chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: LYME
Symptoms: Heart rate decreased
Clinical narrative: Foggy headed (confusion), felt cold, leg pain, low pulse rate, maladministration (above recommended age), tired, weak - report 2001015290-1 described foggy headedness in a pt who rec'd Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the pt and has not been verified by a physician or other HCP. Reportedly, the pt is allergic to all narcotics and to Robaxol. Reportedly she has had arrhythmia's (NOS) for approximately 5 years which were treated with metoprolol (Toprol XL). On 5/31/01, the pt rec'd her 1st dose of Lymerix, she was above the maximum recommended age for immunization. Subsequently, on 5/31/01 she reportedly felt weak and tired. On 6/1/01, reported, she experienced extreme fatigue and felt cold to the bone. The fatigue and coldness persisted on 6/2/01, and she then experienced leg pains and a low pulse rate (50-52 beats per min) all day. She contacted her physician who reportedly feels all adverse events (were) related to vaccine. On 6/3/01, all symptoms continued and she reported that she began feeling very foggy headed. On 6/4/01, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately 2 wks after the vaccine was administered. As of 6/20/01, the adverse events had resolved. The adverse event of foggy headedness does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. The follow up states that the vaccinee was allergic to "all" narcotics, to Robaxil, and to sulfa. Her medical history included hysterectomy, upper back mass NOS, osteoporosis and plantar fasciitis. She received montelukast sodium. On 05/23/2001, the vaccinee received her first .5cc right deltoid dose of LYMErix; she was above the maximum recommended age for immunization. When seen by the physician on 05/23/2001, she complained of a sore right heel and a tick bite. She had a macular rash on the thigh and right abdomen. Impression: rule out Lyme secondary to tick. Amoxicillin three times daily for three weeks was prescribed. Subsequently, on 05/31/2001, she reportedly felt weak and tired. On 06/01/2001, she experienced extreme fatigue and felt "cold to the bone." The fatigue and coldness persisted on 06/02/2001, and she then experienced leg pains and a low pulse rate all day. She contacted her physician, who reportedly "feels all adverse events were related to vaccine." On 06/03/2001, all her symptoms continued and she reported that she began "feeling very foggy headed." On 06/04/2001, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately two weeks afterthe vaccine was administered. As of 06/20/2001, the adverse events had resolved.
Age: 61.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint swelling, Rheumatoid arthritis, Swelling
Clinical narrative: Report 2001015262-1 described RA in a pt who rec'd Lyme disease vaccine recombinant OSPA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the pt and has been verified by a physician or other HCP. The pt is allergic to penicillin. Reportedly, he has had colitis for 30 yrs, it was treated with sulfasalazine (Azulfidine). He did not have a history of Lyme disease. His brother had Crohn's disease and his grandfather had arthritis (NOS). In 8/01, the pt rec'd his 3rd dose of Lymerix. Six months later in 2/01, he reported experienced arthralgia's . He reportedly experienced pain in the shoulders traveling to the legs, hips, knees,and ankles. The pt was seen by an arthritis specialist. The pt reported that swollen shoulders, ankles, hips and knees were noted on physical exam. No warm joints were noted and no joint fluid was obtained. Unspecified lab analyses were performed. The pt reported that the specialist recently made a diagnosis of RA and does not feel the symptoms were related to Lymerix. The pt was treated with methotrexate daily (dose unk), Celecoxib (Celebrex) 200mg twice daily, and Prednisone 15mg daily. As of 6/25/01, the event was ongoing. The adverse event RA does not meet ICH serious criteria, but is being submitted as a expedited report by special FDA request per the 6/28/00 letter. The follow-up states that on 06/02/1999, 07/02/1999 and 05/31/2000, the vaccinee received his first, second, and third doses of LYMErix, respectively. On 09/12/2001, the physician stated that the MTP joints of feet were noted to be swollen on physical exam. No warm joints were noted on physical exam. No joint fluid was obtained. As of 09/12/2001, the outcome of the event was unknown. The most recent info was received from the rheumatologist on 11/14/2001. He wrote,"The pt is treated with methotrexate and prednisone for his rheumatoid arthritis which is currently well controlled. He is having no synovitis. His disease has been relatively stable recently."
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Rash
Clinical narrative: Patient developed a rash and cellulitis after receiving vax.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a pharmacist concerning children a day care who were vaccinated with varicella virus vaccine live. Subsequently, there was a chicken pox outbreak at the day care. The pharmacist reported that many of the children were vaccinated with varicella virus vaccine live from the following lot numbers prior to the outbreak (lot#6229690423E, 6122141124B,6173130769D,6179110778D,6192731357D, and 6277481059H). The records of testing prior to release of the lots were checked by Biological Quality Assurance and found to be satisfactory. The lots comply with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. Per F/U 6/18/02: There were 24 cases of chicken pox breakthrough at the day care. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Pain, Sleep disorder
Clinical narrative: The day following vax the patient developed dull ache on posterior side to underarm going to shoulder. Patient states pain level is a 2. Patient states difficulty sleeping. Treated with Tylenol, but not effective.
