chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Convulsion, Full blood count normal, Streptococcal identification test negative
Clinical narrative: Temp of 101. 1/20/2010- Saw Dr. Strep test neg. Amoxicillin 400 mg. BID for 10 days prescribed. Gave Ibuprophen at 4:30 p.m. Approx. 6:30 p.m. on 01/20/2010 child awoke having seizure(lasted 3-4mins.).  Went to ER. Temp was 104. Gave Tylenol. Gave Rocephin IV.  Temp. down to 101 on discharge.  Maintained temp of 100 for 1 week (relieved with fever med) then spiked  back up. Temp normal 1/8-2/1.  On 2/2 temp back up to 100 and also today - 2/3/10.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Activities of daily living impaired, Asthenia, Cough, Ear congestion, Nasal congestion
Clinical narrative: Symptoms started with nasal congestion on 1/23/2010. On 1/25/2010, patient started to have a sore throat with mild fever. Patient began to take Advil and guaifenesin to relieve fever and congestion. Patient's fever continued, sinus congestion increased, and ears became congested. A cough developed on 1/28/2008. Patient began to cleanse sinuses with saline on 1/29/2009 - much mucus was expelled. She also began to take cough syrup regularly. Patient spent most of her time on the couch - too weak to perform her normal activities. Patient called doctor on 2/1/2010. Azithromycin was prescribed. The next morning the fever broke, sinus congestion is gone, but patient is still weak and experiencing problems with her ears.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Oropharyngeal pain, Pyrexia, Sinus congestion
Clinical narrative: Symptoms started with nasal congestion on 1/23/2010. On 1/25/2010, patient started to have a sore throat with mild fever. Patient began to take Advil and guaifenesin to relieve fever and congestion. Patient's fever continued, sinus congestion increased, and ears became congested. A cough developed on 1/28/2008. Patient began to cleanse sinuses with saline on 1/29/2009 - much mucus was expelled. She also began to take cough syrup regularly. Patient spent most of her time on the couch - too weak to perform her normal activities. Patient called doctor on 2/1/2010. Azithromycin was prescribed. The next morning the fever broke, sinus congestion is gone, but patient is still weak and experiencing problems with her ears.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: CSF protein increased, Gastrointestinal disorder, Guillain-Barre syndrome, Hypoaesthesia facial, Nerve conduction studies abnormal
Clinical narrative: Approximately 1 week after shingles vaccine developed sore throat and was told 'strep'. Week of Dec 21, 2009, had an intestinal illness; Jan 10 and 11, 2010, legs began hurting. Jan 13 increase in leg pain. Jan 14 developed numbness in face and eyes. Jan 15 went to Hospital and was transferred to Medical Center with diagnosis of Guillian-Barre Syndrome. Treatment included plasmapheresis.
Age: 71.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Oropharyngeal pain, Pain in extremity, Pharyngitis streptococcal, Plasmapheresis
Clinical narrative: Approximately 1 week after shingles vaccine developed sore throat and was told 'strep'. Week of Dec 21, 2009, had an intestinal illness; Jan 10 and 11, 2010, legs began hurting. Jan 13 increase in leg pain. Jan 14 developed numbness in face and eyes. Jan 15 went to Hospital and was transferred to Medical Center with diagnosis of Guillian-Barre Syndrome. Treatment included plasmapheresis.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3
Symptoms: Vomiting
Clinical narrative: VOMITING - SEVERAL TIMES IN 1 HOUR.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Weight bearing difficulty
Clinical narrative: Weakness and unable to put any weight on her left leg that lasted 3 days.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: VOMITING - MULTIPLE TIMES IN 1 HOUR.
Age: 48.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Upon IM inj.-immediate wheel appeared at site - palpital for SQ fluid, none found. Pt denied any other s/s of adversity. Pt remained on site x 15 minutes - again denied adverse s/s 2/1/10 pt was phoned by Rph - still denies further s/s.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1), TDAP
Symptoms: Chills, Erythema, Fatigue, Local reaction, Pruritus
Clinical narrative: 20cm x 6cm local reaction, erythema, itching, chills and fatigue reported by patient. Patient saw physician and was given prescriptions for Benadryl and Prednisone.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Patient complained of (L) arm tenderness pain. Slight swelling noted.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Lethargy, Pyrexia, Rhinorrhoea
Clinical narrative: Fever with lethargy approx. 8 hours after vaccination. Reported following day by mother. Denies any other symptoms other than slight "runny nose", temp 102 degrees, treated with Tylenol and Ibuprofen. Improved approx. 36 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU(H1N1), FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt given immunizations on L upper arm. Positive redness, swelling and firmness around immunizations and circumference of arm - Treated with BENADRYL.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Back pain, Diarrhoea, Headache, Neck pain
Clinical narrative: Patient received the H1N1 vax on 1/27/2010 at about 9:15am. Around 11:15am, that same day patient had a headache, and back and neck pain. He also had severe diarrhea. This symptoms have all subsided except for the back pain as of 2/3/2010.
