chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: HEPAB, TYP, YF, HEPAB, TYP, YF
Symptoms: Serum sickness, Stomach discomfort
Clinical narrative: This case was received. There were no serious criteria reported. Based upon appropriate medical judgement this case is considered non-serious. From initial information received on 10Jun04 through an enhanced surveillance program conducted, it was reported that a 48 year old male pt received a dose of Yellow Fever vaccine (manufacturer and lot number not reported), a dose of Typhoid vaccine (manufacturer and lot number not reported) and a dose of Twinrix, on 06Apr04. The lot numbers and routes and sites of administration were not reported. Three days later, the pt developed aches and malaise. Approx one week after immunization, he also developed fevers up to 102 degrees F. The pt saw his physician on 16Apr04 for evaluation of headaches, fever and diarrhea. Lab work was completed, but no results were provided at this time. His significant past medical history includes liver fibrosis and a liver biopsy done in the winter of 2004. He also had a history of ulcerative colitis prior to vaccination and a history of possible lupus three months prior to vaccination. the pt's recovery status was not reported. From additional information received on 17Jun04 it was reported through an enhanced surveillance program that this case occurred. Reportedly the pt received his first dose of YF-Vax, lot number UE128AA, administered SC in the right arm; a dose of Typhim Vi, lot number X0481, administered IM in the left deltoid; and his first dose of Twinrix, lot number AHABA016AA, administered IM in the right deltoid on 06Apr04 between one and four in the afternoon. Three days later, on 09Apr04, he developed generalized aches and malaise. Seven days after vaccination, he experienced a fever up to 102 degrees F. He was seen by a physician on 16Apr04 for a fever of 101.1 degrees F, headache, upset stomach and diarrhea. He was diagnosed with serum sickness. Reportedly, the pt recovered from this experience. Further information is not anticipated, this case is considered closed.
Age: 31.0
Sex: F
Vaccine: TD, TYP, HEPA, TD, TYP
Symptoms: Fatigue, Hepatitis, Jaundice, Myalgia, Pyrexia
Clinical narrative: There was no seriousness criteria reported. In accordance with manufacturer, jaundice was assessed as medically serious (OMIC). From initial information received on 9/27/04 from another manufacturer, initially reported by a health care professional, regarding an adverse event occurring in the USA, it was reported that a 31 year old female patient received her first dose of Hepatitis A vaccine, Havrix, on 9/1/04. The patient also received a dose of Typhim Vi and TD adult vaccines. Information regarding lot number, route and sites of administration were not reported. Approximately six days post immunization the patient experienced jaundice, fever, myalgia, and fatigue. The outcome of these events are unresolved. The physician considered the events to possibly be related to the Havrix vaccination. From additional information received on 10/29/04 from a telephone contact with a nurse at the reporting facility, a request for additional information was made. The nurse stated that she received the request and gave it to the initial reporting physician to complete. The information will be returned via fax as soon as possible. From addiional information received on 04/Jan/2005 from the reporting physician, it was reported that the patient was diagnosed with Hepatitis B and that there was no adverse reaction as per reporter. The patient's recovery status was not updated and is still reported as not recovered. No further information is anticipated, this case is considered closed.
Age: 31.0
Sex: F
Vaccine: TD, TYP, HEPA, TD, TYP
Symptoms: Fatigue, Jaundice, Myalgia, Pyrexia
Clinical narrative: There was no seriousness criteria reported. In accordance with manufacturer, jaundice was assessed as medically serious (OMIC). From initial information received on 9/27/04 from another manufacturer, initially reported by a health care professional, regarding an adverse event occurring in the USA, it was reported that a 31 year old female patient received her first dose of Hepatitis A vaccine, Havrix, on 9/1/04. The patient also received a dose of Typhim Vi and TD adult vaccines. Information regarding lot number, route and sites of administration were not reported. Approximately six days post immunization the patient experienced jaundice, fever, myalgia, and fatigue. The outcome of these events are unresolved. The physician considered the events to possibly be related to the Havrix vaccination. From additional information received on 10/29/04 from a telephone contact with a nurse at the reporting facility, a request for additional information was made. The nurse stated that she received the request and gave it to the initial reporting physician to complete. The information will be returned via fax as soon as possible. From addiional information received on 04/Jan/2005 from the reporting physician, it was reported that the patient was diagnosed with Hepatitis B and that there was no adverse reaction as per reporter. The patient's recovery status was not updated and is still reported as not recovered. No further information is anticipated, this case is considered closed.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Hypotension, Pallor, Pyrexia
Clinical narrative: From initial information received from a health care professional on 21Oct04 regarding an adverse event occurring. It was reported that a 47 year old male pt received a Typhim VI vaccination, lot number X08502, administered in the left deltoid on 19Oct04. Three and a half hours later, the pt returned to the office with a temp of 99.6 degrees F. He was shivering and was pale/grey in color. His blood pressure ranged from 84-90/60. An IV was started and emergency services were called. The pt was taken to an ER, but was not admitted to the hospital. His discharge diagnosis was possible adverse effect of Typhoid immunization. He was instructed to contact his primary care physician for re-evaluation in two to three days. Additional information was received on 22Oct04 from the initial reporter, who confirmed that the episode was considered to be hypotension. The symptoms of hypotension lasted approximately 30 to 40 minutes and the pt recovered. He recovered from the other events on 20Oct04.
