chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Coordination abnormal, Muscular weakness, Nervous system disorder, Pain
Clinical narrative: On 12/2/00, this pt developed right parascapular pain and on 12/6/00 developed right hand weakness and dyscoordination. He has specific weakness of thumb and abduction of fingers with decreased pinch and grip strength. A c-spine MR was performed and did not explain symptoms. A MRI of his brain is pending. A tentative diagnosis has been made of brachial plexitis. F/U rec'd fromreporter 6/27/01 via telephone. the reporte ? that she rec'd f/u info consisting of the following. the pt has not fully recovered and has regained 70% of his strength in the R arm and shoulder and still experiences pain in the R arm  requiring daily use of motrin. The pt is seeing a neurologist. No other info was available, further inof requested from the reporter.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This patient has history of [[name]] Barre' Syndrome with residual symptoms of leg pain and leg spasms. His girlfriend read Influenza information sheet after he received the Flu shot and she became concerned that the patient's residual symptoms were worse after his flu shot. The patient denies that his symptoms are worse, he was evaluated by the doctor who ruled out [[name]] Barre Syndrome or exacerbation of residual symptoms of the syndrome. Hx of GBS as teenager, residual pain in leg- spasma also tendonitis of wrists.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Acne, Asthenia, Flushing, Lymphadenopathy
Clinical narrative: On 12/01/00, the patient received Fluvirin vaccine in the left deltoid. Immediate pruritis at the site, Prescribed Ice. At 10 PM the axillary adenopathy, left arm acne. 12/02/00, malaise and flushed from 12 thru night and day: burning of both legs, PM of 12/02/00, at 6 PM  gradually lost sensation, then strength in both legs (Sat evening). 12/3/00, unable to move legs by 12 AM, crawled to bedroom, later dragged in to be seen by MD at 10 AM (Sunday).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pruritus, Skin burning sensation
Clinical narrative: On 12/01/00, the patient received Fluvirin vaccine in the left deltoid. Immediate pruritis at the site, Prescribed Ice. At 10 PM the axillary adenopathy, left arm acne. 12/02/00, malaise and flushed from 12 thru night and day: burning of both legs, PM of 12/02/00, at 6 PM  gradually lost sensation, then strength in both legs (Sat evening). 12/3/00, unable to move legs by 12 AM, crawled to bedroom, later dragged in to be seen by MD at 10 AM (Sunday).
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: The patient received the flu shot on a Friday approximately 12/29/2000. Saturday morning the patient's arms and under arms broke out with red spots. In 3 days she was broke out all over her body. She went to the urgent care clinic the doctor said it was hives from the flu shot. She itched badly. She took medication 4 weeks then they were all gone.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: On Wednesday, 01/17/01, the patient's left arm ached from the site where the shot was given down her hand. Thursday,01/18/01, the pain was better but still sore at the injection site. Friday, 01/19/01, having numbness on the left arm down to the hand. Feels tired all over with dizziness.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Blindness, Cough, Eye haemorrhage, Headache, Nasal congestion
Clinical narrative: This patient has a runny nose, persistent bronchial cough, Phlegm in throat and chest, headache, eye hemorrhage in the left eye, no vision, vision unclear.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Vision blurred
Clinical narrative: This patient has a runny nose, persistent bronchial cough, Phlegm in throat and chest, headache, eye hemorrhage in the left eye, no vision, vision unclear.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Pt was seen by a local physician who recommended EMG. 07/26/01 Follow up. This information was faxed to VAERS 05/18/2001. Per health dept, the date of the adverse event was 12/21/2000 and thet time 07:30am.
Age: 61.0
Sex: M
Vaccine: FLU3, HEP, HEPA, PPV
Symptoms: Erythema, Injection site oedema, Injection site pain, Rash, Rash maculo-papular
Clinical narrative: 15 hours after receiving immunization in the left arm the patient became swollen and painful with  red splotchy rash. Within 48 hours symptoms subsided.
Sex: F
Vaccine: MEA
Symptoms: Therapeutic reaction time decreased
Clinical narrative: This patient received rubella vaccine but all lab results were negative from any rubella titer or evidence of any antibodies.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Joint range of motion decreased, Pain
Clinical narrative: This patient had 70 mm x 50 mm erythema, left deltoid, 70 mm x 60 mm induration, left deltoid. Decreased range of motion left arm with pain on abduction onset 6 hours post administration 11/15/00.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Pain
Clinical narrative: This patient had a severe onset of localized reaction that began approximately 6 hours post injection. Initially painful adduction of the left arm with gradual increasing erythema and induration at the left deltoid; measuring 70 mm x 60 mm (induration).
