chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: MMR, TD
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 31-year-old white male with no drug reactions/allergies and with Crohn's disease who on 11-OCT-2006 was vaccinated SC in the left arm with MMR (Lot # 649810/0490R). Concomitant therapy included a Td booster, "Pertasa" 4 cups TID, and IMURAN 125mg daily. On 11-OCT-2006 the patient experienced lightheadedness and felt sick in the stomach for 12 hours after vaccination. There were no lab diagnostic studies performed. The outcome  was recovered on 12-OCT-2006 in the PM. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 12-OCT-2006 at 1:00AM the patient simply "did not feel good", and was nauseous and achy. No additional information is expected.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR. The patient currently showed no immunity. The reporter was considering revaccinating the patient. A product quality complaint was not involved. No further information is available.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Irritability
Clinical narrative: Information has been received from a pharmacist concerning her 14 month old niece with no known allergies, a history of pneumonia and collapse of lung "two months ago" due to "diaphragm positioning" which was surgically corrected, reported as "pushed down" who was vaccinated with first and second doses of MMR, VARIVAX, PEDVAXHIB, and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) on 12-SEP-2006 and 25-OCT-2006 respectively. Concomitant medication included montelukast sodium for the patient's history of pneumonia and collapsed lung. It was reported that the patient was "a little cranky" but has not developed any other side effects or symptoms. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a 29 year old female healthcare student who on 20-OCT-2006 was vaccinated with a 0.5 ml subcutaneous dose of MMR. Concomitant vaccine administered on the same day, but at a different site included RECOMBIVAX HB. "Two days post vaccination," on 24-OCT-2006, the patient developed a fever, muscle and joint pain, and injection site pain. The fever had since resolved, but the pain symptoms, while improving to some extent, have remained at the time of the report. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Injection site bruising, Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 49 year old female, who denied having any allergies or medical history, who on 30-OCT-2006 was vaccinated once with a first 0.5 ml subcutaneous dose in the left upper arm of MMR (Lot# 654687/1025F). There was no concomitant medication. Illness at the time of vaccination was denied. Immediately after vaccination, on 30-OCT-2006 the patient experienced redness, swelling, bruising, warmth, and discomfort at the injection site on the left upper arm. The patient had not experienced systemic symptoms. An ice compress was applied to the site but the patient had not noticed improvement at the time of the report. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient recovered on 31-OCT-2006. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information has been received from a health professional concerning a female in her 30s, with no medical history and no allergies, who was vaccinated with a first, second, and third dose of MMR. Subsequently a recent titer was negative for measles. The patient received a fourth dose of MMR (Lot# 653750/0498F). There was no concomitant medication. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the patient only received one dose of MMR at the facility after which she was not titered. The patient had stated to the reporter that this was her fourth dose. No other information was provided. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Eosinophil count decreased, Erythema, Lymphadenopathy, Myalgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old white male with no medical history or allergies who on 19-OCT-2006 at 14:30 was vaccinated in the right arm with a SC 0.5 mL dose of MMR (lot # 653338/0216F). Vaccination history was not available. There patient was illness at the time of vaccination. Vaccination history not available. On 31-OCT-2006 the patient reported developing a low fever(>100), muscle aches, and a red rash on his shoulders. It was also reported that the morning of 31-OCT-2006 the patient developed lymphadenopathy, post-cervical and post-auricular. He also developed a generalized maculo-papular rash over his face with a few patches on his chest and upper back. Unspecified medical attention was sought. A CBC was performed that indicated slightly low levels of white blood cells(3.3) and eosinophils(13). All other values were normal. The patient recovered. The patient did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash maculo-papular, White blood cell count decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old white male with no medical history or allergies who on 19-OCT-2006 at 14:30 was vaccinated in the right arm with a SC 0.5 mL dose of MMR (lot # 653338/0216F). Vaccination history was not available. There patient was illness at the time of vaccination. Vaccination history not available. On 31-OCT-2006 the patient reported developing a low fever(>100), muscle aches, and a red rash on his shoulders. It was also reported that the morning of 31-OCT-2006 the patient developed lymphadenopathy, post-cervical and post-auricular. He also developed a generalized maculo-papular rash over his face with a few patches on his chest and upper back. Unspecified medical attention was sought. A CBC was performed that indicated slightly low levels of white blood cells(3.3) and eosinophils(13). All other values were normal. The patient recovered. The patient did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Information has been received from a physician concerning a 17-year-old patient who on 19-MAR-1991 and 13-SEP-1993 was vaccinated with their first and second 0.5 ml doses of MMR II. On 06-NOV-2006 the patient underwent IGG titers and experienced rubella IGG titers less then 10. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Rubella antibody negative
