chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Rsh began at injection site afternoon after receiving second vaccine dose. Scattered wheals, and site tenderness that evening. Fever, restless sleep during night. Joint aches, tender lymph nodes in neck next am, rash decreased. Rash returned evening after vaccine given; rash on chest, L arm, scrotum, bilateral legs/feet with itching, wheals. Possible low grade temp. Rash much improved following day. Some muscle aches, tender enlarged lymph nodes in neck, groin (bilaterally), not axillary. Given Motrin 600mg to take q 6-8 hrs for next 2-3 days with food. reported to HC 1-25-08 lip swelling and lip numbness on 1-21-2008 evening, denied other symptoms, took Claritin, resolved in am. Recalled at that point similar episode of lip swelling 1/13/08 after vaccine dose on 1/9/2008. Referred to allergist prior to giving 3rd dose. Employee (who is intern/guest researcher) decided to decline 3rd dose at this point as vaccine is not essential to job. Advised to discuss with chief of rabies branch/supervisor and would follow up with allergist for possible pre-treatment prior to 3rd vaccine dose.
Age: 68.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The following day after receiving the tetanus vaccine pt. developed redness in her left arm that has spread to her elbow. It is tender and warm on palpation. Saw PA-C in the ER Urgent care and was placed on Keflex mg 4 times a day for 7 days on 1/26/08.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Pain, Vomiting
Clinical narrative: Pt. received 2nd HPV dose, vomited after leaving facility, felt pain in side and felt "cloudy headed". Returned to Health dept. for observation. Pulse was 88, BP was 120/60, O2 was 98%. Pt. did not vomit anymore but felt faint for 5 minutes. Pt. left health dept. walking, talking o.k. Pt. was at store when she vomited.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Cough, Dizziness, Dysphonia
Clinical narrative: UPON TAKING THE FLU VACCINE, I BECAME ILL, BECAME HOARSE, DIZZY AND WEAK, EXPERIENCED A FEVER AND CHILLS.  MY THROAT HURT-I COUGHED FOR SEVERAL DAYS, MY HEAD HURT, MY BODY ACHED AND I WAS UNABLE TO GET A GOOD NIGHT'S REST.  ULTIMATELY I CAME TO MEDICAL AND WAS GIVEN SEVERAL PRESCRIPTIONS AND WAS 24 SICK-IN-QUARTERS.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Insomnia, Malaise, Pain, Pharyngolaryngeal pain
Clinical narrative: UPON TAKING THE FLU VACCINE, I BECAME ILL, BECAME HOARSE, DIZZY AND WEAK, EXPERIENCED A FEVER AND CHILLS.  MY THROAT HURT-I COUGHED FOR SEVERAL DAYS, MY HEAD HURT, MY BODY ACHED AND I WAS UNABLE TO GET A GOOD NIGHT'S REST.  ULTIMATELY I CAME TO MEDICAL AND WAS GIVEN SEVERAL PRESCRIPTIONS AND WAS 24 SICK-IN-QUARTERS.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: UPON TAKING THE FLU VACCINE, I BECAME ILL, BECAME HOARSE, DIZZY AND WEAK, EXPERIENCED A FEVER AND CHILLS.  MY THROAT HURT-I COUGHED FOR SEVERAL DAYS, MY HEAD HURT, MY BODY ACHED AND I WAS UNABLE TO GET A GOOD NIGHT'S REST.  ULTIMATELY I CAME TO MEDICAL AND WAS GIVEN SEVERAL PRESCRIPTIONS AND WAS 24 SICK-IN-QUARTERS.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV5
Symptoms: Abdominal pain, Constipation, Crying, Decreased appetite, Flatulence
Clinical narrative: Constipation, abdominal cramping, excess gas, inconsolable crying, decrease in appetite, insomnia. The symptom kept building for two weeks until he went almost 24 hours without sleep. Then suddenly things started to get better. We had to administer several suppositories after 6 days of no bowel movements. We also gave him gas drops (Mylicon) to try to relieve his discomfort.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV5
Symptoms: Insomnia, Intestinal functional disorder, X-ray
Clinical narrative: Constipation, abdominal cramping, excess gas, inconsolable crying, decrease in appetite, insomnia. The symptom kept building for two weeks until he went almost 24 hours without sleep. Then suddenly things started to get better. We had to administer several suppositories after 6 days of no bowel movements. We also gave him gas drops (Mylicon) to try to relieve his discomfort.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Temperature of 105 per mother's report, following the administration of the DTaP, IPV, Hib, PCV-7, and rotavirus vaccines.  Also had temp of 103 after 2 month vaccinations, but thought to be within normal limits.  Fever resolved in a day per mother.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Dehydration, Haematochezia, Lethargy, Listless, Pallor
Clinical narrative: Vomiting all intake. Listless, Lethargic, Pale. Dehydrated. Finally a bloody diaper.  02/05/2008 Vax record recd from PCP and TC with PCP.  Date of only Rotavirus vax given noted as 7/9/1999.  WCC (2 month) on 7/9/1999 with normal exam except scaly seborrhea noted. WCC 8/31/99 with normal exam. OV 9/20/99 with c/o vomiting all day. PE (+) for Lethargy, depressed fontanelle, and a LLQ mass felt.  Sent for admission to hospital with Assessment: AGE, ? malrotation, ? volvulus.  F/U 9/23/99-child admitted with currant jelly stools.  DX Intussusception.  Reduced by Barium enema. 02/19/2008 MR received for DOS 9/20-21/1999 with D/C DX:  Intussusception. Infant presented and treated as above.   D/C home next day
