chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Pt. received pneumococcal vaccine 7/8/10 (R) deltoid. Redness and swelling noticed within 1 hour of vaccine administration. BENADRYL and MOTRIN ordered TID. Also made use of cold packs. Area of redness/swelling about 3" x 3" circle. Area warm to touch. 7/9 slight decrease in swelling, warm and painful. Afebrile. No S.O.B localized reaction only 7/12 "Feels great" no pain no redness.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash
Clinical narrative: Rash developed. BENADRYL given - resolved in 10 minutes.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncope x 30 seconds.
Age: 0.0
Sex: M
Vaccine: VARCEL
Symptoms: Dacryostenosis congenital, Drug exposure during pregnancy, Eye disorder, Infantile spitting up, Respiratory tract congestion
Clinical narrative: Information has been received from a nurse practitioner concerning a 1 day old male infant whose mother on 20-AUG-2009, was vaccinated with a dose of VARIVAX (Merck) (lot # 664235/0642Y). Subsequently the patient's mother was pregnant, with last menstrual period (LMP) approximately 23-JUL-2009, and estimated delivery date (EDD) approximately 29-APR-2010. On 27-APR-2010, 40 weeks from LMP, the patient's mother delivered the infant (see WAES# 1007USA00664). Pediatric medical records were received and reviewed and the following experience was identified: congestion, spitting up a lot and eyes matted. At the time of reporting, the outcomes were unknown. On 12-MAY-2010, the patient was found to have bilateral lacrimal duct obstruction. The tear ducts were blocked while drainage with massage. On 18-MAY-2010, the diagnosis was changed to left lacrimal duct obstruction. Treatment plan was massage left tears duct. At the time of reporting, the outcome was unknown. The patient's lacrimal duct obstruction was considered to be a congenital anomaly. The mother's experience has been captured in WAES # 1007USA00664. Additional information has been requested. All available medical records will be provided upon request.
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Convulsion
Clinical narrative: Information has been received from a registered pharmacist concerning a newborn female who on 24-JUN-2010 was vaccinated with 0.5mL of RECOMBIVAX HB IM (Lot # 666188/1491Y). On approximately 24-JUN-2010 the patient experienced apnea and seizures. On an unknown date, the patient recovered from apnea and seizures. The patient was in the hospital and sought medical attention. The pharmacist wanted to know with the lot check it will be tested if there was overfill or contaminates. Apnea and seizures were considered to be immediately life-threatening. This is one of 4 reports from the same reporter. It was noted that three of the four patients had seizures and one of the four had full arrest. It was unknown what patient had which of the reactions. A lot check has been initiated. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Convulsion
Clinical narrative: Information has been received from a registered pharmacist concerning a newborn female who on 25-JUN-2010 was vaccinated with 0.5 mL of RECOMBIVAX HB IM (Lot # 666188/1491Y). On approximately 25-JUN-2010 the patient experienced apnea and seizures. On an unknown date, the patient recovered from apnea and seizures. The patient was in the hospital and sought medical attention. The pharmacist wanted to know with the lot check it will be tested if there was overfill or contaminates. Apnea and seizures were considered to be immediately life-threatening. This is one of 4 reports from the same reporter. It was noted that three of the four patients had seizures and one of the four had full arrest. It was unknown what patient had which of the reactions. A lot check has been initiated. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Electrocardiogram
Clinical narrative: 5-19-10 awoke with left eye swollen and burning - diagnosed as shingles - took VALTREX for 7 days - condition improved. 6-6-10 both legs swollen to knees. 6-14-10 moderate to severe pain on left side of chest. 6-16-10, went to ER, discovered blood clot in left calf, was admitted to hospital and treated for blood clot and possible pulmonary embolism. No PE found. Discharged on 6-18, rash on chest developed on 6-21. Dx shingles. On VALTREX for 7 days, slight rash and moderate pain continues to present.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye burns, Eye swelling, Herpes zoster, Oedema peripheral, Pain
Clinical narrative: 5-19-10 awoke with left eye swollen and burning - diagnosed as shingles - took VALTREX for 7 days - condition improved. 6-6-10 both legs swollen to knees. 6-14-10 moderate to severe pain on left side of chest. 6-16-10, went to ER, discovered blood clot in left calf, was admitted to hospital and treated for blood clot and possible pulmonary embolism. No PE found. Discharged on 6-18, rash on chest developed on 6-21. Dx shingles. On VALTREX for 7 days, slight rash and moderate pain continues to present.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Thrombosis, Ultrasound Doppler
Clinical narrative: 5-19-10 awoke with left eye swollen and burning - diagnosed as shingles - took VALTREX for 7 days - condition improved. 6-6-10 both legs swollen to knees. 6-14-10 moderate to severe pain on left side of chest. 6-16-10, went to ER, discovered blood clot in left calf, was admitted to hospital and treated for blood clot and possible pulmonary embolism. No PE found. Discharged on 6-18, rash on chest developed on 6-21. Dx shingles. On VALTREX for 7 days, slight rash and moderate pain continues to present.
