chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome, Haematocrit normal, Haemoglobin normal, Immunoglobulin therapy, Muscular weakness
Clinical narrative: This is a 59-year old male with no significant past medical history who presented with complaint of muscle weakness, dysphagia, and dysphonia. The weakness began in 10/2009 with painful calves -which he initially attributed to over-working his muscles while exercising-, then progressed to his upper extremities. He reports receiving his flu shot early in October, and that the weakness became worse after the injection. He was hospitalized at an outside facility in 10/2009, 11/2009, and 1/2010 with the same problem of muscle weakness and rash. On his initial admission, approximately 2 weeks after onset of symptoms, his working diagnosis was GUILLAIN-BARRE Syndrome, although his CSF evaluation was inconsistent with GUILLAIN-BARRE Syndrome. There was some speculation after the CSF evaluation that there had not been adequate time for the markers of GUILLAIN-BARRE to develop. After that discharge, he underwent a muscle biopsy, which was reported to be consistent with myositis. His wife reports that on his 11/2009 admission, he had a CK level that was ~ 22,000. He was also noted at that time to have an increasing rash surrounding his neck in a possible shawl sign. After his muscle biopsy, his working diagnosis was changed to dermatomyositis. He appeared to be improving on oral steroids until mid- to late-January when he reported increased difficulty swallowing and increased weakness. At that time, he was admitted again to an outside hospital for IV steroids. He was later transferred to our facility for increased access to specialists and sub-specialists and later management of his dysphagia. For his increasing dysphagia, he was initially started on IV Methylprednisolone, which was later changed to oral prednisone. He, also, received 3 days of IVIG with no improvement or changes in his dysphagia. Prior to discharge, he was started on Cyclophosphamide 100mg orally daily. He was, also, discharged on high dose prednisone and continues with the diagnosis of dermatomyositis secondary to flu vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Myopathy, Myositis, Pain in extremity, Platelet count normal, Rash
Clinical narrative: This is a 59-year old male with no significant past medical history who presented with complaint of muscle weakness, dysphagia, and dysphonia. The weakness began in 10/2009 with painful calves -which he initially attributed to over-working his muscles while exercising-, then progressed to his upper extremities. He reports receiving his flu shot early in October, and that the weakness became worse after the injection. He was hospitalized at an outside facility in 10/2009, 11/2009, and 1/2010 with the same problem of muscle weakness and rash. On his initial admission, approximately 2 weeks after onset of symptoms, his working diagnosis was GUILLAIN-BARRE Syndrome, although his CSF evaluation was inconsistent with GUILLAIN-BARRE Syndrome. There was some speculation after the CSF evaluation that there had not been adequate time for the markers of GUILLAIN-BARRE to develop. After that discharge, he underwent a muscle biopsy, which was reported to be consistent with myositis. His wife reports that on his 11/2009 admission, he had a CK level that was ~ 22,000. He was also noted at that time to have an increasing rash surrounding his neck in a possible shawl sign. After his muscle biopsy, his working diagnosis was changed to dermatomyositis. He appeared to be improving on oral steroids until mid- to late-January when he reported increased difficulty swallowing and increased weakness. At that time, he was admitted again to an outside hospital for IV steroids. He was later transferred to our facility for increased access to specialists and sub-specialists and later management of his dysphagia. For his increasing dysphagia, he was initially started on IV Methylprednisolone, which was later changed to oral prednisone. He, also, received 3 days of IVIG with no improvement or changes in his dysphagia. Prior to discharge, he was started on Cyclophosphamide 100mg orally daily. He was, also, discharged on high dose prednisone and continues with the diagnosis of dermatomyositis secondary to flu vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Red blood cell sedimentation rate normal, White blood cell count normal
Clinical narrative: This is a 59-year old male with no significant past medical history who presented with complaint of muscle weakness, dysphagia, and dysphonia. The weakness began in 10/2009 with painful calves -which he initially attributed to over-working his muscles while exercising-, then progressed to his upper extremities. He reports receiving his flu shot early in October, and that the weakness became worse after the injection. He was hospitalized at an outside facility in 10/2009, 11/2009, and 1/2010 with the same problem of muscle weakness and rash. On his initial admission, approximately 2 weeks after onset of symptoms, his working diagnosis was GUILLAIN-BARRE Syndrome, although his CSF evaluation was inconsistent with GUILLAIN-BARRE Syndrome. There was some speculation after the CSF evaluation that there had not been adequate time for the markers of GUILLAIN-BARRE to develop. After that discharge, he underwent a muscle biopsy, which was reported to be consistent with myositis. His wife reports that on his 11/2009 admission, he had a CK level that was ~ 22,000. He was also noted at that time to have an increasing rash surrounding his neck in a possible shawl sign. After his muscle biopsy, his working diagnosis was changed to dermatomyositis. He appeared to be improving on oral steroids until mid- to late-January when he reported increased difficulty swallowing and increased weakness. At that time, he was admitted again to an outside hospital for IV steroids. He was later transferred to our facility for increased access to specialists and sub-specialists and later management of his dysphagia. For his increasing dysphagia, he was initially started on IV Methylprednisolone, which was later changed to oral prednisone. He, also, received 3 days of IVIG with no improvement or changes in his dysphagia. Prior to discharge, he was started on Cyclophosphamide 100mg orally daily. He was, also, discharged on high dose prednisone and continues with the diagnosis of dermatomyositis secondary to flu vaccine.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Fainted when received the shot, felt really tired, sweated,and black out.