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Vomiting, X-ray
Clinical narrative: Vomiting all intake. Listless, Lethargic, Pale. Dehydrated. Finally a bloody diaper.  02/05/2008 Vax record recd from PCP and TC with PCP.  Date of only Rotavirus vax given noted as 7/9/1999.  WCC (2 month) on 7/9/1999 with normal exam except scaly seborrhea noted. WCC 8/31/99 with normal exam. OV 9/20/99 with c/o vomiting all day. PE (+) for Lethargy, depressed fontanelle, and a LLQ mass felt.  Sent for admission to hospital with Assessment: AGE, ? malrotation, ? volvulus.  F/U 9/23/99-child admitted with currant jelly stools.  DX Intussusception.  Reduced by Barium enema. 02/19/2008 MR received for DOS 9/20-21/1999 with D/C DX:  Intussusception. Infant presented and treated as above.   D/C home next day
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Deafness transitory, Feeling abnormal, Hyperhidrosis, Pallor, Unresponsive to stimuli
Clinical narrative: 5 minutes following vaccine administration, patient began "feeling funny" she walked to the waiting room where she sat down and "the room got blurry and then my hearing went out". Patient was unresponsive x 5-10 seconds. She was breathing during this episode. When she woke, she was diaphoretic and pale. We moved her to an exam room and laid her down. After 15 minutes, we attemped to sit her up, where she became pale and diaphoretic again. We then laid her down and attempted to get her up two more times where the same episode occurred again. We kept her in the clinic for 1 1/2 hours for observation and eventually wheeled her to the car. Mom was instructed to keep observing her and bring her to the ER if necessary. Mom reports today she is still a little shaky, but she is doing okay.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Vision blurred
Clinical narrative: 5 minutes following vaccine administration, patient began "feeling funny" she walked to the waiting room where she sat down and "the room got blurry and then my hearing went out". Patient was unresponsive x 5-10 seconds. She was breathing during this episode. When she woke, she was diaphoretic and pale. We moved her to an exam room and laid her down. After 15 minutes, we attemped to sit her up, where she became pale and diaphoretic again. We then laid her down and attempted to get her up two more times where the same episode occurred again. We kept her in the clinic for 1 1/2 hours for observation and eventually wheeled her to the car. Mom was instructed to keep observing her and bring her to the ER if necessary. Mom reports today she is still a little shaky, but she is doing okay.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Patient presented the next day with cellulitis at injection site and fever of 100.0.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Abasia, Arthralgia, Rash vesicular
Clinical narrative: On Friday 1/25/08 at approx. 11am patient developed rash with hive-like component on both inner thighs and some on upper thighs.  The rash later developed into chicken pox-looking then scabbed over.  Also, developed pain in his hip joints that progressed to severe pain leading him to go to bed, unable to walk due to the pain.  By approx. 4pm on Sunday 1/27/08, pain had subsided completely and patient returned to ambulatory status.  By Monday, 1/28/08 at approx 1pm, only a small amount of rash is still present.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Neck pain, Oedema peripheral
Clinical narrative: She recieved a flu shot 10/25/7 in my office. She has reported constant pain in the arm originating in the area of the injection since.  She saysd that it was very bad for the first 2 months but that it is getting better.  She felt that the area under her arm was also swollen (she thought from lymphnodes) and that the pain starts inher deltoid and it is "piercing".  She can have pain into her neck and she has some decrease range of motion in the shoulder now. She is very certain that this started after her flu shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus
Clinical narrative: ARM SWOLLEN AND TURNED HARD AND RED. SEVERE ITCHING NO REPORTS OF HIVES OR BREATHING PROBLEMS.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PPV
Symptoms: Hypoglycaemia, Pyrexia
Clinical narrative: Fever. Hypoglycemia-Hospitalized with IVF- D10. 1/31/2008 MR received for DOS 1/16-22/2008 with chief complaint of Fever (no D/C DX on D/C Summary). Pt had apparently had some blood sugars below 80 at home 2' to fever and was admitted for supportive care.  Txd with D10 IV.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Developmental delay, Dyskinesia, Feeling abnormal, Gastrooesophageal reflux disease, Somnolence
