chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Respiratory arrest, Vomiting
Clinical narrative: Pt. started vomiting the evening of the immunizations & seemed to stop breathing.  Taken by ambulance to E.R.  Pt. was watched in ER & discharged home the same night.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: Came into office with rash on her back stings & burns.  The rash is at the level of the lumbar dermatome.  FAMVIR 500 mg ordered.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Cried for 4 hours, fever of 102 degrees.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypersensitivity, Oedema peripheral
Clinical narrative: Infant received vaccinations on 2/20/08.  Next day mother saw increased swelling in lower limbs.  Continued to have lower limb swelling.  Infant was taken to PCP.  PCP diagnosed allergic reaction to vaccination.  Infant currently to receive vaccinations from allergist.
Age: 14.0
Sex: F
Vaccine: MNQ, TD, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Both arms where injections were given are hot to touch, raised, rash-like.  Pt was scratching injections.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site infection
Clinical narrative: Redness at site of injection appeared to be infected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased
Clinical narrative: Temperature 24 hours later of 99-101 for 2-3 days following injection.  Patient never reported reactions until she came in for 2nd injection.  Doctor would not authorize 2nd vaccine.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Influenza like illness, Injection site discolouration, Injection site erythema
Clinical narrative: Injection site red. left arm discoloration to elbow left arm inflammation, (L) supra clavicular inflammation of the lymph node. Bowel movement x 3 5/10/08. General body ache. Temp 101.0 f, chills - Flu-like symptoms.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site inflammation, Lymphadenopathy, Pain
Clinical narrative: Injection site red. left arm discoloration to elbow left arm inflammation, (L) supra clavicular inflammation of the lymph node. Bowel movement x 3 5/10/08. General body ache. Temp 101.0 f, chills - Flu-like symptoms.
Age: 51.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth, Skin discolouration
Clinical narrative: On 5-10-08 for T.B. testing/reading, informed staff of red area to left arm red area. Staff noted a red raised half dollar size at injection site and a dime size raised area to R arm injection site. Client given Benadryl and instructed to take Tylenol for discomfort. No other problems noted. Instructed to see M.D. if symptoms worsen, client returned to clinic today 5-13-08 after seeing M.D. Noted with irregular raised red, firm, warm to touch area on left arm. Discoloration noted in area around raised area, tender to touch. Appointment made for client to be seen by Dr.
Age: 51.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Tenderness
Clinical narrative: On 5-10-08 for T.B. testing/reading, informed staff of red area to left arm red area. Staff noted a red raised half dollar size at injection site and a dime size raised area to R arm injection site. Client given Benadryl and instructed to take Tylenol for discomfort. No other problems noted. Instructed to see M.D. if symptoms worsen, client returned to clinic today 5-13-08 after seeing M.D. Noted with irregular raised red, firm, warm to touch area on left arm. Discoloration noted in area around raised area, tender to touch. Appointment made for client to be seen by Dr.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain over injection site with limited ROM on abdomen and pain at shoulder.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid redness, swelling, warmth
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid erythema, warmth, swelling x 3 days proximal/upper 1/3 of UE Motrin for tx
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: C/O (L) arm redness from elbow to shoulder about 48 hours, hot to the touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swollen & indurated DTaP injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid swollen, red and warm
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Head discomfort
Clinical narrative: 30 minutes after injection, child c/o needed to sit down.  Stated head "feels funny".  Child laid on exam table.  Remained conscious, alert, nonmotensive, skin warm/dry.  Strong palpable pulses BUE.  Rested x15 min, then left office with mother.  F/u with mother late afternoon, child was fine, exhibiting normal behavior.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Mom describes (L) arm became hot to touch, swollen red and painful from shoulder to elbow. She states that child still played like normal. She took him to M.D. who told her it was allergic reaction, give Benadryl
Age: 1.3
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Herpes zoster, Rash vesicular
Clinical narrative: Developed shingles - Vesicolor contivent 2-3 cm on Red base no surrounding erythema nontender no itch Distal Lat thigh and R lat buttock L3 distal bottom.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Abasia, Asthenia, Blood product transfusion, CSF glucose normal, CSF protein increased