Clinical narrative: Information has been received from a pharmacist concerning a 28-year-old female with no pertinent medical history and no drug reactions/allergies who was vaccinated "several times" with MMR II. She was noted to have completed her childhood vaccinations, and received one dose of MMR II prior to college in approximately 2006. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the titer was not adequate for protection. On 31-JUL-2006 the patient's titer came out at 14.2. An additional dose of MMR II was given on 30-AUG-2006, and on 20-OCT-2006 the patient's titer came out as 16.5. The patient had no symptoms. Unspecified medical attention was sought. No additional information was available. There was no product quality complaint. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Influenza like illness, Nausea
Clinical narrative: Information has been received from a 40 year old female pharmacist who on 16-AUG-2006 was vaccinated with a dose of MMR II (lot # 650348/0968R). Additional suspect vaccination included a dose of Recombivax HB. The next day, on 17-AUG-2006, the patient experienced nausea and flu-like symptoms. Medical attention was not sought. Subsequently, the patient recovered after one and a half days. There was no product quality complaint involved. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Information has been received from a health professional concerning a male who on an unspecified date was vaccinated with a dose of MMR. Subsequently for five days after vaccination, the patient experienced a stiff neck and headache. No further information was provided. There was no product quality complaint involved. Additional information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Dyspnoea, Erythema, Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse in an allergist's office and a physician concerning a 5 year old male with no known allergies or medical history who on 17-MAY-2006 was vaccinated SC in the deltoid with a second dose of MMR II (lot # 651110/1048R). Concomitant vaccination included a fifth dose of TRIPEDIA (lot # 017774CA) given IM in the deltoid. There was no illness at the time of vaccination. Approximately 15-20 minutes after vaccination the patient developed shortness of breath, hives, generalized pruritis and redness. The patient was also eating an orange lollipop (Dum-Dum) at the time. The patient presented to the ER and was treated with unspecified steroids and BENADRYL. ON an unspecified date the patient recovered. On 02-AUG-2006 the patient was seen by an allergist and was round to have a questionable reaction to the gelatin in the MMR II (lot # 651110/1048R) or to the lollipop. No further information was available. There was no product quality complaint involve.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Laboratory test
Clinical narrative: Information has been received from a 31 year old female Doctor of Pharmacy who "years ago" was vaccinated with MMR II. Subsequently, when a titer was drawn not "too long ago" the patient failed to seroconvert. The patient sought unspecified medical attention and received a booster dose. There was no PQC complaint. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, MMR
Symptoms: Irritability, Rash generalised, Rubella
Clinical narrative: Information has been received from a physician concerning a 15 month old female who on approximately 14-NOV-2006 was vaccinated with MMR II. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and influenza virus vaccine (unspecified). Subsequently, the patient experienced rubella rash all over the body, mostly on the trunk and a few on the face and was irritable after receiving the vaccine. The patient sought medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Allergy test negative, Anaphylactic reaction, Spirometry normal, Urticaria, Wheezing
Clinical narrative: Information has been received from a physician concerning a 4 year old male with mild asthma and no allergies who on an unspecified date in February 2006, was vaccinated with a 0.5 mL second dose of MMR II. Concomitant therapy included montelukast sodium (MSD) and cetirizine hydrochloride (ZYRTEC). It was noted that the patient received the first dose of MMR II "a few years ago" with no adverse reaction noted. Within a few minutes of receiving the vaccine, the patient had an anaphylactic reaction with hives and wheezing. He was treated with an injection of epinephrine (ADRENALINE) and with steroids. His condition resolved and no additional treatment was required. The patient was recently seen by the physician and tested negative was egg, chicken, and gelatin allergies. He was also negative for dust, pollen, and mold. A spirometry the week of 13-NOV-2006 was negative. A product quality complaint was not involved. Follow-up information was received from the physician who reported that he no longer had access to the patient's chart. He noted that the patient did have an immediate reaction to MMR II. The patient's experience was considered to be immediately life-threatening and an other important medical event by the physician. No further information is expected.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 14 month old daughter with no known medical history or allergies who in November 2006, was vaccinated with MMR. There was no concomitant medication. On 23-NOV-2006 the patient experienced a fever and a rash after receiving the vaccine. The patient started out with a fever that the mother thought was related to teething and then developed a rash. The patient recovered on 28-NOV-2006. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from an office receptionist concerning her 12 month old daughter with asthma who on 13-NOV-2006 was vaccinated with MMR II. The child developed a spot on her back shortly afterward. On 21-NOV-2006, the female was given by her mother a 4 mg oral granule sample of montelukast sodium (MSD) for asthma. It was reported that the child's rash seemed to increase to spots all over her entire body. The physician in this case was not the patient's physician and felt the rash was not related to montelukast but rather the MMR II administered on 13-NOV-2006. This physician advised that montelukast therapy be discontinued immediately. Patient outcome was unknown. Additional information is not expected. Unspecified medical attention was sought.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 12-month-old female who on 18-NOV-2006 was vaccinated with a 0.5 ml dose of MMR. On 18-NOV-2006, following vaccination, the patient developed a rash with blisters at the injection site and rash with blisters on the trunk. Unspecified medical attention was sought. No outcome information was reported. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Neck pain, Parotid gland enlargement
Clinical narrative: Information has been received from a physician concerning a 4.5 year old male who on 28-NOV-2006 was vaccinated with MMR. Concomitant therapy included PULMICORT. There was no medical history or allergies. On 30-NOV-2006 the patient experienced a swollen parotid gland, swollen submaxillary gland and sore neck 2 days after receiving the vaccine. The patient sought medical attention. Follow-up information was received from the physician who reported that the patient was doing well and the swollen parotid gland resolved over several days. No further treatment was needed. The patient recovered. No further information is available.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Allergy test positive, Asthma, Bronchospasm, Food allergy, Urticaria
Clinical narrative: Information has been received from a physician and a licensed visiting nurse concerning an 18 month old hispanic male with asthma and an egg allergy who at 11:03 on 29-NOV-2006 was vaccinated SC in the left leg with a "half dose" (also reported as 0.3) of MMR (lot # 649818/0729R) and was vaccinated with the other "half dose" (also reported as 0.3) of MMR (lot # 649818/0729R) at 11:30 on the same day. The patient returned to the clinic two hours later with a generalized urticarial rash all over his body and bronchospasm. The patient was given epinephrine and BENADRYL. On an unspecified date a serum multiallergen radioallergosorbent test showed a class IV egg allergy. On 30-NOV-2006 the patient recovered from the urticarial rash. On an unspecified date the patient recovered from bronchospasm. There was no product quality complaint involved. No other information was provided. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure, Eye irritation, Laboratory test normal
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female, with no medical history, who on 06-DEC-2006 got a small amount of MMR II (Lot# 654821/0805F) splashed into her right eye. Concomitant therapy included Naproxen and MIRENA. Initially, on 06-DEC-2006, the patient experienced burning. A medical assistant irrigated the affected eye and the eye was no longer burning. It was noted that the patient was doing fine and she went to see a health care professional. No product quality complaint was involved. No other information was provided. Additional information has been requested. Follow-up received 06/18/2008. Medical attention was sought and general labs were performed. No medical problems were reported. No further information is expected. This is in follow-up to report (s) previously submitted on 5/30/2007.  It has been determined that WAES #0612USA00966 is a duplicate of WAES #0612USA01077.  Therefore, WAES #0612USA00966 is being deleted from our files and the reports consolidated into WAES #0612USA01077.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure, Eye irritation, Laboratory test
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female, with no medical history, who on 06-DEC-2006 got a small amount of MMR II (Lot# 654821/0805F) splashed into her right eye. Concomitant therapy included Naproxen and MIRENA. Initially, on 06-DEC-2006, the patient experienced burning. A medical assistant irrigated the affected eye and the eye was no longer burning. It was noted that the patient was doing fine and she went to see a health care professional. No product quality complaint was involved. No other information was provided. Additional information has been requested. Follow-up received 06/18/2008. Medical attention was sought and general labs were performed. No medical problems were reported. No further information is expected. This is in follow-up to report (s) previously submitted on 5/30/2007.  It has been determined that WAES #0612USA00966 is a duplicate of WAES #0612USA01077.  Therefore, WAES #0612USA00966 is being deleted from our files and the reports consolidated into WAES #0612USA01077.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure, Eye irritation, Laboratory test normal
Clinical narrative: Information has been received from a health professional concerning a 23 year old female medical assistant who on 06-Dec-2006, was splashed in the right eye with MMR. Concomitant therapy included naproxen and MIRENA. The patient reported having a burning sensation in his eye initially. The patient irrigated the affected eye and it resolved. Medical attention was sought and general labs were performed. Follow-up information was received from the HR manager who reported that the vaccination was given by the medical assistant and some liquid from the syringe splashed into her eye as she retracted the needle. The eye was irrigated with opticlense for 5 minutes. The medical assistant was sent to the clinic for exam and labs. No medical problems were reported. No further information is expected.
