chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial infection, Facial palsy, Herpes zoster, Infection, Nervous system disorder
Clinical narrative: On 1/6/00, pt was vaccinated. In May, 2000, the pt developed parainfluenza virus pneumonia and was hospitalized in the ICU. It was reported that he recovered from this experience. On 8/10/00, he was admitted for swelling of his left mandibular area which was dx'd as another "flare-up" of atypical mycobacteria infection and was started on amikacin sulfate. On 8/14/00, it was noted that he developed many disseminated vesicular lesions on the right side of his tongue, the right ear, and left hand. The pt's temp was 37.9C. The pt was dx'd with herpes zoster and placed on acyclovir. He also developed "Ramsay Hunt Syndrome" which was reported to be a complication of either herpes zoster or herpes simplex virus that involves facial paralysis. It was reported that the pt had right sided facial paralysis and was unable to smile or close his right eye. These experiences were considered to be other in addition to having lesions on the right side of his tongue and ear, that he also has lesions on his hand and arm. He feels the pt was disseminated herpes zoster. It was reported that a specimen was sent for PCR analysis. Additional information has been requested.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Pneumonia, Swelling
Clinical narrative: On 1/6/00, pt was vaccinated. In May, 2000, the pt developed parainfluenza virus pneumonia and was hospitalized in the ICU. It was reported that he recovered from this experience. On 8/10/00, he was admitted for swelling of his left mandibular area which was dx'd as another "flare-up" of atypical mycobacteria infection and was started on amikacin sulfate. On 8/14/00, it was noted that he developed many disseminated vesicular lesions on the right side of his tongue, the right ear, and left hand. The pt's temp was 37.9C. The pt was dx'd with herpes zoster and placed on acyclovir. He also developed "Ramsay Hunt Syndrome" which was reported to be a complication of either herpes zoster or herpes simplex virus that involves facial paralysis. It was reported that the pt had right sided facial paralysis and was unable to smile or close his right eye. These experiences were considered to be other in addition to having lesions on the right side of his tongue and ear, that he also has lesions on his hand and arm. He feels the pt was disseminated herpes zoster. It was reported that a specimen was sent for PCR analysis. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Meningitis
Clinical narrative: A nurse reported that a parent told her that she had heard of cases of meningitis post hepatitis b vax. Upon medical review, the experience of meningitis was considered to be an "Other Medical Event". Also reported was the parent's son who was vaccinated and experienced an adverse event. Follow up notes that neither the nurse nor the physicians were aware of such a report, nor were they aware of any cases of meningitis following the hepatitis B vaccine. She stated that the physician and their staff felt the pt's parents were confusing hepatitis b vaccine with another product. No further information is available.
Age: 0.64
Sex: M
Vaccine: DTP, OPV
Symptoms: Asthma, Disturbance in attention, Febrile convulsion, Lethargy, Speech disorder
Clinical narrative: Infant became lethargic within 6 hours, post vax of DPT #2. He was speech impaired until the age of 10. He has a history of febrile seizures since DPT #2. Child has transient asthma and is working on overcoming dyslexia.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Systemic lupus erythematosus
Clinical narrative: Pt developed lupus SLE.
Age: 1.64
Sex: M
Vaccine: DTP
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: Child was small for gestational age and had delayed psychomotor development from the beginning. Dxed with autism.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Injection site abscess, Pyrexia
Clinical narrative: Within 24 hours post vax, the child started running a fever up to 103. Seen in office on 8/21/00, exam normal except for a pea sized abscess at HIB injection site. Treated with Keflex. On 8/22/00, the pt experienced a febrile seizure for 5-7 minutes with a 20 minute postictal state. Treated in ER with Rocephin.  Follow up on 03/28/2001: "Patient date of birth, age at time of vacc., adverse event onset date/time, Lot # for vaccine 1,2,3,4 is not provided."
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Injection site abscess, Pyrexia, Staring
Clinical narrative: Within 24 hours post vax, the child started running a fever up to 103. Seen in office on 8/21/00, exam normal except for a pea sized abscess at HIB injection site. Treated with Keflex. On 8/22/00, the pt experienced a febrile seizure for 5-7 minutes with a 20 minute postictal state. Treated in ER with Rocephin.  Follow up on 03/28/2001: "Patient date of birth, age at time of vacc., adverse event onset date/time, Lot # for vaccine 1,2,3,4 is not provided."
