chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Tinnitus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of tinnitus in a 49-year-old male subject who was vaccinated with ENGERIX B(GlaxoSmithKline). Previous and/or concurrent vaccination included ENGERIX B (GlaxoSmithKline; unknown; unknown) given on 1 October 2009. Concurrent medications included Bimatoprost (Lumingan). On 13 August 2009 at 10:00 the subject received 1st dose of ENGERIX B (unknown, right arm). On 13 August 2009, less than one day after vaccination with ENGERIX B, the subject experience tinnitus. The lot number was reported as AhB76AA.  The pharmacist reported the subject received a first dose of ENGERIX B on 13 August 2009 and had an acute onset of tinnitus following administration. Even though his tinnitus continued, the subject received a second dose of ENGERIX B on 01 October 2009. The subject had gone to three physicians/specialists to received his tinnitus; however, it still had not resolved. One of the specialist started the subject on a medication (unknown). At the time of reporting, the subject was still experiencing tinnitus and stated that he would not be receiving his third dose of ENGERIX B. The subject was treated with unknown. At the time of reporting tinnitus was unresolved. Follow up information was received on 17 December 2009 from the pharmacist who is also the subject. The pharmacist reported that he had been seeing a specialist physician for the tinnitus.
Age: 1.3
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Convulsion, Erythema, Gaze palsy, Laboratory test, Mydriasis
Clinical narrative: Initial report was received from a physician on 18 January 2010. A 15-month-old male patient with no past medical history received an injection of FLUZONE No Preservative 2009-2010, lot number U327DA (route, site and date of administration not reported) and one hour later, he experienced a seizure. the patient was admitted to the hospital for one to two days. A CT scan was performed which showed asymmetry in the ventricles, no diagnosis. According to the reporter, the patient recovered (date not reported). Documents held by sender: None.
Age: 1.3
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cardiac disorder, Computerised tomogram abnormal, Convulsion
Clinical narrative: Initial report was received from a physician on 18 January 2010. A 15-month-old male patient with no past medical history received an injection of FLUZONE No Preservative 2009-2010, lot number U327DA (route, site and date of administration not reported) and one hour later, he experienced a seizure. the patient was admitted to the hospital for one to two days. A CT scan was performed which showed asymmetry in the ventricles, no diagnosis. According to the reporter, the patient recovered (date not reported). Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Fall, Head injury, Loss of consciousness, Road traffic accident, Scan
Clinical narrative: Received H1N1 Influenza vaccine on 11/16/09 offered free to firefighters through the Department of Health. On 11/23/09, seven days following inoculation, experienced loss of consciousness while riding a motorcycle, resulting in a motorcycle crash, severe concussion and head trauma. Air-flighted to trauma center and hospitalized for 5 days. Released into the care of a neurologist, who ordered a secondary MRI on 12/11 to baseline against MRI taken day of accident on 11/23. First MRI showed significant brain abnormalities, 17 days later, second MRI showed no abnormalities but two remained. Neurologist's diagnosis following the first MRI was encephalitis and ADEM (Acute Disseminated Encephalomyelitis). The reduction of abnormalities in the latter MRI validated that the abnormalities reflected were viral related. Neurologist's diagnosis is that the timeline of receiving the H1N1 vaccine 7 days prior to the adverse affect fall within the 3-30 day window for the vaccine/viral load to impact the immune system. Further, all but two of the lesions on the 11/23 MRI no longer remained on the 12/11 MRI. Finally, no pre-existing conditions or virus existed to result in a loss of consciousness.  All evidence supports the encephalitis and ADEM (Acute Disseminated Encephalomyelitis) diagnosis following the H1N1 inoculation. As of 1/27, still unable to return to work and remain under the care of a neurosurgeon and neuropsychologist for an unknown period of time. Follow-up MRI is scheduled for April 2010.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: X-ray
Clinical narrative: Received H1N1 Influenza vaccine on 11/16/09 offered free to firefighters through the Department of Health. On 11/23/09, seven days following inoculation, experienced loss of consciousness while riding a motorcycle, resulting in a motorcycle crash, severe concussion and head trauma. Air-flighted to trauma center and hospitalized for 5 days. Released into the care of a neurologist, who ordered a secondary MRI on 12/11 to baseline against MRI taken day of accident on 11/23. First MRI showed significant brain abnormalities, 17 days later, second MRI showed no abnormalities but two remained. Neurologist's diagnosis following the first MRI was encephalitis and ADEM (Acute Disseminated Encephalomyelitis). The reduction of abnormalities in the latter MRI validated that the abnormalities reflected were viral related. Neurologist's diagnosis is that the timeline of receiving the H1N1 vaccine 7 days prior to the adverse affect fall within the 3-30 day window for the vaccine/viral load to impact the immune system. Further, all but two of the lesions on the 11/23 MRI no longer remained on the 12/11 MRI. Finally, no pre-existing conditions or virus existed to result in a loss of consciousness.  All evidence supports the encephalitis and ADEM (Acute Disseminated Encephalomyelitis) diagnosis following the H1N1 inoculation. As of 1/27, still unable to return to work and remain under the care of a neurosurgeon and neuropsychologist for an unknown period of time. Follow-up MRI is scheduled for April 2010.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Acute disseminated encephalomyelitis, Blood test, Central nervous system lesion, Concussion, Electroencephalogram