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Convulsion
Clinical narrative: Information has been received from a registered pharmacist concerning a newborn female who on 25-JUN-2010 was vaccinated with 0.5 mL of RECOMBIVAX HB IM (Lot # 666187/1484Y). On approximately 25-JUN-2010 the patient experienced apnea and seizures. On an unknown date, the patient recovered from apnea and seizures. The patient was in the hospital and sought medical attention. The pharmacist wanted to know with the lot check it will be tested if there was overfill or contaminates. Apnea and seizures were considered to be immediately life-threatening. This is one of 4 reports from the same reporter. It was noted that three of the four patients had seizures and one of the four had full arrest. It was unknown what patient had which of the reactions. A lot check has been initiated. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test, Lumbar puncture, Myelitis transverse, Neuromyelitis optica, Nuclear magnetic resonance imaging
Clinical narrative: Devics Syndrome-transverse myelitis.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local swelling
Clinical narrative: 5cm area of local swelling and redness.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Contusion, Pain, Skin mass, Tenderness
Clinical narrative: Localized bruising/lump under skin. Slight pain & tenderness upon touch. Slight sensitivity in lower back/kidney area. Pt took BENADRYL.
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Cardiac arrest
Clinical narrative: Information has been received from a registered pharmacist concerning a newborn female who on 27-JUN-2010 was vaccinated with 0.5mL of RECOMBIVAX HB IM (Lot # 666188/1491Y). On approximately 27-JUN-2010 the patient experienced apnea and full arrest. On an unknown date, the patient recovered from apnea and full arrest. The patient was in the hospital and sought medical attention. The pharmacist wanted to know with the lot check it will be tested if there was overfill or contaminates. Apnea and full arrest were considered to be immediately life-threatening. This is one of 4 reports from the same reporter. It was noted that three of the four patients had seizures and one of the four had full arrest. It was unknown what patient had which of the reactions. A lot check has been initiated. Additional information has been requested.
Age: 1.81
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: 102 fever, lethargy, decreased appetite.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Influenza like illness, Injection site movement impairment, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiff arm at injection site day of vaccine then radiating pain up and down arm with stiffness, feeling achy and "flu like" dizzy.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood test, Headache, Influenza like illness, Menorrhagia
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with a history of caesarean section (about 3 years ago) and with no reactions/allergies who was vaccinated intramuscularly with three doses of GARDASIL (therapy start date was reported as July 2009 and third dose on in the middle of June). Concomitant therapy included PROVERA. After being administered GARDASIL in all three of her dosages, in July 2009 the patient experienced flu-like symptoms. She experienced pain in her body, back and had lingering headaches. She also bled profusely during her menstrual after being administered her third shot on approximately 15-JUN-2010. The patient went to emergency room (ER) on several occasions and had blood work done in the ER after being administered her first shot. The patient was hospitalized on an unspecified date. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with a history of caesarean section (about 3 years ago) and with no reactions/allergies who was vaccinated intramuscularly with three doses of GARDASIL (therapy start date was reported as July 2009 and third dose on in the middle of June). Concomitant therapy included PROVERA. After being administered GARDASIL in all three of her dosages, in July 2009 the patient experienced flu-like symptoms. She experienced pain in her body, back and had lingering headaches. She also bled profusely during her menstrual after being administered her third shot on approximately 15-JUN-2010. The patient went to emergency room (ER) on several occasions and had blood work done in the ER after being administered her first shot. The patient was hospitalized on an unspecified date. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: HEP, SMALL, HEP, SMALL
Symptoms: Cardiac failure congestive, Electrocardiogram normal
Clinical narrative: This report was received from the investigator on 30 June 2010. A 35 year-old male subject with no reported medical history received the following vaccines on 13 August 2009: ACAM2000 (lot number not reported); and Hepatitis B (manufacturer and lot number not reported). On 28 August 2009, 15 days post-vaccination, the subject was diagnosed with unspecified congestive heart failure. An ECG performed 27 August 2009 was normal; Troponin I was not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Sex: F
Vaccine: TTOX
Symptoms: Convulsion, Feeling cold, Screaming
Clinical narrative: A parent reported that her daughter, who was now in her 20's, received as a child (age not specified) a tetanus toxoid vaccine (manufacturer not specified, lot number not provided). Following vaccination the patient had experienced high pitched screaming, seizure, and sensation of feeling cold. The parent stated that the events lasted 6 weeks. The outcome was not reported. The parent declined to provided any further information. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Muscular weakness, Oedema peripheral, Peripheral coldness
Clinical narrative: Swelling right arm.  Cool fingers.  Numbness and weakness right hand.