Age: 1.83
Sex: F
Vaccine: FLU(H1N1), HIBV
Symptoms: Cough, Vomiting
Clinical narrative: Started vomiting and coughing constantly after administration of vaccine. Vomited about 10 times. Received Epinephrine in office and was referred. Steroid given. Sent home on P.O. Preline syrup.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN(H1N1), HIBV, IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None reported. No adverse reaction.  VAERS form completed due to expired H1N1 vaccine given.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered
Clinical narrative: None Stated. No adverse reaction.  VAERS form completed due to expired H1N1 vaccine given.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fall, Head injury, Muscular weakness
Clinical narrative: Recieved flu shot 9/19 from hospital, which is her employer, on 9/19 claims to have had 3 incidents of weakness with falls. Legs gave out, one time hitting head. Not seen in ER. Spoke with Neurologist at hospital, did not think shot was related.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Ammonia increased, Bedridden, Confusional state, Hallucination, Lethargy
Clinical narrative: patient had lethargy for 3 weeks and then presented to the hospital.  Mr. Templeton is a 61 year old Morbidly obese male patient with history and meds. Appears that he recieved H1N1 at another facility in early december.  as noted below.  He is brought to the ER by his wife for altered mental status  and lethargy for the last 2 to 3 weeks.  As per the ER notes patient has  basically been bedridden for about 3 weeks.  Wife is not present at the time of  my interview but wife apparently told the ER staff that the patient has been  hallucinating and just not been himself for the last week. He has history of  getting confused secondary to high ammonia but wife states that this is worse  than that as per the ER note. Patient is a poor historian and denies any active  pains. When asked about his hallucinations he stated "I didn't even get to the  good part."
Age: 60.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Mental status changes
Clinical narrative: patient had lethargy for 3 weeks and then presented to the hospital.  Mr. Templeton is a 61 year old Morbidly obese male patient with history and meds. Appears that he recieved H1N1 at another facility in early december.  as noted below.  He is brought to the ER by his wife for altered mental status  and lethargy for the last 2 to 3 weeks.  As per the ER notes patient has  basically been bedridden for about 3 weeks.  Wife is not present at the time of  my interview but wife apparently told the ER staff that the patient has been  hallucinating and just not been himself for the last week. He has history of  getting confused secondary to high ammonia but wife states that this is worse  than that as per the ER note. Patient is a poor historian and denies any active  pains. When asked about his hallucinations he stated "I didn't even get to the  good part."
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Computerised tomogram, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Feet became numb and very painful. The sensation quickly spread up my legs and I became unable to walk. I sought medical services from my Family Dr. who then refered me to a neurologist who diagnosed GBS. I was not hospitalized and have been recovering slowly at home. GBS is not for the faint hearted as it has changed my life.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Feet became numb and very painful. The sensation quickly spread up my legs and I became unable to walk. I sought medical services from my Family Dr. who then refered me to a neurologist who diagnosed GBS. I was not hospitalized and have been recovering slowly at home. GBS is not for the faint hearted as it has changed my life.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Local reaction, Sensation of heaviness, Swelling
Clinical narrative: Local significant swelling, induration, heaviness, continuing through today.
Age: 1.31
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Irritability, Rash papular, Rash vesicular, Skin lesion
Clinical narrative: Irritable, warm but normal temp, 4 vesicular and papular lesion, starting near injection site on left leg but then other leg, chest and back.  Most recent (papular) lesion yesterday.