Age: 23.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure, Eye irritation, Laboratory test
Clinical narrative: Information has been received from a health professional concerning a 23 year old female medical assistant who on 06-Dec-2006, was splashed in the right eye with MMR. Concomitant therapy included naproxen and MIRENA. The patient reported having a burning sensation in his eye initially. The patient irrigated the affected eye and it resolved. Medical attention was sought and general labs were performed. Follow-up information was received from the HR manager who reported that the vaccination was given by the medical assistant and some liquid from the syringe splashed into her eye as she retracted the needle. The eye was irrigated with opticlense for 5 minutes. The medical assistant was sent to the clinic for exam and labs. No medical problems were reported. No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a company representative concerning her friend's approximately 16 month old grandson who was vaccinated with MMR II. The patient developed a measles like rash several days after vaccination. The friend was unable to describe the type of rash. The patient sought medical attention. At the time of this report, the patient's rash persisted. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Parotid gland enlargement
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of MMR. One month after the patient developed a swollen parietal gland. At the time of the report the patient's swollen parietal gland persisted. Unspecified medical attention was sought. No product quality complaint was involved. The pharmacist did not have any other information about the patient. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Blood albumin decreased, Blood glucose increased, Blood immunoglobulin A, Blood immunoglobulin A increased, C-reactive protein increased
Clinical narrative: Information has been received from a pharmacist concerning a 40 year old female, with sleep apnea, hypertension, obesity and no allergies, and a history of migraine headaches, and a skull fracture on her left side twenty years earlier when she fell of a horse, who, on 14-DEC-2006, was vaccinated with a first intramuscular dose in the arm of MMR II (Lot# 654685/0987F). On 21-DEC-2006 the patient had a headache and numbness on her left side. The patient was seen in the emergency room on 22-DEC-2006 and was sent home. The patient had a plain computed axial tomography of her head on 22-DEC-2006, which was negative. The patient was back in the emergency room on 23-DEC-2006 with an increased headache and no problem swallowing. On the evening of 23-DEC-2006 the patient had numbness in both legs which was progressing to her face and mouth. The patient was then admitted to the hospital on 23-DEC-2006 with headache and diarrhea, plus numbness in her legs that was worsening. On 24-DEC-2006 the patient had a computed axial tomography scan of her head without and with contrast which was negative with no definite enhancing vascular mass or definite aneurysm. The patient was transferred to the intensive care unit on the third day of her stay. On 27-DEC-2006 the patient had an electromyography nerve conduction study done which showed evidence of generalized predominately motor demyelinating secondary axonal neuropathy. The patient was treated with intravenous immune globulin daily, for five days, followed by plasmapheresis for four days. The patient was then treated with plasmapheresis again for three days. The patient was started on physical therapy due to swallowing and speech difficulty. The patient never required ventilator assistance. A diagnosis of Guillain-Barre syndrome was made early in the patient's hospital stay. The patient was discharged from acute care on 12-JAN-2007. As of 24-JAN-2007 the patient remained in the hospital on a unit with a lower level of care for physical and speech therapy. The patient was able to move her arms and legs. She still had weakness in her legs, and was mostly in a wheelchair. Her facial muscles remained weak, however she had regained her swallowing ability. At the time of the report the patient had not recovered and her date of recovery was pending. No product quality complaint was involved. No other information was provided. The patient's Guillain-Barre syndrome was considered to be disabling by the reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: CSF cell count increased, CSF glucose increased, Computerised tomogram normal, Diarrhoea, Dysphagia
