chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Pruritus generalised, Urticaria
Clinical narrative: Pt Rcvd vaccine @ 11am - went home - at 1 PM developed hives & itching (generalized) & shortness of breath - Mother gave child BENDRYL oral & brought to hospital ER - Start IVF's & neb treatments for asthma - D/Cod @ 4 PM
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Brachial plexopathy, Erythema, Injected limb mobility decreased, Pain in extremity
Clinical narrative: 4/29/09 Pt. given Tdap injection during an OV to be seen due to a cat bite. 5/7/09 Pt. returned to office with symptoms of left upper arm pain which became red on 5/5/07. Pt. relates arm pain since receiving injections but redness did not start-until 5/5/09. Could not abduct arm past 15 degrees. Referred to a neuro specialist who diagnosed with post-vaccination brachial plexitis (due to toxin). Prognosis guarded but fair. Pt. is in rehab. and ROM improving - no further pain, just weakness.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Crying, Cyanosis, Pyrexia, Tremor
Clinical narrative: Crying hysterically. Lips and hands turn blue.  Shaking,  fever 103.7 2 days after shots.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site lymphadenopathy
Clinical narrative: Shots done on Tuesday August 11, 2009, mother reports lump on L leg near injection site, still present today.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Red area of warmth and itching on R thigh on day # 2 after shots.
Age: 1.8
Sex: U
Vaccine: HIBV
Symptoms: Lethargy, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: 3-5 days after the Hib vaccine my son had high fever fluctuating Between 101.6 to 100.7 for the next 5 days. He became lethargic at night developed mucus he could only vomit up. The doctor prescribed Amoxicillin.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth, Muscular weakness
Clinical narrative: Site was "hot and red to the touch. And arm muscles felt jiggly." X 2 days.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Throat irritation
Clinical narrative: Approx. 1 minute after inj. patient stated inj site was itching. Area was slightly red, irregular in shape approx 10mm in size and warm to touch. 0817 c/o itchy/tight throat. 0820 patient was given 25mg BENADRYL PO.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Throat tightness
Clinical narrative: Approx. 1 minute after inj. patient stated inj site was itching. Area was slightly red, irregular in shape approx 10mm in size and warm to touch. 0817 c/o itchy/tight throat. 0820 patient was given 25mg BENADRYL PO.
Age: 10.5
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Pt had swelling, erythema and bruising after injection. Erythema was approximately 10 inches area, small bruise about 2 cm (1 inch).
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Itchy rash - of neck, trunk, arms.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling at injection site, red with fever.
Age: 4.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Fatigue, Pyrexia
Clinical narrative: High Fever, bellyache, tired with MOTRIN temp came down, bellyache resolved
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: About 5min after receiving Hep A vaccine, patient passed out. Quickly recovered and was awake and alert within seconds.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Skin reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 22-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline. The subject had no relevant medical history and there were no known adverse events following previous vaccinations. Concurrent medications included TRINESSA. On 19 May 2009 at 16:45 the subject received booster dose of BOOSTRIX (0.5 ml, unknown route, left deltoid). On 21 May 2009, 2 days after vaccination with BOOSTRIX, the subject experienced injection site redness, warmness to touch at injection site and injection site soreness. The redness measured approximately 4.2 centimeters by 4.5 centimeters wide, and had improved by 22 May 2009. At the time of reporting the warmness to touch and soreness at injection site were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 17 August 2009 from the reporting nurse practitioner. BOOSTRIX was given intramuscularly. The subject was allergic to penicillin and sulfa drugs. The subject had no alcohol or tobacco use. Diagnosis was reported as local skin reaction to BOOSTRIX which began on 21 May 2009. The events resolved on approximately 24 May 2009. The nurse practitioner considered the events to be possibly related to BOOSTRIX. The nurse practitioner reported that the events were not serious; however, the nurse practitioner indicated that the events were clinically significant or requiring intervention; the subject was seen and over-the-counter ibuprofen, ice and heat were recommended.