Clinical narrative: Received H1N1 Influenza vaccine on 11/16/09 offered free to firefighters through the Department of Health. On 11/23/09, seven days following inoculation, experienced loss of consciousness while riding a motorcycle, resulting in a motorcycle crash, severe concussion and head trauma. Air-flighted to trauma center and hospitalized for 5 days. Released into the care of a neurologist, who ordered a secondary MRI on 12/11 to baseline against MRI taken day of accident on 11/23. First MRI showed significant brain abnormalities, 17 days later, second MRI showed no abnormalities but two remained. Neurologist's diagnosis following the first MRI was encephalitis and ADEM (Acute Disseminated Encephalomyelitis). The reduction of abnormalities in the latter MRI validated that the abnormalities reflected were viral related. Neurologist's diagnosis is that the timeline of receiving the H1N1 vaccine 7 days prior to the adverse affect fall within the 3-30 day window for the vaccine/viral load to impact the immune system. Further, all but two of the lesions on the 11/23 MRI no longer remained on the 12/11 MRI. Finally, no pre-existing conditions or virus existed to result in a loss of consciousness.  All evidence supports the encephalitis and ADEM (Acute Disseminated Encephalomyelitis) diagnosis following the H1N1 inoculation. As of 1/27, still unable to return to work and remain under the care of a neurosurgeon and neuropsychologist for an unknown period of time. Follow-up MRI is scheduled for April 2010.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Encephalitis, Impaired work ability, Injury, Loss of consciousness, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Received H1N1 Influenza vaccine on 11/16/09 offered free to firefighters through the Department of Health. On 11/23/09, seven days following inoculation, experienced loss of consciousness while riding a motorcycle, resulting in a motorcycle crash, severe concussion and head trauma. Air-flighted to trauma center and hospitalized for 5 days. Released into the care of a neurologist, who ordered a secondary MRI on 12/11 to baseline against MRI taken day of accident on 11/23. First MRI showed significant brain abnormalities, 17 days later, second MRI showed no abnormalities but two remained. Neurologist's diagnosis following the first MRI was encephalitis and ADEM (Acute Disseminated Encephalomyelitis). The reduction of abnormalities in the latter MRI validated that the abnormalities reflected were viral related. Neurologist's diagnosis is that the timeline of receiving the H1N1 vaccine 7 days prior to the adverse affect fall within the 3-30 day window for the vaccine/viral load to impact the immune system. Further, all but two of the lesions on the 11/23 MRI no longer remained on the 12/11 MRI. Finally, no pre-existing conditions or virus existed to result in a loss of consciousness.  All evidence supports the encephalitis and ADEM (Acute Disseminated Encephalomyelitis) diagnosis following the H1N1 inoculation. As of 1/27, still unable to return to work and remain under the care of a neurosurgeon and neuropsychologist for an unknown period of time. Follow-up MRI is scheduled for April 2010.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Road traffic accident
Clinical narrative: Received H1N1 Influenza vaccine on 11/16/09 offered free to firefighters through the Department of Health. On 11/23/09, seven days following inoculation, experienced loss of consciousness while riding a motorcycle, resulting in a motorcycle crash, severe concussion and head trauma. Air-flighted to trauma center and hospitalized for 5 days. Released into the care of a neurologist, who ordered a secondary MRI on 12/11 to baseline against MRI taken day of accident on 11/23. First MRI showed significant brain abnormalities, 17 days later, second MRI showed no abnormalities but two remained. Neurologist's diagnosis following the first MRI was encephalitis and ADEM (Acute Disseminated Encephalomyelitis). The reduction of abnormalities in the latter MRI validated that the abnormalities reflected were viral related. Neurologist's diagnosis is that the timeline of receiving the H1N1 vaccine 7 days prior to the adverse affect fall within the 3-30 day window for the vaccine/viral load to impact the immune system. Further, all but two of the lesions on the 11/23 MRI no longer remained on the 12/11 MRI. Finally, no pre-existing conditions or virus existed to result in a loss of consciousness.  All evidence supports the encephalitis and ADEM (Acute Disseminated Encephalomyelitis) diagnosis following the H1N1 inoculation. As of 1/27, still unable to return to work and remain under the care of a neurosurgeon and neuropsychologist for an unknown period of time. Follow-up MRI is scheduled for April 2010.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Little tiny bumps on neck then throughout the days is covered with the bumps all over body. Bumps started on January 15th and he is covered in them up until this day (January 27th, 2010).
