chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Pyrexia, Rash, Red blood cell count decreased, Skin exfoliation, Syncope
Clinical narrative: Within a week of the vaccination, she was tired, and she had a few nose bleeds (that were hard to stop). Her gums started bleeding when brushing her teeth a few weeks after the vaccine. She then started having high fevers around October 31, 2006,(103, 104, 105)and was eventually hospitalized on November 7, 2007, after a blood test revealed that her blood platelet count was down to 16,000. She had two chest x-rays that were normal. She was diagnosed as having high fever, a low platelet count (platelets got as low as 7,000), and low red blood cells count (which resulted in anemia). While hospitalized, she was twice treated with IVIG that caused her platelet count to rise. She also received intravenous antibiotic treatments that she did not respond to. She was also given Tylenol and later Motrin while hospitalized to control the fever. She is now taking Prednisone for a short period. In addition, she is taking iron pills and Protonix (to protect her stomach from the affects of the steroid medicine). While hospitalized, she also had a CAT Scan (of the head) and ultrasounds of her abdominal area (tests were normal).  12/06/2007 MR received for DOS 11/7-17/2007 with D/C DX:  Evan's Syndrome. Presented to local ED with fever x days, thrombocytopenia and anemia. Pt initially developed cough, rhinorrhea, fatigue and fever. Treated symptomatically for suspected viral infection.  Pt developed increasing fatigue and difficulty leaving bed.  Seen again by PCP with labs and CXR done.  Admitted for further w/u of FUO and thromobcytopenia.  PE (+) for purpura of the external ear, lip ecchymosis (blood blisters), violaceous scaly skin patches involving the malar eminence, and upper extremities. Started on abx and IVIG PMH: Skin disorder x 1.5-2 yrs c/w granuloma annulare.  Rash on face/cutaneous lesions c/w Lupus.  Constipation.  Recurrent sinus infections. Pt developed nausea, dizziness and blurred vision and had a near syncopal episode.  New onset RUQ pain on day 8 with increased LFTs.  Multiple consults by Heme/Onc, Rheum, GI, Neuro and ID. DX of Evan's Syndrome on Day 10 and tx with steroids begun to be continued and F/U as outpt. Per 60 day follow up: She is still experiencing low platelets, which is being controlled by steroid usage (presnisone). 1/15/2010 Patient rec'd other vaccine, hep A on 7/31/08 and she had to be readmitted to the hospital she experienced hair loss, skin rash, fevers, low plackets and joint pain.
Age: 7.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Ultrasound abdomen normal, White blood cell count
Clinical narrative: Within a week of the vaccination, she was tired, and she had a few nose bleeds (that were hard to stop). Her gums started bleeding when brushing her teeth a few weeks after the vaccine. She then started having high fevers around October 31, 2006,(103, 104, 105)and was eventually hospitalized on November 7, 2007, after a blood test revealed that her blood platelet count was down to 16,000. She had two chest x-rays that were normal. She was diagnosed as having high fever, a low platelet count (platelets got as low as 7,000), and low red blood cells count (which resulted in anemia). While hospitalized, she was twice treated with IVIG that caused her platelet count to rise. She also received intravenous antibiotic treatments that she did not respond to. She was also given Tylenol and later Motrin while hospitalized to control the fever. She is now taking Prednisone for a short period. In addition, she is taking iron pills and Protonix (to protect her stomach from the affects of the steroid medicine). While hospitalized, she also had a CAT Scan (of the head) and ultrasounds of her abdominal area (tests were normal).  12/06/2007 MR received for DOS 11/7-17/2007 with D/C DX:  Evan's Syndrome. Presented to local ED with fever x days, thrombocytopenia and anemia. Pt initially developed cough, rhinorrhea, fatigue and fever. Treated symptomatically for suspected viral infection.  Pt developed increasing fatigue and difficulty leaving bed.  Seen again by PCP with labs and CXR done.  Admitted for further w/u of FUO and thromobcytopenia.  PE (+) for purpura of the external ear, lip ecchymosis (blood blisters), violaceous scaly skin patches involving the malar eminence, and upper extremities. Started on abx and IVIG PMH: Skin disorder x 1.5-2 yrs c/w granuloma annulare.  Rash on face/cutaneous lesions c/w Lupus.  Constipation.  Recurrent sinus infections. Pt developed nausea, dizziness and blurred vision and had a near syncopal episode.  New onset RUQ pain on day 8 with increased LFTs.  Multiple consults by Heme/Onc, Rheum, GI, Neuro and ID. DX of Evan's Syndrome on Day 10 and tx with steroids begun to be continued and F/U as outpt. Per 60 day follow up: She is still experiencing low platelets, which is being controlled by steroid usage (presnisone). 1/15/2010 Patient rec'd other vaccine, hep A on 7/31/08 and she had to be readmitted to the hospital she experienced hair loss, skin rash, fevers, low plackets and joint pain.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Fatigue, Headache, Intensive care
