chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.7
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Contusion, Fungal infection, Otitis media, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Ear infection and yeast infection dx'd on 3/31/02. Unexplained bruising and discoloration evident on 4/18/02. Dx'd and treated as ITP (Immune Thrombocytopenic Purpura) with platelet count of 6,000 on 4/19/02. Treated with human immunoglobin on 4/19/02 and 5/8/02 (IV). This is not considered acute until pt has had platelet count in normal range for 6 months (normal range is 150,000-400,000. Platelet destruction began right after immunizations on 3/29/02. It took 3 weeks to the day, to notice enough bruising to get him checked by a physician and have lab work done. He was hospitalized. He was also treated in another city. MD was consulted for treatment on 4/19/02 as well. The pt his still under care and treatment.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia, Urticaria
Clinical narrative: Severe urticarial rash, fever, fussy.  Follow up: Right thigh had site reaction.
Age: 1.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: 12 mo old WF received varicella vac on 08/01/02. Mom called 8/6/02 states child has rash that started on her face and spread to her neck. Mom states looks like chicken pox.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Pyrexia
Clinical narrative: L deltoid inflammation with severe fever 101 degrees, swelling and redness. Spoke with pt 7/11/02 and still has sx, no fever. Continues with redness-now to face and jaw.
Age: 4.8
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Local reaction, upper arm. Itch, swelling, erythematous rash arose 24hrs post injection site of DTaP.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Rash maculo-papular
Clinical narrative: Disseminated rash associated with vaccination; a non-specific immunological reaction, some sort of mild bacteremia conditiona nd mild generalized vaccinia. On 08/02/02, diagnosed with cellulitis due to CDC IND Vaccinia vaccination that he received 7/23/02 L arm. On 7/31/02, he developed increased swelling and redness down the arm from the site of vaccination. On Thursday 08/01/02 he noted a non-pruritic rash over the abdomen and increased pain, redness, drainage and streaking down the arm at the vaccination on Friday. He was placed empirically on Augmentin for suspected cellulitis complication due to the vaccinia vaccination. Cellulitis symptoms improved with the Augmentin therapy. Digital photos were taken of the scattered macular-papular rash over the trunk, neck, scalp, and face. Assessment: macular papular rash, etiology unclear; possible disseminated vaccinia; possible allergic reaction to Augmentin. Cellulitis of the left arm with lymphangitic spread, complicating a primary immunization with vaccinia vaccine; doubt progressive vaccinia; clinically and historicaly improved. Possible vaccinia virus exposure of his girlfrie.d Unlikely vaccinia virus exposure to his girlfriend's immunocompromised father.
Age: 4.5
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Received varivax vaccine 06/21/02. Diagnosed with varicella 5/21/02.
Age: 4.2
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Pain and swelling at site of vaccination. Tx Benadryl 12 5/5, po. 9 tid x 2-3 d, Molin 100/5 po, tid 1-2 days.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Pain and swelling at vaccination site. Benadryl 12/5 po 1/2 q tid x 2-3, Tylenol for pain/fever.
Age: 4.4
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: R thigh with erythematous, warm to touch at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: Broad, erythematous brawny edema, temp 99.2 degrees, moderately well demarcated R lateral deltoid, no fluctuance, no proximal lymphadenitis.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red skin rashes at site of vaccination.
Age: 4.5
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Rec'd 5th DTaP, 4th IPV on 07/30/02 in L ant thigh. On 07/31/02, developed some erythema and edema, then by 08/01/02-increased redness, edema. L ant high with more erythema, taut, edema, 19.5cm x 15cm. Thigh diameter more than 1.5cm over that of R. Cellulitis. Augmentin 400/5 1/1/2 tsp BID x 13d.
Age: 2.25
Sex: U
Vaccine: DTAP, FLU3, HEP
Symptoms: Autism, Blindness, Convulsion, Deafness, Drug toxicity
Clinical narrative: My daughter was given the following vaccines on 07/10/01: (1) DTaP, Tripedia, (2) Influenza, (3) hepatitis B. All these vaccines continued "Thimerosal," the very next day after the vaccines were given, my daughter had seizures. I have a detailed contemporaneous medical record that explain in detail this vaccine injury and the medical expert linked the mercury in thimerosal vaccine or causing my daughter permanent injuries. My daughter had a serious vaccine reaction that cannot be overlooked. I was informed to contact you because you monitor the safety of licensed vaccines. The attached medical report clearly reflects that the adverse event occurring after vaccination was actually caused by the vaccination. On 07/11/01, the next day after pt received the vaccines, pt began having seizures and was admitted to hospital from 07/11/01 to 07/14/01 and treated by a neurologist. It was determined that pt was having seizures diagnosed as "infantile spasms," which continued until 9/25/01 and permanently injured pt. Pt is blind in both eyes and deaf in both ears and mentally retarded caused by the infantile spasms. Diagnosis: blind, deaf, mentally retarded, autism. The dangerous mercury levels combined in all vaccines given o pt on 07/10/01 caused pt's immediate seizures the next day on 07/11/01. Pt was experiencing a normal childhood development until 07/10 & 11/2001, such drastically changed after receiving the vaccines containing Thimerosal. Pt demonstrated autistic like symptoms (infantile spasms) after receiving the injections, such infantile spasms.
