chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Hypoaesthesia, Injection site pain
Clinical narrative: On 12/7/00, pt noticed a "burning sensation" on 1st injection of Rabies. Did not mention to RN. That night she experienced numbness and tingling of right hand. The problem reoccurred, intermittently, only at night. On 12/25/00, numbness began to radiate from hand to elbow, again intermittently and only at night. Approx. on 1/5/01, it became "severe", lost ability to grip, had problem day and night for approx. 2 days. Informed supervisor on 1/6/01. On 1/9/01, numbness subsided, somewhat. Client reports has been lessening.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Injection site erythema, Rash maculo-papular, Skin ulcer
Clinical narrative: On 09/23/00, this infant had a erythematous rash, a swollen left hand, and a swollen left thigh. On 09/25/00, the infant had swollen diffuse redness of the left thigh. On 09/26/00, the infant had tiny; in a group vesicular excoriated lesions on the left thigh; as per mom the left and right hand in between the fingers are getting better. On 09/28/00, the infant had dry erythematous rash, vesicle resolved, between fingers still open blisters, left arm inner  side upper arm dry rash, right arm wrist dry rash, right elbow dry rash, left ear lobe open wound (it's not related to the vaccine). On 10/28/00, right wrist, left thigh rash almost resolved, healed rom.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Blister, Dry skin, Erythema, Injury, Oedema peripheral
Clinical narrative: On 09/23/00, this infant had a erythematous rash, a swollen left hand, and a swollen left thigh. On 09/25/00, the infant had swollen diffuse redness of the left thigh. On 09/26/00, the infant had tiny; in a group vesicular excoriated lesions on the left thigh; as per mom the left and right hand in between the fingers are getting better. On 09/28/00, the infant had dry erythematous rash, vesicle resolved, between fingers still open blisters, left arm inner  side upper arm dry rash, right arm wrist dry rash, right elbow dry rash, left ear lobe open wound (it's not related to the vaccine). On 10/28/00, right wrist, left thigh rash almost resolved, healed rom.
Age: 0.9
Sex: M
Vaccine: PNC, PNC
Symptoms: Otitis media, Rash erythematous, Rash vesicular, Skin ulcer
Clinical narrative: On 09/23/00, this infant had a erythematous rash, a swollen left hand, and a swollen left thigh. On 09/25/00, the infant had swollen diffuse redness of the left thigh. On 09/26/00, the infant had tiny; in a group vesicular excoriated lesions on the left thigh; as per mom the left and right hand in between the fingers are getting better. On 09/28/00, the infant had dry erythematous rash, vesicle resolved, between fingers still open blisters, left arm inner  side upper arm dry rash, right arm wrist dry rash, right elbow dry rash, left ear lobe open wound (it's not related to the vaccine). On 10/28/00, right wrist, left thigh rash almost resolved, healed rom.
Age: 35.0
Sex: M
Vaccine: HEP, TYP, YF, HEP, TYP, YF
Symptoms: Angioneurotic oedema, Chest discomfort, Face oedema
Clinical narrative: Urticaria, periorbital edema, wheezing and SOB which began 45 minutes, post vax. Treated with IV Benadryl, Zantac, Solu-Medrol and symptoms relieved within 30 minutes.
Age: 35.0
Sex: M
Vaccine: HEP, TYP, YF, HEP, TYP, YF
Symptoms: Dyspnoea, Periorbital oedema, Urticaria, Wheezing
Clinical narrative: Urticaria, periorbital edema, wheezing and SOB which began 45 minutes, post vax. Treated with IV Benadryl, Zantac, Solu-Medrol and symptoms relieved within 30 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaemia, Convulsion, Fall, Febrile convulsion, Haematuria
Clinical narrative: It was reported that a 5 year old female pt received a Tripedia, IPOL and an MMR II on 1/3/01 at approx. 13:30. The pt's mother telephoned the health dept on 1/25/01. Reportedly, on 1/24/01, at 09:00, the pt was brushing her teeth and fell into her mothers arm and began having seizure-like activity. EMS was called and delivered her to the ER. The pt's mother is concerned about "link with immunizations". Mother reports CAT scan-WNL. Follow-up with primary doctor on 1/29/01 at 09:00. The ER report shows she was discharged with febrile seizure activity, anemia and hematuria. Reportedly the pt recovered from this experience.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaemia, Febrile convulsion, Haematuria
Clinical narrative: It was reported that a 5 year old female pt received a Tripedia, IPOL and an MMR II on 1/3/01 at approx. 13:30. The pt's mother telephoned the health dept on 1/25/01. Reportedly, on 1/24/01, at 09:00, the pt was brushing her teeth and fell into her mothers arm and began having seizure-like activity. EMS was called and delivered her to the ER. The pt's mother is concerned about "link with immunizations". Mother reports CAT scan-WNL. Follow-up with primary doctor on 1/29/01 at 09:00. The ER report shows she was discharged with febrile seizure activity, anemia and hematuria. Reportedly the pt recovered from this experience.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt had a high fever of 103F and vomiting at 21:00. Seen in ER and in the hospital from 9/18/00 until 9/21/00. Mom reported this to health dept on 1/8/01.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR, OPV
Symptoms: Diabetes mellitus