Clinical narrative: eye starring, Lip smacking, rhythmic movements of upper extremity 2/8/08-records received-HX seizures previously controlled with medication. Seen for multiple seizure acitivty, patient drowsy and dazed afterward.Tonic clonic movements. 3/18/08-records received for 1/12-2/5/08-DC DX: Seizures. Gastroesphageal reflux disease.Admitted with new onset of seizure disorder. Intractable seizures with prolonged periods of somnolence. Left sided exotropia with decreased visual acuity. 1/20/2010 Patient had immunizations. Then noted seizures/behavior abnormal which later diagnosed as seizures. Has developmental delays. No longer in our practice.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Staring, Tardive dyskinesia, Tonic clonic movements, Visual acuity reduced
Clinical narrative: eye starring, Lip smacking, rhythmic movements of upper extremity 2/8/08-records received-HX seizures previously controlled with medication. Seen for multiple seizure acitivty, patient drowsy and dazed afterward.Tonic clonic movements. 3/18/08-records received for 1/12-2/5/08-DC DX: Seizures. Gastroesphageal reflux disease.Admitted with new onset of seizure disorder. Intractable seizures with prolonged periods of somnolence. Left sided exotropia with decreased visual acuity. 1/20/2010 Patient had immunizations. Then noted seizures/behavior abnormal which later diagnosed as seizures. Has developmental delays. No longer in our practice.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted after receiving Gardasil injection.  Pt. given ammonia capsule and was aroused easily.  Pt. color improved and given crackers and Sprite.  Pt. alert and orinted. Pt. advised to remain in clinic for 20 minutes and then left with caretaker.
Age: 1.52
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Local reaction, Skin lesion
Clinical narrative: Patient was given a varicella on 1-2-08. Patient came in on 1-18-08 with complaint of spot on arm. Patient diagnosed with local reaction due to Varicella vaccine.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Patient experienced pain in R shoulder and R arm within 5 days after injection. Pain radiated to neck.  No erythema or swelling noted at site. Patient continues to have pain and decreased range of motion despite physical therapy, anti-inflammatories and pain meds.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Patient experienced pain in R shoulder and R arm within 5 days after injection. Pain radiated to neck.  No erythema or swelling noted at site. Patient continues to have pain and decreased range of motion despite physical therapy, anti-inflammatories and pain meds.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Patient experienced pain in R shoulder and R arm within 5 days after injection. Pain radiated to neck.  No erythema or swelling noted at site. Patient continues to have pain and decreased range of motion despite physical therapy, anti-inflammatories and pain meds.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Rotator cuff syndrome
Clinical narrative: Patient experienced pain in R shoulder and R arm within 5 days after injection. Pain radiated to neck.  No erythema or swelling noted at site. Patient continues to have pain and decreased range of motion despite physical therapy, anti-inflammatories and pain meds.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: Immediately following my flu shot, my entire arm hurt from shoulder down to tips of fingers. It was so painful that I had to go back to the nurse that administered it for help. She was already gone but another nurse advised me to put ice on it and take Acetaminophen (Tylenol), but Ibuprofen since Ibuprofen was found to weaken the serum. I took 800 mg. of Tylenol, but it did not help. After an hour, it still hurt so much that I had to go to our EMS office (in my bldg.) and there I found an RN who gave me an ice pack. I held it on the spot where the shot was given until I had to head home. My arm was painful for that entire day. I then decided to take Ibuprofen which I took 800 mg. That finally relieved my arm pain, until it wore off, then I took another 800 mg., which finally stopped it.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7cm area of swelling, redness, tenderness, and calor overlying deltoid at injection site