Age: 2.25
Sex: U
Vaccine: DTAP, FLU3, HEP
Symptoms: Infantile spasms, Mental retardation severity unspecified
Clinical narrative: My daughter was given the following vaccines on 07/10/01: (1) DTaP, Tripedia, (2) Influenza, (3) hepatitis B. All these vaccines continued "Thimerosal," the very next day after the vaccines were given, my daughter had seizures. I have a detailed contemporaneous medical record that explain in detail this vaccine injury and the medical expert linked the mercury in thimerosal vaccine or causing my daughter permanent injuries. My daughter had a serious vaccine reaction that cannot be overlooked. I was informed to contact you because you monitor the safety of licensed vaccines. The attached medical report clearly reflects that the adverse event occurring after vaccination was actually caused by the vaccination. On 07/11/01, the next day after pt received the vaccines, pt began having seizures and was admitted to hospital from 07/11/01 to 07/14/01 and treated by a neurologist. It was determined that pt was having seizures diagnosed as "infantile spasms," which continued until 9/25/01 and permanently injured pt. Pt is blind in both eyes and deaf in both ears and mentally retarded caused by the infantile spasms. Diagnosis: blind, deaf, mentally retarded, autism. The dangerous mercury levels combined in all vaccines given o pt on 07/10/01 caused pt's immediate seizures the next day on 07/11/01. Pt was experiencing a normal childhood development until 07/10 & 11/2001, such drastically changed after receiving the vaccines containing Thimerosal. Pt demonstrated autistic like symptoms (infantile spasms) after receiving the injections, such infantile spasms.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Hypoaesthesia, Oedema, Pain
Clinical narrative: an hour or so after shot, vomiting, diarrha, then a pain in the back of my head like someone shot me, this headache has been off and on for a week and two days now, swelling in my arms and legs , chest pain, dizziness, blurred vision, disorinated, pain in my arms going from my elbows downward, numbness in the side of my face.My lips numb at times.  Pt had bad headaches for 3 weeks after the shot. Pt still have blurred vision though.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred, Vomiting
Clinical narrative: an hour or so after shot, vomiting, diarrha, then a pain in the back of my head like someone shot me, this headache has been off and on for a week and two days now, swelling in my arms and legs , chest pain, dizziness, blurred vision, disorinated, pain in my arms going from my elbows downward, numbness in the side of my face.My lips numb at times.  Pt had bad headaches for 3 weeks after the shot. Pt still have blurred vision though.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Seizure activity 24-30 hours, after immunizations. Treatment was hospitalization.
Age: 0.3
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Fever up to 102 degrees. Pt lost wt 4oz for two days.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Pt rec'd IPV, PCV and DTaP two days ago. Rash on face, papular erythematous next day. Fading but progress on trunk and back. No fevers.
Age: 1.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Blister, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 1 1/2" x 1 1/2" red and swelling at injection site with pain. Injection given 7/19/02 and her reaction 8/01/02. Started like a red bump then turned into a blister.
Age: 3.5
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Rash vesicular
Clinical narrative: 10-15 vesicles appeared on trunk and arms, 08/07/02, 8 am, Seen by us 3:30 pm 08/07/2002
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm was indurated, hot and red to touch. Shot was given with a biojector not with conventional syringe.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Tremor
Clinical narrative: Episodic whole body tremors developed within days of immunizations. Saw pediatric neurologist on 8/28/01.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion
Clinical narrative: Seizure-one month after vaccine, Mom states could have been sooner, 1st visit  for seizure was 03/26/2001, Vaccines were given 6 days-early.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Light red rash to back, arms, stomach and face, sl fever.
Age: 17.0
Sex: F
Vaccine: HEP, TD
Symptoms: Cold sweat, Dizziness, Dyspnoea, Hyperhidrosis, Oedema peripheral
Clinical narrative: Onset early am itching 07/26/02. When pt awakened states she had some red raised and non-raised areas on body resembling a rash or hives. Some with whitish tops to them. Pt notified health dept by phone. After bath states some of them turned to wheals. Discomfort all over (painful), little dizzy, swelling hands, feet, skin clammy, sweaty. Unsure if temp increased. Areas also to pubic area, little trouble breathing. PC received 1pm. Referred to ER.