Age: 80.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling cold, Muscle spasms, Muscular weakness, Walking aid user
Clinical narrative: The Patient was sitting down to dinner and noticed when she tried to get up her left leg was very weak and she could not stand up without the aid of her husband and her cane which was highly abnormal, her leg also felt very cramped up and over the course of the night she felt very cold and could not warm up for the rest of the night, The next morning she woke up and reported she felt much better with much less weakness noticed in the leg and did not note any chills or muscle cramping, patient felt it was mostly gone by the following evening and was relieved.
Age: 72.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Diarrhoea, Dyspnoea, Joint stiffness, Respiratory tract congestion
Clinical narrative: Started with difficulty breathing at 6pm.  by bedtime was having chills.  had joint stiffness starting about midnight.  By 6am, had diarrhea.  Had congestion in chest with large amt of mucus in lungs that continued until present.
Age: 37.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blood creatine phosphokinase normal, Burning sensation, Full blood count normal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: pain right arm pain spread to arms, hand s feet later to fingers  burning on right wrist area
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Lymphadenopathy
Clinical narrative: swollen glands for over a week
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Back pain, Chest X-ray, Cough, Pain, Pneumonia
Clinical narrative: 58 year old female with chronic health problems , cystic fibrosis and chronic bronchitis received the H1N1 vaccine on 1/18/2010.  The next day she awoke with severe bodyaches, pain in her back, coughing, fever,  productive cough.   Several of her friends and neighbors were confirmed H1N1 .  She saw her physician the next day , chest xray was done and pneumonia was confirmed.  She was placed on antibiotics ,  today ,2/3/2010 she is feeling much better, symptoms  have resolved and tomorrow  2/4/2010 she sees her physician for repeat Chest xray .   States she is back to normal. She received her H1N1 vaccine at the a clinic.   She received the injection in her arm.
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Productive cough, Pyrexia
Clinical narrative: 58 year old female with chronic health problems , cystic fibrosis and chronic bronchitis received the H1N1 vaccine on 1/18/2010.  The next day she awoke with severe bodyaches, pain in her back, coughing, fever,  productive cough.   Several of her friends and neighbors were confirmed H1N1 .  She saw her physician the next day , chest xray was done and pneumonia was confirmed.  She was placed on antibiotics ,  today ,2/3/2010 she is feeling much better, symptoms  have resolved and tomorrow  2/4/2010 she sees her physician for repeat Chest xray .   States she is back to normal. She received her H1N1 vaccine at the a clinic.   She received the injection in her arm.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash, Scarlet fever
Clinical narrative: 3 year old child received H1N1 nasal vaccine on 1/20/10 (second dose) and at 6 PM  had a 101.5 fever, was irritable and  was sleepy. Mom was concerned because he did not eat dinner and she does not have a pediatrician.  His  fever lasted 5 days ,  he developed a rash over his entire body.  He was  diagnosed  with scarlett fever by physician  at the emergency room where they took him the evening of 1/20/2010.  The entire family developed the illness , all are recovered now .   They took him to the ER because they do not have a private doctor or pediatrician.   Symptomatic and supporitve care was recomended by the emregency room.  Mom was reluctant to give further information ie name of hospital.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Somnolence
Clinical narrative: 3 year old child received H1N1 nasal vaccine on 1/20/10 (second dose) and at 6 PM  had a 101.5 fever, was irritable and  was sleepy. Mom was concerned because he did not eat dinner and she does not have a pediatrician.  His  fever lasted 5 days ,  he developed a rash over his entire body.  He was  diagnosed  with scarlett fever by physician  at the emergency room where they took him the evening of 1/20/2010.  The entire family developed the illness , all are recovered now .   They took him to the ER because they do not have a private doctor or pediatrician.   Symptomatic and supporitve care was recomended by the emregency room.  Mom was reluctant to give further information ie name of hospital.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain at site with weakness in arm d/t pain, continued for 2 weeks
Age: 19.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: No reaction on previous exposure to drug, Rash erythematous, Urticaria
Clinical narrative: Pt received injection of H1N1 vaccine through the Health Department, they came to his workplace on 12/22/2009. On 12/26/2009 he developed a red rash with hives more on inside of his both arms than on the outside of his arms, he also had some on his chest and back, but not as many raised areas as on his arms.  He saw a physician on 12/28 and was diagnosed with a rash, as per conversation with mom , he was placed on a "cream" and oral Benadryl".  His symptoms are gone now but according to patient's mom they lasted "well after the New Year" He has received seasonal flu vaccines in the past and had no reaction.  Mom and dad are reluctant to give information over the phone.  Mom stated they do not want to receive "anything in the mail" The patient does not have a private doctor but sees various doctors when necessary.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Cough, Pyrexia, Rhinorrhoea, Syncope