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: CSF white blood cell count, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulins
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Intubation, Lumbar puncture, Mechanical ventilation, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Paraesthesia, Plasmapheresis, Red blood cells CSF positive, Urine analysis abnormal, Urine analysis normal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Wheelchair user
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Abasia, Asthenia, Back pain, Blood product transfusion, Dysphonia
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Electromyogram abnormal, Endotracheal intubation, Eyelid ptosis, Fall, Gait disturbance
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Gastrointestinal tube insertion, Gastrooesophageal reflux disease, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypoaesthesia oral, Intensive care, Mechanical ventilation, Myalgia, Pain in jaw
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngitis, Plasmapheresis, Rash pruritic
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Tracheitis, Weight decreased, Wheelchair user
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 15 year old female with asthma, allergic rhinitis, nickel dermatitis and a history of a fractured toe who on 25-SEP-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 658094/0524U). Concomitant therapy included MENACTRA (Lot U2382BA), ADVAIR, albuterol, CLARITIN and TRIAMCINOLON COMPOSITUM. On 20-DEC-2007, prior to admission, the patient presented with a several day history of numbness and tingling in her extremities, with progressive weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission she felt increasing pharyngitis and numbness and tingling in lips. Three days prior to admission she felt increasing generalized weakness. Two days prior to admission the patient was increasingly hoarse. On the day of admission the patient demonstrated a wide based gait, and was holding onto the wall to walk. She fell in the bath tub and was unable to get up. She had decreased grip strength. She also had a ten pound weight loss one week prior to admission. Some of her symptoms also included acid reflux, global myalgias, jaw pain, and back pain. She had a pruritic rash on her frame. Diagnostic testing performed included an electromyography on 27-DEC-2007 indicating the medial ulnar motor response was very low in amplitude and mildly long in distal latency. A repeat electromyography was performed on 04-JAN-2008 revealed no response obtainable in the median or ulnar motor nerves, and the peroneal motor study showed low amplitude response and MIL. Treatment required admission to the intensive care unit, prolonged period of intubation and ventilator support, plasmapheresis, intravenous immunoglobulin, physical and occupational therapy and nasogastric tube feeding. She also had developed bilateral ptosis and tracheitis. she was diagnosed with Guillain-Barre syndrome on 17-JAN-2008. She was transferred to a rehabilitation unit and remained hospitalized. The patient remains in a wheelchair and was unable to ambulate on her own. The events were considered to be life-threatening. A standard lot check investigation was performed. 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. The original reporting source was not provided. The VAERS ID # is 306868. No further information is available.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, YF, HEPA, MNQ, YF
Symptoms: Back pain, Balance disorder, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Patient had headache, blurred vision, sensitivity to light, loss of balance, back ache, throat ache, right side of body from hip to shoulder and right arm went numb, vomiting, nausea, and weakness of both extremities right side more severe than left. 5/19/08-records received for DOS 5/13-5/14/08-DC DX:  Vaccination reaction, probably the yellow fever, although she had a Hepatitis vaccination too. Presented with headache, neck pain, swelling, muscle aches and edema at the site. Intractable vomiting.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, YF, HEPA, MNQ, YF
Symptoms: Nausea, Pharyngolaryngeal pain, Photophobia, Vision blurred, Vomiting
Clinical narrative: Patient had headache, blurred vision, sensitivity to light, loss of balance, back ache, throat ache, right side of body from hip to shoulder and right arm went numb, vomiting, nausea, and weakness of both extremities right side more severe than left. 5/19/08-records received for DOS 5/13-5/14/08-DC DX:  Vaccination reaction, probably the yellow fever, although she had a Hepatitis vaccination too. Presented with headache, neck pain, swelling, muscle aches and edema at the site. Intractable vomiting.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, YF, HEPA, MNQ, YF
Symptoms: Back pain, Balance disorder, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Patient had headache, blurred vision, sensitivity to light, loss of balance, back ache, throat ache, right side of body from hip to shoulder and right arm went numb, vomiting, nausea, and weakness of both extremities right side more severe than left.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, YF, HEPA, MNQ, YF