Age: 30.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Paraesthesia
Clinical narrative: Patient developed tingling sensation of thumb and 5th finger one hour post-vax.
Age: 30.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Infection, Paraesthesia
Clinical narrative: Patient developed tingling sensation of thumb and 5th finger one hour post-vax.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: The patient developed redness and swelling over the right shoulder the day after vax.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Cold sweat, Convulsion, Hyperhidrosis, Loss of consciousness
Clinical narrative: Post-vax patient lost consciousness for about 5-10 seconds. Patient appeared to have a partial seizure that lasted for one minute. Patient was very clammy and diaphoretic. After 10 minutes patient was semi-alert and follows simple commands. Patient more alert and oriented after 30 minutes and was transported to the hospital by EMS.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme, Pyrexia, Vomiting
Clinical narrative: About 12 days post-vax, patient developed erythema multiforme, fever and vomiting lasting 24 hours.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Dyspnoea, Nasal congestion, Pyrexia, Rash
Clinical narrative: Day after vaccination the patient woke with a rash, fever, cough and congestion. The patient was treated with Medrol PR. On 6/21/2001 the patient experienced shortness of breath and worsening of rash, fever, cough and congestion due to vaccine. The patient reported no relief from Medrol Pack.
Age: 27.0
Sex: F
Vaccine: RUB
Symptoms: Malaise, Pharyngolaryngeal pain
Clinical narrative: Patient experienced malaise, LAD and sore throat for 2 days post-vax.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Nasal congestion, Pyrexia, Rash
Clinical narrative: Patient experienced congestion, spots and a fever of 104F as reaction to having MMR.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, MMR, OPV, VARCEL
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Patient experienced scattered lesions on the upper extremities, chest and upper back. Patient had pruritus with a lesion at the corner of her mouth.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Within 15 min of vax a small wheal appeared around injection site. Then sever wheals appeared just under injection site. 24 hours later the pt developed erythema with increased warmth around site. The pt was diagnosed with allergic reaction. Treated with Benadryl
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache, myalgia and fatigue
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash vesicular
Clinical narrative: The patient experienced a vesiculo papular rash with 50-75 lesions eight days after the vaccination. The rash lasted 5 days. The patients fever was 102-103.5F daily 7, 8, and 9 days after immunization. Irritability was still present 16 days after immunization despite rash and fever resolution.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Patient developed shingles 06/05/2001.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Intussusception
Clinical narrative: The patient developed ileocolic intussusception.  The patient was treated with contrast enema and completely reduced by 6/19/2001.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dizziness, Eye movement disorder, Headache, Hypotonia, Pyrexia
Clinical narrative: The pt experienced a fever of 106, limpness, headache, dizziness, and eyes rolling. This started approximately 2 hours post vax. The 2nd episode 10 hours later and then was sent to a local hospital.
Age: 23.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rash vesicular
Clinical narrative: The pt experienced a sore throat and fever with an onset of patchy vesicular rash.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Oedema, Pain, Pruritus
Clinical narrative: The pt experienced a white bumpy rash which itched for a short time and then hurt and then started to swell and turn red, hot, the size of a silver dollar. The pt was seen by an MD who did not feel this was a reaction to the vax, feels was a bug bite reaction.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: The pt experienced a white bumpy rash which itched for a short time and then hurt and then started to swell and turn red, hot, the size of a silver dollar. The pt was seen by an MD who did not feel this was a reaction to the vax, feels was a bug bite reaction.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Anorexia, Lethargy, Pyrexia, Rash, Rash vesicular
Clinical narrative: 10-11 days post vax the pt experienced a fever for 2 days, and then severe body rash with several vesicles and extreme lethargy with anorexia for 3 days. Treated with Advil and monitoring.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Child developed shingles on left hand and arm on 5/23/01.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Depressed level of consciousness
Clinical narrative: Inconsolable crying and decreased level of alertness.