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site oedema, Injection site pain, Pharyngeal oedema
Clinical narrative: Localized swelling and pain (golf-ball sized per pt). Sensation of swollen throat and neck and headaches. Given Benadryl and Naprosyn.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: The shot area is swollen to the size of a tennis ball, and it is feverish, red, swollen, it itches, and it hurts.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: The shot area is swollen to the size of a tennis ball, and it is feverish, red, swollen, it itches, and it hurts.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Generalised oedema, Rash, Swelling face, Urticaria
Clinical narrative: Hives on both arms and neck. Edema to left forearm which extended to upper shoulder/neck and lower left arm. Positive for shortness of breath. Still have a rash around mouth and lips are still swollen.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Skin nodule
Clinical narrative: 2.5 cm diameter subcutaneous nodule lasting approximately 3 1/2 weeks; accompanying 9-10 cm diameter patch of swelling/redness lasting approximately 1 week on left arm at injection site.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Skin nodule
Clinical narrative: 2-3 cm diameter subcutaneous nodule lasting approximately 3 weeks with accompanying 8-9 cm diameter patch of swelling/redness lasting approximately 1 week on right arm at injection site.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Skin nodule, Vaccine positive rechallenge
Clinical narrative: 2 cm subcutaneous nodule lasting approximately 3 weeks with accompanying approximately 9-10 cm patch of swelling/redness lasting less than 1 week in left arm at injection site.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Skin nodule, Vaccine positive rechallenge
Clinical narrative: 2-3 cm subcutaneous nodule lasting approximately 2 weeks with accompanying patch of swelling and rednes lasting less than 1 week in left arm at injection site.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Skin nodule
Clinical narrative: 2 cm subcutaneous nodule lasting approximately 1+ weeks with accompanying patch of swelling/redness lasting less than 1 week in left arm at injection site.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Skin nodule, Vaccine positive rechallenge
Clinical narrative: 1.5 subcutaneous nodule lasting approximately 2 weeks with accompanying 10 cm diameter patch of redness/swelling on left arm at injection site.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: Next day post vax, the pt experienced severe itching and burning of entire skin. This has continued intermittently to date with varying intensity.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 101 and irritability.
Age: 1.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Convulsion
Clinical narrative: Seizure eight days post vax. A parent reported that her 2 year old son received his first dose of Prevnar on 8/22/00. On 8/30/00, he experienced a seizure. Twenty-two days later, he experienced a second seizure. Seizure is considered a medically important event (OMIC). Follow up information was received from the child's neurologist on 11/14/00, who stated that an EEG was performed and that the results were abnormal. Follow up information received from the vaccine provider on 12/12/00 supplied the Prevnar lot number and stated that the patient had recovered. The neurologist indicated that he had submitted this report directly to VAERS.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain
Clinical narrative: Induration of about 20 mm. Pain and redness at injection site one day post vax. Treated with Motrin for pain and fever.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Hives within 10 minutes post vax. Benadryl given po and hives subsided.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Somnolence
Clinical narrative: 24 hours of sleepiness, mentally clear but very sleepy.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site mass
Clinical narrative: Next day post vax, the pt's mom noticed a red lump in area where injection was given. Brought child in on 8/30. Physician noted 3 cm swelling in right thigh.
Age: 6.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain
Clinical narrative: 11 x 9 cm dark red, tender, warm, itchy, slightly indurated rash. Reaction was around injection site on right deltoid. Resolved in 72 hours with Benadryl.
Age: 11.0
Sex: F
Vaccine: HEP, TD
Symptoms: Dizziness, Syncope
Clinical narrative: Within 5 - 10 minutes post vax pt became dizzy and fainting; duration of episode 3-5 minutes.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Oedema peripheral, Pyrexia, Vasodilation procedure
Clinical narrative: Pts experienced a fever of 104F, swollen leg, warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site pain, Pyrexia, Vasodilation procedure
Clinical narrative: Pt developed a 4 inch area of redness around injection site, left thigh; warmth, tender and slightly firm; low grade fever.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash scratch one day post vax, with no fever, treated with Benadryl.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Feeling cold, Muscular weakness, Pain
Clinical narrative: Pt experienced right knee pain, felt like a nail in the knee, left shoulder as if baseball on shoulder; right shin pain worse, right ankle pain, lower back pain, very cold all over, couldn't sit lower legs hurt, remaining right leg weakness
Age: 1.4
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema
Clinical narrative: Pt experienced a local reaction to vax; 9cm X 12cm area of erythema on left thigh.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Injection site urticaria
Clinical narrative: Pt broke out with 2 - 5 mm wheals around injection site. Treated with Benadryl and ice. Stayed 20 minutes post incident.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: No text provided.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Pt developed 3 wheels around injection site with1i minute of receiving vax. Pt was treated with Diphenhydramine and ice. Pt waited 20 minutes before release.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site oedema
Clinical narrative: Left arm swelling 7.5 inches (6" from deltoid to elbow); right arm size 6.5 inches.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Anorexia, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: One day post vax pt complained of headache, tired, lack of appetite, drinking fluids. Pt came to office with temperature of 100.7. Two days post vax temperature 101 during night - called clinic and talked to nurse; advised to give DT only due to high temperature and vomiting.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Pt experienced high fever and extreme weakness the night after receiving vax.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Coma, Eye movement disorder, Hypotonia, Musculoskeletal stiffness, Tremor
Clinical narrative: Within 5 seconds post vax, pts eyes rolled back, body limp, unresponsive. Pt was moved to floor - head shaking, arms drawn up to chest and right hand clenched. Pt came to in 20 - 30 seconds. Speech was slurred BP 86/56. 12 noon BP 90/60; feel fine. Pt had just eaten crackers and grape juice.
