chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Stomach discomfort, Syncope
Clinical narrative: The patient complained of syncope, upset stomach and diarrhea. Her symptoms started approximately two hours after receiving the vaccines and persisted all night. She states she took Pepto Bismol with no relief. She states she was not ill prior to receiving the vaccines and has no health problems. She has not sought medical attention as of this time. Her symptoms still persist as of 4/20/07 at 8:45 AM.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Computerised tomogram normal, Drug screen positive, Head injury, Laboratory test normal, Loss of consciousness
Clinical narrative: Tonic seizure with loss of consciousness lasting 90 seconds in clinic followed by 60 minute post-ictal state.  Patient received Anthrax vaccine #1 at 2112 on 4/18 and had event within clinic at 2116 of same evening (4/18).  Patient struck head on floor when seizure began.  He was stable and alert at the time of transfer to the Hospital.  Patient presently hospitalized with normal head CT and electrolytes.  Urine testing during hospitalization suggestive of presence of barbiturates in urine although patient reports taking no medications.  Over two hundred vaccines from the same lot were administered within 24 hours of the event in various clinics with no other similar events.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Postictal state, Tonic convulsion
Clinical narrative: Tonic seizure with loss of consciousness lasting 90 seconds in clinic followed by 60 minute post-ictal state.  Patient received Anthrax vaccine #1 at 2112 on 4/18 and had event within clinic at 2116 of same evening (4/18).  Patient struck head on floor when seizure began.  He was stable and alert at the time of transfer to the Hospital.  Patient presently hospitalized with normal head CT and electrolytes.  Urine testing during hospitalization suggestive of presence of barbiturates in urine although patient reports taking no medications.  Over two hundred vaccines from the same lot were administered within 24 hours of the event in various clinics with no other similar events.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: 3-4 days after vaccine administration the patient developed multiple "small red bumps" near injection site that progressively spread to chest wall, left arm and back.  Mildly itchy, not painful. No fever. Otherwise well. On 4/20/07 he sought medical attention.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Pyrexia
Clinical narrative: Pt had fever up to 105, regressed in developmental areas, such as not pulling to stand or trying to walk.  Pt had electrodermal screening and was put on several homeopathic drops and is now walking.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Local reaction - did not seek medical attention
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Lymphadenopathy, Pain
Clinical narrative: Received injection.  On day of injection, patient experienced soreness and throbbing.  On Wednesday 4/19 night, saw increased redness with streaks below site of injection.  Lymp nodes started to enlarge. On Thursday 4/19, used warm packs throughout the day since arm very sore and red. Now, has raised, red, warm area the size of palm of hand about 12 mm below the injection site.  Injection site very hard and red.  Lymph nodes enlarged.  States has been febrile  releived by 3 doses of Ibuprofen since 4/17/2007.  Dr. notified and asked to refer to Dr.   Health Department for follow up.  Dr. and Health Dept notified employee enroute to Health Dept.  States has not taken Benadryl or any other over the counter or prescription meds.  Previous dose in PIMS 11/04/2005.  States forgot had this shot.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Received injection.  On day of injection, patient experienced soreness and throbbing.  On Wednesday 4/19 night, saw increased redness with streaks below site of injection.  Lymp nodes started to enlarge. On Thursday 4/19, used warm packs throughout the day since arm very sore and red. Now, has raised, red, warm area the size of palm of hand about 12 mm below the injection site.  Injection site very hard and red.  Lymph nodes enlarged.  States has been febrile  releived by 3 doses of Ibuprofen since 4/17/2007.  Dr. notified and asked to refer to Dr.   Health Department for follow up.  Dr. and Health Dept notified employee enroute to Health Dept.  States has not taken Benadryl or any other over the counter or prescription meds.  Previous dose in PIMS 11/04/2005.  States forgot had this shot.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Chills, Headache, Joint stiffness, Mobility decreased
