chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody positive, Drug ineffective, Laboratory test abnormal, Parotid gland enlargement, Pyrexia
Clinical narrative: Information has been received from the mother of a 23 year old female who in 1992, at 11 years of age, was vaccinated with a second dose of  measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient received the first dose of vaccine in 1982, at the age of 15 months. On 29 JAN 2004 the patient developed bilateral swollen parotid glands and fever, up to 100 deg F. The mother reported that the patient's physician felt that the patient had mumps and commented, "those antibodies were elevated a little". the patient was treated with ibuprofen for 5-6 days. No known exposure was reported. It was also reported that blood samples were taken 1 and 2 days after the appearance of clinical symptoms, which revealed the presence of Mumps-specific IgG, but Mumps specific IgM was negative. As of 05FEB2004, the patient's mumps persisted.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Information has been received from the mother of a 23 year old female who in 1992, at 11 years of age, was vaccinated with a second dose of  measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient received the first dose of vaccine in 1982, at the age of 15 months. On 29 JAN 2004 the patient developed bilateral swollen parotid glands and fever, up to 100 deg F. The mother reported that the patient's physician felt that the patient had mumps and commented, "those antibodies were elevated a little". the patient was treated with ibuprofen for 5-6 days. No known exposure was reported. It was also reported that blood samples were taken 1 and 2 days after the appearance of clinical symptoms, which revealed the presence of Mumps-specific IgG, but Mumps specific IgM was negative. As of 05FEB2004, the patient's mumps persisted.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning an adult female patient who was vaccinated on an unspecified date with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient had been vaccinated with measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine live twice over the last ten years. Recent titers do not show that the patient had developed immunity against mumps. Unspecified medical attention was sought. It was reported that no treatment was required. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a doctor of pharmacy concerning a pediatric male with an allergy to gelatin, who was administered , on an unspecified date, a 1-10 dilution dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. Subsequently the patient "reacted violently" to the vaccine. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning an adult female who was recently vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. Subsequently, the patient developed joint pain and a low grade fever. Unspecified medical attention was sought. The patient was treated with acetaminophen (Tylenol).The pharmacist reported that another patient developed joint pain and low grade fever post vaccination with measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine . Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Thrombocytopenia
Clinical narrative: Information has been received from a health department nurse concerning a female who at 14 months of age was vaccinated with a first dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. Subsequently, on an unspecified date, the patient developed idiopathic thrombocytopenia. The patient went to the emergency room , but it was unknown if she was hospitalized. At the time of this report, the patient was 4 years old. The patient's outcome was not reported. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an approximately 36 year old male patient who on 23FEB1995 was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. Subsequently, in January 2004 , the patient had a titer that was negative for mumps. Unspecified medical attention was sought. The physician also reported that a female pt was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine and had a recent titer that was negative for measles and an unknown number of patients were vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine and subsequently had negative titers. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Headache, Injection site induration, Malaise, Pyrexia
Clinical narrative: Information has been received from an RN concerning a 28 yo female pt with PCN and Codeine allergies who on 06FEB2004 was vaccinated SC into the left arm with MMR. On 13FEB2004 the pt called the nurse stating she had a slight fever of 99, a tender, warm one inch lump on left arm the size of a quarter on the left arm, malaise and HA two nights prior. There was no rash reported. No lab or diagnostic studies were done. The pt hadn't yet recovered as of 13FEB2004. Additional info has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Tenderness
Clinical narrative: Information has been received from an RN concerning a 28 yo female pt with PCN and Codeine allergies who on 06FEB2004 was vaccinated SC into the left arm with MMR. On 13FEB2004 the pt called the nurse stating she had a slight fever of 99, a tender, warm one inch lump on left arm the size of a quarter on the left arm, malaise and HA two nights prior. There was no rash reported. No lab or diagnostic studies were done. The pt hadn't yet recovered as of 13FEB2004. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Eyelid oedema, Hypersensitivity, Immediate post-injection reaction, Nasal oedema, Rhinorrhoea