Clinical narrative: approximately 10 days after influenza vaccine developed Headache, lassitude and fever to 104 and then mental status changes. Currently intubated with questionable early ADEM in our PICU. 12/10/07-interim records received-patient remains in hospital. DOS 11/20/07-altered mental status. Since Sunday, fever, then sleepy, clenching teeth for several days and unable to take oral medications. Unresponsive with short intermittant eye opening since Sunday.  In route to hospital had a 10-15 minute period of lost of consciousness and coded. PE: eyes fixed to left, teeth clenched, deceribrate posturing, unresponsive to painful stimuli, intermittently whimpers. Intubated.  2/5/08-DC summary received for DOS-11/20-12/27/07-DC DX: Hyper-IgE versus acute disseminated encephalomyelitis. Status epilepticus. Dishcarged to rehab.  Withdrawal symtpoms from Ativan with tachycardia. Per 60 day follow up: Partial recovered from the events. Pt remain on steroids, TRILEPTAL & KEPPRA but is now back in school. Lots of weight gain from steroids.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Intubation, Leukoencephalomyelitis, Liver function test normal, Lumbar puncture normal, Mental status changes
Clinical narrative: approximately 10 days after influenza vaccine developed Headache, lassitude and fever to 104 and then mental status changes. Currently intubated with questionable early ADEM in our PICU. 12/10/07-interim records received-patient remains in hospital. DOS 11/20/07-altered mental status. Since Sunday, fever, then sleepy, clenching teeth for several days and unable to take oral medications. Unresponsive with short intermittant eye opening since Sunday.  In route to hospital had a 10-15 minute period of lost of consciousness and coded. PE: eyes fixed to left, teeth clenched, deceribrate posturing, unresponsive to painful stimuli, intermittently whimpers. Intubated.  2/5/08-DC summary received for DOS-11/20-12/27/07-DC DX: Hyper-IgE versus acute disseminated encephalomyelitis. Status epilepticus. Dishcarged to rehab.  Withdrawal symtpoms from Ativan with tachycardia. Per 60 day follow up: Partial recovered from the events. Pt remain on steroids, TRILEPTAL & KEPPRA but is now back in school. Lots of weight gain from steroids.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Polymerase chain reaction, Pyrexia
Clinical narrative: approximately 10 days after influenza vaccine developed Headache, lassitude and fever to 104 and then mental status changes. Currently intubated with questionable early ADEM in our PICU. 12/10/07-interim records received-patient remains in hospital. DOS 11/20/07-altered mental status. Since Sunday, fever, then sleepy, clenching teeth for several days and unable to take oral medications. Unresponsive with short intermittant eye opening since Sunday.  In route to hospital had a 10-15 minute period of lost of consciousness and coded. PE: eyes fixed to left, teeth clenched, deceribrate posturing, unresponsive to painful stimuli, intermittently whimpers. Intubated.  2/5/08-DC summary received for DOS-11/20-12/27/07-DC DX: Hyper-IgE versus acute disseminated encephalomyelitis. Status epilepticus. Dishcarged to rehab.  Withdrawal symtpoms from Ativan with tachycardia. Per 60 day follow up: Partial recovered from the events. Pt remain on steroids, TRILEPTAL & KEPPRA but is now back in school. Lots of weight gain from steroids.
Sex: U
Vaccine: HEPA, HPVX
Symptoms: Rash
Clinical narrative: rash
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Pain in extremity
Clinical narrative: Patient has had persistent arm pain since administration of Gardasil.  She also may have a cellulitis at the site of administration, but this far out it is difficult to tell if that's where it was given.  She had arm pain immediately after it was given, however.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient comes to the clinic today with a rash on her left arm.  She states that she got a Pneumovax in the office here four days ago.  Two days later she had fever and shaking chills.  Since then the area is warm swollen and red.  She also has body aches.  Now, the rash  is moving down the arm towards the elbow. She denies fever or chills today, SOB, no chest pains or pressures. Orders  Sulfamethoxazole-TMP DS 800-160 MG Tablet;TAKE 1 TABLET TWICE DAILY; Qty20; R0; Rx
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Tremor
Clinical narrative: Patient comes to the clinic today with a rash on her left arm.  She states that she got a Pneumovax in the office here four days ago.  Two days later she had fever and shaking chills.  Since then the area is warm swollen and red.  She also has body aches.  Now, the rash  is moving down the arm towards the elbow. She denies fever or chills today, SOB, no chest pains or pressures. Orders  Sulfamethoxazole-TMP DS 800-160 MG Tablet;TAKE 1 TABLET TWICE DAILY; Qty20; R0; Rx
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Jaw disorder, Swelling
Clinical narrative: 245 hours after vaccine pt complained of swelling in jaw
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS/SWELLING AROUND INJECTION SITES, INJECTION SITE HARD AND WARM TO THE TOUCH (ALL SYMPTOMS ON LEFT ARM)
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: PT RECEIVED ROTAVIRUS AT 15 WEEKS.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, No reaction on previous exposure to drug, Pruritus generalised
Clinical narrative: Patient's L arm became very sore the day after she got the shot.  She became itchy all over her the body the next day. She took benedryl for the itching and it stopped but the arm soreness never did go away, even though approximately two weeks have lapsed since she got the shot.She stated that she has been getting the flu shots for many years and has never had a reaction before.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Pt. complained of fever, chills and body aches lasting approximately 24 hrs.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU3, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Rash erythematous, Rash papular