Age: 17.0
Sex: F
Vaccine: HEP, TD
Symptoms: Pain, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Onset early am itching 07/26/02. When pt awakened states she had some red raised and non-raised areas on body resembling a rash or hives. Some with whitish tops to them. Pt notified health dept by phone. After bath states some of them turned to wheals. Discomfort all over (painful), little dizzy, swelling hands, feet, skin clammy, sweaty. Unsure if temp increased. Areas also to pubic area, little trouble breathing. PC received 1pm. Referred to ER.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Face felt tingling. Itching around face and neck area.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Vaccine given 11am 7/30. Mild generalized urticaria 7pm same day. NO anaphylactic symptoms. Diet same as always, no previous history of allergy or hives.
Age: 1.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Irritability, Pyrexia, Roseola
Clinical narrative: Pt developed fever and irritability immediately after vaccines. Rash developed 6 days later-consistent with roseola
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Discomfort, Erythema, Oedema
Clinical narrative: 8-8-02  Noted approximately 3" X 3" area of erythematous edema to Rt. deltoid area.  Child denies complaints of discomfort.  Encouraged parent to apply cold packs to site and monitor over weekend.  Child's mother verbalized her plan to administer OTC Tylenol and Benadryl to the child when they got home today for redness, swelling, and discomfort.  Mother to report to health center via phone on Monday 8-12-02 for follow-up.  Questions were encouraged and answered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Erythema multiforme
Clinical narrative: ON 7/29/2002 PATIENT CAME INTO OFFICE WITH SPOTTING ON BOTH LEGS,AFTER GETTING VACCINES ON 7/23/2002. DIAGNOSES WAS ERYTHEMA MULTIFORME (695.1). BOLD APPEARING ON RIGHT THIGH, FAINT APPEARING ON RIGHT LOWER LEG AND ON THE LEFT THIGH. ALSO COMPLAINTS OF BEING SICK TO STOMACH 1 DAY AFTER SHOTS FOR 24 HOURS. STATE SUPPLIED VAC.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bronchiolitis, Convulsion, Cough, Electroencephalogram abnormal, Lung disorder
Clinical narrative: At 2:30 pm on 07/10/01, patient experienced seizure activity, temperature 100 degrees F, and some coughing. Patient went to the emergency room on 07/10/01 and was hospitalized, EEG done and CXR done. CXR= PBID. Additional information received on 08/06/02 from telephone call to the vaccine provider's office, it was reported by the nurse that this patient, the second twin, died on 04/15/02. She stated that the report was sent to VAERS on both twins in July of 2001. Request for autopsy was made from the Medical examiner's office. clarification of VAERS report: Under "Recovery status", both yes and unknown were checked. She explained that infant recovered from initial adverse event, but unknown about continued seizures and death. Case linked with U200020034. Upon internal review of the report, it was deemed necessry to make amendments to the narrative section to remove the names of the health care professionals. Also amended the date of telephone contact with pediatrician's office to 8/1/02 and added quotation from telephone contact. Further info awaited. From follow-up correspondence received at manufacturer on 8/9/02 from VAERS, it was confirmed that VAERS received autopsy report for both twins. VAERS identification number is 173767. From mailed correspondence received at manufacturer on 8/22/02 from medical examiner, autopsy report was provided. Case is closed.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: At 2:30 pm on 07/10/01, patient experienced seizure activity, temperature 100 degrees F, and some coughing. Patient went to the emergency room on 07/10/01 and was hospitalized, EEG done and CXR done. CXR= PBID. Additional information received on 08/06/02 from telephone call to the vaccine provider's office, it was reported by the nurse that this patient, the second twin, died on 04/15/02. She stated that the report was sent to VAERS on both twins in July of 2001. Request for autopsy was made from the Medical examiner's office. clarification of VAERS report: Under "Recovery status", both yes and unknown were checked. She explained that infant recovered from initial adverse event, but unknown about continued seizures and death. Case linked with U200020034. Upon internal review of the report, it was deemed necessry to make amendments to the narrative section to remove the names of the health care professionals. Also amended the date of telephone contact with pediatrician's office to 8/1/02 and added quotation from telephone contact. Further info awaited. From follow-up correspondence received at manufacturer on 8/9/02 from VAERS, it was confirmed that VAERS received autopsy report for both twins. VAERS identification number is 173767. From mailed correspondence received at manufacturer on 8/22/02 from medical examiner, autopsy report was provided. Case is closed.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Pulmonary oedema, Therapeutic agent toxicity