Age: 17.0
Sex: M
Vaccine: HEP, TD
Symptoms: Urticaria
Clinical narrative: The pt experienced hives to the bilateral inner forearms and palms of both hands. This occurred approximately 3 hours post vax. Treated with Benadryl, Zyrtec.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: Full blown varicella with >100 pox marks, 19 days, post vax. Had a low-grade temperature. Rx'd with Zovirax 300mg po every 6 hours X 5 days.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Diarrhoea, Headache
Clinical narrative: Reported mild headache, joint pain and diarrhea today.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Grand mal convulsion, Postictal state
Clinical narrative: Grand mal seizure for 45 seconds and 30 minutes post-ictal. First seizure. Obviously no proof of causality.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Dry throat, Dysphagia, Hypertension, Pharyngeal oedema
Clinical narrative: After 20 minutes, pt complained of dry, swelling in roof of mouth, dry throat making it difficult to swallow. BP 134/100, P-68, T-98.4F. No SOB or other difficulties breathing. Observed for a total of 45-60 minutes. No edema of roof of mouth or uvula or throat observed.
Age: 2.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt developed chickenpox (vesicles and scabs) after varicella vaccine.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Agitation, Anxiety, Malaise, Pain
Clinical narrative: Pt developed soreness in arm, agitation and anxiety attack within hours of shot. Pt otherwise calm and relaxed. Pt stated he felt "weird."
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Injection site cellulitis left arm developed 1 week after vaccine administration, requiring oral cephalexin.  Patient seen at regular intervals (06/27/2001, 06/29/2001,..)
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Feeling hot, Pruritus, Swelling, Tenderness
Clinical narrative: Left deltoid area, pain, swelling, warmth, indiration, itchiness, and tenderness
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Infection, Pruritus, Rash
Clinical narrative: Mom states that child had shots 06/22/01.  Rash appeared 06/24/2001 states rash comes and goes- child itches a lot.  Seen in clinic 06/25/01- 3pm rash noted on face and trunk - child states he itches a lot.  Seen by Dr- mom states he has an appointment in one week.
Age: 1.7
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Infection, Urticaria
Clinical narrative: 9 days after receiving varicella and mmr injections, pt had onset of hives under right arm and left groin area; these became generalized over body. no fever, taken to prompt care, given zyrtec. hives lasted 3 days.  11 days after hives appeared, pt had 8 pox, followed by spontaneous recovery.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Diarrhoea, Infection
Clinical narrative: Diarrhea - A report was received from Wyeth (8-99130-003A) regarding events in Ohio.  A territory representative reported that an infant received the first dose of Rota Shield and, later that evening, developed mild diarrhea which resolved the same evening.  Follow-up information received from the infant's mother indicated that her 4 month old son received Roth Shield, DTaP (Wyeth-Lederle), Hib (Wyeth-Lederle) and IPV (PMC France) vaccines in January 1999.  Within 24 hours, the infant developed diarrhea.  He recovered.  No additional information was provided with correspondence returned to Aventis Pasteur US on 19 Jan 2000. From follow up #2 correspondene received on 12/10/01 it was reported that the pt received the vaccinations on 1/29/99. No treatment was required. The pt recovered from this experience and is healthy. The lot numbers and the route/site info for the products were also provided. No further info is expected, this case is closed.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Colitis, Gastrointestinal disorder, Haematochezia
Clinical narrative: A Physician reports that after vaccinations in June 1999, his pt had flecks of blood in his stools. On week post immunization his stools became mucousy. Three weeks post immunization, his stools were completely mucous. The pt became irritable and crampy before passing each stool. The child was entirely breast fed. The Dr instructed the the mother to begin feeding the child with Nutramigen, but no change in stools occurred. Slimy stools persisted as of 07/19/1999. The Dr diagnosed possible colitis.
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The pt received his vaccinations on 12/09/99 and within 24 hours he developed an injection site reaction with redness, warmth and swelling. Upon internal review it is deemed necessary to amend the latest received dte for this report to read correspondence received on 11/16/01. This case is closed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: It was reported that a 5 year old female received on IPOL vaccination on 3/13/00 and that same day, the pt developed a 20mm area of redness at the site of injection. From correspondence received on 3/30/00, it was reported that the pt also received DTAP Acel-Imune (Lederle) and MMR (Merck) on 3/13/00. The pt reportedly recovered from this experience. Additional pt, vaccine and responsible physician information was also provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: On 04/13/2000 post-vax, the patient developed a local reaction of 5cm of swelling. A physician evaluated the patient. From correspondence received from Aventis Pasteur on 05/02/2000, additional patient, vaccine and responsible physician information was provided.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site atrophy, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site vesicles
Clinical narrative: Post vaccination the patient developed atrophy at the injection site. Information received 05/12/2000 states the patient's parents noticed a smooth indentation in the outer right thigh area, at or lateral to the site where the IPV was given. The site never scabbed, and remained red, swollen, blistered and tender.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site mass
Clinical narrative: Approximately one week after the vaccination the patient developed a lump at the injection site.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Abscess
Clinical narrative: On 05/10/2000 the patient developed a sterile abscess of his left thigh. The patient was treated at the hospital IND and packing, culture - sterile. On 06/12/2000 the patient developed a sterile abscess of his right thigh. The culture was lost at the lab. The patient was treated with Augmentin. Further information has been requested.