Age: 48.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site pain, Myalgia, Pain
Clinical narrative: This employee reports that she experienced soreness and redness at injection site beginning approx 5-6 hours after dose; followed by total body aches and generalized muscular pain that lasted approx 72 hours after dose. Symptoms relieved with MOTRIN 400mg p.o.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (L) arm redness, heat, induration distal to vaccine site.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red, warm, itchy spot on left arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site induration, Injection site swelling, Oedema peripheral
Clinical narrative: Arm swollen, firm lump.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local reaction to Lt Vastus Lateralis with PENTACEL IM and ROTATEQ PO 6/28/2010. 1.5 cm red area with mild induration. TYLENOL effective for discomfort.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash papular
Clinical narrative: Telephone call per Mom: Diverse bumps occured on arms legs and chest one and one half days after immunization with Prevnar 13. Bumps are somewhat itchy and resolving with time. No fever or symptoms of illness.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Dizziness, Erythema, Injection site swelling, Pyrexia
Clinical narrative: Raised swollen area right glute at site of injection. Pt. complained of fever chills and dizziness. Area of redness measuring 6 by 3 inches.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR
Symptoms: Aggression, Blood lead, Dermatitis diaper, Full blood count, HIV test
Clinical narrative: Rash noted to diaper area per mom. Child had been fussy with tantrums for the past 2 weeks (since father detained d/t incident-not involving this child but father was primary caregiver while mother went to work). No fevers. Was told had a diaper rash. On exam, erythematous patch to right ankle area and zoster lesion to right lower back area starting from midline and moving down buttock (dermatome T1).
Age: 1.05
Sex: F
Vaccine: HEPA, MMR
Symptoms: Herpes zoster, Irritability, Metabolic function test, Rash erythematous, Varicella virus test
Clinical narrative: Rash noted to diaper area per mom. Child had been fussy with tantrums for the past 2 weeks (since father detained d/t incident-not involving this child but father was primary caregiver while mother went to work). No fevers. Was told had a diaper rash. On exam, erythematous patch to right ankle area and zoster lesion to right lower back area starting from midline and moving down buttock (dermatome T1).
Age: 1.51
Sex: F
Vaccine: DTP, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Chicken Pox lesions on face, legs, hands and feet.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Appx 2 hrs after injection experienced - nausea, vomiting, slight sob dizziness. Broke out in sweat, abd cramps. Diarrhea-nausea abd cramps and diarrhea continued 7-2-10 most of night. Drank and kept down water et used ice packs, 12 hrs after onset - symptoms are improving - abd cramps, diarrhea and nausea come in waves and are off and on-continues to experience improvement.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Nausea, Vomiting
Clinical narrative: Appx 2 hrs after injection experienced - nausea, vomiting, slight sob dizziness. Broke out in sweat, abd cramps. Diarrhea-nausea abd cramps and diarrhea continued 7-2-10 most of night. Drank and kept down water et used ice packs, 12 hrs after onset - symptoms are improving - abd cramps, diarrhea and nausea come in waves and are off and on-continues to experience improvement.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram, Erythema, Nausea, Oedema peripheral
Clinical narrative: Patient started with redness and swelling on LA after receiving the 3rd dose of GARDASIL vaccine.  On 7/2/10 pt. started with symptoms of nausea and dizziness.  Pt was seen in office on 7/2/10 and EKG was ordered.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Muscular weakness, Nausea
Clinical narrative: Developed nausea and muscle weakness on the day about 2-3 hrs. after vaccine was given.  Had muscle weakness in lower legs X 4 days and could not climb stairs to her apartment.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Malaise, Pallor
Clinical narrative: Immediately after last injection of HPV, client became pale, and stated "I don't feel well". We placed client in supine position. Clients BP was 112/78, 10 min later stated I feel better". Sitting BP was 110/78.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom called after hours on 7/3/10, 2 days after vaccine given and reported site (L) arm very red and swollen.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Severe high temp child had febrile seizure pt was admitted.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Irritability, Lethargy, Pyrexia, Rash papular
Clinical narrative: Fever of 102o F, fussy, lethargic and a few red spots on her arms and legs. Medicated with Ibuprofen. In the next few days the fever came down and the red bumps are on her face, arms and legs are fading.