Clinical narrative: Pt developed diabetes over time. Dx'd 11/20/99 with Diabetes Type I. The follow up received on 6/19/01 states, "Thank you for referring pt to our clinic for consultation regarding diabetes management. As you know, pt was diagnosed with diabetes on October 20th. She was initially hospitalized, having large ketonuria and a blood sugar over 480. The parents state that things have been going reasonably well, although they find it very difficult to manage pt's diabtes. They feel that her blood sugars fluctuate drastically. She has not had any siezures. She has had a blood sugar as low as 25, at which time she wsa very groggy. She had another hypoglycemic event, with a blood sugar of 35, at which time she could not walk. She has had some blood sugar swings up into the 400's and 500's. However, in reviewing her blood sugars for the past few weeks, most of the blood sugars have been between 100 and 300. The parents have been talking with you for insulin adjustments, and numerous appropriate insulin adjustments have been made over the past six weeks or so. She is currently taking 4 1/2 units of NP and 1/2 unit of regular in the morning and no insulin in the evening. Upon awakening, her blood sugars have generally been in the 100 to 300 range. Pt is eating fairly well. She has three meals and three to four snacks per day. If her blood sugar is high, her snack is generaly withheld. Occasionally she will refuse to eat, and then the parents feel in a panic that hse is going to have a hypoglycemic event soon afterward. Pt has been back to her normal energy level and routine. She is still nursing occasionally, although the mother has been trying to limit the amount that pt is breast feeding. The mother had been fairly close to weaning pt at the time of the birth of pt's 6 month old sibling, but between that and then the diagnosis of diabetes a few months later, pt has continued to breast feed. The parents come in with several questions today. They are wondering whether the fluctuations in pt's blood sugars are typical. They also wonder whether pt's younger sister should receive immunizations, as they have read that immunizations may be the cause of the increased prevalence of diabetes in young children. They do note that pt's blood sugar tends to fall rahter quickly after Humalog insulin, and it also falls in the mid-afternon, between 1 and 2pm. They find it difficult to give pt extra Humalog insulin, asthey are unsure if her blood sugar is going to fall from previous insulin dosages. In looking at pt's blood sugars at bedtime, of late she frequently has been going to bed with relatively high blood sugars, i.e. over 200."  Follow up: "Actual date is unknown.  Onset was very gradual.  Destruction of Islet cells which produce insulin can be immediate or take several years."
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: Abasia, Arthralgia, Muscular weakness, Myalgia, Myositis
Clinical narrative: On 12/31/00, pt developed some muscle aches and pains. By 1/1/01, he had severe myositis/joint pains/weakness and could not walk or even feed himself. Admitted to hospital on 1/1/01 to rule out Guillain-Barre Syndrome and other causes. All tests were normal.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This infants right thigh turned red and had swollen 30 seconds after administration of Prevnar vaccine. Ice was applied to the area and Benadryl was given. Mom stayed in the office 30 minutes after the reaction to the med. The mom was instructed to call if fever, swelling increase or became irritable
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying
Clinical narrative: The infant is screaming and crying.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Screaming
Clinical narrative: After receiving Vaccinations the infant became very irritable, crying for 48 hours.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Drooling, Dyskinesia, Eye disorder
Clinical narrative: Approximately 30 hours after receiving a vaccine series, the patient had a 20-30 second episode of "eye blinking" and drooling as well as "jerking" arms and legs. The episode was self limited, with no obvious sequelae.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Erythema
Clinical narrative: This infant had erythema 2 x 4 cm one day following immunization, Prevnar #2. At the time of Prevnar #1, she had the same reaction.
Age: 1.2
Sex: F
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Physician from a from another Pediatric facility inquired as to what immunization was given on 01/16/01. The patient presents today with 2 clusters of papules. The doctor said it was a local vaccine reaction. Treatment with Benadryl.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This patient had fine red colored rash appear on both legs around his injection sites within 1-2 hours of immunization and lower legs. Feeling today, no induration, swelling. No treatment needed.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: On 01/19/01, this patient received her vaccinations in the PM. Her arm started to swell, sting, and she complained of pain, and severe redness for several days. The patient took Tylenol when necessary and Ibuprofen for 2 days. Today the swelling and redness is decreased.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Pruritus, Rash
Clinical narrative: This patient had a rash on her face and upper chest area, it was itchy, and she had watery eyes. The patient took Benadryl and it resolved.