Age: 1.31
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Irritable, warm but normal temp, 4 vesicular and papular lesion, starting near injection site on left leg but then other leg, chest and back.  Most recent (papular) lesion yesterday.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event occurred, no treatment needed. Vaccine given to inappropriate age.  Not licensed for this age.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Autopsy, Death, Respiratory arrest
Clinical narrative: No symptons,or signs prior to child not breathing. Child taken to ER and CPR was implemented.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pruritus, Rash
Clinical narrative: Both shoulders sore, rash/itching on back of forearms.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. called the evening of his shot given earlier that day reporting arm at injection site very red & swollen.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal discomfort, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, X-ray limb normal
Clinical narrative: Severe pain left shoulder, cannot raise arm above shoulder height.
Age: 21.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Pain, Pruritus
Clinical narrative: Called 2 days after receiving injection reporting rash at injection site and spreading across chest. Itching and hurts. Being evaluated today in office at 4:20.
Age: 21.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Rash
Clinical narrative: Called 2 days after receiving injection reporting rash at injection site and spreading across chest. Itching and hurts. Being evaluated today in office at 4:20.
Age: 21.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Called 2 days after receiving injection reporting rash at injection site and spreading across chest. Itching and hurts. Being evaluated today in office at 4:20.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP, DTAP, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Seen 3/30 & reports that "several days after" injections started with swollen, painful, warm upper arm, started on LEVAQUIN, being re-evaluated today in office.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP, DTAP, PPV
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Seen 3/30 & reports that "several days after" injections started with swollen, painful, warm upper arm, started on LEVAQUIN, being re-evaluated today in office.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: Convulsion, Pyrexia, Tremor
Clinical narrative: Fever of 105 and was convulsing and shaking for hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Musculoskeletal pain, Pain in extremity
Clinical narrative: Developed pain under right arm, by shoulder blade, lasted 4 days, then same pain under left arm still on going, no redness, just burning.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Chills, Headache, Neck pain, Pyrexia, Vomiting
Clinical narrative: Fever (102), chills, headache, pain in neck, vomiting.  Over the course of 24 hours.
Age: 0.71
Sex: U
Vaccine: DTAP, PNC
Symptoms: Dermatitis diaper, Rash generalised
Clinical narrative: Mother reports rash in diaper area within 24 hours from shot.  Rash moved to torso then whole body within 3 days - 0 fever.  Feeling normal other than rash.
Age: 35.0
Sex: M
Vaccine: FLU(H1N1), HEPA
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Back / shoulder itching + rash.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blindness transient, Syncope
Clinical narrative: Fainted & lost vision briefly 10 minutes after vaccine.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Feeling hot, Immediate post-injection reaction, Syncope
Clinical narrative: Patient c/o feeling hot immediately after HPV injection.  She fainted, was placed on her left side on exam table.  She was alert and responsive in 3-4 seconds to verbal stimuli.  Vital signs stable. Dc'd  home with mom.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Developed cellulitis in arm vaccine given. Seen in ER and by PCP. Started on ATB.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Muscular weakness, Pain, Pyrexia
Clinical narrative: Patient has fever 101.7 - broke 3/25/10 at 4:30 PM.  Aching.  Sore at site & weakness in arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site vesicles, Local reaction
Clinical narrative: Following day after KINRIX and MMR, had large red area around injection site-Progressed to swelling and vessicles by day #3 after shots. Seen in clinic on 3/25 and 3/26 for evaluation-started on oral Prednisone and Benadryl for significant local hypersensitivity reaction.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Diet refusal, Dizziness postural, Fatigue, Feeling hot, Pallor
Clinical narrative: Pale today (3/30/10), feels hot when she stands up and very dizzy on 3/30/10. She had a busy weekend and she is tired. Didn't eat last night and went to bed at 6 pm.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient receive VZV on ROA on 3/23/10, pt got area swollen & red. Area hurts only with touch. On 3/26/10 patient came to clinic because redness has not gone away told to do warm compression for 15 minutes at a time. Approx. 4cm/red/soft/no tender.
Age: 1.49
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Listless, Pyrexia
Clinical narrative: Had vaccine @ 2:30 pm (3-19-10), started fever @ 4 pm (3-19) went to Hospital ER @ 10 pm w/105 fever, seizure & listlessness. Given TYLENOL & MOTRIN. Watched till 1 am & discharged f/u with Dr. 3-24-10.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Hypertension
Clinical narrative: Red face, neck, chest within minutes. Hypertension. Pounding in head.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Fall, Hyperhidrosis
Clinical narrative: Pt started to experience weakness accompanied with diaphoresis; witness describe pt fell to the floor. Ambulance called by co-worker, transported to hospital.