Clinical narrative: 04/17 08.30P Arm and shoulder stiff, swollen and inflamed. Very tender, unable to raise arm above waist level.Headache and temperature, shivers. 04/18 08.30A arm still as above, made appointment to see doctor. Treatment injection of Methylprednisolone Sodium Succ. 125MG/2ML inj recon soln 60mg im x 1 intramuscular and Diphenhydramine HCL 50 MG/ML inj soln 25 mg im x 1 intramuscular.  Observation for 2 hours.  Benadry 25 MG oral cap 1 tab po q 4-6hoursIbrufen 800 MG oral tab 1 tab po tid prn pain Propxyphene N-Acetaminophen 100 MG-650 MG tab 1 tab Q4-6H Prn pain. Ice applied to left arm and chest, elevate as much as possible.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: 04/17 08.30P Arm and shoulder stiff, swollen and inflamed. Very tender, unable to raise arm above waist level.Headache and temperature, shivers. 04/18 08.30A arm still as above, made appointment to see doctor. Treatment injection of Methylprednisolone Sodium Succ. 125MG/2ML inj recon soln 60mg im x 1 intramuscular and Diphenhydramine HCL 50 MG/ML inj soln 25 mg im x 1 intramuscular.  Observation for 2 hours.  Benadry 25 MG oral cap 1 tab po q 4-6hoursIbrufen 800 MG oral tab 1 tab po tid prn pain Propxyphene N-Acetaminophen 100 MG-650 MG tab 1 tab Q4-6H Prn pain. Ice applied to left arm and chest, elevate as much as possible.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Pt complained of cold sores on lip and in nares.Pt has past history of cold sores. Pt to be treated with Valtrex 500mg bid
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Skin lesion
Clinical narrative: Pt complained of cold sores on lip and in nares.Pt has past history of cold sores. Pt to be treated with Valtrex 500mg bid
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: 2 days post vaccine, had firmness, redness at injection site (R arm), progressed within a day to same only covering area from shoulder to just above elbow. no systemic signs of illness. area is painful and itchy. treating symptomatically with benadryl and motrin. will follow.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hot flush, Injection site pain, Muscle twitching, Myalgia
Clinical narrative: Headache, generalized muscle aches/pain, hot flashes, 7/10 left shoulder pain (injection site) and left are twitching.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Convulsion, Dizziness, Headache
Clinical narrative: Had HPV4 immunization at approx. 6:00pm and at 9:00pm patient had a seizure.  she was taken to the Emergency department and kept overnight.  This Am she is still experiencing severe dizziness with loss of balance and headache.  5/18/07 Received medical records from ER which reveal patient was at hospital getting ready for sleep study when she had abdominal pain & a witnessed seizure.  Loaded w/Pb & referred to PCP. PMH: FINAL DX: new onset seizures.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Computerised tomogram, Convulsion, Dizziness, Nausea
Clinical narrative: Had HPV4 immunization at approx. 6:00pm and at 9:00pm patient had a seizure.  she was taken to the Emergency department and kept overnight.  This Am she is still experiencing severe dizziness with loss of balance and headache.  5/18/07 Received medical records from ER which reveal patient was at hospital getting ready for sleep study when she had abdominal pain & a witnessed seizure.  Loaded w/Pb & referred to PCP. PMH: FINAL DX: new onset seizures.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Urine analysis normal
Clinical narrative: Had HPV4 immunization at approx. 6:00pm and at 9:00pm patient had a seizure.  she was taken to the Emergency department and kept overnight.  This Am she is still experiencing severe dizziness with loss of balance and headache.  5/18/07 Received medical records from ER which reveal patient was at hospital getting ready for sleep study when she had abdominal pain & a witnessed seizure.  Loaded w/Pb & referred to PCP. PMH: FINAL DX: new onset seizures.
Age: 73.0
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Menactra given instead on Medomune.  No adverse events.
Age: 0.58
Sex: F
Vaccine: PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Gave Boostrix ( AC52B013AA exp 12/20/08)instead of Pediarix for third vaccination. Only noticed after another nurse entereding information into system brought it to my attention. Patient stayed 20 post vacinations without any adverse reaction. Note sent to parent to return to clinic but did not return as requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Received varicella vaccine on 06/29/2000.  Was diagnosed in our office with chickenpox on 03/16/2007 - had itchy red bumps for 4-5 days all over body;also with red, inflamed vaginal area for 4-5 days.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia facial, Paraesthesia
Clinical narrative: A few minutes after the vaccine was administered, the patient stated that the left side of her face felt numb and was tingly. We let her rest for 15 minutes and the feeling did not subside. I contacted her primary health provider and I gave her 50mg benadryl IM, and she had total relief of her symptoms within five minutes. She left for home with her mother in stable condition, with instructions to call us if she had any other problems.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Barium swallow abnormal, Blood culture, C-reactive protein, Chest X-ray, Full blood count
