chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an RN concerning a 31 year old female who on 4/14/01 was vaccinated with the 2nd dose of varicella virus vaccine live. Her 1st vaccination was in 10/00. Subsequently, the pt reported that she had become pregnant shortly following the 2nd dose of varicella virus vaccine live. Follow-up information was received from an RN who reported that the pt has been lost to follow-up but that shortly after she received the vaccine she indicated that she was pregnant but never returned a positive pregnancy test. Subsequently, the pt indicated that she "lost the baby" and that she did not feel it was from the vaccine. Follow-up information was received from an RN who reported that she has doubts about the validity of the report of pregnancy from this pt/employee. She stated that the employee had "issues", that despite repeated requests, the employee would not bring in proof of a positive pregnancy test or a doctor's examination. The pt is no longer employed at the facility. Due to the uncertainty of the report, the pt will be dis-enrolled from the pregnancy registry and the pregnancy will be considered unconfirmed. No further information is available.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Bradycardia, Dyspnoea, Fatigue, Loss of consciousness
Clinical narrative: Information has been received from a RN and a physician concerning an 81 year old female who was vaccinated on 04-DEC-2001 with a second dose of pneumococcal vaccine 23 polyvalent. The pt was vaccinated with the first dose of an unspecified pneumococcal vaccine about 15 years ago without incident. The second dose was given on 04-DEC-2001 at 13:20 in the office. About 12 hours later, the pt had to be seen by paramedics, but not taken to the ER due to a rash across the abdomen, bradycardia, severe itching of the hands and face, SOB and passing out. The pt was treated per "anaphylactic reaction protocol" including epinephrine and Medrol. On 05-DEC-2001 per a phone interview between the pt and the physician, the pt was fatigued but stable and "clearly turning around" with the itching resolving. Upon internal reviwe, the pt's anaphylactic reaction was considered an other medical event. Additional information has been requested. Additional information was received from the registered nurse. The patient was vaccinated with an influenza vaccine (manufacturer unknown) approximately 10 days prior to vaccination with pneumococcal vaccine 23 polyvalent. It was reported that the patient received pneumococcal vaccine 23 polyvalent in the left arm. The patient subsequently recovered from the anaphylactic reaction. Upon internal review, the patient's anaphylactic reaction was considered an other medical event. No additional information is expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a RN and a physician concerning an 81 year old female who was vaccinated on 04-DEC-2001 with a second dose of pneumococcal vaccine 23 polyvalent. The pt was vaccinated with the first dose of an unspecified pneumococcal vaccine about 15 years ago without incident. The second dose was given on 04-DEC-2001 at 13:20 in the office. About 12 hours later, the pt had to be seen by paramedics, but not taken to the ER due to a rash across the abdomen, bradycardia, severe itching of the hands and face, SOB and passing out. The pt was treated per "anaphylactic reaction protocol" including epinephrine and Medrol. On 05-DEC-2001 per a phone interview between the pt and the physician, the pt was fatigued but stable and "clearly turning around" with the itching resolving. Upon internal reviwe, the pt's anaphylactic reaction was considered an other medical event. Additional information has been requested. Additional information was received from the registered nurse. The patient was vaccinated with an influenza vaccine (manufacturer unknown) approximately 10 days prior to vaccination with pneumococcal vaccine 23 polyvalent. It was reported that the patient received pneumococcal vaccine 23 polyvalent in the left arm. The patient subsequently recovered from the anaphylactic reaction. Upon internal review, the patient's anaphylactic reaction was considered an other medical event. No additional information is expected.
Age: 0.08
Sex: M
Vaccine: DTP, HEP, HIBV, IPV, PNC
Symptoms: Cyanosis, Dyskinesia, Neonatal apnoeic attack, Pallor, Respiratory disorder
Clinical narrative: The grandmother of a 1 month old male reported that the infant received injections of Prevnar (1st dose), Hib-Titer (1st dose), DTP, poliomyelitis vaccine and Hep-B vaccine on 12/10/01. At approx. 21:00 on 12/10/01, that the pt's apnea machine alarmed, his lips "turned blue" and his body was "very" pale. His arms and legs were noted to be "jerking" and he stopped breathing. Cardiopulmonary resuscitation was performed and he was revived. He was than transported to a hospital. He reportedly has a nasogastric tube in place and has "sleep, central and obstructed apnea".