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Pruritus
Clinical narrative: Numbness in the arm where injection was given which moved to the leg, feet and face ending in itching in my mouth and tongue.  Emergency room gave me Benadryl and watched me for an hour.  Sending me home with instructions to continue Benadryl for 2 days which I did, when I stopped the symptoms returned. I then saw my PC dr and she gave me 4 days of prednisone.  I really hope this stops soon and will never receive this vaccine again or allow my children to receive it.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Persistent soreness and weakness in arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site urticaria, Rash macular, Skin discolouration
Clinical narrative: 2-3 cm wheal on left lateral thigh, temp of 103 - pink, flat to slightly raised confluent macular rash to forehead, chest and back - treated with TYLENOL/MOTRIN, BENADRYL and cold compress.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Distress and pain for 2 days, then rash appeared and shingles diagnosed.
Age: 1.35
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Computerised tomogram head, Neurological examination, Unresponsive to stimuli
Clinical narrative: seizure followed by 12 minutes of unresponsiveness and lethargy for the remainder of the day until second seizure at midnight.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram, Electrocardiogram, Grand mal convulsion
Clinical narrative: Gran Mal Seizures
Age: 14.0
Sex: M
Vaccine: FLU3, HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Per family pt grabbed his head and family held him up to keep from falling. Placed on bench with feet elevated. Vital signs taken, Pt given drink and brownie, mom stated he had not eaten since breakfast. Pt stated no longer dizzy after eating. Pt left facility.
Age: 1.27
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: The patient's left thigh was swollen and red, which is the injection site. The patient had a slight fever. The patient has recovered.
Age: 85.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Pancytopenia
Clinical narrative: Severe diarrhea
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Diarrhoea, Diet refusal, Erythema, Full blood count abnormal, Injection site rash
Clinical narrative: 1-21-10 - vomited, then okay rest of day. 1-22-10 - red cheek, swollen bumps, diarrhea (AM) fever 101. 1-22-10 - (PM) got bumps on leg; at injection site. 1-23-10 - to doctors office visit with rash and bumps over limbs, wasn't drinking fever, vomiting admitted to hospital.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Liver function test abnormal, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: 1-21-10 - vomited, then okay rest of day. 1-22-10 - red cheek, swollen bumps, diarrhea (AM) fever 101. 1-22-10 - (PM) got bumps on leg; at injection site. 1-23-10 - to doctors office visit with rash and bumps over limbs, wasn't drinking fever, vomiting admitted to hospital.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Chills, Decreased appetite, Pyrexia
Clinical narrative: High grade fever, chills, not eating. ER visit 01/26/2010, was given instrutions on how to mange a high fever that keeps coming back and sent home. Today 01/27/2010 is back to his PCP, no update yet on what doctor has said. Had no previous illness, and no one sick in home.
Age: 56.0
Sex: M
Vaccine: HEPA, MNQ, TD, TYP, YF
Symptoms: Diarrhoea, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: PT. STATE HEADACHE, DIARRHEA, RASH, AND FEVER FOR 1 DAY. PT. ALSO COMPLAIN OF MUSCLE ACHE
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in upper left arm at site of injection lasting until present.  MD recommended physical therapy.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Diarrhoea, Disturbance in attention, Nausea, Pain
Clinical narrative: Woke up Abruptly with vomiting, diarrhea, & body Aches at 0200 01/24/10 which lasted 24 hours. Then had nausea, body aches, restlessness, & "lack of concentration" with "cold sweats" for the next 2 - 3 days.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Restlessness, Vomiting
Clinical narrative: Woke up Abruptly with vomiting, diarrhea, & body Aches at 0200 01/24/10 which lasted 24 hours. Then had nausea, body aches, restlessness, & "lack of concentration" with "cold sweats" for the next 2 - 3 days.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bedridden, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Headaches, Fevers /Chills, severe body aches, rapid HR, loss of appetite, vomiting and diarrhea.  Diarrhea for 3 1/2 days, joint pain for 3 days.  Reports completely bedridden on 1/22, was too painful to move.  As of 1/27/10 the patient just has some residual headache.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Heart rate increased, Pain, Pyrexia, Vomiting
Clinical narrative: Headaches, Fevers /Chills, severe body aches, rapid HR, loss of appetite, vomiting and diarrhea.  Diarrhea for 3 1/2 days, joint pain for 3 days.  Reports completely bedridden on 1/22, was too painful to move.  As of 1/27/10 the patient just has some residual headache.