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Full blood count abnormal, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 14-AUG-2007 a 60 year old female with immune-mediated thrombocytopenic purpura (ITP, from 1993), allergies to dust, pollen and some insects, persistent vertigo, allergy to IVP dye, allergy to TALWIN and DEMEROL and no pre-existing illness at vaccination time was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 658082/0744U) in the left arm. Concomitant therapy included LIPITOR, EVISTA, multiple vitamins and low dose aspirin. On 14-AUG-2007 the injection site became red, very itchy hot. On 15-AUG-2007 the redness increased. The patient experienced swelling at the site and itchy. The nurse was contacted. On 16-AUG-2007 the redness and swelling increased and began travelling down arm towards elbow. The doctor visited concerned about infection. The antibiotic and antihistamine was prescribed. The lab work (blood) was taken. Cellulitis and possible allergic reaction were diagnosed. It was also reported in the office visit medical records (13-AUG-2007 TO 16-AUG-2007) that the patient was seen for reaction to ZOSTAVAX (Merck) on 16-AUG-2007. There was large red indurated area in the patient's left arm. On 17-AUG-2007 lab results were received. The patient's platelet count, which was in normal range prior, was less than 39000 (extremely low). The completed blood cells count with platelet was 69000. The patient was referred to the hematologist, who followed the progress and continued until counts were back in normal range. The outcome of the events was unknown. The reporter considered the events to be immediately 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. No further information is available. The original reporting source was not provided. The VAERS ID # is 297900.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 14-AUG-2007 a 60 year old female with immune-mediated thrombocytopenic purpura (ITP, from 1993), allergies to dust, pollen and some insects, persistent vertigo, allergy to IVP dye, allergy to TALWIN and DEMEROL and no pre-existing illness at vaccination time was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 658082/0744U) in the left arm. Concomitant therapy included LIPITOR, EVISTA, multiple vitamins and low dose aspirin. On 14-AUG-2007 the injection site became red, very itchy hot. On 15-AUG-2007 the redness increased. The patient experienced swelling at the site and itchy. The nurse was contacted. On 16-AUG-2007 the redness and swelling increased and began travelling down arm towards elbow. The doctor visited concerned about infection. The antibiotic and antihistamine was prescribed. The lab work (blood) was taken. Cellulitis and possible allergic reaction were diagnosed. It was also reported in the office visit medical records (13-AUG-2007 TO 16-AUG-2007) that the patient was seen for reaction to ZOSTAVAX (Merck) on 16-AUG-2007. There was large red indurated area in the patient's left arm. On 17-AUG-2007 lab results were received. The patient's platelet count, which was in normal range prior, was less than 39000 (extremely low). The completed blood cells count with platelet was 69000. The patient was referred to the hematologist, who followed the progress and continued until counts were back in normal range. The outcome of the events was unknown. The reporter considered the events to be immediately 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. No further information is available. The original reporting source was not provided. The VAERS ID # is 297900.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Allergy test, Dyspnoea, Heart rate increased, Laboratory test normal, Nasal congestion
Clinical narrative: Information has been received from a nurse concerning a 7 year old male with no pertinent medical history and no drug allergies who on 18-JUN-2008 was vaccinated subcutaneously with the second 0.5mL booster dose of VARIVAX (Merck) (LOT# 660042/1899U). There was no concomitant medication. The first dose of VARIVAX (Merck) was received in 2002 at another office. On 18-JUN-2008, the physician's notes stated that 5 minutes after receiving VARIVAX (Merck), sneezing started in the patient. The mother of the patient was driving home and on the way the sneezing increased, there was difficulty breathing and palpitations. The mother drove back to the office and the patient had urticaria lesions on the eye lids, nasal congestion, pulse oximetry was 97%, heart rate was 90 per minute and lungs were clear. At 4:20 PM, the patient was given 10mL BENADRYL by mouth. Unspecified time, patient still experienced difficulty breathing through the nose and physician observed a swelling of nasal mucosal. The patient was given epinephrine SQ at 4:29 PM. Patient still had palpitations, blood pressure of 120/80 and heart rate 120 per minute that at an unspecified time went down to 90 per minute. EMS was called and patient was transferred to an emergency room. The patient was reported to have recovered on 18-JUN-2009. An allergy testing was done on an unspecified date after patient had recovered. The allergy test's outcome was not provided. All adverse events were considered to be immediately life-threatening and other important medical events. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Nasal inflammation, Oxygen saturation normal, Palpitations, Sneezing, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 7 year old male with no pertinent medical history and no drug allergies who on 18-JUN-2008 was vaccinated subcutaneously with the second 0.5mL booster dose of VARIVAX (Merck) (LOT# 660042/1899U). There was no concomitant medication. The first dose of VARIVAX (Merck) was received in 2002 at another office. On 18-JUN-2008, the physician's notes stated that 5 minutes after receiving VARIVAX (Merck), sneezing started in the patient. The mother of the patient was driving home and on the way the sneezing increased, there was difficulty breathing and palpitations. The mother drove back to the office and the patient had urticaria lesions on the eye lids, nasal congestion, pulse oximetry was 97%, heart rate was 90 per minute and lungs were clear. At 4:20 PM, the patient was given 10mL BENADRYL by mouth. Unspecified time, patient still experienced difficulty breathing through the nose and physician observed a swelling of nasal mucosal. The patient was given epinephrine SQ at 4:29 PM. Patient still had palpitations, blood pressure of 120/80 and heart rate 120 per minute that at an unspecified time went down to 90 per minute. EMS was called and patient was transferred to an emergency room. The patient was reported to have recovered on 18-JUN-2009. An allergy testing was done on an unspecified date after patient had recovered. The allergy test's outcome was not provided. All adverse events were considered to be immediately life-threatening and other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Dizziness, Headache, Muscular weakness, Vertigo, Vomiting
Clinical narrative: The evening following the vaccine patient was very tired. The morning when she woke up for school she was extremely dizzy and could not stand up. Her balance was off and she had an excruciating headache. Her legs were weak and she could not walk straight. We went to the ER around 7 am.  She was evaluated given pain medication.  Her primary DR was contacted we were advised to call her during the day to provide her updates.  We were told to watch her as her symptoms resembled GBS. The headache pain and dizzyness continued throughout the day and got worse. She began to feel tingling and strange sensations in her legs. We called Dr and were told to come in.  By now she could not stand her legs were too weak. Her reflexes were tested in the DRs offices and she was given a nurological eval in the office. We were then sent to another Hospital. The Drs office called ahead. Her symptoms continued to worsen.  She was evaluated and admitted to the hospital with concerns of GBS. The tingling sensation moved from her legs to arms and back to the legs. These symptoms continued off and on for a month. She was reevaluated my a pediatric Neurologist in March. GBS was ruled out.  It was determined by both doctors that this was a bad reaction to this vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Balance disorder, Dizziness, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: The evening following the vaccine patient was very tired. The morning when she woke up for school she was extremely dizzy and could not stand up. Her balance was off and she had an excruciating headache. Her legs were weak and she could not walk straight. We went to the ER around 7 am.  She was evaluated given pain medication.  Her primary DR was contacted we were advised to call her during the day to provide her updates.  We were told to watch her as her symptoms resembled GBS. The headache pain and dizzyness continued throughout the day and got worse. She began to feel tingling and strange sensations in her legs. We called Dr and were told to come in.  By now she could not stand her legs were too weak. Her reflexes were tested in the DRs offices and she was given a nurological eval in the office. We were then sent to another Hospital. The Drs office called ahead. Her symptoms continued to worsen.  She was evaluated and admitted to the hospital with concerns of GBS. The tingling sensation moved from her legs to arms and back to the legs. These symptoms continued off and on for a month. She was reevaluated my a pediatric Neurologist in March. GBS was ruled out.  It was determined by both doctors that this was a bad reaction to this vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Headache, Muscular weakness, Paraesthesia, Vaccination complication
Clinical narrative: The evening following the vaccine patient was very tired. The morning when she woke up for school she was extremely dizzy and could not stand up. Her balance was off and she had an excruciating headache. Her legs were weak and she could not walk straight. We went to the ER around 7 am.  She was evaluated given pain medication.  Her primary DR was contacted we were advised to call her during the day to provide her updates.  We were told to watch her as her symptoms resembled GBS. The headache pain and dizzyness continued throughout the day and got worse. She began to feel tingling and strange sensations in her legs. We called Dr and were told to come in.  