Age: 1.94
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Red spots on back, stomach, neck and arms. ?Chicken pox atypical rash.
Age: 16.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Vision blurred
Clinical narrative: From initial information received on 14Jun04 from a health care professional regarding an adverse event occurring. It was reported that a 16 year old male pt received a dose of Typhim VI, lot number W13443, administered IM in the left deltoid and a dose of Hep A vaccine, lot number VHA814A2, admin IM in the left deltoid on 12Jun04. After receipt of the Hep A vaccine and while the Typhim VI was being administered, the pt experienced paleness, sweats, nausea, dizziness and blurred vision. He was treated with Benadryl and oral fluids and the events resolved within five minutes.
Age: 49.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Laboratory test abnormal, Myalgia, Nausea, Pyrexia
Clinical narrative: From initial information received on 13Sep04 from another manufacturer regarding an adverse event occurring. It was reported by a pharmacist that a 48 year old female pt received a dose of Typhim VI as well as a first dose of Havrix, admin in the right thigh on 18Aug04. The route and site of admin were not reported for the Typhim VI product. The lot numbers were not reported for either product. Approx two days later, on 20Aug04, the pt experienced a fever greater than 101 degrees F, nausea and vomited twice. On 26Aug04, the fever and vomiting resolved. On 27Aug04, the myalgias got worse. The pt was seen in the ER. A complete blood count revealed a white blood count of 4.6 and a lymphocyte count of 51%. The pt was told in the ER that the events were probably due to a viral infection. On  29Aug04, the pt experienced dizziness. She was seen by a neurologist. A CAT scan was normal. At the time of the initial reporting, the myalgia had worsened and the dizziness and nausea were ongoing. The reporting pharmacist considered the events to not be related to vaccination with Havrix. The pt's recovery status was unk at the time of this report.
Age: 49.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Viral infection, Vomiting
Clinical narrative: From initial information received on 13Sep04 from another manufacturer regarding an adverse event occurring. It was reported by a pharmacist that a 48 year old female pt received a dose of Typhim VI as well as a first dose of Havrix, admin in the right thigh on 18Aug04. The route and site of admin were not reported for the Typhim VI product. The lot numbers were not reported for either product. Approx two days later, on 20Aug04, the pt experienced a fever greater than 101 degrees F, nausea and vomited twice. On 26Aug04, the fever and vomiting resolved. On 27Aug04, the myalgias got worse. The pt was seen in the ER. A complete blood count revealed a white blood count of 4.6 and a lymphocyte count of 51%. The pt was told in the ER that the events were probably due to a viral infection. On  29Aug04, the pt experienced dizziness. She was seen by a neurologist. A CAT scan was normal. At the time of the initial reporting, the myalgia had worsened and the dizziness and nausea were ongoing. The reporting pharmacist considered the events to not be related to vaccination with Havrix. The pt's recovery status was unk at the time of this report.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Abnormal behaviour, Autoimmune disorder, Blood thyroid stimulating hormone increased, Chills, Clumsiness
Clinical narrative: Felt dizzy, disoriented, was dropping things on floor, behavioral changes, felt really weird. 4 hours later fever started, chills, muscle aches, flu-like symptoms, severely nauseated, felt like if had taken mind altering drugs. Shingles by 29th spread to back, increased Zanvir dose, severely nauseated after vax, like auto immune system crashed. Severe headaches, very intense, still having them, would wake up at night, took medication. Went to see endocrinologist on 01/11/05 since had been feeling so poorly and BP was still high, TSH levels at 111 (back on 11/23/04 normal levels), they were back to normal on 1/24 when saw doctor again. Nausea started to subside by 1/20/2005 and today felt only fatigued. Visited massage therapist because LA felt numb and tingling and nurse mentioned it was a pinched nerve. Since Vax on 12/27 rapid heart rate and would wake up at night with nightmares, subside by 1/27/05. No fever on 12/27; thus received other vax. Outbreak of shingles around waist, doctor visit on 12/20/04 prescribed Zanvir (1000mg). Nausea after vax, fever, fever also caused auto immune system to weaken.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Disorientation, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Felt dizzy, disoriented, was dropping things on floor, behavioral changes, felt really weird. 4 hours later fever started, chills, muscle aches, flu-like symptoms, severely nauseated, felt like if had taken mind altering drugs. Shingles by 29th spread to back, increased Zanvir dose, severely nauseated after vax, like auto immune system crashed. Severe headaches, very intense, still having them, would wake up at night, took medication. Went to see endocrinologist on 01/11/05 since had been feeling so poorly and BP was still high, TSH levels at 111 (back on 11/23/04 normal levels), they were back to normal on 1/24 when saw doctor again. Nausea started to subside by 1/20/2005 and today felt only fatigued. Visited massage therapist because LA felt numb and tingling and nurse mentioned it was a pinched nerve. Since Vax on 12/27 rapid heart rate and would wake up at night with nightmares, subside by 1/27/05. No fever on 12/27; thus received other vax. Outbreak of shingles around waist, doctor visit on 12/20/04 prescribed Zanvir (1000mg). Nausea after vax, fever, fever also caused auto immune system to weaken.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Herpes zoster, Hypertension, Hypoaesthesia, Influenza like illness, Insomnia
