chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Burning sensation mucosal, Dyspnoea, Hyperhidrosis, Oral pain, Pharyngolaryngeal pain
Clinical narrative: Pt received MMR and influenza shots at approx. 7AM, then reported to work as LPN at medical center.  At approx. 11AM he experienced sudden onset of a burning sensation in his mouth and throat and shortness of breath.  He was on his way to the ED when he experienced diaphoresis.  A medical alert was called and he was given epinephrine 0.3 mg SQ.  He was awake and alert, but complaining of difficulty breathing when the ED physician arrived on the scene.  He was tranported to the ED where he received Benadryl 50 mg IV and SoluMedrol 125 mg IV.  He was observed for 3 hours before being discharged to home.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Influenza, Laboratory test abnormal
Clinical narrative: 12-7-06 Patient flu shot pain began in right elbow one or two hours after receiving flu vaccine. Patient reports the joint was sensitive to touch and a sharp pain upon movement. Patient reports that the next day 12-8-06 the same pain moved to his left ankle then to the upper part of the Left side of his neck. He reports the pain more severe in this area. Next the pain moved to his Right knee he felt he could not straighten his leg. Patient reports pain then moved to his Left hand between his index and second fingers then to back of neck and it is (12-13-06) in his Left shoulder area. Patient reports pain now as "not bad" with a dull pain when he raises his arm. Patient reports he went to his family physician on 12-11-06 where he was given a steroid shot that "seems to have helped." At that visit to his physician the patient reports that lab work to rule out side effects of the Lipitor he takes was drawn and found to be negative. A flu test was performed and came back positive for flu. Patient reports not having experienced an adverse event with any flu shots in the future.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Lethargy, Tremor
Clinical narrative: Patient received vaccine in late afternoon. Wife stated patient awoke next am with extreme lethargy, unable to dress/feed himself, began having mild trembling. Trembling has ceased, remains lethargic and unable to dress/feed self. Wife reported condition to physician, who agreed pt was more lethargic.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Irritability, Rash, Skin ulcer
Clinical narrative: Patient developed rash 10 days after vaccine given. Rash on back,front, torso, legs free head and scalp 750 lesions. "Cranky".
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Rash
Clinical narrative: Received third dose of Rabies vaccine on 11/29/06. Returned to medical doctor on 11/30/2006 complained of rash for past 2-3 days and arthralgia of fingers for 1-2 days.  Treated with Prednisone and antihistamines. Symptoms resolved. Returned to medical doctor on 12/16/06. States that rash and arthralgia returned on 12/9/06. Medical doctor prescribed antihistamine and above.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Acne, Pruritus
Clinical narrative: Mother called this AM 0910, son told her he noticed "itchy pimples" last night. Per mom 6-8 pimple like bumps on back of leg, groin, and stomach. No fever.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Initial report received on 29/Aug/2006 from a health care provider. A 17 year old male patient had received an intramuscular, right deltoid injection of Adacel, lot number C2457A, on 10/Aug/2006. The next day, the patient developed "pain severe, nausea, vomiting, headache and fever at 101". At the time of this report, the patient had not recovered. Follow up information received on 03 October 2006 from a health care professional. The case was reviewed and there was no additional information at this time. The reporter in this case is the same as in case 2006-02300.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Muscular weakness, Pain, Swelling
Clinical narrative: Initial report received on 14/Sep/2006 from a health care provider. A patient, gender and age not provided, had received an intramuscular, left deltoid injection of Adacel, lot number not provided, on 12/Sep/2006. Two days later, the patient experienced weakness in the left arm, was unable to hold a cup in the left hand and had pain under the left armpit. Illness at the time of vaccination, other medications and past medical history were "not provided". "None of the above" was checked on the reporting form, in the box where information is requested concerning whether the patient was hospitalized or required an emergency room or doctor's visit. At the time of this report, the patient had not recovered. Follow up information received on 20 September 2006 from a health care professional. Two days post vaccination, the patient was examined in a physician's office and had a small amount of swelling in his left lymph node. Treatment included Ibuprofren for pain, and the application of ice. Adacel lot number was provided as C2406BA. The event did not require hospitalization, and no laboratory testing was needed. The patient recovered from the event and "is doing well."