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Nephrotic syndrome
Clinical narrative: A physician reported that a 4 year old male received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine on 12/11/00, when he was 3 years old. On 11/5/01, he was admitted to the hospital to rule out appendicitis. On 11/6/01, he went to the OR for presumed perforated appendicitis but his appendix was normal. He was found to have "a lot of pus" in his abdomen. A swab was sent for culture. Lab data revealed a negative culture. The child was subsequently given a dx of nephrotic syndrome. No additional information was available as of the date of this report.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Dysarthria, Hypoaesthesia, Muscular weakness, Ophthalmoplegia
Clinical narrative: It was reported that a 26 year old male pt received a dose of Fluzone SV '01-'02 on 12/6/01 at noon. The dose was given in his right deltoid. The pt has been previously immunized with influenza vaccine once prior (2 years ago). At approx. 21:00, on 12/6/01, he began to feel numbness in his face and he could not shut his eye and had difficulty moving his facial muscles on one side. The pt was evaluated by an MD on 12/7/01. No dx as of yet. The pt now has slurred speech and is planning to see another physician for a second opinion.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated
Clinical narrative: On 13-NOV-2001, the pt received a Fluvirin injection IM on the left deltoid muscle. On the morning of the next day, the pt experienced an asthma attack on 15-NOV-2001. The reporter provided no information on the inpatient therapy regimen. The pt was discharged from hospital on 19-NOV-2001 and has recovered. The reporter assessed the relationship of study medication to the event as possible. Also stated event may have contributed to by the pt's medical history.
Age: 0.2
Sex: F
Vaccine: DTAP, HBPV, IPV
Symptoms: Cough, Pyrexia, Rhinitis, Vomiting
Clinical narrative: Admitted to Med Center 10/12/2001 with temp 101 at home, runny nose, congestion, cough, vomiting, no diarrhea. Diagnosed with febrile illness.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: The pt developed severe auto-immune arthritis with chronic pain.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Injection site reaction
Clinical narrative: Pt received flu vaccine on 12/14/2001. Now with erythema and blistering 1.5 cm by 1.5 cm at injection site.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Several days post injection bilateral hip aches down legs, getting better.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Oedema, Pain, Rash maculo-papular
Clinical narrative: After injection, approximately 6 hours, left deltoid began hurting, then turned red and swollen at site, raised 1/4", not hard, centered, it stayed about 18 hours. Client did not apply ice or any treatment, thereafter it went away without difficulty.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Parasthesias left arm post flu shot.
Age: 34.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Pain, Pharyngitis, Pyrexia
Clinical narrative: Sore arm and throat, feverish feeling 30-45 minutes after immunizations. Temperature 100 F. No cough, no dysnea, no paresthesias and no pint swelling.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Joint range of motion decreased, Oedema, Pain
Clinical narrative: Patient complained of redness and swelling at site extending to elbow. Patient received injection in right arm. Pt stated he can hardly bend his arm and it is painful. Symptoms began the same evening of receiving the injection. Instructed pt when he reported symptoms on 12/14/2001 to apply warm compresses to arm and take Tylenol or Motrin for pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hyperhidrosis, Malaise, Pain, Pharyngitis
Clinical narrative: Vaccine administered 11/19/2001. Symptoms began 11/20/2001; achy, feeling of "coming down with something." Head cold symptoms for 2 days, weakness and pain in all four extremities for 7 days, frequent, spontaneous sweats; minor sore throat and difficulty breathing. Sweats, SOB still present on 12/07.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinitis
Clinical narrative: Vaccine administered 11/19/2001. Symptoms began 11/20/2001; achy, feeling of "coming down with something." Head cold symptoms for 2 days, weakness and pain in all four extremities for 7 days, frequent, spontaneous sweats; minor sore throat and difficulty breathing. Sweats, SOB still present on 12/07.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Nausea, Oedema, Pain, Pyrexia
Clinical narrative: Fever 102, nausea, swollen arm/shoulder for 3 days, chills and shoulder/arm sore for 3 days.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pyrexia
Clinical narrative: At 1:30 PM pt was weak and feverish. At 2:30 PM pt took Tylenol and went to sleep. Did not take temperature. At 5 PM felt fine.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: VZV given 09/24/2001. Shingles rash develop early December 2001. Seen 12/07/2001.
Age: 1.8
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Urticaria began on leg opposite to injection site. No wheezing. Treatment: Beandryl.
Age: 1.25
Sex: F
Vaccine: HBPV, MMR, PNC
Symptoms: Cough, Crying, Injection site hypersensitivity, Pyrexia, Rhinitis
Clinical narrative: Fever up to 104 12/14/2001 to present. Redness at site (3/4" diameter ring around it) right thigh. Redness gone 3 days later. Clear runny nose and cough. Moaned and cried sine immunization given; tired. Advised to give Advil 3 times a day for 3 days and report any streaking. APAP, too. Increase fluids.
Age: 1.25
Sex: F
Vaccine: HBPV, MMR, PNC
Symptoms: Screaming
Clinical narrative: Fever up to 104 12/14/2001 to present. Redness at site (3/4" diameter ring around it) right thigh. Redness gone 3 days later. Clear runny nose and cough. Moaned and cried sine immunization given; tired. Advised to give Advil 3 times a day for 3 days and report any streaking. APAP, too. Increase fluids.