Age: 0.9
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Haematoma, Pyrexia
Clinical narrative: Pt experienced hematoma with fever; treated with antibiotics.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia
Clinical narrative: Pt developed a fever to 102 at 12 -24 hours post vaccination.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: One day post vax pts left thigh was swollen, red and warm.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Agitation, Crying, Injection site erythema
Clinical narrative: Approximately 10-15 minutes post vax, pt developed erythema at injection site. Pt was crying uncontrollably and could not be comforted by parents. Pt treated with Benadryl. Redness also developed at this site.
Age: 11.0
Sex: F
Vaccine: HEP, TD
Symptoms: Dyskinesia, Hypersensitivity, Nausea, Pyrexia, Vomiting
Clinical narrative: Pts grandmother stated that the pt was having a reaction to her shots. Nurse obtained information from grandmother; pt had fever of 105F, temperature is now 103.4F; pt having nausea and vomiting; pt jerking in her sleep. Grandmother states pt was seen by her MD and was told that she is allergic to Hep B vax.
Age: 20.0
Sex: F
Vaccine: HEP, TD
Symptoms: Hypotension, Malaise, Pallor
Clinical narrative: 2-3 minutes post vax, pt became pale and stated that she did not feel well. Pt was placed in a supine position with legs elevated. BP 104/60, pulse 82, resp 18 non-labored. Pt recovered in 15-20 minutes. Last BP taken 112/80, pulse 86, resp 18. Left health dept ambulatory.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Pallor
Clinical narrative: Pt given immunizations. Mother standing outside doorway holding sibling. After 1st shot pt began to cry and continued to cry throughout the duration of shots. Immediately pt was given to Mom to comfort. Within 5 minutes mom states "Oh my gosh" "His color don't look right!" Something is wrong with my baby!" Mom immediately handed baby to the nurse.
Age: 11.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Approximately 24 hours post vax fever of 103 developed, no rash, no LDC. Ten days post vax pt developed fever of 102.7, with rash on face, chest, and arms. Rash started on abdomen, no pruritis, pt has history of hives. Pt treated with Tylenol and fever decreased. No diarrhea.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Nausea
Clinical narrative: Pt experienced swelling of injection site, redness. Pt complained of feeling hot and nauseated.
Age: 8.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Dyspnoea, Erythema, Hypoxia, Nasal congestion, Periorbital oedema
Clinical narrative: Pt experienced periorbital swelling, redness, nasal congestion and dyspnea and wheezing within 1 minute post vax. RA sats decreases to 88%, Pt was given Benadryl and EpiPen Jr with in 10 minutes was much better with RA sats 96%
Age: 8.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Wheezing
Clinical narrative: Pt experienced periorbital swelling, redness, nasal congestion and dyspnea and wheezing within 1 minute post vax. RA sats decreases to 88%, Pt was given Benadryl and EpiPen Jr with in 10 minutes was much better with RA sats 96%
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Pruritus, Rash
Clinical narrative: Pt developed a rash, red circular erythema, itchy and tender to site. Pt was treated with Benadryl.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Pt was treated with Augmentin. No other information provided.
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt developed 3 cm circular red erythematous left deltoid area with tenderness. Pt was treated with Keflex.
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Crying, Pruritus, Pyrexia, Rash papular
Clinical narrative: Subsequent to receiving vax pt presented in office (08/07/2000) with whole body rash, papular lesions that itched; child uncomfortable; crying; temperature up to 102F.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Pt presented with classical herpes zoster on 07/24/2000. He had a history of receiving chicken pox vaccine, but no history of wild virus induced disease.
Sex: F
Vaccine: DT, HIBV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Pt experienced swelling and pain. Pt refused to walk, had moderate swelling of thigh and knee, tenderness over out thigh where injections given.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Face oedema, Pruritus
Clinical narrative: It was reported that male pt received Yellow Fever vaccine on June 28, 1999. Reportedly that same day the pt experienced facial swelling and an itchy throat. The pt denied egg allergies.
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Paraesthesia
Clinical narrative: Pt developed tingling down left arm on Aug 16, 1999. On Aug 17, 1999 tingling sensation continued in arm and hand. Pt denied any color change in extremity of swelling.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: It was reported that a 22 year old female received Rabies Imovax on 9/11/99 and reportedly, the pt experienced flu-like symptoms after the 1st post-exposure vaccine. Nausea and vomiting for 4 days after the 2nd post-exposure vaccine. The pt reportedly recovered from this experience. From additional information received on 11/15/99, it was reported, "10/17/99 pt returned with complaint of low level nausea, also seeing PMD. 10/15/99, pt stated feeling a little better.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Influenza like illness, Injury, Pain
Clinical narrative: It was reported that a 54 year old male received a Rab-Rabies Imovax vaccination on 9/28/99. Reportedly, after the 5th dose, the pt developed flu-like symptoms and also experienced dizziness and pain in the left leg where bite occurred. From additional information received on 10/6/99, it was reported that the pt recovered from this experience. From additional information received on 10/25/99, it was reported that no additional information is available at this time.