Age: 1.3
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Within 24 hours post-vax, the patient developed a local area of redness and swelling at the injection site. Further information was requested.
Age: 1.25
Sex: F
Vaccine: DTPHIB, IPV
Symptoms: Difficulty in walking, Injection site erythema, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Pt developed fever of 102-103 and an injection site reaction characterized by a large knot, redness and warmth. Pt favored left leg while walking. Reportedly, pt recovered from this experience. As of 2/14/00, no further info was available. This case is closed.
Age: 0.25
Sex: F
Vaccine: HIBV, IPV
Symptoms: Agitation, Injection site swelling, Rash
Clinical narrative: At 3:30pm the same day of the vaccination, the patient developed marked swelling at the injection site with a rash on her abdomen and unconsolable crying. The patient recovered.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: After receiving vaccination the pt developed cellulitis at the injection site.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Sometime after vaccination the pt developed a local reaction of redness and swelling as well as vomiting.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site induration, Pyrexia
Clinical narrative: The same day of vaccinations the pt developed a temperature of 101F and a hard bump at the site of the injection.
Age: 0.3
Sex: F
Vaccine: DTPHIB, IPV
Symptoms: Injection site reaction, Pyrexia, Screaming
Clinical narrative: On the same day of vaccinations the pt developed a fever of 102 to 103 degree F and an injection site reaction. The pt's mother reported that the child cried very painfully after injection was given for 1-2 hours.
Age: 0.08
Sex: U
Vaccine: HIBV, IPV
Symptoms: Agitation, Irritability
Clinical narrative: After receiving vaccinations, a6 week old pt developed persistant crying and irritability.
Sex: U
Vaccine: HIBV, IPV
Symptoms: Crying
Clinical narrative: Following the vax, the pt developed persistent crying and irritability. No specifics provided. Further information is requested.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Blindness, Child maltreatment syndrome, Contusion, Convulsion, Deafness
Clinical narrative: Information has been received from a health professional concerning a 2 month old male with a respiratory infection being treated with 10/23/00 was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant suspect therapy included poliovirus vaccine (IPOL) on 10/23/00 and diphtheria toxoid/pertussis vaccine/tetanus on 10/23/00. The pt's grandmother reported that the day after vaccination, on 10/24/00, the pt developed continuous crying and was seen in the physician's office. The pt was hospitalized on 11/23/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. The pt was discharged on 12/20/00 with a dx of shaken baby syndrome with brain damage, blindness and deafness. Pt was on a feeding tube and phenobarbital for seizures. No further information is available. Upon internal review, seizures were considered "Other Medical Events". Follow up information received on Nov 26,2001 indicated that this was not a reaction to vaccine and that it was a "shaken baby syndrome" as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice were the patient was seen.  The physician felt that continuous crying, respiratory failure, bruising around mouth, swollen tongue, brain damage, blind. deaf and seizures were not related to the therapy with hepatitis b vaccine recombinant (yeast). Upon internal review seizures were considered to be an other important medical event.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Delirium, Petechiae, Respiratory failure, Screaming, Tongue oedema
Clinical narrative: Information has been received from a health professional concerning a 2 month old male with a respiratory infection being treated with 10/23/00 was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant suspect therapy included poliovirus vaccine (IPOL) on 10/23/00 and diphtheria toxoid/pertussis vaccine/tetanus on 10/23/00. The pt's grandmother reported that the day after vaccination, on 10/24/00, the pt developed continuous crying and was seen in the physician's office. The pt was hospitalized on 11/23/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. The pt was discharged on 12/20/00 with a dx of shaken baby syndrome with brain damage, blindness and deafness. Pt was on a feeding tube and phenobarbital for seizures. No further information is available. Upon internal review, seizures were considered "Other Medical Events". Follow up information received on Nov 26,2001 indicated that this was not a reaction to vaccine and that it was a "shaken baby syndrome" as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice were the patient was seen.  The physician felt that continuous crying, respiratory failure, bruising around mouth, swollen tongue, brain damage, blind. deaf and seizures were not related to the therapy with hepatitis b vaccine recombinant (yeast). Upon internal review seizures were considered to be an other important medical event.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Blindness, Child maltreatment syndrome, Contusion, Convulsion, Crying
