chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.24
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Around 5 AM on 11/4/01, pt woke up crying so father got up and fed him formula and cereal. Father laid in recliner with baby on chest. About an hour later when mother got up and went to where they were, she found the baby dead. Father upset "that he might have smothered the baby."
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Heart rate increased
Clinical narrative: A consumer reported that her 69 year old father received Flu Shield vaccine ('00-'01) in 11/00. According to the daughter, in 12/00, her father "couldn't get (his) heart in rhythm and it was racing". His health care provider cardioverted the pt X 2 and he also had a cardiac ablation procedure. He was hospitalized. No additional information was available as of the date of this report.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a 57 year old male who in 1992 was vaccinated with a 1st dose and on 10/25/01 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. On 10/27/01, the pt was admitted to the hospital with cellulitis. On 10/30/01, the pt was still hospitalized and was receiving treatment with vancomycin. The nurse reported that she was not certain of the pt's status as of 11/2/01. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood urine, Infection, Leukocytosis, Pruritus, Pyrexia
Clinical narrative: Pt had no history of varicella and varicella titer was negative. Fifteen days post vax pt started running a fever. 10/29/01 pt noted the appearance of red spots that over 10 days erupted and evolved like varicella only with a longer time period than expected. On 10/31/01 pt was given Atarax for itching and rash. Pt continued with a low grade fever of 100.3-100.5 daily. On 11/7/01, a nurse made a home visit which was followed by blood tests and a chest x-ray on 11/8/01, and pt was started on Acyclovir. On 11/10/01, pt had more blood tests and a urinalysis. She was started on Cipro for a possible UTI. On 11/13/01, pt's fever increased to 102F, and she was admitted to the hospital for evaluation.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Red blood cell sedimentation rate increased, Thrombocythaemia, Urinary tract infection
Clinical narrative: Pt had no history of varicella and varicella titer was negative. Fifteen days post vax pt started running a fever. 10/29/01 pt noted the appearance of red spots that over 10 days erupted and evolved like varicella only with a longer time period than expected. On 10/31/01 pt was given Atarax for itching and rash. Pt continued with a low grade fever of 100.3-100.5 daily. On 11/7/01, a nurse made a home visit which was followed by blood tests and a chest x-ray on 11/8/01, and pt was started on Acyclovir. On 11/10/01, pt had more blood tests and a urinalysis. She was started on Cipro for a possible UTI. On 11/13/01, pt's fever increased to 102F, and she was admitted to the hospital for evaluation.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatinine increased, Cardiac disorder, Cardiac failure, Cardiac failure congestive, Cardiomyopathy
Clinical narrative: Pt was admitted to hospital with symptoms of congestive heart failure. Pt was normally in excellent health. Cardiologist's diagnosis was active viral myocarditis.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Myocarditis, Viral infection
Clinical narrative: Pt was admitted to hospital with symptoms of congestive heart failure. Pt was normally in excellent health. Cardiologist's diagnosis was active viral myocarditis.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia
Clinical narrative: Generalized Weakness, lodd ofL.E.function, Hospitalized 08/26/01, dx with GBS
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Headache, Intracranial pressure increased, Irritability, Meningitis, Musculoskeletal stiffness
Clinical narrative: Pt developed headache, nausea, irritability, stiff neck, vomiting, sleepiness all the time, and loss of peripheral vision. Doctor's won't conclude 100% that it was due to Hepatitis B vax. FU states pt has severe optic neuropathy OD and mild optic neuropathy OS, both secondary to parainfectious meningitis with increased intracranial pressure. Per doc 213384, 60 day follow-up, no further information is available. Per annual follow up: pt has not recovered. He has some permanent visual (optic atrophy) impairment.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Nausea, Neuropathy, Optic atrophy, Pneumonia, Somnolence