Clinical narrative: At 2:30 pm on 07/10/01, patient experienced seizure activity, temperature 100 degrees F, and some coughing. Patient went to the emergency room on 07/10/01 and was hospitalized, EEG done and CXR done. CXR= PBID. Additional information received on 08/06/02 from telephone call to the vaccine provider's office, it was reported by the nurse that this patient, the second twin, died on 04/15/02. She stated that the report was sent to VAERS on both twins in July of 2001. Request for autopsy was made from the Medical examiner's office. clarification of VAERS report: Under "Recovery status", both yes and unknown were checked. She explained that infant recovered from initial adverse event, but unknown about continued seizures and death. Case linked with U200020034. Upon internal review of the report, it was deemed necessry to make amendments to the narrative section to remove the names of the health care professionals. Also amended the date of telephone contact with pediatrician's office to 8/1/02 and added quotation from telephone contact. Further info awaited. From follow-up correspondence received at manufacturer on 8/9/02 from VAERS, it was confirmed that VAERS received autopsy report for both twins. VAERS identification number is 173767. From mailed correspondence received at manufacturer on 8/22/02 from medical examiner, autopsy report was provided. Case is closed.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: Information has been received from a registered nurse concerning a retired 68 year old Caucasian female patient with a history of shoulder disorder who on 11/11/01 at 09:20 was vaccinated IM in the right arm with the first 0.5 mL dose of pneumococcal vaccine 23 polyvalent (lot number 640577/0995L). Concomitant vaccination on 11/11/2001 at 09:20 included the first dose of influenza virus vaccine (FLUZONE) IM in the left arm (lot number U0703AA). The patient had no illnesses at the time of vaccination. On 11/12/01 at 13:30 the patient complained of a sore spot and stated that she could not lift her arm. The patient stated that it was immobilized. The arm was not swollen or red, and there was no lump. The patient was advised to apply ice and heat. The patient was seen by her rheumatologist and a chiropractor. On 11/15/01 the patient stated that the arm was better and that she could use her arm, however, she still had some weakness. In follow up it was reported that the patient's physician thought that the patient may have also had pruritus in the arm. No further information is expected.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a retired 68 year old Caucasian female patient with a history of shoulder disorder who on 11/11/01 at 09:20 was vaccinated IM in the right arm with the first 0.5 mL dose of pneumococcal vaccine 23 polyvalent (lot number 640577/0995L). Concomitant vaccination on 11/11/2001 at 09:20 included the first dose of influenza virus vaccine (FLUZONE) IM in the left arm (lot number U0703AA). The patient had no illnesses at the time of vaccination. On 11/12/01 at 13:30 the patient complained of a sore spot and stated that she could not lift her arm. The patient stated that it was immobilized. The arm was not swollen or red, and there was no lump. The patient was advised to apply ice and heat. The patient was seen by her rheumatologist and a chiropractor. On 11/15/01 the patient stated that the arm was better and that she could use her arm, however, she still had some weakness. In follow up it was reported that the patient's physician thought that the patient may have also had pruritus in the arm. No further information is expected.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: Information has been received from a health professional concerning a 39 year old white male who on 10/17/01 at 9:00 am was vaccinated with pneumococcal vaccine 23 polyvalent in the left arm. Concomitant therapy included influenza virus vaccine (Fluzone). That evening, the patient experienced a sore left arm, stiffness, and difficulty lifting his arm. On 11/26/01, the patient reported his arm was still 'a little sore" and he still had difficulty raising his arm above his head. There was no swelling, redness or a lump noted. The patient was instructed to call back or see a physician if the problem persisted. As of 01/15/02, the patient had not called back. The patient did not seek medical attention. Additional information is not expected.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Information has been received from a health professional concerning a 39 year old white male who on 10/17/01 at 9:00 am was vaccinated with pneumococcal vaccine 23 polyvalent in the left arm. Concomitant therapy included influenza virus vaccine (Fluzone). That evening, the patient experienced a sore left arm, stiffness, and difficulty lifting his arm. On 11/26/01, the patient reported his arm was still 'a little sore" and he still had difficulty raising his arm above his head. There was no swelling, redness or a lump noted. The patient was instructed to call back or see a physician if the problem persisted. As of 01/15/02, the patient had not called back. The patient did not seek medical attention. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female patient who on 10/30/01 at 11:00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 637345/1449K) IM in the left arm and a dose of influenza virus vaccine (FLUZONE) (lot number U0600AA) IM in the right arm. On 10/31/01 at 08:00 the patient developed redness and swelling in the left arm. The patient was seen by her physician and was prescribed amoxicillin trihydrate, clavulanate potassium (AUGMENTIN) 875mg, two tablets daily for cellulitis. On 1/8/02, the cellulitis resolved. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received friom a registered nurse concerning a 51 year old female who on 10/27/01 was vaccinated with pneumococcal vaccine 23 polyvalent, IM injection  (Lot # 637345/1449K). Concurrent therapy included influenza virus vaccine (Fluzone), IM injection, with which the patient had been vaccinated in the same arm earlier that same day at a different clinic. On the evening of 10/27/01,the patient experienced redness, swelling, and pain at the injection site; she also felt a knot, and a rash appeared. The patient did not see a physician; on 11/05/01, the patient still had a "pin-size" knot , with no redness. On that date, the patient  was considered to be recovered with "no problems". The knot,rash and injection site swelling, redness, and pain were all considered to be non-serious. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Skin nodule
