chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Candidiasis, Crying, Decreased appetite, Haematoma, Hot flush
Clinical narrative: 1st shot 3/8/02, HEB 1, congested, irritable, fussy. 2nd shot 5/1/02, IPV/OPV, DTaP, DTP, DT/TD, HIB, PPV, very congested, irritable, high pitch cry, fever, hot and cold flashes, cold sores-thrash, sleepy, no eating well. No solutions. Doctors say baby has "SBS." Subdural heamtoma, non-accidental trauma, multiple rib fractures.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Nasal congestion, Pyrexia, Somnolence
Clinical narrative: 1st shot 3/8/02, HEB 1, congested, irritable, fussy. 2nd shot 5/1/02, IPV/OPV, DTaP, DTP, DT/TD, HIB, PPV, very congested, irritable, high pitch cry, fever, hot and cold flashes, cold sores-thrash, sleepy, no eating well. No solutions. Doctors say baby has "SBS." Subdural heamtoma, non-accidental trauma, multiple rib fractures.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: CSF test abnormal, Guillain-Barre syndrome
Clinical narrative: Guillain-Barré sndrome. IV, IgG, plasmapheresis. Recovering.
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Convulsion, Grand mal convulsion
Clinical narrative: After her first baby shots, my child slept for 3 days-I took her to local doctor, he said not to let her have any more pertussion on DPT shot. At age 3, she had her 1st grand mal seizure. She is 23 and has uncontrolled epilepsy. Small seizures prior to age 3 were common and I did not know they were seizures.
Age: 1.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Jaundice, Lethargy, Vomiting
Clinical narrative: Child received vaccines at HD. According to mother received DPT, IPV & Prevnar. Onset vomiting that evening. Contacted me, pediatrician, by phone next day at 11:30am. Placed on clear liquids and improved. Contacted office after hour at 12:30 pm on Sunday, 08/04/02, stating child vomiting intermittently was lethargic and looking yellow. Child seen in ER. He was seen by pediatric Gastroenterologist on 08/07/02 with a diagnosis of transient hepatitis of unknown etiology. Liver enzymes will repeated next week and ultrasound of liver as well
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Feeling hot, Urticaria
Clinical narrative: Hives all over body with heat radiating from hives. No temperature.  Follow up: No site reaction, Prescribed benadryl.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Irritability
Clinical narrative: Post imms X 4 days,pt would awaken with high-pitched cry, was fussy, still fed, no fever, no soreness (normal growth and development). This by history today, 08/07/02, Since 03/29/02, wasn't seen in interim.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyspnoea
Clinical narrative: Told by parents over phone that was having trouble breathing-went to ER.  Follow up: prescription not on ER form.
Age: 0.2
Sex: M
Vaccine: HBHEPB, IPV, PNC, TTOX
Symptoms: Crying, Pyrexia
Clinical narrative: Mom reports "temperature of 100.6, responsive to Tylenol at 3AM, started crying 24 hours post shots (08/01) and cried for 14 hour straight. Took child to ER and sent home due to no significant findings, Baby cried again again the following day for 6 hours and mom visited ER with the same results. Mom reports "baby cried until Sunday, (08/04).
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, PNC
Symptoms: Stupor, Tremor
Clinical narrative: On day of immunizations had episode during feeding of "fast body shaking"-20 seconds, "out of it" Not responsive during event, Finished feeding and slept 3 hours after, acting fine since, No fever, Mom calls next day still active wekk
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Allergic rash (hives) broke out behind ears and on neck of child. Benadryl (children's) given for relief of itching
Age: 5.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Erythema, Injection site vesicles
Clinical narrative: "Blister" at site of injection, Red as "a coke can", Blister burst "spontaneously" Size of  a nickel per mother's statement
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: He started screaming, crying and could not be consoled for 8 hours straight. Loud and light pitch scream.