Age: 43.0
Sex: M
Vaccine: RAB
Symptoms: Dermatitis bullous
Clinical narrative: It was reported that a male pt received a Rabies Imovax ID vaccination on 08/17/1999. Reportedly several days after the injection the pt developed a blister like rash on arm, face and back. The pt reportedly was not seen by a health care provider. On 10/4/1999 it was reported that the pt recovered from this experience. From correspondence received it was reported that the pt did not report adverse reaction until after the 8/17/1999 injection.
Age: 45.0
Sex: F
Vaccine: RAB, TD
Symptoms: Dermatitis bullous, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: It was reported that a female pt received a Rabies Imovax ID and a TD-TD ADS Adult vaccination on 08/10/1999. Reportedly several days after the injection the pt developed a blister like rash on arm, face and back. A health care provider reportedly did not see the pt. From correspondence received 10/4/1999, it was reported that the pt recovered from this experience. From correspondence received 4/3/2000, it was reported that the pt experienced shortness of breath and dizziness 45 minutes post injection on 4/10/1999. Pt used inhaler for asthma and symptoms. In the evening of 8/10/1999, the pt developed a headache, neck pain, nausea and increase in urination. Pt states have some symptoms with Tylenol. Pt had blister-like rash on arms shoulders for next few days.
Age: 45.0
Sex: F
Vaccine: RAB, TD
Symptoms: Neck pain, Pollakiuria
Clinical narrative: It was reported that a female pt received a Rabies Imovax ID and a TD-TD ADS Adult vaccination on 08/10/1999. Reportedly several days after the injection the pt developed a blister like rash on arm, face and back. A health care provider reportedly did not see the pt. From correspondence received 10/4/1999, it was reported that the pt recovered from this experience. From correspondence received 4/3/2000, it was reported that the pt experienced shortness of breath and dizziness 45 minutes post injection on 4/10/1999. Pt used inhaler for asthma and symptoms. In the evening of 8/10/1999, the pt developed a headache, neck pain, nausea and increase in urination. Pt states have some symptoms with Tylenol. Pt had blister-like rash on arms shoulders for next few days.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: It was reported that a 24 year old female received an Imovax ID vaccination on August 18, 1999. Reportedly that same day the pt experienced hives on her arms and chest.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Constipation, Rash
Clinical narrative: It was reported that a 19 year old female received a Rabies Imovax on 8/14/99. Reportedly, the pt developed weakness, constipation and rash.
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: It was reported that a 40 year old male patient received a Rabies Imovax IM vaccination on 11/15/1999. Reportedly on 11/20/1999, the patient developed hives. The patient was seen in the emergency department and treated with epinephrine, oral Benadryl and oral steroids. Pt was seen by a doctor at clinic on 11/22/1999 and given another dose of epinephrine and Benadryl, discontinued steroids. The pt reportedly received a pre-exposure series with Imovax ID in October 1998 and experienced no reactions. From additional information received on 12/3/1999, it was reported that the pt also developed a rash on the back of his legs and trunk along with itching. Reportedly the patient recovered from this experience.
Age: 31.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Headache, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: It was reported that a 31 year old female received a Rabies Imovax IM vaccination on 02/25/2000. Reportedly on 02/26/2000, the pt complained of pain, swelling, redness and warmth at the injection site. The pt also developed a rash and itching at the site. The patient developed a fever of 100 degrees F, a headache and muscle aches.
Age: 31.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Myalgia, Pyrexia
Clinical narrative: It was reported that a 31 year old female received a Rabies Imovax IM vaccination on 02/25/2000. Reportedly on 02/26/2000, the pt complained of pain, swelling, redness and warmth at the injection site. The pt also developed a rash and itching at the site. The patient developed a fever of 100 degrees F, a headache and muscle aches.
Age: 31.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: It was reported that a 31 year old female received a Rabies Imovax IM vaccination on 02/25/2000. Reportedly on 02/26/2000, the pt complained of pain, swelling, redness and warmth at the injection site. The pt also developed a rash and itching at the site. The patient developed a fever of 100 degrees F, a headache and muscle aches.
Age: 31.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Injection site warmth, Myalgia, Pruritus, Pyrexia
Clinical narrative: It was reported that a 31 year old female received a Rabies Imovax IM vaccination on 02/25/2000. Reportedly on 02/26/2000, the pt complained of pain, swelling, redness and warmth at the injection site. The pt also developed a rash and itching at the site. The patient developed a fever of 100 degrees F, a headache and muscle aches.