Clinical narrative: Two episodes of extreme paleness/lethargy/unresponsiveness. First occurred about 6 hrs after immunizations - lasted about 10 minutes. Second occured while in ER and was witnessed by medical staff. No choking, gagging, spitting or vomiting.  No jerking or abnormal movements. No cyanosis or apnea.  05/01/2007 Record received for an o/n hospital stay for 2 episodes of extreme paleness, lethargy, and shallow breathing.  Parent reports child initially looked pale and sleepy, but later noted he turned white, became unresponsive, and was difficult to arrouse.  The episode lasted ~10 minutes. Breathing was shallow but did not stop.  No cyanosis.  A 2nd witnessed episode occured in the ER.  PE: WNL. Assessment: Possible Life Threatening within 6 hours of 2 mon. imms.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Lethargy, Metabolic function test, Pallor, Unresponsive to stimuli, Urine analysis
Clinical narrative: Two episodes of extreme paleness/lethargy/unresponsiveness. First occurred about 6 hrs after immunizations - lasted about 10 minutes. Second occured while in ER and was witnessed by medical staff. No choking, gagging, spitting or vomiting.  No jerking or abnormal movements. No cyanosis or apnea.  05/01/2007 Record received for an o/n hospital stay for 2 episodes of extreme paleness, lethargy, and shallow breathing.  Parent reports child initially looked pale and sleepy, but later noted he turned white, became unresponsive, and was difficult to arrouse.  The episode lasted ~10 minutes. Breathing was shallow but did not stop.  No cyanosis.  A 2nd witnessed episode occured in the ER.  PE: WNL. Assessment: Possible Life Threatening within 6 hours of 2 mon. imms.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, PPV, RV5, DTAP, HBHEPB, PNC, RV5
Symptoms: Intussusception, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 01-MAR-2007 was vaccinated with a 2 mL PO third dose of Rotateq. Concomitant vaccination included a dose of pneumococcal, polyval (MSD), a dose of HIB and a dose of DTaP. On 19-MAR-2007 the patient developed intussusception and was hospitalized. Surgery was not required. Subsequently, the patient recovered from intussusception on 3/21/07. There was no product quality complaint involved. Additional information has been requested. 5/4/07 Received medical records from hospital which reveal patient seen in ER on 3/20-3/21/07 for vomiting, abdominal pain, inconsolable fussiness, lethargy & dark heme + diarrhea stools. Kept overnight for observation.  Did well, tolerated oral feedings & was d/c to home w/o complication. FINAL DX: Intussusception, reduced by air enema. 5/29/07 Received vax record which confirmed RO as reported.  VAERS database updated w/other vax info.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, PPV, RV5, DTAP, HBHEPB, PNC, RV5
Symptoms: Barium enema, Faeces discoloured, Haematochezia, Intussusception, Ultrasound abdomen
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 01-MAR-2007 was vaccinated with a 2 mL PO third dose of Rotateq. Concomitant vaccination included a dose of pneumococcal, polyval (MSD), a dose of HIB and a dose of DTaP. On 19-MAR-2007 the patient developed intussusception and was hospitalized. Surgery was not required. Subsequently, the patient recovered from intussusception on 3/21/07. There was no product quality complaint involved. Additional information has been requested. 5/4/07 Received medical records from hospital which reveal patient seen in ER on 3/20-3/21/07 for vomiting, abdominal pain, inconsolable fussiness, lethargy & dark heme + diarrhea stools. Kept overnight for observation.  Did well, tolerated oral feedings & was d/c to home w/o complication. FINAL DX: Intussusception, reduced by air enema. 5/29/07 Received vax record which confirmed RO as reported.  VAERS database updated w/other vax info.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, PPV, RV5, DTAP, HBHEPB, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 01-MAR-2007 was vaccinated with a 2 mL PO third dose of Rotateq. Concomitant vaccination included a dose of pneumococcal, polyval (MSD), a dose of HIB and a dose of DTaP. On 19-MAR-2007 the patient developed intussusception and was hospitalized. Surgery was not required. Subsequently, the patient recovered from intussusception on 3/21/07. There was no product quality complaint involved. Additional information has been requested. 5/4/07 Received medical records from hospital which reveal patient seen in ER on 3/20-3/21/07 for vomiting, abdominal pain, inconsolable fussiness, lethargy & dark heme + diarrhea stools. Kept overnight for observation.  Did well, tolerated oral feedings & was d/c to home w/o complication. FINAL DX: Intussusception, reduced by air enema. 5/29/07 Received vax record which confirmed RO as reported.  VAERS database updated w/other vax info.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site swelling, Rash pruritic, Scab, Skin exfoliation