Clinical narrative: Information has been received from a pharmacist concerning a 40 year old female, with sleep apnea, hypertension, obesity and no allergies, and a history of migraine headaches, and a skull fracture on her left side twenty years earlier when she fell of a horse, who, on 14-DEC-2006, was vaccinated with a first intramuscular dose in the arm of MMR II (Lot# 654685/0987F). On 21-DEC-2006 the patient had a headache and numbness on her left side. The patient was seen in the emergency room on 22-DEC-2006 and was sent home. The patient had a plain computed axial tomography of her head on 22-DEC-2006, which was negative. The patient was back in the emergency room on 23-DEC-2006 with an increased headache and no problem swallowing. On the evening of 23-DEC-2006 the patient had numbness in both legs which was progressing to her face and mouth. The patient was then admitted to the hospital on 23-DEC-2006 with headache and diarrhea, plus numbness in her legs that was worsening. On 24-DEC-2006 the patient had a computed axial tomography scan of her head without and with contrast which was negative with no definite enhancing vascular mass or definite aneurysm. The patient was transferred to the intensive care unit on the third day of her stay. On 27-DEC-2006 the patient had an electromyography nerve conduction study done which showed evidence of generalized predominately motor demyelinating secondary axonal neuropathy. The patient was treated with intravenous immune globulin daily, for five days, followed by plasmapheresis for four days. The patient was then treated with plasmapheresis again for three days. The patient was started on physical therapy due to swallowing and speech difficulty. The patient never required ventilator assistance. A diagnosis of Guillain-Barre syndrome was made early in the patient's hospital stay. The patient was discharged from acute care on 12-JAN-2007. As of 24-JAN-2007 the patient remained in the hospital on a unit with a lower level of care for physical and speech therapy. The patient was able to move her arms and legs. She still had weakness in her legs, and was mostly in a wheelchair. Her facial muscles remained weak, however she had regained her swallowing ability. At the time of the report the patient had not recovered and her date of recovery was pending. No product quality complaint was involved. No other information was provided. The patient's Guillain-Barre syndrome was considered to be disabling by the reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Headache, Hypoaesthesia, Intensive care
Clinical narrative: Information has been received from a pharmacist concerning a 40 year old female, with sleep apnea, hypertension, obesity and no allergies, and a history of migraine headaches, and a skull fracture on her left side twenty years earlier when she fell of a horse, who, on 14-DEC-2006, was vaccinated with a first intramuscular dose in the arm of MMR II (Lot# 654685/0987F). On 21-DEC-2006 the patient had a headache and numbness on her left side. The patient was seen in the emergency room on 22-DEC-2006 and was sent home. The patient had a plain computed axial tomography of her head on 22-DEC-2006, which was negative. The patient was back in the emergency room on 23-DEC-2006 with an increased headache and no problem swallowing. On the evening of 23-DEC-2006 the patient had numbness in both legs which was progressing to her face and mouth. The patient was then admitted to the hospital on 23-DEC-2006 with headache and diarrhea, plus numbness in her legs that was worsening. On 24-DEC-2006 the patient had a computed axial tomography scan of her head without and with contrast which was negative with no definite enhancing vascular mass or definite aneurysm. The patient was transferred to the intensive care unit on the third day of her stay. On 27-DEC-2006 the patient had an electromyography nerve conduction study done which showed evidence of generalized predominately motor demyelinating secondary axonal neuropathy. The patient was treated with intravenous immune globulin daily, for five days, followed by plasmapheresis for four days. The patient was then treated with plasmapheresis again for three days. The patient was started on physical therapy due to swallowing and speech difficulty. The patient never required ventilator assistance. A diagnosis of Guillain-Barre syndrome was made early in the patient's hospital stay. The patient was discharged from acute care on 12-JAN-2007. As of 24-JAN-2007 the patient remained in the hospital on a unit with a lower level of care for physical and speech therapy. The patient was able to move her arms and legs. She still had weakness in her legs, and was mostly in a wheelchair. Her facial muscles remained weak, however she had regained her swallowing ability. At the time of the report the patient had not recovered and her date of recovery was pending. No product quality complaint was involved. No other information was provided. The patient's Guillain-Barre syndrome was considered to be disabling by the reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Lymphocyte count abnormal, Muscular weakness, Neuropathy, Neutrophil count increased, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a pharmacist concerning a 40 year old female, with sleep apnea, hypertension, obesity and no allergies, and a history of migraine headaches, and a skull fracture on her left side twenty years earlier when she fell of a horse, who, on 14-DEC-2006, was vaccinated with a first intramuscular dose in the arm of MMR II (Lot# 654685/0987F). On 21-DEC-2006 the patient had a headache and numbness on her