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a consumer and follow up information from a registered nurse  concerning her 4 year old son with a history of difficulty in breathing (present prior to administration of vaccines on 12/03/03) which had not been diagnosed and was noted to be possible allergic asthma and who received a first dose of MMRII on 12/14/00 which was well tolerated. On 12/03/03  at 10:30 am the pt was vaccinated subcutaneous in the right arm with a second  dose of MMRII (Lot # 645626/0396N). Concomitant therapy included albuterol nebulizer as needed and vaccination on 12/03/03  at 10:30 am witha fourth dose of poliovirus vaccine inactivated (IPOL) (Lot #W1619) given IM in the left arm and a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (lot # DTPA616A2) given IM in the left arm. On the way home from the office, on 12/03/03, her son had a severe allergic reaction. He had facial swelling and broke out into hives. The mother reported she took her son back to the physician. The pt received a prednisone injection. Eventually he recovered from this event. Follow up information reported that immediately after vaccine, patient with a runny nose, nasal membranes edematous and upper eyelids edematous. The patient was given one and a half teaspoons of prednisolone (Prelone). The registered nurse reported this required a doctor visit and she also reported the patient recovered. Upon internal review severe allergic was determined to be an other important medical event (OMIC). No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a consumer and follow up information from a registered nurse  concerning her 4 year old son with a history of difficulty in breathing (present prior to administration of vaccines on 12/03/03) which had not been diagnosed and was noted to be possible allergic asthma and who received a first dose of MMRII on 12/14/00 which was well tolerated. On 12/03/03  at 10:30 am the pt was vaccinated subcutaneous in the right arm with a second  dose of MMRII (Lot # 645626/0396N). Concomitant therapy included albuterol nebulizer as needed and vaccination on 12/03/03  at 10:30 am witha fourth dose of poliovirus vaccine inactivated (IPOL) (Lot #W1619) given IM in the left arm and a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (lot # DTPA616A2) given IM in the left arm. On the way home from the office, on 12/03/03, her son had a severe allergic reaction. He had facial swelling and broke out into hives. The mother reported she took her son back to the physician. The pt received a prednisone injection. Eventually he recovered from this event. Follow up information reported that immediately after vaccine, patient with a runny nose, nasal membranes edematous and upper eyelids edematous. The patient was given one and a half teaspoons of prednisolone (Prelone). The registered nurse reported this required a doctor visit and she also reported the patient recovered. Upon internal review severe allergic was determined to be an other important medical event (OMIC). No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Eyelid oedema, Face oedema, Rhinorrhoea, Tracheal oedema, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a consumer and follow up information from a registered nurse  concerning her 4 year old son with a history of difficulty in breathing (present prior to administration of vaccines on 12/03/03) which had not been diagnosed and was noted to be possible allergic asthma and who received a first dose of MMRII on 12/14/00 which was well tolerated. On 12/03/03  at 10:30 am the pt was vaccinated subcutaneous in the right arm with a second  dose of MMRII (Lot # 645626/0396N). Concomitant therapy included albuterol nebulizer as needed and vaccination on 12/03/03  at 10:30 am witha fourth dose of poliovirus vaccine inactivated (IPOL) (Lot #W1619) given IM in the left arm and a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (lot # DTPA616A2) given IM in the left arm. On the way home from the office, on 12/03/03, her son had a severe allergic reaction. He had facial swelling and broke out into hives. The mother reported she took her son back to the physician. The pt received a prednisone injection. Eventually he recovered from this event. Follow up information reported that immediately after vaccine, patient with a runny nose, nasal membranes edematous and upper eyelids edematous. The patient was given one and a half teaspoons of prednisolone (Prelone). The registered nurse reported this required a doctor visit and she also reported the patient recovered. Upon internal review severe allergic was determined to be an other important medical event (OMIC). No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a public health center nurse concerning a school-aged pt (age and gender not reported, who after age one, had been vaccinated with 0.5mL first and second doses of MMRII (Lot # not reported). Subsequently the pt developed rubella, which was confirmed by IgM. The pt had a reddish rash, swollen lymph nodes, but no history of fever. Unspecified medical attention was sought. The pt's outcome was not reported. It was also reported that the pt's sibling had been vaccinated with MMRII and developed rubella (WAES # 0403USA01315).  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a public health center nurse concerning a school-aged pt (age and gender not reported) who, after age 1 had been vaccinated with 0.5mL first and second doses of MMRII (Lot # not reported). Subsequently the pt developed rubella, which was confirmed by IgM. The pt had a reddish rash, swollen lymph nodes, but no history of fever. Unspecified medical attention was sought. The pt's outcome was not reported. It was also reported that the pt's sibling had been vaccinated with MMRII and developed rubella (WAES # 0403USA01259).  Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Blepharitis, Drug administration error