Clinical narrative: Information has been received friom a registered nurse concerning a 51 year old female who on 10/27/01 was vaccinated with pneumococcal vaccine 23 polyvalent, IM injection  (Lot # 637345/1449K). Concurrent therapy included influenza virus vaccine (Fluzone), IM injection, with which the patient had been vaccinated in the same arm earlier that same day at a different clinic. On the evening of 10/27/01,the patient experienced redness, swelling, and pain at the injection site; she also felt a knot, and a rash appeared. The patient did not see a physician; on 11/05/01, the patient still had a "pin-size" knot , with no redness. On that date, the patient  was considered to be recovered with "no problems". The knot,rash and injection site swelling, redness, and pain were all considered to be non-serious. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 74 yr old female who on 10/27/2001 at 0700 was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot number 637345/1449K). Concomitant vaccination the same day included a dose of influenza virus vaccine (Fluzone) (lot number U0685AA) given IM in the left arm. There was no illness at the time of vaccination. On 10/23/2001 at 0900 the pt developed a large red spot below injection site. Itchy redness spread almost to her elbow and under her arms. No swelling was noted. She applied ice all day. On 10/25/2001 the symptoms decreased. On 10/26/2001, the pt recovered. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: (onset of large red spot) was on 10/24/2001 at 9 am. ...It was reported that "most symptoms resolved" and the pt recovered on 10/26/2001. No further info is expected.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 74 yr old female who on 10/27/2001 at 0700 was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot number 637345/1449K). Concomitant vaccination the same day included a dose of influenza virus vaccine (Fluzone) (lot number U0685AA) given IM in the left arm. There was no illness at the time of vaccination. On 10/23/2001 at 0900 the pt developed a large red spot below injection site. Itchy redness spread almost to her elbow and under her arms. No swelling was noted. She applied ice all day. On 10/25/2001 the symptoms decreased. On 10/26/2001, the pt recovered. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: (onset of large red spot) was on 10/24/2001 at 9 am. ...It was reported that "most symptoms resolved" and the pt recovered on 10/26/2001. No further info is expected.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 60 year old female with no known allergies who on 1/15/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637345/1449K). There was no concomitant medication. On 1/16/02, the pt experienced significant body aches, fever and chills; which were significant enough to be of having the flu. She tested negative for influenza. Unspecified medical attention was sought. It was reported that 2 other pts (WAES 0202USA00635 and 0202USA00636) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 60 year old female with no known allergies who on 1/15/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637345/1449K). There was no concomitant medication. On 1/16/02, the pt experienced significant body aches, fever and chills; which were significant enough to be of having the flu. She tested negative for influenza. Unspecified medical attention was sought. It was reported that 2 other pts (WAES 0202USA00635 and 0202USA00636) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Joint range of motion decreased
Clinical narrative: Information has been received from a health professional concerning a 70 year old male with no known allergies who on 1/8/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637345/1449K). There was no concomitant medication. On 1/8/02, the pt experienced significant body aches, large area of erythema (at least 3" X 3"), redness, pain and "1 pt lost range of motion in the arm for 24 hours". Unspecified medical attention was sought. It was reported that 2 other pts (WAES 0202USA00633 and 0202USA00636) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: (the vaccination was) IM in the left deltoid. ..No laboratory evaluations were performed. The outcome of the pt's experience was unknown...No additional info is expected.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain
Clinical narrative: Information has been received from a health professional concerning a 70 year old male with no known allergies who on 1/8/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637345/1449K). There was no concomitant medication. On 1/8/02, the pt experienced significant body aches, large area of erythema (at least 3" X 3"), redness, pain and "1 pt lost range of motion in the arm for 24 hours". Unspecified medical attention was sought. It was reported that 2 other pts (WAES 0202USA00633 and 0202USA00636) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: (the vaccination was) IM in the left deltoid. ..No laboratory evaluations were performed. The outcome of the pt's experience was unknown...No additional info is expected.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cough, Sneezing
Clinical narrative: Information has been received from a 52 year old male with a history of lung cancer and no known allergies who "two weeks ago" (approximately 12/27/01) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy that same day included a dose of influenza virus vaccine (manuf not reported). Other concomitant therapy included levothyroxine na (Synthroid), Dilantin, Axid, and folic acid. After he was vaccinated, the pt experienced pain in the pelvic area. It was noted that the pain eventually went away. It was reported that the pt has also been experiencing cold symptoms and a stuffy nose. Unspecified medical attention was sought. No further info is available.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Nasal congestion, Pelvic pain, Pharyngitis, Rhinitis