Age: 45.0
Sex: M
Vaccine: HEPAB, IPV, MEN, TDAP, TYP, YF
Symptoms: Arthralgia, Blood count normal, Blood creatine phosphokinase normal, Chills, Decreased appetite
Clinical narrative: Multiple symptoms at various times for 10 days from vaccines.  Fatigue & symptoms of cold virus such as little appetite and food having poor flavor for several days. 06/26, severe sore muscles & tendons in neck (left side) and left wrist. Fatigue seemed to be compounding through 06/28. 06/29 - 06/30, uncontrollable chills & shivering & low grade fever (100 degrees).  Per advice of Dr., visited another doctor on 06/30 to get a vitals report and blood tests.
Age: 45.0
Sex: M
Vaccine: HEPAB, IPV, MEN, TDAP, TYP, YF
Symptoms: Dysgeusia, Fatigue, Laboratory test normal, Myalgia, Nasopharyngitis
Clinical narrative: Multiple symptoms at various times for 10 days from vaccines.  Fatigue & symptoms of cold virus such as little appetite and food having poor flavor for several days. 06/26, severe sore muscles & tendons in neck (left side) and left wrist. Fatigue seemed to be compounding through 06/28. 06/29 - 06/30, uncontrollable chills & shivering & low grade fever (100 degrees).  Per advice of Dr., visited another doctor on 06/30 to get a vitals report and blood tests.
Age: 45.0
Sex: M
Vaccine: HEPAB, IPV, MEN, TDAP, TYP, YF
Symptoms: Neck pain, Pyrexia, Red blood cell sedimentation rate normal, Tendon pain
Clinical narrative: Multiple symptoms at various times for 10 days from vaccines.  Fatigue & symptoms of cold virus such as little appetite and food having poor flavor for several days. 06/26, severe sore muscles & tendons in neck (left side) and left wrist. Fatigue seemed to be compounding through 06/28. 06/29 - 06/30, uncontrollable chills & shivering & low grade fever (100 degrees).  Per advice of Dr., visited another doctor on 06/30 to get a vitals report and blood tests.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Injection site pain, redness, swelling that progressed in size followed by evolution of hives one day later.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction, Pain, Pain in extremity, Similar reaction on previous exposure to drug
Clinical narrative: My daughter had a severe reaction to her first GARDASIL injection, but she had a flu shot the same day, so we thought she was reacting to that....achy, burning pain up and down her arms and legs. 2 months later she had her second GARDASIL injection and had a similar, but more severe reaction. She begged me to cut her arms off because the pain was so bad, and she said that each arm felt like it weighed 1500  pounds! She is normally a pain-tolerant teenager and not whiny about a little pain, so I knew it was a major deal. We are not planning to get the 3rd injection, as I have no intention of seeing her go through that, or worse, again! Her symptoms only lasted 24 hours.
Sex: U
Vaccine: TDAP
Symptoms: Medication residue
Clinical narrative: Med was cloudy and had particles undissolved after mixing and warming. Did not dispense.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Cold sweat, Dizziness
Clinical narrative: Patient administered age appropriate vaccine and after receiving vaccines had felt weak, dizzy and clammy. Client's head brought down to knees. Client fanned and cold compress applied to neck and facial areas. Client offered crackers and juice. Verbalized feeling better after treatment.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: PATIENT WAS BROUGHT INTO CLINIC BY FOSTER MOTHER. FOSTER MOTHER STATES THAT PATIENT HAD A FEVER BETWEEN 103-104 AND DIARRHEA AND VOMITING SINCE THE BABY RECEVIED SHOTS. (ALSO CHILD HAS HAD DIARRHEA OFF AND ON SINCE 6/10) PATIENT WAS THEN ADMITED TO MEDICAL CENTER. PATIENT WAS DISCHARGED FROM ON 7/9/10.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Red, swollen, itch left thigh.