Age: 63.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Computerised tomogram, Fatigue, Headache, Lumbar puncture
Clinical narrative: Fatigue, pounding headache, fever 105 degrees F, bodyache. To Urgent Care 3/31/10, pain med was given. Not better, to ER 4/1/10-CT head, spinal tab, blood work: normal, discharged home with pain med. 4/2/10 little better
Age: 63.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue, pounding headache, fever 105 degrees F, bodyache. To Urgent Care 3/31/10, pain med was given. Not better, to ER 4/1/10-CT head, spinal tab, blood work: normal, discharged home with pain med. 4/2/10 little better
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pallor
Clinical narrative: (L) upper arm w/ area of erythema and mild swelling, mildly tender, blanching use cool compress, Motrin prn or Benadryl prn.
Age: 28.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Intensive care
Clinical narrative: Per a conversation with the mother he was admitted into ICU for several days with H1N1.
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Grand mal convulsion
Clinical narrative: 3 Tonic Clonic seizures on 7-6-2009 12 hours of Tonic Clonic seizures on 2-12-2010
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given 2 doses of Hep B vaccine 10mcg/0.5ml.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute disseminated encephalomyelitis, Multiple sclerosis
Clinical narrative: Information has been reported in a published article concerning a young women who were vaccinated with a dose of GARDASIL and approximately 1 month later presented to clinics with a demyelinating syndrome that subsequently met criteria for multiple sclerosis. At the time of report the outcome was unknown. The reporter felt that aggressive acute disseminated encephalomyelitis was related to therapy with GARDASIL. Upon internal review, multiple sclerosis was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute disseminated encephalomyelitis, Multiple sclerosis
Clinical narrative: Information has been reported in a published article concerning a young women who were vaccinated with a dose of GARDASIL and approximately 1 month later presented to clinics with a demyclinating syndrome that subsequently met criteria for multiple sclerosis. At the time of report the outcome was unknown. The reporter felt that aggressive acute disseminated encephalomyelitis was related to therapy with GARDASIL. Upon internal review, multiple sclerosis was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 0.28
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC, RV1
Symptoms: Diarrhoea, Irritability, Ultrasound abdomen, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Extreme fussy, some diarrhea
Age: 0.28
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC, RV1
Symptoms: Abdominal pain
Clinical narrative: Extreme fussy, some diarrhea
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Aborted pregnancy, Drug exposure during pregnancy, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning a 24 year old female with no pertinent medical history and no drug reactions/allergies who was vaccinated in June 2008 and on 11-AUG-2009 with a dose of GARDASIL. There was no concomitant medication. On 11-AUG-2009, the patient had a positive urine pregnancy test. The estimated gestational age at the time of this reporting was four weeks. The last menstruation period was approximately 12-JUL-2009 and the estimated delivery date would be approximately 18-APR-2010. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Follow-up information has been received concerning a female patient with no significant past medical history and one elective termination who in June 2008 was vaccinated with the first dose of GARDASIL somewhere else and on 11-AUG-2009 was vaccinated with the second 0.5 ml dose of GARDASIL (Lot# 659655/0940X). There were no concomitant therapies. On 21-AUG-2009 ultrasound was performed which revealed that the dating was 6 2/7 weeks. On 31-AUG-2009 the patient signed the consent form for the Merck registry for GARDASIL. Follow-up information has been received indicated that the patient aborted her pregnancy due to personal reasons. Upon internal review, the aborted pregnancy was considered to be an other important medical event. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Feeling hot, Nervousness
Clinical narrative: 40 minutes after getting shingle shot, she experienced dry mouth, nervousness and heating sensation.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiplegia, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Initial and follow-up information has been received from a Licensed Practical Nurse concerning a 20 year old female with no pertinent medical history and no drug allergies who on 05-JAN-2010 was vaccinated intramuscularly in right deltoid arm with the first 0.5 mL dose of GARDASIL (LOT# 0669Y). Concomitant therapy included DEPO-PROVERA. The patient felt numbness from head to toe right after receiving the vaccine. There was no lab diagnostic study performed. She recovered few minutes later. On 29-MAR-2010, a voice mail message was received from the nurse. It was reported that the patient received no other vaccines at the time of the GARDASIL vaccination. The nurse said that according to the patient directly after receiving the first dose, the patient was paralyzed on the right side for one minute. Even though medical staff was available, the patient did not tell them of this event. Therefore no treatment was given and no referrals were made. It wasn't until the patient came in for the second dose did the staff learn of the incident. The second dose of GARDASIL was not given. Upon internal review, paralyzed on the right side for one minute was determined to be an other important medical event. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Autoimmune hepatitis, Liver transplant, Myelitis transverse, Renal failure