Symptoms: Nausea, Pharyngolaryngeal pain, Photophobia, Vision blurred, Vomiting
Clinical narrative: Patient had headache, blurred vision, sensitivity to light, loss of balance, back ache, throat ache, right side of body from hip to shoulder and right arm went numb, vomiting, nausea, and weakness of both extremities right side more severe than left.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Herpes zoster, Inflammatory carcinoma of the breast
Clinical narrative: Normal mammogram in 3/07. During physical in 4/07 was given Zostavax-shingles vaccine. Days later developed symptoms on chest. Was told it was shingles-from the vaccine. Did not improve and was biopsied. Diagnosed as Inflammatory Breast Cancer.  5/16/08 Death certificate states COD as metastatic inflammatory breast cancer.  5/16/08 Reviewed PCP medical records of 4/19/07-7/10/2007 which reveal patient experienced good health on 4/19/07 w/a normal breast exam.  Returned on 6/15/07 with rash on right breast x 2-3 weeks.  Vesicular rash in T8 dermatome that was crusting over but had been pruritic & tender.  Dx w/shingles.  Returned 7/10/07 because rash was not healing.  Exam at that time revealed a keloid type rash over the anterior chest & right breast into the axilla.  A biopsy was done & started on antibiotic for surrounding erythema.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception 4/29/08  6/20/08 Reviewed hospital medical records of 4/29-5/1/2008. FINAL DX: Intussusception, surgically reduced Records reveal patient experienced restlessness, cramping intermittent abdominal pain, bilious emesis, constipation x 3-4 days.  Air contrast enema was initially successful then IS recurred overnight.  BE then was unsuccessful & taken to OR for laparoscopy.  Improved & d/c to home on oral antibiotics for recent OM.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: 5-4-08- temp 104; rash. 5-5-08 temp rash admitted to hospital. 5/27/2008 MR received for DOS 5/5-7/2008 with D/C DX: Fever and Rash. Infant presented to ER with 4 day hx of fever up to 104'F and rash which began 5/4/08 which was spreading. Infant had some nausea and vomiting over past few days as well.  PE (+) for irritability, fine, macular, blanching rash over torso, extremities and face. Bilateral inguinal lymph nodes palpated. TMs erythematous.  Conjunctival injection noted as well as cough and runny nose.  Intially thought to be Kawasaki's, but r/o by cardiology and ID.  Most c/w wild type measles. Measles cx (-). Rash faded over time and pt d/c.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Laboratory test, Neck pain
Clinical narrative: Vaccine on 5/6, on 5/7 with mid-retrosternal chest pain with radiation to left lower rib cage and left neck - still with pains on 5/13.  5/30/08 ER record from 5/07/2008 received with DX: Chest pain, possibly musculoskeletal in origin. Pt reported sudden onset of stabbing constant chest pain, unrelieved. 7/10 intensity. Also c/o L sided neck pain.  PE WNL. Cause of chest pain unclear.  D/C to f/u with cardiologist. 6/20/2008 Received cardio F/U report dated 5/29/08 with DX: Chesp pain noncardiac in origin. PE (+) for tenderness on palpation of the L axilla area to LUQ. Feet puplish and cold with reduced perfusion and face flushed. Suspected muskuloskeletal pain/costochondritis tx with NSAIDs.  Pulmonary consult for chest nodule negative with resolution of the nodule.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Mass, Oedema peripheral, Skin warm
Clinical narrative: Pt. had ADACEL vaccine on 5/5/08.  On 5/7/08 went to school nurse with large, hard knot on left arm, red, swollen, feverish.  No trouble with breathing.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Malaise
Clinical narrative: Patient experienced 2 weeks of lethargy and malaise subsequent to PNEUMOVAX.  Back to normal state of health since.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Rash pruritic
Clinical narrative: 1. Shot 29th ~10 AM.  2. Notice enlarging rash anteriolateral left thigh with pruritus 30th.  3. Continued enlargement of rash 8x6 inch nearly semicircle left thigh pruritic, Tx with BENADRYL.  4. 2nd May present for eval.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Purpura, Rash erythematous, Rash maculo-papular
Clinical narrative: Diffuse rashes all over body for past 4 days.  Started from abd & spread to entire whole body, maculopapular, erythematous, purpuric.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Developed large local mactrin at injection sites (9 x 7cm on one thigh, 7 x 5.5cm on other thigh).  PGM - allergic to tetanus shot per mother.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R upper arm red and swollen.  Vac given on arm DTaP and varicella.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Rash macular, Tenderness
Clinical narrative: Tender, red macule, approximately 24 hours after Varicella vaccine administration.  Temperature 99.4.  Macule = 6 cm consistant with cellulitis.  Patient will be treated with Augmentin, 4 mg PO BID.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient came into clinic 5-13-08.  Thigh was swollen 9inch x 5 inches warm to touch ice pack applied.  BENADRYL and MOTRIN given (right thigh).  Patient will return in morning for follow up.