Age: 76.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Myalgia
Clinical narrative: Pt experienced arthralgia/myalgia subsequent to receiving the second dose of Havrix, with gradual improvement over 5-7 days.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Pt developed cellulitis and was treated with antibiotics.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Pruritus, Rash, Urticaria
Clinical narrative: Approximately 2 hours post vax, the pt relates onset of rash and itching around both ankles. Pt states she was at work at wildlife refuge and notice symptoms while walking back to the house from animal cages. Rash initially appeared as discrete, red, raised dots. Pt denies SOB, wheezing, fever, nausea. Admits to malaise which started the day after vax was administered and lasted approximately 16 - 18 hours. Pt states arm was sore to touch following vax. After approximately one day, ankle rash evolved into welts which covered both ankles in a three inch band. Welts were not fluid filled but described by pt as wide and raised. Welts did not extend to feet or lower legs. Pt states she noticed a couple of similar welts across her back following the bra line. No other symptoms. Pt states she has been taking Benadryl and using topical cortisone to relieve itching. Ankles remain reddened and become itchy when warm.
Age: 42.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt developed a 50 cent sized induration with redness at injection site. 2 days prior to observation pt states redness radiated to left axillary.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Convulsion, Dyspnoea, Pyrexia
Clinical narrative: Two days post vax, the pt developed a high fever of 103.4 degrees, seizures and experienced difficulty breathing.
Age: 57.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Pt states he didn't feel right after vax. The next day a knot the size of an egg developed and arm was painful. Pt directed to treat with warm compress, Advil and to rest arm. Pt seen in the office the next day for swelling, redness and pain in upper left arm. Pt treated with Biaxin. Symptoms didn't improve and pt was seen in the ER 10 days post vax. Pt was treated with Augmentin.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema, Rash maculo-papular
Clinical narrative: Within minutes of receiving vax, the DTaP injection site became red and swollen. Pt became splotchy on face, neck, behind ears and down to chest area. Pt was treated with Benadryl and ice packs at site of DTaP and Hib. Pt would continuously cry.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: One day post vax, the pt developed localized redness and swelling which progressively worsened. By two days post vax the pt had experienced a huge amount of swelling and redness extending to posterior aspect of leg. Pt seen by physician but no treatment given other than cool compress to site. Swelling and redness gradually subsided and completed resolved within 7 - 10 days.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Pain
Clinical narrative: 5-6 days post vax, the pt experienced severe pain and aching in left arm extending to fingers. Pt developed numbness of thumb and fore finger with tingling sensation. After 4 months, the pt still experiences numbness after almost 3 months of physical therapy. Pt is being treated with ????? and Vioxx daily and has used codeine for pain.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pt reported that the afternoon of receiving the vax, he felt achey and nauseated. He vomited several times that evening. One day post vax his fever rose to 101 - 102 degrees and he continued with achiness. Two days post vax he felt fine. Pt reported no local reaction at injection site.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Feeling hot, Screaming
Clinical narrative: Subsequent to receiving vax, mom states that pt cried painful cry inconsolably  for over 3 hours. Pt was given Tylenol  prior to and every 4 hours without relief. No temperature taken however, mom states that pt was warm to the touch. Referred to PCP.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Abscess, Arthralgia, Headache, Injection site erythema, Injection site oedema
Clinical narrative: 24 - 48 hours post vax the pt experienced nausea, headaches and body and joint aches; especially knees, elbows and hips. Left arm was red and swollen from elbow to shoulder with warmth in general area. Pt also felt general malaise. Attending physician felt pt may have sterile abscess. Pt treated with Tylenol and applied cold compress to left arm. Pt did not have a fever at the time of examination. Follow up information received from a CNP stated that the pts symptoms had completely resolved within one week of onset. No prescription drugs were used.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Injection site warmth, Malaise, Nausea, Pain
Clinical narrative: 24 - 48 hours post vax the pt experienced nausea, headaches and body and joint aches; especially knees, elbows and hips. Left arm was red and swollen from elbow to shoulder with warmth in general area. Pt also felt general malaise. Attending physician felt pt may have sterile abscess. Pt treated with Tylenol and applied cold compress to left arm. Pt did not have a fever at the time of examination. Follow up information received from a CNP stated that the pts symptoms had completely resolved within one week of onset. No prescription drugs were used.
