, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia, Occult blood positive
Clinical narrative: Diarrhea x 3 wks and hematochezia - No treatment given - resolved on own after 3 wks. Diarrhea = 8-9/day. (-) gross blood, (+) hemoccult. (-) mucus, no weight loss.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Auricular swelling, Erythema, Pruritus, Urticaria
Clinical narrative: I received the final injection of the GARDASIL vaccine on 10/21/2007 and on 01/05/2008 I woke up in the morning with red, swollen and itchy ear lobes. Since then, I have had full body hives.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Full blood count normal, Headache, Laboratory test normal, Nausea, Protein urine present
Clinical narrative: Vice-Like 7/10 frontal headache, nausea
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Urine analysis abnormal, Urine ketone body present
Clinical narrative: Vice-Like 7/10 frontal headache, nausea
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: C/o limited range of motion when working out with personal trainer of L arm. Noticed problem 2 days after receiving ZOSTAVAX injection. C/o soreness of L arm. No swelling noted. ROM progressively worse since 11/19/09. Never saw MD. Returned to health dept 4/10 to report prob. with arm.
Age: 1.36
Sex: F
Vaccine: HIBV, PNC
Symptoms: Hyperventilation, Hypotonia, Lymphadenopathy, Pyrexia
Clinical narrative: Within 1-2 hrs heavy breathing, increased fever, swollen lymph nodes, limp.  To Urgent care sat. A.M. (4/17/10) continues. to have fever spikes 4/20/10.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Rash generalised, Urticaria
Clinical narrative: By mother's report - Rec'd MMR II and VARIVAX 4/14/10 at 315 pm, mom noticed 4/15 at 300 child had itching - noted redness around injection site on both arms and gave BENADRYL. The next AM mom noticed redness on her cheeks and a little more on her arms. She gave her BENADRYL and sent her to school. When pt returned home from school at 3 pm - mom noted redness on her cheeks and mom noted what she said was hives/rash/redness from head to toe, called Health Unit and we recommended she see PMD or go to hospital. ER MD gave corticosteroids and BENADRYL. This problem has not resolved yet child stay home from school today.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PNC, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Gave child ZOSTAVAX instead of varicella vaccine. Medication error.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt experienced mild swelling to injection site 4 days after injection given. No fever. Also experienced redness and skin warmth.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 65.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Asthenia, Cough, Ear congestion, Pyrexia
Clinical narrative: Fever. Joint ache. Weakness. Severe cough. Blocked ears.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain, Neck pain
Clinical narrative: Narrative: Pt developed injection site reaction following vaccination. Site was warm to touch and very swollen. Patient stated pain is in his right shoulder and neck area. Rates pain-7/10. Instant cold pack applied to site and APAP or Ibuprofen or Tramadol given for pain. Symptoms: . 1. injection site reaction, swelling, painful, red. Treatment Drugs Used: 1 - ACETAMINOPHEN Dose: 650 Units: MG Freq: QID Route: PO.
Age: 41.0
Sex: F
Vaccine: FLUN3, HEPA, TYP
Symptoms: Dysphagia, Dyspnoea, Erythema, Lip swelling, No reaction on previous exposure to drug
Clinical narrative: On 9/25/09 the pt received FLUMIST (never had before--previously received influenza injection), HepA (2nd or third dose) and typhoid (possibly #4) at 0730. Approximately 45 minutes later the pt noted generalized itching and about 15 minutes later she noted hives on her arms and face. Within 10 minutes the pt complained of difficulty swallowing and breathing, increased hives and "lip swelling". The pt was taken to the medical dept where she was treated with epinephrine, oxygen and IV fluids. The pt states that she was unresponsive (?almost fainted) for a short period of time. At 1300 the pt was d/c home with some minor skin redness remaining. The pt denied and further episodes of hives, angioedema, difficulty breathing or swallowing. Pt had no new foods or medications prior to the immunizations. No history of prior adverse reactions to vaccinations; Pt has seasonal allergies which she treated with BENADRYL or ZYRTEC prn. Pt denies prior formal allergy testing. No food/latex allergies.
Age: 41.0
Sex: F
Vaccine: FLUN3, HEPA, TYP
Symptoms: Presyncope, Pruritus generalised, Radioallergosorbent test negative, Seasonal allergy, Skin test negative
Clinical narrative: On 9/25/09 the pt received FLUMIST (never had before--previously received influenza injection), HepA (2nd or third dose) and typhoid (possibly #4) at 0730. Approximately 45 minutes later the pt noted generalized itching and about 15 minutes later she noted hives on her arms and face. Within 10 minutes the pt complained of difficulty swallowing and breathing, increased hives and "lip swelling". The pt was taken to the medical dept where she was treated with epinephrine, oxygen and IV fluids. The pt states that she was unresponsive (?almost fainted) for a short period of time. At 1300 the pt was d/c home with some minor skin redness remaining. The pt denied and further episodes of hives, angioedema, difficulty breathing or swallowing. Pt had no new foods or medications prior to the immunizations. No history of prior adverse reactions to vaccinations; Pt has seasonal allergies which she treated with BENADRYL or ZYRTEC prn. Pt denies prior formal allergy testing. No food/latex allergies.
Age: 41.0
Sex: F
Vaccine: FLUN3, HEPA, TYP
Symptoms: Unresponsive to stimuli, Urticaria
Clinical narrative: On 9/25/09 the pt received FLUMIST (never had before--previously received influenza injection), HepA (2nd or third dose) and typhoid (possibly #4) at 0730. Approximately 45 minutes later the pt noted generalized itching and about 15 minutes later she noted hives on her arms and face. Within 10 minutes the pt complained of difficulty swallowing and breathing, increased hives and "lip swelling". The pt was taken to the medical dept where she was treated with epinephrine, oxygen and IV fluids. The pt states that she was unresponsive (?almost fainted) for a short period of time. At 1300 the pt was d/c home with some minor skin redness remaining. The pt denied and further episodes of hives, angioedema, difficulty breathing or swallowing. Pt had no new foods or medications prior to the immunizations. No history of prior adverse reactions to vaccinations; Pt has seasonal allergies which she treated with BENADRYL or ZYRTEC prn. Pt denies prior formal allergy testing. No food/latex allergies.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site swelling, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: Had some swelling at injection at initial shot, but generalized urticaria after booster. Generalized hives. No arthralgia. No abd pain.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Blister, Erythema, Nodule, Pathology test, Skin lesion excision
Clinical narrative: Pt received PNEUMOVAX (R) arm, then developed red "blister," which became a nodule, gradually enlarging since.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenitis, Pain, Pyrexia, Skin warm
Clinical narrative: Woke up with fever, pain with warmness of left armpit on day after vaccine.  Did not improve so saw MD on 4-17-10, treated with CID/SF antibiotics, pain medicine for infection of lymph glands.  Is beginning to improve now.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Nausea, Pruritus, Urticaria
Clinical narrative: Nausea - Immediately.  Itchy skin - 24 hours.  Hives - both legs 48 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Had DTAP/IPV, MMR, VAR on 3/30/10. On 4/2 came in w/reaction to arm w/DTAP. Dr. figured reaction to Tet. Redness and cellulitis to arm at injection site only of DTAP/IPV area.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: The evening he received the PNEUMOVAX his arm became red and warm to the touch. He was seen here in the office. Dr prescribed an antibiotic for him.