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Medication error, Pregnancy test false positive
Clinical narrative: No adverse effect. Initial report received on 26 October 2006 from a health care professional. A 17 year old female patient, with no significant past medical history of obstetrician history, had received a .5mL left deltoid, intra-muscular injection of Adacel, lot number C2609AA, and a .5mL right deltoid, intra-muscular injection of Menactra, lot number U2150CA, on 26 October 2006. That afternoon, the patient found out that she was pregnancy with her first child. The date of her last menstrual period was on 15 September 2006. The expected date of delivery was not reported. For the reported, the patient has not experienced any adverse events since the administration of the Adacel and Menactra on 26/October/2006.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Contusion, Erythema, Feeling hot, Injection site induration
Clinical narrative: Initial report received from a physician in the USA on 02 November 2006. An 11 year old male patient felt warm (febrile) on the eve of his vaccination with Adacel (lot number C2609AA, route of administration not reported) in the right deltoid on 26 October 2006. At his visit to the ER on 29 October 2006, he had 10x5cm local redness, induration, and slight bruising was present on his right deltoid. The diagnosis was cellulitis and antibiotics were prescribed. He visited his doctor on 30 October 2006-the redness/induration were resolving but not completely gone. He had his last vaccine at 4-6 years old and he did not have any illness at the time of vaccination. The doctor was unsure of the needle length used. At the time of the report, the patient was not recovered.
Sex: U
Vaccine: TDAP
Symptoms: Hypoaesthesia, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: Initial report received on 01/09/2006 from a health care corporation. A cluster of four patients had received an injection of Adacel, lot number not reported, on an unspecified date. Routes and sties of administration were not reported. Per the reporter, "a hospital he deals with" had four patient who had experienced numbness in their hands, redness and soreness at the site and difficulty raising their arms post vaccination. Recovery status was not reported. Additional medically relevant information was not provided.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Cough decreased, Dry skin, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Initial report received on 29 September 2006 from the patient. A 29 year old female patient had received a first dose, intramuscular, left deltoid injection of Adacel, lot number not provided. on  19 September 2006. Eight to twelve hours later, the patient experience flu like signs and symptoms, fever, congestion, cough, and soreness and redness at the injection site. The patient also experienced a small dry area of skin above the injection site. The patient recovered from these events. It was also determined that the patient was pregnant. Her LMP was 29 August 2006, and her estimated date of delivery is 31 May 2007.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Nasal congestion, Pyrexia, Unintended pregnancy
Clinical narrative: Initial report received on 29 September 2006 from the patient. A 29 year old female patient had received a first dose, intramuscular, left deltoid injection of Adacel, lot number not provided. on  19 September 2006. Eight to twelve hours later, the patient experience flu like signs and symptoms, fever, congestion, cough, and soreness and redness at the injection site. The patient also experienced a small dry area of skin above the injection site. The patient recovered from these events. It was also determined that the patient was pregnant. Her LMP was 29 August 2006, and her estimated date of delivery is 31 May 2007.
Sex: U
Vaccine: TDAP
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Headache
Clinical narrative: Initial report received from a healthcare professional on 06 October 2006. An 11 year old female patient received a first dose of Adacel (lot number unknown), an intramuscular injection, into the left deltoid. The patient had not received any concomitant vaccines. The patient had allergies to dairies, egg, soy and wheat. The patients medical history included asthma and eczema and denies illness at the time of vaccination (03 October 2006). The patient did not have any problems following prior vaccinations. No specific information about prior exposure was provided. On 03 October 2006, within hours after the patient had received Adacel, the patient experienced fatigue, headache, decreased appetite and stomach pains. The patient was seen by a physician. It was not reported if any corrective treatment was given. At the time of this report (06 October 2006), the patient had not recovered.
Age: 27.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Blister
Clinical narrative: Employee received Varivax #1 12/1/06 along with Hep B #3 and MMR #1.  He reported to EH on 12/21/06 with vesicles on trunk, arms, neck, and head that he states started appearing on 12/18/06.  He states they worsened each day.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Carpal tunnel syndrome, Hypoaesthesia, Oedema peripheral, Paraesthesia