left side. The patient was seen in the emergency room on 22-DEC-2006 and was sent home. The patient had a plain computed axial tomography of her head on 22-DEC-2006, which was negative. The patient was back in the emergency room on 23-DEC-2006 with an increased headache and no problem swallowing. On the evening of 23-DEC-2006 the patient had numbness in both legs which was progressing to her face and mouth. The patient was then admitted to the hospital on 23-DEC-2006 with headache and diarrhea, plus numbness in her legs that was worsening. On 24-DEC-2006 the patient had a computed axial tomography scan of her head without and with contrast which was negative with no definite enhancing vascular mass or definite aneurysm. The patient was transferred to the intensive care unit on the third day of her stay. On 27-DEC-2006 the patient had an electromyography nerve conduction study done which showed evidence of generalized predominately motor demyelinating secondary axonal neuropathy. The patient was treated with intravenous immune globulin daily, for five days, followed by plasmapheresis for four days. The patient was then treated with plasmapheresis again for three days. The patient was started on physical therapy due to swallowing and speech difficulty. The patient never required ventilator assistance. A diagnosis of Guillain-Barre syndrome was made early in the patient's hospital stay. The patient was discharged from acute care on 12-JAN-2007. As of 24-JAN-2007 the patient remained in the hospital on a unit with a lower level of care for physical and speech therapy. The patient was able to move her arms and legs. She still had weakness in her legs, and was mostly in a wheelchair. Her facial muscles remained weak, however she had regained her swallowing ability. At the time of the report the patient had not recovered and her date of recovery was pending. No product quality complaint was involved. No other information was provided. The patient's Guillain-Barre syndrome was considered to be disabling by the reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Plasmapheresis, Red blood cell abnormality, Speech disorder, White blood cell count increased
Clinical narrative: Information has been received from a pharmacist concerning a 40 year old female, with sleep apnea, hypertension, obesity and no allergies, and a history of migraine headaches, and a skull fracture on her left side twenty years earlier when she fell of a horse, who, on 14-DEC-2006, was vaccinated with a first intramuscular dose in the arm of MMR II (Lot# 654685/0987F). On 21-DEC-2006 the patient had a headache and numbness on her left side. The patient was seen in the emergency room on 22-DEC-2006 and was sent home. The patient had a plain computed axial tomography of her head on 22-DEC-2006, which was negative. The patient was back in the emergency room on 23-DEC-2006 with an increased headache and no problem swallowing. On the evening of 23-DEC-2006 the patient had numbness in both legs which was progressing to her face and mouth. The patient was then admitted to the hospital on 23-DEC-2006 with headache and diarrhea, plus numbness in her legs that was worsening. On 24-DEC-2006 the patient had a computed axial tomography scan of her head without and with contrast which was negative with no definite enhancing vascular mass or definite aneurysm. The patient was transferred to the intensive care unit on the third day of her stay. On 27-DEC-2006 the patient had an electromyography nerve conduction study done which showed evidence of generalized predominately motor demyelinating secondary axonal neuropathy. The patient was treated with intravenous immune globulin daily, for five days, followed by plasmapheresis for four days. The patient was then treated with plasmapheresis again for three days. The patient was started on physical therapy due to swallowing and speech difficulty. The patient never required ventilator assistance. A diagnosis of Guillain-Barre syndrome was made early in the patient's hospital stay. The patient was discharged from acute care on 12-JAN-2007. As of 24-JAN-2007 the patient remained in the hospital on a unit with a lower level of care for physical and speech therapy. The patient was able to move her arms and legs. She still had weakness in her legs, and was mostly in a wheelchair. Her facial muscles remained weak, however she had regained her swallowing ability. At the time of the report the patient had not recovered and her date of recovery was pending. No product quality complaint was involved. No other information was provided. The patient's Guillain-Barre syndrome was considered to be disabling by the reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an adult female who in October 2006 was vaccinated with a dose of MMR II. In October 2006, the patient and developed redness, swelling, and itching at the injection site. The patient was seen in the physician's office three days after the vaccination for these symptoms and was treated with an unspecified antibiotic. No laboratory or diagnostic studies were performed. The patient outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Blood thyroid stimulating hormone, Dizziness, Headache, Hypoaesthesia, Malaise