Age: 31.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Headache, Vomiting
Clinical narrative: It was reported that a 31 year old female received an Imovax Rabies ID vaccination on 4/28/2000. Reportedly 4 hours later the pt developed a headache, vomiting and joint pain in her arms and hand, which lasted 24 hours. She reported these symptoms to her PMD, The pt recovered from this experience.
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dysarthria, Feeling abnormal
Clinical narrative: It was reported that a 54 year old male pt received Rabies Imovax IM vaccination on May 31, 2000 at 2:15 pm. Reportedly by 3:00 pm that same day the pt started feeling drugged, speech slurred, mouth didn't work right. Felt like a car was sitting in him. Reportedly the pt recovered from this experience.
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dysarthria, Sedation, Sensation of pressure
Clinical narrative: It was reported that a 54 year old male pt received Rabies Imovax IM vaccination on May 31, 2000 at 2:15 pm. Reportedly by 3:00 pm that same day the pt started feeling drugged, speech slurred, mouth didn't work right. Felt like a car was sitting in him. Reportedly the pt recovered from this experience.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Difficulty in walking, Ear disorder, Eye disorder, Muscle spasms, Panic reaction
Clinical narrative: One day post vax, the pt developed whole body spasms and felt she could not walk, which lasted for less than 1 year. She also reported that her ears had become sensitive to vibration and her eyes were sensitive. These symptoms were mostly resolved except for panic attacks. On 10/98 she received a second flu vaccine and the next day experienced similar episode of body spasm and panicky feeling.
Sex: U
Vaccine: LYME
Symptoms: Swelling
Clinical narrative: On an unspecified date, the pt received an injection of Lymerix and some time later, the pt developed severe swelling in the arm, hand and shoulder (same arm that the injection was given). As of 8/29/00, the outcome is unknown.  Follow up on 02/02/2001: "Shoulder swelling in a 78 year old female prescribed Lymerix.  This report was received from a physician via a sales representative.  Follow up information was received from the physician.  The patient was taking no concurrent medications.  Concurrent medical conditions included degenerative joint disease (since the 1980's).  On an unspecified date, the patient received an injection of Lymerix (dose and series number not specified).  On 06/24/2000 the patient developed severe swelling in the arm, hand, and shoulder in the same arm that the injection was given.  The physician felt the symptoms were related to Lymerix.  Information received on 11/03/2000 reported that the events resolved.  The event of "swelling in shoulder" does not meet ICN serious criteria but is being submitted as an expedited report by special request per the 06/28/2000 letter.  The initial section of this report was submitted on 09/07/2000.
Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Headache, Influenza like illness
Clinical narrative: Within 2 days post vax, the pt reported experienced a severe headache and flu symptoms. He was seen in the ER on 8/30/00 where unspecified labs and cat scan of the head were performed. He was placed on antibiotics. As of 9/5/00, the events were slowly resolving.  Follow up on 02/21/2001: "Follow up was received from a physician.  His physician noted that the patient also developed myalgias, arthralgias, and a slight cough, noted as mild.  The physician felt the events were possibly related to Lymerix but also noted they may have been associated with an upper respiratory infection.  Information received from the physician on 02/08/2001 reported that the events resolved.  Arthralgias do not meet ICH serious criteria but are being submitted as an expedited report by special request per the 06/08/2000 letter.  The initial section of this report was submitted on 09/07/2000."
Sex: U
Vaccine: LYME, LYME
Symptoms: Arthralgia
Clinical narrative: Sometime following the vax the pt experienced joint pain. An MD visit was required. As on 8/30/00, the outcome of the event is ongoing.
Sex: U
Vaccine: LYME, LYME
Symptoms: Arthralgia, Fatigue, Headache, Tinnitus
Clinical narrative: Sometime following the vax the pt experienced joint pain. An MD visit was required. As on 8/30/00, the outcome of the event is ongoing.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Acne, Arthralgia, Atrioventricular block, Back pain, Cardiovascular disorder
Clinical narrative: The pt experienced knee pains, weakness of legs, muscle soreness in legs, falling, limping, and a back ache. Diagnosed with Guillain Barre Syndrome.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Fall, Gait disturbance, Guillain-Barre syndrome, Hyperlipidaemia, Muscular weakness
Clinical narrative: The pt experienced knee pains, weakness of legs, muscle soreness in legs, falling, limping, and a back ache. Diagnosed with Guillain Barre Syndrome.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Prostatic disorder
Clinical narrative: The pt experienced knee pains, weakness of legs, muscle soreness in legs, falling, limping, and a back ache. Diagnosed with Guillain Barre Syndrome.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Anaemia, Blood potassium increased, Congenital arterial malformation, Haematocrit decreased, Platelet count increased
Clinical narrative: Fever of 102.8F (rectal) in less than 48 hours, post vax.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia, Red blood cell count decreased
Clinical narrative: Fever of 102.8F (rectal) in less than 48 hours, post vax.