Clinical narrative: FEVER,FAINTED,COUGH,RUNNY NOSE FOR 5 DAYS
Age: 0.95
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Mass, Pain
Clinical narrative: Chief complaint; Painful lumps in neck Diagnosis; Shingles 053.9
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Dyspnoea, Eye discharge, Eye irritation, Rash, Rash pruritic
Clinical narrative: shortness of breath, lump in throat, eyes secreting mucus and scratchy and my body broke out in a rash. Emergency room administered ranitidine, diphenhydramine, methylprednisolone and I have to take prednisone for 5 days and Benadryl for the itchy rash
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Sensation of foreign body
Clinical narrative: shortness of breath, lump in throat, eyes secreting mucus and scratchy and my body broke out in a rash. Emergency room administered ranitidine, diphenhydramine, methylprednisolone and I have to take prednisone for 5 days and Benadryl for the itchy rash
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Antiphospholipid antibodies negative, Arthralgia, Blood immunoglobulin G increased, Clumsiness
Clinical narrative: Within 1 month after receiving vaccination progressive clumsiness noted with complaints of leg pain with inability to run without falling.  Eventually, lost ability to run and only able to participate in some aspects of gym classes.  Alternate written assignments had to be done.  On April 9,2008 had severe pain to left leg while in bed.  While stepping up onto school bus, passed out.  Complained of dizziness at that time.  pain progressed to right leg that day with tingling and numbness.  Taken to ED, CT scan of head and labs done.  Referred to neurologist.  Many blood tests performed, EMG, nerve conduction studies, MRI's. May 1, 2008 reported right leg pain worsening and now present in right hip and waist.  Referred to neurologist due to progressive weakness and right leg lag.  Adaptations have had to be made at school through the 504B plan to accomodate for her disabilities.  Stairs are very challenging.  Swallowing difficulties started within last 3 months.  Now seeing neurologist, rheumatologist, endocrinologist to find cause of proximal weakness. Lots of autoimmune studies have been done and repeated.  No answer to this problem for a child who was in perfect health prior to this vaccination.  Bills are immensely expensive and continue.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, DNA antibody positive, Dizziness, Dysphagia, Electromyogram abnormal
Clinical narrative: Within 1 month after receiving vaccination progressive clumsiness noted with complaints of leg pain with inability to run without falling.  Eventually, lost ability to run and only able to participate in some aspects of gym classes.  Alternate written assignments had to be done.  On April 9,2008 had severe pain to left leg while in bed.  While stepping up onto school bus, passed out.  Complained of dizziness at that time.  pain progressed to right leg that day with tingling and numbness.  Taken to ED, CT scan of head and labs done.  Referred to neurologist.  Many blood tests performed, EMG, nerve conduction studies, MRI's. May 1, 2008 reported right leg pain worsening and now present in right hip and waist.  Referred to neurologist due to progressive weakness and right leg lag.  Adaptations have had to be made at school through the 504B plan to accomodate for her disabilities.  Stairs are very challenging.  Swallowing difficulties started within last 3 months.  Now seeing neurologist, rheumatologist, endocrinologist to find cause of proximal weakness. Lots of autoimmune studies have been done and repeated.  No answer to this problem for a child who was in perfect health prior to this vaccination.  Bills are immensely expensive and continue.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Gait disturbance, Haematology test normal, Hypoaesthesia, Laboratory test normal
Clinical narrative: Within 1 month after receiving vaccination progressive clumsiness noted with complaints of leg pain with inability to run without falling.  Eventually, lost ability to run and only able to participate in some aspects of gym classes.  Alternate written assignments had to be done.  On April 9,2008 had severe pain to left leg while in bed.  While stepping up onto school bus, passed out.  Complained of dizziness at that time.  pain progressed to right leg that day with tingling and numbness.  Taken to ED, CT scan of head and labs done.  Referred to neurologist.  Many blood tests performed, EMG, nerve conduction studies, MRI's. May 1, 2008 reported right leg pain worsening and now present in right hip and waist.  Referred to neurologist due to progressive weakness and right leg lag.  Adaptations have had to be made at school through the 504B plan to accomodate for her disabilities.  Stairs are very challenging.  Swallowing difficulties started within last 3 months.  Now seeing neurologist, rheumatologist, endocrinologist to find cause of proximal weakness. Lots of autoimmune studies have been done and repeated.  No answer to this problem for a child who was in perfect health prior to this vaccination.  Bills are immensely expensive and continue.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle enzyme, Muscular weakness, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Within 1 month after receiving vaccination progressive clumsiness noted with complaints of leg pain with inability to run without falling.  Eventually, lost ability to run and only able to participate in some aspects of gym classes.  Alternate written assignments had to be done.  On April 9,2008 had severe pain to left leg while in bed.  While stepping up onto school bus, passed out.  