Clinical narrative: 11-21-07 Suddenly developed diffused eryth. rash ears, neck, and upper chest 5 min. post receipt of  vaccines. There were also few papular rash over the upper chest.  Rash gradually resolved  over 15-20  min. Left clinic without rash. No SOB, itching, no swelling of  lips. RX Benadryl 25 mg po now, 911 if dec. severe symptoms AD.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pneumovax in left deltoid. 24 hours later, redness from injection site to 8 cm distal. Warm to touch.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysphonia, Malaise, Nausea, Pharyngolaryngeal pain
Clinical narrative: Immediately after receiving the vaccination, I felt very nauseated and dizzy.  I left work early to go home because I was not feeling well. Later, that day I was very, very hoarse, with a very sore throat. I took the afternoon off and purchased some over the counter sore throat medicine and took some Benadryl Allergy Sinus Medicine.  Thanks to the vaccination I missed the Thanksgiving holiday.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Sever rashes covering legs and arms developed over the two weeks following influenza immunization.  Treatment included Prednisone (80gs/day).
Age: 1.15
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash on abd, crusty, itchy.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Autopsy, Peripheral coldness, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: None stated.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Autopsy, Sudden infant death syndrome, Unevaluable event
Clinical narrative: None stated.
Age: 1.2
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC, FLU3, HIBV, MMR, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Seriousness criteria: Other-Medically Significant Initial report received from a health care provider on 08 November 2007. A 14-month-old male patient with a history of one febrile seizure, had received a right arm intramuscular injection of ActHIB, lot number UF195AA, and a left arm intramuscular injection of Fluzone No Preservative 2007-2008, lot number U2479AA, and a left arm subcutaneous injection of MMR manufactured by Merck, lot number 0183U and a right arm intramuscular injection of Pneumo (Prevnar) manufactured by Wyeth, lot number B47442E on 05 November 2007 at 09:30AM and later that evening, he developed a fever (temperature not specified) and experienced a febrile seizure. The event required a doctor visit or emergency room visit (not specified ) and experienced a febrile seizure. The event required a doctor visit or emergency room visit (not specified at the time of the report). The patient recovered from the event. The patient's history included one febrile seizure which occurred on 12 October 2007. No further information was provided.
Age: 1.2
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC, FLU3, HIBV, MMR, PNC
Symptoms: Condition aggravated, Febrile convulsion, Pyrexia
Clinical narrative: Seriousness criteria: Other-Medically Significant Initial report received from a health care provider on 08 November 2007. A 14-month-old male patient with a history of one febrile seizure, had received a right arm intramuscular injection of ActHIB, lot number UF195AA, and a left arm intramuscular injection of Fluzone No Preservative 2007-2008, lot number U2479AA, and a left arm subcutaneous injection of MMR manufactured by Merck, lot number 0183U and a right arm intramuscular injection of Pneumo (Prevnar) manufactured by Wyeth, lot number B47442E on 05 November 2007 at 09:30AM and later that evening, he developed a fever (temperature not specified) and experienced a febrile seizure. The event required a doctor visit or emergency room visit (not specified ) and experienced a febrile seizure. The event required a doctor visit or emergency room visit (not specified at the time of the report). The patient recovered from the event. The patient's history included one febrile seizure which occurred on 12 October 2007. No further information was provided.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Heat therapy, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a PharmD concerning a 67 year old female with arthritis who on 09-NOV-2007 was vaccinated intramuscularly in the deltoid muscle with 0.5ml Pneumovax 23 (lot# 9064U) and a influenza virus vaccine (manufacturer unknown) in the same arm but at a different site. Concomitant therapy included nabumetone (RELAFEN) and fosinopril sodium (MONOPRIL). Later in the day on 09-NOV-2007, the patient experienced pain and limited mobility in arm. The reaction became progressively more severe over the weekend. PharmD advise the patient to go to Urgent care. The patient was unable to be seen at Urgent care and took Ibuprofen, nabumetone (RELAFEN) and used a heating pad for symptomatic relief. The PharmD had not spoken with the patient since the weekend therefore the patient's outcome is unknown at the time of this report. The pharmD felt that the patient's pain and limited mobility in the arm were considered to be disabling. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a PharmD concerning a 67 year old female with arthritis who on 09-NOV-2007 was vaccinated intramuscularly in the deltoid muscle with 0.5ml Pneumovax 23 (lot# 9064U) and a influenza virus vaccine (manufacturer unknown) in the same arm but at a different site. Concomitant therapy included nabumetone (RELAFEN) and fosinopril sodium (MONOPRIL). Later in the day on 09-NOV-2007, the patient experienced pain and limited mobility in arm. The reaction became progressively more severe over the weekend. PharmD advise the patient to go to Urgent care. The patient was unable to be seen at Urgent care and took Ibuprofen, nabumetone (RELAFEN) and used a heating pad for symptomatic relief. The PharmD had not spoken with the patient since the weekend therefore the patient's outcome is unknown at the time of this report. The pharmD felt that the patient's pain and limited mobility in the arm were considered to be disabling. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning a 24 year old female friend with no reported medical history who on 31-OCT-2007 was vaccinated with Gardasil. Concomitant therapy received on the same day included tetanus toxoid and medroxyprogesterone acetate (DEPO-PROVERA). The representative reported that on approximately 12-NOV-2007 her friend who received the vaccine developed paralysis and said it was "creeping up her body and she is experiencing tingling and numbness, which is making it difficult to walk". The patient had been taken to the emergency room but specifics are unknown. No further information was provided. No lot number was given. Lab diagnostics included blood tests at the emergency room but no results were given. The patient had not recovered. Paralysis was considered to be immediately life threatening. Additional information has been requested. 7/10/08-records received for DOS 11/14/07-Impression:numbness in extremities per patient. Presented with C/O numbness in hands and elbows bilaterally, started two days ago and getting progressively worse. Seen in ED. PE:normal, including neuro exam.  Follow-up information was received from a physician who reported that the patient's symptoms began on 12-NOV-2007. The patient went to the emergency room on 13-NOV-2007, but was not diagnosed with anything and was not admitted. The patient went to see her physician for the first time on 14-NOV-2007. The physician reported that examined her and sent her home. The patient's boyfriend researched the internet and called the physician as he felt the patient my have been suffering from [[name]] BARRRE because her symptoms were worsening. The physician instructed them to go to the emergency room. The patient was admitted on 14-NOV-2007 and was diagnosed with [[name]] BARRE syndrome. The physician did not know who the patients primary care physician was, nor did he know the name of the doctor that treated her at the hospital. He has not received a discharge summary of the hospitalization on 14-NOV-2007, and is not sure if the patient provided his name as the primary care physician. The physician reported that the patient did not receive MENACTRA. She had no pertinent medical history and no allergies. The physician reported that the patient had some slurred speech yesterday when he called to follow up on her status. The physician also reported that as far as he knows the patient is "in patient" at the hospital as of 05-DEC-2007. The physician has not received any lab diagnostic test result of EMG results and was not sure if he will obtain any unless the patient listed him as the primary care physician. [[name]] BARRE was considered to be immediately life threatening and disabling. Follow-up information indicated that the physician had no further contact with the patient. No further information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia, Laboratory test
Clinical narrative: Information has been received from a consumer concerning a 24 year old female friend with no reported medical history who on 31-OCT-2007 was vaccinated with Gardasil. Concomitant therapy received on the same day included tetanus toxoid and medroxyprogesterone acetate (DEPO-PROVERA). The representative reported that on approximately 12-NOV-2007 her friend who received the vaccine developed paralysis and said it was "creeping up her body and she is experiencing tingling and numbness, which is making it difficult to walk". The patient had been taken to the emergency room but specifics are unknown. No further information was provided. No lot number was given. Lab diagnostics included blood tests at the emergency room but no results were given. The patient had not recovered. Paralysis was considered to be immediately life threatening. Additional information has been requested. 7/10/08-records received for DOS 11/14/07-Impression:numbness in extremities per patient. Presented with C/O numbness in hands and elbows bilaterally, started two days ago and getting progressively worse. Seen in ED. PE:normal, including neuro exam.  Follow-up information was received from a physician who reported that the patient's symptoms began on 12-NOV-2007. The patient went to the emergency room on 13-NOV-2007, but was not diagnosed with anything and was not admitted. The patient went to see her physician for the first time on 14-NOV-2007. The physician reported that examined her and sent her home. The patient's boyfriend researched the internet and called the physician as he felt the patient my have been suffering from [[name]] BARRRE because her symptoms were worsening. The physician instructed them to go to the emergency room. The patient was admitted on 14-NOV-2007 and was diagnosed with [[name]] BARRE syndrome. The physician did not know who the patients primary care physician was, nor did he know the name of the doctor that treated her at the hospital. He has not received a discharge summary of the hospitalization on 14-NOV-2007, and is not sure if the patient provided his name as the primary care physician. The physician reported that the patient did not receive MENACTRA. She had no pertinent medical history and no allergies. The physician reported that the patient had some slurred speech yesterday when he called to follow up on her status. The physician also reported that as far as he knows the patient is "in patient" at the hospital as of 05-DEC-2007. The physician has not received any lab diagnostic test result of EMG results and was not sure if he will obtain any unless the patient listed him as the primary care physician. [[name]] BARRE was considered to be immediately life threatening and disabling. Follow-up information indicated that the physician had no further contact with the patient. No further information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Paraesthesia, Paralysis