Clinical narrative: Pt developed headache, nausea, irritability, stiff neck, vomiting, sleepiness all the time, and loss of peripheral vision. Doctor's won't conclude 100% that it was due to Hepatitis B vax. FU states pt has severe optic neuropathy OD and mild optic neuropathy OS, both secondary to parainfectious meningitis with increased intracranial pressure. Per doc 213384, 60 day follow-up, no further information is available. Per annual follow up: pt has not recovered. He has some permanent visual (optic atrophy) impairment.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Visual field defect, Vomiting
Clinical narrative: Pt developed headache, nausea, irritability, stiff neck, vomiting, sleepiness all the time, and loss of peripheral vision. Doctor's won't conclude 100% that it was due to Hepatitis B vax. FU states pt has severe optic neuropathy OD and mild optic neuropathy OS, both secondary to parainfectious meningitis with increased intracranial pressure. Per doc 213384, 60 day follow-up, no further information is available. Per annual follow up: pt has not recovered. He has some permanent visual (optic atrophy) impairment.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Abdominal pain upper, Blindness, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Pt developed headache, nausea, irritability, stiff neck, vomiting, sleepiness all the time, and loss of peripheral vision. Doctor's won't conclude 100% that it was due to Hepatitis B vax. FU states pt has severe optic neuropathy OD and mild optic neuropathy OS, both secondary to parainfectious meningitis with increased intracranial pressure. Per doc 213384, 60 day follow-up, no further information is available. Per annual follow up: pt has not recovered. He has some permanent visual (optic atrophy) impairment.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Oedema, Vomiting
Clinical narrative: Pt developed headache, nausea, irritability, stiff neck, vomiting, sleepiness all the time, and loss of peripheral vision. Doctor's won't conclude 100% that it was due to Hepatitis B vax. FU states pt has severe optic neuropathy OD and mild optic neuropathy OS, both secondary to parainfectious meningitis with increased intracranial pressure. Per doc 213384, 60 day follow-up, no further information is available. Per annual follow up: pt has not recovered. He has some permanent visual (optic atrophy) impairment.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Autism, Drug toxicity, Laboratory test abnormal
Clinical narrative: Pt was diagnosed with autistic disorder at the age of 5. Parents and pt's doctor believe it is due to mercury in the immunizations he received. Lab and hair tests show pt is toxic with high levels of several heavy metals. Pt is currently being detoxed.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: Pain, erytheme at injection site in right deltoid. One week later had fever, malaise and extremely weak.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Sore, tender, painful left shoulder down to elbow.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Flushing, Somnolence, Tongue disorder
Clinical narrative: Administered 0.5 mg Flu vaccine left deltoid at 10:20AM. AT 10:35AM pt alerted staff of flushing, "swallowing strange" and "tongue curling". At 10:40AM Benadryl 25mg given. At 12:30PM pt reports resolution of symptoms, swallowing and tongue sensation. SL. residual groggy 2 hours Benadryl.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Employee Received Flu vaccine 10/23/2001 At 2pm, 0.5 mL IM left deltoid. Reported on 10/25/2001 that half hour after injection experienced upper lip and nose area tingling, slight numbness. Persisted for one hour. No treatment resolved.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: The day after the Flu shot, I experienced dizzy spells. These lasted 1.5 days.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot
Clinical narrative: A knot the size of baseball, red, hot where the knot is.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Throat tightness
Clinical narrative: Within minutes of Flu vaccine c/o itching. Referred to internal medicine given Benadryl 15mg PO, within 10 minutes c/o throat closing, difficult to breath, given Epi 0.3 ml, no relief. Was referred to ER.
Age: 0.7
Sex: F
Vaccine: DT, HIBV
Symptoms: Aphasia, Drug toxicity, Muscle spasticity
Clinical narrative: After 2nd set of shots, some spastic movement noted, but most noticeable was after her 3rd set (June 2000), her speech, (babbling & saying da-da) had stopped and has not said anything since.