Clinical narrative: Information has been received from a 52 year old male with a history of lung cancer and no known allergies who "two weeks ago" (approximately 12/27/01) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy that same day included a dose of influenza virus vaccine (manuf not reported). Other concomitant therapy included levothyroxine na (Synthroid), Dilantin, Axid, and folic acid. After he was vaccinated, the pt experienced pain in the pelvic area. It was noted that the pain eventually went away. It was reported that the pt has also been experiencing cold symptoms and a stuffy nose. Unspecified medical attention was sought. No further info is available.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Autism, Thrombocytopenia
Clinical narrative: Information has been received from a foreign legal firm regarding a case in litigation concerning a 30 month old female who on 12/4/00 was vaccinated with MMR II. Concomitant therapy on 12/04/00 included varicella virus vaccine live. It is alleged that on 01/16/02, unspecified initial symptoms started and that the pt "turned out to be affected by autistic syndrome and post-vaccinal thrombocytopenia due to the experimental prophylaxis vaccine P32 combined with MMR." It is further alleged that, "as documented by the evaluations conducted on the little girl," the pt suffered irreversible permanent damage. It is also alleged that the pt's parents, besides suffering existential damage, have been compelled to bear considerable medical expenses. Upon internal review the autism was considered to be an other medical event. Additional info has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male with no past medical history and no known allergies who on 6/16/95 was vaccinated with the 1st dose of MMRII (lot 0906W provided, is invalid for this product). The 2nd dose of MMRII (lot 0830 provided, is invalid for this product) was given on 6/22/98. There was no concomitant medications. Subsequently, the pt developed autism. The pt sought medical attention. Upon internal review, autism was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: On 03/04/02, the patient was diagnosed with pervasive developmental delay. Upon internal review, pervasive developmental disorder was considered to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Convulsion, Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning a 1 year old Hispanic male who on 6/12/02 was vaccinated with varicella virus vaccine live. It was reported that while hospitalized in the ICU, the child broke out with less than 5 chicken pox lesions. At the time of this report, the outcome of the chicken pox was unknown. Conflicting follow-up from an RN reported that the child required hospitalization for 11 days. Further conflicting follow-up received from an RN at a physician's office revealed that the pt was 1st seen in the practice on 3/26/02 for a 1st visit for an ear infection. At that time, there was no history of any allergies and there was no significant past medical history of problems with previous vaccinations. The child's next visit was on 6/6/02 which was a well visit and the child received vaccinations with MMRII (lot 640913/1117L), Haemophilus B conjugate vaccine + hepatitis B vaccine recombinant (yeast) (lot 637096/1173K), and varicella virus vaccine live (lot 641594/0200M). The child's next visit to the clinic was on 7/2/02, which was documented as a post hospitalization check-up. In the child's chart, it was documented that the child was in the hospital for 1 and half weeks for seizures. The child was reported to be stable at this visit and was to be followed up in 2 weeks which was a failed to show appointment. No further information was available pertaining to the hospitalization. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HEP, TD
Symptoms: Abdominal pain lower, Back pain, Blood pressure increased, Chest pain, Conversion disorder
Clinical narrative: Pt received Hep-B and TD vaccinations in right arm and 5 minutes later, pt complained of feeling headachy, dizzy, nauseous and dry mouth. There was no local reaction. Pt was not tachycardic; skin was warm and dry; BP was stable; no respiratory distress. 10-15 minutes later, pt complained of lower left abdominal pain that radiated up to the lower left chest and into the back. The doctor watched the pt for 45 minutes and his condition did not improve, so he was sent to the ER. The pt's BP went up to 150/100. They will call MD on 7/29/02 to follow-up on pt's condition. F/U received on 7/29/02: The pt was admitted to the hospital due to pt's continued complaints of previous symptoms and a new symptom: spot before the eyes. The working dx from the physicians is that the pt has had a conversion reaction. According to the pt's wife, the pt now has left-side paralysis and periods of shortness of breath, in which his heart rate also increases. His BP is 130/110. The pt was transferred to another facility for a second opinion. The pt is undergoing an evaluation that includes an MRI or Cat Scan. F/U information received 8/1/02: The pt was discharged on 7/31/02. According to the pt's wife, the pt's testing was normal and the pt's "left-side weakness was caused by a migraine equivalent from the Hep-B shot". F/U care for the pt includes occupational health at the hospital. The pt's wife stated that the pt still had left-sided weakness but was able to walk and raise his left arm above his head at discharge. The pt's medications are Imitrex, Vioxx and Folic Acid.