Clinical narrative: Information has been received from a consumer concerning a 24 year old female friend with no reported medical history who on 31-OCT-2007 was vaccinated with Gardasil. Concomitant therapy received on the same day included tetanus toxoid and medroxyprogesterone acetate (DEPO-PROVERA). The representative reported that on approximately 12-NOV-2007 her friend who received the vaccine developed paralysis and said it was "creeping up her body and she is experiencing tingling and numbness, which is making it difficult to walk". The patient had been taken to the emergency room but specifics are unknown. No further information was provided. No lot number was given. Lab diagnostics included blood tests at the emergency room but no results were given. The patient had not recovered. Paralysis was considered to be immediately life threatening. Additional information has been requested. 7/10/08-records received for DOS 11/14/07-Impression:numbness in extremities per patient. Presented with C/O numbness in hands and elbows bilaterally, started two days ago and getting progressively worse. Seen in ED. PE:normal, including neuro exam.  Follow-up information was received from a physician who reported that the patient's symptoms began on 12-NOV-2007. The patient went to the emergency room on 13-NOV-2007, but was not diagnosed with anything and was not admitted. The patient went to see her physician for the first time on 14-NOV-2007. The physician reported that examined her and sent her home. The patient's boyfriend researched the internet and called the physician as he felt the patient my have been suffering from [[name]] BARRRE because her symptoms were worsening. The physician instructed them to go to the emergency room. The patient was admitted on 14-NOV-2007 and was diagnosed with [[name]] BARRE syndrome. The physician did not know who the patients primary care physician was, nor did he know the name of the doctor that treated her at the hospital. He has not received a discharge summary of the hospitalization on 14-NOV-2007, and is not sure if the patient provided his name as the primary care physician. The physician reported that the patient did not receive MENACTRA. She had no pertinent medical history and no allergies. The physician reported that the patient had some slurred speech yesterday when he called to follow up on her status. The physician also reported that as far as he knows the patient is "in patient" at the hospital as of 05-DEC-2007. The physician has not received any lab diagnostic test result of EMG results and was not sure if he will obtain any unless the patient listed him as the primary care physician. [[name]] BARRE was considered to be immediately life threatening and disabling. Follow-up information indicated that the physician had no further contact with the patient. No further information is expected.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cyanosis, Fatigue, Unresponsive to stimuli
Clinical narrative: 2day hx of extra tired after shots. No other symptoms (D) 2 after shots/found non responsive/cyanotic/face down.  11/30/07 Reviewed vax record from pcp which confirms dose/lot as reported & provided vax date of 10/17/2007.  1/8/07 Reviewed autopsy report which states COD as SIDS.  Other finding at autopsy was probe patent foramen ovale.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Intra-uterine death, Laboratory test
Clinical narrative: Information has been received through the Merck pregnancy registry, from a physician, concerning a 19 year old female who in March 2007, was vaccinated with a second dose of Gardasil. Subsequently the patient received her two doses of the vaccine and then became pregnant. Unspecified medical attention was sought. Follow up information received from the mother of the patient, indicated that in September 2006, her daughter received the first dose of Gardasil, on an unknown date the second dose, and in February 2007 the third dose of Gardasil (lot #'s not provided). She reported her daughter became pregnant in April 2007. In November, when 7 months pregnant, her daughter was admitted to the hospital for abdominal pain, and on 04-NOV-2007, she "lost her baby." The child "had no heartbeat and was dead for a week in her womb. The child was not fully formed." She added that the fetus's eyes, ears and nose were not fully developed. Her daughter remained in the hospital for "about a week." At the time of this report, she was recovering from the event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician's assistant concerning a 12 year old female with no reported medical history who on approximately 15-SEP-2007 was vaccinated with Gardasil. It was noted that this was not where the vaccine was administered, rather they were the patient's family physician. On 06-OCT-2007 the patient died in her sleep. No further information was provided. No lot number was given. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Disturbance in attention, Dysgeusia, Fall, Grand mal convulsion, Headache