Age: 2.8
Sex: F
Vaccine: HBPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Swelling of leg at injection site. Fever up to 102.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia
Clinical narrative: Left upper arm red, swollen ant warm to touch from deltoid to elbow. Temperature 97.5 then elevated to 100.5 for night shift, down with Tylenol 650mg PO. On 11/16/2001 still red with decrease of swelling, afebrile.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Received flu shot at 9:20AM and 11:45AM broke out in the hives on 10/24/2001. Hives lasted about 2.5 hours.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Large red spot. Warm to touch.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Vaccination done on 10/26/2001. Malaise and body aches started on 10/29/2001 afternoon. Fever on 10/29/2001 night. Responded to Motrin. Muscle aches slowly improving, but currently have scratchy throat. No fever in past 4-5 days.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives begining evening of 11/02/2001, lasting thru 11/04/2001. Took Benadryl syrup to relieve itching. Total body, except head.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling hot, Rash erythematous
Clinical narrative: Raised, red welt half way around arm. Very hot and sensitive in same area also in underarm.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Developed Swelling around injection site extending to an area of approximately 2.5 inches in circumference, pain at site, extending to left side of neck, left upper extremity "tightness" reported. Treatment: took OTC Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema, Pain, Urticaria
Clinical narrative: Swollen, red and painful to touch area (upper arm). Hives on my upper right arm. This lasted for 2-3 days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Dysphagia, Dyspnoea, Injection site erythema, Injection site oedema
Clinical narrative: Approximately 20 minutes after receiving the influenza injection on 11/06/2001, client reported that her hands, especially the palms, and her feet were itchy and that her hands seemed to be somewhat swollen, requiring her to remove her rings. RN informed her supervisor and telephoned the HD MD, who advised that this was a "normal variation" and that client should take 25mg of Benadryl when she gets home. About an hour later, around 4:05 PM, client reported to another nurse in Clinic that her bottom lip was itchy, slightly swollen and her tongue was tingling. This nurse consulted with the supervisor, who instructed her to promptly call MD for further guidance. MD advised client to take two 25 mg Benadryl immediately and go home, which client did. By the time the client arrived home, she was experiencing some difficulty swallowing along with some soreness in her throat and was beginning to have some difficulty breathing. Her husband accompanied her to the ER, where she received epinephrine with IV fluids, an injection of Benadryl and an oral dose of Prednisone. She was observed for an hour, her symptoms improved and she was discharged with a Prescription of Zantac and Claritin, as well as continued Prednisone. Client also reports that she has had some local redness, swelling and discomfort in the left deltoid area around the injection site.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Paraesthesia, Pharyngolaryngeal pain, Pruritus
Clinical narrative: Approximately 20 minutes after receiving the influenza injection on 11/06/2001, client reported that her hands, especially the palms, and her feet were itchy and that her hands seemed to be somewhat swollen, requiring her to remove her rings. RN informed her supervisor and telephoned the HD MD, who advised that this was a "normal variation" and that client should take 25mg of Benadryl when she gets home. About an hour later, around 4:05 PM, client reported to another nurse in Clinic that her bottom lip was itchy, slightly swollen and her tongue was tingling. This nurse consulted with the supervisor, who instructed her to promptly call MD for further guidance. MD advised client to take two 25 mg Benadryl immediately and go home, which client did. By the time the client arrived home, she was experiencing some difficulty swallowing along with some soreness in her throat and was beginning to have some difficulty breathing. Her husband accompanied her to the ER, where she received epinephrine with IV fluids, an injection of Benadryl and an oral dose of Prednisone. She was observed for an hour, her symptoms improved and she was discharged with a Prescription of Zantac and Claritin, as well as continued Prednisone. Client also reports that she has had some local redness, swelling and discomfort in the left deltoid area around the injection site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Application site reaction
Clinical narrative: Large 12cm diameter local reaction left upper extremity.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: Right thigh red, warm to touch. Three inches diameter area. Atarax Rx
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Fatigue, Insomnia, Pyrexia
Clinical narrative: Parents described high pitch cry for approximately 12 hours would fall asleep exhausted for a while and woke up screaming. Difficult to console. Also refused to eat and unable to sleep that night of receiving the vaccines, would wake up screaming off and on. Pt had low grade fever temp 100 for about 12 hours also.