Age: 1.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Mother states child ran fever for a few days after, Then approx 07/28/02 again started running fever irritable and diarrhea.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Rash papular, Rash pustular
Clinical narrative: 30 pox over body over 5 days
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Flushing, Hyperventilation, Influenza like illness, Rash
Clinical narrative: Chills, Felt flushed, flu-like symptoms with rash on abdomen and under breasts and welts on hips. Became short of breath. Went to ED was given in Benadryl and steroid therapy. Rabies titer done in lieu of #2 rabies injection, Client had prior post rabies tx 1997
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Chills, Felt flushed, flu-like symptoms with rash on abdomen and under breasts and welts on hips. Became short of breath. Went to ED was given in Benadryl and steroid therapy. Rabies titer done in lieu of #2 rabies injection, Client had prior post rabies tx 1997
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: Developed Fever 104 Rectal - Tx'd with Motrin @IZAM
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At 48 hours s/p vaccine pt had developed, 7cm x10 cm warm, tender, indurated area around injection site, no erythema noted, (left upper deltoid)Also had 1 cm, tender, mobile, left axilla was treated with Keflex 500 mg bid x 7d beginning 08/01/00
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Acne, Erythema, Eye oedema, Face oedema, Rash
Clinical narrative: Approx. 8 hours after immunizations, the child developed edema around face and eyes and entire body turned reddish. Also developed a pimple-like rash. No fever, but was on Tylenol every 4 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Convulsion, Hypotonia, Musculoskeletal stiffness, Pallor
Clinical narrative: Within 20 minutes after receiving shots, my daughter went extremly pale and complained of a stomach-ache. We had just left dr's office when she had a seizure/convulsion her body stiffened, her arms were raised and her fists were clenched. I ran back into the dr's office for help. When I returned to the car, she was still stiff and shaking. I pulled her from the car and ran with her to the doctor. At this point her body went limp and within minutes opened her eyes. She seemed awake but not alert for a minute more and remained extremly pale for 15-20 minutes. We remained in the dr's oiffice under observation for 30 minutes or so, then left. Doctor felt reaction was due more to stress of getting the shot than to the  actual vaccine; however I do not agree. Although she may have felt some anxiousness, she did not appear stressed she did not fuss or try to avoid getting the shots and did not cry or pull away when VA gave her the shots. They even commented on how great she was about getting the shots. I believe she had a reaction to the vaccine
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Stupor, Tremor
Clinical narrative: Within 20 minutes after receiving shots, my daughter went extremly pale and complained of a stomach-ache. We had just left dr's office when she had a seizure/convulsion her body stiffened, her arms were raised and her fists were clenched. I ran back into the dr's office for help. When I returned to the car, she was still stiff and shaking. I pulled her from the car and ran with her to the doctor. At this point her body went limp and within minutes opened her eyes. She seemed awake but not alert for a minute more and remained extremly pale for 15-20 minutes. We remained in the dr's oiffice under observation for 30 minutes or so, then left. Doctor felt reaction was due more to stress of getting the shot than to the  actual vaccine; however I do not agree. Although she may have felt some anxiousness, she did not appear stressed she did not fuss or try to avoid getting the shots and did not cry or pull away when VA gave her the shots. They even commented on how great she was about getting the shots. I believe she had a reaction to the vaccine
Age: 4.7
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid-area red, swollen, warm to touch, client denied pain at site.
Age: 0.8
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia
Clinical narrative: Febrile symptoms within 72 hours of immunizations.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Noted redness on 8/6/02 of left thigh. Came for office visit on 8/7/02 and had a very large (15cm X 18cm) of erythema, induration and heat; almost the whole circumference of the leg on left thigh surrounding injection site.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Had a 20cm area of redness and induration surrounding shot site on anterior thigh, mildly warm and tender to touch. Pt afebrile and walking well. Both shots given 3cm apart. Previously, no reaction to DTAP. No rash elsewhere.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt presents to clinic with left leg swelling and redness. Received vaccines on the previous day. No fever noted. Dx: Left leg shot reaction to DTAP. Treatment: Monitor.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Hallucination, visual, Injection site pain, Irritability, Pyrexia
Clinical narrative: Received Hep-A at 17:00 and 4-6 hours afterwards, complained of thigh pain, developed temperature of 104.3F (ax), very irritable, talked about snakes and seemed to be picking critters off shirt. Admitted for observation due to increased temperature and irritability.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site pain, Pyrexia, Rash papular
Clinical narrative: Red rash over whole body; 2 types (red papular and red erythematous rash. Also redness and pain at injection site with low-grade fever X 4 days.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site, increasing in size to 2 3/4" X 3".