Age: 35.0
Sex: M
Vaccine: LYME
Symptoms: Injection site hypersensitivity, Pruritus
Clinical narrative: Three to four inch wide by three to four inch long redness, itchy area. Noted 2 weeks after injection and lasted 2 days. Used cortizone cream, went away.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability, Oedema, Rash
Clinical narrative: A few hours post vaccine child became irritable and developed lacy edematous rash to forehead.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Lymphangitis
Clinical narrative: The pt developed redness and tenderness surrounding the vaccinia (primary rxn) vaccination site with lymphangitis spread to the axilla. Treated with 5 days of Levaquin 500mg/day.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The pt developed a tender, red, swollen and warm area around the site of the vaccinia vaccination; treated with Levaquin 500mg day X 5 days.
Age: 47.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The pt developed a 2cm tender, red and warm area around the site of the vaccinia vaccination; treated with Augmentin 875mg BID X 5 days.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphangitis
Clinical narrative: The pt developed pain, localized swelling and redness at the site of primary reaction to the vaccinia vaccine with lymphangitis that spread to axilla; treated with 5 days of Tequin 400mg/day.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The pt developed a swollen, tender and red area around the site of the injection radiating to the elbow; treated with Augmentin 875mg BID X 10 days.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphangitis
Clinical narrative: The pt developed red, tender and swelling (primary rxn) around the site of the vaccinia vaccination with lymphangitis; treated with Tequen 400mg X 5 days.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The pt developed a 4cm area of warm, tender, red and swelling around the site of the vaccinia vaccine. It was treated with Levaquin 500mg X 5 days.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The pt developed a 6cm red, warm and tender area around the site of the vaccinia vaccination; treated with 5 days of Levaquin 500mg.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Lymphangitis
Clinical narrative: The pt developed tenderness and redness on a 2cm area around the site of the vaccinia vaccination with lymphangitis distally; treated with Levaquin 500mg a day X 5 days.
Age: 30.0
Sex: F
Vaccine: HEP, SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The pt developed a 2" area of tenderness that was red and swollen around the site of the vaccinia vaccination; treated with Cipro 500mg BID X 5 days.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Lymphangitis
Clinical narrative: The pt developed localized tenderness and redness over the site of vaccinia vaccination with lymphangitis to axilla; treated with 5 days of Augmentin, 875mg BID.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The pt developed a red, swollen, tender and warm area over the site of vaccinia vaccination with drainage from primary site and 1 1/2cm tender left arm in the left axilla; treated with Ceftin 250mg BID X 5 days.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphangitis
Clinical narrative: The pt developed a 4cm red, swollen and tender area around the site of vaccinia vaccination with lymphangitis to axilla; treated with Tequin 400mg X 7 days.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The pt developed a 3" warm, red, tender and swollen area over the site of vaccinia vaccination. Treated with Ceftin 250mg BID X 5 days.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Headache, Influenza like illness, Injection site erythema
Clinical narrative: A 30 year old male with a history of 2 or 3 smallpox immunizations during childhood and "no takes" was vaccinated on 11/5/01 (signed in to clinic at 08:45, 19th pt of the day). Past medical history remarkable for 2 previous episodes of cellulitis following fairly minor skin trauma. On day 2, post vax, he developed a fever (99.0F-102.7F per vaccine adverse event card) which persisted until day 12. Also noted malaise, headache and chills. Nurse's note on day 5 describes above, plus "vaccinoid" response. Employee phoned clinic on 11/15/01 complaining of flu-like illness and temperature to 103.7F in the past 24 hours. When seen at the clinic that afternoon, he was noted to have a temperature of 100.6F and tachycardia. A 1.5cm scab c/w primary vaccine response was noted, with 8cm X 10cm area of surrounding erythema and induration. No drainage or lymphangitic streaking were noted. Site was unroofed with sterile needle and small amount of serous drainage was collected on sterile swab (culturette). Bacterial culture showed no growth. Employee was treated for presumed cellulitis with Rocephin, 1gm IM, plus cephalexin 500mg BID. Upon recheck the following AM, pt was afebrile and tachycardic and induration at site had resolved without any change in area of redness. Contact on 11/17/01 and 11/18/01 by phone revealed no further report of fever and continued resolution of soreness and redness. Recheck on 11/19/01 revealed well-scabbed primary reaction without surrounding inflammation. Temperature was 98.2F and pulse was 68. No complaints since that time. Clinical dx: probable cellulitis plus vigorous primary response to vaccine.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site induration, Malaise, Monocytosis, Pyrexia, Tachycardia
Clinical narrative: A 30 year old male with a history of 2 or 3 smallpox immunizations during childhood and "no takes" was vaccinated on 11/5/01 (signed in to clinic at 08:45, 19th pt of the day). Past medical history remarkable for 2 previous episodes of cellulitis following fairly minor skin trauma. On day 2, post vax, he developed a fever (99.0F-102.7F per vaccine adverse event card) which persisted until day 12. Also noted malaise, headache and chills. Nurse's note on day 5 describes above, plus "vaccinoid" response. Employee phoned clinic on 11/15/01 complaining of flu-like illness and temperature to 103.7F in the past 24 hours. When seen at the clinic that afternoon, he was noted to have a temperature of 100.6F and tachycardia. A 1.5cm scab c/w primary vaccine response was noted, with 8cm X 10cm area of surrounding erythema and induration. No drainage or lymphangitic streaking were noted. Site was unroofed with sterile needle and small amount of serous drainage was collected on sterile swab (culturette). Bacterial culture showed no growth. Employee was treated for presumed cellulitis with Rocephin, 1gm IM, plus cephalexin 500mg BID. Upon recheck the following AM, pt was afebrile and tachycardic and induration at site had resolved without any change in area of redness. Contact on 11/17/01 and 11/18/01 by phone revealed no further report of fever and continued resolution of soreness and redness. Recheck on 11/19/01 revealed well-scabbed primary reaction without surrounding inflammation. Temperature was 98.2F and pulse was 68. No complaints since that time. Clinical dx: probable cellulitis plus vigorous primary response to vaccine.