By now she could not stand her legs were too weak. Her reflexes were tested in the DRs offices and she was given a nurological eval in the office. We were then sent to another Hospital. The Drs office called ahead. Her symptoms continued to worsen.  She was evaluated and admitted to the hospital with concerns of GBS. The tingling sensation moved from her legs to arms and back to the legs. These symptoms continued off and on for a month. She was reevaluated my a pediatric Neurologist in March. GBS was ruled out.  It was determined by both doctors that this was a bad reaction to this vaccine.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram normal, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on 13-AUG-2007 was vaccinated intramuscularly on her left deltoid with the second dose of GARDASIL (Lot # 658222/0927U). Concomitant therapy included YASMIN. On 01-NOV-2007 two months after her second vaccination the patient experienced a seizure. The patient sought medical attention and went to an unspecified emergency room. The patient was prescribed TOPAMAX, DEPAKOTE, KEPPRA in the beginning of November 2007. The patient underwent two magnetic resonance imaging (MRI), two electroencephalography (EEG), two electrocardiogram (EKG) and a 24 hour EEG which were all negative. Unknown if the third dose of GARDASIL was given at the office as 05-AUG-2009. The patient recovered from seizure. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Chemotherapy, Computerised tomogram, Lip and/or oral cavity cancer, Radiotherapy
Clinical narrative: I received the 1st round of Gardasil July 7, 2008. Towards the end of August 2009 a lesion formed on my tongue. I have been diagnosed with Oral Cancer. I have had 2 surgeries and will be completing Radiation and Chemo. 8/20/09 GYN medical records received. Annual GYN Exam.   8/20/09 GYN medical records received. Annual GYN Exam.   9/8/09 Head & Neck Clinic consultation records DOS 12/19/08 to 8/14/09 Assessment: Recurrent T2N2cM0 Squamous Cell Carcinoma of the left lateral oral tongue with extracapsular spread. Patient presented with a sore area on her tongue which was persistant and progressed. Intraoral partial glossectomy, modified neck dissection. T2N1M0 squamous cell carcinoma. Left and right sided neck mass. Left parotidectomy and bilateral neck dissections.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Surgery, Tongue ulceration
Clinical narrative: I received the 1st round of Gardasil July 7, 2008. Towards the end of August 2009 a lesion formed on my tongue. I have been diagnosed with Oral Cancer. I have had 2 surgeries and will be completing Radiation and Chemo. 8/20/09 GYN medical records received. Annual GYN Exam.   8/20/09 GYN medical records received. Annual GYN Exam.   9/8/09 Head & Neck Clinic consultation records DOS 12/19/08 to 8/14/09 Assessment: Recurrent T2N2cM0 Squamous Cell Carcinoma of the left lateral oral tongue with extracapsular spread. Patient presented with a sore area on her tongue which was persistant and progressed. Intraoral partial glossectomy, modified neck dissection. T2N1M0 squamous cell carcinoma. Left and right sided neck mass. Left parotidectomy and bilateral neck dissections.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, low grade fever x 2-3 days reported by mother (no office visit). Gave pain reliever, sx resolved.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Blood culture positive, CSF culture positive, Cerebrovascular accident, Condition aggravated, Death
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced pneumococcal meningitis, pneumococcal sepsis, upper respiratory infection and stroke. The patient received the fourth dose on 30-May-2009. The patient also received the first dose of VAQTA (Merck) on 30-May-2009. During the winter of 2008-2009 the patient experienced wheezing, treatment unknown. On 09-Jun-2009 the patient was seen in the office with wheezing treated with ORAPRED in addition to PULMICORT and Albuterol inhalation therapy. On 13-Jun-2009 follow-up showed the wheezing resolved. On 20-Jun-2009 the patient presented to the physician with a two day history of fever, fussiness and being uncomfortable per the parents. In the office the child engaged with the staff and was playful. He was afebrile with no cough noted and was diagnosed with an upper respiratory infection, treatment unknown. On 21-Jun-2009 the parents telephoned the office and "seemed nervous which was not normal for them". The physician examined the child and noticed a drooping eye, side unknown, and was diagnosed with stroke. This event was considered medically important. The child was admitted to the local hospital and on an unknown date was transported to another hospital. On 23-Jun-2009 the child died. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis. Serotype testing was not performed at the time of this report but is being requested by the child's physician. No additional information was available at this time of this report.  8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. Assessment: Fever. meningitis. Patient earlier this day presented at ED with fever. Seen later for drooping and swelling of right eyelid and vomiting after Advil. Moderate distressed, photophobia, fussiness. Not alert, moaning, hypotonic. 9/1/09-records received for 6/23/09-COD-Pneumococcal meningitis, septic shock, acute respiratory distress syndrome, multiorgan failure, left hemispheric infarct. Transferred from another facility after presenting with febrile illness, progressive lethargy and poor feeding and worsening respiratory distress. Developed respiratory failure intubation and ventilator support, developed shock, multiorgan failure.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Discomfort, Eye disorder, Irritability, Meningitis pneumococcal, Pneumococcal sepsis