Clinical narrative: Information has been received from a health professional concerning a 2 month old male with a respiratory infection being treated with 10/23/00 was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant suspect therapy included poliovirus vaccine (IPOL) on 10/23/00 and diphtheria toxoid/pertussis vaccine/tetanus on 10/23/00. The pt's grandmother reported that the day after vaccination, on 10/24/00, the pt developed continuous crying and was seen in the physician's office. The pt was hospitalized on 11/23/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. The pt was discharged on 12/20/00 with a dx of shaken baby syndrome with brain damage, blindness and deafness. Pt was on a feeding tube and phenobarbital for seizures. No further information is available. Upon internal review, seizures were considered "Other Medical Events". Follow up information received on Nov 26,2001 indicated that this was not a reaction to vaccine and that it was a "shaken baby syndrome" as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice were the patient was seen.  The physician felt that continuous crying, respiratory failure, bruising around mouth, swollen tongue, brain damage, blind. deaf and seizures were not related to the therapy with hepatitis b vaccine recombinant (yeast). Upon internal review seizures were considered to be an other important medical event.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Deafness, Injury, Nervous system disorder, Petechiae, Respiratory failure
Clinical narrative: Information has been received from a health professional concerning a 2 month old male with a respiratory infection being treated with 10/23/00 was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant suspect therapy included poliovirus vaccine (IPOL) on 10/23/00 and diphtheria toxoid/pertussis vaccine/tetanus on 10/23/00. The pt's grandmother reported that the day after vaccination, on 10/24/00, the pt developed continuous crying and was seen in the physician's office. The pt was hospitalized on 11/23/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. The pt was discharged on 12/20/00 with a dx of shaken baby syndrome with brain damage, blindness and deafness. Pt was on a feeding tube and phenobarbital for seizures. No further information is available. Upon internal review, seizures were considered "Other Medical Events". Follow up information received on Nov 26,2001 indicated that this was not a reaction to vaccine and that it was a "shaken baby syndrome" as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice were the patient was seen.  The physician felt that continuous crying, respiratory failure, bruising around mouth, swollen tongue, brain damage, blind. deaf and seizures were not related to the therapy with hepatitis b vaccine recombinant (yeast). Upon internal review seizures were considered to be an other important medical event.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Tongue oedema
Clinical narrative: Information has been received from a health professional concerning a 2 month old male with a respiratory infection being treated with 10/23/00 was vaccinated with a dose of Hep-B vaccine recombinant (yeast). Concomitant suspect therapy included poliovirus vaccine (IPOL) on 10/23/00 and diphtheria toxoid/pertussis vaccine/tetanus on 10/23/00. The pt's grandmother reported that the day after vaccination, on 10/24/00, the pt developed continuous crying and was seen in the physician's office. The pt was hospitalized on 11/23/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. The pt was discharged on 12/20/00 with a dx of shaken baby syndrome with brain damage, blindness and deafness. Pt was on a feeding tube and phenobarbital for seizures. No further information is available. Upon internal review, seizures were considered "Other Medical Events". Follow up information received on Nov 26,2001 indicated that this was not a reaction to vaccine and that it was a "shaken baby syndrome" as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice were the patient was seen.  The physician felt that continuous crying, respiratory failure, bruising around mouth, swollen tongue, brain damage, blind. deaf and seizures were not related to the therapy with hepatitis b vaccine recombinant (yeast). Upon internal review seizures were considered to be an other important medical event.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hernia, Pulmonary haemorrhage, Sudden infant death syndrome
Clinical narrative: Found dead/possible SIDS. Autopsy pending. When found baby was still warm. Tried CPR to no avail. Autopsy report states final anatomic diagnoses: hemorrhges, lungs; s/p ligaton of patent ductus arteriosus; umbilical hernia, small. Death certificate states cause of death to be SIDS.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Abasia, Arthralgia, Bone disorder, Gait disturbance, Pyrexia
Clinical narrative: The week after receiving vaccine, the pt had three molars come in which coincided with joint pain in knees and hips. On day 10, 5/21/01, she couldn't stand or extend her knees. Her temperature was 101.6 which only lasted a few hours. She was seen by MD who order Advil every 5-6 hours. As of 5/29/01, she still could not bend over to pick things up, but she was able to walk with gait difficulty. It was noted that her knees and hips seem to be the only joints affected and that she was going to see the MD again on 5/30/01. Additional info received from pharmacist indicated that the pt was diagnosed with discitis upon further evaluation and MRI. It was reported that the MD feels confident that this experience was not related to the vaccination. The pt is now receiving a 6-week course of antibiotics and is "doing better." Upon internal review the pt's discitis was considered to be an other important medical event. Addtl info has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aphasia, Autism, Constipation, Diarrhoea