Age: 21.0
Sex: F
Vaccine: MMR, TD
Symptoms: Eye swelling, Ocular hyperaemia, Pruritus
Clinical narrative: Pt states her eye became red, swollen and itchy the next morning after receiving the vax. She returned to the Board of Health two days post vax and her eyes were still red and itchy.
Age: 20.0
Sex: F
Vaccine: MMR, TD
Symptoms: Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: One day post vax, the pt awoke with pain in her left deltoid area accompanied by redness and swelling, fever, and numbness of entire left arm.
Sex: M
Vaccine: LYME
Symptoms: Injection site pain
Clinical narrative: Subsequent to receiving the third dose of Lymerix, the pt experienced injection site soreness.  As of 09/27/2000, the outcome is unknown.
Sex: M
Vaccine: LYME
Symptoms: Infection
Clinical narrative: Subsequent to receiving first and second doses of Lymerix, the pt tested positive for Lyme disease. The pt had no symptoms. As of 10/02/2000, the outcome of the event is ongoing.
Age: 31.0
Sex: F
Vaccine: LYME
Symptoms: Feeling hot, Flushing, Nausea, Syncope, Vomiting
Clinical narrative: Approximately 3-4 hours post vax the pt felt warm and flush to the point of passing out, was nauseous and vomited (or almost vomited). As of 10/13/2000, the outcome of the events is unknown.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Injection site oedema, Pain
Clinical narrative: Subsequent to receiving one dose of Lymerix, the pt was achy for 3-4 days. This event resolved. Subsequent to receiving the second dose of Lymerix, the pt was achy for 48 hours. This adverse event resolved. Subsequent  to receiving the third dose of Lymerix, the pt experienced edema and ache in his upper left arm. This adverse event resolved. No treatment was given. As of 10/16/2000, the outcome of the events is resolved.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: Subsequent to receiving  the second dose of Lymerix the pt experienced bad reactions whenever she received a bug bite. The bite broke out and scabbed up leaving scars. A doctor visit was required and the pt was treated with lindane which didn't really help. As of 10/20/2000 the outcome of the event is ongoing.
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: Subsequent to receiving vax, the pt developed arthralgias and arthritis. As of 10/26/2000, the outcome of the events is unknown.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: On an unspecified date, the pt received a dose of Lymerix which did not go into arm. On 4/5/99 at 11:30 the pt received her third dose. 90 minutes later, she experienced severe chills, body aches, fever, fatigue and malaise. The pt went to bed. As of 9/25/00, the outcome of the events is unresolved.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: Subsequent to receiving unspecified doses of Lymerix or placebo, the pt was bitten by a tick. The bite left a red mark at the site of the bite.  As of 10/27/2000, the outcome of the event is unknown.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Subsequent to receiving the third dose of Lymerix, the pt experienced symptoms of gastroesophagal reflux disease. These did not cause hospitalization or disability. The reporter considered the event to be probably unrelated to Lymerix, and attributed the temporal relationship to coincidence. As of 11/17/2000, the outcome is ongoing.
Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Subsequent to receiving one dose of Lymerix, the pt was achy all over. The outcome is ongoing. Subsequent to receiving the second dose of Lymerix, the pt continued to feel achy all over. No treatment was given. The physician plans to administer the third Lymerix dose in November, 2000. The physician stated that he was not sure if the adverse event is related to Lymerix, due to the pts complaint of achiness prior to the first Lymerix dose given. As of 11/02/2000, the outcome of the event is ongoing.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Tendonitis
Clinical narrative: Subsequent to receiving second dose of Lymerix, the pt experienced tendinitis in the right arm. As of 11/01/2000, the outcome of the event was not completely resolved; the right arm flared with use. Subsequent to receiving the third dose of Lymerix, the pt experienced tendinitis in his elbows. No treatment was given. The reporting physician stated that the tendinitis was moderate in intensity and possibly related to Lymerix. He stated that the tendinitis could be associated with the pts occupation of landscaper. As of 12/13/2000, the outcome of the event is unknown.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: On 09/28/2000 the pt received one dose of Lymerix. On 10/12/2000 the pt had a positive pregnancy test. The pts last menstrual period was 09/07/2000; the estimated delivery date is 06/14/2001. Follow up states that the vaccinee had four previous pregnancies resulting in normal births. On 06/20/2001, at 40 weeks gestational age, the vaccinee delivered a male infant by spontaneous vaginal delivery. Birth weight was eight pounds and nine ounces. Neonatal status was recorded as "normal." His apgar scores were 8/10at one minute and 9/10 at five minutes. Mother and infant experienced "no complications" and "no problems."