Age: 47.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Pain, Rash pustular
Clinical narrative: A 47 year old male vaccinated on 11/5/01 (signed in to clinic at 08:40, 17th pt of the day). Recheck on 11/13/01 revealed 1.5cm scabbing pustule with 14cm surrounding erythema and tenderness of left axilla. The nurse noted 'obvious reaction to tape'. Recheck on 11/14/01 revealed same area of erythema, no fever. (No central clearing in area of gauze, as would be typical for simple tape reaction). Pt empirically started on cephalexin 500mg BID. Next day, erythema noted to be much improved and the pt stated that he was feeling better. On 11/20/01, sent e-mail stating "Rash is almost gone. No further problems". Clinical dx: possible cellulitis, r/o vigorous primary response to vaccine.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Injection site erythema, Lymphadenopathy
Clinical narrative: A 44 year old male vaccinated at 14:00 on 11/6/01 (do not know which vaccine vial used, but presumed to be same as 11/5). On 11/15/01 recheck revealed primary response along with 4cm area of redness extending down medial arm from vaccine site. Recheck on 11/16/01 revealed only faint redness of medial arm in area previously described, 5-6 erythematous "rays" noted extending from vaccine site in all quadrants. Pt was afebrile and site was not tender. Because of previous 3 cases of presumed cellulitis among 11/5/01 and 11/6/01 vaccinees, the pt was treated with cephalexin as a precaution. Recheck of site on 11/19/01 revealed afebrile pt with no real change in appearance of site. On 11/20/01, e-mail from pt stated that scab had fallen off, "all is looking fine" and no other problems. Clinical dx: probable lymphangitic response to vaccine, r/o early cellulitis.
Age: 50.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Lymphoedema
Clinical narrative: A 50 year old female vaccinated at 14:15 on 10/29/01, using reconstituted that morning with preservative-free diluent (vaccine lot 4008284, diluent lot 040601). On 11/15/01 recheck revealed primary response with crusting scab and 3cm surrounding induration. Redness noted in areas in contact with tape and pt was switched to paper tape for dressing changes. On 11/6/01 recheck revealed 3" (about 7.5cm) redness and induration surrounding vaccine site. Fullness of axilla on the same side as vaccine site was noted without palpable node. The pt was empirically begun on Augmentin, 250mg TID and redness and induration noted to be "mostly gone" by the nurse who rechecked pt on 11/9/01. Clinical dx: 'possible secondary infection of vaccine site, vs late reaction to vaccine components'.
Age: 47.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: A 47 year old male was vaccinated at 10:45 on 11/6/01. On 11/13/01 recheck, noted to be c/w primary response. On 11/15/01 recheck because of "increased redness, swelling and tenderness of site that revealed 1.5cm primary response with 3" X 4" surrounding erythema and induration with sharply defined borders. Temperature noted to be 99.1F. Pt empirically begun on cephalexin 500mg BID. Recheck on 11/16/01 revealed a temperature of 97.8F and 1.5cm scab surrounded by 1.25-1.5cm of induration with faint erythematous border. Border was not sharply defined at this point. On 11/19/01 recheck, reveal "trace scattered induration at margin of primary response" with "very faint scattered erythema mostly distal to primary response site". Clinical dx: probable cellulitis, r/o vigorous primary response to vaccine.
Age: 47.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site swelling
Clinical narrative: A 47 year old male was vaccinated at 10:45 on 11/6/01. On 11/13/01 recheck, noted to be c/w primary response. On 11/15/01 recheck because of "increased redness, swelling and tenderness of site that revealed 1.5cm primary response with 3" X 4" surrounding erythema and induration with sharply defined borders. Temperature noted to be 99.1F. Pt empirically begun on cephalexin 500mg BID. Recheck on 11/16/01 revealed a temperature of 97.8F and 1.5cm scab surrounded by 1.25-1.5cm of induration with faint erythematous border. Border was not sharply defined at this point. On 11/19/01 recheck, reveal "trace scattered induration at margin of primary response" with "very faint scattered erythema mostly distal to primary response site". Clinical dx: probable cellulitis, r/o vigorous primary response to vaccine.