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received for the Merck Pregnancy Registry from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot# unknown).  "The patient came in on 24-DEC-2007 to receive a dose of Gardasil, but when she arrived at the office they found out the patient was pregnant, but the date of gestation was unspecified by the reporter.  The nurse reported that they did not give the dose of Gardasil the patient was supposed to receive another dose of Gardasil, but what dose was unspecified by the reporter.  No further AE information was given.  Medical attention was sought.  The estimated date of delivery was unknown.  Follow-up information was received.  The patient's name was updated.  It was reported that the patient had a miscarriage.  The physician does not think it was caused by Gardasil.  Upon internal review miscarriage is considered to be an other medical event (OME).  Follow-up information was received on from a registered nurse on 22-JAN-2008.  It was reported that the patient did not have a miscarriage it was planned termination of the fetus by the patient.  Upon internal review abortion induced is considered to be an other medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Blood urine present, Chest pain, Chills, Flank pain, Micturition urgency
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no medical history, who on 02-JAN-2008 was vaccinated with a first dose of Gardasil (Lot# 659653/1448U).  Concomitant suspect vaccinations included Varivax.  Other concomitant vaccinations included HAVRIX.  On 03-JAN-2008 the patient experienced urinary urgency and frequency.  On 03-JAN-2008 a urinary analysis was performed and showed a trace of blood in the urine.  The patient improved within 48 hours.  The patient then experienced right flank pain, chest pain with chills, and no fever.  On 10-JAN-2008 the patient was admitted to the hospital and experienced nausea and loss of weight.  The patient was better by 11-JAN-2008 and was released from the hospital.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.  03/03/2008 MR received for DOS 01/6-10/2008 with DX: Pyelonephritis. Pt presented to ED with c/o sudden onset flank pain (R chest, flank, back).  Pt txd x 3 days for UTI sx of frequency and urgency). On abx.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Nausea, Pollakiuria, Urine analysis abnormal, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no medical history, who on 02-JAN-2008 was vaccinated with a first dose of Gardasil (Lot# 659653/1448U).  Concomitant suspect vaccinations included Varivax.  Other concomitant vaccinations included HAVRIX.  On 03-JAN-2008 the patient experienced urinary urgency and frequency.  On 03-JAN-2008 a urinary analysis was performed and showed a trace of blood in the urine.  The patient improved within 48 hours.  The patient then experienced right flank pain, chest pain with chills, and no fever.  On 10-JAN-2008 the patient was admitted to the hospital and experienced nausea and loss of weight.  The patient was better by 11-JAN-2008 and was released from the hospital.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.  03/03/2008 MR received for DOS 01/6-10/2008 with DX: Pyelonephritis. Pt presented to ED with c/o sudden onset flank pain (R chest, flank, back).  Pt txd x 3 days for UTI sx of frequency and urgency). On abx.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Chest pain, Chills, Flank pain, Micturition urgency, Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no medical history, who on 02-JAN-2008 was vaccinated with a first dose of Gardasil (Lot# 659653/1448U).  Concomitant suspect vaccinations included Varivax.  Other concomitant vaccinations included HAVRIX.  On 03-JAN-2008 the patient experienced urinary urgency and frequency.  On 03-JAN-2008 a urinary analysis was performed and showed a trace of blood in the urine.  The patient improved within 48 hours.  The patient then experienced right flank pain, chest pain with chills, and no fever.  On 10-JAN-2008 the patient was admitted to the hospital and experienced nausea and loss of weight.  The patient was better by 11-JAN-2008 and was released from the hospital.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.  03/03/2008 MR received for DOS 01/6-10/2008 with DX: Pyelonephritis. Pt presented to ED with c/o sudden onset flank pain (R chest, flank, back).  Pt txd x 3 days for UTI sx of frequency and urgency). On abx.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Pollakiuria
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no medical history, who on 02-JAN-2008 was vaccinated with a first dose of Gardasil (Lot# 659653/1448U).  Concomitant suspect vaccinations included Varivax.  Other concomitant vaccinations included HAVRIX.  On 03-JAN-2008 the patient experienced urinary urgency and frequency.  On 03-JAN-2008 a urinary analysis was performed and showed a trace of blood in the urine.  The patient improved within 48 hours.  The patient then experienced right flank pain, chest pain with chills, and no fever.  On 10-JAN-2008 the patient was admitted to the hospital and experienced nausea and loss of weight.  The patient was better by 11-JAN-2008 and was released from the hospital.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.  03/03/2008 MR received for DOS 01/6-10/2008 with DX: Pyelonephritis. Pt presented to ED with c/o sudden onset flank pain (R chest, flank, back).  Pt txd x 3 days for UTI sx of frequency and urgency). On abx.