Age: 16.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Synovitis
Clinical narrative: Four months subsequent to receiving the third dose of Lymerix, the pt presented with monoarticular knee synovitis. His serology at the time revealed antibodies to 93, 66, 41, 31, 30, 28 and 21 kDa antigens on IgG and 93 and 41 on IgM. The authors stated that since it was difficult for clinicians to differentiate either between either vaccine induced arthritis or Lyme arthritis in a pt, the pt was treated with a full course of doxycycline therapy. Four months later the pt was asymptomatic. It was commented by the authors that this was likely a delayed vax induced arthritis. The events of the knee synovitis and arthritis do not meet ICH serious criteria, but are being submitted as an expedite report by special FDA request.
Age: 10.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Synovitis
Clinical narrative: One month post vax the pt developed bilateral knee synovitis. Over the five ensuing months, the pt developed intermittent asymmetrical oligoarthritis of his knees, ankles, elbows and proximal interphalangeal joints at roughly monthly intervals. His serum five months post vax revealed antibodies to 93, 69, 66, 64, 54, 53, 41, 29, 31, 30, 28, 26, 25, 22 and 21 kDa antigens and none on IgM. He was also noted to carry HLA-DR4. The authors stated that since it was difficult for clinicians to differentiate between either vax induced arthritis or Lyme arthritis in a pt, the pt was treated with antibiotics. Two months later the pt was asymptomatic. It was commented by the authors that this was likely a case of delayed vax induced arthritis, although the extent of immune response suggests either current or past B, burgdorferi exposure with disease reactivation induced by the vax. The events of the knee synovitis and oligoarthritis do not meet ICH serious criteria but are being submitted as an expedite report by special FDA request.
Sex: U
Vaccine: LYME
Symptoms: Injection site erythema
Clinical narrative: At the time of dermatology consult the pt reported recent immunization with Lymerix. At some time later, the pt developed redness at the injection site.
Age: 31.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: In August, 2000 and October, 2000, the pt received first and second doses of Lymerix. The pt recently discovered that she was pregnant. The date of the last menstrual period was 10/24/2000 and the estimated delivery date is 08/01/2001. As of 11/27/2000, the outcome of the pregnancy is ongoing.
Age: 31.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: On 11/21/2000 the pt received the first dose of Lymerix. Subsequently she was found to be pregnant. The date of her last menstrual period was 10/21/2000, the date of the positive pregnancy test was 11/28/2000 and the estimated delivery date is 07/30/2001. As of 11/30/2000 the outcome of the pregnancy is ongoing. The follow-up states that on 10/13/2000, the vaccinee had an appendectomy and a ruptured ovarian cyst. On 09/14/2001, the vaccine provider stated,"We have no reports on the outcome of her possible pregnancy."
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: Subsequent to receiving the third dose of Lymerix, the pt noticed soreness in the deltoid muscle (NOS). On follow-up the reporter stated that the pt did not experience a side effect from the Lymerix, but rather had a muscle condition that was not caused by the vax. As of 12/14/2000 the outcome of the event is unknown.
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Within 24 hours post vax, the pt experienced flu-like symptoms, soreness at the injection site and a fever. She did not seek medical attention. She recovered within 48 hours.