Age: 1.25
Sex: M
Vaccine: MMR, PNC
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site swelling, Lacrimation increased
Clinical narrative: 12/11/01, healthy, immunizations given. 12/12/01, red raised and tender area at the site of right thigh of 4cm in diameter. 12/13/01, temperature 102.9F (ax) at night. 12/14/01, redness gone, temperature 103.6F (ax), increasing cough, watery eyes and runny nose. 12/15/01, seen in office and was given Advil, fluids and observed. 12/17/01, watery eyes, runny nose, temperature 99.2F (ax) and decreased cough. Taking fluids well.
Age: 1.25
Sex: M
Vaccine: MMR, PNC
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: 12/11/01, healthy, immunizations given. 12/12/01, red raised and tender area at the site of right thigh of 4cm in diameter. 12/13/01, temperature 102.9F (ax) at night. 12/14/01, redness gone, temperature 103.6F (ax), increasing cough, watery eyes and runny nose. 12/15/01, seen in office and was given Advil, fluids and observed. 12/17/01, watery eyes, runny nose, temperature 99.2F (ax) and decreased cough. Taking fluids well.
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hypertonia, Hypotonia
Clinical narrative: 2 hours, post vax, the pt developed 3 episodes of clonic movement of the right arm and right leg X 15 seconds with 5 minute spacing between episodes. No loss of consciousness. He seemed normal 20 minutes later. Exam done within 24 hours. No focal deficits. Neurologist's exam was normal.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: The pt developed hives, erythema and itching within 30 minutes of receiving MMR. He was given Benadryl 12.5mg and symptoms improved.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Lymphadenopathy, Pain, Pyrexia, Rash
Clinical narrative: The pt states that she developed chills and fever and her left arm and lymph nodes under her left arm became very sore and aching as well as into back, approx. 12 hours post vax. She had a light facial rash, 24 hours post vax, that faded quickly. No reaction at the injection site.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash macular
Clinical narrative: Left lateral thigh with 6" diameter erythemic, macular, swollen area and tender to touch. Treated with Atarax, Motrin and compresses.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 20 minutes of vaccine administration, the pt had hives on neck, trunk, groin and thighs with a feeling of itching in mouth as well. He saw his provider within 60-90 minutes of 1st symptoms. He was given Zyrtec po.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Infection, Proctitis, Pruritus
Clinical narrative: The pt developed varicella lesions on 12/4/01. Treatment on 12/6/01 with Zovirax 2 1/2 tsp qid X 5 days. Also had strep proctitis on 12/6/01. Atarax prescribed for itching. He will recover.
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: The area around the injection site was warm, indurated and erythematous (15cm X 13cm and 4cm X 3.5cm).
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: The pt developed a rash on her torso, arms and legs. She had the shot at approx. 14:30 and the rash and itching started approx. 20:00. Went to the doctor and said it could be related to sulfa antibiotic taken the previous week and was referred to an allergist.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Headache, Hyperhidrosis, Muscular weakness
Clinical narrative: The pt developed chills, muscle aches, headache, stomach pain and fever which started 18 hours, post vax, and lasted about 3 days. Then she had a lot of sweating. She relapsed on 11/26/01 and had similar symptoms with joint pain and weakening in muscles.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: The pt developed chills, muscle aches, headache, stomach pain and fever which started 18 hours, post vax, and lasted about 3 days. Then she had a lot of sweating. She relapsed on 11/26/01 and had similar symptoms with joint pain and weakening in muscles.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Irritability, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: The pt developed a temperature of 103.4F and irritable. He had URI symptoms X 2 days.
Age: 0.8
Sex: F
Vaccine: IPV
Symptoms: Hypotonia, Pyrexia
Clinical narrative: The pt was limp and had a temperature of 103F which started on 11/21/01. Mom says "there's chickenpox in our family right now too. I called the MD and the receptionist said to give her ibuprofen." Mom was advised by the RN to see her MD or go to ER. On 11/26/01, the mom stated "the child was seen in ER and given Benadryl. She ran a fever for 2 days, but is fine now".
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Rash, Tongue discolouration
Clinical narrative: The child's father reported a fine rash and white spots on his tongue and itching of skin rash.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR
Symptoms: Agitation, Erythema, Urticaria, Vomiting
Clinical narrative: The pt's face was red, he was very agitated, vomiting with hives on face and legs. He was given Epinephrine 1:1000, Benadryl 25mg q 6 hours X 48 hours and Advil 1 tsp po now and q 6 hours. Improvement was seen right away.