Age: 12.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Cerebral haemorrhage, Head injury, Syncope
Clinical narrative: Information has been received from a business manager for a physician concerning a 12 year old female who on an unknown date was vaccinated with her first dose of Gardasil.  It was reported that the patient received four injections (therapy unspecified) at that time.  Subsequently on an unknown date the patient experienced syncope, hit her head and cerebral bleeding and was hospitalized.  It was reported that subsequently, on an unknown date, the patient had full recovery.  This is one of several reports received from the same source.  No further information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Wound, Wrong technique in drug usage process
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 12-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. On 09-JAN-2008 the patient was vaccinated intramuscularly in the left upper arm with a 0.5 ml second dose of Gardasil (659055/1522U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 09-JAN-2008 the patient developed pain to the arm right after receiving the injection. The pain radiates down the left arm and has gotten worse since the injection. The patient called and was seen by her family physician, who told her that the injection was given improperly into the tendon or ligament causing a puncture wound. The patient last saw the reporting physician on 14-JAN-2008. At that time there was no bruising noted at the site. The patient was not able to lift her left arm. The patient has been using TYLENOL,  CELECOXIB, and heat as prescribed by her family physician. The patient's outcome was reported as not recovered. The patient's mother is requesting an MRI of the left arm, it has not been ordered at this time. There was no product quality complaint involved. Follow up information was received from the licensed practical nurse indicating that she would consider the patient to have temporary incapacity of her arm and therefore felt that the events were disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no drug reactions/allergies who in March 2007, was vaccinated with Gardasil (lot# unknown).  There was no concomitant medication.  In May 2007, the patient received her second dose of Gardasil (lot# unknown).  The caller reported that on 30-JUL-2007 the patient experienced a miscarriage when she was 2 and 1/2 months pregnant.  Caller was not aware as to when the patient learned about her pregnancy.  Caller reported that the patient missed the third dose of Gardasil vaccine which was supposed to be given to her in "October 2007".  The patient's LMP was approximately 22-OCT-2007 and is now 3 months pregnant again.  The patient's estimated date of delivery is "July 2008".  No further information was provided.  Upon internal review miscarriage is considered to be an other medical event (OME).  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Stomatitis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with 0.5 ml Gardasil (lot and batch number not provided).  Subsequently the patient experienced loss of vision and stomatitis.  The patient was reported to be recovering.  Upon internal review vision loss was considered to be an other important medical event.  No further information is available.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Blood test abnormal, Brain damage, CSF test abnormal, Inappropriate schedule of drug administration, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 9-year-old female who in approximately 2004 "about 4 years ago" was inadvertently given MMR II "twice within one week apart" when she was 5 years old. On an unspecified date, it was reported the patient may have developed subacute sclerosing panencephalitis due to the high dose of MMR II. It was also reported the patient is terminally ill and has severe brain damage. On an unspecified date the patient had the following diagnostic labs performed: "MMR positive in the serum and cerebrospinal fluid". At the time of the report the patient's status was not recovered. A product quality complaint was not involved. The adverse events reported were considered to be disabling, life threatening and required hospitalization. Additional information has been requested. 4/28/08-records received for DOS:12/18/07-2/14/08-DC DX: Progressive encephalopathy diagnosis secondary to subacute sclerosing panecephalitis (SSPE). Treated with plasmapheresis for progressive neurological deterioration with decreased motor skills with inability to walk and swallow difficulty.  New on set seizure disorder. G tube placement Treated with IVIG.  During IVIG treatment developed tremor, hypertonicity and drooling. Became unresponsive to verbal tactile stimulus only minimal withdrawal to painful stimulus, comatose state, nonambulatory with positive clonus, hypertonic. Transferred to chronic care facility.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, Rubella antibody positive, Subacute sclerosing panencephalitis, Terminal state
Clinical narrative: Information has been received from a physician concerning a 9-year-old female who in approximately 2004 "about 4 years ago" was inadvertently given MMR II "twice within one week apart" when she was 5 years old. On an unspecified date, it was reported the patient may have developed subacute sclerosing panencephalitis due to the high dose of MMR II. It was also reported the patient is terminally ill and has severe brain damage. On an unspecified date the patient had the following diagnostic labs performed: "MMR positive in the serum and cerebrospinal fluid". At the time of the report the patient's status was not recovered. A product quality complaint was not involved. The adverse events reported were considered to be disabling, life threatening and required hospitalization. Additional information has been requested. 4/28/08-records received for DOS:12/18/07-2/14/08-DC DX: Progressive encephalopathy diagnosis secondary to subacute sclerosing panecephalitis (SSPE). Treated with plasmapheresis for progressive neurological deterioration with decreased motor skills with inability to walk and swallow difficulty.  New on set seizure disorder. G tube placement Treated with IVIG.  During IVIG treatment developed tremor, hypertonicity and drooling. Became unresponsive to verbal tactile stimulus only minimal withdrawal to painful stimulus, comatose state, nonambulatory with positive clonus, hypertonic. Transferred to chronic care facility.
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site mass, Injection site swelling, Nerve injury
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a "single dose" of Zostavax (Oka/Merck).  On an unspecified date, post vaccination, the patient experienced redness and swelling at the injection site.  It later developed into a hard mass under her arm away from the injection site.  The patient had surgery to remove the mass but did not allow the mass to be fully removed and she now suffers from nerve damage.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  The adverse events reported were considered to be Other Medically Important Events (OME) by the reporter.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Insomnia, Irritability, Pyrexia
Clinical narrative: 103 degree F fever, irritability.  No sleep.  Facial flushing immediately following vaccine (1 hour).