Age: 1.11
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash started on legs, spread over rest of body.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: HA, Fever, Diarrhea.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Areflexia, Blood human chorionic gonadotropin negative, Computerised tomogram normal, Drug screen negative, Full blood count
Clinical narrative: Sudden onset of lower leg weakness bilateral with numbness and absent DTR's in lower extremities occurred while awaiting to dance hula in a hotel, was taken to hospital 7/8-9/10 observation overnight, discharge the fd - AM walking. FHX - Father with viral illness contact with daughter x 2 days.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematocrit normal, Haemoglobin normal, Hypoaesthesia, Lymphocyte count increased, Metabolic function test
Clinical narrative: Sudden onset of lower leg weakness bilateral with numbness and absent DTR's in lower extremities occurred while awaiting to dance hula in a hotel, was taken to hospital 7/8-9/10 observation overnight, discharge the fd - AM walking. FHX - Father with viral illness contact with daughter x 2 days.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Monocyte percentage, Muscular weakness, Neutrophil count decreased, Platelet count normal, White blood cell count normal
Clinical narrative: Sudden onset of lower leg weakness bilateral with numbness and absent DTR's in lower extremities occurred while awaiting to dance hula in a hotel, was taken to hospital 7/8-9/10 observation overnight, discharge the fd - AM walking. FHX - Father with viral illness contact with daughter x 2 days.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha-1 acid glycoprotein normal, Computerised tomogram normal, Full blood count, Hypoaesthesia, Metabolic function test
Clinical narrative: Sudden onset of lower leg weakness bilateral with numbness and absent DTR's in lower extremities occurred while awaiting to dance hula in a hotel, was taken to hospital 7/8-9/10 observation overnight, discharge the fd - AM walking. FHX - Father with viral illness contact with daughter x 2 days.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mood altered, Muscular weakness, Sick relative
Clinical narrative: Sudden onset of lower leg weakness bilateral with numbness and absent DTR's in lower extremities occurred while awaiting to dance hula in a hotel, was taken to hospital 7/8-9/10 observation overnight, discharge the fd - AM walking. FHX - Father with viral illness contact with daughter x 2 days.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Angiogram, Cerebrovascular accident, Echocardiogram, Hemiparesis, Nuclear magnetic resonance imaging
Clinical narrative: Right middle cerebral artery stroke-left hemiparesis, admitted to hospital. Rx: ASA, supportive care.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Angiogram, Cerebrovascular accident, Disability, Echocardiogram, Hemiparesis
Clinical narrative: Right middle cerebral artery stroke-left hemiparesis, admitted to hospital. Rx: ASA, supportive care.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Right middle cerebral artery stroke-left hemiparesis, admitted to hospital. Rx: ASA, supportive care.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Mom called office on 7-9-2010, child (L) deltoid, swollen - Mom denied redness, fever or pain - Advice given for care to (L) deltoid and to watch closely for any change - In ER on 7-10-2010 - At hospital - admitted for 23 hrs for cellulitis to (L) arm - placed on antibiotics for redness and swelling at (L) arm injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Gaze palsy, Injection site discolouration, Injection site erythema, Injection site macule
Clinical narrative: 7-8-10 mother returned to office after she had called 911 and child was examined by paramedics for imz rxn. Child crying with red legs and spots on his legs. Eyes rolled back. No LOC. At OV child consolable with few blue/red macules on lower extremities. Sent home after reevaluated.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site rash
Clinical narrative: 7-8-10 mother returned to office after she had called 911 and child was examined by paramedics for imz rxn. Child crying with red legs and spots on his legs. Eyes rolled back. No LOC. At OV child consolable with few blue/red macules on lower extremities. Sent home after reevaluated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red - hot, swelling at injection site.  Rt delt. BENADRYL and LORATADINE given.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Patient vomited immediately after administration of Rotavirus vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus, Skin discolouration
Clinical narrative: C/o dark spot on (R) arm after immunizations 3 wks ago on 6/15/10.  States initially no fever, blister, redness or swelling.  States child c/o sl. itching problem #1 other dyschromia (R) bicep.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Approx 15 min after receiving vaccines pt became faint and went to knees we laid her down, checked blood pressure, gave water, she recovered in 10 - 15 minutes.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Measles antibody positive, Myalgia, Pyrexia
Clinical narrative: On day 2 after receipt of MMR 7/6/10, developed 104 degrees F. fever, muscle aches and headache not relieved w/ TYLENOL. Also (R) ankle pain at site of old injury. On 7/12/10, temp. is normal and has only residual.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody positive
Clinical narrative: On day 2 after receipt of MMR 7/6/10, developed 104 degrees F. fever, muscle aches and headache not relieved w/ TYLENOL. Also (R) ankle pain at site of old injury. On 7/12/10, temp. is normal and has only residual.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: This case was reported by a physician, via GSK representative, and described the occurrence of lump injection site in a 4-year-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). The subject had not experienced similar reaction with individual DTaP or IPV vaccinations. On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown thigh). At an unspecified time after vaccination with KINRIX, the subject experienced lump injection site and injection site pruritus. The lump was described as "like a baseball with itching". There were no systemic adverse events. At the time of reporting the outcome of the events was unspecified.