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Hypoaesthesia
Clinical narrative: Immediately following this patient's injection she experienced numbness and tingling in her hand on the side where the injection was given. She also reports a flushed "hot" sensation all over. Obese sickness had completely resolved within 2 hour or less, and there were no residual effects.  Follow up:  Patient lost to follow-up, cannot contact.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This patient's mother called, the patient vomited 2 times in 6 hours after his vaccination was given. He was fine within 12 hours.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Postnasal drip, Pyrexia
Clinical narrative: This patient developed a sore throat with post nasal drip, a severe cough followed with a fever; within 2 days after his vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Rash, Urticaria
Clinical narrative: On Monday, 01/08/01, at 9 PM, the patient had a rash on her body. On Tuesday, 01/09/01, the patient experienced itching, hives and throat swelling. The doctor administered Cortizone treatment lasting 7 days. The patient stated by Thursday, 01/11/01, she had no signs of hives, itching, rash or throat swelling
Age: 1.39
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Rash, Tongue oedema
Clinical narrative: Approximately 2 hours post vax, while eating chicken nuggets and honey mustard, the pt began to develop a rash around the mouth and tongue began to swell. Pt had no difficulty breathing. Pt was referred to Hospital. ER physician diagnosed oversensitivity.
Age: 31.0
Sex: F
Vaccine: HEPA, TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received Hep A and Td on 11/19/1999; on 11/23 pt developed red raised sensitive spot at vaccine site with 12x13cm area redness, pain. Pt received Cephlexin 500 bid times 1 week. Resolved by 11/26/1999.
Age: 5.3
Sex: M
Vaccine: DT
Symptoms: Hypersensitivity, Injection site induration, Injection site warmth
Clinical narrative: Approximately 12 hours post vax, pt developed 6X7 cm warm indurated area around injection site with no pain or fever. Presumed local allergic reaction. Pt treated with Claritin10 mg, close clinical follow up.  Event resolved within 48 hours.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Erythema
Clinical narrative: 4.5 X 5 cm nearly circular, erythema dredges, center clear with raised edges, blanch unchanged since onset.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Erythema, Injection site mass, Pyrexia, Swelling
Clinical narrative: Mom states child would sleep for long intervals then wake up screaming until he threw up. Reports fever of 101.6 last pm, this AM low grade fever, left leg has large knot, red and swollen. On phone call  all night with 250Kids hotline.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Irritability, Vomiting, Wheezing
Clinical narrative: Four days post vax, mom reported the pt was fussy and spitting up. Reported wheezing. Pt was seen by physician six days post vax who stated symptoms were due to stomach problems and treated with Prevacid.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 12/13/00 pt was given DTaP given at Health Dept.  12/15/00 seen at HD with caregiver, no fever. Reports child able to play, walk normal act at this age. Left thigh redness and warm to touch, measures 3x2 inch.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: On 1/9/01 child began having diarrhea, loose brown 5-6 times day, no vomiting, taking bottle. Only small amount temperature did not take it, playing, still having diarrhea today when went to Dr. 1/12/01.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, redness, cool compress applied to leg.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, RAB, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh red and swollen.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Arthralgia, Diarrhoea, Erythema, Hypersensitivity, Injection site rash
Clinical narrative: On 1/3/01 the pt experienced a rash that started at the injection site on arms and legs and worked down legs and arms. The rash was fine that turned red. Cheeks were red and there was a rash on the stomach. 1/4/01 the pt was holding joints like they were hurting. The pt was also cranky and had diarrhea. Saw an MD who said it was an allergic reaction to the vaccine.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Irritability
Clinical narrative: On 1/3/01 the pt experienced a rash that started at the injection site on arms and legs and worked down legs and arms. The rash was fine that turned red. Cheeks were red and there was a rash on the stomach. 1/4/01 the pt was holding joints like they were hurting. The pt was also cranky and had diarrhea. Saw an MD who said it was an allergic reaction to the vaccine.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Convulsion, Hypotonia, Pyrexia, Staring
Clinical narrative: The pt developed a fever of 102 approximately 1-2 hours post vax. The mother found the infant in his bed with eyes wide open and with a fixed stare. She said the infant was limp for approximately 2-3 minutes. She immediately called 911 and the infant was transported by ambulance to the ER. The infant was observed for 23 hours. The infant was diagnosed with a seizure. No prescriptions were given and the pt has not experienced any sequelae. The pt's maternal great uncle and great-great grandmother have a hx of seizures beginning in childhood.
Age: 1.6
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Dyskinesia, Febrile convulsion, Pyrexia
Clinical narrative: The pt experienced a fever of 103 at 2:00am on 1/3/01. The pt also experienced "jerky movements" seen at the ER. The pt was diagnosed with febrile seizure. The pt was treated with Tylenol, and Motrin.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Influenza like illness
Clinical narrative: Approximately 10-14 days post vax, the pt developed flu-like symptoms and a seizure was experienced. No fever was present.