Clinical narrative: Information has been received from a registered nurse at a dermatology office, concerning a 17 year old female patient who on 20-SEP-2006 was vaccinated with the first dose of Gardasil (Lot #653736/0868F), and on 05-JAN-2007, with the second dose of Gardasil (Lot #655165/1425F) at an OB-GYN office. The nurse reported that on 05-JAN-2007, following the second vaccination, the patient, immediately got at bump on the right arm," by approximately 19-JAN-2007 ("within 2 weeks of the vaccination"), the patient's "arm was cabby, scaly and bigger, than spread to whole body and face;" the patient developed a severe rash with itching. Prior to the first visit at the dermatology office, the nurse confirmed that the patient reported she had received treatment (date not specified) from a clinic, involving 2 courses of methylprednisone and cephalexin. On 27-JAN-2007, when the patient initially visited the dermatology office, the nurse indicated that the rash "looked like a sunburn that had peeled, was swollen, flaked and scabbed." Treatment on 27-JAN-2007 included an injection of DEPO-MEDROL), MOISTEREL cream (OTC). At the time of this report, it was unknown if the patient had recovered; the patient had a follow up visit scheduled at the dermatology office for 17-APR-2007. The reporter considered the severe rash with itching, peeling, swelling, flaking and scabbing to be disabling as the patient had missed school, and also an other medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: Information has been received from a registered nurse at a dermatology office, concerning a 17 year old female patient who on 20-SEP-2006 was vaccinated with the first dose of Gardasil (Lot #653736/0868F), and on 05-JAN-2007, with the second dose of Gardasil (Lot #655165/1425F) at an OB-GYN office. The nurse reported that on 05-JAN-2007, following the second vaccination, the patient, immediately got at bump on the right arm," by approximately 19-JAN-2007 ("within 2 weeks of the vaccination"), the patient's "arm was cabby, scaly and bigger, than spread to whole body and face;" the patient developed a severe rash with itching. Prior to the first visit at the dermatology office, the nurse confirmed that the patient reported she had received treatment (date not specified) from a clinic, involving 2 courses of methylprednisone and cephalexin. On 27-JAN-2007, when the patient initially visited the dermatology office, the nurse indicated that the rash "looked like a sunburn that had peeled, was swollen, flaked and scabbed." Treatment on 27-JAN-2007 included an injection of DEPO-MEDROL), MOISTEREL cream (OTC). At the time of this report, it was unknown if the patient had recovered; the patient had a follow up visit scheduled at the dermatology office for 17-APR-2007. The reporter considered the severe rash with itching, peeling, swelling, flaking and scabbing to be disabling as the patient had missed school, and also an other medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Asthenia, Sensory loss, Syncope
Clinical narrative: Information has been received from  physician's assistant concerning a 16 year old female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. it was reported that the patient was seen in the emergency room and the patient "collapsed, experienced weakness, sensory loss in extremities and the patient could not walk" after receiving Gardasil. The patient was hospitalized and the length of hospitalization was unknown. At the time of the report, it was unknown, if the patient recovered. The reporter considered collapsed, experienced weakness, sensory loss in extremities and could not walk to be disabling. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy breast abnormal, Breast cancer, Breast mass, Cervical dysplasia, Condition aggravated
Clinical narrative: Information has been received from a registered nurse, concerning a 26 year old female patient with a low grade squamous intraepithelial lesion, cervical dysplasia and cervical intraepithelial neoplasia-1 (18-AUG-2006), who on 16-OCT-2006 was vaccinated with the first dose, 0.5ml, IM in the left arm, of Gardasil (Lot #654540/0800F). There was no concomitant medication. On 15-DEC-2006, at an office visit scheduled to determine if she was pregnant, the patient reported that she felt a small lump in her left breast that had been there since approximately 15-NOV-2006 ("approximately one month'). The nurse added that the patient was sent to the hospital for a pregnancy test, which was negative. On 09-JAN-2007, the patient had a mammogram of the left breast which recommended that she undergo a biopsy, and on 17-Jan-2007, an ultrasound guided core biopsy of the left breast was performed; on 19-Jan-2007, the biopsy result showed "invasive and intraductal breast carcinoma." On 20-Jan-2007 the patient was vaccinated with the second dose, 0.5 ml, IM in the left arm, of Gardasil (Lot #654540/0800F). On 21-MAR-2007, a repeat Pap smear result was positive for human papilloma virus, and the nurse added that the usual treatment to remove the abnormal cells with the loop electrosurgical excision procedure (LEEP), was not performed due to the patient's breast cancer diagnosis. The nurse stated that the patient was scheduled to be seen by 2 surgeons for consideration and opinions of a bilateral mastectomy, and indicated that the patient would undergo chemotherapy following the surgery. The reporter considered the patient's invasive and intraductal breast carcinoma and/or positive human papilloma virus results to be immediately life-threatening and an other significant medical event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Mammogram abnormal, Mastectomy, Papilloma viral infection, Pregnancy test negative