Complained of dizziness at that time.  pain progressed to right leg that day with tingling and numbness.  Taken to ED, CT scan of head and labs done.  Referred to neurologist.  Many blood tests performed, EMG, nerve conduction studies, MRI's. May 1, 2008 reported right leg pain worsening and now present in right hip and waist.  Referred to neurologist due to progressive weakness and right leg lag.  Adaptations have had to be made at school through the 504B plan to accomodate for her disabilities.  Stairs are very challenging.  Swallowing difficulties started within last 3 months.  Now seeing neurologist, rheumatologist, endocrinologist to find cause of proximal weakness. Lots of autoimmune studies have been done and repeated.  No answer to this problem for a child who was in perfect health prior to this vaccination.  Bills are immensely expensive and continue.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia, Vitamin D decreased
Clinical narrative: Within 1 month after receiving vaccination progressive clumsiness noted with complaints of leg pain with inability to run without falling.  Eventually, lost ability to run and only able to participate in some aspects of gym classes.  Alternate written assignments had to be done.  On April 9,2008 had severe pain to left leg while in bed.  While stepping up onto school bus, passed out.  Complained of dizziness at that time.  pain progressed to right leg that day with tingling and numbness.  Taken to ED, CT scan of head and labs done.  Referred to neurologist.  Many blood tests performed, EMG, nerve conduction studies, MRI's. May 1, 2008 reported right leg pain worsening and now present in right hip and waist.  Referred to neurologist due to progressive weakness and right leg lag.  Adaptations have had to be made at school through the 504B plan to accomodate for her disabilities.  Stairs are very challenging.  Swallowing difficulties started within last 3 months.  Now seeing neurologist, rheumatologist, endocrinologist to find cause of proximal weakness. Lots of autoimmune studies have been done and repeated.  No answer to this problem for a child who was in perfect health prior to this vaccination.  Bills are immensely expensive and continue.
Age: 35.0
Sex: M
Vaccine: ANTH, FLUX(H1N1), SMALL, TYP, ANTH, FLUX(H1N1), SMALL, TYP
Symptoms: Convulsion, Loss of consciousness, Loss of consciousness
Clinical narrative: After receiving anthrax vaccine, Pt lost consciousness and then went into convulsions x 1 min. Regained consciosuness x 1 min, then lost consciousness again with convulsions x 1 min. Regained consciousness and then was transported by ambulance to nearest civilian ER. Pt also received H1N1, smallpox, and typhoid prior to anthrax vaccine that morning.
Age: 35.0
Sex: M
Vaccine: ANTH, FLUX(H1N1), SMALL, TYP, ANTH, FLUX(H1N1), SMALL, TYP
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: After receiving anthrax vaccine, Pt lost consciousness and then went into convulsions x 1 min. Regained consciosuness x 1 min, then lost consciousness again with convulsions x 1 min. Regained consciousness and then was transported by ambulance to nearest civilian ER. Pt also received H1N1, smallpox, and typhoid prior to anthrax vaccine that morning.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Electromyogram abnormal, Nerve conduction studies abnormal, Radial nerve palsy
Clinical narrative: Wrist drop on same side as vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: large hives and welts on my upper body - back, chest and arms
Sex: M
Vaccine: MEA
Symptoms: Gastroenteritis viral
Clinical narrative: Information has been received from a consumer concerning her son who, "4 weeks ago", on approximately 13-JAN-2009, was vaccinated with a dose of ATTENUVAX. More than 2 weeks later, her son was vaccinated with a dose of MUMPSVAX. On approximately 10-FEB-2009 the child had a "stomach virus". The patient visited the physician for it. The consumer reported that her pediatrician routinely gave the monovalents on a 2 weeks spacing interval to all children in the practice. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: MEA, PNC
Symptoms: Irritability, Pyrexia, Vaccination complication
Clinical narrative: Information has been received from a consumer concerning her 15 month old son with no pertinent medical history and no drug reactions or allergies, who in approximately September 2008, was vaccinated with a dose of MEASLES virus vaccine (Enders-Edmonston). Concomitant therapy included PREVNAR. The child's mother reported that she remembered measles virus vaccine live (Enders-Edmonston) was given at 15 months of age and experienced a fever of 104F for 3 days, then on the 12th day after vaccination a high fever again for 3 days. The child also experienced moodiness after receiving the vaccine. At time of reporting, the patient had recovered. The patient sought medical attention as his mother called the office. There were no lab or diagnostic studies performed. The consumer also reported that the patient experienced an adverse event with rubella virus vaccine live (HPV-77) (WAES#0902USA02199) and VARICELLA virus vaccine live (Oka/Merck) (WAES# 0902USA02200). Follow-up information received on 27-FEB-2009 from a physician stated that the patient received the first dose of measles virus vaccine live (Enders-Edmonston) on 21-OCT-2008 (lot # 654623/0034U), subcutaneously. The patient received the first dose of HAVRIX (lot # AHAVB297CA) intramuscularly into the right deltoid on 07-OCT-2008. The reporter stated that the patient did not call or had an office visit after the vaccine adverse effect. No laboratories studies performed, no illness at time of vaccination. At the time of this report, the patient had recovered on an unspecified date. No further information is available.