Age: 28.0
Sex: M
Vaccine: HEP, TD
Symptoms: Dizziness, Dry mouth, Dyspnoea, Heart rate increased, Hemiplegia
Clinical narrative: Pt received Hep-B and TD vaccinations in right arm and 5 minutes later, pt complained of feeling headachy, dizzy, nauseous and dry mouth. There was no local reaction. Pt was not tachycardic; skin was warm and dry; BP was stable; no respiratory distress. 10-15 minutes later, pt complained of lower left abdominal pain that radiated up to the lower left chest and into the back. The doctor watched the pt for 45 minutes and his condition did not improve, so he was sent to the ER. The pt's BP went up to 150/100. They will call MD on 7/29/02 to follow-up on pt's condition. F/U received on 7/29/02: The pt was admitted to the hospital due to pt's continued complaints of previous symptoms and a new symptom: spot before the eyes. The working dx from the physicians is that the pt has had a conversion reaction. According to the pt's wife, the pt now has left-side paralysis and periods of shortness of breath, in which his heart rate also increases. His BP is 130/110. The pt was transferred to another facility for a second opinion. The pt is undergoing an evaluation that includes an MRI or Cat Scan. F/U information received 8/1/02: The pt was discharged on 7/31/02. According to the pt's wife, the pt's testing was normal and the pt's "left-side weakness was caused by a migraine equivalent from the Hep-B shot". F/U care for the pt includes occupational health at the hospital. The pt's wife stated that the pt still had left-sided weakness but was able to walk and raise his left arm above his head at discharge. The pt's medications are Imitrex, Vioxx and Folic Acid.
Age: 28.0
Sex: M
Vaccine: HEP, TD
Symptoms: Migraine, Nausea, Visual disturbance
Clinical narrative: Pt received Hep-B and TD vaccinations in right arm and 5 minutes later, pt complained of feeling headachy, dizzy, nauseous and dry mouth. There was no local reaction. Pt was not tachycardic; skin was warm and dry; BP was stable; no respiratory distress. 10-15 minutes later, pt complained of lower left abdominal pain that radiated up to the lower left chest and into the back. The doctor watched the pt for 45 minutes and his condition did not improve, so he was sent to the ER. The pt's BP went up to 150/100. They will call MD on 7/29/02 to follow-up on pt's condition. F/U received on 7/29/02: The pt was admitted to the hospital due to pt's continued complaints of previous symptoms and a new symptom: spot before the eyes. The working dx from the physicians is that the pt has had a conversion reaction. According to the pt's wife, the pt now has left-side paralysis and periods of shortness of breath, in which his heart rate also increases. His BP is 130/110. The pt was transferred to another facility for a second opinion. The pt is undergoing an evaluation that includes an MRI or Cat Scan. F/U information received 8/1/02: The pt was discharged on 7/31/02. According to the pt's wife, the pt's testing was normal and the pt's "left-side weakness was caused by a migraine equivalent from the Hep-B shot". F/U care for the pt includes occupational health at the hospital. The pt's wife stated that the pt still had left-sided weakness but was able to walk and raise his left arm above his head at discharge. The pt's medications are Imitrex, Vioxx and Folic Acid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Hypersensitivity, Injection site hypersensitivity, Injection site rash, Lacrimation increased
Clinical narrative: Hive over region of immunization. Coughing, runny nose, sneezing, watery eyes, diffuse erythematous rash with pruritis. Pt given Epinepherine, Benadryl, Zyrtec, and Prednisone.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Rash erythematous, Rhinorrhoea, Sneezing
Clinical narrative: Hive over region of immunization. Coughing, runny nose, sneezing, watery eyes, diffuse erythematous rash with pruritis. Pt given Epinepherine, Benadryl, Zyrtec, and Prednisone.