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a RN concerning a 42 year old female LPN who on 03/18/04 "accidentally got an eye splash in the right eye" with MMRII (Lot # not available).  The pt was treated with a "water eye rinse". The nurse reported that after the eye wash the pt's eye felt like sandpaper had scratched it. It was unknown if the pt recovered. The pt sought unspecified medical attention. No product quality complaint involved.  Upon follow-up the RN reported that while the LPN was administering the measles virus vaccine live (+) mumsp virus vaccine live (+)  rubella virus vaccine live to a patient at 3:40 pm it was inadvertenly splashed into her right eye. The nurse flushed her eye for 1 minute with water. The nurse's eye became dry and "scratchy." Approximately 9 days later the nurse was diagnosed with blepharitis. It was unknown if the nurse recovered. No further information is available.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/28/2004. Initial and follow-up information has been received from a RN concerning a 15 month old male pt with no medical history reported and with no illness at the time of vaccination who on 03/10/04 at 9:30 am  was vaccinated SC in the left thigh with a first dose  0.5mL dose of MMRII (Lot # 646072/0806N). The patient was also vaccinated with a fourth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix), which was administered intramuscularly in the right thigh, at 9:30 am on 10-Mar-2004. On 16-Mar-2004, the patient developed a fever (body temperature measurements not provided). On 18-Mar-2004, the patient developed a "rash (measles-like)" (initially reported as a red rash from head to toe). Subsequently, the patient recovered (date not provided). Unspecified medical attention was sought. No further information is available.
Age: 45.0
Sex: M
Vaccine: MMR, TTOX
Symptoms: Sexual dysfunction
Clinical narrative: Information has been received from a physician concerning an approximately 45 year old male with a hx of catarax surgery after an eye injury (in approx 1985) who on 13MAR2004 was vaccinated with a dose of MMR. On 13MAR2004, the pt was concomitantly vaccinated with a dose of tetanus toxoid. On 19MAR2004, the pt contacted the physician and reported he was experiencing sexual dysfunction with ejaculation and erection problems. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Conjunctivitis, Drug ineffective, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Information has been received from an allergist concerning a 12 month old female with a hx of chronic eczema and recurrent otitis media who on 05MAR2004 was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. On 05MAR2004, the pt was concomitantly vaccinated with a dose of varicella virus vaccine live. On 05MAR2004, it was noted that the pt had a rash and therapy with sulfamethoxazole/trimethoprim was discontinued. On 08MAR2004, the pt developed a fever and rash. On 11MAR2004, the pt developed a viral exanthema described by the parents of the pt as a diffuse measles like rash from the head to the toes. The patient also had conjunctivitis and rhinitis. The pt was seen by the reporting physician and was treated with  Eldel, Triamnic, Motrin, oatmeal bath, and Zyrtec. No additional info is expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rhinitis, Viral infection
Clinical narrative: Information has been received from an allergist concerning a 12 month old female with a hx of chronic eczema and recurrent otitis media who on 05MAR2004 was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. On 05MAR2004, the pt was concomitantly vaccinated with a dose of varicella virus vaccine live. On 05MAR2004, it was noted that the pt had a rash and therapy with sulfamethoxazole/trimethoprim was discontinued. On 08MAR2004, the pt developed a fever and rash. On 11MAR2004, the pt developed a viral exanthema described by the parents of the pt as a diffuse measles like rash from the head to the toes. The patient also had conjunctivitis and rhinitis. The pt was seen by the reporting physician and was treated with  Eldel, Triamnic, Motrin, oatmeal bath, and Zyrtec. No additional info is expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no known allergies and a history of eczema (April 2003) who on19MAR2004 was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. On 19MAR2004, the pt was concomitantly vaccinated with a dose of varicella virus vaccine live. On 26MAR2004, the pt developed a fever of 102F and a rash on her trunk, arm and face. On 30MAR2004,the pt was seen in the office with the same symptoms. At the time of this report, no treatment was prescribed. Additional info has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Eye irritation, Medication error, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female pt who was inadvertently splashed in the left eye with measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine while drawing up the vaccine to administer it to a pt. It was reported that she had her eye rinsed and made an appointment with an ophthalmologist. The pt wore contacts and it ripped later in the day. The pt had some irritation, discomfort and itchiness in her eye. It was reported that "it was treated as a blood borne pathogen." Additional info has been requested.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Drug toxicity, Kidney infection