Clinical narrative: Received vaccination at work in a Hospital at approximately 9am on Monday, November 6, 2006 in my right upper arm.  Awakened at 3:30am the next morning, Tuesday, November 7, 2006 with severe tingling and numbness in BOTH hands.  I am left handed.  I have had NO history of numbness or tingling in either arm.  Was concerned about possible stroke or MI symptoms.  Took B/P at home and it registered 188/110.  Took 2 ASA and rechecked B/P several times.  Numbness and tingling and swelling in both hands did not subside.  Went to hospital OR (where I am employed) and rechecked by B/P there.  It was still 180/98.  Numbness and tingling persisted, so I presented at  Emergency Room and was seen by MD.  I was especially concerned about the left hand numbness as it was my dominant hand.  I have never had ANY problems with prior symptoms such as these before.  He examined me, drew lab work, and monitored my elevated B/P.  The digits involved in my hands were thumbs, index fingers, middle fingers, and the inner aspect of the ring fingers.  He diagnosed the problem as carpal tunnel and I was discharged with a left arm splint as this was my dominant hand.  I reported these symptoms to EOHS on Thursday morning, Novmeber 9th to see if any other prior reactions had been reported.  She called MD and there had been some report of Carpal Tunnel in the immunized side, but none bilaterally.  I, at no time, lost no time at work throughout this ordeal.  There was a time lapse between the immunization reporting and this document, because I had a conference for 10 days, then the day I returned, my Mother died and I had another week off for funeral arrangements and support for my Father.  I only mention this to explain the time lapses and delays between the occurrence and consultation with physicians.  The symptoms continued and still are present.  I tried Ibuprofin, but it provided no relief.  My internist at a Clinic was unavailable and I saw his colleague on Friday, December 8th @ 3:20pm (the soonest appointment available).  He confirmed the diagnosis of bilateral carpal tunnel and said I didn't need an EMG as the diagnosis was definitive to him.  They set up an appointment with a Hand Surgeon on Wednesday, December 27th @ 3:30pm which was the soonest I could see him also.  I await the visit and remedy and have seen the EOHS nurses several times for consultation.  I continue to wear bilateral hand splints and this seems to help some of the numbness, but it is still VERY present in the same 4 1/2 digits on both hands.  An employee incident was completed as requested by EOHS on December 6, 2006.  Note that I am due for my second dose of Rubella vaccine for employment, but it is suggested that I defer than until after this situation is resolved.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Pt was hospitalized 1/12/06 for uncomplicated childbirth.  Prior to discharge on 1/14/06, she was given influenza vaccine, pneumococcal vaccine (due to h/o splenectomy), and Depo Provera.  It appears all vaccines were given in right buttock.  Later that day, she developed general malaise, then sweats and chills.  Her temperature that evening was 102.  She presented to the ED on 1/15/06 with fever (100.4), sweats, and chills.  Exam revealed an area of 8-10 cm expanding erythema with induration at her injection site on right buttock.  Given her history of splenectomy related to Hodgkin's lymphoma, she was admitted for IV antibiotic therapy (Rocephin, vancomycin, and clindamycin) for right buttock cellulitis.  She was discharged to home two days later.  MR received revealing a 2 night admission for c/o fever, chills, and sweats one day following Pneumovax and Flu vax.   Pt. noted that she had a fever the evening of her vaccines, and the following day presented to the ER per her obstetrician's instructions. She was noted to have an 8-10 cm area of expanding erythema and induration on the right buttock at the injection sites.  She was admitted for IV antibiotic therapy for right buttock cellulitis. She was discharged home. Assessment: Right buttock cellulitis.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Pt was hospitalized 1/12/06 for uncomplicated childbirth.  Prior to discharge on 1/14/06, she was given influenza vaccine, pneumococcal vaccine (due to h/o splenectomy), and Depo Provera.  It appears all vaccines were given in right buttock.  Later that day, she developed general malaise, then sweats and chills.  Her temperature that evening was 102.  She presented to the ED on 1/15/06 with fever (100.4), sweats, and chills.  Exam revealed an area of 8-10 cm expanding erythema with induration at her injection site on right buttock.  Given her history of splenectomy related to Hodgkin's lymphoma, she was admitted for IV antibiotic therapy (Rocephin, vancomycin, and clindamycin) for right buttock cellulitis.  She was discharged to home two days later.  MR received revealing a 2 night admission for c/o fever, chills, and sweats one day following Pneumovax and Flu vax.   Pt. noted that she had a fever the evening of her vaccines, and the following day presented to the ER per her obstetrician's instructions. She was noted to have an 8-10 cm area of expanding erythema and induration on the right buttock at the injection sites.  She was admitted for IV antibiotic therapy for right buttock cellulitis. She was discharged home. Assessment: Right buttock cellulitis.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache, Pain, Pyrexia
Clinical narrative: mother called day after vaccination to report child woke in a.m. complaining of headache, stomachache, fever of 101, and achiness
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Blood pressure increased, Lipids decreased, Lymphopenia, Pruritus
Clinical narrative: Patient developed itching on trunk, groin, ax  illary, and blistering on wrist. Patient went to visit her doctor, her BP was 200/110, p/111.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: Patient developed itching on trunk, groin, ax  illary, and blistering on wrist. Patient went to visit her doctor, her BP was 200/110, p/111.