Age: 13.0
Sex: M
Vaccine: MEA
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Information  has been received from a consumer concerning his 13 year old son with sensitivity to unspecified vaccines with a history of allergy to vaccine who in January 2009, was vaccinated with MMR. In January 2009, the patient experienced high fever, rash and generally not feeling well. Subsequently, the patient was recovered.  Additional information is not expected.
Age: 1.29
Sex: M
Vaccine: MEA
Symptoms: Abnormal behaviour, Adverse event, Coeliac disease, Diarrhoea, Drooling
Clinical narrative: Information has been received from a consumer concerning her 15 year old son with allergy to eggs and oatmeal and patient's mother with SJOREN'S syndrome who on 26-MAR-2008 was vaccinated with the first dose of measles virus vaccine. There was no concomitant medication. On 02-APR-2008, "seven days after receiving his first dose", the patient developed a hot, red face, limping, gait, decreased urination, loose stools, increased drooling. The patient also exhibited "unusual behavior" such as staring and rocking as well as hitting his arms and legs. The patient was examined by his unspecified physician but no treatment was recommended. The symptoms resolved without treatment in one month.  The mother also reported that subsequently the patient exhibited similar symptoms seven days after receiving is first dose of VARIVAX (Merck) (WAES # 0903USA00002).  Follow-up information received from the patient's mother which reported that in approximately March 2009, "recently", her son was diagnosed with celiac disease and this might be the reason he experienced the adverse event.  The mother reported in follow up that her other son had a similar reaction when he got HIB (OMPC) and PREVENAR concomitantly (WAES# 0903USA02851).  No further information is available.
Age: 1.29
Sex: M
Vaccine: MEA
Symptoms: Dysuria, Erythema, Gait disturbance, Staring
Clinical narrative: Information has been received from a consumer concerning her 15 year old son with allergy to eggs and oatmeal and patient's mother with SJOREN'S syndrome who on 26-MAR-2008 was vaccinated with the first dose of measles virus vaccine. There was no concomitant medication. On 02-APR-2008, "seven days after receiving his first dose", the patient developed a hot, red face, limping, gait, decreased urination, loose stools, increased drooling. The patient also exhibited "unusual behavior" such as staring and rocking as well as hitting his arms and legs. The patient was examined by his unspecified physician but no treatment was recommended. The symptoms resolved without treatment in one month.  The mother also reported that subsequently the patient exhibited similar symptoms seven days after receiving is first dose of VARIVAX (Merck) (WAES # 0903USA00002).  Follow-up information received from the patient's mother which reported that in approximately March 2009, "recently", her son was diagnosed with celiac disease and this might be the reason he experienced the adverse event.  The mother reported in follow up that her other son had a similar reaction when he got HIB (OMPC) and PREVENAR concomitantly (WAES# 0903USA02851).  No further information is available.
Sex: F
Vaccine: MEA
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter who in the "end of November 2008", was vaccinated with a dose of ATTENUVAX.  After receiving ATTENUVAX, the patient developed hives and fever.  She sought physician's medical attention.  The outcome of the patient was not reported.  Follow-up information was received on 22-JAN-2009 indicating no additional information.  Follow-up information was received on 12-MAR-2009 from the mother indicating her daughter, the patient had fever after receiving ATTENUVAX.  No further information is available.
Sex: M
Vaccine: MEA, MU, RUB
Symptoms: Aphasia, Developmental delay
Clinical narrative: Information has been received from a consumer concerning her 6.5 year old son who was vaccinated with three doses of measles virus vaccine live(Ender-Edmonston). Secondary suspect therapy included three doses of MUMPSVAX and MERUVAX (Wistar RA 27/311). The monovalents were given at 12, 13 and 14 months, on approximately January 2004, February 2004, and March 2004, respectively. On an unspecified date, the patient experienced "late talker", with developmental delays and trouble with word retrieval. The outcome of the events and action taken were unknown. No further information is available.
Sex: M
Vaccine: MEA
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his son who was vaccinated with ATTENUVAX (lot # not reported). Subsequently the patient experienced fever and seizure after getting ATTENUVAX.  The outcome of the patient was unknown the patient sought unspecified medical attention.  Upon internal review, seizure was determined to be an other important medical event.  No further information is available.
Sex: M
Vaccine: MEA, RUB
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her son with milk allergy, banana allergy, wheat and dairy, who on 19-JAN-2007 was vaccinated with a dose of ATTENUVAX.  There was no concomitant medication.  In approximately June 2007 (reported as after vaccination), the patient experienced fever which lasted for 3 days.  On an unspecified date the patient was seen by his physician.  Subsequently, the patient recovered from fever.  The patient subsequently experienced fever while on therapy with MERUVAX.  This is one report from several from the same source.  Additional information has been requested.