Clinical narrative: Information has been received from a company representative who overheard a physician mention information concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot number not provided). On an unknown date, the patient experienced "transverse mellitus" after getting GARDASIL which resulted in autoimmune hepatitis, which led to renal failure and liver transplant. The patient's outcome was unknown at the time of reporting. Upon internal review, myelitis transverse was considered to be an other important medical event. Attempts are being made to verify the existence of an identifiable patient and reporter. This is one of two reports from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Alopecia, Amenorrhoea, Hepatic enzyme increased, Skin papilloma
Clinical narrative: Information has been received from a company representative who overheard a physician mention information concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot number not provided). On an unknown date, the patient experienced "transverse mellitus" after getting GARDASIL which resulted in autoimmune hepatitis, which led to renal failure and liver transplant. The patient's outcome was unknown at the time of reporting. Upon internal review, myelitis transverse was considered to be an other important medical event. Attempts are being made to verify the existence of an identifiable patient and reporter. This is one of two reports from the same source.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site cellulitis
Clinical narrative: 2.5 cms x 2 cms oval cellulitis @ Dtap site. 1 cm x 1 cm round cellulitis @ IPU site. Placed on warm compress & antibiotic AUGMENTIN.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with the second 0.5 ml dose of GARDASIL. Concomitant therapy included "SSRI". It was reported that the patient had a known history of seizures however had been off her seizure medications since she was 8 years old. Subsequently, on an unknown date the patient experienced two seizures. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a Physician's Assistant concerning a 16 year old female patient who on an unspecified dates was vaccinated with all three doses of GARDASIL. Three months later the patient experienced seizures. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Upon internal review seizures was considered to be an other important medical event. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt received PNEUMOVAX injection on 3/15/10. Pt. stated he had approx 8-10 days of (L) u arm edema (from anticub to shoulder), erythema and pain. Pt. had limited ROM and pain during this time.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Computerised tomogram, Pneumonia, White blood cell count, X-ray
Clinical narrative: On 11/3/05 I was given the Influenza and pneumococcal vaccine. On 9/26/09 I was diagnosed with pneumonia on my left side of my lung. I was discharged on Oct. 1, 2009. Hospital gave me another influenza and pneumococcal vaccine. I was re-admitted on Oct 5, 2009 until Oct. 12, 2009 with double pneumonia. I do not understand why if vaccinated in 2005 and 2009 why I got pneumonia much less double pneumonia.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erosion, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female inpatient with drug hypersensitivity to aspirin, COUMADIN and Metformin who on 05-FEB-2010, was vaccinated as a routine order before discharge while she was a patient in the hospital with a 0.5 ml dose of PNEUMOVAX (664000/0621Y). After the patient was discharged and was at home she developed redness and swelling of her arm at the injection site. This progressed to an "eaten away" area on her arm. The patient was readmitted to the hospital and was being treated with packing to the area and vancomycin. The reporting pharmacist requested a lot check for lot # 664000/0621Y. At the time of the report the patient had not recovered. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt became pregnant while suing ORTO - TRICYCLEN LO, which she failed to take regularly. LMP 1/27/09 - Had received GARDASIL 12/11/08 - 2/20/09.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Injection site erythema, Injection site swelling
Clinical narrative: Patient did not state when onset started but contacted pharmacy on 4/2/2010 ~9:30am.  Stated that she was hot and cold but no fever.  The site of injection was red and swollen.  She said a cold compress did help and we suggested an antihistamine as well as calling her physician.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: left thigh redness since 3/22/10 however 4/2/10 area doubled in size and became hard and slightly swollen
Age: 14.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Hypothyroidism, Type 1 diabetes mellitus
Clinical narrative: Pt diagnosed with insulin dependant diabetes 7/13/09.  Received GARDASIL 6/6/08, 8/8/08, & 1/2/09.  Younger sister recently diagnosed with IDDM and parent questioning possible role of vaccine.  Pt also subsequently diagnosed with hypothyroidism.