Age: 1.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Pt had an allergic reaction hives on his face, swollen face. Gave him Benadryl. He had chicken noodle soup #3 approximately 3:00 or 3:30 that day.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Pt rec'vd MMR #2 Rt arm with Tdap (L) arm 1/23/08. Noted some redness, soreness at both injection sites next day. Then on 1/23 she noted a lump at (L) arm injection site along with sl. itch and The Rt arm sx improved but Lump persists at (L) arm with some tenderness 20 mm palpable nodule with 25mm diam overlying erythema, no axillary nodes. Temp 99.1. To Reck in 7-10 days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness. Pt watched it for a while, improving steadily. Afebrile BP 150/40, pulse 80, R 16. Fairly linear oval 4 cm longest dimension, slightly raised. Pt given Dicloxacillin. Pt to f/u in office on 1-31-08.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Hypoaesthesia, Influenza serology negative, Streptococcal identification test negative, White blood cell count increased
Clinical narrative: Onset of sx. on 1/24/08; numbness in R arm & legs; seen in ER - pt had elevated WBC; Flu & strep were negative.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Parent called on 01-23-08 at 10:10am.  Area around injection red & painful & warm to touch.  Reaction started off as a size of a quarter and spread further.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, TYP, VARCEL
Symptoms: Body temperature increased, Erythema, Skin warm, Tenderness
Clinical narrative: Immunizations given 12/24/07.  Eve of 12/24, left upper outer arm became red & warm to touch.  By 12/25 pm, area was very red, tender & temp was 100.8 and red area was size of mom's hand (fist).  By 12/26 pm red area was size of mom's outstretched hand and temp was 100.2.  She was seen by Dr. 12/26, 12/27 & 12/28.  Rx-Keflex 500 mg QID x5 days.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Lg red area, warm to touch, raised (bump) approx 5 cm, at injection site. Pt c/o achy pain in joints one day, Tylenol relieved symptoms.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Convulsion, Gaze palsy, Muscle rigidity, Syncope, Tremor
Clinical narrative: After 2 vaccines were given to pt. she started to pass out (faint).  Mom shouted pt was having a seizure.  Pt. was shaking, rigid & eyes were rolling back for very short time 4-5 seconds.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Immediate post-injection reaction, Rash papular
Clinical narrative: Pt was given the below named vaccines she immediately developed papular erythematous lesion on the face and extremities which was covered by 0.1 ml of epinephrine and 1.5cc of Prelone.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, C-reactive protein, Eye oedema, Full blood count, Parvovirus B19 serology
Clinical narrative: Vomiting x1; urticaria all over body; eye edema; positive large wheal eruptions abs, feet, arms, hand; joint pain.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Red blood cell sedimentation rate, Streptococcal identification test, Urticaria, Vomiting
Clinical narrative: Vomiting x1; urticaria all over body; eye edema; positive large wheal eruptions abs, feet, arms, hand; joint pain.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Prolonged muscle soreness at injection site. From stabbing pain to ache. Not as painful as the first 2 mos after shot. Now periodic soreness at site. Aches.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Pain in extremity, Tenderness
Clinical narrative: On 1/16/08, patient phoned office to report some redness and tenderness of left arm.  On 1/17/08, client reported to myself that left upper arm where she received pneumonia and flu was the size of a "baseball" in redness, very warm, painful to touch.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blister, Skin lesion
Clinical narrative: Multiple spots on back, neck, trunk, arms and legs with blisters.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Got varicella shot 2 days ago - 2 days out - arm erythemic 4 inch diameter area - hot and tender. Tx - warm soaks, Cephalexin Cap, Triamicinolone cream and Atarax.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Neuralgia, Wheezing
Clinical narrative: Nurse hit nerve when shot given - excruciating pain - 1/21/08. Almost cured. Cough 15 min after - lungs were wheezing. Called doctor and then called again in a couple of days. Respond 1/2/08! Nurseline a fantastic help. Empire. dose second to flu.
Age: 1.2
Sex: M
Vaccine: HIBV, MMRV, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: No adverse event
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Local reaction
Clinical narrative: Large local reaction Varicella #2 Motrin, ice prn
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossitis, Rash erythematous
Clinical narrative: Small red rash on leg (calf), painful red inflamed area on tongue 2 days after injection.  Pt went to doctor on day 12 (1/24/08) and received prescription for Magic Mouthwash.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Rash and blisters - antibiotic Prednisone, Vicodin - Neurontin.