Clinical narrative: Felt dizzy, disoriented, was dropping things on floor, behavioral changes, felt really weird. 4 hours later fever started, chills, muscle aches, flu-like symptoms, severely nauseated, felt like if had taken mind altering drugs. Shingles by 29th spread to back, increased Zanvir dose, severely nauseated after vax, like auto immune system crashed. Severe headaches, very intense, still having them, would wake up at night, took medication. Went to see endocrinologist on 01/11/05 since had been feeling so poorly and BP was still high, TSH levels at 111 (back on 11/23/04 normal levels), they were back to normal on 1/24 when saw doctor again. Nausea started to subside by 1/20/2005 and today felt only fatigued. Visited massage therapist because LA felt numb and tingling and nurse mentioned it was a pinched nerve. Since Vax on 12/27 rapid heart rate and would wake up at night with nightmares, subside by 1/27/05. No fever on 12/27; thus received other vax. Outbreak of shingles around waist, doctor visit on 12/20/04 prescribed Zanvir (1000mg). Nausea after vax, fever, fever also caused auto immune system to weaken.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Malaise, Myalgia, Nausea, Nerve compression, Nightmare
Clinical narrative: Felt dizzy, disoriented, was dropping things on floor, behavioral changes, felt really weird. 4 hours later fever started, chills, muscle aches, flu-like symptoms, severely nauseated, felt like if had taken mind altering drugs. Shingles by 29th spread to back, increased Zanvir dose, severely nauseated after vax, like auto immune system crashed. Severe headaches, very intense, still having them, would wake up at night, took medication. Went to see endocrinologist on 01/11/05 since had been feeling so poorly and BP was still high, TSH levels at 111 (back on 11/23/04 normal levels), they were back to normal on 1/24 when saw doctor again. Nausea started to subside by 1/20/2005 and today felt only fatigued. Visited massage therapist because LA felt numb and tingling and nurse mentioned it was a pinched nerve. Since Vax on 12/27 rapid heart rate and would wake up at night with nightmares, subside by 1/27/05. No fever on 12/27; thus received other vax. Outbreak of shingles around waist, doctor visit on 12/20/04 prescribed Zanvir (1000mg). Nausea after vax, fever, fever also caused auto immune system to weaken.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Felt dizzy, disoriented, was dropping things on floor, behavioral changes, felt really weird. 4 hours later fever started, chills, muscle aches, flu-like symptoms, severely nauseated, felt like if had taken mind altering drugs. Shingles by 29th spread to back, increased Zanvir dose, severely nauseated after vax, like auto immune system crashed. Severe headaches, very intense, still having them, would wake up at night, took medication. Went to see endocrinologist on 01/11/05 since had been feeling so poorly and BP was still high, TSH levels at 111 (back on 11/23/04 normal levels), they were back to normal on 1/24 when saw doctor again. Nausea started to subside by 1/20/2005 and today felt only fatigued. Visited massage therapist because LA felt numb and tingling and nurse mentioned it was a pinched nerve. Since Vax on 12/27 rapid heart rate and would wake up at night with nightmares, subside by 1/27/05. No fever on 12/27; thus received other vax. Outbreak of shingles around waist, doctor visit on 12/20/04 prescribed Zanvir (1000mg). Nausea after vax, fever, fever also caused auto immune system to weaken.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Injection site hypersensitivity, Pruritus, Urticaria
Clinical narrative: From initial information received on 1/24/05 from a healthcare professional regarding an adverse event occurring, it was reported that a 47 year old male patient received a dose of FLUZONE, lot number U1579AA, administered IM in the left deltoid on 1/21/05. Twelve hours later, the patient developed generalized itching and hives as well as chest tightness and shortness of breath. The patient treated himself with Benadryl and went to the emergency room. His pulse oximetry in the emergency room was 89%. He was treated with steroids and discharged home. Per the reporter, the patient received influenza vaccine annually with no reactions reported. Reportedly, the patient recovered from these events. (OMIC)
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Myalgia
Clinical narrative: Patient complained of redness and muscle aching in area where shot was given and down forearm, right arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Slight redness right deltoid injection site complained of itching, no warmth, no redness, no respiratory difficulty.