Clinical narrative: Information has been received from a registered nurse, concerning a 26 year old female patient with a low grade squamous intraepithelial lesion, cervical dysplasia and cervical intraepithelial neoplasia-1 (18-AUG-2006), who on 16-OCT-2006 was vaccinated with the first dose, 0.5ml, IM in the left arm, of Gardasil (Lot #654540/0800F). There was no concomitant medication. On 15-DEC-2006, at an office visit scheduled to determine if she was pregnant, the patient reported that she felt a small lump in her left breast that had been there since approximately 15-NOV-2006 ("approximately one month'). The nurse added that the patient was sent to the hospital for a pregnancy test, which was negative. On 09-JAN-2007, the patient had a mammogram of the left breast which recommended that she undergo a biopsy, and on 17-Jan-2007, an ultrasound guided core biopsy of the left breast was performed; on 19-Jan-2007, the biopsy result showed "invasive and intraductal breast carcinoma." On 20-Jan-2007 the patient was vaccinated with the second dose, 0.5 ml, IM in the left arm, of Gardasil (Lot #654540/0800F). On 21-MAR-2007, a repeat Pap smear result was positive for human papilloma virus, and the nurse added that the usual treatment to remove the abnormal cells with the loop electrosurgical excision procedure (LEEP), was not performed due to the patient's breast cancer diagnosis. The nurse stated that the patient was scheduled to be seen by 2 surgeons for consideration and opinions of a bilateral mastectomy, and indicated that the patient would undergo chemotherapy following the surgery. The reporter considered the patient's invasive and intraductal breast carcinoma and/or positive human papilloma virus results to be immediately life-threatening and an other significant medical event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Surgery
Clinical narrative: Information has been received from a registered nurse, concerning a 26 year old female patient with a low grade squamous intraepithelial lesion, cervical dysplasia and cervical intraepithelial neoplasia-1 (18-AUG-2006), who on 16-OCT-2006 was vaccinated with the first dose, 0.5ml, IM in the left arm, of Gardasil (Lot #654540/0800F). There was no concomitant medication. On 15-DEC-2006, at an office visit scheduled to determine if she was pregnant, the patient reported that she felt a small lump in her left breast that had been there since approximately 15-NOV-2006 ("approximately one month'). The nurse added that the patient was sent to the hospital for a pregnancy test, which was negative. On 09-JAN-2007, the patient had a mammogram of the left breast which recommended that she undergo a biopsy, and on 17-Jan-2007, an ultrasound guided core biopsy of the left breast was performed; on 19-Jan-2007, the biopsy result showed "invasive and intraductal breast carcinoma." On 20-Jan-2007 the patient was vaccinated with the second dose, 0.5 ml, IM in the left arm, of Gardasil (Lot #654540/0800F). On 21-MAR-2007, a repeat Pap smear result was positive for human papilloma virus, and the nurse added that the usual treatment to remove the abnormal cells with the loop electrosurgical excision procedure (LEEP), was not performed due to the patient's breast cancer diagnosis. The nurse stated that the patient was scheduled to be seen by 2 surgeons for consideration and opinions of a bilateral mastectomy, and indicated that the patient would undergo chemotherapy following the surgery. The reporter considered the patient's invasive and intraductal breast carcinoma and/or positive human papilloma virus results to be immediately life-threatening and an other significant medical event. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Body temperature increased, Chills, Erythema, Hyperhidrosis, Induration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included ADACEL also given on 02-APR-2007 in the right arm. On 03-APR-2007, the patient experienced muscle aching and called the office. On 04-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included ADACEL also given on 02-APR-2007 in the right arm. On 03-APR-2007, the patient experienced muscle aching and called the office. On 04-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included ADACEL also given on 02-APR-2007 in the right arm. On 03-APR-2007, the patient experienced muscle aching and called the office. On 04-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Body temperature fluctuation, Body temperature increased, Chills, Erythema, Hyperhidrosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included ADACEL also given on 02-APR-2007 in the right arm. On 03-APR-2007, the patient experienced muscle aching and called the office. On 04-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Induration, Myalgia, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included ADACEL also given on 02-APR-2007 in the right arm. On 03-APR-2007, the patient experienced muscle aching and called the office. On 04-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Computerised tomogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging brain normal, Respiratory syncytial virus infection, Virus serology test