Age: 33.0
Sex: M
Vaccine: LYME
Symptoms: Anxiety, Chest pain, Dyspnoea, Laboratory test abnormal
Clinical narrative: Less than one hour post vax, the pt experienced dyspnea and chest pain which lasted three hours and then resolved. Lymerix was discontinued. An ECG taken on 07/06/2000 showed ST elevations (NR: none). A cardiac evaluation yielded no cardiac disease. The reporting physician stated that the event could be associated with the pts anxiety disorder. As of 12/12/2000 the outcome of the event is recovered without complications.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: Case logically deleted; no indication in records provided that an SB product was administered.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Erythema, Oedema peripheral
Clinical narrative: On 8/21/00, the pt received her 4th dose of Infanrix in her right thigh. Approx. 90 minutes, post vax, she developed hives on her face, chest, axilla and buttock. This was initially thought to be heat rash, but she then developed slight breathing difficulty followed by wheezing. The pt was observed to have slightly swollen feet. Her face and arms were red and she had a "tight" cough with slight retractions. Her oxygen saturation level was 100%. She was treated with diphenhydramine and hospitalized for observation. She recovered within 8 hours and was discharged. The reporting physician stated that the anaphylactic reaction was "possibly related to any of the 3 injections given". As of 1/30/01, the outcome of the events is recovered.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria, Wheezing
Clinical narrative: On 8/21/00, the pt received her 4th dose of Infanrix in her right thigh. Approx. 90 minutes, post vax, she developed hives on her face, chest, axilla and buttock. This was initially thought to be heat rash, but she then developed slight breathing difficulty followed by wheezing. The pt was observed to have slightly swollen feet. Her face and arms were red and she had a "tight" cough with slight retractions. Her oxygen saturation level was 100%. She was treated with diphenhydramine and hospitalized for observation. She recovered within 8 hours and was discharged. The reporting physician stated that the anaphylactic reaction was "possibly related to any of the 3 injections given". As of 1/30/01, the outcome of the events is recovered.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: After having 2 injections of Lymerix vaccine, I have developed chronic joint pain. Is this the autoimmune associated arthritis theorized to be caused by the Lymerix vaccine? This joint pain has been unresponsive to physical therapy, cortisone injections, and NSAID's.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Antinuclear antibody positive, Aphasia, Disturbance in attention
Clinical narrative: Pt developed regression. Child was developing normally. Started talking and could even sing Happy Birthday and a made up song using her middle name. She sang everybody loves me. The regression was gradual until she lost all language and comprehension ability and all social behavior.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory distress
Clinical narrative: It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 12/28/00. Reportedly, on 1/20/01, the pt was admitted to the hospital with the dx of respiratory distress. The pt spent 3 days in MICU. The pt's mother states that the pt is in "fragile" health so does not go out. Pt's mother and her husband have not had the flu and neither have the nurses who visit the pt. The pt's physician feels it was the vaccine which caused this. The pt is still having some respiratory problems but is getting back to baseline.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: The same day as vax, on 5/19/99, the pt became dizzy and developed a fever, nausea, and headache. He recovered within 24 hours without treatment, The pt received his second injection of Lymerix on 6/17/99 he had no adverse experience following this injection. The pt received his third injection on 5/11/00. The next day on 5/12/00 the pt became tired and experienced pain at the injection site. The injection site pain resolved. The pt was still tired as of 1/30/01.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: The same day as vax, on 5/19/99, the pt became dizzy and developed a fever, nausea, and headache. He recovered within 24 hours without treatment, The pt received his second injection of Lymerix on 6/17/99 he had no adverse experience following this injection. The pt received his third injection on 5/11/00. The next day on 5/12/00 the pt became tired and experienced pain at the injection site. The injection site pain resolved. The pt was still tired as of 1/30/01.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: On an unspecified date, the pt received her third dose of Lymerix. Subsequently, the pt experienced arthritis versus arthralgia, reportedly. As of 1/31/01 the outcome of the event is unknown.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Anorexia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: The morning after the vax, the pt complained of dizziness with a fever of 101.5 and chills. Fatigue, loss of appetite, body aches all over. The pt remained in bed for 2-3 days, drank fluids and took Tylenol. The area is approximately 2-3 inches in diameter with redness and induration on the right deltoid area. The arm is red hot to the touch and sore. The pt has experienced lingering fatigue.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Pain, Pyrexia
Clinical narrative: The morning after the vax, the pt complained of dizziness with a fever of 101.5 and chills. Fatigue, loss of appetite, body aches all over. The pt remained in bed for 2-3 days, drank fluids and took Tylenol. The area is approximately 2-3 inches in diameter with redness and induration on the right deltoid area. The arm is red hot to the touch and sore. The pt has experienced lingering fatigue.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral, Pyrexia
Clinical narrative: The pt experienced a fever on the night of administration. Over the next several days, the left arm swelled to twice the size of the right arm. Mild cellulitis was noted at the next visit. Treated with Keflex.