Age: 78.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Peliosis hepatis
Clinical narrative: Pt developed extreme fatigue for the past 2 years which is treated with prednisone and Imuran for auto immune hepatitis.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Feeling hot, Oedema
Clinical narrative: Swelling and increased temperature over the left arm deltoid area.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Pt had DPT and Polio vaccine given in left arm, MMR given in right arm, given on July 25, 2001. Reaction occur 07/27/2001, red area, swollen and hot to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Tenderness
Clinical narrative: Red, tender, hard local reaction 3.5 inches in size.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No description provided
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Rash
Clinical narrative: Cellulitis and viral exanthema.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Viral infection
Clinical narrative: Chicken pox lesions onset 11/13/2001, afebrile, itchy, symptomatic treatment.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Rash
Clinical narrative: Mother noticed rash 10/31/2001, 3 spots on face and trunk and diaper area. 11/01/2001 one spot on ear and arm associated with cough for 2 days and HA at presentation.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: Left arm very edematous warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: The patient experienced swelling, redness and induration at the injection site 3 days post vax.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Urticaria
Clinical narrative: The patient developed a large area of erythema with urticaria on the left arm from the elbow, past the shoulder with swelling.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Hypoaesthesia oral, Injection site hypersensitivity, Injection site oedema, Injection site rash
Clinical narrative: The patient developed a rash, swelling, and redness at the injection site. The patient was flushed, nauseated, had hand, arm and shoulder pain. The patient's tongue was numb and tingling.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain, Paraesthesia
Clinical narrative: The patient developed a rash, swelling, and redness at the injection site. The patient was flushed, nauseated, had hand, arm and shoulder pain. The patient's tongue was numb and tingling.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site rash, Pruritus
Clinical narrative: 11/12/2001 the patient experienced local erythema of the left arm in an area 12cm x 15cm. The patient was treated with Benadryl for itching, TAC cream and cool compresses.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypersensitivity, Urticaria, Vasodilation procedure
Clinical narrative: Reaction after her CT. #3 Hep B vaccine given 10/29/01. Check out hot flashes, hives, dizziness and red bruised. CT area at injection site. Symptoms occurred that same evening.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP
Symptoms: Cyanosis, Syncope
Clinical narrative: Approximately 5-10 minutes after receiving vaccine suddenly stopped crying, "passed out" according to eye-witness, and turned blue in color. The pt was immediately returned to provider's office where he continued to "sleep" until removed from car seat and taken, "taken exam room. He awoke gradually and pleasantly. Immediate a subsequent PE's were normal. Immediate PO2 sats were 96. Patient was observed for another 2 hours and vital signs weere monitored for approximately every 15 minutes to half hour. All vitals remained within normal levels and PO2 sats gradually elevated to 98 over the course of observation.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Screaming, Urticaria
Clinical narrative: Cried forcefully immediately after receiving vaccines for approx. 5 minutes then suddenly stopped crying and fell asleep. The pt simultaneously broke out into an urticarial rash of the head, face and torso. The immediate Temp was 99.1 rectal. Immediate PE and subsequent PE's were normal. Pt was observed for approx. 2 hours in the office while he feed and rested easily.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lymph node pain, Lymphadenopathy
Clinical narrative: Mid-afternoon, the day of the vaccination, the patient experienced swelling and tenderness of the glands under each ear and down the side of the throat towards the thyroid. The patient did not have a fever but by mid-afternoon the next day the patient had chills for about 3 hours.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site pain, Joint stiffness
Clinical narrative: Post vax the patient experienced redness and soreness at the injection site. Approximately 1 month later the patient was noticing stiffness in his joints.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The patient developed a rash on her face, ears, backside and arm. The patient was treated with Prednisone. On 11/12 the rash is better.
Age: 44.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Ascites, Cardiomegaly, Chest pain, Chills, Dehydration
Clinical narrative: It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt's CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx'd. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3.
Age: 44.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, HIV test positive, Haemoptysis, Heart rate increased, Hepatic cirrhosis
Clinical narrative: It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt's CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx'd. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3.
Age: 44.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hepatomegaly, Hyperventilation, Hypotension, Hypoxia, Malaise
Clinical narrative: It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt's CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx'd. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3.
Age: 44.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Meningitis, Night sweats, Oliguria, Pallor, Pleural effusion
Clinical narrative: It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt's CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx'd. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3.