Age: 14.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Hypothyroidism, Laboratory test, Pollakiuria, Polydipsia, Type 1 diabetes mellitus
Clinical narrative: Pt diagnosed with insulin dependant diabetes 7/13/09.  Received GARDASIL 6/6/08, 8/8/08, & 1/2/09.  Younger sister recently diagnosed with IDDM and parent questioning possible role of vaccine.  Pt also subsequently diagnosed with hypothyroidism.
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Sick relative, Type 1 diabetes mellitus
Clinical narrative: Patient received GARDASIL vaccine 8/5/09, 12/12/09 and 2/15/10. Pt diagnosed with type 1 diabetes on 3/29/10. Sister also with IDDM (Vaers Filled out) Parents Questioning Role of vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Laboratory test, Pollakiuria, Polydipsia, Type 1 diabetes mellitus
Clinical narrative: Patient received GARDASIL vaccine 8/5/09, 12/12/09 and 2/15/10. Pt diagnosed with type 1 diabetes on 3/29/10. Sister also with IDDM (Vaers Filled out) Parents Questioning Role of vaccine.
Age: 1.02
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Incorrect dose administered, Pyrexia
Clinical narrative: Pt. given 3rd dose of seasonal flu vaccine; developed fever of 104 and had febrile seizure. Taken by ambulance to H.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Local reaction 2" induration and 3 1/2" erythema at injection site (R) vastus lateralis. Tx with KEFLEX for early cellulitis.
Age: 25.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Back pain
Clinical narrative: Pt had TWINRIX #1 3/24/10, no prob. RTC for TWINRIX #2 3/31/10. states woke up 4/1/10 w/ back pain & b/l knee stiffness. Back pain has resolved, knee discomfort unchanged. No significant PMH.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot administered ~ 11 AM Upper outer (L) thigh cried immediately. Parents called within 2 hrs (L) thigh red swollen warm to touch pt. still crying anytime thigh touched.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fevers > 103 with TYLENOL.  Vomiting X 10.  Rash on face.
Sex: U
Vaccine: TDAP
Symptoms: Headache, Swollen tongue
Clinical narrative: This case was reported in a literature article and described the occurrence of swelling of tongue in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included hepatitis A vaccine inactivated  ;manufacturer unspecified given on an unspecified date; hepatitis B vaccine recombinant ;manufacturer unspecified;unknown given on an unspecified date; meningococcal acwy vaccine (non-gsk) ;Aventis Pasteur;unknown given on an unspecified date. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling of tongue and headache. The author considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unspecified. The author considered the events were considered to be potentially related to vaccination with BOOSTRIX.
Age: 75.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Aphasia, Asthenia, Cerebellar haemorrhage
Clinical narrative: Initial Health Authority report received on 02 Mar 2010: This patient received influenza virus vaccine H1N1 (manufacturer unknown) of an unspecified dose, on 08 Dec 2009. On the same day, the patient experienced cerebellar haemorrhage, aphasia and asthenia. The events were reported as serious. The outcome of the events was not reported. Follow-up report received from local Health authority on 30 Mar 2010: The patient did not receive Novartis vaccine. Therefore, this case would be deactivated.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Pyrexia
Clinical narrative: Body aches at 3pm, severe body pain starting at 6 pm on 3/25/10 later that night extreme weakness and had fever 102-103 did not check temperature. Started and lasted all day Thursday 3/25/10. Remained in bed all day until Sat unable to move until Sat night 3/27/10. Sunday normal.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: 6 days after injection patient came back complaining of red mark at injection site. PharmD and Nurse examined site and there was approximately 3-4 inch red circle around injection site. Currently negative itching and the reaction was getting smaller. Patient stated it had covered entire back of upper arm. Patient was counseled to contact doctor if it did not clear up within a couple of days or got worse.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Nasal congestion, Oropharyngeal pain, Rhinorrhoea, Sensation of heaviness
Clinical narrative: Heaviness all over--more pronounced in the chest.  Next day sore throat, stuffy nose and thick mucus
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Pt. had a macular papular rash that is on face, torso, bilateral arms, back and going down both legs. Reports a low grade fever the day before.