Clinical narrative: Severe kidney infection. Pain in lower back; unable to work or function due to extreme toxic reaction. Bed ridden for 3 weeks.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hyperaemia, Pyrexia, Rash, Vomiting
Clinical narrative: vomiting,fever 103, generalised hyperemic rash . no tx
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Received phone call from physician reporting significant swelling in left theigh.  Client refused to walk or crawl.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Pruritus, Rash pustular
Clinical narrative: 06/22/04 Patient presented to our ED via ambulance.  During his flight he noticed a few pustules were becoming larger and was quite itchy.  He showed them to his sargent who sent him to the ED for evaluation.  Presently is still here and has been seen by our ID doctor on 06/23/04 with probable generalized vaccinia.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Infection, Irritability, Otitis media, Pyrexia, Rash
Clinical narrative: PATIENT CAME INTO CLINIC WITH RASH COVERING SCALP, BACK OF EARS, NECK AND TRUNK AREA. RASH STARTED BEHIND EARS YESTERDAY AND HAS SINCE SPREAD. PT HAS HAD 102-103 FEVER. VERY FUSSY AND HAS BEEN SLEEPING ALOT. (ALSO WAS DIAGNOSED WITH LEFT ACUTE OTITIS MEDIA.)
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling, Pruritus, Urticaria
Clinical narrative: GENERALIZED ITCHING AND HIVES WITHIN 10 MINUTES OF ADMINISTERING VACCINE.  SWELLING AT INJECTION SITE.
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 12x12cm erythmatous hot area R shoulder at site of tetanus injection
Age: 3.0
Sex: M
Vaccine: DTAPH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh red and swollen
Sex: U
Vaccine: HBHEPB, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Urticaria
Clinical narrative: Information has been received from a physician concerning a white pt with a medical history of premature birth at 32-34 weeks and a concurrent condition of bronchiolitis and asthma diagnosed on 12/09/03 who on 12/16/03 at 11:30 am was vaccinated in the left thigh with a first dose of MMRII (Lot # 646122/0610N). Concomitant therapy included vaccination with a third dose in the right thigh of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (Lot # 646697/0756N). There was no illness at the time of vaccination. On 12/16/03 at 11:30am, the pt developed a ring of erythema, warmth, swelling and hives (2-3) around injection site "left thigh immediately after shot administration." There were no diagnostic lab test performed. The symptoms resolved 30 minutes after treatment with Benadryl 10mg orally and the pt recovered on 12/16/03.  No further information is expected.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Anorexia, Dyspnoea, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: This is a 19-year-old who had been in his usual health when he received his primary smallpox and anthrax vaccinations. He went home on leave three days after receiving his immunizations. Approximately four days after receiving the vaccinations, he states that he began to loose appetite. On the eighth day post vaccination he developed a fever of 103.8° F orally and became nauseous and began vomiting. On the 10th day post vaccination he reported to the Emergency Department because of severe headache, on-going fever, chills, nausea and vomiting. He describes the headache as starting in the lower occipital area and radiated around the side of his head bilaterally to the frontal area, sharp, rated 10/10 in intensity. His head pain was worse in supine position, however in sitting position pain radiated down spine, with associated numbness in bilateral legs. He reports that his vision is now blurred, and there is more intense blurring with headaches.  He was admitted and placed in the medical intensive care unit for approximately 24 hours. He reports that his CT scan in the ED showed possible cerebral edema and inflammation of the meninges. He underwent three (3) lumbar punctures, but the physicians were unsuccessful in obtaining central spinal fluid (CSF). He was started on IV antibiotics. The next morning he was seen by neurology and three additional attempts at obtaining CSF were attempted with final success. Over the next three to four days, his fever, chills, nausea and vomiting slowly subsided.   He continues to have headaches that average 5/10 in intensity, dull and mostly in occipital region. Pain is relieved medication and rest. He is unable to drive more than 30 miles safely. Has impaired vision and increased pain intensity with bright light. He has sharp, shooting pain in his bilateral lower extremities, 5/10 in intensity, and occurs with prolonged sitting, walking, or lifting. Pain is constant when working and does not ever completely subside. In addition, he experiences intermittent pain radiating down left arm associated with neck stiffness. He is currently undergoing physical therapy for "marginal loss of strength on left side of body".