Age: 1.2
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Had hives 24 hours after receiving flu vaccine.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Pt received 2nd Gardasil; Tdap, Hep A on 3/29/07 and 3rd HPV on 1/21/08, 2nd Hep A, and flu vaccine. Pt had syncope spell in office after vaccines given. On 1/21/08 - went to dance class x 3 hours after left office. Pt has not had dizzy spells and sore throat since 1/21/08.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Gaze palsy, Muscle twitching, Screaming
Clinical narrative: sx's started yest: twitching arms, rolling eyes, crying/screaming alot
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza, Influenza serology positive, Pyrexia
Clinical narrative: Influenza symptoms (cough, fever) with positive nasopharyngeal test for influenza despite influenza vaccine (inadequate total # of immunizations).
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Influenza serology positive, Pyrexia, Virus culture positive
Clinical narrative: Had influenza symptoms (fever, cough) and positive NP swab for influenza despite adequate immunization.  1/6/06, 2/6/06, 12/5/06, 11/21/07.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Pt came in today 1/25/08 with a bright red rash all over body - had received MMR on 1/14/08.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash macular, Skin lesion
Clinical narrative: Red macular lesions on each anterior thigh near sites of vaccination.
Age: 11.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 24h after vaccination the site was noted to be raised, red, hot and tender to touch about 2" diameter. By the following morning the dark red area encompassed almost the entire upper arm. The child exhibited no systemic sxs. As of today the area is about 3" diameter, light pink, tender but not hot.
Age: 11.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Approximately 24h after vaccination the site was noted to be raised, red, hot and tender to touch about 2" diameter. By the following morning the dark red area encompassed almost the entire upper arm. The child exhibited no systemic sxs. As of today the area is about 3" diameter, light pink, tender but not hot.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: three days of diarrhea and vomiting.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Localized swelling, erythema on Lt arm, max about IPV site.
Age: 1.7
Sex: M
Vaccine: HEPA, MMR
Symptoms: Diarrhoea, Dyskinesia, Pyrexia
Clinical narrative: -fever to 104 x 4 days, diarrhea x 1 involuntary jerky movement of arm-Treatment
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Swelling
Clinical narrative: Patient describes swelling and erythema upper arm and extending to triceps area with temp 101 for 2-3 days.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Fine, erythematous, pruritic rash over most of body including face and scalp.  No fever, redness or swelling at injection site or other symptoms.  No known allergies, no new meds or foods.  Pruritis relieved with Benadryl but still has rash several hours after Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Developed diffuse erythematous puritic rash from head to toe with 45 min -> 1 hr of 4 injections given. Given Benadryl IM and Depo Medrol IM, rash resolved within 15 min. BP 90/52 resp WNL
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Eyelid oedema, Oedema peripheral
Clinical narrative: Swelling of eyelids and left hand and arm; seen by HCP 1-12-07; given benadryl
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: Severe pain in left shoulder centered in muscle area near injection site.  Used pain pills Darvon for relief.  Pain lasted two full weeks.
Sex: U
Vaccine: VARCEL
Symptoms: Immunisation
Clinical narrative: Immunization local as 4 inches x 2 1/2 inches
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Pruritus, Reaction to previous exposure to any vaccine
Clinical narrative: Mild erythema noted around injection site.  Child c/o mild itching.  Informed by nurse who administered vaccine to follow-up with their medical doctor if symptoms worsen.  Informed of local reactions after vaccines.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: 48 hrs after vaccination, multiple red steaks, evolving into 2mm bright red (viola) papules, few small vesicles on both forearms. (+) itching
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Large local reaction
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Local swelling, redness, fever x 3-4d. Treated with azithromycin, ice/ibuprofen.
Age: 1.35
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Body temperature increased, Irritability, Rash
Clinical narrative: Mother called: C/O Red Rash on Back/and/Legs. T. 100.3 Cranky. Tylenol advised For discomfort
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Feeling hot, Pain, Pain in extremity, Swelling
Clinical narrative: Left deltoid localized pain with swelling, warm to touch, tingling in fingers.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash macular, Skin warm
Clinical narrative: Developed facial warmth, then another person noticed blotches on her face and arms.  Then she felt itching.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin, Blister, Dermatitis psoriasiform, Erythema, Perivascular dermatitis
Clinical narrative: 3-4 days after shot - pt noticed a pimple-like mark over area - then the are expanded to a circular, quarter-sized red-raw area that had tiny blisters on it.  Pt has seen 4 doctors and the 5th is scheduled for today - out of 5 MDs - 2 are specialists.