Age: 1.76
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Erythema, Injection site swelling
Clinical narrative: Erythematus - swelling at injection site right deltoid.
Age: 0.16
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Developed incontrollable seizure that lasted 3 hours after waking from nap.  Also had episode that mom described as eye rolling back with jerking that lasted a few seconds followed by several minutes.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Headache, Myalgia, Pyrexia, Tenderness
Clinical narrative: Received injection on 12/27/2004 (MMR and Tetanus Booster) .  Reported to work 12/28 stating had fever to 104, muscle aches, Headache.  No redness at injection sites, just tenderness.  Sent home from work.  Better within 48 hours.
Age: 1.28
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Rash
Clinical narrative: Scattered spots over body, some scabs on 01/21/05. Fever 100-102 degrees on 01/20/05.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site reaction on left upper arm with pain and redness. Began 2 days after shot was given. Treatment: Elidel Cream bid to rash and Zithromax suspension 250 mg 1/2 tsp po qd for 7 days.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: On1/13/05, fever 102.7 degrees and urticaria of the right thigh,1/15/05, increasing in size until 01/17/05 when it was 6 cm in diameter.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Asthenia, Coordination abnormal, Dizziness, Rash
Clinical narrative: 1/18/05: Pale, 01/19/05: Rash, 01/20/05: Seemed dizzy and week., 01/21/05: Balanced seemed off, mother witnessed no seizure or increase in temperature.
Age: 1.6
Sex: F
Vaccine: DT, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: 01/26/05, rash just started after noon today, patient has had varicella vaccine in the past.  Skin exam showed classic dew drop on a rose petal erythematous lesions with central vesicle on the back and anterior torso and neck area. Impression: Minor diagnosis of Varicella. Treatment: Isolation, Aveeno baths and Benadryl prn
Age: 0.94
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Aspiration, Irritability, Malaise, Social avoidant behaviour
Clinical narrative: Patient passed away while sleep. After vaccination, was very fussy, uncomfortable, did not want to participate in therapy. Autopsy Report received on 2/02/2005 states aspiration.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain , erythema swelling of right upper arm which started after injection
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Visual disturbance
Clinical narrative: Lightheaded, unable to tolerate bright lights , not able to swallow.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Fatigue, Movement disorder, Myalgia
Clinical narrative: 1/18/05 this is to report an apparent reaction to flu vaccination received 12/02/2004 at city hall, after that date left town and still away. Approx 5-6 days after the shot, I developed very severe pains in upper extremities, in forearm and tricep muscles, joints, and esp shoulder joints on both sides. Never had anything like that before and was tennis player, exerciser to present. Was not able to lift arms above shoulder level for weeks. Still some tenderness, but gradually cleared after 3 weeks went to orthopedic surgeon for exam. He first thought had rotator cuff injury, but pain was both shoulders, worse left side of injection. He took x-ray which showed normal joint. Then he diagnosed bursitis which recommended ibuprofen or cortisone injection. I took ibu 6 days then stopped in order to avoid medications when possible. Gradual improvement since, and will soon resume gym workouts. Only possible other factor, is that I had general malaise for one week before injection low grade, that I attributed to some kind of infection, probably throat. I'm ending this to be of assistance to your evaluations; will be interested if others had any problems - thank you.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Rash
Clinical narrative: itchy rash trunk and UR.