Age: 56.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Pt states that subsequent to receiving first vax (03/22/2000), he experienced soreness at the injection site for 1-2 days. Approximately one month post vax, (04/28/2000), he experienced soreness at the injection for 1 day. On 11/17/2000 pt had no complaints. On 12/02/2000 pt did not have a reaction but complained of soreness at the site of the first immunization. Area red and the size of a dime accompanied by pruritus.
Age: 56.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site pain
Clinical narrative: Pt states that subsequent to receiving first vax (03/22/2000), he experienced soreness at the injection site for 1-2 days. Approximately one month post vax, (04/28/2000), he experienced soreness at the injection for 1 day. On 11/17/2000 pt had no complaints. On 12/02/2000 pt did not have a reaction but complained of soreness at the site of the first immunization. Area red and the size of a dime accompanied by pruritus.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: A pharmacist reported that a female received an injection on Influenza virus vaccine (manufacturer unknown) and subsequently experienced an anaphylactic reaction. The reporter did note that this information was "questionable" and there is no documentation of the reported event. Anaphylactic reaction is considered medically important.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Seven days post vax, the pt developed an injection site reaction characterized by a welt with itching and pain. The pt recovered.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Subsequent to receiving vax, the pt developed a 4 X 8 cm wheal. She recovered.
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: Subsequent to receiving vax, the pt developed a severe nosebleed. The pt recovered.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Subsequent to receiving vax, the pt experienced bloodshot eyes. Follow up information was received 01/29/2001 from the original reporting nurse that indicated that the patient received Flu Shield (2000-2001 Formula) on an unspecified date. No adverse events or bloodshot eyes resulted.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Subsequent to receiving vax, the pt developed flu-like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 39 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Subsequent to receiving vax, the pt developed a low-grade fever (less than 100 degrees F) and general aching that persisted for one day.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Subsequent to receiving vax, the pt developed flu like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 31 employees experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Pt reported that subsequent to receiving vax, she developed Bell's Palsy. No further information was available at the date of this report.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Subsequent to receiving vax, the pt developed a severe local injection site reaction.
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Subsequent to receiving vax, the pt developed an injection site reaction characterized by severe pain and swelling. As of 12/13/2000, the pts arm remained tender. No further information was available at the date of this report.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Arthralgia, Headache, Injection site haemorrhage, Injection site pain, Neck pain
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Anaemia, Contusion, Difficulty in walking, Dysphagia, Fatigue
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Headache, Injection site pain, Leukaemia, Memory impairment, Neck pain
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Pain, Pharyngeal oedema, Platelet count decreased, Speech disorder, Syncope
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Thinking abnormal, Tremor, Weight decreased
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Anaemia, Anorexia, Blood disorder, Chest pain, Headache
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Hypokinesia, Hypoxia, Malaise, Memory impairment, Myeloid leukaemia
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Neck pain, Oedema, Pain, Pharyngeal oedema, Platelet count decreased
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 74.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Pyrexia, Speech disorder, Tremor
Clinical narrative: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.
Age: 0.8
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: The pt had a generalized tonic/clonic seizure at home and then went to the ER. Then she had a second seizure in the ER.
Age: 33.0
Sex: M
Vaccine: TTOX
Symptoms: Respiratory arrest
Clinical narrative: The pt went into respiratory arrest within minutes of receiving a tetanus toxoid injection.
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: Hypoaesthesia
Clinical narrative: The pt developed numbness from the shoulder to the knees. Was admitted to the hospital for observation for several days.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt had full left thigh swelling, redness, induration and warmth at 48-72 hours, post vax. He was admitted to the hospital X 24 hours for IV antibiotics in case it was cellulitis.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Cerebellar ataxia, Disorientation, Dizziness, Nystagmus, Vomiting
Clinical narrative: At 07:00 on 1/18/01, pt started vomiting and seemed dizzy. Seen MD at 08:30 with disorientation and nystagmus. Sent via EMS to medical center. Dx'd with acute cerebral ataxia. Was discharged on 1/19/01.F/U altered LOC ,refusing to stand,IV started, blood drawn. Pt vomiting, dizzy, reaction to Prevanar. Pt was admitted for observation.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Feeling hot, Respiratory distress, Urticaria, Wheezing
Clinical narrative: The pt developed respiratory distress, wheezing, urticaria on the same day as vax. Skin color was red and skin was warm. Treated with epinephrine. Transferred to ER for observation and possible admission.