Age: 0.24
Sex: M
Vaccine: HEP, RV1
Symptoms: Blood test normal, Breath sounds abnormal, Bronchial secretion retention, Bronchiolitis, Chest X-ray abnormal
Clinical narrative: After receiving the HEP B and ROTAVIRUS vaccine patient's respiratory illness became a lot worse. He was diagnosed with Bronchiolitis and possibly some other viral sickness. He was prescribed a Nebulizer with Albuterol, which inflamed his symptoms and caused him from going from no fever to 103.6 within one hour of time. Doctor was called and was prescribed Amoxicillin without being seen in the doctor's office. After a few days fever went away but respiratory issues were still severe. Patient went back to doctor on 01-02-2010, he was then prescribed Prednisolone Sodium Phosphate, which made him eat more and sleep maybe an hour a day. Did not seem to help with his respiratory issues. 01-05-2010, patient back at doctor, chest x-ray done and blood work. X-Ray showed mucous in his bronchial area and blood work reported back okay. 01-11-2010, patient was admitted to hospital for observation. Nothing changed and was dismissed the following day. 01-18-2010, patient went to doctor for post-hospital check up. Patient was still sick, asked for a referral to see a specialty doctor in Pediatric Pulmonology. 01-20-2010, seen Dr. An x-ray was taken of patient's chest. Dr. reported back that there was bronchi that were plugged with mucous and that patient's breathing sound worse that some of the kids in the hospital. Patient was admitted to Hospital on 01-20-2010 for observation. Patient was discharged on 01-21-2010. His lungs sounded better. Patient's wheezing and congestion will fluctuate throughout the day/night. At times patient will sound good and other times he is having hard time breathing. To this date 01-27-2010 patient is still sick.
Age: 0.24
Sex: M
Vaccine: HEP, RV1
Symptoms: Condition aggravated, Dyspnoea, Increased appetite, Insomnia, Pyrexia
Clinical narrative: After receiving the HEP B and ROTAVIRUS vaccine patient's respiratory illness became a lot worse. He was diagnosed with Bronchiolitis and possibly some other viral sickness. He was prescribed a Nebulizer with Albuterol, which inflamed his symptoms and caused him from going from no fever to 103.6 within one hour of time. Doctor was called and was prescribed Amoxicillin without being seen in the doctor's office. After a few days fever went away but respiratory issues were still severe. Patient went back to doctor on 01-02-2010, he was then prescribed Prednisolone Sodium Phosphate, which made him eat more and sleep maybe an hour a day. Did not seem to help with his respiratory issues. 01-05-2010, patient back at doctor, chest x-ray done and blood work. X-Ray showed mucous in his bronchial area and blood work reported back okay. 01-11-2010, patient was admitted to hospital for observation. Nothing changed and was dismissed the following day. 01-18-2010, patient went to doctor for post-hospital check up. Patient was still sick, asked for a referral to see a specialty doctor in Pediatric Pulmonology. 01-20-2010, seen Dr. An x-ray was taken of patient's chest. Dr. reported back that there was bronchi that were plugged with mucous and that patient's breathing sound worse that some of the kids in the hospital. Patient was admitted to Hospital on 01-20-2010 for observation. Patient was discharged on 01-21-2010. His lungs sounded better. Patient's wheezing and congestion will fluctuate throughout the day/night. At times patient will sound good and other times he is having hard time breathing. To this date 01-27-2010 patient is still sick.
Age: 0.24
Sex: M
Vaccine: HEP, RV1
Symptoms: Respiratory disorder, Upper respiratory tract congestion, Viral infection, Wheezing
Clinical narrative: After receiving the HEP B and ROTAVIRUS vaccine patient's respiratory illness became a lot worse. He was diagnosed with Bronchiolitis and possibly some other viral sickness. He was prescribed a Nebulizer with Albuterol, which inflamed his symptoms and caused him from going from no fever to 103.6 within one hour of time. Doctor was called and was prescribed Amoxicillin without being seen in the doctor's office. After a few days fever went away but respiratory issues were still severe. Patient went back to doctor on 01-02-2010, he was then prescribed Prednisolone Sodium Phosphate, which made him eat more and sleep maybe an hour a day. Did not seem to help with his respiratory issues. 01-05-2010, patient back at doctor, chest x-ray done and blood work. X-Ray showed mucous in his bronchial area and blood work reported back okay. 01-11-2010, patient was admitted to hospital for observation. Nothing changed and was dismissed the following day. 01-18-2010, patient went to doctor for post-hospital check up. Patient was still sick, asked for a referral to see a specialty doctor in Pediatric Pulmonology. 01-20-2010, seen Dr. An x-ray was taken of patient's chest. Dr. reported back that there was bronchi that were plugged with mucous and that patient's breathing sound worse that some of the kids in the hospital. Patient was admitted to Hospital on 01-20-2010 for observation. Patient was discharged on 01-21-2010. His lungs sounded better. Patient's wheezing and congestion will fluctuate throughout the day/night. At times patient will sound good and other times he is having hard time breathing. To this date 01-27-2010 patient is still sick.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Ocular hyperaemia, Swelling face, Throat irritation
Clinical narrative: REDNESS OF EYES, SWELLING OF FACE, AND SCRATCHY THROAT.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Death, Diarrhoea, Gait disturbance
Clinical narrative: He had diarrhea many times throughout the night and all day the next day. I live an hour and a half from him and he traveled home on Tuesday having to stop to go to the bathroom twice.  He got home and had diarrhea all day on Tuesday 12/15/2009.  He also told me all week that he was feeling very weak.  He was even having trouble walking.  I had told him all week to go to the emergency room and he kept telling me he would be ok.  Finally on Friday 12/18/2009 he agreed to call the emergency squad after I told him I would meet him at the Hospital.  The emergency squad arrived and being a big man he decided to walk to the squad.  He went down the first of two steps and died. They tried to bring him back but was unsuccessful.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Dizziness, Headache, Hypoaesthesia