Age: 0.5
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Topical reaction: edematous, erythematous area about 6 cm in diameter and central edema.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8cm X 6cm red, swollen upper left arm.
Age: 11.0
Sex: F
Vaccine: DT, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: On 7/31/02, pt had temperature of 105.8 (oral) and so was taken to ER. Broke out in the evening after the vaccine with a truncal rash about 72 hours later.
Age: 11.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Pyrexia
Clinical narrative: High-grade fever up to 104F.
Age: 1.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Irritability, Screaming
Clinical narrative: Very irritable, crying non-stop from awakening at 08:00.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Rash papular
Clinical narrative: Fever X 2 days after Varivax given on 7/22/02. After 10 days, post vax, started to get red, papular-vesicular lesions on legs, trunk, arms, face and scalp. Pruritic.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Child awoke the next morning after immunization given with confluent hives about 22 hours after MMR. Child treated with IM Benadryl followed by every 6 hours oral Benadryl and will follow-up tomorrow. No steroids given secondary to no respiratory compromise and recent live virus vaccine.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Irritability, Photophobia
Clinical narrative: After the 3rd and 4th doses, had headache, increased irritability and increased photophobia which lasted for weeks. Better each progressive day. Irritability and photophobia are not unusual for this client according to her but ? were increased.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: Pt was administered 2 Typhoid VI vaccines. No signs/symptoms of reaction noted. Pt was told to report reaction ASAP.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Child received DTP on 8/5/02 and on 8/6/02, mom says left arm where this immunization was given is red and swollen from shoulder all the was down to elbow which started around 17:00. Mom brought child to clinic at 08:00 on 8/7/02. Arm is swollen and red from shoulder down to elbow and complains of itching.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Hands and feet just itch really bad; slight redness on palms and feet and in between fingers and toes.
Age: 4.8
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh red and swollen 6 1/2cm X 5cm around injection site. Warm to touch. Treated with Benadryl and Orapred 1 tsp po QD.
Age: 4.9
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 14cm erythema on right anterior thigh with swelling and tenderness.
Age: 0.2
Sex: M
Vaccine: UNK
Symptoms: Screaming
Clinical narrative: Prolonged crying (post vaccine), lasting 6 hours.
Age: 3.5
Sex: F
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Mother phoned in at 04:45 to report red, raised and hardened area on left arm (2" X 2").
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Called about 5 minutes after vaccination with MMR, Comvax and Varivax with bilateral thigh urticarial reaction with erythema initially 3cm and increased to 5-6cm diameter. No cardiorespiratory compromise; BP-84/43; HR-130's with good pulses. Benadryl 12.5mg po X 1 with improved symptoms.
Age: 0.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: After MMR shot on 8/2/02 at 16:00; at 23:00 started getting high fever of 103-104.7F constant.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash
Clinical narrative: Rash on upper chest, back and right shoulder. Itch from rash, in nose and throat. Not treated. Took own antihistamine for relief.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area 8cm X 8cm, red and warm to touch on left upper arm.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria versus E. minor (doubt) given prednisolone and Benadryl.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: Received meningitis vaccine and PPD. A few hours later, developed hives on legs. Confirmed by doctor's exam the next day.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Blotchy rash which started within 2 hours of receiving vaccine. Did not seem to be itchy. Lasted about 2 days. Slightly raised irregular blotches.