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced pneumococcal meningitis, pneumococcal sepsis, upper respiratory infection and stroke. The patient received the fourth dose on 30-May-2009. The patient also received the first dose of VAQTA (Merck) on 30-May-2009. During the winter of 2008-2009 the patient experienced wheezing, treatment unknown. On 09-Jun-2009 the patient was seen in the office with wheezing treated with ORAPRED in addition to PULMICORT and Albuterol inhalation therapy. On 13-Jun-2009 follow-up showed the wheezing resolved. On 20-Jun-2009 the patient presented to the physician with a two day history of fever, fussiness and being uncomfortable per the parents. In the office the child engaged with the staff and was playful. He was afebrile with no cough noted and was diagnosed with an upper respiratory infection, treatment unknown. On 21-Jun-2009 the parents telephoned the office and "seemed nervous which was not normal for them". The physician examined the child and noticed a drooping eye, side unknown, and was diagnosed with stroke. This event was considered medically important. The child was admitted to the local hospital and on an unknown date was transported to another hospital. On 23-Jun-2009 the child died. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis. Serotype testing was not performed at the time of this report but is being requested by the child's physician. No additional information was available at this time of this report.  8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. Assessment: Fever. meningitis. Patient earlier this day presented at ED with fever. Seen later for drooping and swelling of right eyelid and vomiting after Advil. Moderate distressed, photophobia, fussiness. Not alert, moaning, hypotonic. 9/1/09-records received for 6/23/09-COD-Pneumococcal meningitis, septic shock, acute respiratory distress syndrome, multiorgan failure, left hemispheric infarct. Transferred from another facility after presenting with febrile illness, progressive lethargy and poor feeding and worsening respiratory distress. Developed respiratory failure intubation and ventilator support, developed shock, multiorgan failure.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Pyrexia, Streptococcal identification test positive, Upper respiratory tract infection, Wheezing
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced pneumococcal meningitis, pneumococcal sepsis, upper respiratory infection and stroke. The patient received the fourth dose on 30-May-2009. The patient also received the first dose of VAQTA (Merck) on 30-May-2009. During the winter of 2008-2009 the patient experienced wheezing, treatment unknown. On 09-Jun-2009 the patient was seen in the office with wheezing treated with ORAPRED in addition to PULMICORT and Albuterol inhalation therapy. On 13-Jun-2009 follow-up showed the wheezing resolved. On 20-Jun-2009 the patient presented to the physician with a two day history of fever, fussiness and being uncomfortable per the parents. In the office the child engaged with the staff and was playful. He was afebrile with no cough noted and was diagnosed with an upper respiratory infection, treatment unknown. On 21-Jun-2009 the parents telephoned the office and "seemed nervous which was not normal for them". The physician examined the child and noticed a drooping eye, side unknown, and was diagnosed with stroke. This event was considered medically important. The child was admitted to the local hospital and on an unknown date was transported to another hospital. On 23-Jun-2009 the child died. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis. Serotype testing was not performed at the time of this report but is being requested by the child's physician. No additional information was available at this time of this report.  8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. Assessment: Fever. meningitis. Patient earlier this day presented at ED with fever. Seen later for drooping and swelling of right eyelid and vomiting after Advil. Moderate distressed, photophobia, fussiness. Not alert, moaning, hypotonic. 9/1/09-records received for 6/23/09-COD-Pneumococcal meningitis, septic shock, acute respiratory distress syndrome, multiorgan failure, left hemispheric infarct. Transferred from another facility after presenting with febrile illness, progressive lethargy and poor feeding and worsening respiratory distress. Developed respiratory failure intubation and ventilator support, developed shock, multiorgan failure.