Clinical narrative: Information has been received from a physician concerning a 37 (also reported as 38) year old female graduate school student with a history of an "upset stomach" and some muscle aches (also reported as no significant past medical history including no history of neurologic disease or immune compromise) who on 19-DEC-2006 was vaccinated in the arm with a dose of MMR (lot # 654543/0699F) after laboratory studies performed showed positive measles and mumps titers but negative rubella titer. There was no concomitant medication. There was no illness at the time of vaccination. On 21-DEC-2006 (also reported as 4 days after vaccination), the patient developed numbness in her right leg (from the thigh through the foot) on the contralateral side to which the vaccine was administered. The patient also reported tingling in the right leg including the anterolateral thigh which increased with standing or lying down. Subsequently the patient developed nausea (which increased between the time of onset and 12-JAN-2007) and diarrhea (1 large explosive bowel movement). It was also reported that the patient had intermittent buzzing in the right ear, frontal headaches for 24 hours/day (also reported as 24 hours), and some muscle aches in the shoulders and thighs. The patient also "felt sick" with dizziness and was "febrile" although the health care provider was not sure if her temperature was taken (the only temperature reported was 98.3). The patient had no back pain, sciatica or rash. ON 12-JAN-2007 a complete blood count, complete metabolic panel and thyroid stimulation hormone level were normal. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient had no known adverse events following prior vaccination. No additional information provided. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Metabolic function test normal, Mumps antibody test positive, Myalgia, Nausea
Clinical narrative: Information has been received from a physician concerning a 37 (also reported as 38) year old female graduate school student with a history of an "upset stomach" and some muscle aches (also reported as no significant past medical history including no history of neurologic disease or immune compromise) who on 19-DEC-2006 was vaccinated in the arm with a dose of MMR (lot # 654543/0699F) after laboratory studies performed showed positive measles and mumps titers but negative rubella titer. There was no concomitant medication. There was no illness at the time of vaccination. On 21-DEC-2006 (also reported as 4 days after vaccination), the patient developed numbness in her right leg (from the thigh through the foot) on the contralateral side to which the vaccine was administered. The patient also reported tingling in the right leg including the anterolateral thigh which increased with standing or lying down. Subsequently the patient developed nausea (which increased between the time of onset and 12-JAN-2007) and diarrhea (1 large explosive bowel movement). It was also reported that the patient had intermittent buzzing in the right ear, frontal headaches for 24 hours/day (also reported as 24 hours), and some muscle aches in the shoulders and thighs. The patient also "felt sick" with dizziness and was "febrile" although the health care provider was not sure if her temperature was taken (the only temperature reported was 98.3). The patient had no back pain, sciatica or rash. ON 12-JAN-2007 a complete blood count, complete metabolic panel and thyroid stimulation hormone level were normal. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient had no known adverse events following prior vaccination. No additional information provided. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Information has been received from a physician concerning a 37 (also reported as 38) year old female graduate school student with a history of an "upset stomach" and some muscle aches (also reported as no significant past medical history including no history of neurologic disease or immune compromise) who on 19-DEC-2006 was vaccinated in the arm with a dose of MMR (lot # 654543/0699F) after laboratory studies performed showed positive measles and mumps titers but negative rubella titer. There was no concomitant medication. There was no illness at the time of vaccination. On 21-DEC-2006 (also reported as 4 days after vaccination), the patient developed numbness in her right leg (from the thigh through the foot) on the contralateral side to which the vaccine was administered. The patient also reported tingling in the right leg including the anterolateral thigh which increased with standing or lying down. Subsequently the patient developed nausea (which increased between the time of onset and 12-JAN-2007) and diarrhea (1 large explosive bowel movement). It was also reported that the patient had intermittent buzzing in the right ear, frontal headaches for 24 hours/day (also reported as 24 hours), and some muscle aches in the shoulders and thighs. The patient also "felt sick" with dizziness and was "febrile" although the health care provider was not sure if her temperature was taken (the only temperature reported was 98.3). The patient had no back pain, sciatica or rash. ON 12-JAN-2007 a complete blood count, complete metabolic panel and thyroid stimulation hormone level were normal. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient had no known adverse events following prior vaccination. No additional information provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 28-year-old female with no medical history or allergies, who in 2001 was vaccinated with a dose of MMR II. There was no concomitant medication. On 20-OCT-2006 the patient had a mumps titer drawn, it was reported that the titer was 0.13. Unspecified medical attention was sought and the patient was vaccinated with a dose of MMR II due to the low mumps titer and a low Varicella titer, less than 0.9. (WAES# 0703USA05492). It was reported that the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: MMR
Symptoms: High-pitched crying, Personality change, Photosensitivity reaction
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old patient who in 2005 ("two years ago"); at seven years of age, was vaccinated with a first dose of MMR II. Subsequent to being vaccinated the patient developed an unspecified personality change, photosensitivity and a high pitched cry. The patient recovered from the reported events at an unspecified time. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered pharmacist (R.Ph.) concerning a 15-month-old male with no pertinent medical history or allergies, who on 11-JAN-2007 was vaccinated with a dose of MMR II. Concomitant therapy included vitamins with fluoride. On 17-JAN-2007 the patient experienced fever of 101 degrees Fahrenheit. He was treated with TYLENOL. The child also had a fever of 103 degrees Fahrenheit that started on the evening of 18-JAN-2007 and lasted through the night until about 3 am. The fever at one point had reached 104 degrees Fahrenheit. He was treated with TYLENOL. The child had another fever of 101 degrees Fahrenheit that occurred in the late afternoon of 19-JAN-2007 and he was given TYLENOL again. The child was fever free since 20-JAN-2007. On 22-JAN-2007 the child developed a rash that was barely noticeable on the head and torso. The physician's office instructed to give the child BENADRYL as needed. Unspecified medical attention was sought but no laboratory or diagnostic tests were performed. At the time of this report, the patient had not recovered. No product quality complaints were involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who received a total of 3 doses of MMR and has a negative titer for measles antibodies. Medical attention was sought. Follow-up information was received from the patient who reported that she had seroconverted on everything except has negative titer for German measles after receiving the 4th dose of MMR. Titers were drawn in 2001, 2004 and approximately February 2007. The patient received 4 doses of Hepatitis B vaccine in order to seroconvert. A titer was drawn in 2001 and was negative so she received a booster, her titer was checked again and was positive. At the time of the report the patient had not recovered.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 28-OCT-1988 and 19-MAR-1992 was vaccinated with a first and second dose of MMR II. "Recently", in approximately January 2007, the patient had a negative antibody test for measles. Antibody levels for mumps and rubella were satisfactory. The reason for testing was not provided. The vaccine was not administered at the present office and no further records are available. Unspecified medical attention was sought. There is no other information to report.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning an approximately 14 month old male who on 24-MAR-2003 was vaccinated SC with a 0.5ml first dose of MMR II. Subsequently, shortly after his first vaccine, the patient experienced a rash over entire body and fever of 104 F. Subsequently, the patient recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Electroencephalogram, Febrile convulsion, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no known history who on 16-FEB-2005 was vaccinated with a first of MMR II. On 11-AUG-2005 he was vaccinated IM with a second dose of MMR II (lot # 649241/0032R). It was reported that the child experienced 2 convulsions (1 febrile and 1 non febrile) several months after receiving his second dose of vaccine. The child experienced a febrile seizure on 01-JAN-2006 (previously reported as 01-FEB-2006). On 30-MAY-2006 the patient experienced a non febrile seizure. The child was seen by a neurologist and seems to be fine, but the physician feels his present status is uncertain. An EEG was done on an unknown date and results were not reported. The neurologist report was not available. Upon internal review, convulsions were considered to be other important medical events. Additional information has been requested.