Clinical narrative: Memory loss. R side of body numb. Headache. Dizziness.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Parents wanted to break down vaccines and come back too soon for more vaccines and received them. No complaints or problems. No adverse reaction.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Patient states that Sunday 1/24/10 in afternoon started w/itching and progressively got worse Sunday night and into Monday AM. Called Dr. Monday since still itching and blotchy red skin on arms, abdomen, neck, face, and legs-instructed to take BENADRYL. Tuesday still itchy and skin blotchy, so seen by Dr. and gave him shot and prescription for medication for itching prn.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt received PNEUMOVAX vaccine 1/25 @ ~ 6:45 pm & that night had fever of 104.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Pain in extremity, Urticaria
Clinical narrative: Had 1 hive on right cheek and left arm pain. Began Benadryl at 5:00 PM and continued for 24 hours.  Hive resided and no further hives developed.  Left arm pain was not as severe as with dose #2.  Resolved within 3 days.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site swelling
Clinical narrative: Swelling around injection site.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Computerised tomogram, Headache, Laboratory test
Clinical narrative: Received H1N1 1-14-10, pt developed severe HA 1/15/10 which lasted over 4 days. Had to go to Emergency Room and clinic several times for pain relief.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm deltoid @ site of injection of H1N1 vaccine 4 cm x 5 1/2 cm indurated, swollen erythematous minimally tender + warm area measured + treated with topical antibiotics.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Arthralgia, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Local redness and pain. Fever, nausea, L side body pain. Arthralgias.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized reaction at site of inj. swollen and red/mom gave her Benadryl.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Nausea
Clinical narrative: Student stated he felt lightheaded and nauseous, ate crackers, water and rested x 15 min. before stating he felt better to go to class.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Confusional state, Convulsion, Feeling cold, Pallor, Syncope
Clinical narrative: Approximate 5 min after receiving H1N1 injection child reportedly fainted and had seizure like activity was incontinent of urine. Remained pale, cold and some confusion. Applied O2 and was transported to ER. He was observed and released. Questions of hx of seizures in the past.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urinary incontinence
Clinical narrative: Approximate 5 min after receiving H1N1 injection child reportedly fainted and had seizure like activity was incontinent of urine. Remained pale, cold and some confusion. Applied O2 and was transported to ER. He was observed and released. Questions of hx of seizures in the past.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Student stated he felt "woozy". Laid down x 10 minutes and ate crackers. Stated he felt better and resumed class.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye disorder, Eye infection, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a pharmacist concerning a 30 year old female patient who on 08-OCT-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported). After receiving VARIVAX the patient developed chicken pox and possible ocular lesions. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a pharmacist who indicated that the patient had been hospitalized with ocular lesions. The pharmacist reported that they obtained samples from the ocular lesions which were sent for viral testing. The patient was still hospitalized because they were trying to determine the etiology of the infection, diagnose the patient and determine what the patient's treatment plan would be. It was also mentioned that the patient had skin lesions which had already healed. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Deafness, Ear infection, Headache, Myalgia
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a patient who on 09-SEP-2009 was vaccinated with a dose of ZOSTAVAX (Merck). The patient experienced "temporal arteritis and polyneuralgia" after receiving ZOSTAVAX (Merck). The patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist concerning a 66 year old female delivery driver with no illness at the time of the vaccination, no chronic disease and milk allergy no on 16-SEP-2009 (Previously reported as of 09-SEP-2009) was vaccinated subcutaneously with a first dose of ZOSTAVAX (Merck) (lot# 663880/0791Y) into right arm. Approximately 2-3 weeks after receiving vaccine, on approximately 07-OCT-2009, the patient began having pain in arms, legs and hips. The patient also began having severe headaches and started having ear infections and hearing loss. The patient was treated with multiple antibiotics and steroids which helped with muscle pain temporarily. On 10-DEC-2009 the patient was prescribed IBUPROFEN 800 mg which slightly helped with pain in muscles. Family physician recently sent the patient to a vascular surgeon. The vascular surgeon took blood levels of sedimentation rate of 96 mm/hour. At the time of the report, the patient was undergoing temporal biopsy in the next week. So far the patient had been diagnosed with polyneuralgia and being tested for temporal arteritis. At the time of the report, the patient had not recovered. Upon internal review, hearing loss was determined to be an other important medical event. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Red blood cell sedimentation rate increased, Temporal arteritis