Age: 4.9
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Left upper arm from shoulder to 1/2 way down upper arm, red, swollen and "bump" noted at injection site by mother. Area not painful. No fever.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Fatigue, Infection, Pallor, Pyrexia, Rash
Clinical narrative: Rash the 1st night, lasting a couple of days (mild). No cold symptoms, more fatigue and paleness of skin last week. One episode of wheezing yesterday. Highest temp 103.8F (rectal) on 8/4/02. On 8/6/02, 3 chickenpox on chickenpox developed.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Wheezing
Clinical narrative: Rash the 1st night, lasting a couple of days (mild). No cold symptoms, more fatigue and paleness of skin last week. One episode of wheezing yesterday. Highest temp 103.8F (rectal) on 8/4/02. On 8/6/02, 3 chickenpox on chickenpox developed.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling cold, Feeling hot, Rash
Clinical narrative: Client stated, within 4 hours after receiving Hep-B injection, she began to break out with rash in pelvic area and large bumps on arms and lower legs which became hot, flushed with periods of coolness to body.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal pain, Injection site erythema
Clinical narrative: Local redness, cramping and abdominal discomfort, lasting 2 days. Began 6 hours after shots given.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Hypertension, Injection site erythema, Injection site vesicles, Skin exfoliation
Clinical narrative: As part of a CDC protocol, he was given a smallpox vaccine on 3/6/02, along with a number of co-workers. He had what seemed to be a pretty good take at that time. He had no problems and had complete resolution of what limited systemic complaints he had, as well as complete resolution of the eschar at the inoculation site. He has been well until about a week ago, at which time, he noticed a blister directly overlying the site of the prior inoculation. He recalls no trauma associated with that blister. A day or so after he noted the blister, it resolved, and he does not recall any drainage associated with resolution, but did notice some eschar formation, which is now nearly resolved. He has had no systemic complaints of any king, nor has he had any lesions anywhere else on the body. He is here for follow-up as he thought it was probably prudent to at least have this looked at, given that this is part of a study involving the CDC and given that it is a rather unusual occurrence. I am not aware of any other co-workers with similar problems. We have had no work from anyone, and this employee does not know of anyone else with a similar problem. He is alert, oriented and comfortable. There is an area of erythema that is well circumscribed and appears to be directly overlying the prior injection site. This is just less than a centimeter in diameter. This is a small area of eschar just to the posterior aspect of midline of the erythematous area. There is no induration. There is no blistering and there is no discharge or drainage. There is no left inguinal adenopathy. Although there are a number of abrasions over the forearms of both arms related to minor trauma 3 days ago, there are no other skin lesions noted. I think what might have happened is that there may have been a small, walled off amount of inoculant that may have ruptured and subsequently formed eschar. Since this is not associated with any symptoms or other skin lesions and appears to be nearly resolved now, I do not think he will have any sequelae or any associated problems. I do not think there is any risk of the almost nearly-healed lesion being contagious at this point.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 59 year old Caucasian male with hypertension, hyperlipidemia and diabetes who on 01/28.02 was vaccinated  IM in the left deltoid with a first dose  of pneumococcal vaccine 23 polyvalent (lot # 637263/1448K). The nurse reported that the patient was well at the time of vaccination. On 01/30/02, the patient called his physician's office and reported that the injection site was red and he had a rash and a sore at the site. The physician ordered diphenhydramine hydrochloride (Benadryl) cream to the area and to call back if the symptoms worsened. On 01/31/02, the patient saw his physician and complained of the injection site being red and hard to touch. A diagnosis of cellulitis was made and the patient was treated with amoxicillin (Augmentin) 875 mg BID for 10 days. The patient was seen again in the office on 02/06/02 and the physician noted marked improvement in the cellulitis but still some redness at the site.  The patient was considered to be recovered as of 02/06/02. The reporter also reported thata 26 year old male developed cellulitis after vaccination with pneumococcal vaccine 23 polyvalent (MSD) (lot # 641114/1387L) (WAES0202USA02499). The reporter stated a concern about the particular lot of vaccine. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Information has been received from registered nurse concerning a female who on 02/15/2002 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot number 641027/1051L). On 02/15/2002, the pt developed a "huge"arm, red, sore, and a headache. Unspecified medical attention was sought. The nurse reported that 5 pts developed injection site pain, erythema, swelling, and a headache post vaccination with pneumococcal vaccine 23 polyvalent (see WAES0203USA2415). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Information has been received from a physician concerning a 63 year old female pt who on 2/13/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 2/18/02, the pt developed a swollen arm. Unspecified medical attention was sought. Additional info has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Oedema, Pain, Pruritus