Age: 1.3
Sex: F
Vaccine: MMRV
Symptoms: Medication error
Clinical narrative: MMR-V (Pro-Quad) was given IM instead of SQ.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Musculoskeletal stiffness, Nausea, Neck pain, Pain
Clinical narrative: Recepient experienced immediate burning where innoculated. Was aching, tired, and nauseous within 1/2 hour of shot. Neck became sore and stiff. Symptoms lasted for about ten(10) days
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Skin burning sensation
Clinical narrative: Recepient experienced immediate burning where innoculated. Was aching, tired, and nauseous within 1/2 hour of shot. Neck became sore and stiff. Symptoms lasted for about ten(10) days
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Fatigue, Hypoaesthesia, Neck pain
Clinical narrative: This case was reported by a lawyer via a statement of injuries and described the occurrence of neck pain in a male subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown).  At an unspecified time after vaccination with Lymerix, the subject experienced pain in his neck and down his spine, knee pain, shoulder pain, fatigue, tingling in legs, and leg numbness. He underwent bilateral total knee replacements, and pain management included prescription narcotics and epidural injections. The statement alleged that the events negatively impacted his activities of daily living and enjoyment of life. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Paraesthesia, Shoulder pain
Clinical narrative: This case was reported by a lawyer via a statement of injuries and described the occurrence of neck pain in a male subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown).  At an unspecified time after vaccination with Lymerix, the subject experienced pain in his neck and down his spine, knee pain, shoulder pain, fatigue, tingling in legs, and leg numbness. He underwent bilateral total knee replacements, and pain management included prescription narcotics and epidural injections. The statement alleged that the events negatively impacted his activities of daily living and enjoyment of life. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were was unspecified.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Contusion, Platelet count decreased
Clinical narrative: 17 days after patient received MMR, varicella vaccine, HiB, and PCV7, she was seen in this office with severe bruising. A platelet count was done with a result of 5000. She was hospitalized and received intravenous immunoglobulin. Followup platelt count was 42000. Platelt count on 12/4/06 was 324000, and on 12/22 was 334000. 12/28/06-Hem Onc consultation report received and reviewed DX: Isolated thrombocytopenia on CBC consistent with ITP.  RX with IVIG.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Neck pain, Pyrexia, Rash, Salivary hypersecretion
Clinical narrative: current symptoms as of 12-23-06-high fever (up to 104), rubbing eyes/face, rash, thick saliva, lethargic, very sleepy, whimpering, back of neck possibly hurting
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: current symptoms as of 12-23-06-high fever (up to 104), rubbing eyes/face, rash, thick saliva, lethargic, very sleepy, whimpering, back of neck possibly hurting
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthropathy, Blood glucose increased, Blood pressure increased, Difficulty in walking
Clinical narrative: 3 days after second hepatitis b vaccine, knee gave out and repeatedly gives out with severe pain and inability to walk.  Cortisone shot into knee followed next day with flushing on face and chest, elevated blood pressure, fever, hot flashes, insomnia, tacchycardia, swollen throat, thirst.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Hot flush, Insomnia, Pharyngeal oedema, Pyrexia
Clinical narrative: 3 days after second hepatitis b vaccine, knee gave out and repeatedly gives out with severe pain and inability to walk.  Cortisone shot into knee followed next day with flushing on face and chest, elevated blood pressure, fever, hot flashes, insomnia, tacchycardia, swollen throat, thirst.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Tachycardia, Thirst, White blood cell count increased
Clinical narrative: 3 days after second hepatitis b vaccine, knee gave out and repeatedly gives out with severe pain and inability to walk.  Cortisone shot into knee followed next day with flushing on face and chest, elevated blood pressure, fever, hot flashes, insomnia, tacchycardia, swollen throat, thirst.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Diarrhoea, Nausea, Pain
Clinical narrative: About 11 hrs after receiving vaccine, suddenly began to experience severe abdominal cramps, nausea, diarrhea, and body aches.  Reaction lasted for about 6 hours.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Developed a rash and swelling of the arm in which she received the vaccine.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Localized pain, itching, redness, heat and swelling at injection site. Gave Benadryl for itching and swelling and possible allergic reaction and Motrin/Tylenol for pain.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Localized pain, itching, redness, heat and swelling at injection site. Gave Benadryl for itching and swelling and possible allergic reaction and Motrin/Tylenol for pain.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site reaction, Lymphadenopathy
Clinical narrative: Pt had smallpox vaccination on 12/14/06, and began to have left shoulder joint pain with spreading erythema from inoculation site down the anterior surface of the shoulder and axillary region with painful, swollen lymph node in left axilla.  Pt complained of feverish symptoms and itching at the site.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Pyrexia
Clinical narrative: Pt had smallpox vaccination on 12/14/06, and began to have left shoulder joint pain with spreading erythema from inoculation site down the anterior surface of the shoulder and axillary region with painful, swollen lymph node in left axilla.  Pt complained of feverish symptoms and itching at the site.
Age: 1.1
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Red, raised rash on belly and upper back and cheeks.  No meds. Temp. 103.6.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: On 12/22/2006, about 2 hours post injection, patient noticed Left upper arm began to ache. No redness or bruising noted. 24 hours post injection, patient noticed swelling in Left arm extending from Left upper arm through Left forearm. Slight residual edema noticed in Left arm yet today on 12/26/2006. No redness noticed. No longer has pain in arm.