Clinical narrative: Patient had onset of generalized tonic clonic seizures evening 2 days after immunizations. Patient had 3 days of URI's x 1 and fever prior to immunizations. Patient hospitalized for continued seizures. Patient received Dilantin and Heparin.  5/22/07 Received hospital clinic medical records which reveal patient experienced congestion, rhinorrhea, cough, vomiting, fever for 3 days prior to vax on 2/23/07.  Dx w/viral URI & treated symptomatically.  Vax record confirms that reported on VAERS form.  7/31/07 Received medical records from hospital which reveal patient experienced cough, runny nose & cold s/s.  Had seizures x 3 on 2/25/07.  Temp 99.4.  Tx w/dilantin. FINAL DX: convulsive epilepsy; acute URI; acute sinusitis; developmental delay.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Cold sweat, Computerised tomogram abnormal, Dizziness, Fall, Head injury
Clinical narrative: 940 AM found patient on floor with fists lasted approx. 3-5 seconds after patient responsive but c/o headache, dizziness, nausea - BP 122/82 - skin cool and clammy - MD in to check patient c/o of same symptoms but with onset of vomiting - responsive at all times but drowsy  - transported to hospital 1030 AM. (when patient fell she hit her head on a cabinet).  05/29/2007 MR received for o/n hospitalization for subdural hematoma. Pt had a  vaso-vagal syncopal episode after receiving vax, which resulted in a fall where pt. hit head. (+) LOC and seizure.  PE: (+) for occipital tenderness. Not oriented to date. T4-L5 tenderness. Final DX: Head injury.  L Parietal-frontal SDH.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Headache, Nausea, Somnolence, Vomiting
Clinical narrative: 940 AM found patient on floor with fists lasted approx. 3-5 seconds after patient responsive but c/o headache, dizziness, nausea - BP 122/82 - skin cool and clammy - MD in to check patient c/o of same symptoms but with onset of vomiting - responsive at all times but drowsy  - transported to hospital 1030 AM. (when patient fell she hit her head on a cabinet).  05/29/2007 MR received for o/n hospitalization for subdural hematoma. Pt had a  vaso-vagal syncopal episode after receiving vax, which resulted in a fall where pt. hit head. (+) LOC and seizure.  PE: (+) for occipital tenderness. Not oriented to date. T4-L5 tenderness. Final DX: Head injury.  L Parietal-frontal SDH.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Erythema, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Tetanus reaction. Patient received her tetanus shot on March 8th. She initially just noted a little bit of redness and pain at the site but not too bad for several days. On the 12th, in the evening she noted that her third, fourth, and fifth digits on her right hand, the arm she got her tetanus shot in, were numb and tingly and upper arm and armpit, breast area was quite swollen and tender, She also noted a large red mark below the site of injection. She initially tried some Benadryl, ibuprofen 800 mg, cold compresses, etc. and was able to get some sleep that first night. By yesterday, however 800 mg of ibuprofen ongoing and regular Benadryl was not helping; in fact her pain and swelling is getting worse. She called out clinic and was recommended to come in for evaluation. Today, she feels things are little bit better although she now is noting some pain extending up into her neck and face and just a general funny feeling around her shoulder blade, her neck, and her face. She denies any fevers, chills. She denies any new skin changes. She denies any injuries to this area. She denies any symptoms in her lower extremities or her left arm and is otherwise feeling well. No nausea or vomiting. She had a good appetite, etc. No weakness in her right arm just pain. She has been able to continue to work. Allergies to Codeine and Morphine.  04/23/2007 VAERS report submitted with medical records attached. Several OVs including 2 Neuro consults.  1st OV of 3/15/2007 Pt c/o numbness and tingling in the 3rd, 4th, and 5th digits of the R hand, the arm she got her tetanus shot in. Swelling and tenderness noted in the R upper arm, armpit, and breast area.  pain progressed into her neck, face and shoulder blade.  No weakness or skin changes noted.  Report of 3/21/2007 shows pain and swelling improved, however now having pain and cold sensation around shoulder blade radiating to neck and upper back. Neurology consult 3/27/2007 shows no evidence of any focal neuritis or radiculopathy.  Impression:  Likely an allergic reaction to Adacel. 2nd Neuro consult 4/5/07 with Assessment of Brachial Neuritis which chronology suggests was a reaction to tetanus shot. 01/12/2010 Pt has ongoing Brachial Neuritis & severe pain. hse is on Neucontin & Ambien. Inaddition she has been getting stellate nerve blocks every month with sore pain relief.