Age: 3.9
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular
Clinical narrative: The pt experienced multiple papules and pustules.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Face oedema, Oedema
Clinical narrative: Within 1 hour post vax, the pt developed generalized swelling of whole body including face and eyelids. Was seen at the ER on 9/14.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site induration
Clinical narrative: The pt experienced induration to the left leg.
Age: 14.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash
Clinical narrative: 1-2 days post vax, the pt has a pimply rash at the site. The area later became red and hard. Treated on 1/26/01 with Benadryl and steroids.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received DTaP vax in left upper thigh, developed surrounding redness/swelling. Seen 2/1/01 had mild redness 8cm surrounding injection site, mild swelling, no tenderness, no secondary cellulitis.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Joint stiffness, Pain, Shoulder pain, Tenderness
Clinical narrative: Pt reports soreness, tenderness and pain in right upper arm area. Developed shortly after Td booster, unresolved three months later. Pt denies any swelling or erythremia in right upper arm following injection. Palpation of right upper arm reveals no erythremia, or swelling, no lumps, and although patient states arm is sore in this area, no guarding or flinching occurs during palpation. Pt reports pain in right shoulder area that prevents her from sleeping if she rolls over onto it in her sleep. Pt reports pain with excessive movement. Pt reports regular use of Tylenol has not resolved pain. Pt also reports increased soreness and stiffness in right shoulder area upon waking in the morning.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Pt experienced hives and urticaria approx. 2 hours, post vax. Treated with Benadryl po and symptoms subsided without complications.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, edema, erythema and tenderness to left leg. Treatment: Atarax every 6 hours, Tylenol every 4 hours and warm compresses. Did not keep appt. for follow-up. Attempted to contact by phone but no answer. Allergy reaction (local).
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Approx. 10:00, pt received IZ and approx. 15 minutes, no side effects reported. Mother returned at 14:00 with client who had a fine rash to body. No difficulty breathing. Was advised to see PMD.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A 66 year old female reported that she received an injection of Pnu-Immune 23 on 10/25/00. Within 3 hours of the vaccine administration, the patient was not feeling well. The following day, she developed an injection site reaction in her left arm characterized by swelling, redness, and pain which extended through her left shoulder, mid-back, and neck. She was seen by the physician and diagnosed with necrotizing cellulitis. The patient was hospitalized on 10/26/00. An MRI was performed; however, the results were not available. The reporter stated that the physician felt she was "going into shock" and central venous line was inserted. She was treated with IV fluids, Unasyn (Ampicillin / Sulbactam) and Morphine. The patient was discharged on 10/27/00 with an unspecified antibiotic. Reporter also states that the physician felt she was "allergic to the Pneumonia vaccine". Follow up information received from the physician on 03/07/2001 indicated the patient was diagnosed with angioedema and injection site edema rather than fasciitis/shock. The patient's symptoms resolved rapidily and she recovered.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Neck pain, Necrosis, Pain, Shock
Clinical narrative: A 66 year old female reported that she received an injection of Pnu-Immune 23 on 10/25/00. Within 3 hours of the vaccine administration, the patient was not feeling well. The following day, she developed an injection site reaction in her left arm characterized by swelling, redness, and pain which extended through her left shoulder, mid-back, and neck. She was seen by the physician and diagnosed with necrotizing cellulitis. The patient was hospitalized on 10/26/00. An MRI was performed; however, the results were not available. The reporter stated that the physician felt she was "going into shock" and central venous line was inserted. She was treated with IV fluids, Unasyn (Ampicillin / Sulbactam) and Morphine. The patient was discharged on 10/27/00 with an unspecified antibiotic. Reporter also states that the physician felt she was "allergic to the Pneumonia vaccine". Follow up information received from the physician on 03/07/2001 indicated the patient was diagnosed with angioedema and injection site edema rather than fasciitis/shock. The patient's symptoms resolved rapidily and she recovered.