Age: 44.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pneumonia, Sepsis, Splenomegaly, Varices oesophageal, Ventricular tachycardia
Clinical narrative: It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt's CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx'd. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous
Clinical narrative: Pt believes she became pregnant on 1/19/01 after receiving varicella virus vaccine on 12/14/00. Pt's last menstrual period was on 1/5/01. The pt planned to see her health care provider on 2/2/01. The OB/GYN reported the pt had no previous pregnancies. No fetal heart beat was detected on two ultrasounds. The pt had a spontaneous abortion on 3/13/01, 9 5/7 weeks from her last menstrual period. The products of conception were examined. It was not known if the fetus was normal. No further info is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 11/7/01, one day post vax, pt experienced a bad reaction which included severe swelling and redness at injection site. The pt was seen in the ER and was admitted due to additional concerns with his pre-existing cardiac condition. The reporter indicated a concern with the lot number. It was reported that the pt's wife (WAES 01111505) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Addtl info has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Alopecia, Arthralgia, Difficulty in walking, Nausea, Oral intake reduced
Clinical narrative: Information has been received regarding a case in litigation concerning a 5 year old female who prior to vaccination was described as being "a well and healthy, normally developing, happy young girl" who on 8/10/00 was vaccinated with MMRII. It was reported that the pt subsequently developed a high fever, severe salmon colored rash and extreme pain in her lower extremity joints. She was admitted to the hospital on 9/29/00 and discharged from the hospital on 10/6/00. She was dx'd with systemic juvenile rheumatoid arthritis or "Still's disease". The pt had "profound" pain in her lower extremities and joints, difficulty walking, poor appetite, nausea, weight loss, arthritis, fever, hair loss and severe rashes over her entire body, rendering her permanently and totally disabled. It was expected that she would continue to suffer mental and physical impairments and pain in the future. Systemic juvenile rheumatoid arthritis was reported to be disabling. No further information is available.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rheumatoid arthritis, Skin discolouration, Weight decreased
Clinical narrative: Information has been received regarding a case in litigation concerning a 5 year old female who prior to vaccination was described as being "a well and healthy, normally developing, happy young girl" who on 8/10/00 was vaccinated with MMRII. It was reported that the pt subsequently developed a high fever, severe salmon colored rash and extreme pain in her lower extremity joints. She was admitted to the hospital on 9/29/00 and discharged from the hospital on 10/6/00. She was dx'd with systemic juvenile rheumatoid arthritis or "Still's disease". The pt had "profound" pain in her lower extremities and joints, difficulty walking, poor appetite, nausea, weight loss, arthritis, fever, hair loss and severe rashes over her entire body, rendering her permanently and totally disabled. It was expected that she would continue to suffer mental and physical impairments and pain in the future. Systemic juvenile rheumatoid arthritis was reported to be disabling. No further information is available.
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Pyrexia, Vomiting
Clinical narrative: Information has been received from an aunt of a female consumer who on an unspecified date was vaccinated with hepatitis A virus vaccine inactivated. Subsequently, the pt vomited for 2 days straight and experienced a fever of 102F. The child was treated with promethazine hydrochloride (Phenergan) which stopped the vomiting. On 11/2/01, the pt experienced a seizure. The child was hospitalized for the events. It was reported that the child had "several more" seizures while in the hospital. The events were considered to be immediately life-threatening. At the time of this report, the outcome of the fever and seizure was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Gastrointestinal disorder, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his 13 year old daughter who on 9/17/01 at 14:30 (also reported as 15:30) was vaccinated with a 1st dose (lot 639764/0587L) IM in the left arm of hepatitis A virus vaccine inactivated. On 9/17/01, at 22:30, the pt was taken to the hospital with a fever of 101F and stomach cramps (it was also reported that the abdominal pain began in the morning of 9/18/01). Follow-up information received from a physician indicated that the pt underwent an appendectomy on 9/18/01 and symptoms resolved. It was noted that the pt's abdominal pain was secondary to the appendicitis. A pathological exam on 9/19/01 dx'd the pt with an "acute appendicitis with early fibrinopurulent periappendicitis" that was "negative for malignancy". The pt was hospitalized for 6 days. The physician felt that the abdominal pain and the appendicitis were not related to the therapy with hepatitis A virus vaccine inactivated. No further info is available.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Autism
Clinical narrative: Autism which showed the 1st signs at 2 years of age. Showed some possible signs earlier. Mother received MMR on 10/24/1995 while nursing. Per 1 year follow up: Pt did not recover. Pt has an "Autism" diagnosis which I believe was caused by his frequent and large number of vaccines- containing Thimerasol before 6 months of age.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Cold sweat, Coma, Convulsion
Clinical narrative: Approximately 4 hours post vax, pt became cool, clammy, and unresponsive. She was taken to ER where she was observed to have a generalized tonic-clonic seizure lasting 1 minute. She required endotracheal tube with bag ventilation and IV fluids.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Henoch-Schonlein purpura, Thrombocytopenic purpura
Clinical narrative: Pt developed Henoch-Schonlein purpura vs ITP.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Blood creatine phosphokinase increased, Unevaluable event
Clinical narrative: Pt developed polymyositis with weakness which began 11/7/01. Follow up letter from reporter dated 11/16/2001 states that "After further investigating the PCP discover that this pt was not experiencing adverse event onset due to Hep A. VAERS was notified immediately."