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Hypotonia, Mental retardation severity unspecified
Clinical narrative: Could not control any of his body; very floppy baby. Diagnosed with Microencephaly and ataxic CP. Per 60 day follow up. Pt has not recovered. Mother reports that her son is mentally retarded as a result of the vaccination. The annual follow up received on 9/3/03 states pt is profoundly mentally retarded his condition has not changed.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Hypotonia, Neurodevelopmental disorder, Staring
Clinical narrative: Could not lift or control her head; could not focus her eyes and baby was very floppy. Diagnosed with developmental delay and genetic disorder. Follow up report received 10/29/02 states, " Mother report that her daughter is mentally retarded as a result of vaccine". The annual follow up received on 9/3/03 states pt is profoundly mentally retarded and requires 24 hrs assistance.
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Hypotonia, Neurodevelopmental disorder
Clinical narrative: At 3 months, noticed he could not lift head, could not grasp with his hands and he was very floppy baby. Diagnosed with microcephaly, seizure disorder, mental retardation and CP. follow up report received 10/29/02 "Mother report that her son is mentally retarded as a result of the vaccine". The annual follow up received on 9/3/03 states continues much the same. Profoundly mentally retarded.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Appx. 100x150mm nodule with swelling and redness by day three after vaccine. Zone was warm and tender to the touch. No other reactions. On 8/09/02, pt presents with 15cm diam. firm, non tender subcutaneous nodule in right deltoid area and another 1cm nodule in right deltoid.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth
Clinical narrative: Appx. 100x150mm nodule with swelling and redness by day three after vaccine. Zone was warm and tender to the touch. No other reactions. On 8/09/02, pt presents with 15cm diam. firm, non tender subcutaneous nodule in right deltoid area and another 1cm nodule in right deltoid.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC
Symptoms: Abscess
Clinical narrative: Developed small sterile abscess at site of Prevnar injection. Moist heat
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Oedema, Parotitis
Clinical narrative: On 6/9 mom noted swelling. Dx on 6/10- R parotitis. Rx'd with Augmentin and lemon lollipops.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Pt's mom report swelling, redness and bruising on both upper arms at injection sites, developed approximately 12 hours after imm given. Now approx. 4 1/2cm erythema with induration and bruise L upper arm, 2cm on R arm with erythema.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Convulsion, Gaze palsy, Hypotonia, Postictal state, Pyrexia
Clinical narrative: Partial complex seizure consisting of head bobbing, hypotonia and apparent respiratory arrest, associated with fever, 5 hours after a completely normal physical exam and administration of Prevnar, MMR and Hib vaccines. (two doses of Tylenol had been given.) No family history of seizures. Seen in ER, then 10 days later, by Pediatric Neurologist. The mother reports that 10 days ago, the parents noted that her head was slowly leaning to the right and her mouth was open. They also noted her eyes to be deviated up and to the right. The episode lasted a few seconds and she was limp when her father picked her up. He felt that she was not breathing and administered rescue breaths and she began to open her eyes. She was taken to ER by EMS and was sleepy and not very responsive on the way there. She vomited in the ER and had a temperature of 103F. No work-up was done and she was discharged. Clinically, the episode appears to have been a seizure, however, no treatment is recommended at this time.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Respiratory arrest, Torticollis
Clinical narrative: Partial complex seizure consisting of head bobbing, hypotonia and apparent respiratory arrest, associated with fever, 5 hours after a completely normal physical exam and administration of Prevnar, MMR and Hib vaccines. (two doses of Tylenol had been given.) No family history of seizures. Seen in ER, then 10 days later, by Pediatric Neurologist. The mother reports that 10 days ago, the parents noted that her head was slowly leaning to the right and her mouth was open. They also noted her eyes to be deviated up and to the right. The episode lasted a few seconds and she was limp when her father picked her up. He felt that she was not breathing and administered rescue breaths and she began to open her eyes. She was taken to ER by EMS and was sleepy and not very responsive on the way there. She vomited in the ER and had a temperature of 103F. No work-up was done and she was discharged. Clinically, the episode appears to have been a seizure, however, no treatment is recommended at this time.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Mom states on 8/7/02 pt developed swelling around site of injection L  area. Pt received DTaP/IPV.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had a 6cm x 5cm raised, red area over L deltoid where DTaP was given.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site mass
Clinical narrative: Shots given 8/1/02. 8/7/02 mother called to report child had "large marble size knot" to Rt leg. By records this was site of Hep B/Hib (Comvax) vaccine. Mother reports knot occurred two days post shots received and remain at present and using cold compresses at present. Advised to warm next 24 hous. PMD was notified. NO fever or redness reported. No c/o pain by child.
Age: 4.6
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Infection, Pyrexia, Rash
Clinical narrative: Rash over entire body and elevated fever. Developed chicken pox disease.
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt developed edema and erythema L thigh where vaccine was administered the day before. Rx: Beadryl, continueation of prelone syrup as previously prescribed, Keflex x 10 days.