Age: 50.0
Sex: M
Vaccine: FLUN3
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Headache, Muscular weakness, Pain
Clinical narrative: Slight paresthesia of fingertips 12/30 Aching and weakness in legs 01/01 Increase weakness in legs and hospitalized 01/06  01/28/05 Pt states he had hx of a headache and lethargy early in December.  Wife and son had 'stomach bug' (gas, bloating, diarrhea) in mid December,'but I didn't get it', and back pain on 12/17 which went down his leg 'like sciatica'. Pt continues with out pt therapyand finds fatigue most difficult part of recovery.  02/16/05 Discharge summary received for 1/6-1/13/2005 FINAL DX: Guillain-Barre syndrome & spinal headache, improved.  Time line is FluMist vax on 12/29/04, developed leg pain, weakness and numbness starting 01/01/05. He was evaluated in PMP on 01/06/05 and admitted w suspected onset of GBS.  Exam revealed deceased reflexes and increased CSF protein. Was evaluated and treated by neurologist given 4 courses of plasmapheresis, symptoms improved and was discharged home 01/13/05 w/outpatient rehab & Neuro f/u.
Age: 50.0
Sex: M
Vaccine: FLUN3
Symptoms: Paraesthesia
Clinical narrative: Slight paresthesia of fingertips 12/30 Aching and weakness in legs 01/01 Increase weakness in legs and hospitalized 01/06  01/28/05 Pt states he had hx of a headache and lethargy early in December.  Wife and son had 'stomach bug' (gas, bloating, diarrhea) in mid December,'but I didn't get it', and back pain on 12/17 which went down his leg 'like sciatica'. Pt continues with out pt therapyand finds fatigue most difficult part of recovery.  02/16/05 Discharge summary received for 1/6-1/13/2005 FINAL DX: Guillain-Barre syndrome & spinal headache, improved.  Time line is FluMist vax on 12/29/04, developed leg pain, weakness and numbness starting 01/01/05. He was evaluated in PMP on 01/06/05 and admitted w suspected onset of GBS.  Exam revealed deceased reflexes and increased CSF protein. Was evaluated and treated by neurologist given 4 courses of plasmapheresis, symptoms improved and was discharged home 01/13/05 w/outpatient rehab & Neuro f/u.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Pruritus, Skin burning sensation
Clinical narrative: Reddened, warm, raised area at injection site.  Complainted of  burnig and itching at injection site.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Swollen and redness on left shoulder/ upper left chest/ left side of neck.  Currently being treated for cellulitis.  Prescribed Keflex and ibuprofen.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Pain
Clinical narrative: Inadverted inoculation to left neck area
Age: 55.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain
Clinical narrative: Pain right mid triceps area, late November.  Same site as vaccine given April 2004
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Coma, Convulsion, Pyrexia, Tremor
Clinical narrative: 1/14/2005 Varicella Vaccine administered 1/19/2005 Temp 102/shaking /2 minutes unresponisve /staring 1/20/2005 Exam-no focal symptoms for fever?  vaccine Rx. Referred to peds /neuroloyg for flu seizure
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: Incessant crying- high pitch cry
Age: 0.24
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Coma, Somnolence
Clinical narrative: 30 minutes after vaccines became sleepy. 6 hours later pt was unresponsive. His hands were drawn and clenched. Taken to ER by parents. Remained unresponsive for 30-45 min (no reaction on thighs at injection sites).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: 1/18/05 redness, swelling. 9cm x 11cm, 01/19/05 arm more involved, increased to 17cmx19cm red, warm to touch, swollen. Non painful to touch. Given Augmentin 400mg PO bid x10 days. To call if becomes worse.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Approx 3 in diameter raised edema, warm to touch pt c/o pain/itching to site, in no s/sx of resp distress, inst to administer 2 tsp Benadryl every 6-8 hours, Ibuprofen 3 tsp PO every 6-8 hours and alternate warm/cold compress and to call back or return to clinic if no improvements
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abnormal behaviour
Clinical narrative: Acting out, aggressive behavior, the day after vaccines were given
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Malaise, Otitis media, Pyrexia, Rash erythematous
Clinical narrative: Fever x 2 days 8-10 after vaccine, generalized lacy red rash worse on upper back, mild malaise with rash 10-16 days after vaccine, Ear infection 14 days after vaccine.