Clinical narrative: In March 1993, pt experienced repetitive behavior and playing without imagination. In June and July 1993 the pt experienced lack of communication. In October 1993, the pt experienced flu and vomiting. In December 1992 the pt experienced echolalic speech, lack of bowel control, and chronic soiling. The pt experienced upper respiratory tract infection in February 1994, September 1994, October 1994, November 1994, February 1995 and June 1995. In December 1994 pt experienced temperature, earache and diarrhea. In July 1995, pt experienced enteritis. The pt also experienced chronic constipation. Autism was diagnosed in 1996. The autism was considered a significant medical event. No further info is available.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Ear pain, Enteritis, Faecal incontinence, Influenza, Pyrexia
Clinical narrative: In March 1993, pt experienced repetitive behavior and playing without imagination. In June and July 1993 the pt experienced lack of communication. In October 1993, the pt experienced flu and vomiting. In December 1992 the pt experienced echolalic speech, lack of bowel control, and chronic soiling. The pt experienced upper respiratory tract infection in February 1994, September 1994, October 1994, November 1994, February 1995 and June 1995. In December 1994 pt experienced temperature, earache and diarrhea. In July 1995, pt experienced enteritis. The pt also experienced chronic constipation. Autism was diagnosed in 1996. The autism was considered a significant medical event. No further info is available.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Upper respiratory tract infection, Vomiting
Clinical narrative: In March 1993, pt experienced repetitive behavior and playing without imagination. In June and July 1993 the pt experienced lack of communication. In October 1993, the pt experienced flu and vomiting. In December 1992 the pt experienced echolalic speech, lack of bowel control, and chronic soiling. The pt experienced upper respiratory tract infection in February 1994, September 1994, October 1994, November 1994, February 1995 and June 1995. In December 1994 pt experienced temperature, earache and diarrhea. In July 1995, pt experienced enteritis. The pt also experienced chronic constipation. Autism was diagnosed in 1996. The autism was considered a significant medical event. No further info is available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: On 6/8/01, 1 day post vaccine, the pt developed redness and swelling at the injection site and was admitted to the hospital with cellulitis. The MD reported that 3 other pts had received vaccinations from the same vial w/out incident. Cultures done were positive for infection. As of 6/12/01, the pt remained hospitalized. On 6/14/01, the MD reported that there was only 1 positive blood culture (previously reported as 2) showing bacterial growth. As the growth was now identified as coagulase negative staph aureus and the concurrent WBC count was only 5.300, this was regarded as a contaminant. Therefore, there are no positive blood cultures. It was reported that the pt was discharged from the hospital and was placed on oral cephalexin (Keflex). The reporter expressed a concern with the lot #. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Addtl info has been requested. Follow-up info indicated that the pt was hospitalized from 06/08/2001 until 06/13/2001 with a discharge diagnosis of cellulitis. Subsequently the pt recovered. It was reported that the physician was not convinced that the pt's diagnosis was associated with pneumococcal vaccine 23 polyvalent. No further info is available.
Age: 0.4
Sex: M
Vaccine: DTP, HBHEPB, IPV
Symptoms: Asthma
Clinical narrative: On 7/12/99, 4 days post vaccine, the pt experienced acute asthma attack. He was hospitalized and administered standard asthma care for 9 days. He did well in the hospital and was discharged home w/out complications. The reporting investigator felt that acute asthma attack was possibly related to study therapy. No further info is available.
Age: 0.3
Sex: M
Vaccine: DTP, HBHEPB, IPV
Symptoms: Dyskinesia, Encephalopathy, Microcephaly, Myoclonus
Clinical narrative: On 4/28/00, 4 days post vaccination, pt experienced greater than 20 myoclonic jerks during the day and was hospitalized for 1 day. There was no cyanosis. It was reported that the patient had microcephalopathy and status encephalopathy. Subsequently the pt recovered. The microcephalopathy and status encephalopathy were considered significant medical events. The reporting investigator felt that the events were possibly related to study therapy. No further info is available.
Age: 1.4
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: On the evening of 3/6/01, pt developed a temperature of 104.6 and difficulty breathing.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Pruritus, Pyrexia, Rash macular, Rhinorrhoea
Clinical narrative: Red macular rash over entire body and face. No vesicles, no papules. Had pruritus and also a low-grade fever and URI symptoms, rhinorrhea. Had 1 day of fever and rash, then better. Treated with Benadryl.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Rash macular, Rhinorrhoea
Clinical narrative: Red macular rash over entire body and face. No vesicles, no papules. Had pruritus and also a low-grade fever and URI symptoms, rhinorrhea. Had 1 day of fever and rash, then better. Treated with Benadryl.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: On 6/25/01, pt had generalized tonic/clonic seizure with temperature of 102F. No other source of temperature other than recent vaccine.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Local redness, pain, low-grade fever, induration that cleared on 6/24/01.