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 50 yr old female with a history of pneumonia  who on 02/19/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent, (lot number 641531/1352L). That evening the pt's arm was described as "swollen twice the size of normal from shoulder to elbow," and painful with limited movement in her shoulder. It was also reported that the pt had itching. The pt sought unspecified medical attention. The symptoms, according to the reporter, resolved, but the time frame was unknown. No further information is expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a 48 year old female with penicillin allergy, sulfa allergy, an allergy to Ludiomil, dust allergy, dairy allergy, dog allergy and allergy to some cats and a history of hysterectomy 1996, biopsy 1993, and hospitalization 2000 for bleeding ulcers in colon and lower intestine who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included rofecoxib 25mg and Prozac. Subsequently, the pt's upper arm became swollen and she ran a fever of 101.5 degs. F. Her doctor feels that it was an allergic reaction. Unspecified medical attention was sought. Further info received from a physician indicated that the pt was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent on 12/7/01. On 12/7/01, the pt developed a fever of 101 F, redness at injection site and soreness. The outcome of the events was unknown. Additional info has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Abscess drainage, Rash, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 77 yr old male with hypertension, chronic obstructive pulmonary disease, anemia, gout and allergies to sulfamethoxazole (+) trimethoprim (Bactrim) and amoxicillin trihydrate (+) clavulanate potassium (Augmentin). On 01/31/2002 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 639396/0718L), in the deltoid. Concomitant therapy included furosemide sodium (Lasix (furosemide sodium)) (40mg) (qd), allopurinol (Allopurinol MSD) (300 mg) (qd), clonidine (0.1 mg bid) and colchicine (0.5) (bid), famotidine (Pepcid) (20mg) (bid), and theophylline (Thesol) (1 tablet) (qd). On 02/01/2002, the day following vaccination, the pt developed a rash, wheals, and itchy fluid-filled red streaks that were below the injection site, at the deltoid. It was reported that the rash was between the injection site and elbow. The pt was seen in the Dr.'s office on 02/08/2002, when the symptoms were still present. It was noted that at that time the pt reported that " he had a fever earlier." The pt was prescribed diphenhydramine hcl (Benadryl) and prednisone. On 02/15/2002 the pt was seen again at which time he felt better and the symptoms had resolved. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Agitation, Crying
Clinical narrative: Information has been received from a physician concerning a 17 week old male with a history of hospitalization for meningitis and bronchiolitis who on 2/25/02 was "accidently" vaccinated with pneumococcal vaccine 23 polyvalent. On 2/25/02 the pt was also vaccinated with diphtheria toxoid/pertussis vaccine/tetanus toxoid, poliovirus vaccine inactivated and HIB conjugate vaccine (manuf unk). On 2/25/02 the pt's mother reported that he was awake during the night and was being fussy. On 2/25/02 the pt's ear was reported as negative. However, the pt was prescribed amoxicillin 250/5ml, one teaspoon, twice daily for 10 days for a possible ear infection. On 2/26/02 the pt was seen again and remained fussy, afebrile and screaming with his left ear slightly pink. It was reported that the child previously had meningitis and was hospitalized on 12/8/01 and seen in the office for follow-up on 12/13/01. It was also reported that the child previously had brionchiolitis and was RSV negative. Additional info has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received on 2/26/02 from a physician concerning a 70 year old female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed a sore arm. The pt sought unspecified medical attention. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Medication error
Clinical narrative: Information has been received on 2/28/02 from a registered nurse who was inadvertently vaccinated with a dose of pneumococcal vaccine 23 polyvalent, intradermally, instead of given a tuberculin test. The consumer reported having a lot of reaction at the site. On 2/28/02 the consumer reported that "about a year ago, although not intradermally," she was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 2/28/02 it was reported that the pt had not spoken to her physician yet. The pt did not seek medical attention. No further info is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received on 2/28/02 from a licensed practical nurse concerning an adult male who was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently the pt developed local site redness. It was reported that the pt had received a previous dose within "the past six months." This does not comply with the recommended dosage schedule. The pt was treated with Keflex. The reporter had questioned concerns with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received on 2/28/02 from a licensed practical nurse concerning an adult female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, within 24 hours of being vaccinated, the pt developed redness a few inches below the injection site on the inner aspect of the arm. The pt was treated with Keflex. The nurse also reported that an adult male pt had a similar reaction (WAES0203USA00045), as well as several cases in a doctor's office 'across the hall," (WAES0203USA00276). The reporter had questioned concerns with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. the lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old female pt with asthma who on 10/29/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. In March 2002, the pt's titer results were very low. Unspecified medical attention was sought. Additional info has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 57 year old female who in late January 2002 or February, was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included Azulfidine 500mg BID, Arava 20mg QID, Levoxyl 200mg QD, Ultram 50 Q 4-6 PRN and Estradiol. Two weeks after vaccination the pt experienced swelling in her legs from knee through her foot. Her skin was red, but not a rash, on the front of legs only. Unspecified medical attention was sought. Additional info has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 68 yr old male who on 02/12/2002 was vaccinated IM in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot number 640577/0995L). On 02/13/2002 the pt experienced an injection site inflammation and redness,swelling, and pain. Subsequently, the pt recovered. No further information is expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 56 year old female patient with no known drug allergies who on 4/1/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently on 4/01/02, within minutes of the vaccination, the patient developed a site reaction. No description of the reaction was available at the time of the report. Unspecified medical attention was sought. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a 56 yr old male pt with a seasonal allergy who on 04/01/2002 was vaccinated IM with 0.5ml of pneumococcal vaccine 23 polyvalent (lot number 64057/0995L) in the left deltoid. In less than a 24 hr. period from vaccination, the pt was noted to have red streaks going into the left armpit. The pt also had swollen lymph gland in the left armpit. The pt had no complaints of pain or fever. Unspecified medical attention was sought. The reporter requested a lot check on pneumococcal vaccine 23 polyvalent (lot number 640577/0995L). She also reported that the results of the lot check be forwarded to the office. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning his wife who in approximately 1989 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. It was reported that the patient had pneumovax 17 prior to receiving pneumococcal vaccine 23 polyvalent. The patient developed some kind of rash for which she had to take steroids after receiving the pneumococcal vaccine 23 polyvalent. The physician indicated that it was a really bad adverse event. The physician did not want to file an adverse event and would barely give his name. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (lot # 641130? 116L). Subsequently the patient experienced injection site pain, injection site itching and redness and the site was warm to the touch. It was reported that the symptoms were almost like a cellulitis and went down to the elbow . The patient was afebrile. The nurse reported that the experience were severe and diphenhydramine (Benadryl) was needed to be given to the patient. It was in reported that the patient had previously received vaccination with pneumococcal vaccine 23 polyvalent and did not have a problem. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release  of this lot have been checked and found to be satisfactory. The lot complies with the standards and was release. Additional information has been requested. The nurse also reported that following vaccination with pneumococcal vaccine 23 polyvalent, two other females patient experienced injection site pain, swelling, itching, redness, pain and swelling (see WAES# 0204USA02065).
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (lot # 641130? 116L). Subsequently the patient experienced injection site pain, injection site itching and redness and the site was warm to the touch. It was reported that the symptoms were almost like a cellulitis and went down to the elbow . The patient was afebrile. The nurse reported that the experience were severe and diphenhydramine (Benadryl) was needed to be given to the patient. It was in reported that the patient had previously received vaccination with pneumococcal vaccine 23 polyvalent and did not have a problem. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release  of this lot have been checked and found to be satisfactory. The lot complies with the standards and was release. Additional information has been requested. The nurse also reported that following vaccination with pneumococcal vaccine 23 polyvalent, two other females patient experienced injection site pain, swelling, itching, redness, pain and swelling (see WAES# 0204USA02065).
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a Dr. of pharmacy concerning a female pt with sulfa and mercury allergies who's current medications include dilitiazem hydrochloride (manufact. unknown) who was vaccinated with her "last dose" of pneumococcal vaccine 23 polyvalent, "sometime ago." Subsequently the pt experienced injection site swelling and redness in the left arm. Medical attention was not sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning a white female with allergies to sulfa, penicillin, and iodine who on 2/20/02 was vaccinated with pneumococcal vaccine 23 polyvalent, IM (lot # 637487/1071K). The patient's illnesses at the time of the vaccination included vitamin B-12 deficiency, asthma, and hypertension. Subsequently, the patient experienced severe reactions. On 2/21/02, the patient's injection site became large, red and swollen. The swelling involved the arm from the elbow to under the armpit. The patient also had weaping of fluid from her arm. Additional information received from the registered nurse indicated that that the patient also developed arm edema and arm pain from her elbow to shoulder and extending into the axillary region. The patient did not develop a fever. The patient sought medical attention and was treated with ice and ibuprofen (dose and duration not reported). Subsequently, the patient recovered from large, red injection site, swollen injection site, from the elbow to under the armpit, arm edema and arm pain from her elbow to shoulder and extending into axillary region. Information was also received concerning two other patients (demographics unknown) who were vaccinated with pneumococcal vaccine 23 polyvalnt (date of vaccination unknown) (lot # 637487/1071K) (WAES0202USA02371). Follow up information was received from the registered nurse who reported that she only had information on one patient because the other physicians could not recall the names of the other two patients. The registered nurse reported that she knew that none of the patients required hospitalization and none of the patients went to the emergency room. The reporter expressed a concern regarding the lot number (1071K). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is available.