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a patient who on 09-SEP-2009 was vaccinated with a dose of ZOSTAVAX (Merck). The patient experienced "temporal arteritis and polyneuralgia" after receiving ZOSTAVAX (Merck). The patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist concerning a 66 year old female delivery driver with no illness at the time of the vaccination, no chronic disease and milk allergy no on 16-SEP-2009 (Previously reported as of 09-SEP-2009) was vaccinated subcutaneously with a first dose of ZOSTAVAX (Merck) (lot# 663880/0791Y) into right arm. Approximately 2-3 weeks after receiving vaccine, on approximately 07-OCT-2009, the patient began having pain in arms, legs and hips. The patient also began having severe headaches and started having ear infections and hearing loss. The patient was treated with multiple antibiotics and steroids which helped with muscle pain temporarily. On 10-DEC-2009 the patient was prescribed IBUPROFEN 800 mg which slightly helped with pain in muscles. Family physician recently sent the patient to a vascular surgeon. The vascular surgeon took blood levels of sedimentation rate of 96 mm/hour. At the time of the report, the patient was undergoing temporal biopsy in the next week. So far the patient had been diagnosed with polyneuralgia and being tested for temporal arteritis. At the time of the report, the patient had not recovered. Upon internal review, hearing loss was determined to be an other important medical event. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Laboratory test abnormal, Myalgia, Systemic lupus erythematosus
Clinical narrative: Information has been received from a consumer concerning herself, a 67 year old female with lupus erythematosus and fibromyalgia who on 15-SEP-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). Concomitant therapy included LORTAB, LORAZEPAN (generic unspecified), fexofenadine hydrochloride, CELEBREX, ENAPRIL, LIPITOR, COUMADIN, metoprolol and amlodipine. About one week after receiving the vaccine, on 22-SEP-2009 the patient experienced muscle pain in her legs and then later the pain started to move to her buttocks and arms. The consumer reported that she saw her physician about the pain and she had some blood work done which showed she was positive for lupus. The consumer stated that the physician did other tests, which the names were unspecified, and they came back negative. The consumer reported that recently she saw a rheumatologist who was thinking she may have fibromyalgia. The consumer reported that she still has muscle pain. At the time of reporting, the outcome of the events was reported as recovering. The lupus was considered to be an other important medical event. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 88 year old female patient with hyperthyroidism, coronary artery disease, hypertension, chronic obstructive pulmonary disease and atrial fibrillation who "about 2 years ago", in approximately 2008 was vaccinated with "a single dose" of 0.65 ml of ZOSTAVAX (Merck) subcutaneously. According to the physician, the patient was hospitalized on 04-JAN-2010 for chronic obstructive pulmonary disease exacerbation and was put on high doses of steroids. Then, on an unspecified date, prior to developing shingles, the patient was discharged from hospital. About 3 days later of hospitalization, on 07-JAN-2010 the patient presented with zoster outbreak on her left upper thigh. The physician also mentioned that she saw the patient last week (on approximately 14-JAN-2010) and started her on famciclovir. At time of reporting the patient was recovering. The physician considered exacerbation of chronic obstructive pulmonary disease and zoster outbreak to be disabling. additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Proctalgia, Rash
Clinical narrative: Information has been received from a physician (also reported as an office manager) concerning a 62 year old female patient with no pertinent medical history who on 19-JUN-2008 was vaccinated with a 0.65ml single dose of ZOSTAVAX (Merck). There was no concomitant medication. On 18-JAN-2010 the patient experienced severe pain and terrible rash in her rectal area. The rash was around her right buttocks. It was painful and couldn't move. The patient went to the doctor's office for medical attention. No laboratory diagnostic studies were ferformed. The patient was prescribed  ZOVIRAX, ULTRAM and advised on some symptomatic treatment (manufacturers unspecified) and the patient came back the next day and stated that nothing helped. THe patient was then prescribed other medication including NEURONTIN and ketorolac tromethamine. The patient had not come back for follow-up since then. At the time of the report, the patient had not recovered. The patient's severe pain and terrible rash in rectal area, around right buttocks were considered to be disabling by the reporter. No further information is available.
Age: 0.13
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an 8 week old patient who in January 2010, was orally vaccinated with the first dose of ROTATEQ. In January 2010, the physician suspected the patient may have had intussusception. The patient was seen on 21-Jan-2010 and was fine. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF, HEPAB, IPV, TYP, YF
Symptoms: Abdominal pain, Chest discomfort, Dysphonia, Dyspnoea, Erythema
Clinical narrative: Developed hives on face, red and watering eyes, hoarseness, SOB,abdominal pain, chest discomfort, urticaria on face and trunk after immunizations were given.  After a few minutes pt c/o tightness in his chest. MO auscultated wheezing in bilat lower lung lobes.  Pt received Yellow Fever, IPV, Twinrix, and Typhoid Fever. MO gave 50mg IM Benadryl with little relief to patient, when wheezing began, MO ordered O2, IV line, 500ml of NS bolus and 0.3mg Epinephrine given SC.  When EMS arrived pt still had tightness in chest and abdomen but the uticaria was improved.  EMS gave him an albuterol nebulizer during transport to hospital.