Age: 17.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Fatigue, Headache, Rash generalised, Rash pruritic
Clinical narrative: Mother reports her son had headache at bed time on 1/23/08 and awoke with headache. Came home from school at lunch time feeling tired, had headache had full body rash that began to itch in afternoon mom treating with Tylenol and bedrest.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Pruritus
Clinical narrative: Pt reports 3" long x 1 1/2" wide red area at injection site & itching on 1/26; on 1/27 pt reports additional blisters at injection site.  Went to walk in clinic on 1/26 & started on Benadryl 25 mg po q 6 hours & cortisone cream.  Saw MD at church on 1/27 & started on acyclovir 800 mg po q 4 hours x7 days.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Asthma, Hypoaesthesia, Nausea, Sinusitis
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female with asthma who on 03-SEP-2007 was vaccinated with her third dose of GARDASIL intramuscularly in the left deltoid at 12:00. Within 15 minutes of the vaccine the patient felt nauseous followed by a feeling like an asthma attack was occurring. The patient tried her inhaler but it did not help. She collapsed in her dorm room. Emergency services were called and the patient was given oxygen. The medics inserted an IV but never used. The patient complained of feeling numb and the medics helped to unclench her hands and feet. She was taken to the emergency room at a hospital where the symptoms subsided. The patient checked herself out after 2 hours in the emergency room. The patient denied receiving any medication. The patient developed a serious sinus infection and felt weak for 2-3 days after the vaccine. The patient did not use her inhaler the first two times. The patient's first GARDASIL vaccination was on 27-FEB-2007 and her second dose was on 27-APR-2007. Additional information has been requested. This is in follow-up report(s) previously submitted on 1/15/2008. The patient's first GARDASIL vaccination was on 27-FEB-2007 and her second dose was on 27-APR-2007. Follow up information was received on 21-FEB-2008 and it was reported that the patient is presently doing well. No other information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female with asthma who on 03-SEP-2007 was vaccinated with her third dose of GARDASIL intramuscularly in the left deltoid at 12:00. Within 15 minutes of the vaccine the patient felt nauseous followed by a feeling like an asthma attack was occurring. The patient tried her inhaler but it did not help. She collapsed in her dorm room. Emergency services were called and the patient was given oxygen. The medics inserted an IV but never used. The patient complained of feeling numb and the medics helped to unclench her hands and feet. She was taken to the emergency room at a hospital where the symptoms subsided. The patient checked herself out after 2 hours in the emergency room. The patient denied receiving any medication. The patient developed a serious sinus infection and felt weak for 2-3 days after the vaccine. The patient did not use her inhaler the first two times. The patient's first GARDASIL vaccination was on 27-FEB-2007 and her second dose was on 27-APR-2007. Additional information has been requested. This is in follow-up report(s) previously submitted on 1/15/2008. The patient's first GARDASIL vaccination was on 27-FEB-2007 and her second dose was on 27-APR-2007. Follow up information was received on 21-FEB-2008 and it was reported that the patient is presently doing well. No other information is expected.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Blood test normal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed a large red, swollen and painful area around the injection site. The redness, pain and swelling are on the patient's anterior and lateral sides of her arm; approximately 2/3 of the patient's arm is swollen and painful.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Malaise, Movement disorder, Pyrexia, Speech disorder
Clinical narrative: 5 hours post injection on 02/06/07, the patient experienced acute onset of fever, malaise, inability to move, shortness of breath, and difficulty speaking. 911 was called, but the patient did not go to the hospital. Follow up received 02/22/07: The patient was seen at the doctor's office on 02/09/07. The patient said her symptom resolved 2-3 hours after they began on 02/06/07, and they have not occurred.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Patient had inflammation of nerves in the right arm, where Td was administered. Patient complained of arm being sore, red, tender and having limited movement of the arm. Adverse event onset was sometime prior to 02/05/07, when patient contacted the doctor with the complaint. On 02/28/07 patient came for a follow up visit and noted that there was less pain in the arm, although arm movement was still limited. Patient received Td injection to a dog bite. *Continues on next page* Follow up obtained on 03/20/2007: Reporter clarified that during the follow up visit on 02/28/07 patient's arm movement was limited because of pain and that patient had a normal neurological exam and no local inflammation reaction. Patient felt better and has recovered, although it took a month for the pain to go away.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Chest pain, Ear pain, Electromyogram, Neck pain, Pain in extremity
Clinical narrative: The patient received Td vaccination on 2/5/07 in his left deltoid due to an eye injury at work. The patient developed pain in his neck behind his left ear which radiated down his left arm, into his chest and down his left leg. The patient saw his family doctor on 2/12 and was referred to a neurologist on 2/12. The neurologist prescribed Flexeril. Follow-up from 05/08/08. Adverse event onset date was 02/05/07; patient no longer attends the doctor's office, patient's recovery status remains unknown.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: The patient received Td vaccination on 2/5/07 in his left deltoid due to an eye injury at work. The patient developed pain in his neck behind his left ear which radiated down his left arm, into his chest and down his left leg. The patient saw his family doctor on 2/12 and was referred to a neurologist on 2/12. The neurologist prescribed Flexeril. Follow-up from 05/08/08. Adverse event onset date was 02/05/07; patient no longer attends the doctor's office, patient's recovery status remains unknown.