Age: 68.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Report 2001003270-1 describes knee joint pain in a 68 year old male who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. Allergies, medical history, and concomitant medications are not specified. In 1999, and in early 2000, the vaccinee received his first and second doses of Lymerix, respectively. "Shortly" after dose 2 of Lymerix, the vaccinee developed such severe pain in his joint that he was unable to work. He subsequently under went exploratory surgery in July, 2000, and reportedly was told that he will need knee replacement. This report is considered serious due to the need for hospitalization and the inability of the vaccinee to work. As of 02/01/01, the out come of the event is unknown. The serious adverse event of "knee joint pain" is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Back pain, Difficulty in walking, Fatigue
Clinical narrative: In March, 1999 and May, 1999, the vaccinee received her 1st and 2nd dose of Lymerix, respectively. Following the 2nd dose, the vaccinee experienced what she described as severe disabling joint pain all over her body. This pain then localized in her back, neck, knees, elbows, fingers and jaw. The pain tends to get progressively worse as the day goes on. When it is bad in her knees, she has difficulty walking by the end of the day. On days that the pain strikes her elbows, she had difficulty lifting by day's end. Due to the extreme fatigue she has experienced, she is forced to go to bed by 19:00. This case is considered serious because the events are disabling. As of 2/1/00, the outcome of the events is unknown.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Neck pain, Pain in jaw
Clinical narrative: In March, 1999 and May, 1999, the vaccinee received her 1st and 2nd dose of Lymerix, respectively. Following the 2nd dose, the vaccinee experienced what she described as severe disabling joint pain all over her body. This pain then localized in her back, neck, knees, elbows, fingers and jaw. The pain tends to get progressively worse as the day goes on. When it is bad in her knees, she has difficulty walking by the end of the day. On days that the pain strikes her elbows, she had difficulty lifting by day's end. Due to the extreme fatigue she has experienced, she is forced to go to bed by 19:00. This case is considered serious because the events are disabling. As of 2/1/00, the outcome of the events is unknown.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: A nurse reported that a pt received an injection of Pnu-Imune-23 on 1/31/2001. The following day, the pt developed a fever of 102F and an injection site reaction characterized by redness and soreness. The pt was hospitalized and treated with unspecified antibiotics and steroids. As of the date of this report, the pt's symptoms were improving. Follow-up info received from the physician on 3/7/01, indicated that the pt was a 54 year old female. She recovered.
Age: 14.0
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Rash on body (hives) which occurred 5 hours, post vax. Pt was treated with Benadryl at home. Did not see MD, but reported event by phone.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Reddened, firm and warm to touch area at right thigh.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Convulsion, Eye movement disorder, Musculoskeletal stiffness, Otitis media, Pyrexia
Clinical narrative: Pt received DTAP, IPV and Prevnar vaccines during well child visit; went home and was ok. At 22:00, pt observed by parents to have a seizure while sleeping (eyes rolled back, clenched fist). Parents took him to ER where a fever was detected and also had respiratory symptoms. Pt here today, 2 weeks later, still with respiratory symptoms; OM.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Respiratory disorder
Clinical narrative: Pt received DTAP, IPV and Prevnar vaccines during well child visit; went home and was ok. At 22:00, pt observed by parents to have a seizure while sleeping (eyes rolled back, clenched fist). Parents took him to ER where a fever was detected and also had respiratory symptoms. Pt here today, 2 weeks later, still with respiratory symptoms; OM.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Feeling hot, Joint swelling, Neck pain
Clinical narrative: The pt received her 1st injection of Lyme disease vaccine in the fall of 1998 and the 2nd dose 1 month following the 1st. She had no adverse experiences following receipt of the 1st two injections. The pt received her 3rd injection of Lymerix, 1 month following the 2nd one. Approx. 1 month following the 3rd injection, the pt developed right elbow edema, redness, pain and heat. She also developed bilateral ankle edema; no redness or heat was noted in the ankles. She experienced cervical pain at times. She also experienced joint pain in both shoulders; the pain was worse in the right shoulder. The right shoulder pain continued to worsen over the next 2 years. The pt reported that she had not been seen by a physician at the time of "flare ups", but planned to be evaluated by an orthopedic surgeon.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Pyrexia
Clinical narrative: After 3rd Rabies vaccine injection, pt's right upper arm experienced numbness and tingling in hand with loss of feeling in right hand for 5 hours duration. Complained of dizziness and feeling "just not right". Stated temperature was 103F-101F, during the night. No breathing or swallowing difficulties. Temperature is now 98.9F. Treated with Benadryl.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Rash macular, Urticaria