Age: 70.0
Sex: F
Vaccine: RUB
Symptoms: Chest discomfort, Discomfort, Feeling hot, Hyperkinesia, Injection site erythema
Clinical narrative: information has been recieved from a registered nurse (RN) concerning a 70 yr old white female with penicillin allergy, arthritis, "aeroallergies", and bronchial asthma who on 04/15/2002 in the am, was vaccinated with a second dose of pneumococcal vaccine23 polyvalent (lot number 641114/1052L), administered SC, in the left arm. Concomitant therapy (dates not specified) included fluticasone propionate + salmeterol xinafoate (Advair Diskus) 250/50 "1x2", montelukast sodium (MSD) 10 mg HS, mometasone furoate (Nasonex cream) BID "to affected area". On 04/15/2002 about 30 mins after leaving the physician's office, the pt's left arm started to become painful and erythematous. She felt heat at the site and developed some swelling/edema. The discomfort and swelling continued and intensified overnight. The following morning, the pt went back to her physician and he gave her a diphenhydramine hydrochloride (Benadryl) injection, methylprednisolone acetate (Depo-Medrol) injection, and started her on a coarse of oral methylprednisolone (Medrol).At that time, the physician documented "?" reaction to pneumococcal vaccine 23 polyvalent. The pt reportedly had difficulty moving her arm. "Severe progressive local RX S/P pneumococcal vaccine 23 polyvalent) vaccine am 24 hrs was documented. The timing of the reaction was described as "nocturnal/exercise" and modifying factors included "exertion/weather". The pt also developed >150mm x 60mm induration of the left arm and general malaise. Associated signs and symptoms included nocturnal respiratory distress, chest tightness, and exertional dyspnea. She denied shortness of breath or dysphagia. Review of systems was completed, with the pt denying any additional complaints. Additional abnormal physical assessment findings included "moderate distress", nasal turbinates mildly edematous, and "SL PND" Lungs were reported to be "clear P & A" with "good breath sounds". Vital signs were as follows: pule 99, otic temperature 98.2, and BP 120/72, measured with a standard cuff. In additional, peak flow/vital capacity was reported as 285 and oxygen saturated was 96. It was documented that pulmonary function tests were last performed in April 2002, the pt recovered. the physician also reported that on an unspecified date in 1997 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent with no reactions or problems. Nocturnal respiratory distress, chest tightness, exertional dyspnea, "moderate distress", nasal turbinates mildly edematous, And "SL PND" were considered to be incidental findings. No additional information is available.