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Nausea, Pharyngolaryngeal pain, Pyrexia, Vomiting
Clinical narrative: This is a 19-year-old who had been in his usual health when he received his primary smallpox and anthrax vaccinations. He went home on leave three days after receiving his immunizations. Approximately four days after receiving the vaccinations, he states that he began to loose appetite. On the eighth day post vaccination he developed a fever of 103.8° F orally and became nauseous and began vomiting. On the 10th day post vaccination he reported to the Emergency Department because of severe headache, on-going fever, chills, nausea and vomiting. He describes the headache as starting in the lower occipital area and radiated around the side of his head bilaterally to the frontal area, sharp, rated 10/10 in intensity. His head pain was worse in supine position, however in sitting position pain radiated down spine, with associated numbness in bilateral legs. He reports that his vision is now blurred, and there is more intense blurring with headaches.  He was admitted and placed in the medical intensive care unit for approximately 24 hours. He reports that his CT scan in the ED showed possible cerebral edema and inflammation of the meninges. He underwent three (3) lumbar punctures, but the physicians were unsuccessful in obtaining central spinal fluid (CSF). He was started on IV antibiotics. The next morning he was seen by neurology and three additional attempts at obtaining CSF were attempted with final success. Over the next three to four days, his fever, chills, nausea and vomiting slowly subsided.   He continues to have headaches that average 5/10 in intensity, dull and mostly in occipital region. Pain is relieved medication and rest. He is unable to drive more than 30 miles safely. Has impaired vision and increased pain intensity with bright light. He has sharp, shooting pain in his bilateral lower extremities, 5/10 in intensity, and occurs with prolonged sitting, walking, or lifting. Pain is constant when working and does not ever completely subside. In addition, he experiences intermittent pain radiating down left arm associated with neck stiffness. He is currently undergoing physical therapy for "marginal loss of strength on left side of body".
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Anorexia, Asthenia, Brain oedema, Chills, Headache
Clinical narrative: This is a 19-year-old who had been in his usual health when he received his primary smallpox and anthrax vaccinations. He went home on leave three days after receiving his immunizations. Approximately four days after receiving the vaccinations, he states that he began to loose appetite. On the eighth day post vaccination he developed a fever of 103.8° F orally and became nauseous and began vomiting. On the 10th day post vaccination he reported to the Emergency Department because of severe headache, on-going fever, chills, nausea and vomiting. He describes the headache as starting in the lower occipital area and radiated around the side of his head bilaterally to the frontal area, sharp, rated 10/10 in intensity. His head pain was worse in supine position, however in sitting position pain radiated down spine, with associated numbness in bilateral legs. He reports that his vision is now blurred, and there is more intense blurring with headaches.  He was admitted and placed in the medical intensive care unit for approximately 24 hours. He reports that his CT scan in the ED showed possible cerebral edema and inflammation of the meninges. He underwent three (3) lumbar punctures, but the physicians were unsuccessful in obtaining central spinal fluid (CSF). He was started on IV antibiotics. The next morning he was seen by neurology and three additional attempts at obtaining CSF were attempted with final success. Over the next three to four days, his fever, chills, nausea and vomiting slowly subsided.   He continues to have headaches that average 5/10 in intensity, dull and mostly in occipital region. Pain is relieved medication and rest. He is unable to drive more than 30 miles safely. Has impaired vision and increased pain intensity with bright light. He has sharp, shooting pain in his bilateral lower extremities, 5/10 in intensity, and occurs with prolonged sitting, walking, or lifting. Pain is constant when working and does not ever completely subside. In addition, he experiences intermittent pain radiating down left arm associated with neck stiffness. He is currently undergoing physical therapy for "marginal loss of strength on left side of body".