Age: 22.0
Sex: F
Vaccine: FLU3, RUB
Symptoms: Chest discomfort, Face oedema, Headache, Pruritus, Wheezing
Clinical narrative: Given Rubella and Flu vaccine and 1/2 hour, post vax, had a headache and itching which continued into facial swelling, chest tightness and wheezing. Returned to UHS with symptoms and was given epinephrine and Benadryl IM and sent to ER.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blood urine, Ear disorder, Infection, Irritability, Rash
Clinical narrative: The night of the vaccination, the pt experienced blood in urine, unexplained hives and rash including red dots on palms of hands, severe ear infection, fussiness, rash around mouth and diaper area. Usually is an extremely happy baby.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urticaria
Clinical narrative: The night of the vaccination, the pt experienced blood in urine, unexplained hives and rash including red dots on palms of hands, severe ear infection, fussiness, rash around mouth and diaper area. Usually is an extremely happy baby.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Apnoea, Bradycardia, Cyanosis
Clinical narrative: Within 15 seconds of 2nd vaccine the pt developed bradycardia, cyanosis, and rigid apnea, head turned right. Pt given stimulation for apnea and O2 and pulse ox monitoring. Pt regained normal state approximately 5-10 minutes later. Entire episode lasted 2-3 minutes.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Cough, Irritability, Otitis media, Pyrexia, Rhinorrhoea
Clinical narrative: Within 3 hours of vax, the pt developed irritability, low grade fever up to 100.8, rhinorrhea and cough. 2 days later he was diagnosed with otitis media and treated with Amoxicillin.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Eight days post vax, pts parent noted 2-3 small red bumps on abdomen. The next day the sitter call parent saying the pt had red bumps on the face and abdomen.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema
Clinical narrative: 3-4 hours post vax, pt awakened from nap with entire trunk and legs very red. Pt was treated with Benadryl and within 2 hours redness was gone. No swelling, fever of trouble breathing was noted.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Infection, Injection site hypersensitivity
Clinical narrative: The pt developed a mild generalized varicella as well as local varicella rash at the injection site appearing 10 days post vax.
Age: 0.7
Sex: F
Vaccine: DTAP, HBHEPB, HEP, IPV, PNC
Symptoms: Crying, Hypotonia, Staring
Clinical narrative: Mom first reported AE on 1/18/01. Evening of vax, pt developed a dozed look had been crying alot, had been limp, no longer able to sit up by herself, eyes frequently rolled back mother reports these symptoms occurred five times a day for approximately 1 min at a time for the 1st week after vax, symptoms were slowing down 1/18 on 1/19 all was normal.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass
Clinical narrative: Feb 19 1999 onset of lump in left deltoid Feb 20, 1999.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site mass, Pain
Clinical narrative: Within 30 minutes my left arm had shooting pain down to my pinky and ring finger (which went numb for several hours) and though my left shoulder. I still have a large lump and alot of pain in my shoulder and upper arm.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Staring
Clinical narrative: Within 3-5 minutes after receiving the flu vac pt started swaying legs at arms back and fourth in a spastic movement - appeared to happen more with the right leg left arm. Pt was staring down an did not report to verbal question. No hx of seizures or hearing problems pt did not remember anything that occurred. Lasted about 10 seconds
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Influenza like illness, Pharyngitis, Rhinitis
Clinical narrative: Less than 12 hours started cold/flu signs & symptoms runny nose, sore throat, cough. Less than 48 hours was in ER due to difficulty breathing. Have been ill on and off ever since (stomach flu, colds)
Age: 53.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Anorexia, Injection site erythema, Injection site oedema, Injection site pain, Nausea
Clinical narrative: Injection 11:30 -6pm soreness of arm, redness and swelling of arm from elbow to shoulder 36 hours started up inner arm into axillary. Chills, fever, lost of appetite, nausea.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Pyrexia
Clinical narrative: Injection 11:30 -6pm soreness of arm, redness and swelling of arm from elbow to shoulder 36 hours started up inner arm into axillary. Chills, fever, lost of appetite, nausea.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anorexia, Erythema, Fatigue, Headache, Oedema
Clinical narrative: 24 hours after injection - fatigue, generalized achiness, arm was red, swollen & painful. Fever, headache, chills, redness size of grapefruit, loss of appetite.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: 24 hours after injection - fatigue, generalized achiness, arm was red, swollen & painful. Fever, headache, chills, redness size of grapefruit, loss of appetite.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Left arm swelling B/W elbow and wrist 2 x normal size. Red/warm to touch. Uncomfortable, painful to touch. Family provider seen on 1/4/01. Dx reaction to immunization, question pneumonia vaccine and or tx. Resolved by 1/8/01.