Age: 21.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF, HEPAB, IPV, TYP, YF
Symptoms: Lacrimation increased, Ocular hyperaemia, Urticaria, Wheezing
Clinical narrative: Developed hives on face, red and watering eyes, hoarseness, SOB,abdominal pain, chest discomfort, urticaria on face and trunk after immunizations were given.  After a few minutes pt c/o tightness in his chest. MO auscultated wheezing in bilat lower lung lobes.  Pt received Yellow Fever, IPV, Twinrix, and Typhoid Fever. MO gave 50mg IM Benadryl with little relief to patient, when wheezing began, MO ordered O2, IV line, 500ml of NS bolus and 0.3mg Epinephrine given SC.  When EMS arrived pt still had tightness in chest and abdomen but the uticaria was improved.  EMS gave him an albuterol nebulizer during transport to hospital.
Age: 21.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF, HEPAB, IPV, TYP, YF
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Developed hives on face, red and watering eyes, hoarseness, SOB,abdominal pain, chest discomfort, urticaria on face and trunk after immunizations were given.  After a few minutes pt c/o tightness in his chest. MO auscultated wheezing in bilat lower lung lobes.  Pt received Yellow Fever, IPV, Twinrix, and Typhoid Fever. MO gave 50mg IM Benadryl with little relief to patient, when wheezing began, MO ordered O2, IV line, 500ml of NS bolus and 0.3mg Epinephrine given SC.  When EMS arrived pt still had tightness in chest and abdomen but the uticaria was improved.  EMS gave him an albuterol nebulizer during transport to hospital.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Injection site erythema, Injection site pruritus, Throat irritation
Clinical narrative: She had redness and itching at injection site. No shortness of breath. Reddness then spread to her back. She was offered a Benedryl and refused it and went home and took 50mg of Benedryl. Her husband, a nurse tried to get her to go the the ER when she developed a tickle in her throat and a cough but she refused. She states she took another 25 mg of Benadryl and felt better and went to bed. When I spoke to her on 1/26/2010 at 10 am, she said some of the throat symptoms returned and she was going to make an appointment with her doctor.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Swollen tongue, Urticaria
Clinical narrative: Client waited 20 minutes after receiving vaccine and had no reaction at that time. After leaving center, about 6:45 PM, client began itching and noticed hives developing on neck, and arms and tongue swelling.  Client went to local hospital emergency room and received treatment with, epinephrine, benadryl, pepsid and prednisone.  Was treated and released home.  Client came to community clinic for follow up on 01/22/2010.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Patient came by pharmacy on 1/26/10 to complain of rash that formed on her chest with in 24 hours of recieveing the h1n1 shot. Patient did not call her doctor and rash went away on its own. Rash was still present on 1/26/10.
Age: 75.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Itching and hives arm bands on arms. Itching all over pelvic area bright red.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Hypokinesia, Mobility decreased, Myalgia, Pain
Clinical narrative: left arm soreness, progressively lost ability to move arm, lasted 4 days. Symptoms of severe pain, limited mobility and numbness occurred in right arm 5 weeks later. Went to family physician, treated with methylprednisolone p.o.;improvement within 5 days after treatment initiated. No lab or testing done.
Age: 69.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Body temperature increased, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore Throat, Cough, Wheezing, Temp of 102, Sneezing, Soreness, Lack of energy. Treatment: Ibuprophen, Lots of liquide, Bed rest
Age: 69.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Sneezing, Wheezing
Clinical narrative: Sore Throat, Cough, Wheezing, Temp of 102, Sneezing, Soreness, Lack of energy. Treatment: Ibuprophen, Lots of liquide, Bed rest
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Injection site pain, Nausea
Clinical narrative: Ha lost night (not unusual further). Liquid diarrhea. Stomach cramps @7:30am today. Nausea later on ~ 11:30. No vomit, chills, no temp taken. Hx thyroid problems that effect temp. Left arm still sore @ injection site. No redness or swelling 1/13/10 talk to client feeling better. No diarrhea, decreased stomach upset no nausea.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal X-ray, Abdominal discomfort, Asthenia, Constipation, Drooling
Clinical narrative: Overall weakness, started drooling, decreased leg hypertonia, decreased abdominal muscle function, extreme constipation with inability to pass stool without daily Fleet enema. Still able to walk, but slower.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Gait disturbance, Hypotonia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Overall weakness, started drooling, decreased leg hypertonia, decreased abdominal muscle function, extreme constipation with inability to pass stool without daily Fleet enema. Still able to walk, but slower.
Age: 80.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Injection site erythema, Nausea, Scab
Clinical narrative: My arm is still red (but fading) where the shot was administered-2 weeks later. The redness is about 1/2 inch diameter and has a crusted cover. No pain is associated with it when first observed on 1/18/10 it was bright red and weepy. Two hours after receiving the shot. I felt somewhat nauseous-lasted only 5-10 minutes.