Age: 6.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Convulsion, Neurodevelopmental disorder, Staring
Clinical narrative: Within 5 minutes of receiving vax, pt had a staring spell followed by tonic-clonic seizure.   Doc 208117 states the following: patient with history of developmental delay and seizures.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Irritability, Pyrexia, Wheezing
Clinical narrative: Pt became very fussy with a fever of 102F and was crying constantly in the office. The fever started early AM. She was hospitalized to r/o sepsis.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: Local erythema, edema and raise of temperature. Area measured 11cm by 10cm.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Anorexia, Nasal congestion, Pyrexia, Rash
Clinical narrative: Nasal decongestion. Rash, fever, decreased appetite, 102 rectally.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Vomiting
Clinical narrative: Mother states they went out of town after immunizations. Child vomited 5 times all day Saturday, slept well Saturday night, no other problem or symptoms.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Eighteen month old boy given Varivax on 10/29/2001. Presented 11/13/2001 with redness/puffiness at site of Varivax and left inguinal node. Skin with blanching erythema, not indurated, not tender; left inguinal node about 1.5cm in diameter, mobile; given Augmentin as unable to rule out early cellulitis/edemitis.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Oedema, Swelling
Clinical narrative: Marked swelling, warmth, edema shoulder to elbow.
Sex: M
Vaccine: UNK
Symptoms: Dysphonia, Urticaria
Clinical narrative: Hives, hoarse throat... Went to ER.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Anorexia, Irritability, Pyrexia, Rash papular
Clinical narrative: Fever, papular rash, irritability and anorexia.
Age: 17.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Swelling to 3 1/2 inches surrounding injection site with pink erythema warmth and tenderness. No fever, no lymphangitis.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Local reaction treated with benadryl, cool compresses, cortisone cream.
Age: 8.5
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Rash maculo-papular
Clinical narrative: Local rash erythematous maculopapular on R deltoid near and around Pneumovax site which erupted immediately after shot was given and responded well to Zyrtex 10mg and singular 5mg, benadryl.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: The patient's right upper arm had diffused induration, 100mm long x 40mm wide. The patient developed inflammation, redness and tenderness. The patient was treated with ice packs.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Convulsion, Dyspnoea, Eye movement disorder, Headache, Loss of consciousness
Clinical narrative: At 3:00 pm the patient's mother noticed the patient had a fever and the child had slowed down. The patient was treated with Tylenol. The patient complained of his head hurting him. The patient's temperature before the Tylenol was 104F. The patient had trouble breathing, his heart was beating hard, a possible seizure, his eye were up in his head, had a loss of consciousness and his temperature was up to 106F. The patient was taken to the hospital. The patient's temperature was 104F for the next 3 days. Two weeks later the patient was diagnosed with strep. The mother states the Dr says it was from Prevnar.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Palpitations, Pyrexia, Sluggishness
Clinical narrative: At 3:00 pm the patient's mother noticed the patient had a fever and the child had slowed down. The patient was treated with Tylenol. The patient complained of his head hurting him. The patient's temperature before the Tylenol was 104F. The patient had trouble breathing, his heart was beating hard, a possible seizure, his eye were up in his head, had a loss of consciousness and his temperature was up to 106F. The patient was taken to the hospital. The patient's temperature was 104F for the next 3 days. Two weeks later the patient was diagnosed with strep. The mother states the Dr says it was from Prevnar.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Pt called, check out warm to touch, itching, red.