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Hypoaesthesia, Meningism, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: This is a 19-year-old who had been in his usual health when he received his primary smallpox and anthrax vaccinations. He went home on leave three days after receiving his immunizations. Approximately four days after receiving the vaccinations, he states that he began to loose appetite. On the eighth day post vaccination he developed a fever of 103.8° F orally and became nauseous and began vomiting. On the 10th day post vaccination he reported to the Emergency Department because of severe headache, on-going fever, chills, nausea and vomiting. He describes the headache as starting in the lower occipital area and radiated around the side of his head bilaterally to the frontal area, sharp, rated 10/10 in intensity. His head pain was worse in supine position, however in sitting position pain radiated down spine, with associated numbness in bilateral legs. He reports that his vision is now blurred, and there is more intense blurring with headaches.  He was admitted and placed in the medical intensive care unit for approximately 24 hours. He reports that his CT scan in the ED showed possible cerebral edema and inflammation of the meninges. He underwent three (3) lumbar punctures, but the physicians were unsuccessful in obtaining central spinal fluid (CSF). He was started on IV antibiotics. The next morning he was seen by neurology and three additional attempts at obtaining CSF were attempted with final success. Over the next three to four days, his fever, chills, nausea and vomiting slowly subsided.   He continues to have headaches that average 5/10 in intensity, dull and mostly in occipital region. Pain is relieved medication and rest. He is unable to drive more than 30 miles safely. Has impaired vision and increased pain intensity with bright light. He has sharp, shooting pain in his bilateral lower extremities, 5/10 in intensity, and occurs with prolonged sitting, walking, or lifting. Pain is constant when working and does not ever completely subside. In addition, he experiences intermittent pain radiating down left arm associated with neck stiffness. He is currently undergoing physical therapy for "marginal loss of strength on left side of body".
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Photophobia, Pyrexia, Vision blurred, Vomiting
Clinical narrative: This is a 19-year-old who had been in his usual health when he received his primary smallpox and anthrax vaccinations. He went home on leave three days after receiving his immunizations. Approximately four days after receiving the vaccinations, he states that he began to loose appetite. On the eighth day post vaccination he developed a fever of 103.8° F orally and became nauseous and began vomiting. On the 10th day post vaccination he reported to the Emergency Department because of severe headache, on-going fever, chills, nausea and vomiting. He describes the headache as starting in the lower occipital area and radiated around the side of his head bilaterally to the frontal area, sharp, rated 10/10 in intensity. His head pain was worse in supine position, however in sitting position pain radiated down spine, with associated numbness in bilateral legs. He reports that his vision is now blurred, and there is more intense blurring with headaches.  He was admitted and placed in the medical intensive care unit for approximately 24 hours. He reports that his CT scan in the ED showed possible cerebral edema and inflammation of the meninges. He underwent three (3) lumbar punctures, but the physicians were unsuccessful in obtaining central spinal fluid (CSF). He was started on IV antibiotics. The next morning he was seen by neurology and three additional attempts at obtaining CSF were attempted with final success. Over the next three to four days, his fever, chills, nausea and vomiting slowly subsided.   He continues to have headaches that average 5/10 in intensity, dull and mostly in occipital region. Pain is relieved medication and rest. He is unable to drive more than 30 miles safely. Has impaired vision and increased pain intensity with bright light. He has sharp, shooting pain in his bilateral lower extremities, 5/10 in intensity, and occurs with prolonged sitting, walking, or lifting. Pain is constant when working and does not ever completely subside. In addition, he experiences intermittent pain radiating down left arm associated with neck stiffness. He is currently undergoing physical therapy for "marginal loss of strength on left side of body".
Age: 0.58
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Meningitis, Pyrexia, Rash, Sepsis
Clinical narrative: Death within 48 hours of vaccine. Patient presented with high grade fever to 105 within 24 hours of vaccine. Seen at hospital on 6/17/04 (informant states); worked up, released from hospital ED 6/18/04. Fever and spots and pronounced dead.  Nurse follow up on 08/10/04 states: "Septicemia."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abscess, Cellulitis
Clinical narrative: None stated.  Nurse follow up on 06/25/2004: "DELETE: react uneval, ADD: cellulitis, abscess."  Nurse follow up on 06/25/04 states: "No new information."