Clinical narrative: Red, blotchy, urticaria rashes on face and scalp, as well as, chest and back about 2 minutes, post vax. Treated with Benadryl po.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Pt become nauseated and vomited, post vax, of HBV. Pt was layed down and informed she could leave facility once she was ok, if she did not have any problems. At 11:00, no complaints at this time to me other than a headache; has not eaten yet today. No nausea and vomiting currently and states she is able to walk now. Grandmother is taking her home and should eat. At 15:30, grandmother called and said pt still has a headache and took Tylenol. At 23:30, has eaten and kept food down, Informed to try ice pack and drink small amount of orange juice and try Advil or Motrin in about 2 hours. If problems persist or worsen, go to MD or ER. Informed that I would call and check on her tomorrow, if I did not hear from her again today. On 01/10/01 at 08:50, grandmother says child is ok and returned to school today.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Per mother, around 12:00 on 1/26/01, right arm began to turn red and swell. Child began to complain of headache. Mom also began to notice child had chills and seemed to be acting like she was ill. Gave Tylenol for mild fever but temperature continued to climb. By 1/27/01 AM, child's temperature was 105F and arm had swollen to "the size of an orange". Per mom, her also was red and hot. Took child to ER, where they were told that she had had a vaccine reaction and released her home with Motrin. Follow-up visit with PMD arranged. Saw PMD and was told to use ibuprofen and continue with Motrin. Per mom, no redness or swelling, now.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Pallor, Palpitations
Clinical narrative: On 2/5/01, pt awoke with heart pounding, chest discomfort, SOB and pale. At 07:15, saw MD for signs and symptoms above. Pulse Oximetry-96%, P-114. Physician told pt that the cause of symptoms were likely, viral infection.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Viral infection
Clinical narrative: On 2/5/01, pt awoke with heart pounding, chest discomfort, SOB and pale. At 07:15, saw MD for signs and symptoms above. Pulse Oximetry-96%, P-114. Physician told pt that the cause of symptoms were likely, viral infection.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Convulsion
Clinical narrative: This child received immunization at 1 PM on 6/28/00, 6 hours later after the immunization the patient had a seizure, head pulled to the right side, shoulder started jerking, non responsive for 10 minutes. The patient was taken to the ER a pediatrician was called and the patient was admitted to the hospital. The doctors ruled out everything except Pertussis; had an allergic reaction to the Pertussis vaccine. The patient was discharged on 06/30/00, was taken to the neurologist; diagnosed with cerebral palsy and focal seizure. Has not had anymore seizures. Is now stiff in his right leg, mother is having motor skills tested.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Cerebral palsy, Convulsion, Dyskinesia, Hypersensitivity, Lethargy
Clinical narrative: This child received immunization at 1 PM on 6/28/00, 6 hours later after the immunization the patient had a seizure, head pulled to the right side, shoulder started jerking, non responsive for 10 minutes. The patient was taken to the ER a pediatrician was called and the patient was admitted to the hospital. The doctors ruled out everything except Pertussis; had an allergic reaction to the Pertussis vaccine. The patient was discharged on 06/30/00, was taken to the neurologist; diagnosed with cerebral palsy and focal seizure. Has not had anymore seizures. Is now stiff in his right leg, mother is having motor skills tested.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Musculoskeletal stiffness, Torticollis
Clinical narrative: This child received immunization at 1 PM on 6/28/00, 6 hours later after the immunization the patient had a seizure, head pulled to the right side, shoulder started jerking, non responsive for 10 minutes. The patient was taken to the ER a pediatrician was called and the patient was admitted to the hospital. The doctors ruled out everything except Pertussis; had an allergic reaction to the Pertussis vaccine. The patient was discharged on 06/30/00, was taken to the neurologist; diagnosed with cerebral palsy and focal seizure. Has not had anymore seizures. Is now stiff in his right leg, mother is having motor skills tested.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Apnoea, Cyanosis, Shock
Clinical narrative: This patient presented to ED in shock. The patient was then transported to PICU. The patient in shock requiring cardiopulmonary resuscitation. The patient expired approximately 72 hours after admission. The patient had received Prevnar the day prior to admission. Autopsy shows baby was cyanotic, not breathing
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: The pt died from sudden infant death syndrome on 1/6/01 within 18 hours of vaccine administration.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: On 12/19/00, the pt experienced progressive worsening fever, erythema, right arm pain, edema and induration. The pt was diagnosed by a physician with cellulitis. She was treated with oral Cephalexin for 7 days and two courses of IV Cephalexin as an outpatient in her physicians office. The pt's symptoms completely resolved by 12/29/00. Upon internal review the pt's experience was considered an other "important medical event". Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: On 12/19/00, the pt experienced progressive worsening fever, erythema, right arm pain, edema and induration. The pt was diagnosed by a physician with cellulitis. She was treated with oral Cephalexin for 7 days and two courses of IV Cephalexin as an outpatient in her physicians office. The pt's symptoms completely resolved by 12/29/00. Upon internal review the pt's experience was considered an other "important medical event". Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Infection, Malaise, Osteomyelitis
Clinical narrative: After an unspecified dose of Lymerix, the pt became extremely ill with among other symptoms severe joint and back pain. Reportedly at a physician's recommendation, the pt underwent coccygectomy in 9/99. This surgery reported was ineffective and directly resulted in an osteomyelitis infection. As of 2/1/01, the outcome of the events is unknown.