Age: 2.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Herpes zoster, Infection, Pruritus
Clinical narrative: The pt developed a rash (papular pustules), initially tender then itchy, only on 1 dermatome. Symptoms are only compatible with dx of shingles (Herpes Zoster) after varivax.
Age: 0.3
Sex: F
Vaccine: UNK
Symptoms: Rash papular, Sleep disorder
Clinical narrative: Post vax, the pt couldn't sleep well and had a papular rash on her upper chest, neck and into her scalp.
Age: 0.3
Sex: M
Vaccine: UNK
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: The pt developed a "fibrous tissue (lump) on anterior thigh, secondary to immunization. Received immunizations 1 month prior to ER visit.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: The pt had 5-10 lesions and a low temperature X 1-2 days.
Age: 0.2
Sex: M
Vaccine: UNK
Symptoms: Irritability, Oral intake reduced, Vomiting
Clinical narrative: The pt was fussy, vomiting, not eating well and crying.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Irritability
Clinical narrative: The pt was fussy and irritable.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Rash
Clinical narrative: Rash on scalp, face, trunk, upper extremeties,two days after immunization. No other symptoms reported.
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a female pt who on 01-SEP-2001 was vaccinated with varicella virus vaccine live. The physician reported the pt scheduled an OB appointment "because the pt believed that she was pregnant as she was apparently ovulating at the time she received the vaccination". No adverse experiences were reported. No further detail were provided. Follow up information provided indicated the date of the pt's last menstrual period was 20-AUG-2001 and the estimated date of delivery was 27-MAY-2002. The pt had a diagnostic ultrasound which showed and IUP of 8.5 weeks, no fetal motion and diagnosed as a missed abortion. The pregnancy outcome was a spontaneous abortion at 12 3/7 weeks from the pt's LMP. the pt did not have any illnesses, infections nor was she taking any prescription drugs. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Encephalitis, Neurodevelopmental disorder
Clinical narrative: Information has been received from a physician for a case in litigation concerning a 7 year old male who in approximately 1998 was vaccinated with MMR II, also referred to as the "triple measles vaccine" by the physician. The pt presented with a history of recent psychomotor retardation without any associated history or signs of an infectious or neoplastic process. Investigation concluded that the etiology lay in a subacute sclerosing panencephalitic process attributable to the MMR II. The pt manifested no allergies to egg protein and his immediate post vaccination course had been uneventful. There had been no evidence of measles prior to the vaccination and his psychomotor development had been normal until the onset of symptoms. Subsequently, in approximately August 2001 the pt died.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Irritability, Skin ulcer
Clinical narrative: Information has been received from an RN concerning her 12 month old son with developmental delay, microcephaly (not cerebral palsy), seizure and cognitive disturbance (unable to communicate verbally) who in approx. 2/99, was vaccinated with varicella virus vaccine live. On approx. 11/21/01, the pt developed seizures which were worse than usual. On approx. 11/23/01, the child became cranky, crabby and miserable. His mother noted "mosquito-bite" like lesions in his diaper area. The mother called her physician who at that time did not consider the lesions to be chickenpox because blisters did not appear. The child was unable to sleep that night and the next day, the child developed blisters, some of which were "blistery". The blisters appeared on his left upper thigh and leg (approx. 10), trunk between the abdomen and chest (4 to 5), neck (2) and ear (1). The mother reported that she felt that the blisters were mild and she was able to count the lesions. The mother also reported that approx. 3-4 weeks prior to the appearance of the blisters, she received a letter indicating that someone in her child's school had developed chickenpox. Her son had not had direct contact with the person in question. The child was treated with acetaminophen (Tylenol) "around the clock" and did not develop a fever at any time. The child recovered from "his experience". The RN also reported that her other son developed chickenpox while on therapy with varicella virus vaccine live (WAES0112USA01812). Additional information has been requested. Follow up info from a physician indicated that the child "did not have any reaction to the vaccine." The report was only filed because in December 2001 the child developed varicella infection despite having had the vaccine. Upon internal review the seizures were considered an other important medical event (OMIC). The registered nurse also reported that her other son developed chickenpox after receiving varicella virus vaccine live (WAES0112USA01812).