Age: 1.6
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash - trunk - back & front & forehead.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Arthralgia, Lymphadenopathy, Upper respiratory tract infection
Clinical narrative: Parotid gland swelling, arthralgia, URI symptoms.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Angina pectoris, Asthenia, Back pain, Blood pressure increased, Chest pain
Clinical narrative: Developed tachycardia, weakness in the lower extremities, followed by elevated blood pressure and left arm, chest, arm, neck, and back pain.  Pain and weakness continue today as well as elevated blood pressure.  I have been diagnosed with Brachial Neuritis as a result of receiving the flu shot.  I continue treatment at another facility. 7/21/08-records received for DOS 11/27/07-After flu vaccine on 11/7/07-C/O feeling bad, chest pain, back pain and left sided neck pain. Cramp like pain across chest. Dysphagia. Assessment:atypical chest pain. 12/3/07-C/O tremor and tic of temporal muscles eye, epididymitis.  Follow-up Information 12-JUN-2009: Numbness in the left leg and arm. Headaches daily. Upper left chest and back pain. Fatigue and weakness. Lacking stamina. A rise in blood pressure. I have been to specialists who have run test and determined that I have chronic polyneuropathy as a result of Guillain-Barre Syndrome from receiving flu shots.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: Developed tachycardia, weakness in the lower extremities, followed by elevated blood pressure and left arm, chest, arm, neck, and back pain.  Pain and weakness continue today as well as elevated blood pressure.  I have been diagnosed with Brachial Neuritis as a result of receiving the flu shot.  I continue treatment at another facility. 7/21/08-records received for DOS 11/27/07-After flu vaccine on 11/7/07-C/O feeling bad, chest pain, back pain and left sided neck pain. Cramp like pain across chest. Dysphagia. Assessment:atypical chest pain. 12/3/07-C/O tremor and tic of temporal muscles eye, epididymitis.  Follow-up Information 12-JUN-2009: Numbness in the left leg and arm. Headaches daily. Upper left chest and back pain. Fatigue and weakness. Lacking stamina. A rise in blood pressure. I have been to specialists who have run test and determined that I have chronic polyneuropathy as a result of Guillain-Barre Syndrome from receiving flu shots.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Neck pain, Pain in extremity, Polyneuropathy chronic, Radiculitis brachial
Clinical narrative: Developed tachycardia, weakness in the lower extremities, followed by elevated blood pressure and left arm, chest, arm, neck, and back pain.  Pain and weakness continue today as well as elevated blood pressure.  I have been diagnosed with Brachial Neuritis as a result of receiving the flu shot.  I continue treatment at another facility. 7/21/08-records received for DOS 11/27/07-After flu vaccine on 11/7/07-C/O feeling bad, chest pain, back pain and left sided neck pain. Cramp like pain across chest. Dysphagia. Assessment:atypical chest pain. 12/3/07-C/O tremor and tic of temporal muscles eye, epididymitis.  Follow-up Information 12-JUN-2009: Numbness in the left leg and arm. Headaches daily. Upper left chest and back pain. Fatigue and weakness. Lacking stamina. A rise in blood pressure. I have been to specialists who have run test and determined that I have chronic polyneuropathy as a result of Guillain-Barre Syndrome from receiving flu shots.