Age: 1.0
Sex: F
Vaccine: HBPV, MMR, VARCEL
Symptoms: Dermatitis bullous, Pruritus, Rash papular
Clinical narrative: Exposed to varicella 2 weeks ago, began rash 2 days ago has 15-20 papular lesion on trunk and neck. Taking Benedryl for itching.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Swelling and erythema of right deltoid
Age: 0.62
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Agitation, Crying, Irritability, Pyrexia
Clinical narrative: Mom states baby extremely fussy, agitation couldn't calm baby for 8-9 hr. Reports baby fever at about 9:20pm cont all next day at the next day although mom didn't check temp reports baby fine by the 3rd day.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Contusion, Eye oedema, Serum sickness, Urticaria
Clinical narrative: Mother reports she noted whelps on lower stomach and back which spread to legs and under arms. This occurred on 10/25/04 IMUN given on 10/22/04. By the end of the day whelps were on face and back of ears. Afebrile and not fussy. Mother states she remembers this happening once before but doesn't remember if it occurred in connection with IMUN. Reports once whelps occur the head turns white and in less than 1 hour and whelp turns red, in appearance and then goes to a bruised appearance. Seen Dr on 10/25/04 reports dx with hives not whelps. No improvement seen so on 10/27/04 seen Dr with Serum sickness most likely DTP immune reaction. Had lab work done at Hospital u/a and blood work up. By this time child's face and eyes were very swollen per mother report. Hives/whelps had covered entire body.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site oedema
Clinical narrative: Child received shots 1/17/2005, on 1/19/05 mom said child's arm twice normal size and hurts. Used Tylenol and ice. Sent to ER, diagnosis cellulitis, local reaction from immunization. To use Benadryl and Advil
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pneumonia
Clinical narrative: Pt called stating her arm where she got her pneumonia shot yesterday was sore, swollen and red. Pt advised to use cold compresses, Ibuprofen every 6 hours and call if it gets any worse.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Injection site erythema, Pruritus
Clinical narrative: Allergic reaction to Dtap in left arm; erythematous, pruritis
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Myalgia, Pain
Clinical narrative: Soreness began day after injection and progressively worsened.  Unable to lift arm above head now.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Soreness started day of shot.  Arm sore when reaching for seat-belt or putting on coat.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Blood creatine phosphokinase increased, Myalgia, Myositis, Rhabdomyolysis
Clinical narrative: Patient had increased muscle aches along with increased CPK levels (Max 2012 IU/L). Discharge Summary received on 2/16/2005 states myositis and rhabdomyolisis.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Arm became sore night of vaccination.  Stayed sore for about 3 weeks.  Felt worse at night and first thing in morning.  Had a massage yesterday and arm is somewhat better today.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: 11/17/2004: sore arm, fever T100.4F, Tylenol given. 11/18/2004: redness, swelling near/around injection site, diphenhydramine, ranitidine, compresses given. Keflex started for possible infection. 11/20/04: reaction resolved. (reaction involved right arm)
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 11/17/2004: sore arm, fever T100.4F, Tylenol given. 11/18/2004: redness, swelling near/around injection site, diphenhydramine, ranitidine, compresses given. Keflex started for possible infection. 11/20/04: reaction resolved. (reaction involved right arm)
Age: 1.61
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Erythema, Feeling hot, Injection site discolouration, Skin ulcer, Tenderness
Clinical narrative: Round, erythematous lesion 7x5cm  on right thigh, mildly warm to touch non tender. Blanches with pressure.
Age: 1.52
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: DIAGNOSED VARICELLA 1/26/2005 >50 LESIONS
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypokinesia, Pain, Rash
Clinical narrative: 3 YEAR OLD MALE SEEN IN THE EMERGENCY ROOM FOR RASH IN A DERMATOMAL DISTRIBUTION IN THE LEFT SCAPULAR REGION EXTENDING TO LEFT DELTOID, ELBOW AND FOREARM. CHILD WAS IN PAIN, COULD NOT ELEVATE ARM 90 DEGREES. RASH BEGAN NIGHT PRIOR TO VISITING EMERGENCY ROOM.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Paraesthesia, Urticaria
Clinical narrative: Starting the day after his flu shot on 1/19/05, he started getting a mysterious outbreak of pinpoint sized red hives up his arms on the inside (especially the left one where he received the flu shot), and around the neck area.  He stated is started Thursday AM, 1/20/05, with a sore arm that started feeling 'tingly', mainly in his left arm and traveling up his neck and going to his right arm as well.  He stated the hives come and go, and have lasted until today, 1/27/05.  Last night on 1/26/05, he stated his left arm and upper chest and neck began to itch, and a cluster of what looked like small, flat mosquito bite-like hives appeared up his left arm.  They lasted for approximately 2 hours and went away; he did not take any OTC or prescription meds to treat the hives.  He stated his hives last from approximately 1/2 day to all day long.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Tenderness
Clinical narrative: ( + ) REDNESS, ERYTHEMA, TENDER RIGHT ARM IN ARE MMR.