Age: 1.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Local redness, pain, low-grade fever, induration that cleared on 6/24/01.
Age: 0.5
Sex: F
Vaccine: DTAPH, MMR, PPV, VARCEL
Symptoms: Leukocytosis, Pyrexia
Clinical narrative: Pt was taken to the ER at 1 AM the day post vax with a fever of 105. Fever lasted until that evening at 8:30 PM. Pt was treated with 2 shots of Rocephin IM.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Irritability, Pruritus, Rash papular
Clinical narrative: Child developed crops of small papules with occasional small vesicular lesions on the trunk and extremities, the day after immunizations were given. Denies any fever. Child is irritable at times, itchy. Mom reports that he is eating, drinking and playing intermittently. Pt was given Benadryl by mouth while at the clinic which he had to continue every 6 hours for the next 5-7 days on recheck. Mom advised to seek medical help at ER as needed over the weekend and at office. Otherwise, will recheck him in 4-5 days.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Somnolence
Clinical narrative: Pt developed increased sleepiness w/in hours post vax. He had no signs or symptoms of infection. Sleepiness lasted about 24 hrs.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Injection site induration, Rash
Clinical narrative: On 6/21/01 at 11:30 AM, immunizations given. "Red bumps", per mom, on back, head and neck as soon as left, post vax. Progressed to around nose and mouth with red bumps. Went to doctor about noon. On Friday, 6/22/01, red rash spread to back and tummy. Went to doctor and was given Benadryl. On 6/24/01, red rash not going away, 1/2 dollar-sized induration (proximal lvl). Gave prednisone. On 6/26/01, no signs or symptoms of red rash and no complaint of breathing problems. No SOB. Had 5mm induration (proximal lvl). No other signs, symptoms or other complaints.
Age: 0.75
Sex: M
Vaccine: DTAP, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh cellulitis at site of DTAP injection. Mother reports that normal/usual skin prep was done before injection. Clinical exam; there was an expanding area of erythema, edema, tenderness and warm to touch. Clinical dx cellulitis. Pt given oral antibiotics.
Age: 1.0
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: Pt developed fever and jerking of extremities within 24 hours post vax.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Injection site pain, Joint swelling
Clinical narrative: In September 1999, pt recvd first dose of Lymerix. Within 24 hrs post vax, he experienced soreness at the injection site. In the Spring of 2000, he began experiencing "burning" in his knee joints. He was scheduled to be seen by a healthcare professional on 6/27/01. He had not yet recvd any medical tx for the knee discomfort. As of 6/27/01, the burning sensation in the knee joints was ongoing. The outcome of the soreness at the injection site was not specified. The adverse event of "burning in the knee joints" does not meet ICH serious criteria but is being submitted as an expedited report by special FDA request. The follow-up info received on 10/11/2001 states that the physician did not confirm the injection site soreness. In May 2000, he was seen by the vaccine provider, who noted swollen and warm knee joints on physical examination. It was not specified if joint fluid was obtained. Erythrocyte sedimentation rate, measured on an unspecified date, was 1mm/hr. Antinuclear antibody titer was measured on an unspecified date; results were not available as of 10/11/2001. An unspecified Lyme test date performed was negative. The vaccie provider considered the burning pain in the knee joints to be mild in intensity and possibly related to LYMErix administration. The joint symptoms resolved in October 2001.
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain
Clinical narrative: Approximately 1 year after last Anthrax shot, pt developed soreness at injection site. Pt had soreness to the touch and when moving arm in certain directions.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Hemiparesis, Paraesthesia
Clinical narrative: Complaining of tingling and weakness in right arm and right leg X 1 week. Equal strength assessed bilaterally in all extremities. Has been taking Rabana BID (4 tsp in last week). This is a wine derivative from radishes in a foreign country.
Age: 4.8
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Bacterial infection, Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Pt's right deltoid became hot, red and swollen to size of "orange" per mother one day post vax. Pt taken to Urgent Care and MD said it looked like a cellulitis and gave her IV antibiotics to cover "staph" infection. Pt seen on Monday and was on Augmentin. The site was warm, pink, nontender and slightly edematous. MD thinks it may have been a local allergic rx. Site never was tender but did itch on 6/22. No pustule at injection site.
Age: 4.8
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Pt's right deltoid became hot, red and swollen to size of "orange" per mother one day post vax. Pt taken to Urgent Care and MD said it looked like a cellulitis and gave her IV antibiotics to cover "staph" infection. Pt seen on Monday and was on Augmentin. The site was warm, pink, nontender and slightly edematous. MD thinks it may have been a local allergic rx. Site never was tender but did itch on 6/22. No pustule at injection site.