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain, Nerve block, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Tetanus reaction. Patient received her tetanus shot on March 8th. She initially just noted a little bit of redness and pain at the site but not too bad for several days. On the 12th, in the evening she noted that her third, fourth, and fifth digits on her right hand, the arm she got her tetanus shot in, were numb and tingly and upper arm and armpit, breast area was quite swollen and tender, She also noted a large red mark below the site of injection. She initially tried some Benadryl, ibuprofen 800 mg, cold compresses, etc. and was able to get some sleep that first night. By yesterday, however 800 mg of ibuprofen ongoing and regular Benadryl was not helping; in fact her pain and swelling is getting worse. She called out clinic and was recommended to come in for evaluation. Today, she feels things are little bit better although she now is noting some pain extending up into her neck and face and just a general funny feeling around her shoulder blade, her neck, and her face. She denies any fevers, chills. She denies any new skin changes. She denies any injuries to this area. She denies any symptoms in her lower extremities or her left arm and is otherwise feeling well. No nausea or vomiting. She had a good appetite, etc. No weakness in her right arm just pain. She has been able to continue to work. Allergies to Codeine and Morphine.  04/23/2007 VAERS report submitted with medical records attached. Several OVs including 2 Neuro consults.  1st OV of 3/15/2007 Pt c/o numbness and tingling in the 3rd, 4th, and 5th digits of the R hand, the arm she got her tetanus shot in. Swelling and tenderness noted in the R upper arm, armpit, and breast area.  pain progressed into her neck, face and shoulder blade.  No weakness or skin changes noted.  Report of 3/21/2007 shows pain and swelling improved, however now having pain and cold sensation around shoulder blade radiating to neck and upper back. Neurology consult 3/27/2007 shows no evidence of any focal neuritis or radiculopathy.  Impression:  Likely an allergic reaction to Adacel. 2nd Neuro consult 4/5/07 with Assessment of Brachial Neuritis which chronology suggests was a reaction to tetanus shot. 01/12/2010 Pt has ongoing Brachial Neuritis & severe pain. hse is on Neucontin & Ambien. Inaddition she has been getting stellate nerve blocks every month with sore pain relief.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Tetanus reaction. Patient received her tetanus shot on March 8th. She initially just noted a little bit of redness and pain at the site but not too bad for several days. On the 12th, in the evening she noted that her third, fourth, and fifth digits on her right hand, the arm she got her tetanus shot in, were numb and tingly and upper arm and armpit, breast area was quite swollen and tender, She also noted a large red mark below the site of injection. She initially tried some Benadryl, ibuprofen 800 mg, cold compresses, etc. and was able to get some sleep that first night. By yesterday, however 800 mg of ibuprofen ongoing and regular Benadryl was not helping; in fact her pain and swelling is getting worse. She called out clinic and was recommended to come in for evaluation. Today, she feels things are little bit better although she now is noting some pain extending up into her neck and face and just a general funny feeling around her shoulder blade, her neck, and her face. She denies any fevers, chills. She denies any new skin changes. She denies any injuries to this area. She denies any symptoms in her lower extremities or her left arm and is otherwise feeling well. No nausea or vomiting. She had a good appetite, etc. No weakness in her right arm just pain. She has been able to continue to work. Allergies to Codeine and Morphine.  04/23/2007 VAERS report submitted with medical records attached. Several OVs including 2 Neuro consults.  1st OV of 3/15/2007 Pt c/o numbness and tingling in the 3rd, 4th, and 5th digits of the R hand, the arm she got her tetanus shot in. Swelling and tenderness noted in the R upper arm, armpit, and breast area.  pain progressed into her neck, face and shoulder blade.  No weakness or skin changes noted.  Report of 3/21/2007 shows pain and swelling improved, however now having pain and cold sensation around shoulder blade radiating to neck and upper back. Neurology consult 3/27/2007 shows no evidence of any focal neuritis or radiculopathy.  Impression:  Likely an allergic reaction to Adacel. 2nd Neuro consult 4/5/07 with Assessment of Brachial Neuritis which chronology suggests was a reaction to tetanus shot. 01/12/2010 Pt has ongoing Brachial Neuritis & severe pain. hse is on Neucontin & Ambien. Inaddition she has been getting stellate nerve blocks every month with sore pain relief.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Rotavirus administered on 4/13/07 seen in ER for vomiting, diarrhea T 103.5 > 4/14/07 Admitted Diarrhea and Dehydration 4/16/07 weight decreased 17oz. follow up visit, weight up 5 1/2 oz. 4/19/07 PLAN: follow weight 1 week.  4/27/07 Received medical records from hospital which reveal patient experienced vomiting, fever & diarrhea for 2 days.  Seen in ER & d/c to home.  Vomiting & diarrhea persisted & was admitted on 4/16/07.   Exam revealed reddened TMs.  Admitted for IVF & monitoring.  No D/C summary or consults available at this time. FINAL DX: none provided.  Will request medical records when complete. 6/1/07 Received hospital D/C summary which reveals pt d/c to home 4/17/07. FINAL DX: acute gastroenteritis, resolved; UTI, ruled out.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood sodium normal, Blood urea increased, Body temperature increased, Dehydration, Diarrhoea