Age: 35.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Unintended pregnancy
Clinical narrative: Patient received MMR on 6/28/06 and 8/15/06 patient got pregnant around 8/10/06.
Age: 35.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pregnancy test false positive
Clinical narrative: Patient received MMR on 6/28/06 and 8/15/06 patient got pregnant around 8/10/06.
Age: 52.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Mouth and hands swollen, dizzy unable to help self to bathroom. Reported by patient on 12/10/2006.  2/1/07 Received medical records from hospital which reveal patient admitted from 12/11-12/22/06 who experienced lower extremity weakness day after the flu shot & had fallen at home.  Leg weakness had been steadily increasing over 2 days with numbness of legs which started distally & spread upward.  Patient went to outlying hospital ER & was D/C.  Then hands became weak & was dropping items & patient voice started to change & had double vision.  Admit exam revealed inability to move eyes in all directions, diplopia, palate elevation impaired, prox/distal weakness, decreased sensation to pinprick, ataxic finger to nose & heel to knee to shin tests.  By the time of admit, unable to walk w/o assistance.  Quinton cath placed & received plasmapheresis x 4. Patients vision returned to normal.  Final course was held due to cardiac changes of atrial flutter which resolved when treatment d/c.  Patient received intensive PT & was then transferred to rehab facility. FINAL DX: GBS, Miller Fisher syndrome.
Age: 52.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Dizziness, Swelling
Clinical narrative: Mouth and hands swollen, dizzy unable to help self to bathroom. Reported by patient on 12/10/2006.  2/1/07 Received medical records from hospital which reveal patient admitted from 12/11-12/22/06 who experienced lower extremity weakness day after the flu shot & had fallen at home.  Leg weakness had been steadily increasing over 2 days with numbness of legs which started distally & spread upward.  Patient went to outlying hospital ER & was D/C.  Then hands became weak & was dropping items & patient voice started to change & had double vision.  Admit exam revealed inability to move eyes in all directions, diplopia, palate elevation impaired, prox/distal weakness, decreased sensation to pinprick, ataxic finger to nose & heel to knee to shin tests.  By the time of admit, unable to walk w/o assistance.  Quinton cath placed & received plasmapheresis x 4. Patients vision returned to normal.  Final course was held due to cardiac changes of atrial flutter which resolved when treatment d/c.  Patient received intensive PT & was then transferred to rehab facility. FINAL DX: GBS, Miller Fisher syndrome.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Eye irritation, Headache, Pain, Pharyngolaryngeal pain
Clinical narrative: rec'd flu shot@ 2 pm About 3 hrs later, had sore throat, then burning eyelids, then severe aches, headache, shivers, retired to bed, totally incapacitated 7.30, lay in a fetal state for 3 1/2 hrs, found an ambien hoarded away, got up at 10 am, still zonked but not aching. I think this happened to me about 10 or more years ago, have not had a flu shot since,guess I won't again!
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a consumer concerning an 8 year old patient who may have been vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced a mild case of chickenpox and died while recovering from the chickenpox. The exact cause of the patients death was not determined, but local officials say they doubt chickenpox is to blame. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old female who on 04 Dec 2006 was vaccinated PO with the third dose of rotavirus vaccine. The RN reported that on 08 Dec 2006, the patient developed bloody diarrhea. Unspecified medical attention was sought. At the time of this report, the patients blood diarrhea persisted. Upon internal review, blood diarrhea was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dry eye, Visual disturbance
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with a history of dysfunctional uterine bleeding (DUB) and anaemia who on 14 Sep 2006 was vaccinated with HPV vaccine (lot 0800F, batch 654540), 0.5 ml, IM, once. Concomitant therapy included Yasmin. In approximately November 2006 (last couple weeks), the patient experienced extreme eye dryness after receiving HPV vaccine. The patient's eye was so dry that she had a hard time seeing. On an unspecified date, the patient sought unspecified medical attention. Eventually, the patient had a duct implant put in her eyes by a specialist to help with the dryness. The patient was recovering from the event of extreme eye dryness. Extreme eye dryness was considered to be disabling and an other important medical event (OMIC). Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Apparent life threatening event, Body temperature increased, Chills, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old male patient with recurrent diverticulitis, degenerative disc disease, sore throat and insomnia and a history of rib fracture and clavicle fracture from car accident (1999), splenectomy, gall stones and small bowel obstruction and no known allergies who on 11-DEC-2006 was vaccinated with a dose of PNEUMOVAX 23 (lot # 655152/0889F) (0.5 mL) in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified) in the same arm but different site. Other concomitant therapy included NYQUIL and ibuprofen. The patient's initial visit that day was for sore throat, he was evaluated, and given a prescription for trazadone for insomnia and amoxicillin. The patient then received the vaccinations. Within 24 hours post-vaccination the patient presented to the office with swelling of the left arm below the injection site and experienced a high fever of 104 F, chills and headache. The patient was treated with ROCEPHIN. On 13-DEC-2006 the patient appeared and swelling of left arm expanded to 5 times the original size, and patient's temperature went to 105 F. The patient was treated with 1 gram of ROCEPHIN. a CBC lab performed showed elevated WBC result of 23.5, and platelet count was elevated at 419. The patient was sent to a hospital. At the time of the report, it was unknown if the patient was hospitalized. At the time of the report the patient was considered to be not recovered. It was noted that the patient received pneumococcal 23v polysaccharide vaccine in 1999 with no untoward effects. The nurse requested a lot check. The reporter considered the patient's experiences to be disabling, life-threatening and other medical events (OMIC). Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Insomnia, Intervertebral disc degeneration, No reaction on previous exposure to drug, Oropharyngeal pain
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old male patient with recurrent diverticulitis, degenerative disc disease, sore throat and insomnia and a history of rib fracture and clavicle fracture from car accident (1999), splenectomy, gall stones and small bowel obstruction and no known allergies who on 11-DEC-2006 was vaccinated with a dose of PNEUMOVAX 23 (lot # 655152/0889F) (0.5 mL) in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified) in the same arm but different site. Other concomitant therapy included NYQUIL and ibuprofen. The patient's initial visit that day was for sore throat, he was evaluated, and given a prescription for trazadone for insomnia and amoxicillin. The patient then received the vaccinations. Within 24 hours post-vaccination the patient presented to the office with swelling of the left arm below the injection site and experienced a high fever of 104 F, chills and headache. The patient was treated with ROCEPHIN. On 13-DEC-2006 the patient appeared and swelling of left arm expanded to 5 times the original size, and patient's temperature went to 105 F. The patient was treated with 1 gram of ROCEPHIN. a CBC lab performed showed elevated WBC result of 23.5, and platelet count was elevated at 419. The patient was sent to a hospital. At the time of the report, it was unknown if the patient was hospitalized. At the time of the report the patient was considered to be not recovered. It was noted that the patient received pneumococcal 23v polysaccharide vaccine in 1999 with no untoward effects. The nurse requested a lot check. The reporter considered the patient's experiences to be disabling, life-threatening and other medical events (OMIC). Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Platelet count increased, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old male patient with recurrent diverticulitis, degenerative disc disease, sore throat and insomnia and a history of rib fracture and clavicle fracture from car accident (1999), splenectomy, gall stones and small bowel obstruction and no known allergies who on 11-DEC-2006 was vaccinated with a dose of PNEUMOVAX 23 (lot # 655152/0889F) (0.5 mL) in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified) in the same arm but different site. Other concomitant therapy included NYQUIL and ibuprofen. The patient's initial visit that day was for sore throat, he was evaluated, and given a prescription for trazadone for insomnia and amoxicillin. The patient then received the vaccinations. Within 24 hours post-vaccination the patient presented to the office with swelling of the left arm below the injection site and experienced a high fever of 104 F, chills and headache. The patient was treated with ROCEPHIN. On 13-DEC-2006 the patient appeared and swelling of left arm expanded to 5 times the original size, and patient's temperature went to 105 F. The patient was treated with 1 gram of ROCEPHIN. a CBC lab performed showed elevated WBC result of 23.5, and platelet count was elevated at 419. The patient was sent to a hospital. At the time of the report, it was unknown if the patient was hospitalized. At the time of the report the patient was considered to be not recovered. It was noted that the patient received pneumococcal 23v polysaccharide vaccine in 1999 with no untoward effects. The nurse requested a lot check. The reporter considered the patient's experiences to be disabling, life-threatening and other medical events (OMIC). Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Dizziness, Full blood count abnormal, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old female with a history of asthma, muscle contractions, headache and fibromyalgia who on 25-SEP-2006 was vaccinated in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 651357/0391F). Concomitant therapy included CELEXA, WELLBUTRIN XL, MIDRIN, ADVAIR, and influenza vaccine (unspecified and also administered in the left deltoid). Within 24 hours post-vaccination the patient experienced tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever of 101.7 degrees Fahrenheit, severe headache. Reportedly with unknown treatment. On 27-SEP-2006 the patient had a complete blood count (CBC) drawn at the office and elevated "20,700" and was sent to the hospital. At the hospital the patient was given IV antibiotics, ultrasound of upper left arm. The patient was hospitalized until 01-OCT-2006 with the diagnosis of fever secondary to vaccination, and "glucocytosis secondary to vaccination." At the time of the report, it was not reported if the patient recovered. The reporter considered tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever secondary to vaccination, severe headache and glucocytosis secondary to vaccination and CBC elevated 20,700 were considered to be immediately life-threatening, disabling and other important medical events (OMIC). A lot check of concern has been requested. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain, Pyrexia, Syncope, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old female with a history of asthma, muscle contractions, headache and fibromyalgia who on 25-SEP-2006 was vaccinated in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 651357/0391F). Concomitant therapy included CELEXA, WELLBUTRIN XL, MIDRIN, ADVAIR, and influenza vaccine (unspecified and also administered in the left deltoid). Within 24 hours post-vaccination the patient experienced tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever of 101.7 degrees Fahrenheit, severe headache. Reportedly with unknown treatment. On 27-SEP-2006 the patient had a complete blood count (CBC) drawn at the office and elevated "20,700" and was sent to the hospital. At the hospital the patient was given IV antibiotics, ultrasound of upper left arm. The patient was hospitalized until 01-OCT-2006 with the diagnosis of fever secondary to vaccination, and "glucocytosis secondary to vaccination." At the time of the report, it was not reported if the patient recovered. The reporter considered tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever secondary to vaccination, severe headache and glucocytosis secondary to vaccination and CBC elevated 20,700 were considered to be immediately life-threatening, disabling and other important medical events (OMIC). A lot check of concern has been requested. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old female with a history of asthma, muscle contractions, headache and fibromyalgia who on 25-SEP-2006 was vaccinated in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 651357/0391F). Concomitant therapy included CELEXA, WELLBUTRIN XL, MIDRIN, ADVAIR, and influenza vaccine (unspecified and also administered in the left deltoid). Within 24 hours post-vaccination the patient experienced tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever of 101.7 degrees Fahrenheit, severe headache. Reportedly with unknown treatment. On 27-SEP-2006 the patient had a complete blood count (CBC) drawn at the office and elevated "20,700" and was sent to the hospital. At the hospital the patient was given IV antibiotics, ultrasound of upper left arm. The patient was hospitalized until 01-OCT-2006 with the diagnosis of fever secondary to vaccination, and "glucocytosis secondary to vaccination." At the time of the report, it was not reported if the patient recovered. The reporter considered tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever secondary to vaccination, severe headache and glucocytosis secondary to vaccination and CBC elevated 20,700 were considered to be immediately life-threatening, disabling and other important medical events (OMIC). A lot check of concern has been requested. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Cellulitis, Conjunctivitis, Eye discharge, Otitis media, Pyrexia
Clinical narrative: Initial information has been received from a physician on 08-DEC-2006 concerning a 12 month old male with a history of eczema, who on 09-NOV-2006 was vaccinated with a 0.5 mL first dose of hepatitis A virus vaccine inactivated given IM. Additional suspect therapy included a 0.5 mL first dose of Proquad given SC. Concomitant therapy included alclometasone diproprionate (ACLOVATE) ointment as needed for eczema. The patient's mother had strep throat at the time of vaccination. On 15-NOV-2006, the patient developed upper respiratory infection symptoms (non-serious) with goopy eyes and fever of up to 104 degrees tympanic (non-serious). On 17-NOV-2006, the patient was diagnosed with a viral disease and conjunctivitis (non-serious). The patient received acetaminophen (TYLENOL) and ibuprofen (MOTRIN) as needed from 15-NOV-2006 through 18-NOV-2006 for the fever. The subject also received gentamicin sulfate (GENTAK) ophthalmic drops from 17-NOV-2006 through 22-NOV-2006 for treatment of conjunctivitis. All symptoms resolved on 22-NOV-2006. On 26-NOV-2006, the subject experienced right ear drainage and a red spot on his right cheek. On 28-NOV-2006, the symptoms continued and he was diagnosed with right otitis media with rupture of the tympanic membrane and cellulitis of the face. The patient was hospitalized on 28-NOV-2006 for treatment of his cellulitis and on-going ear infection. On 28-NOV-2006, the patient started a course of ampicilin/sulbactam (UNASYN) IV and ofloxacin (FLOXIN) otic drops. The patient also had CBC, ESR/CRF, blood culture and ear culture performed. On 30-NOV-2006, the patient was discharged from the hospital. The patient had excellent regression of cellulitis and his ear discharge was resolving as well. The subject was discharged on a course of clavulanate potassium-amoxicillin (AUGMENTIN) and polymyxin B sulfate-hydrocortisone-neomycin (CORTISPORIN) otic drops. On 07-DEC-2006, a follow-up visit reported the otitis media and cellulitis were resolved. The investigator considered all events to be related to the study medication. Further information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Tympanic membrane perforation, Upper respiratory tract infection, Viral infection