Clinical narrative: Information has been received from a pharmacist concerning his 15 year old daughter who in September 2007 was vaccinated with Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). A couple minutes after getting the vaccination, the patient suffered a grand mal seizure and fell on the ground in the office. She recovered from the grand mal seizure and was sent home. The pharmacist's wife reported that a couple weeks after the vaccination, her daughter could not focus and would forget things. The symptoms caused problems in school, and her grades dropped. It was also reported that the patient had bad headaches, a lack of concentration, a change in personality, nausea and tasted blood in her mouth. In the last two weeks, the symptoms worsened. The patient is having daily headaches and petit mal seizures. She is going to be seen by a neurologist. At the time of this report, the symptoms persisted. The pharmacist considered his daughter's symptoms to be disabling. Additional information has been requested.  3/24/2009 MR received from CDC.  Case re-opened.  Neuro consult 11/26/07 with dx:  post vaccination encephalopathy. Pt may be having absence seizures.  Generalized seizure after injection. Pt is intellectually impaired at this time. Per MR, pt had a tonic-clonic seizure a few minutes s/p Gardasil vax in 9/2007.  Post-ictal and sore afterwards.  since that time pt has had recurring staring spells, memory loss, dramatic drop in school grades (As to Fs), constant fatigue and confusion. Pt reports some visual disturbance of the L eye, H/As, occasional numbness of the hands and sphincter control issues. Currently being tx for UTI 2' to blood in the urine. Not fully oriented on exam.  PE WNL.  3/31/09 Additional records received from above neuro which include a neuropsychological eval dated 11/29-12/19/2007 with DX:  Conversion D/O. Adverse reaction to HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Immediate post-injection reaction, Memory impairment, Nausea, Personality change, Vision blurred
Clinical narrative: Information has been received from a pharmacist concerning his 15 year old daughter who in September 2007 was vaccinated with Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). A couple minutes after getting the vaccination, the patient suffered a grand mal seizure and fell on the ground in the office. She recovered from the grand mal seizure and was sent home. The pharmacist's wife reported that a couple weeks after the vaccination, her daughter could not focus and would forget things. The symptoms caused problems in school, and her grades dropped. It was also reported that the patient had bad headaches, a lack of concentration, a change in personality, nausea and tasted blood in her mouth. In the last two weeks, the symptoms worsened. The patient is having daily headaches and petit mal seizures. She is going to be seen by a neurologist. At the time of this report, the symptoms persisted. The pharmacist considered his daughter's symptoms to be disabling. Additional information has been requested.  3/24/2009 MR received from CDC.  Case re-opened.  Neuro consult 11/26/07 with dx:  post vaccination encephalopathy. Pt may be having absence seizures.  Generalized seizure after injection. Pt is intellectually impaired at this time. Per MR, pt had a tonic-clonic seizure a few minutes s/p Gardasil vax in 9/2007.  Post-ictal and sore afterwards.  since that time pt has had recurring staring spells, memory loss, dramatic drop in school grades (As to Fs), constant fatigue and confusion. Pt reports some visual disturbance of the L eye, H/As, occasional numbness of the hands and sphincter control issues. Currently being tx for UTI 2' to blood in the urine. Not fully oriented on exam.  PE WNL.  3/31/09 Additional records received from above neuro which include a neuropsychological eval dated 11/29-12/19/2007 with DX:  Conversion D/O. Adverse reaction to HPV vaccine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pain in extremity, Pharyngeal oedema, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female with depression, anxiety and gastroesophageal reflux disease and a history of drug hypersensitivity to PREDNISONE, ZOLOFT and "BENREX" who on 19-OCT-2007 was vaccinated intramuscularly with a 0.5ml dose of Gardasil (lot# 657621/0387U). Concomitant therapy included PRILOSEC, DIFENTUM, EFFEXOR, SEROQUEL and ORTHO TRI-CYCLEN. On 19-OCT-2007, the patient experienced difficulty breathing with possible throat swelling post vaccination. The patient also had arm pain and bumps on arm (not specific). The patient was treated in the emergency room with VISTARIL and ULTRAM and was hospitalized overnight. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 16 or 17 year old female who on an unspecified date was vaccinated with Gardasil (lot# unknown). On an unspecified date the patient had a seizure at home. Medical attention was sought. The patient went to the emergency room and her pediatrician ordered unspecified tests. The patient may have received an IUD (intrauterine device) at the same office visit as the Gardasil vaccination. At the time of reporting it was unknown if the patient had recovered; "there has been no determination on the seizures". No other details were available. upon internal review, seizures is considered to be an other medical event (OME). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a female with no known drug reactions/allergies who on an unspecified date was vaccinated with Pneumovax 23 single dose vaccine, injection. After receiving a single dose of Pneumovax 23, the patient developed "what looked like a bad case of cellulitis," and the arm where the dose was administered (unspecified) was very large and profound. A complete blood count revealed the patient's white cell count went "way up (results not provided)." Subsequently the patient was admitted to the hospital for an unspecified amount of time. On 13-NOV-2007 the physician received a telephone call saying the patient was "okay" and had been released. It was reported the patient had recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Neuropathy