Age: 45.0
Sex: M
Vaccine: YF
Symptoms: Cold sweat, Myalgia, Rash
Clinical narrative: Pt had multiple vaccines 3/30 (typhoid, H1N1 injectable, TDAP, Anthrax, IPV) and received Yellow Fever on 3/31.  Evening of 3/31 reports myalgias, clammy feeling and noticed rash on right forearm.  On 4/1 rash was mild but on 4/2 rash extended to both arms and across back and chest.  Pt saw provider 4/2 and was given.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Complains of arm pain and swelling at injection site. Symptoms continued for at least 10 days. Patient noted significant swelling 8 days post vaccination. Seen in office on day 10. Normal exam. No rash, swelling noted. Able to perform ADLS independently. Good ROM on exam. Treated with ibuprofen in office.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Mild frontal headache for 3 days, worse at night & when bending over. Treated with OTC ibuprofen.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest X-ray normal, Cough, Influenza serology negative, Lacrimation increased, Pyrexia
Clinical narrative: cough, fever, runny nose and eyes
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rhinorrhoea
Clinical narrative: cough, fever, runny nose and eyes
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Patient became light-headed and pale. Patient was placed in shock postition on exam table, ice-pack to base of neck. Patient stated no breakfast and no liquid intake yet this AM. Given approx 300cc's water and piece hard candy. After 15 to 20 minutes symptoms resolved.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 5X6cm redness and swelling; warm to touch; pt. and caregiver deny pt. having any shortness of breath and/or difficulty breathing
Age: 20.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dehydration, Dizziness, Dyspnoea, Gait disturbance, Heart rate increased
Clinical narrative: I was vomiting violently, running a temp of 103 degrees, and having problems breathing. I was dizzy and needed assistance walking. I was taken to the hospital with a rapid heart rate, shortness of breath, dehydration and a fever of 103. I was given intravenous fluids, anti-nausea meds, oxygen and meds for fever.
Age: 20.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Vomiting, X-ray normal
Clinical narrative: I was vomiting violently, running a temp of 103 degrees, and having problems breathing. I was dizzy and needed assistance walking. I was taken to the hospital with a rapid heart rate, shortness of breath, dehydration and a fever of 103. I was given intravenous fluids, anti-nausea meds, oxygen and meds for fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper thigh with reddened, swollen area about the size of a baseball at injection site of DTaP, warm to touch, even through jeans per MOC, painful. Ibuprofen given and ice pack to reduce swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Large Local reaction to injection site.  Warm to the touch.  Swelling was 11 x 9 cm.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU(H1N1), IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: 9 1/2cm D local reaction in R deltoid (erythema, induration).
Age: 0.76
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3, PNC
Symptoms: Full blood count normal, Pyrexia, White blood cell count normal
Clinical narrative: Fever 104.
Age: 1.08
Sex: M
Vaccine: PNC
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 0.62
Sex: M
Vaccine: HIBV, PNC
Symptoms: Crying, Irritability, Screaming, Tremor
Clinical narrative: Screaming, crying, fussy and left leg shaky after vaccines. Pt seen in our office 4/2/10.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warmth 10x6 cm area at site of injection.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red swollen and tender to the touch. Patient dx with cellulitis due adverse reaction and was prescribed AUGMENTIN 500mg BID; will recheck pt within 24-48 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Headache, Induration, Insomnia, Muscle twitching
Clinical narrative: Severe headache for 12 hrs, dramatic muscle twitching, arms & legs for 12 hrs. Could not sleep & could not stop moving for the 12 hrs. Raised, sore, red & hot welt (silver dollar size) on arm for 5 days now.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Severe headache for 12 hrs, dramatic muscle twitching, arms & legs for 12 hrs. Could not sleep & could not stop moving for the 12 hrs. Raised, sore, red & hot welt (silver dollar size) on arm for 5 days now.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Vaccine injection site was sore for the first few days following vaccination. On 4/1/10, pt reported increasing discomfort, redness and hardness at the injection site.  Reported tender to touch.  Vaccine provider notified by phone 4/2/10. Recommended ice and call to MD. On 4/3/10, pt was prescribed cephalexin 500mg three times a day for 7 days.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Hypotension, Peripheral coldness, Syncope
Clinical narrative: fainting, sweating and cold at extremities, hypotension
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed mood, Influenza like illness, Malaise, Pyrexia, Vertigo
Clinical narrative: Slight fever; general malaise; vertigo; flu-like symptoms; depression of mood
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Hypothyroidism, Type 1 diabetes mellitus
Clinical narrative: frequent drinking and urinating over a period of a couple weeks  diagnosed with type 1 diabetes and hypo-thyroidism
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Hypothyroidism, Laboratory test, Pollakiuria, Polydipsia, Type 1 diabetes mellitus