Age: 0.28
Sex: M
Vaccine: DTAPIPV, HEP, IPV, PNC, RV5
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of vomiting in a 3-month-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline), IPV.  Concurrent vaccination included ENGERIX-B, GlaxoSmithKline given on 15 June 2010; PREVNAR (non-gsk); PFIZER given on 15 June 2010; ROTATEQ (non-gsk); Merck given on 15 June 2010.  On 15 June 2010 the subject received 1st dose of KINRIX (unknown route, left thigh), 1st dose of IPV (details unknown), and experienced overdose.  On 15 June 2010, the same day after vaccination with IPV and KINRIX, the subject experienced vomiting.  At the time of reporting the events were unresolved.  The physician considered the events were possibly related to vaccination with KINRIX and IPV.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk).  The subject's medical history included allergy to amoxicillin.  Concurrent vaccination included MMR II (non-gsk); Merck given on 15 June 2010.  Concurrent medications included Tuberculin PPD given on the left forearm on 15 June 2010.  On 15 June 2010 the subject received 1st dose of KINRIX (.5 ml, unknown route, left thigh), 2nd dose of varicella virus vaccine (Non-GSK) (unknown route, left thigh).  On 15 June 2010, less than one day after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced injection site redness and injection site warmth.  The events occurred on her left thigh.  The subject was treated with BENADRYL.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were possibly related to vaccination with KINRIX and Varicella virus vaccine (Non-GSK).
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site scar, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Initial report received from a consumer on 12 October 2009.  A 63 year-old female patient reported that she was vaccinated with ADACEL (Sanofi Pasteur, lot number C2863AA), 0.1 milliliters via an intradermal injection to the left inner deltoid on 29 April 2008.  Post vaccination, the patient's arm was swollen and red one half way around.  Eighteen months post vaccination, the patient reported still having a mark where the vaccination was administered.  The patient received a tetanus vaccination ten years prior to this report and reported swelling of her arm following that vaccination.  No further information is expected.  List of documents held by sender: none
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia, Restlessness
Clinical narrative: Initial report was received 04 June 2009 from a health care professional as part of a cluster. A 24-year-old female patient, had received a left deltoid injection (route not reported) of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) at 3 PM on 13 January 2009, and the following morning, on 14 January 2009, she developed chills and muscle and joint pain which had been worse in her legs and buttocks. At 5 PM that same day she developed a fever of 101 degrees Fahrenheit and subsequently had a restless night sleep. By the following evening on 15 January 2009, the symptoms had resolved and the patient recovered. The events did not require a doctor's visit. This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients. The other four identified patients have been captured in case numbers 2009-00586, 2009-02398, 2009-02400, and 2009-0401. This case also has the same reporter as case number 2009-00128.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: Initial report was received 04 June 2009 from a health care professional as part of a cluster. A 24-year-old female patient, had received a left deltoid injection (route not reported) of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) at 3 PM on 13 January 2009, and the following morning, on 14 January 2009, she developed chills and muscle and joint pain which had been worse in her legs and buttocks. At 5 PM that same day she developed a fever of 101 degrees Fahrenheit and subsequently had a restless night sleep. By the following evening on 15 January 2009, the symptoms had resolved and the patient recovered. The events did not require a doctor's visit. This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients. The other four identified patients have been captured in case numbers 2009-00586, 2009-02398, 2009-02400, and 2009-0401. This case also has the same reporter as case number 2009-00128.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Malaise, Pain, Poor quality sleep, Pyrexia
Clinical narrative: Initial report was received 04 June 2009 from a health care professional as part of a cluster.  A 51-year-old female patient with no concurrent illness, had received a right deltoid injection (route not reported) of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) between 7 and 8 AM on 13 January 2009, and at midnight on 13 January 2009, she developed fever, chills, general malaise, achiness all over and restless sleep.  She had a past medical history of reflux and seasonal allergies and had been taking NEXIUM and CLARITIN concomitantly.  The events did not require a doctor's visit.  According to the reporter, the symptoms resolved on 15 January 2009 and the patient recovered.  This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients.  The other four identified patients have been captured in case numbers 2009-00586, 2009-02398, 2009-02399, and 2009-02401.  This case also has the same reporter as case number 2009-00128. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Lethargy, Myalgia, Night sweats