Age: 38.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Generalized redness in 24 hours. Friday 1/5/01 upper arm red and very painful. Today began to subside.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest pain, Gastrointestinal disorder, Lymphadenopathy, Musculoskeletal stiffness, Nausea
Clinical narrative: 1/4 nausea and GI, 1/5 stiff neck, chest pain, swollen lymph groin, 1/6 achy, more chest pain, 1/8 severe chest pain with pleurisy. MD said maybe pneumonia vax.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pleurisy
Clinical narrative: 1/4 nausea and GI, 1/5 stiff neck, chest pain, swollen lymph groin, 1/6 achy, more chest pain, 1/8 severe chest pain with pleurisy. MD said maybe pneumonia vax.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypotension, Tinnitus
Clinical narrative: Immediately after receiving vaccine client c/o ringing in ears and lightheadedness. Had client lie down, elevated feet and used ammonia inhalant. BP consistent 94/46. Felt better in approx 10 minutes and BP 100/60 after walking around before release 1/18/2000. Client had no further problem.
Age: 33.0
Sex: F
Vaccine: FLU3, HEP, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Approximately 12 hours post vax area around puncture site became swollen, warm and red. Used warm compresses. Still a problem next morning. Exam done by MD 24 hours post injection. Dx as local reaction to vax. Arm did not improve and patient saw private MD, dx cellulitis placed on Amoxicillin. 1/11/01 Arm improved. Pt incidentally developed pneumonia in both lungs and pancreatitis in the early post vax period.
Age: 33.0
Sex: F
Vaccine: FLU3, HEP, PPV
Symptoms: Pancreatitis, Pneumonia
Clinical narrative: Approximately 12 hours post vax area around puncture site became swollen, warm and red. Used warm compresses. Still a problem next morning. Exam done by MD 24 hours post injection. Dx as local reaction to vax. Arm did not improve and patient saw private MD, dx cellulitis placed on Amoxicillin. 1/11/01 Arm improved. Pt incidentally developed pneumonia in both lungs and pancreatitis in the early post vax period.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Groin pain, Hypoaesthesia, Joint range of motion decreased, Oedema, Pain
Clinical narrative: The pt states she awoke with pain in her left axilla, left arm and left inguinal groin area. States the left arm feels numb, tingly, and swollen. It was hard to put through ROM. wonders if related to injection on left side on 1/22.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Coma, Cyanosis, Headache, Hypotonia
Clinical narrative: Pt had a reaction from her shot. Mom stated that post she dropped pt off at Daycare. The Daycare worker call her back because c/o head hurting turned blue around lips then pt went limp. It fell out of chair daycare worker caught her lowered her to the floor pt did not fully loose consciousness but she would not respond verbally or to stimuli. By the time mom got back to daycare she came back started speaking the episode lasted for 20 minutes mom immediately took her to doctor. He could not explain to mom what happen to patient. It could be possibly a reaction from the vax or something else. Mom wanted me to be aware of the episode because the literature I gave her said that a rare reaction like this one could occur.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left arm pain and swelling apporx. 8 hours after injection.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site oedema, Lymph node pain, Pain, Pyrexia
Clinical narrative: The pt experienced pain, erythema, chills, fever with axillary pain and tenderness at the lymph nodes and swelling at the site.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site abscess, Injection site erythema, Injection site mass, Pain
Clinical narrative: Same day as vax the pt experienced pain which lasted through day 4. On day 4 the pt experienced a 1-2 inch red skin with nodule or abscess deep in the tissue. Day 7-11 the pt's symptoms are resolving. No fever was noted.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Anorexia, Screaming
Clinical narrative: Subsequent to receiving vax, pt experienced crying, irritability and loss of appetite from evening of vax which lasted three days. Pt seen in ER on 01/25/2001 for persistent screaming and loss of appetite. Seen in office 01/26/2001 for irritability.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration, Skin burning sensation, Urticaria
Clinical narrative: On 1/23/01 the pt experienced redness and burning. The pt's whole arm hurt. The next day, large red whelp and hardness, but was still red. Two days later the whelp is beginning to resolve.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt experienced local redness and irritation at injection site.