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Cough, Diarrhoea, Disturbance in attention
Clinical narrative: Information has been received from a physician concerning a 44 year old white female RN with depression, periorbital darkening, "hereditary" tremor, "bursitis" of the left knee and allergies to morphine, droperidol and butorphanol (Stadol) and a history of asthma "that occurred mostly during childhood", hysterectomy, oophorectomy and vaccination with an unspecified hepatitis vaccine, who on 8/24/01 was vaccinated with a 4th dose of Hep-B vaccine recombinant (yeast) in the left deltoid (lot 639853/0672L). The physician reported that the pt was a new employee to the hospital who indicated that she received an "unknown" hepatitis vaccine when it first came out approx. "10-15 years ago". The pt had antibody titers drawn which were "negative". She was then advised to received the Hep-B vaccine series. On 8/24/01, within 5-10 minutes of receiving the vaccine, she began experiencing multiple organ symptoms. On 8/24/01, the pt experienced general sense of warmth, sweating, pain and swelling at the site of injection, diaphoresis and numbness of the affected arm. She complained of difficulty swallowing but not of difficulty breathing. She felt dizzy and nauseous but did not vomit. She was treated with Benadryl and IV steroids in the ER. She had no respiratory symptoms. Most of her symptoms were subjective and not objective. She received a 1 week course of prednisone. On 8/27/01, the pt felt drowsy and fatigued like she was coming down with the flu and "felt mentally not connected". On 9/4/01, the pt developed diarrhea, vomited once, felt tired, felt like her "thyroid zone" was swollen and her throat felt scratchy. She became out of breath when climbing up stairs. The physician reported that the rheumatoid factor was elevated to 10 times the normal level. The pt was referred to a rheumatologist. On 10/4/01, the pt had a constant global headache and crampy abdominal pain with watery diarrhea. The pt was fatigued and dyspneic with a non-productive cough, watery nasal discharge and sore throat. The injection site was still tender and swollen but not red. The pt had general myalgias, arthralgias, sweating, neurasthenia and a poor appetite. The physician confirmed that the pt's symptoms went on for at least several weeks and she was out of work for a while. The pt had returned to work on "light duty". The physician reported that as of 12/6/01, the pt had no improvement on extended course of prednisone in high dose and she had not recovered. The physician felt her symptoms were not vaccine related. The pt's positive rheumatoid factor, abdominal pain, decreased appetite, headache, diarrhea, diaphoresis, dysphagia, increased erythrocyte sed rate, dyspnea, influenza-like disease, injection site reaction, decreased mental acuity, vomiting, swelling, nausea, neurosis and hypesthesia were disabling. No additional information is expected.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dysphagia, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Information has been received from a physician concerning a 44 year old white female RN with depression, periorbital darkening, "hereditary" tremor, "bursitis" of the left knee and allergies to morphine, droperidol and butorphanol (Stadol) and a history of asthma "that occurred mostly during childhood", hysterectomy, oophorectomy and vaccination with an unspecified hepatitis vaccine, who on 8/24/01 was vaccinated with a 4th dose of Hep-B vaccine recombinant (yeast) in the left deltoid (lot 639853/0672L). The physician reported that the pt was a new employee to the hospital who indicated that she received an "unknown" hepatitis vaccine when it first came out approx. "10-15 years ago". The pt had antibody titers drawn which were "negative". She was then advised to received the Hep-B vaccine series. On 8/24/01, within 5-10 minutes of receiving the vaccine, she began experiencing multiple organ symptoms. On 8/24/01, the pt experienced general sense of warmth, sweating, pain and swelling at the site of injection, diaphoresis and numbness of the affected arm. She complained of difficulty swallowing but not of difficulty breathing. She felt dizzy and nauseous but did not vomit. She was treated with Benadryl and IV steroids in the ER. She had no respiratory symptoms. Most of her symptoms were subjective and not objective. She received a 1 week course of prednisone. On 8/27/01, the pt felt drowsy and fatigued like she was coming down with the flu and "felt mentally not connected". On 9/4/01, the pt developed diarrhea, vomited once, felt tired, felt like her "thyroid zone" was swollen and her throat felt scratchy. She became out of breath when climbing up stairs. The physician reported that the rheumatoid factor was elevated to 10 times the normal level. The pt was referred to a rheumatologist. On 10/4/01, the pt had a constant global headache and crampy abdominal pain with watery diarrhea. The pt was fatigued and dyspneic with a non-productive cough, watery nasal discharge and sore throat. The injection site was still tender and swollen but not red. The pt had general myalgias, arthralgias, sweating, neurasthenia and a poor appetite. The physician confirmed that the pt's symptoms went on for at least several weeks and she was out of work for a while. The pt had returned to work on "light duty". The physician reported that as of 12/6/01, the pt had no improvement on extended course of prednisone in high dose and she had not recovered. The physician felt her symptoms were not vaccine related. The pt's positive rheumatoid factor, abdominal pain, decreased appetite, headache, diarrhea, diaphoresis, dysphagia, increased erythrocyte sed rate, dyspnea, influenza-like disease, injection site reaction, decreased mental acuity, vomiting, swelling, nausea, neurosis and hypesthesia were disabling. No additional information is expected.