Clinical narrative: Initial report was received 04 June 2009 from a health care professional as part of a cluster.  A 47-year-old female patient with no concurrent illness and no pre-existing medical conditions, had received a right deltoid injection of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) between 3 and 4 PM on 16 January 2009, and the following morning at 11 AM on 17 January 2009, she developed shaking chills, a mild headache, profound lethargy, some muscle aches and night sweats.  The events did not require a doctor's visit.  According to the reporter, the patient took Ibuprofen and felt better the following morning on 18 January 2009, and recovered.  This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients.  The other four identified patients have been captured in case number 2009-00586, 2009-02398, 2009-02399, and 2009-02400.  This case also has the same reporter as case number 2009-00128.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Initial report was received 04 June 2009 from a health care professional as part of a cluster.  A 47-year-old female patient with no concurrent illness and no pre-existing medical conditions, had received a right deltoid injection of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) between 3 and 4 PM on 16 January 2009, and the following morning at 11 AM on 17 January 2009, she developed shaking chills, a mild headache, profound lethargy, some muscle aches and night sweats.  The events did not require a doctor's visit.  According to the reporter, the patient took Ibuprofen and felt better the following morning on 18 January 2009, and recovered.  This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients.  The other four identified patients have been captured in case number 2009-00586, 2009-02398, 2009-02399, and 2009-02400.  This case also has the same reporter as case number 2009-00128.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Muscular weakness, Oedema peripheral
Clinical narrative: Initial report received on 01 June 2009 from a health care professional. A 48 year old female patient with a history of allergies to penicillin and fentamyl, scoliosis, osteoarthritis and high blood pressure received ADACEL (lot number C3068AA) in the left deltoid on 27 May 2009. On 28 May 2009 the patient developed swelling of her extremity, shaking, weakness in her left arm, fatigue, stomach pain, and chest pain. The patient was initially in the doctor's office on 29 May 2009 for another issue but was also examined for the reactions post vaccination at that time. At the time of the vaccination, the patient had a cat bite and was on DOXYCYCLINE. Other concomitant therapy included ULTRAM, PRAVASTATIN, VICODIN, LOTREL, AMITRIPTYLINE, SINGULAIR, ZOLOFT, ALBUTEROL inhaler, ALLEGRA, XANAX, NASONEX. The patient's recovery status was unknown at the time of the report. Follow-up information was received 12 June 2009 from a health care professional. It was unknown if the patient or their siblings had ever experienced any adverse events following previous vaccinations. According to the reporter, the patient recovered from the event on 29 May 2009. No further information was provided.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Initial report received on 01 June 2009 from a health care professional. A 48 year old female patient with a history of allergies to penicillin and fentamyl, scoliosis, osteoarthritis and high blood pressure received ADACEL (lot number C3068AA) in the left deltoid on 27 May 2009. On 28 May 2009 the patient developed swelling of her extremity, shaking, weakness in her left arm, fatigue, stomach pain, and chest pain. The patient was initially in the doctor's office on 29 May 2009 for another issue but was also examined for the reactions post vaccination at that time. At the time of the vaccination, the patient had a cat bite and was on DOXYCYCLINE. Other concomitant therapy included ULTRAM, PRAVASTATIN, VICODIN, LOTREL, AMITRIPTYLINE, SINGULAIR, ZOLOFT, ALBUTEROL inhaler, ALLEGRA, XANAX, NASONEX. The patient's recovery status was unknown at the time of the report. Follow-up information was received 12 June 2009 from a health care professional. It was unknown if the patient or their siblings had ever experienced any adverse events following previous vaccinations. According to the reporter, the patient recovered from the event on 29 May 2009. No further information was provided.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Headache, Influenza like illness, Injection site erythema
Clinical narrative: This case was received from a health care professional on 22 June 2009.  A 43-year-old female, with a history of environmental allergies, penicillin allergy, anemia, and hypothyroidism, received an intramuscular left deltoid injection of ADACEL on 27 May 2009 (lot number UF460BA, Sanofi - Pasteur Ltd. lot number C3066).  Approximately 24 hours post-vaccination, the patient complained of severe flu-like symptoms, including lethargy, shortness of breath, rash on the torso, chills, body aches, and headache.  She also complained of redness, warmth, and tenderness at the left deltoid.  She was seen in the office on 29 May 2009, and her physician prescribed increased fluids, an ice pack to the injection site, and ALEVE as needed.  She was subsequently described as feeling 20% better.  Follow up information received on 07 July 2009 from a health care professional.  The patient recovered and did not require additional treatment.  No additional information was provided.  Follow up information received.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site warmth, Lethargy, Pain, Rash