Sex: F
Vaccine: MEA, MU, RUB
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of ATTENUVAX, a dose of of MERUVAX, and  a dose of MUMPSVAX.  Subsequently the patient experienced high fever.  This is one report of several from the same source.  Additional information has been received from an unspecified source who stated that a patient can not be identified. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MEA
Symptoms: Diarrhoea, Fatigue, Measles antibody positive, Pyrexia
Clinical narrative: Information has been received from an employee health nurse concerning a 38 year old female employee with measles titer 0.82, no drug allergies, and "she does have medical problems": list not provided, who on 07-JUL-2009 was vaccinated with the last of two ATTENUVAX vaccine (Enders-Edmonston) (lot#659617/0187X), SC. There was concomitant medication according to the reporter that "I'm sure she is but I don't have a list". Within 6 hours the patient experienced fever of 102 degrees F, diarrhea and fatigue. The patient made a phone call to seek medical attention. The patient had not recovered at the time of report. Additional information has been requested.
Sex: M
Vaccine: MEA
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been requested from a consumer concerning her son who in June 2009, was vaccinated with a dose of ATTENUVAX vaccine (Enders-Edmonston). The consumer reported that her son experienced a fever and rash after receiving ATTENUVAX vaccine. The patient was seen at an unspecified urgent care facility. The fever resolved with TYLENOL after 2 days and the rash resolved without treatment in 10 days. No further information is available.
Sex: U
Vaccine: MEA, MU
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a Certified Dental Technician (C.D.T) concerning a child patient with egg allergy who on an unspecified date was vaccinated with the first dose of ATTENUVAX. Secondary suspect therapy included the first dose of MUMPSVAX II. It was reported that when the patient was given the first dose of ATTENUVAX and MUMPSVAX II "his arm swelled up a little bit". The outcome of the patient was unknown. No further information is available.
Sex: M
Vaccine: MEA
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a consumer concerning her son who was vaccinated with a dose of ATTENUVAX vaccine (Enders-Edmonston) last year and subsequently his arm swelled. The reporter called to check available of mumps vaccine. No further information is available.
Sex: F
Vaccine: MEA
Symptoms: Measles
Clinical narrative: Information has been received from a consumer concerning her daughter who years ago on an unspecified date was vaccinated with a dose of ATTENUVAX vaccine (Enders-Edmonston) (Lot number not provided). Subsequently the patient experienced a slight case of ATTENUVAX a few days later. The patient sought unspecified medical attention. On an unknown date, the patient recovered from a slight case of measles. The consumer "was sure that her daughter was already infected with measles before she was vaccinated and that the outbreak had nothing to do with the vaccination". No further information is available.
Sex: M
Vaccine: MEA, RUB
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning her son who on unspecified dates was vaccinated with the first doses of MMR II (MSD). On unspecified dates the patient was vaccinated with the second doses of ATTENUVAX and MERUVAX II (MSD). It was reported that the patient was sick a couple of times and was not able to get vaccinated with the MUMPSVAX (MSD). At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MEA
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter who at 15 months of age was vaccinated with the first 0.5 mL dose of ATTENUVAX (Lot number was not provided). Subsequently, the patient experienced allergic reaction to ATTENUVAX. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: MEA
Symptoms: Pharyngitis streptococcal, Scarlet fever, Staphylococcal infection
Clinical narrative: Information has been received from a consumer concerning her 37 year old son with immune system disorder who in approximately August 2009, "about a month ago" was vaccinated with a single dose of ATTENUVAX. Sometimes last week, the patient developed staph infection, strep throat and scarlet fever. The patient saw his physician and was given anti-biotics (name and manufacturer unspecified). It was reported that the reporter did not know if the vaccine caused the patient to have these experiences. At the time of the report, the patient's status was unknown. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, MEA
Symptoms: Antibody test abnormal, Measles antibody positive
Clinical narrative: Information has been received from a consumer concerning a 4 year old male patient with no pertinent medical history and no drug reactions/allergies who in July 2009, was vaccinated with a 0.5ml single dose ATTENUVAX. Concomitant therapy included DTaP. In June 2009, the patient had a titer test done which showed that the patient's titer level for measles virus was nearly five times greater than it should be. Unspecified medial attention was sought. At the time of the report, the patient had not recovered. No further information is available.
Age: 1.58
Sex: M
Vaccine: MEA
Symptoms: Allergy to plants, Asthma, Bronchial hyperreactivity, Chest X-ray normal, Food allergy
Clinical narrative: Information has been received from a consumer concerning her 12 month old son with no pertinent medical history and no reported allergies, who in June 2007,  was vaccinated with a dose ATTENUVAX vaccine (Enders-Edmonston) (dose, route and lot number not provided). There were no concomitant medication. The mother reported that one week after receiving ATTENUVAX vaccine (Enders-Edmonston) approximately June 2007, his son developed asthma and allergies to pineapple, watermelon, crab, shrimp, nuts and trees. At the time of the report the patient had not recovered from the events. No labs studies were performed. The patient sought unspecified medical attention. Follow-up information was received from a nurse practitioner (N.P.). It was reported that the 20 month old male patient who on 08-MAY-2007 was vaccinated into the left thigh with a first dose of ATTENUVAX vaccine (enders-Edmonston) (lot # 654623/0034U). Concomitant therapy included a third dose of TRIPEDIA, lot # C2553AA that was given into the left thigh on 20-APR-2007. There was no illness at time of the vaccination. It was reported that on 12-MAY-2007, the patient experienced a reactive airway disease (RAD). The patient required an ER visit with no admission in Nov 2007, and had 3 office visits for RAD. The patient required neb treatments and prednisone. Lab tests included chest X-ray with a negative result. Subsequently, the patient recovered on an unknown date. It was reported that on 29-JUN-2007 the patient was vaccinated into the left thigh with a first dose of rubella virus vaccine live (Wistar RA 27/31 (MSD, lot # 655408/0036U). No further information is available.