Age: 35.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Eye inflammation, Immune system disorder, Influenza like illness, Joint swelling
Clinical narrative: Following the 2nd dose, the pt experienced flu like symptoms. Soon after that her knee became really swollen and had it drained 3 times, had 2 surgeries. After the 3rd shot, her problems really began. She developed auto immune arthritis reaction in her body. She had inflammation in her eye which was treated by a retina specialist. She was placed on prednisone.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Headache, Hypoaesthesia, Myalgia
Clinical narrative: The pt experienced joint pains to the left leg, left elbow, knees, wrists. The pt has muscle aches in left neck-shoulder area, nausea, headaches off and on, tired. Sometimes the joint pain is so bad, the pt had trouble sleeping. The pt has complained of numbness in arms upon waking.  Follow up on 11/29/2001: "We do not maintain VA records at this facility.  Diagnosis and treatment of adverse events that occurred following completion of Anthrax vaccine series 12/1998.  PE, lab, diag tests, treatment, and outcome.  "
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea
Clinical narrative: The pt experienced joint pains to the left leg, left elbow, knees, wrists. The pt has muscle aches in left neck-shoulder area, nausea, headaches off and on, tired. Sometimes the joint pain is so bad, the pt had trouble sleeping. The pt has complained of numbness in arms upon waking.  Follow up on 11/29/2001: "We do not maintain VA records at this facility.  Diagnosis and treatment of adverse events that occurred following completion of Anthrax vaccine series 12/1998.  PE, lab, diag tests, treatment, and outcome.  "
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Colitis, Faeces discoloured, Haematochezia, Speech disorder, White blood cell count increased
Clinical narrative: Four days post vax, the pt experienced bright green mucous stools. Two days after that the pt had blood in his green stool. The pt saw a physician on 12/18 and after several stool samples a diagnosis of allergic colitis was made. The pt has been placed on special formula, he could not tolerate breast milk. pER DOC 214441,Annual follow-up, patient continues to have allergies, green stools. Speech delays.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Infection, Injection site abscess
Clinical narrative: Abscess on right buttock, at injection site. Abscess drained and cultured on 1/13/01. Treated with Keflex; changed to Augmentin on 1/16/01. Abscess on left thigh drained and cultured and treated with Keflex, stated by doctor on 2/5/01.
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Crying, Hypokinesia, Pyrexia
Clinical narrative: Less than 24 hours, post vax, pt had a low-grade fever, crying fits and less arm movement. Brought to MD. Parents reassured but cautioned to call MD if symptoms persists. Contacted mom the next day and child is ok; no more fever.
Age: 5.0
Sex: M
Vaccine: IPV, PNC
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: 5 X 7 raised, edematous, inflammed area of dorsal right thigh, warm to touch, 12 hours, post vax. Treatment: ice pack, Motrin and Benadryl PRN and return if needed.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports that soon after vaccine was given, pt had redness of injection site starting. No worse than initially and no interference with activity. Still ambulating well. Office visit on 2/7/01, mom reports no increase in redness but questionable increased edema. Area with 2" X 1 1/2" of erythema, edema and hot to touch. Bears weight. Treat with Tylenol prn and cool compresses. Will monitor for worsening.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Hypokinesia, Irritability
Clinical narrative: Fussy and not want to walk on the leg that she got the shot in.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Coma, Hypotonia, Pyrexia
Clinical narrative: Fever 101F, within 1 hour, post vax. Pt was "floppy and limp" with decreased responsiveness.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: The mother noted a golf ball sized swelling on 2/6/01 one day post vax. It progressed the next day to involve entire thigh from knee to inguinal area with redness, firm to touch non-tender. The pt still acting normal. Swelling down slightly on 2/8/01.
Age: 0.2
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Cyst
Clinical narrative: On 1/8/01, MD evaluated a knot on pt's head as a cyst. Pt was referred to another doctor. CT Scan ordered and on 1/24/01 was read as having no lesions or masses. Cyst on parietal area, resolved.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Rash
Clinical narrative: Rash started on head and spread to rest of body over a period of 24 hours. Treated with Benadryl. On 2/9/01, pt's mother stated rash had completely covered child but rash is healed.
Age: 0.7
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC, DTAP, PNC
Symptoms: Hypersensitivity, Oedema peripheral, Pruritus, Pyrexia, Urticaria
Clinical narrative: Pt started with hives on trunk. On 2/3/01, by the end of day, had a temperature of 103F, increased hives and itching. Went to ER and they gave Benadryl, Tylenol alternating with Motrin. On 2/4/01, swelling hands and feet. On 2/5/01 to ER and referred and they think is Prevnar. If no better in 3 days, return.
Age: 0.7
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC, DTAP, PNC
Symptoms: Cyanosis, Hypersensitivity, Urticaria
Clinical narrative: Pt started with hives on trunk. On 2/3/01, by the end of day, had a temperature of 103F, increased hives and itching. Went to ER and they gave Benadryl, Tylenol alternating with Motrin. On 2/4/01, swelling hands and feet. On 2/5/01 to ER and referred and they think is Prevnar. If no better in 3 days, return.