Age: 70.0
Sex: F
Vaccine: RUB
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Malaise, Respiratory distress
Clinical narrative: information has been recieved from a registered nurse (RN) concerning a 70 yr old white female with penicillin allergy, arthritis, "aeroallergies", and bronchial asthma who on 04/15/2002 in the am, was vaccinated with a second dose of pneumococcal vaccine23 polyvalent (lot number 641114/1052L), administered SC, in the left arm. Concomitant therapy (dates not specified) included fluticasone propionate + salmeterol xinafoate (Advair Diskus) 250/50 "1x2", montelukast sodium (MSD) 10 mg HS, mometasone furoate (Nasonex cream) BID "to affected area". On 04/15/2002 about 30 mins after leaving the physician's office, the pt's left arm started to become painful and erythematous. She felt heat at the site and developed some swelling/edema. The discomfort and swelling continued and intensified overnight. The following morning, the pt went back to her physician and he gave her a diphenhydramine hydrochloride (Benadryl) injection, methylprednisolone acetate (Depo-Medrol) injection, and started her on a coarse of oral methylprednisolone (Medrol).At that time, the physician documented "?" reaction to pneumococcal vaccine 23 polyvalent. The pt reportedly had difficulty moving her arm. "Severe progressive local RX S/P pneumococcal vaccine 23 polyvalent) vaccine am 24 hrs was documented. The timing of the reaction was described as "nocturnal/exercise" and modifying factors included "exertion/weather". The pt also developed >150mm x 60mm induration of the left arm and general malaise. Associated signs and symptoms included nocturnal respiratory distress, chest tightness, and exertional dyspnea. She denied shortness of breath or dysphagia. Review of systems was completed, with the pt denying any additional complaints. Additional abnormal physical assessment findings included "moderate distress", nasal turbinates mildly edematous, and "SL PND" Lungs were reported to be "clear P & A" with "good breath sounds". Vital signs were as follows: pule 99, otic temperature 98.2, and BP 120/72, measured with a standard cuff. In additional, peak flow/vital capacity was reported as 285 and oxygen saturated was 96. It was documented that pulmonary function tests were last performed in April 2002, the pt recovered. the physician also reported that on an unspecified date in 1997 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent with no reactions or problems. Nocturnal respiratory distress, chest tightness, exertional dyspnea, "moderate distress", nasal turbinates mildly edematous, And "SL PND" were considered to be incidental findings. No additional information is available.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from an RN concerning a 77 year old Caucasian female pt with an allergy to penicillin who on 4/10/02 was vaccinated IM in the left deltoid, with a dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, the pt experienced injection site pain, swelling, itching and redness and the site was hot to the touch. It was reported that the symptoms were almost like a cellulitis and went down to the elbow. The pt was afebrile. The nurse reported that the experiences were severe and Benadryl was needed to be given to the pt. It was also reported that the pt had previously received vaccination with pneumococcal vaccine 23 polyvalent and did not have a problem. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Conflicting follow-up information received from a physician reported that on 4/10/02, the pt was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent. On 4/10/02, the pt developed erythema, edema and pain and was treated with over the counter Benadryl and warm compresses. The outcome of the events was not reported. No further information is expected. The nurse also reported that following vaccination with pneumococcal vaccine 23 polyvalent, 2 other female pts experienced injection site pain, swelling, itching, redness and warmth (WAES 0204USA01568 and 0204USA02064) and a 3rd pt experienced pain, swelling and redness (WAES 0204USA02065).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from an RN concerning a 67 year old Caucasian female pt who on 4/10/02 was vaccinated IM, in the left deltoid, with a dose pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, the pt experienced injection site pain, swelling, itching and redness and the site was hot to the touch. It was reported that the symptoms were almost like a cellulitis and went down to the elbow. The pt was afebrile. The nurse reported that the experiences were severe and Benadryl was needed to be given. It was also reported that the pt had previously received pneumococcal vaccine 23 polyvalent and did not have a problem. Unspecified medical attention was sought. Conflicting follow-up from the pt's physician, reported that the pt had received any previous doses of pneumococcal vaccine 23 polyvalent and that on 4/10/02, the pt experienced erythema, edema and pain. The pt was treated with over the counter Benadryl and warm compresses and subsequently, recovered. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected. The nurse also reported that 2 other female pts experienced injection site pain, swelling, itching, redness and warmth (WAES 0204USA01568 and 0204USA02063) and a 3rd pt experienced pain, swelling and redness (WAES 0204USA02065) following vaccination with pneumococcal vaccine 23 polyvalent.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an RN and a physician concerning an 81 year old Caucasian female who on the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, on 4/11/02, the pt experienced redness, edema and severe throbbing pain from her right shoulder down her right arm below her elbow. It was reported that the experiences were severe and the pt was placed on over the counter Benadryl and was treated with warm compresses. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected. The nurse also reported that 3 other female pts experienced injection site pain, swelling, itching, redness and warmth following vaccination with pneumococcal vaccine 23 polyvalent (see WAES 0104USA0158, 0204USA02063 and 0204USA02064).