Age: 14.0
Sex: M
Vaccine: DTAP, HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: This case was received from a health care professional via another manufacturer (case ID number 2009S1013958), on 13 August 2009. A 14-year-old male patient, with no reported medical history, received TDAP (manufacturer reported as sanofi pasteur) and Amnesteem (Mylan Pharmaceuticals); lot numbers and dates of administration not reported. He subsequently experienced dyspnea and hives. No additional information was reported.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis infective, Surgery
Clinical narrative: Information has been received from a medical assistant concerning a 79 year old male with a history of stroke, anaemia, dementia, hypersomnia, alzheimer's disease, hypertension, sinus bradycardia, acute nasopharyngitis, vitamin b12 deficiency, low back pain and seborreic keratosis who on 12-JUN-2009 was vaccinated with the first dose of PNEUMOVAX  (lot# 662874/1125X). The following weekend on approximately 19-JUN-2009 the patient was treated in the Emergency Room for a left shoulder infection. The patient required surgery for the infection. At the time of the report, the patient recovered from left shoulder infection. The left shoulder infection was considered to be other medically important event. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Body aches and temp. 99 started 8/7 red, hard, swollen area at injection site (approx 10 cm in circumference and down arm form inj site - started to subside 8/18
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Musculoskeletal pain, Pain in extremity
Clinical narrative: Burning sensation and pain in shoulder, lower legs and feet started morning of 8/11 and increased in intensity as day progressed. Lasted until 1 AM 8/12 until she fell asleep 3p on 8/12 feet still burning slightly.
Age: 27.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Dizziness
Clinical narrative: Pt. felt light headed & weak at 01:00 on 8-8-09 - went to Hospital ER & stayed until 05:00 on 8/8/09. Low grade temp - 99.7 (o) Had IV fluids & dose of TYLENOL. She states that MD thought she had reaction to meningitis shot given at BTM on 8-7-09. To home at 05:00 on 8/8/09.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, X-ray limb
Clinical narrative: Received flu vaccine Nov. 2008 - within weeks of injection, noticed changes in movement of arm (left) - positive stiffness with limited range of motion...  Currently under care of orthopedic surgeon.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP
Symptoms: Body temperature increased, Immediate post-injection reaction, Injection site pain
Clinical narrative: 08.17.09 - R arm soreness, immed. after shot.  Hep A + Typhoid Increase T=100 to the 8th- 101 to the 8th 08.18.09 @ 8 am.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Anorexia, Nausea, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Arm swollen, itching in arm, warm to touch at 2:30 PM.  Around 5:30 PM face was itching and arm was itching.  Arm swollen in 4" diameter.  Nausea & no appetite.  States reaction similar to shellfish allergic reaction.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Vaccine were given, pt tolerated well. The following morning pt found quarter sized area of redness with a whelp at area of injection site - area is red and warm to touch with minimal pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Heart rate increased, Injection site rash, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient was given PNEUMOVAX morning approximately equal to 10 AM 8/4/09, by that afternoon arm became sore with diminished R.O.M. following morning she noted rash at injection at that time had fever, increase HR, increase BP within 6day Sx resolve.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient was given PNEUMOVAX morning approximately equal to 10 AM 8/4/09, by that afternoon arm became sore with diminished R.O.M. following morning she noted rash at injection at that time had fever, increase HR, increase BP within 6day Sx resolve.