Clinical narrative: This case was received from a health care professional on 22 June 2009.  A 43-year-old female, with a history of environmental allergies, penicillin allergy, anemia, and hypothyroidism, received an intramuscular left deltoid injection of ADACEL on 27 May 2009 (lot number UF460BA, Sanofi - Pasteur Ltd. lot number C3066).  Approximately 24 hours post-vaccination, the patient complained of severe flu-like symptoms, including lethargy, shortness of breath, rash on the torso, chills, body aches, and headache.  She also complained of redness, warmth, and tenderness at the left deltoid.  She was seen in the office on 29 May 2009, and her physician prescribed increased fluids, an ice pack to the injection site, and ALEVE as needed.  She was subsequently described as feeling 20% better.  Follow up information received on 07 July 2009 from a health care professional.  The patient recovered and did not require additional treatment.  No additional information was provided.  Follow up information received.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Initial report received on 22 July 2009 from a health care professional. A 51 year old female patient received ADACEL reported as both intradermally in the left forearm and intramuscularly in the left deltoid (lot number not known) and APLISOL (manufacture JHP, lot number 111056) intramuscularly in the right forearm on 20 July 2009. On 21 July 2009 the patient experienced a burning sensation at the site which was a 5x5 cm area. The next day the patient had a 5x5 cm raised red area with a 1x1 cm higher raised area in center with a white area in the center of this inner raised area. The patient required a doctor's visit. No further information was provided. The patient was not recovered at that time. List of Documents held by Sender: none.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Muscular weakness, Myositis, No reaction on previous exposure to drug
Clinical narrative: Initial report received on 07 July 2009 from a health care professional.  A 59 year old female patient received ADACEL (lot number unknown) in the right arm on 18 June 2009 for "stepping on something".  The patient had a prior TD dose more than 10 years ago.  On 02 July 2009 the patient developed weakness and a decrease in strength in the right arm and hand.  The patient was not evaluated by a neurologist, but had a doctor's visit.  Information regarding the visit was not provided.  The patient was not recovered at the time of the report.  Follow up information received on 14 September 2009 from a health care professional who reported that the patient was seen in the office on 02 July 2009 and was diagnosed with myositis.  The patient had slowly improved since then.  No labs or treatment were received.  The patient did not have reactions with vaccinations received in the past and did not have an illness at the time of vaccination.  Route of administration was reported as intramuscular.  No further information was received.  Follow-up information received on 16 November 2009 from a health care professional reported the outcome of the adverse event as resolved on 03 November 2009.  It was also reported that no prior doses of vaccine were given.  Follow-up information received on 04 January 2010 from a health care professional.  Per the reporter the lot number is not available as the vaccination was not done at their facility.  List of Documents held by Sender: none.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site pain, Neutrophil percentage increased, Pyrexia, White blood cell count increased
Clinical narrative: A 65 year old female received ADACEL (lot number unknown) intramuscularly in the left deltoid and PNEUMOVAX (manufacturer Merck, lot number unknown) on 28 July 2009. On 29 July 2009 the patient developed an 18 cm diameter area of erythema, fever of 101, and pain at the site. The patient did not develop lymphadenopathy. The patient was seen in the emergency room and was started on KEFLEX. The next day the patient was seen in the doctor's office with no improvement and was started on clindamycin. A of 01 August 2009 the patient was 33-50% improved. WBC was 12 and seg 83%. No further information was provided. List of Documents held by Sender: none.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abdominal discomfort, Headache, Hypoaesthesia, Injection site reaction, Neck pain
Clinical narrative: This case was received from a health care professional on August 2009. A 51-year-old female patient, with a history of multiple food and drug allergies, received the following vaccines on 28 July 2009: ADACEL (lot number C32500AA) and PNEUMOVAX 23 (Merck, lot number 0310Y). She was also taking an ALBUTEROL rescue inhaler concomitantly. Two days post vaccination, on 30 July 2009, the patient experienced headache, neck pain, jaw pain, and a localized injection site reaction. Six days post-vaccination, on 03 August 2009, she complained of abdominal upset and numbness of the ankle, foot and leg. The patient sought medical attention for the event; no additional information was provided. Follow up information received on 29 September 2009 from a health care professional who stated that the patient did not have an illness at the time of vaccination. The patient received ADACEL intramuscularly in the right upper extremity and PNEUMOVAX 23 intramuscularly in the left upper extremity. The patient was reported as recovered.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Pain in jaw
Clinical narrative: This case was received from a health care professional on August 2009. A 51-year-old female patient, with a history of multiple food and drug allergies, received the following vaccines on 28 July 2009: ADACEL (lot number C32500AA) and PNEUMOVAX 23 (Merck, lot number 0310Y). She was also taking an ALBUTEROL rescue inhaler concomitantly. Two days post vaccination, on 30 July 2009, the patient experienced headache, neck pain, jaw pain, and a localized injection site reaction. Six days post-vaccination, on 03 August 2009, she complained of abdominal upset and numbness of the ankle, foot and leg. The patient sought medical attention for the event; no additional information was provided. Follow up information received on 29 September 2009 from a health care professional who stated that the patient did not have an illness at the time of vaccination. The patient received ADACEL intramuscularly in the right upper extremity and PNEUMOVAX 23 intramuscularly in the left upper extremity. The patient was reported as recovered.