Sex: M
Vaccine: MEA, MU, RUB
Symptoms: Adverse drug reaction, Malaise
Clinical narrative: Information has been received from a consumer concerning her son with down's syndrome, transient leukemia, unbalanced atrioventricular canal defect, coarctation of the aorta and kung disease who was vaccinated with the first dose of ATTENUVAX. Other suspect therapies included MERUVAX II and MUMPSVAX. It was reported by the patient's mother that "I was fortunate enough to have my son's first shots available to me as individual injections. He had reactions to two of the three and became quite ill. Imagine if the two would have been in one injection. My son is medically fragile with a  seizure cardiac defect and lung issues." The patient's outcome was not reported. No further information is available.
Sex: F
Vaccine: MEA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning one of her female baby who on approximately 09-MAR-2009 (*three weeks ago*) was vaccinated with ATTENUVAX. On approximately 16-MAR-2009 (7 days after receiving ATTENUVAX) the patient throw up for a couple of days and had fever. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: MEA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning one of her baby who on unspecified date was vaccinated with ATTENUVAX. After receiving the ATTENUVAX the patient developed fever. This is one of two reports from the same source. Additional information has been requested.
Age: 1.7
Sex: F
Vaccine: MEA
Symptoms: Pyrexia
Clinical narrative: Information has been received form a mother concerning her 20 month old daughter with no medical history or allergy who "a few months ago", was vaccinated with ATTENUVAX (lot# not reported). There was no concomitant medication, "Soon after getting the vaccine", the patient developed a fever of 105F. The patient was evaluated at a local emergency room but was not hospitalized. The fever resolved in 4 days and the patient fully recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 1.7
Sex: F
Vaccine: MEA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a mother concerning her 20 month old daughter with no medical history or allergy who "a few months ago", was vaccinated with ATTENUVAX (lot# not reported). There was no concomitant medication. "Soon after getting the vaccine", the patient developed  a fever of 105F. The patient was evaluated at a local emergency room but was not hospitalized. The fever resolved in 4 days and the patient fully recovered. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: MEA
Symptoms: Body temperature increased, Flushing, Injection site rash, Purpura, Pyrexia
Clinical narrative: Information has been received from a consumer, concerning her daughter who on an unspecified date was vaccinated with a dose of ATTENUVAX. Subsequently, after the patient received the vaccination she experienced a fever and developed an injection site rash. Follow up information received from the consumer indicated that her daughter also experienced flushing in her face. At the time of the report, the outcome was not reported. Follow up information has been received from the consumer concerning her daughter. The patient's mother reported that her daughter developed purpura after she received a dose of ATTENUVAX (lot # 659617/0448X). At the time of the report, the patient's status was unknown. Follow up information has been received from the consumer who reported that the patient had fever 105 degrees F (11-14 days into the vaccine), rash described as some red blotchy, and purple, small spots on facial area, temple area and blotchy face. Then this subsided with in the next two weeks. Then a fever and rash occurred about 4 days later. Additional information has been requested.
Sex: F
Vaccine: MEA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her kindergarten age daughter who was vaccinated with a dose of ATTENUVAX. The patient experienced high fever after receiving the vaccine. This is one of several reports from the same source. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: MEA
Symptoms: Diarrhoea, Measles, Pyrexia, Rash
Clinical narrative: Information has been received from a mother concerning her then approximately two year old male with asthma and hypersensitivity who "some time" in 2002 was vaccinated with ATTENUVAX (dose, route and lot number not reported). There was no concomitant medication. The mother reported "about two weeks after receiving the vaccine", the patient had a high fever, diarrhea and then broke out in a rash and the patient was diagnosed with the measles. The patient was recovered in "unspecified date" and he sought medical attention at the physician's office. Additional information is not expected.
Age: 1.4
Sex: M
Vaccine: MEA
Symptoms: Body temperature increased, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning his 16 month old son with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with a dose of ATTENUVAX. There was no concomitant medication reported. It was reported that "same day of the vaccination" the patient developed fever of 103 degrees F and rash on his arm and chest. The patient did not seek medical attention. It was reported that the patient recovered 2 or 3 days after the vaccination. The reporter also indicated that the patient developed an adverse experience after another vaccine WAES # 0905USA01701. Additional information has been requested.