Age: 1.01
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Asthma, Pyrexia, Similar reaction on previous exposure to drug, Tonsillitis
Clinical narrative: Had immunization on 01/10/2005 11:30AM. Saw in Dr office 1/13/05 with c/o running temp up to 103.6 since. 1/10/05. Diagnosed on 1/13/05 with tonsillitis and RAD and placed on antibiotic. (3 reaction to immunizations)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swollen, red, arm at site
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 6x6 cm tender erythematous indurated area right anterior thigh.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: With 1st shot became nauseated, had slight headache and sweaty. Second shot, patient had no symptoms. With 3rd shot had real bad headache, cold chills and aching joints, that lasted 36 hours. One week later itching rash on back of neck and shoulders.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: With 1st shot became nauseated, had slight headache and sweaty. Second shot, patient had no symptoms. With 3rd shot had real bad headache, cold chills and aching joints, that lasted 36 hours. One week later itching rash on back of neck and shoulders.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Bacterial infection, Decreased appetite, Drug ineffective, Fatigue
Clinical narrative: 12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  "Coded" ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza
Clinical narrative: 12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  "Coded" ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anorexia, Atelectasis, Atrial fibrillation, Chest pain, Contusion
Clinical narrative: 12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  "Coded" ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dyspnoea, Hyperglycaemia, Hyperhidrosis, Hypoalbuminaemia
Clinical narrative: 12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  "Coded" ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyponatraemia, Laboratory test abnormal, Lethargy, Metabolic alkalosis, Myalgia
Clinical narrative: 12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  "Coded" ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Pain, Pleural effusion, Pneumonia, Skin ulcer
Clinical narrative: 12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  "Coded" ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urinary tract infection
Clinical narrative: 12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  "Coded" ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, OPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: We held off on getting my daughters shots until she was 3. Originally we were just going to hold off for the first year of her life to let her body build up its own immunity. So in Nov. 2004, she received her second shot of Dtap,polio, and HepB. She showed signs of a fever of 104.0, and I called her nurse and they said that was normal. She had a raised red mark about the size of a nickel on her leg where they injected the medicine. Its not NORMAL for a body to reject the medicine to where it puts the body in danger.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Received Varicella injection and the next day noted swelling and redness at the injection site, along with body aches and headache.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Laboratory test abnormal, Leukocytosis, Pulmonary embolism, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a registered nurse regarding a 6 month old male patient who received a third dose on 9/28/04. On the same day, the patient also received a dose of Act-Hib, a dose of Tripedia, a dose of Polio Vaccine and a dose of Engerix B. On 9/30/04, the patient developed pseudomonal sepsis and on 10/4/04, the child expired. No relevant medical history. Indication for Prevnar was immunization. Product was administered on 9/28/04. Dose regimen was 0.5ml 1 time per day (IM). Additional suspect vaccines included: Tripedia, Engerix B, Act-Hib, and Polio vaccine. Patient was not taking concomitant therapy. On 9/30/04, the patient developed a fever. On 10/2/04, the reporter stated, "the child was hospitalized with a diagnosis of sepsis." The child's temperature on admission was 103.7 degrees F. On an unspecified date during hospitalization, a blood culture was performed which isolated pseudomonas. The reporter stated, "no other organism was identified." A complete blood count was also performed. The only result indicated by the reporter, was the white count listed as .8. On 10/4/04, the patient expired. The reported cause of death was unknown to the reporter. An autopsy was performed on an unspecified date. The reporter stated the cause of death written on the autopsy report was multiple pulmonary emboli. Also written on the autopsy report was a showering of emboli. The reporter indicated that the autopsy report recommended a genetic evaluation. The reporter indicated that the patient received Prevnar, lot A74399K; however, a product quality has verified that this is not a valid lot number. Telephone follow up conducted on 1/24/05, to obtain a valid lot number was unsuccessful. Reporter verified lot number listed on patient's chart, as A74399K. Information regarding these events has been forwarded to the other manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report. Received Autopsy Report which revealed blood c/s & autopsy lung c/s were + for pseudomonas aeruginosa.  COD stated as multiple pulmonary emboli & sepsis.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Sepsis