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: The pt experienced a fever that developed 3 days post vax.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: 4 hours post vax, the pt started running fever of 102. Motrin was given to decrease temperature.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Rash
Clinical narrative: 24 hours post vax, the child broke out in full body rash.
Age: 12.0
Sex: F
Vaccine: PNC
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site mass, Injection site oedema, Pyrexia
Clinical narrative: 4 hours post vax, the pt developed a low grade fever and vomited one time. Localized and extended edema of left upper arm. Examined in clinic 3 days post vax. The pt's left upper arm was indurated, erythematous, and warm.
Age: 12.0
Sex: F
Vaccine: PNC
Symptoms: Vomiting
Clinical narrative: 4 hours post vax, the pt developed a low grade fever and vomited one time. Localized and extended edema of left upper arm. Examined in clinic 3 days post vax. The pt's left upper arm was indurated, erythematous, and warm.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Influenza like illness
Clinical narrative: Post vax, the pt experienced flu-like symptoms for a couple of days. After this time, the headaches that had developed never went away. They slowly got less severe but never gone. Now they are there everyday in a low grade level.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Injection site hypersensitivity, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Pts right arm was swollen and red 12cm X 12cm, accompanied by a fever. Pt had blotchy red on polio arm at site. 3 day post vax the affected area measured 11cm X 12cm with pain and headache.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilation procedure
Clinical narrative: 6 days post vax, pt phoned stating right deltoid area red, hot, swollen the size of a softball, but has gone down considerably. Saw PCP. Pt stated PCP thought it was an allergic reaction and treated with Keflex in case this was an infection.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: Immediately following injection, pt broke out in a localized rash on ant aspect of left arm resulting in 7-8 pruritic raised red lesions.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Began on chest and legs/fevers.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Infection
Clinical narrative: In with mild case of chickenpox
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Pt experienced swollen thigh, local reaction.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site oedema
Clinical narrative: Pt experienced swollen thigh; local reaction.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: 2 hours post vax pt experienced increased erythema at site and entire thigh - both thighs and to waist increased swelling a right leg.resolved with time waiting in ER. Pt developed redness, decreased with ice and Tylenol. Not seen at ER, 5 hour wait told to follow up with physician
Age: 28.0
Sex: F
Vaccine: DT
Symptoms: Chest pain, Hypoaesthesia, Oedema peripheral, Rash
Clinical narrative: Pt experienced chest pains, numbness in right arm, swelling under right arm and above collar bone; neck pains (muscular) on right side of neck, rashy feeling under arm and above collar bone; bruised feeling under skin above collar bone. Symptoms lingered for about 6 days. Chest pains still lingering as of 08/29/2000.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt broke out in a rash on back and face which moved to extremities. Rash consisted of bright red, pin sized bumps. Mother thinks the rash was itchy.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Pt developed firm, hard, tender area approximately 30 mm in circumference and harder knot approximately 2 mm in center of area on left upper arm. Reaction began one day post vax and became worse each day. Was seen by physician 5 days post onset.
Age: 10.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Approximately 5 minutes post vax, pt fainted and tonic-clonic movements of his right UE were noted. No apnea, no cyanosis. Pt regained consciousness approximately a minute after event with stable BP and pulse.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: Pt developed cluster of vesicles at site of vaccine approximately 10 days post vax. Soon after developed fever as well. Pts sibling had same reaction with varicella vaccine.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Vasodilation procedure
Clinical narrative: Mom states redness size of quarter appeared on left thigh 24 hours post vax. Over course of next 24 hours swelling and redness increased in size spread to approximately 20 cm X 20 cm. Left upper thigh redness, swelling, tender, warm to touch. Area marked 48 hours post vax in office to call if further swelling or extension of redness. Pt treated with Benadryl.
Age: 4.0
Sex: F
Vaccine: TD
Symptoms: Aphthous stomatitis, Crying, Diarrhoea, Dyskinesia, Ocular hyperaemia
Clinical narrative: 2 days post vax pt awakened with legs hurting, upset stomach, cranky and fingers hurt. By that afternoon pt developed a fever of 101, chills, jerking severely when sleeping, dozing on and off all day. The next two days pt experienced diarrhea, upset stomach, crying, cancor sores. The pt then developed red right eye, cranky, and crying, legs sore. This continued for months. Pt is no trying to reverse immune function with homeopathy.
Age: 4.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Stomach discomfort
Clinical narrative: 2 days post vax pt awakened with legs hurting, upset stomach, cranky and fingers hurt. By that afternoon pt developed a fever of 101, chills, jerking severely when sleeping, dozing on and off all day. The next two days pt experienced diarrhea, upset stomach, crying, cancor sores. The pt then developed red right eye, cranky, and crying, legs sore. This continued for months. Pt is no trying to reverse immune function with homeopathy.