Age: 0.7
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC, DTAP, PNC
Symptoms: Oedema peripheral, Pruritus, Pyrexia, Urticaria
Clinical narrative: Pt started with hives on trunk. On 2/3/01, by the end of day, had a temperature of 103F, increased hives and itching. Went to ER and they gave Benadryl, Tylenol alternating with Motrin. On 2/4/01, swelling hands and feet. On 2/5/01 to ER and referred and they think is Prevnar. If no better in 3 days, return.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: On 1/23/01, went to the ER with a high fever of 105.2F. While in the ER, was noted to have a seizure lasting less than 20 seconds. Returned to normal after that.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: 8cm X 5cm area of swelling noted to left thigh with some central induration.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Dizziness, Fatigue, Gastrointestinal disorder, Hepatic enzyme abnormal
Clinical narrative: Fatigue, malaise, foggy-headed feeling; started in August 1999, got significantly worse in May 2000. November 1999 through March 2000 had severe knee and jaw pain. Had elevated liver enzymes and other GI symptoms since June 2000 and are ongoing. Vision changes noted over past several months. Had other symptoms, too numerous to list her; may or may not be related. Received follow-up Lymerix injections in June 1999 and May 31, 2000.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Laboratory test abnormal, Malaise, Visual disturbance
Clinical narrative: Fatigue, malaise, foggy-headed feeling; started in August 1999, got significantly worse in May 2000. November 1999 through March 2000 had severe knee and jaw pain. Had elevated liver enzymes and other GI symptoms since June 2000 and are ongoing. Vision changes noted over past several months. Had other symptoms, too numerous to list her; may or may not be related. Received follow-up Lymerix injections in June 1999 and May 31, 2000.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Neuropathy peripheral, Paralysis, Vaccine positive rechallenge
Clinical narrative: Post vax, Anthrax #4 (within 2-3 days) left peripheral 7th nerve palsy. Post vax, Anthrax #2 (within 2-3 days) left peripheral 7th nerve palsy.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling
Clinical narrative: Pt had significant swelling of upper left arm, starting 24 hours, post vax, 2nd dose of Anthrax vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Light rash of lower extremities. No hives. Returned to clinic about 15 minutes, post vax. No SOB or dyspnea. Treated with Benadryl po X 24 hours.
Age: 12.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Pt given flu shot in left deltoid and Pneumovax in right deltoid on 1/26/01. He presents to office with painful left arm and axillary lymphadenopathy.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Pt received flu vaccine on 12/1/00 in left deltoid. On 12/14/00, pt complained of some pain at site and returned to clinic on 1/25/01 with severe pain, needle-like feeling in the area and swelling. MD noted some irregularity in area. Comfort measures employed, NSAIDS and pt referred to physical therapy.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received pneumonia and flu vaccines on 1/30/01. Complained of right arm where pneumonia shot was given as being swollen and painful to touch. Site edematous and warm to touch.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Gingival pain, Neck pain, Pain, Peritonitis
Clinical narrative: On 1/18/01, begin having right ear and neck pain. At noon, started getting leg aches. PCP Rx's with antibiotic Zithromax X 5 days; beginning swelling and again went to PCP. Dx'd peritonitis and Rx'd another antibiotic but got GI symptoms. Rx'd with steroid for swelling; stayed swollen for 4 days. Saw PCP again on 1/23/01. On 1/18/01 had fever and chills. Went to dentist for cleaning on 1/3/01 and complained of gum discomfort on left side, 5 days later.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Swelling
Clinical narrative: On 1/18/01, begin having right ear and neck pain. At noon, started getting leg aches. PCP Rx's with antibiotic Zithromax X 5 days; beginning swelling and again went to PCP. Dx'd peritonitis and Rx'd another antibiotic but got GI symptoms. Rx'd with steroid for swelling; stayed swollen for 4 days. Saw PCP again on 1/23/01. On 1/18/01 had fever and chills. Went to dentist for cleaning on 1/3/01 and complained of gum discomfort on left side, 5 days later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swollen, indurated area on left arm and tender to touch.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Erythema, Pruritus, Pyrexia
Clinical narrative: Student states, his hands and face began to itch approx. 15 minutes, post vax, with generalized redness. Was given Benadryl po 50mg with good results. BP-140/90; AP-90; T-98F; anxious, breathing easy. Signs and symptoms upon discharge from IZ area.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Administration site swelled with redness and felt warm to touch. MD gave pt antibiotic to ward off infection.
Age: 1.3
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 24 hours, post vax, injection site became inflamed, swollen and hot into joint area and to knee (left VL). Child did not run a fever. Local reaction only. Seems to be itching. 48 hours, post vax, much improved.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Post vax, pt had redness, swelling and itching at site of injection, erythema 6cm and warm to touch. Provider thought reaction to bandaid, due to print of bandaid on arm; no redness. On 1/16/01, pt had Hep-B/MSD/0721K/IM/LA/#6 with redness, swelling and itching, middle to lower third of upper arm and warm to touch but non-tender. Nothing at site of injection. No bandaid applied at this site. Pt received 3 doses of HBV, out of state, 2 years ago but had no reaction. Needed proof so repeated series.
Age: 0.9
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness a little larger than the size of a quarter on left deltoid X 7 days.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: Urticaria, starting a few hours, post vax, and persistent X 9 days. On 2/2/01, seen by health care professional and treated with Benadryl. No further follow-up.