Sex: U
Vaccine: MEA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her child who was vaccinated with ATTENUVAX (lot number, route number and site not reported). The patient had "a reaction" to ATTENUVAX. It was unknown if the patient sought medical attention. The outcome was not reported. The patient also had a fever and was "all out of shots" after receiving MERUVAX (MSD, WAES0905USA02997). No further Information is available.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Body temperature increased, Infection, Injection site infection, Staphylococcal skin infection, Toxic shock syndrome
Clinical narrative: 102.9 temperature, pyogenic superinfection of primary smallpox vaccine site, staph aureus with early TSS.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, MMR, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Asthma, Condition aggravated
Clinical narrative: Initial report was received on 27 January 2010 from another manufacturer, identification number A0837213A. "This case was reported by a healthcare professional and described the occurrence of asthmatic attack in a 15-month-old male subject who was vaccinated with PEDIARIX. Concurrent medical conditions included asthma and gluten intolerance. Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on 14 September 2009; MMR vaccine (non-gsk); Merck; unknown; unknown given on 12 November 2009. On 12 November 2009 the subject received 2nd dose of PEDIARIX (.5 ml, unknown, left thigh). On 13 November 2009, one day after vaccination with PEDIARIX, the subject experienced asthmatic attack. The healthcare professional reported the asthma attack occurred after the second dose of PEDIARIX was administered. The healthcare professional considered the event was disabling. At the time of reporting the outcome of the asthma attack was resolved. The healthcare professional considered the event was possibly related to vaccination with PEDIARIX. Follow-up information was received on 19 January 2010, via healthcare professional who clarified that the first dose PENTACEL (non-GSK) administered on 14 September 2009. The 2nd dose in the series was PEDIARIX given on 12 November 2009. The subject experienced an asthma attack with previous vaccination of PENATCEL; non-GSK manufacturer; Intramuscular; unknown and PREVENAR; non-GSK manufacturer; unknown given on 14 September 2009. The asthma attack occurred and resolved on 14 September 2009. The healthcare professional considered the asthma attack serious. The healthcare professional reported the subject experienced an asthmatic attack after receiving 2nd dose of PEDIARIX (.5 ml, unknown, left thigh) and 1st dose of MMR vaccine (Merck) (.5 ml, subcutaneous, right thigh) on 12 November 2009. The asthma attack occurred on 12 November 2009 and resolved the same day. The healthcare professional reported the asthma attack was not disabling but did consider the asthma attack as "serious". The healthcare professional associated the asthma attack to medical history/ concurrent illness and as a "reaction to stress/upset due to pain or discomfort of injections". The healthcare professional reconsidered the previous report of asthma attack possibly related to vaccination with PEDIARIX to an unknown relationship with PEDIARIX and MMR vaccine (Merck)." List of Documents held by Sender: none.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, MMR, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Asthma, Condition aggravated, Similar reaction on previous exposure to drug
Clinical narrative: Initial report was received on 27 January 2010 from another manufacturer, identification number A0837213A. "This case was reported by a healthcare professional and described the occurrence of asthmatic attack in a 15-month-old male subject who was vaccinated with PEDIARIX. Concurrent medical conditions included asthma and gluten intolerance. Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on 14 September 2009; MMR vaccine (non-gsk); Merck; unknown; unknown given on 12 November 2009. On 12 November 2009 the subject received 2nd dose of PEDIARIX (.5 ml, unknown, left thigh). On 13 November 2009, one day after vaccination with PEDIARIX, the subject experienced asthmatic attack. The healthcare professional reported the asthma attack occurred after the second dose of PEDIARIX was administered. The healthcare professional considered the event was disabling. At the time of reporting the outcome of the asthma attack was resolved. The healthcare professional considered the event was possibly related to vaccination with PEDIARIX. Follow-up information was received on 19 January 2010, via healthcare professional who clarified that the first dose PENTACEL (non-GSK) administered on 14 September 2009. The 2nd dose in the series was PEDIARIX given on 12 November 2009. The subject experienced an asthma attack with previous vaccination of PENATCEL; non-GSK manufacturer; Intramuscular; unknown and PREVENAR; non-GSK manufacturer; unknown given on 14 September 2009. The asthma attack occurred and resolved on 14 September 2009. The healthcare professional considered the asthma attack serious. The healthcare professional reported the subject experienced an asthmatic attack after receiving 2nd dose of PEDIARIX (.5 ml, unknown, left thigh) and 1st dose of MMR vaccine (Merck) (.5 ml, subcutaneous, right thigh) on 12 November 2009. The asthma attack occurred on 12 November 2009 and resolved the same day. The healthcare professional reported the asthma attack was not disabling but did consider the asthma attack as "serious". The healthcare professional associated the asthma attack to medical history/ concurrent illness and as a "reaction to stress/upset due to pain or discomfort of injections". The healthcare professional reconsidered the previous report of asthma attack possibly related to vaccination with PEDIARIX to an unknown relationship with PEDIARIX and MMR vaccine (Merck)." List of Documents held by Sender: none.