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Pain
Clinical narrative: Swelling and tenderness around injection site. Approximately 2 1/2"x3 1/2".
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis
Clinical narrative: Site bruised. Pt an Coumadin. No complaints.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash macular
Clinical narrative: Pt complained of itching, "Blotches on face and hands." Went into Church service. Over the counter Benadryl, Report OK by end of service.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: The patient experienced gradually increasing erythema, pain and itching at the injection site. The area is 3.5cm x 5cm.
Age: 1.08
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash
Clinical narrative: The patient's mother states the patient had a fever of 103F and a rash on the day of vaccinations. The patient was seen in the ER and was diagnosed with a reaction to the vaccination. The mother states you could feel the rash.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema
Clinical narrative: Swollen has and red arm from just above right shoulder to just below elbow for one week.
Age: 48.0
Sex: F
Vaccine: PNC
Symptoms: Unevaluable event
Clinical narrative: A nurse reported that an unidentified adult inadvertently received Prevnar vaccine. No adverse event had occurred at that time. No additional information was available as of the date of this report. Plan to revaccinate next year with Pneumovax 23.
Age: 48.0
Sex: F
Vaccine: PNC
Symptoms: Drug administration error
Clinical narrative: A nurse reported that an unidentified adult inadvertently received Prevnar vaccine. No adverse event had occurred at that time. No additional information was available as of the date of this report.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Feeling hot, Injection site induration
Clinical narrative: Pt received pneumococcal vaccine right deltoid on 11/06/2001. 11/08/2001 telephoned PHN, notes induration  (5 cm by 3 cm) erythema, warmth, tenderness, chills w/o fever. PHN referred to MD, diagnosed with cellulitis and placed on Keflex 500mg bid for 10 days. No prior reactions to vaccines.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Pt received pneumococcal vaccine right deltoid on 11/06/2001. 11/08/2001 telephoned PHN, notes induration  (5 cm by 3 cm) erythema, warmth, tenderness, chills w/o fever. PHN referred to MD, diagnosed with cellulitis and placed on Keflex 500mg bid for 10 days. No prior reactions to vaccines.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Generalized urticaria 3-4 hives after vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Dysgeusia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Taste of formaldehyde for two days. Extreme pain in neck. Could not lift or turn head. Strep throat.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site mass
Clinical narrative: Unusual lump on left leg and refusal to mear weight 10/31/2001 AM onset transfer to ER where increased WBC greater than 24,000 and CRP equals 3.2; negative X-ray. Resolved in a few days. Repeat WBC.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rash, Rash erythematous
Clinical narrative: Generalized rash including palms and soles. Raised reddened areas times 4 on thighs.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness, Feeling cold, Headache, Heart rate increased
Clinical narrative: Fever 101.3, headache, dizziness, rapid pulse, stomach ache, felt cold.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 101.3, headache, dizziness, rapid pulse, stomach ache, felt cold.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Flu vaccine given 11/09/2001 about noon. Sunday AM rash left ear, spread to back of neck, right ear and back of right hand, itching, burning. Treatment: Benadryl by mouth, rash stopped spreading, still there.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Developed fever with left arm becoming red and swollen from injection site to elbow. Arm was also very painful. Injection, 11/01/2001, Symptoms 11/02/2001 PM which progressively worsened, urgent care clinic 11/05/2001, diagnosis Staph infection and placed on antibiotics.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Following AM on waking, noticed reddened, hot, swollen, itchy area approximately 6"x4" upper arm, around site of injection. Took Benadryl with ice to area. Resolved in 3 days.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Nausea
Clinical narrative: Pt was given vaccination (Fluzore). In 10 minute pt was flushed skin warm to touch and slightly nauseous. Sat for 10 minutes and felt slightly better and wanted to leave. Returned in 1/2 hour still queasy and flushed. Administered Epipen. Felt better in 5 minutes. Pt remained better on 11/08/2001 as well.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Tachyarrhythmia
Clinical narrative: Rapid and irregular heartbeat after retiring approx 10pm - continuing through the night keeping me awake