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Agitation, Antisocial behaviour, Autism, Encephalopathy
Clinical narrative: Persistent, inconsolable screaming and behavior occurred within 24 hours of vaccination. This was followed by loss of communication skills, social skills, ease with food and general regression in all areas. Treatment: speech, occupational  and behavioral therapy.  Nurse follow up on 07/21/04 states: "strabismus, developmental delays  As per annual follow up report: Residual symptoms of autism, asperger continue, not withstanding extensive treatment and progress.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Laboratory test abnormal, Screaming
Clinical narrative: Persistent, inconsolable screaming and behavior occurred within 24 hours of vaccination. This was followed by loss of communication skills, social skills, ease with food and general regression in all areas. Treatment: speech, occupational  and behavioral therapy.  Nurse follow up on 07/21/04 states: "strabismus, developmental delays  As per annual follow up report: Residual symptoms of autism, asperger continue, not withstanding extensive treatment and progress.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis, Dizziness, Hypersensitivity, Injection site rash
Clinical narrative: ~6days after receiving MMR vaccine Pt had onset of bilateral knee and hip aches/pain. Lightheadedness and fever by her report. Also reports ~3" rash at the site of the injection. Advised ER eval ( ER report attached) Pt reports Hx. of Arthritis. Final diagnosis in ER was allergic reaction. -IV fluid, Toradol, Zofran, Solumedrol. "I'm finally feeling normal" on 06/22/04.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: ~6days after receiving MMR vaccine Pt had onset of bilateral knee and hip aches/pain. Lightheadedness and fever by her report. Also reports ~3" rash at the site of the injection. Advised ER eval ( ER report attached) Pt reports Hx. of Arthritis. Final diagnosis in ER was allergic reaction. -IV fluid, Toradol, Zofran, Solumedrol. "I'm finally feeling normal" on 06/22/04.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Hypertonia, Malaise, Neck pain
Clinical narrative: Pt in clinic on 06/02/2004 for RPR, PPD, and TD. She states she started feeling bad and arm and shoulder stiff on 06/03/2004. Then neck started hurting and small knot appeared 6/4/04, slightly raised clavical area. TD given in the Deltoid-Left neck pain complaints.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Left arm swollen and red sore to touch
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Urticaria
Clinical narrative: Received call on 05/14/04 from client to report an allergic reaction from Immunization received on 05/10/04. Reports red hive rash generalized, called MD-instructed to take Benadryl (all this occurred within 1 hr of injection of tetanus toxoid at health dept) After taking Benadryl and sleeping about an hour later no rash or problems noted.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Varivax given 5/13/04. Positive, confirmed varicella 6/7/04.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Had low fever during the night but did not wake up crying. This morning had 103.5 temp at 7:15AM. Tylenol brought fever down to normal. Minimal redness at the site of the IPV infection in a linear patter. The other 3 sites look normal.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema
Clinical narrative: 7cm x 7 cm area of redness and swelling to right thigh.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Had varicella vaccine 04/03/1997. Now (6/18/04) presents with full case of chicken pox.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying, Feeling hot, Irritability, Screaming
Clinical narrative: Irritability/crying for 3-4 days after immunization with Pediarix and Hib. Tactile warmth.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema, Tenderness
Clinical narrative: Diffuse leg swelling from point of injection in ant thigh distally to knee, mild erythema/tenderness.
Age: 1.0
Sex: M
Vaccine: IPV, PNC, VARCEL
Symptoms: Infection
Clinical narrative: Has chickenpox. Dad has resolving shingles.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypokinesia, Injection site erythema, Pain, Urticaria
Clinical narrative: Pt received Pneumovax on 05/17/04. She called our office on 05/19/04 c/o arm immediately painful after injection given and continues to be sore. Also broke out with welts, redness at injection area on 5/18/04. States hurts to even move arm on 5/19/04. Saw nurse practitioner on 5/19/04, presented Prednisone 30mg taper Benadryl x 2 days for erythema at site with raised wheals entire upper arm. Follow up appt. 5/25/04 with Dr. Reaction resolved.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Medication error, Unevaluable event
Clinical narrative: NONE. Vaccine expired 05/15/2004 Pediarix
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Medication error, Unevaluable event
Clinical narrative: NONE. Vaccine was expired 05/15/2004 Pediarix
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Temp 100, chills, headache, body aches, mild pain at injection site starting 13 1/2 hrs post injection for 24hrs Tx: ice to site, Tylenol
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Temp 99, headache, body aches x 24hrs, Less severe than the one on 6/9/04. Treated W/ Tylenol
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site induration, Lymphadenopathy, Rash papular
Clinical narrative: Small pimples in clusters at site of Varicella immunization. There is induration under that area as well as regional lymph node enlargements.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Ecchymosis, Erythema, Pain