Clinical narrative: frequent drinking and urinating over a period of a couple weeks  diagnosed with type 1 diabetes and hypo-thyroidism
Age: 12.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Sick relative, Type 1 diabetes mellitus
Clinical narrative: frequent drinking and urinating
Age: 12.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Laboratory test, Pollakiuria, Polydipsia, Type 1 diabetes mellitus
Clinical narrative: frequent drinking and urinating
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac flutter, Dizziness, Tremor
Clinical narrative: Dizziness, lightheaded, heart fluttering, tremors
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Injection site pain, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: stiffness of left arm and pain where injection of PPV Vacine..with severe rash and inflammation the following day
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Skin warm
Clinical narrative: stiffness of left arm and pain where injection of PPV Vacine..with severe rash and inflammation the following day
Age: 1.75
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 101.8 starting on 4/3/10 and spiked to 103.1 on 4/4/10. Tylenol given without relief- Motrin given.  Fever resolved after 24 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia facial
Clinical narrative: Zoster vaccine given 8/20/09 in afternoon. Pox (L) forehead 8/27/09. Numbness left side of face from cheek to chin from 8/28 - 8/31/09. Resolved by 9/1/09.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Apnoea, Cardiovascular function test, Neurological examination, Pulmonary function test
Clinical narrative: Lethargic after vaccine was administered. No temperature. Heavy sleep at night (unusual for him). ALTE approx 16 hours later. Patient stopped breathing. Blue lips and face. CPR administered.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Apparent life threatening event, Cyanosis, Hypersomnia, Lethargy, Respiratory arrest
Clinical narrative: Lethargic after vaccine was administered. No temperature. Heavy sleep at night (unusual for him). ALTE approx 16 hours later. Patient stopped breathing. Blue lips and face. CPR administered.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Resuscitation
Clinical narrative: Lethargic after vaccine was administered. No temperature. Heavy sleep at night (unusual for him). ALTE approx 16 hours later. Patient stopped breathing. Blue lips and face. CPR administered.
Age: 1.36
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Contusion, Full blood count, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Vaccine administered 2/1/2010. Bruises on 2/13/2010. Rash on 2/19/10 seen in office. OBC. Platelet count 48. Idiopathic Thrombocytopenia.
Age: 1.36
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Contusion, Full blood count, Idiopathic thrombocytopenic purpura, Platelet count decreased, Platelet count increased
Clinical narrative: Vaccine administered 2/1/2010. Bruises on 2/13/2010. Rash on 2/19/10 seen in office. OBC. Platelet count 48. Idiopathic Thrombocytopenia.
Age: 1.36
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Vaccine administered 2/1/2010. Bruises on 2/13/2010. Rash on 2/19/10 seen in office. OBC. Platelet count 48. Idiopathic Thrombocytopenia.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nervousness, Pain, Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient came into the pharmacy one day after vaccination and had a zoster like rash at the injection site and had some pain and cellulitis. At the time of the report, the patient's status was unknown. Follow-up information has been received from the pharmacist concerning a 88 year old female patient who on 22-MAR-2010 was vaccinated with a dose of ZOSTAVAX (Merck). When the patient arrived at the pharmacy for vaccination she was too shaky to complete the paperwork. Several days later she developed a rash that was diagnosed as shingles and prescribed VALTREX and LORTAB. On 28-MAR-2010 the patient became confused "like a stroke" and called the pharmacy and it was recommended that she go to the ER. Instead she went to a relative's home and passed away during that night. The cause of death may have been a subdural (reported as "subdermal") hematoma as the result of a fall. Upon internal review, "like a stroke" was determined to be an other important medical event. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Cerebrovascular accident, Confusional state, Death, Fall
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient came into the pharmacy one day after vaccination and had a zoster like rash at the injection site and had some pain and cellulitis. At the time of the report, the patient's status was unknown. Follow-up information has been received from the pharmacist concerning a 88 year old female patient who on 22-MAR-2010 was vaccinated with a dose of ZOSTAVAX (Merck). When the patient arrived at the pharmacy for vaccination she was too shaky to complete the paperwork. Several days later she developed a rash that was diagnosed as shingles and prescribed VALTREX and LORTAB. On 28-MAR-2010 the patient became confused "like a stroke" and called the pharmacy and it was recommended that she go to the ER. Instead she went to a relative's home and passed away during that night. The cause of death may have been a subdural (reported as "subdermal") hematoma as the result of a fall. Upon internal review, "like a stroke" was determined to be an other important medical event. Additional information has been requested.