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Pt experienced fever of 105.2 tympanic rectal equivalent; pink flat rash - trunk.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site erythema, Pain, Paraesthesia
Clinical narrative: It was reported that a 45 year old female received Imovax IM on 8/12/99. The pt experienced redness at the injection site and 15-20 minutes, post vax, she felt pain and tingling in her fingers, from her hand to her elbow and also pain in the left side of her face. 12 days, post vax, she felt pain and tingling down the left arm. The pt was seen by HCP.
Age: 48.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Anorexia, Arthralgia, Asthenia, Diarrhoea, Disturbance in attention
Clinical narrative: Pt stated that she experienced fever, nausea, vomiting, diarrhea, weakness, joint pain, loss of appetite, blurred vision, heart palpitations and was unable to focus mentally. A physician evaluated the pt. Pt treated herself with Benadryl. From additional information received on 9/23/99, additional pt and vaccine information provided.
Age: 48.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Nausea, Palpitations, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Pt stated that she experienced fever, nausea, vomiting, diarrhea, weakness, joint pain, loss of appetite, blurred vision, heart palpitations and was unable to focus mentally. A physician evaluated the pt. Pt treated herself with Benadryl. From additional information received on 9/23/99, additional pt and vaccine information provided.
Age: 48.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Agitation, Alopecia, Anorexia, Arthralgia, Coordination abnormal
Clinical narrative: Pt stated that she experienced fever, nausea, vomiting, diarrhea, weakness, joint pain, loss of appetite, blurred vision, heart palpitations and was unable to focus mentally. A physician evaluated the pt. Pt treated herself with Benadryl. From additional information received on 9/23/99, additional pt and vaccine information provided.
Age: 48.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Disturbance in attention, Dizziness, Dry skin, Headache, Hemiparesis
Clinical narrative: Pt stated that she experienced fever, nausea, vomiting, diarrhea, weakness, joint pain, loss of appetite, blurred vision, heart palpitations and was unable to focus mentally. A physician evaluated the pt. Pt treated herself with Benadryl. From additional information received on 9/23/99, additional pt and vaccine information provided.
Age: 48.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Hypoaesthesia, Loss of consciousness, Muscle twitching, Nausea, Neuralgia
Clinical narrative: Pt stated that she experienced fever, nausea, vomiting, diarrhea, weakness, joint pain, loss of appetite, blurred vision, heart palpitations and was unable to focus mentally. A physician evaluated the pt. Pt treated herself with Benadryl. From additional information received on 9/23/99, additional pt and vaccine information provided.
Age: 48.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Neuropathy, Palpitations, Vision blurred, Weight decreased
Clinical narrative: Pt stated that she experienced fever, nausea, vomiting, diarrhea, weakness, joint pain, loss of appetite, blurred vision, heart palpitations and was unable to focus mentally. A physician evaluated the pt. Pt treated herself with Benadryl. From additional information received on 9/23/99, additional pt and vaccine information provided.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Headache
Clinical narrative: It was reported that a 26 year old female received Imovax vaccine on 7/7/99. The pt developed headaches following the injections. This reaction progressively got worse.
Age: 37.0
Sex: F
Vaccine: RAB, TD
Symptoms: Back pain, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Muscle aches, nausea and vomiting with 2 dry heaves, neck pain and lower back pain, headache, dizziness and blurred vision, post vax. Cleared within 2 hours.
Age: 37.0
Sex: F
Vaccine: RAB, TD
Symptoms: Neck pain, Vision blurred, Vomiting
Clinical narrative: Muscle aches, nausea and vomiting with 2 dry heaves, neck pain and lower back pain, headache, dizziness and blurred vision, post vax. Cleared within 2 hours.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It was reported that a 22 year old female had a 5cm to 5.5cm red, swollen, tender reaction at injection site, within 48 hours of the 2nd injection. It was reported that the pt recovered. From follow-up information received on 9/30/99, it was reported, "Reviewed, no additional information at this time".
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Abnormal behaviour, Anxiety, Conversion disorder, Crying, Headache
Clinical narrative: It was reported that a 10 year old male experienced headache and hysteria (uncontrollable crying), after each dose of Rabies Imovax IM. No specifics were provided. From additional information received by phone it was reported that the doctor believes reaction was due to premedication and not related to vaccine. Additional pt, vaccine and responsible physician information was also provided. From additional information received on 11/9/99, it was reported. "Twelve to eighteen hours, post vax, repeatedly, the boy complained of headache, globally without nausea or vomiting but with increased emotional liability. Pt demonstrated extremes of emotional response, fuss, anxiety, sadness-over mainly minor events as if the feeling was appropriate but was amplified 10,000 fold. Reasoning to calm down or over come negative emotions was largely unsuccessful. Duration of "hysteria" was 36 to 48 hours associated findings were headache, complaints that limbs felt heavy and muscles weak (without objective loss of strength), and general pallor. Anxieties have continued more or less daily. Hysteria was decreased by regular Motrin use." The pt still complains of headaches.