Clinical narrative: Information has been received from a RN concerning a 4 year old male pt with no reported medical history who on 01/26/04 was vaccinated SC into the right thigh with a second dose of MMRII (Lot # 646124/0615N). Concomitant vaccinations on 01/26/04 included a fifth dose of DTAP (Daptacel, Lot # C1612AA) IM into the left thigh and a fourth dose of IPV (Lot # X0367) SC into the left thigh. It was reported that the pt was not ill at the time of vaccination.  On 02/06/04 the pt's mother called the physician's office to report atht he pt had developed ecchymosis (black and blue) about 3 inches and to the left of the immunization site which was painful to the touch. The pt's mother reported that she first saw this ecchymosis on 01/27/04.  The pt was seen by the physician and on the right leg 4 inch by 2 1/2 inch erythematous lesion was noted. The pt was treated with Cutivate cream. As of 02/16/04 the pt had not yet improved and the area was sore to the touch. The pt was referred to a dermatologist. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a woman at a doctor's office concerning a 30's year old female who on an unspecified date was vaccinated with a dose of MMRII (Lot # not reported). It was reported that the pt came to the office to have titers done before she became pregnant.  It was found that she had no protection against measles and rubella. Unspecified medical attention was sought. It was noted that there was no record of the initial vaccination with MMRII, but the pt was sure she had had it. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a RN concerning a 15 month old child who on 02/10/04 was vaccinated in the left leg with a dose of MMRII (Lot # 646740/0822N). The nurse reported that the pt experienced a local site reaction and developed redness at the injection site. The pt was observed and no treatment was needed. The reporter has requested a lot check. The records of testing prior to release of this lot (646740/0822N) have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse reported another child who experienced a similar reaction after therapy with MMRII (WAES # 0402USA01555).  The nurse also reported that triplets experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01433, 0402USA01540, 0402USA04541).  The nurse reported another child who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01546).  It was noted that the triplets had the worst reaction.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a RN concerning a 14 month old  female child with no illness at the time of vaccination and no allergies and no past medical history who on 10-Feb-2004 was vaccinated subcutaneous in the  right leg with a first dose of MMRII (Lot # 646740/0822N).  The nurse reported that the pt experienced a local site reaction and developed redness at the injection site. The pt was observed and no treatment was needed. Subsequently the patient recovered. The reporter has requested a lot check. The records of testing prior to release of this lot (646740/0822N) have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available. The nurse reported another child who experienced a similar reaction after therapy with MMRII (WAES # 0402USA01554).  The nurse also reported that triplets experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01433, 0402USA01540, 0402USA04541).  The nurse reported another child who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01546).  It was noted that the triplets had the worst reaction.
Sex: U
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: Information has been received from a physician concerning a pt who on an unknown date was vaccinated with MMRII (Lot # not reported). Subsequently the pt developed redness (location unspecified).  The pt sought unspecified medical attention. At the time of this report the outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a RN concerning a pt who on 02/12/04 was vaccinated with a dose of MMRII. On 02/18/04 the pt developed a rash. On 02/23/04 the rash was still present. No lot # or further information was available at that time. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the pt's were vaccinated via the inappropriate route (WAES # 0402USA01852).  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 15 year old female pt who on 03/05/93 was vaccinated SC with a second 0.5mL dose of MMRII (Lot # not reported). On 04/18/89 she was vaccinated with a first dose of MMRII (Lot # not reported). On 01/23/04 the pt had titers drawn and they were negative for rubella. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Haemorrhage
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with MMRII (Lot # 646555/0812N). Subsequently, the pt developed bruising at injection site and bleeding through the skin. It was unknown if the pt recovered. The physician reported that "she will not use this lot # on anyone else."  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also described the events of another pt who developed a swollen thigh which was painful and caused limping after being vaccinated with MMRII (WAES # 0401USA01898). Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an approximately 38 year old female pt who on an unspecified date was vaccinated with a dose of MMRII (Lot # not available). Subsequently, a recent titer was negative for measles. Unspecified medical attention was sought.  The physician also reported that a male pt was vaccinated with a dose of MMRII and had a titer that was negative for mumps (WAES # 0402USA01110) and an unknown number of pt's were vaccinated with a dose of MMRII and subsequently had negative titers (WAES # 04042USA01993).  Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning her 17 month old daughter, with no medical history and no allergies, who on 02/26/04 was vaccinated with a dose of MMRII (Lot # not reported). The vaccine was given via the IM route. There were no concomitant medications. On 02/28/04 the pt developed a fever. The fever was around 103-104F with the highest registered being 104.9F. On 02/29/04 the pt vomited. On 03/01/04 the pt still had the fever, but a lower grade which was being controlled with Tylenol. Unspecified medical attention was sought. Additional information has been requested.