Clinical narrative: Rotavirus administered on 4/13/07 seen in ER for vomiting, diarrhea T 103.5 > 4/14/07 Admitted Diarrhea and Dehydration 4/16/07 weight decreased 17oz. follow up visit, weight up 5 1/2 oz. 4/19/07 PLAN: follow weight 1 week.  4/27/07 Received medical records from hospital which reveal patient experienced vomiting, fever & diarrhea for 2 days.  Seen in ER & d/c to home.  Vomiting & diarrhea persisted & was admitted on 4/16/07.   Exam revealed reddened TMs.  Admitted for IVF & monitoring.  No D/C summary or consults available at this time. FINAL DX: none provided.  Will request medical records when complete. 6/1/07 Received hospital D/C summary which reveals pt d/c to home 4/17/07. FINAL DX: acute gastroenteritis, resolved; UTI, ruled out.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test abnormal, Vomiting, Weight decreased
Clinical narrative: Rotavirus administered on 4/13/07 seen in ER for vomiting, diarrhea T 103.5 > 4/14/07 Admitted Diarrhea and Dehydration 4/16/07 weight decreased 17oz. follow up visit, weight up 5 1/2 oz. 4/19/07 PLAN: follow weight 1 week.  4/27/07 Received medical records from hospital which reveal patient experienced vomiting, fever & diarrhea for 2 days.  Seen in ER & d/c to home.  Vomiting & diarrhea persisted & was admitted on 4/16/07.   Exam revealed reddened TMs.  Admitted for IVF & monitoring.  No D/C summary or consults available at this time. FINAL DX: none provided.  Will request medical records when complete. 6/1/07 Received hospital D/C summary which reveals pt d/c to home 4/17/07. FINAL DX: acute gastroenteritis, resolved; UTI, ruled out.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood creatinine normal, Blood urea increased, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Rotavirus administered on 4/13/07 seen in ER for vomiting, diarrhea T 103.5 > 4/14/07 Admitted Diarrhea and Dehydration 4/16/07 weight decreased 17oz. follow up visit, weight up 5 1/2 oz. 4/19/07 PLAN: follow weight 1 week.  4/27/07 Received medical records from hospital which reveal patient experienced vomiting, fever & diarrhea for 2 days.  Seen in ER & d/c to home.  Vomiting & diarrhea persisted & was admitted on 4/16/07.   Exam revealed reddened TMs.  Admitted for IVF & monitoring.  No D/C summary or consults available at this time. FINAL DX: none provided.  Will request medical records when complete. 6/1/07 Received hospital D/C summary which reveals pt d/c to home 4/17/07. FINAL DX: acute gastroenteritis, resolved; UTI, ruled out.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: Rotavirus administered on 4/13/07 seen in ER for vomiting, diarrhea T 103.5 > 4/14/07 Admitted Diarrhea and Dehydration 4/16/07 weight decreased 17oz. follow up visit, weight up 5 1/2 oz. 4/19/07 PLAN: follow weight 1 week.  4/27/07 Received medical records from hospital which reveal patient experienced vomiting, fever & diarrhea for 2 days.  Seen in ER & d/c to home.  Vomiting & diarrhea persisted & was admitted on 4/16/07.   Exam revealed reddened TMs.  Admitted for IVF & monitoring.  No D/C summary or consults available at this time. FINAL DX: none provided.  Will request medical records when complete. 6/1/07 Received hospital D/C summary which reveals pt d/c to home 4/17/07. FINAL DX: acute gastroenteritis, resolved; UTI, ruled out.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Adenovirus infection, Appendicectomy, Barium enema, Haematemesis, Haematochezia
Clinical narrative: 4/14/07 - Presented with "coffee ground emesis" and bloody stools. Mom took him to ER, dx'd with adenovirus and intussusception. Unable to reduce with barium enema reduced with surgery. S/P Appendectomy. 6/1/07 Received vax record from PCP which indicates RO Lot # is as reported & was 2nd dose.  VAERS database updated w/same. 6/5/07 Received hospital medical records which reveal patient experienced diarrhea x 7 days, bloody mucous x 1 day & abdominal pain.  Also w/rhinorrhea, cough & sneeze.  Admitted 4/14-4/17/07 for bacterial gastroenteritis.  On initial hospital day had coffee ground emesis.    Taken to OR for laproscopic reduction of IS & appendectomy.  Stable post op FINAL DX: Ileocolic intussusception, surgically reduced; adenovirus.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Polymerase chain reaction, Surgery, Virus serology test, Vomiting
Clinical narrative: 4/14/07 - Presented with "coffee ground emesis" and bloody stools. Mom took him to ER, dx'd with adenovirus and intussusception. Unable to reduce with barium enema reduced with surgery. S/P Appendectomy. 6/1/07 Received vax record from PCP which indicates RO Lot # is as reported & was 2nd dose.  VAERS database updated w/same. 6/5/07 Received hospital medical records which reveal patient experienced diarrhea x 7 days, bloody mucous x 1 day & abdominal pain.  Also w/rhinorrhea, cough & sneeze.  Admitted 4/14-4/17/07 for bacterial gastroenteritis.  On initial hospital day had coffee ground emesis.    Taken to OR for laproscopic reduction of IS & appendectomy.  Stable post op FINAL DX: Ileocolic intussusception, surgically reduced; adenovirus.