Age: 77.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hemiparesis, Syncope
Clinical narrative: Approx. 18 hours after the patient received his H1N1 vaccine, he got up out of his chair and collapsed. Was taken to ER, diagnosed with a brain aneurysm the size of a dime on the left side of his brain. He is now having left side weakness.
Age: 0.84
Sex: F
Vaccine: FLU(H1N1), MMR
Symptoms: Body temperature increased, Erythema, Irritability, Rash macular
Clinical narrative: Patient had 99.9 temp and developed red, macular rash all over the body on 1/20/10. She is fussy. No other symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Oral discomfort, Paraesthesia oral, Throat irritation
Clinical narrative: Patient said she tastes the medicine in her mouth. I told her have a seat she started feeling itchy throat, tingling mouth and burning between gums and lips. I gave her 50 mg/ml injection Benadryl and took vitals every 15 minutes. No problem breathing.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash 3 days - BENADRYL.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Did not seek treatment went to family Dr. Received PT/meds-Doruocet/Lodeine-(inflam). Localized swelling at site/ lower arm within one day. At home initially tx with motrin/ice and heat alternating and exercise.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Returned call to mom regarding immunization. Patient had immunizations 12/3. By 12/5 mom says there was an area the size of a popcan that was swollen, red and hot to the touch on her right arm. Had received the DTAP and Varicella in the right deltoid. By Sunday had doubled in size. There were treating it with cold pack. By 12/7 it was back to popcan size and she is feeling ok. Mom says there was a reaction in the past to an immunization,but she does not remember what shot nor when.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Headache, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever 103 F, swelling at injection site approximately 8 hours after injection, nausea, and headache. Went to ER, treated with Ibuprofen and stayed for observation 24 hours. All symptoms were resolved the next day 1/14/10.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea on 12/24/09. 5 AM 12/25/09 diarrhea, nausea, vomiting and settled down about 10 PM 12/25/09.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Fatigue, Headache, Lacrimation increased, Pyrexia
Clinical narrative: Runny nose and eyes-minimal-2-3 days, extreme tiredness-3 days, achy joints-2 days, low grade fever-2 days, throbbing headache-3 days.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose and eyes-minimal-2-3 days, extreme tiredness-3 days, achy joints-2 days, low grade fever-2 days, throbbing headache-3 days.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Pharyngeal oedema
Clinical narrative: Headache, swollen throat very quickly after vaccination. Drinking lots of water. RPh (pt remained in room for another 20 min). Initially after pt. showed no signs (physically) of an allergic rxn. Breathing/talking normally.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Varicella eruptions/exam them 2 wks after vaccination with varicella.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Altered state of consciousness, Confusional state, Immediate post-injection reaction, Injection site pain, Memory impairment
Clinical narrative: Altered mental status 48 hours after vaccine. Couldn't remember how to turn on and off TV or lights, wandered at home confused, wet her bed. Arm where vaccine administered was immediately sore, swollen next day resolved 7 days later.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Urinary incontinence
Clinical narrative: Altered mental status 48 hours after vaccine. Couldn't remember how to turn on and off TV or lights, wandered at home confused, wet her bed. Arm where vaccine administered was immediately sore, swollen next day resolved 7 days later.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood glucose increased, Loss of consciousness, Tremor
Clinical narrative: Patient shook 3-5 minutes after shot then slumped over. Gave patient water and within 5-10 minutes, patient shook and passed out again. Patient has history of fainting when given shots or blood work. 20 mintues after given candy, patient's blood sugar was 161.
Age: 43.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: stomach/gut cramps, similar to menstrual cycle. Bloated gut. Syntoms persisted after defecation.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever, tenderness at injection site of PEDIARIX
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Diarrhea - still on going @ 11:15AM. Chills, sweats, muscle aches, pain, headache.
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pain
Clinical narrative: Diarrhea - still on going @ 11:15AM. Chills, sweats, muscle aches, pain, headache.
Age: 74.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Ataxia, Guillain-Barre syndrome, Lumbar puncture abnormal, Paraesthesia, Paraesthesia oral
Clinical narrative: Leg ataxia with paresthesia of arms and mouth.  Hospitalized and treated for Guillain Barre Syndrome with 2x IVIG.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1), FLUX, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching, redness, and swelling on left shoulder about 4-5 inches in diameter. itching, redness, and swelling on right shoulder about 2 inches in diameter
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Patient experienced edema, erythema, and pruritis at left arm injection site. Cold compress provided temporary relief.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cellulitis, Pyrexia
Clinical narrative: fever Tm 102.5 and cellulitis 2 inch diameter of left thigh
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient reports having a light red circle at the Zostavax injection site.  She reports it does not itch, is not painful, is not raised, and is not warm to the touch.  I have not personally seen the adverse reaction.