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Pallor, Sensation of heaviness
Clinical narrative: It was reported that a 10 year old male experienced headache and hysteria (uncontrollable crying), after each dose of Rabies Imovax IM. No specifics were provided. From additional information received by phone it was reported that the doctor believes reaction was due to premedication and not related to vaccine. Additional pt, vaccine and responsible physician information was also provided. From additional information received on 11/9/99, it was reported. "Twelve to eighteen hours, post vax, repeatedly, the boy complained of headache, globally without nausea or vomiting but with increased emotional liability. Pt demonstrated extremes of emotional response, fuss, anxiety, sadness-over mainly minor events as if the feeling was appropriate but was amplified 10,000 fold. Reasoning to calm down or over come negative emotions was largely unsuccessful. Duration of "hysteria" was 36 to 48 hours associated findings were headache, complaints that limbs felt heavy and muscles weak (without objective loss of strength), and general pallor. Anxieties have continued more or less daily. Hysteria was decreased by regular Motrin use." The pt still complains of headaches.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Pain
Clinical narrative: It was reported that a 35 year old male pt received a Rabies Imovax IM vaccination on 8/23/99 and reportedly, the pt experienced moderate to severe knee and leg pain in both lower extremities, starting about 2-3 days after the vaccine was given and increasing with each dose. The pt's doctor prescribed Naprosyn, which is alleviating the condition.
Age: 1.7
Sex: M
Vaccine: RAB, UNK
Symptoms: Cough, Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Four days post third dose, the pt developed a rash, fever of 99.3, irritability, cough and vomiting. No further information is available at this time.
Age: 39.0
Sex: F
Vaccine: RAB, UNK
Symptoms: Abdominal pain, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: It was reported that a 39 year old female received a post exposure series of Rabies Imovax IM vax after her husband handled a rabid raccoon that was killed by a dog. The series was started on 9-29-1999, and the last dose was given on 10-27-1999. The pt also received Rabies Immune Globulin on 9-29-1999. Out of the  five Rabies vax's the pt developed adverse reaction after three. Post 2nd dose pt experienced malaise. Post third dose, the pt experienced malaise, headache, nausea, abdominal pain and diarrhea. Post fourth dose pt again experienced the same symptoms.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Agitation, Confusional state, Dizziness, Headache, Lethargy
Clinical narrative: It was reported on 8-29-1999, a male pt was bitten on the back of the right hand by a pet cat. By the next morning, the patient's hand was extremely swollen, red, painful and draining pus. The pt went to a urgent care clinic they gave pt Ancef IM, a tetanus injection and Augmentin as well as Celebrex and Lortab for inflammation and pain. Because the cat could not be found right away it was suggested that the patient receive rabies injections. During the afternoon of 08-30-1999, the pt began feeling worse and was taken to the ER. He was given one injection of Human Diploid Vax. The pt was suppose to receive Hyperab Rabies.   Immune Globulin but pharmacy did not have any. Pt to return in the am for this vax. That night the pt became extremely nervous and confused, agitated and developed a very bad headache as well as uncontrollable twitching. Pt returned morning of 8-31-1999 for vax, received 11.8 cc IM divided into four injections. Pt continued to be dizzy and confused. Throughout the day the pt became very agitated and continued to have the twitching although to a somewhat less degree. During the evening of 08-31-1999, the pt lost control of his bladder. Because the cat was found and placed in the required quarantine for observation, the pt did not have to continue rabies series. More than three months have gone by since the cat bite and the various treatments received and the pt is still experiencing episodes of lethargy, malaise, dizziness and muscle aches and pains. It was reported that the pt is improving now after 3 months.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Malaise, Muscle twitching, Myalgia, Nervousness, Urinary incontinence
Clinical narrative: It was reported on 8-29-1999, a male pt was bitten on the back of the right hand by a pet cat. By the next morning, the patient's hand was extremely swollen, red, painful and draining pus. The pt went to a urgent care clinic they gave pt Ancef IM, a tetanus injection and Augmentin as well as Celebrex and Lortab for inflammation and pain. Because the cat could not be found right away it was suggested that the patient receive rabies injections. During the afternoon of 08-30-1999, the pt began feeling worse and was taken to the ER. He was given one injection of Human Diploid Vax. The pt was suppose to receive Hyperab Rabies.   Immune Globulin but pharmacy did not have any. Pt to return in the am for this vax. That night the pt became extremely nervous and confused, agitated and developed a very bad headache as well as uncontrollable twitching. Pt returned morning of 8-31-1999 for vax, received 11.8 cc IM divided into four injections. Pt continued to be dizzy and confused. Throughout the day the pt became very agitated and continued to have the twitching although to a somewhat less degree. During the evening of 08-31-1999, the pt lost control of his bladder. Because the cat was found and placed in the required quarantine for observation, the pt did not have to continue rabies series. More than three months have gone by since the cat bite and the various treatments received and the pt is still experiencing episodes of lethargy, malaise, dizziness and muscle aches and pains. It was reported that the pt is improving now after 3 months.