Clinical narrative: Information regarding Prevnar was received from a registered nurse regarding a 6 month old male patient who received a third dose on 9/28/04. On the same day, the patient also received a dose of Act-Hib, a dose of Tripedia, a dose of Polio Vaccine and a dose of Engerix B. On 9/30/04, the patient developed pseudomonal sepsis and on 10/4/04, the child expired. No relevant medical history. Indication for Prevnar was immunization. Product was administered on 9/28/04. Dose regimen was 0.5ml 1 time per day (IM). Additional suspect vaccines included: Tripedia, Engerix B, Act-Hib, and Polio vaccine. Patient was not taking concomitant therapy. On 9/30/04, the patient developed a fever. On 10/2/04, the reporter stated, "the child was hospitalized with a diagnosis of sepsis." The child's temperature on admission was 103.7 degrees F. On an unspecified date during hospitalization, a blood culture was performed which isolated pseudomonas. The reporter stated, "no other organism was identified." A complete blood count was also performed. The only result indicated by the reporter, was the white count listed as .8. On 10/4/04, the patient expired. The reported cause of death was unknown to the reporter. An autopsy was performed on an unspecified date. The reporter stated the cause of death written on the autopsy report was multiple pulmonary emboli. Also written on the autopsy report was a showering of emboli. The reporter indicated that the autopsy report recommended a genetic evaluation. The reporter indicated that the patient received Prevnar, lot A74399K; however, a product quality has verified that this is not a valid lot number. Telephone follow up conducted on 1/24/05, to obtain a valid lot number was unsuccessful. Reporter verified lot number listed on patient's chart, as A74399K. Information regarding these events has been forwarded to the other manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report. Received Autopsy Report which revealed blood c/s & autopsy lung c/s were + for pseudomonas aeruginosa.  COD stated as multiple pulmonary emboli & sepsis.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Pulmonary embolism, Sepsis
Clinical narrative: Information regarding Prevnar was received from a registered nurse regarding a 6 month old male patient who received a third dose on 9/28/04. On the same day, the patient also received a dose of Act-Hib, a dose of Tripedia, a dose of Polio Vaccine and a dose of Engerix B. On 9/30/04, the patient developed pseudomonal sepsis and on 10/4/04, the child expired. No relevant medical history. Indication for Prevnar was immunization. Product was administered on 9/28/04. Dose regimen was 0.5ml 1 time per day (IM). Additional suspect vaccines included: Tripedia, Engerix B, Act-Hib, and Polio vaccine. Patient was not taking concomitant therapy. On 9/30/04, the patient developed a fever. On 10/2/04, the reporter stated, "the child was hospitalized with a diagnosis of sepsis." The child's temperature on admission was 103.7 degrees F. On an unspecified date during hospitalization, a blood culture was performed which isolated pseudomonas. The reporter stated, "no other organism was identified." A complete blood count was also performed. The only result indicated by the reporter, was the white count listed as .8. On 10/4/04, the patient expired. The reported cause of death was unknown to the reporter. An autopsy was performed on an unspecified date. The reporter stated the cause of death written on the autopsy report was multiple pulmonary emboli. Also written on the autopsy report was a showering of emboli. The reporter indicated that the autopsy report recommended a genetic evaluation. The reporter indicated that the patient received Prevnar, lot A74399K; however, a product quality has verified that this is not a valid lot number. Telephone follow up conducted on 1/24/05, to obtain a valid lot number was unsuccessful. Reporter verified lot number listed on patient's chart, as A74399K. Information regarding these events has been forwarded to the other manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report. Received Autopsy Report which revealed blood c/s & autopsy lung c/s were + for pseudomonas aeruginosa.  COD stated as multiple pulmonary emboli & sepsis.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Pulmonary embolism, Sepsis
Clinical narrative: Information regarding Prevnar was received from a registered nurse regarding a 6 month old male patient who received a third dose on 9/28/04. On the same day, the patient also received a dose of Act-Hib, a dose of Tripedia, a dose of Polio Vaccine and a dose of Engerix B. On 9/30/04, the patient developed pseudomonal sepsis and on 10/4/04, the child expired. No relevant medical history. Indication for Prevnar was immunization. Product was administered on 9/28/04. Dose regimen was 0.5ml 1 time per day (IM). Additional suspect vaccines included: Tripedia, Engerix B, Act-Hib, and Polio vaccine. Patient was not taking concomitant therapy. On 9/30/04, the patient developed a fever. On 10/2/04, the reporter stated, "the child was hospitalized with a diagnosis of sepsis." The child's temperature on admission was 103.7 degrees F. On an unspecified date during hospitalization, a blood culture was performed which isolated pseudomonas. The reporter stated, "no other organism was identified." A complete blood count was also performed. The only result indicated by the reporter, was the white count listed as .8. On 10/4/04, the patient expired. The reported cause of death was unknown to the reporter. An autopsy was performed on an unspecified date. The reporter stated the cause of death written on the autopsy report was multiple pulmonary emboli. Also written on the autopsy report was a showering of emboli. The reporter indicated that the autopsy report recommended a genetic evaluation. The reporter indicated that the patient received Prevnar, lot A74399K; however, a product quality has verified that this is not a valid lot number. Telephone follow up conducted on 1/24/05, to obtain a valid lot number was unsuccessful. Reporter verified lot number listed on patient's chart, as A74399K. Information regarding these events has been forwarded to the other manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report. Received Autopsy Report which revealed blood c/s & autopsy lung c/s were + for pseudomonas aeruginosa.  COD stated as multiple pulmonary emboli & sepsis.