Clinical narrative: Initial information has been received from a physician on 08-DEC-2006 concerning a 12 month old male with a history of eczema, who on 09-NOV-2006 was vaccinated with a 0.5 mL first dose of hepatitis A virus vaccine inactivated given IM. Additional suspect therapy included a 0.5 mL first dose of Proquad given SC. Concomitant therapy included alclometasone diproprionate (ACLOVATE) ointment as needed for eczema. The patient's mother had strep throat at the time of vaccination. On 15-NOV-2006, the patient developed upper respiratory infection symptoms (non-serious) with goopy eyes and fever of up to 104 degrees tympanic (non-serious). On 17-NOV-2006, the patient was diagnosed with a viral disease and conjunctivitis (non-serious). The patient received acetaminophen (TYLENOL) and ibuprofen (MOTRIN) as needed from 15-NOV-2006 through 18-NOV-2006 for the fever. The subject also received gentamicin sulfate (GENTAK) ophthalmic drops from 17-NOV-2006 through 22-NOV-2006 for treatment of conjunctivitis. All symptoms resolved on 22-NOV-2006. On 26-NOV-2006, the subject experienced right ear drainage and a red spot on his right cheek. On 28-NOV-2006, the symptoms continued and he was diagnosed with right otitis media with rupture of the tympanic membrane and cellulitis of the face. The patient was hospitalized on 28-NOV-2006 for treatment of his cellulitis and on-going ear infection. On 28-NOV-2006, the patient started a course of ampicilin/sulbactam (UNASYN) IV and ofloxacin (FLOXIN) otic drops. The patient also had CBC, ESR/CRF, blood culture and ear culture performed. On 30-NOV-2006, the patient was discharged from the hospital. The patient had excellent regression of cellulitis and his ear discharge was resolving as well. The subject was discharged on a course of clavulanate potassium-amoxicillin (AUGMENTIN) and polymyxin B sulfate-hydrocortisone-neomycin (CORTISPORIN) otic drops. On 07-DEC-2006, a follow-up visit reported the otitis media and cellulitis were resolved. The investigator considered all events to be related to the study medication. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Hypoaesthesia, Pyrexia
Clinical narrative: Information has been received from a physician concerning an "over 60" year old female who in approximately December 2006, was vaccinated with a dose of ZOSTAVAX. Subsequently, 3-4 days after receiving ZOSTAVAX the patient developed numbness in her legs, lips and around her mouth, and a fever. The patient "could not walk" due to this event. The patient was referred to a neurologist to rule out Guillain-Barre Syndrome. The patient was also referred to an infectious disease specialist to determine if the event was vaccine related. At the time of the report the patient's numbness had improved but she was still spiking a temperature of 100-101 degrees. Unspecified "blood work" was performed. The patient was discharged from the hospital after 11 days as an inpatient. There was no product quality complaint involved. No additional information was available. The reporter considered the patient's events to be disabling and serious for hospitalization. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: HBHEPB
Symptoms: Meningitis
Clinical narrative: Information has been received from a nurse practitioner concerning a 2 month old female who was vaccinated with a first dose of COMVAX (0.5 mL). Subsequently, the patient developed meningitis (unspecified if bacterial or viral) and was hospitalized. The patient was diagnosed and given an "antibiotic to cure the problem." The physician at the hospital stated that the patient should not receive any more COMVAX. At the time of the report the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Pain, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a female physician assistant (age not reported) who on 03 Oct 2006 was vaccinated intramuscularly with the first 0.5ml dose of HPV vaccine. Concomitant therapy included an unspecified therapy for asthma. On 03 Oct 2006, immediately after receiving the HPV vaccine, she developed extreme pain on her skin and broke out in hives all over her body. The physician assistant stated that it felt like a cat clawing on her skin. The physician assistant went to the emergency room and was treated with asthma medication but was not admitted. No ER date was provided. On an unspecified date, the patient was recovering from the events. On 05 Dec 2006, the patient was vaccinated with a second dose of HPV vaccine. Subsequently, the patient developed an outbreak of hives in a circle around the site of injection. At the time of this report, the outcome of the event was unknown. The physician assistant considered the events of extreme pain on her skin and broke out in hives all over her body to be other important medical events as the patient was treated with asthma medication in the ER (OMIC). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Disability, Injected limb mobility decreased
Clinical narrative: Information has been received from a physician concerning a 67 year old male with pertinent medical history and drug reactions/allergies reported as unspecified who on 06-Dec-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#655152/0889F). Concomitant therapy was unspecified. On 06-Dec-2006, the patient could not use his arm for almost a day. The patient sought medical attention. No lab diagnostics were performed. At the time of requesting, the patient was recovering. The phyisican considered the event to be disabling. Additional information has been requested.