Age: 1.2
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Red area a site of injection - dime size SubQ mass.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Lymphadenitis
Clinical narrative: A serious report of lymphadenitis has been received from a study investigator concerning a female child participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. ON 18-OCT-2008, the subject received FLUMIST. The subject was admitted to the hospital for lymphadenitis on 25-Nov-2008. The length of stay was two days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthritis bacterial
Clinical narrative: A serious report of septic arthritis has been received from a study investigator concerning a 39-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 19-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for septic arthritis on 16-Dec-2008. The length of stay was three days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Deafness
Clinical narrative: A serious report of hearing loss/deafness has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 08-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for hearing loss/deafness on 05-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Injury
Clinical narrative: A serious report of trauma has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 28-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Bacteraemia, Urinary tract infection
Clinical narrative: A serious report of urinary tract infection and bacteremia has been received from a study investigator concerning a 44-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 01-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for urinary tract infection and bacteremia on 19-Dec-2008. The length of stay was two days. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Injury
Clinical narrative: A serious report of trauma has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 26-Sep-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 17-Oct-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Nail disorder
Clinical narrative: A serious report of nail disorder has been received from a study investigator concerning a 44-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for nail disorder on 11-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Injury
Clinical narrative: A serious report of trauma has been received from a study investigator concerning a 41-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 23-Oct-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 07-Nov-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Sleep apnoea syndrome, Tonsillitis
Clinical narrative: A serious report of sleep apnea and tonsillitis has been received from a study investigator concerning a 43-month-old female subject participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 09-Jan-2009, the subject received FLUMIST. The subject was admitted to the hospital for sleep apnea and tonsillitis on 16-Jan-2009. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Congenital anomaly
Clinical narrative: A serious report of congenital anomaly has been received from a study investigator concerning a 37-month-old male (subject number 29395693) participating in post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 02-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly on 23-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Pneumonia, Sleep apnoea syndrome
Clinical narrative: A serious report of sleep apnea and pneumonia has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for sleep apnea and pneumonia on 04-Dec-2008. The length of stay was three days. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Encopresis
Clinical narrative: A serious report of encopresis has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 08-Jan-2009, the subject received FLUMIST. The subject was admitted to the hospital for encopresis on 20-Jan-2009. The length of stay was two days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Congenital anomaly
Clinical narrative: A serious report of congenital anomaly has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population for 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly on 09-Nov-2008. The length of stay was five days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Abscess, Post procedural complication
Clinical narrative: A serious report of abscess and postsurgical state/complication has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-NOV-2008, the subject received FLUMIST. The subject was admitted to the hospital for abscess and postsurgical state/complication on 27-Nov-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Congenital anomaly, Epilepsy
Clinical narrative: A serious report of congenital anomaly and epilepsy has been received from a study investigator concerning a 26-month-old female subject participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly and epilepsy on 28-Nov-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Vomiting
Clinical narrative: A serious report of abdominal pain and vomiting has been received from a study investigator concerning a 30-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 14-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for abdominal pain and vomiting on 11-Dec-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Injury
Clinical narrative: A serious report of trauma has been received from a study investigator concerning a 36-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 20-Oct-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 21-Oct-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, MNQ, TDAP
Symptoms: Blood glucose normal, Blood pressure normal, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: Patient was in waiting room about 10 to 15 minutes after vaccination and was waiting to leave the building when patient began to complain of 'feeling funny.' Patient was brought back into exam room and patient stated that her head hurt, she felt dizzy and she felt hot. Patient was brought back into an exam room and allowed to lie down. Vitals were taken and were wnl. After lying down in the exam room for five minutes, patient stated that she felt better and wanted to leave.