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 44 year old white female RN with depression, periorbital darkening, "hereditary" tremor, "bursitis" of the left knee and allergies to morphine, droperidol and butorphanol (Stadol) and a history of asthma "that occurred mostly during childhood", hysterectomy, oophorectomy and vaccination with an unspecified hepatitis vaccine, who on 8/24/01 was vaccinated with a 4th dose of Hep-B vaccine recombinant (yeast) in the left deltoid (lot 639853/0672L). The physician reported that the pt was a new employee to the hospital who indicated that she received an "unknown" hepatitis vaccine when it first came out approx. "10-15 years ago". The pt had antibody titers drawn which were "negative". She was then advised to received the Hep-B vaccine series. On 8/24/01, within 5-10 minutes of receiving the vaccine, she began experiencing multiple organ symptoms. On 8/24/01, the pt experienced general sense of warmth, sweating, pain and swelling at the site of injection, diaphoresis and numbness of the affected arm. She complained of difficulty swallowing but not of difficulty breathing. She felt dizzy and nauseous but did not vomit. She was treated with Benadryl and IV steroids in the ER. She had no respiratory symptoms. Most of her symptoms were subjective and not objective. She received a 1 week course of prednisone. On 8/27/01, the pt felt drowsy and fatigued like she was coming down with the flu and "felt mentally not connected". On 9/4/01, the pt developed diarrhea, vomited once, felt tired, felt like her "thyroid zone" was swollen and her throat felt scratchy. She became out of breath when climbing up stairs. The physician reported that the rheumatoid factor was elevated to 10 times the normal level. The pt was referred to a rheumatologist. On 10/4/01, the pt had a constant global headache and crampy abdominal pain with watery diarrhea. The pt was fatigued and dyspneic with a non-productive cough, watery nasal discharge and sore throat. The injection site was still tender and swollen but not red. The pt had general myalgias, arthralgias, sweating, neurasthenia and a poor appetite. The physician confirmed that the pt's symptoms went on for at least several weeks and she was out of work for a while. The pt had returned to work on "light duty". The physician reported that as of 12/6/01, the pt had no improvement on extended course of prednisone in high dose and she had not recovered. The physician felt her symptoms were not vaccine related. The pt's positive rheumatoid factor, abdominal pain, decreased appetite, headache, diarrhea, diaphoresis, dysphagia, increased erythrocyte sed rate, dyspnea, influenza-like disease, injection site reaction, decreased mental acuity, vomiting, swelling, nausea, neurosis and hypesthesia were disabling. No additional information is expected.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Myalgia, Nausea, Pharyngolaryngeal pain, Rheumatoid factor
Clinical narrative: Information has been received from a physician concerning a 44 year old white female RN with depression, periorbital darkening, "hereditary" tremor, "bursitis" of the left knee and allergies to morphine, droperidol and butorphanol (Stadol) and a history of asthma "that occurred mostly during childhood", hysterectomy, oophorectomy and vaccination with an unspecified hepatitis vaccine, who on 8/24/01 was vaccinated with a 4th dose of Hep-B vaccine recombinant (yeast) in the left deltoid (lot 639853/0672L). The physician reported that the pt was a new employee to the hospital who indicated that she received an "unknown" hepatitis vaccine when it first came out approx. "10-15 years ago". The pt had antibody titers drawn which were "negative". She was then advised to received the Hep-B vaccine series. On 8/24/01, within 5-10 minutes of receiving the vaccine, she began experiencing multiple organ symptoms. On 8/24/01, the pt experienced general sense of warmth, sweating, pain and swelling at the site of injection, diaphoresis and numbness of the affected arm. She complained of difficulty swallowing but not of difficulty breathing. She felt dizzy and nauseous but did not vomit. She was treated with Benadryl and IV steroids in the ER. She had no respiratory symptoms. Most of her symptoms were subjective and not objective. She received a 1 week course of prednisone. On 8/27/01, the pt felt drowsy and fatigued like she was coming down with the flu and "felt mentally not connected". On 9/4/01, the pt developed diarrhea, vomited once, felt tired, felt like her "thyroid zone" was swollen and her throat felt scratchy. She became out of breath when climbing up stairs. The physician reported that the rheumatoid factor was elevated to 10 times the normal level. The pt was referred to a rheumatologist. On 10/4/01, the pt had a constant global headache and crampy abdominal pain with watery diarrhea. The pt was fatigued and dyspneic with a non-productive cough, watery nasal discharge and sore throat. The injection site was still tender and swollen but not red. The pt had general myalgias, arthralgias, sweating, neurasthenia and a poor appetite. The physician confirmed that the pt's symptoms went on for at least several weeks and she was out of work for a while. The pt had returned to work on "light duty". The physician reported that as of 12/6/01, the pt had no improvement on extended course of prednisone in high dose and she had not recovered. The physician felt her symptoms were not vaccine related. The pt's positive rheumatoid factor, abdominal pain, decreased appetite, headache, diarrhea, diaphoresis, dysphagia, increased erythrocyte sed rate, dyspnea, influenza-like disease, injection site reaction, decreased mental acuity, vomiting, swelling, nausea, neurosis and hypesthesia were disabling. No additional information is expected.