Age: 41.0
Sex: F
Vaccine: HIBV, IPV, PPV, TD
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Vaccines given on 6/23/01. Pt states left buttock turned red with itching at site and generalized body itching 2 days post vax. Pt states that cleared up in 2 days, at which time right buttock turned red around injection site which remains pink and raised rash today on 6/29/01. Afebrile.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reaction noted on 6/15/01 as an area of swelling, redness and warmth. No treatment was given. The swelling was gone by 6/19/01. Redness (3cm diameter) was still present.
Age: 78.0
Sex: F
Vaccine: DT, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt developed a 3 cm region of induration and redness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Cough, Erythema, Swelling face, Wheezing
Clinical narrative: Child healthy. Family denied any known allergies. Pre-kindergarten physical and MMRII, DTAP, Varivax, and IPV given. Approx. 10 minutes, post vax, child became red, eyes and lips swollen, wheezing and coughing. PO Benadryl was given. BP-108/66, R-16. 911 called and EMTS took child to ER, awake, alert and able to speak.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Contusion, Cough, Crying, Fatigue, Feeling hot
Clinical narrative: Child healthy. Family denied any known allergies. Pre-kindergarten physical and MMRII, DTAP, Varivax, and IPV given. Approx. 10 minutes, post vax, child became red, eyes and lips swollen, wheezing and coughing. PO Benadryl was given. BP-108/66, R-16. 911 called and EMTS took child to ER, awake, alert and able to speak.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Musculoskeletal stiffness, Palpitations, Pruritus, Rash, Somnolence
Clinical narrative: Child healthy. Family denied any known allergies. Pre-kindergarten physical and MMRII, DTAP, Varivax, and IPV given. Approx. 10 minutes, post vax, child became red, eyes and lips swollen, wheezing and coughing. PO Benadryl was given. BP-108/66, R-16. 911 called and EMTS took child to ER, awake, alert and able to speak.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Swelling face, Wheezing
Clinical narrative: Child healthy. Family denied any known allergies. Pre-kindergarten physical and MMRII, DTAP, Varivax, and IPV given. Approx. 10 minutes, post vax, child became red, eyes and lips swollen, wheezing and coughing. PO Benadryl was given. BP-108/66, R-16. 911 called and EMTS took child to ER, awake, alert and able to speak.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: No data recorded.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Body temperature increased, Nausea, Syncope
Clinical narrative: Elevated temperature up to 102 F. Pt felt like he was going to pass out and was a little nauseous.
Age: 22.0
Sex: F
Vaccine: RAB, TD
Symptoms: Urticaria
Clinical narrative: Urticarial type rash on face, chest and back
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Chills, Erythema, Feeling hot, Lymphadenopathy, Myalgia
Clinical narrative: Pt inadvertently given Tetanus Toxoid Absorbed Purogenated vaccine that was not stored in refrigeration for 3 mos (storage requirements for this product are refrigeration at 2-8 degrees C). The pt experienced symptoms which included: chills, right arm warmth, pain, swelling and redness up to her neck, right arm lymph node swelling and severe muscle pain in leg, veins and body.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Oedema peripheral, Pain
Clinical narrative: Pt inadvertently given Tetanus Toxoid Absorbed Purogenated vaccine that was not stored in refrigeration for 3 mos (storage requirements for this product are refrigeration at 2-8 degrees C). The pt experienced symptoms which included: chills, right arm warmth, pain, swelling and redness up to her neck, right arm lymph node swelling and severe muscle pain in leg, veins and body.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Balance disorder, Coordination abnormal, Cough, Dyspnoea, Intention tremor
Clinical narrative: Pt developed ataxia after Varicella injection. Intention tremor, and worsening problems with loosing her balance. She initially had an upper respiratory tract infection with croup symptoms about 4 days prior to the onset of ataxia. Fever 102.7F, tremor
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Laboratory test abnormal, Laryngitis, Pyrexia, Upper respiratory tract infection
Clinical narrative: Pt developed ataxia after Varicella injection. Intention tremor, and worsening problems with loosing her balance. She initially had an upper respiratory tract infection with croup symptoms about 4 days prior to the onset of ataxia. Fever 102.7F, tremor
Age: 1.7
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Swelling
Clinical narrative: Pt's Mom noticed area to rt upper leg swollen when awakening on 05/25/01 in am. Pt check at health dept at 2 pm. Right leg swollen from knee to hip area-no redness or heat to area.
Age: 1.7
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt's Mom noticed area to rt upper leg swollen when awakening on 05/25/01 in am. Pt check at health dept at 2 pm. Right leg swollen from knee to hip area-no redness or heat to area.