Clinical narrative: Information has been received from a 66 year old male with acid reflux, asthma and a balance problem associated with the inner ear, ringing in his ears and no known drug reactions/reactions who two years ago in November 2005, was vaccinated with an unspecified pneumonia vaccine (manufacturer unknown). Concomitant therapy included atenolol, an unspecified acid reflux medication and unspecified asthma medication. Two years ago in November 2005, after receiving the vaccine, the patient developed cellulitis which began on his arm and traveled to his feet which turned black and blue. He was hospitalized for three weeks. On an unspecified date the patient recovered from the events. At the time of this report (13-NOV-2007) the patient was suffering from neuropathy in both ankles due to his cellulitis. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Abscess limb
Clinical narrative: Information has been received from an office manager concerning a 51 year old female who on 08-NOV-2007 was vaccinated with Pneumovax 23 single dose series vaccine, injection, in the right arm (lot # 658673/0990U). Concomitant therapy included esomeprazole magnesium (NEXIUM), clonazepam (KLONOPIN) and promethazine. It was reported that after the patient received her Pneumovax 23 vaccine, she had developed an abscess in her right arm where she received the vaccination. The patient had gone to the emergency room (ER) and told the physician there that she had received Pneumovax 23 vaccine at her physician's office. Subsequently the patient was admitted to the hospital (date unspecified), and as of 13-NOV-2007, was still there and recovering from the event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Laboratory test, Vomiting
Clinical narrative: Information has been received from a physician and a nurse concerning a 4 month old male (also reported as 19 weeks old) who on 23-AUG-2007 was vaccinated with Rotateq (Lot # 657615/008U). Concomitant therapy included ActHIB, Prevnar and Pediarix all given on 23-AUG-2007. The physician reported that the patient experienced vomiting and blood in the stool and on 06-NOV-2007 the patient was diagnosed with intussusception. The nurse reported that the patient had surgery and is "doing fairly well now." Additional information has been requested.  11/28/2007 Vax record received.  Info updated in VAERS database. 02/01/2008 MR received for DOS 11/6-7/2007 with D/C DX: Dehydration. 2' DX: Intussusception s/p reduction by air enema. Pt presented to ER with 2 day hx of crampy abdominal pain, and intermittant lethargy, nausea and vomiting. Decreased UO and PO intake.  IS noted on Air enema and reduced by same. Pt had one bloody bowel movement then a normal one following. D/C home next day with good po intake and UO.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal faeces, Acidosis, Choking, Cyanosis, Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 2-month-old full term otherwise healthy male with gastroesophageal reflux disease and no drug reactions/allergies who on 08-NOV-2007 was vaccinated with a first 2mL PO dose of Rotateq. Concomitant therapy that day included DTaP (unspecified), Prevnar, and HIB (manufacturer unknown). On 14-NOV-2007, 6 days after receiving the first dose of Rotateq, the patient was seen in the emergency room after experiencing "choking" and "turned blue". The patient also had a fever, vomited twice, and "looked a little dry". Bloodwork showed acidosis. The patient was admitted to the hospital, and was also noted to have multiple episodes of foul-smelling, explosive stool. The stool was positive for rotavirus. Subsequently the patient was diagnosed with rotavirus. The patient was hospitalized with respiratory difficulties, choking, and diarrhea. At the time of the report, the patient was still hospitalized. The patient was noted to be "feeling better", with 3-4 subsequent epsidoes of watery stool, and vomited twice. Acidosis has resolved. The patient is breastfed, and not in daycare. It was noted that the mother and sibling were ill 3 weeks prior with a diarrheal illness that lasted 24 hours. Laboratory diagnostic studies performed included: complete blood count, basic metabolic profile with electrolytes, and rotavirus screen. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dry skin, Full blood count, Liver function test, Metabolic function test abnormal, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 2-month-old full term otherwise healthy male with gastroesophageal reflux disease and no drug reactions/allergies who on 08-NOV-2007 was vaccinated with a first 2mL PO dose of Rotateq. Concomitant therapy that day included DTaP (unspecified), Prevnar, and HIB (manufacturer unknown). On 14-NOV-2007, 6 days after receiving the first dose of Rotateq, the patient was seen in the emergency room after experiencing "choking" and "turned blue". The patient also had a fever, vomited twice, and "looked a little dry". Bloodwork showed acidosis. The patient was admitted to the hospital, and was also noted to have multiple episodes of foul-smelling, explosive stool. The stool was positive for rotavirus. Subsequently the patient was diagnosed with rotavirus. The patient was hospitalized with respiratory difficulties, choking, and diarrhea. At the time of the report, the patient was still hospitalized. The patient was noted to be "feeling better", with 3-4 subsequent epsidoes of watery stool, and vomited twice. Acidosis has resolved. The patient is breastfed, and not in daycare. It was noted that the mother and sibling were ill 3 weeks prior with a diarrheal illness that lasted 24 hours. Laboratory diagnostic studies performed included: complete blood count, basic metabolic profile with electrolytes, and rotavirus screen. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 2-month-old full term otherwise healthy male with gastroesophageal reflux disease and no drug reactions/allergies who on 08-NOV-2007 was vaccinated with a first 2mL PO dose of Rotateq. Concomitant therapy that day included DTaP (unspecified), Prevnar, and HIB (manufacturer unknown). On 14-NOV-2007, 6 days after receiving the first dose of Rotateq, the patient was seen in the emergency room after experiencing "choking" and "turned blue". The patient also had a fever, vomited twice, and "looked a little dry". Bloodwork showed acidosis. The patient was admitted to the hospital, and was also noted to have multiple episodes of foul-smelling, explosive stool. The stool was positive for rotavirus. Subsequently the patient was diagnosed with rotavirus. The patient was hospitalized with respiratory difficulties, choking, and diarrhea. At the time of the report, the patient was still hospitalized. The patient was noted to be "feeling better", with 3-4 subsequent epsidoes of watery stool, and vomited twice. Acidosis has resolved. The patient is breastfed, and not in daycare. It was noted that the mother and sibling were ill 3 weeks prior with a diarrheal illness that lasted 24 hours. Laboratory diagnostic studies performed included: complete blood count, basic metabolic profile with electrolytes, and rotavirus screen. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Choking, Dehydration, Diarrhoea, Full blood count
Clinical narrative: Information has been received from a registered nurse concerning a 2-month-old full term otherwise healthy male with gastroesophageal reflux disease and no drug reactions/allergies who on 08-NOV-2007 was vaccinated with a first 2mL PO dose of Rotateq. Concomitant therapy that day included DTaP (unspecified), Prevnar, and HIB (manufacturer unknown). On 14-NOV-2007, 6 days after receiving the first dose of Rotateq, the patient was seen in the emergency room after experiencing "choking" and "turned blue". The patient also had a fever, vomited twice, and "looked a little dry". Bloodwork showed acidosis. The patient was admitted to the hospital, and was also noted to have multiple episodes of foul-smelling, explosive stool. The stool was positive for rotavirus. Subsequently the patient was diagnosed with rotavirus. The patient was hospitalized with respiratory difficulties, choking, and diarrhea. At the time of the report, the patient was still hospitalized. The patient was noted to be "feeling better", with 3-4 subsequent epsidoes of watery stool, and vomited twice. Acidosis has resolved. The patient is breastfed, and not in daycare. It was noted that the mother and sibling were ill 3 weeks prior with a diarrheal illness that lasted 24 hours. Laboratory diagnostic studies performed included: complete blood count, basic metabolic profile with electrolytes, and rotavirus screen. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test, Respiratory arrest, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 2-month-old full term otherwise healthy male with gastroesophageal reflux disease and no drug reactions/allergies who on 08-NOV-2007 was vaccinated with a first 2mL PO dose of Rotateq. Concomitant therapy that day included DTaP (unspecified), Prevnar, and HIB (manufacturer unknown). On 14-NOV-2007, 6 days after receiving the first dose of Rotateq, the patient was seen in the emergency room after experiencing "choking" and "turned blue". The patient also had a fever, vomited twice, and "looked a little dry". Bloodwork showed acidosis. The patient was admitted to the hospital, and was also noted to have multiple episodes of foul-smelling, explosive stool. The stool was positive for rotavirus. Subsequently the patient was diagnosed with rotavirus. The patient was hospitalized with respiratory difficulties, choking, and diarrhea. At the time of the report, the patient was still hospitalized. The patient was noted to be "feeling better", with 3-4 subsequent epsidoes of watery stool, and vomited twice. Acidosis has resolved. The patient is breastfed, and not in daycare. It was noted that the mother and sibling were ill 3 weeks prior with a diarrheal illness that lasted 24 hours. Laboratory diagnostic studies performed included: complete blood count, basic metabolic profile with electrolytes, and rotavirus screen. There was no product quality complaint. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Diarrhoea, Gastroenteritis viral, Headache, Lumbar puncture normal
Clinical narrative: Initial report received on 13 November 2007 from a health care professional. A 35-year-old female patient, with no concurrent illnesses, or pre-existing medical conditions, had received a right deltoid dose of Decavac, lot number U1961EA, on 06 November 2007. The route of administration was not provided. The following day, the patient presented to the emergency room with complaint of headache, neck pain, temperature of 101.5 degrees Fahrenheit, nausea, and diarrhea. She was treated with intravenous fluids, Rocephin, and Toradol, and was diagnosed with viral gastroenteritis. A lumbar puncture was completed and was negative for meningitis. The patient was discharged to home the same day with Vicodin for her headache. At the time of this report, it was "unknown" if the patient had fully recovered. The reporter for this case is the same as for case 2007-03867.