chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Joint stiffness, Tendonitis
Clinical narrative: Pt is a 24 year old gentleman who had a tetanus shot in his left arm on July 26th because of a superficial injury on his left ring finger. He developed arm or shoulder stiffness within 4 hours of that episode and it has gotten gradually and steadily worse since then. He has been using Tylenol 3 or 4 tablets twice a day. No other medications. Pt has a great deal of tenderness along the lateral superior edge of the rotator cuff at the edge of the AC joint. He has a positive impingement sing at 80 degrees of abduction and also with internal rotation. Assessment: rotator cuff tendinitis, possibly precipitated by his tetanus immunization. He is instructed in pendulum range of motion exercises. He is given Bextra 20mg to talke 1 po qd, #15 samples. He is to ice this if it is particularly bother ing him. He is to follow-up if this is not gradually improving.
Age: 11.0
Sex: F
Vaccine: TTOX
Symptoms: Blindness, Cold sweat, Coma, Fall, Pallor
Clinical narrative: TT given 8:05am L deltoid, 8:15am pt's vision went black and she fell to floor. Pt was unresponsive approximately 5 sec. Pt came to and vomited x 1 clear liquid. Skin cold, clammy, pallor. BP 110/58 and 110/62 (sitting and lying down). Denies HA, dizziness, or stomach ache c/o feeling "shaky." Pt back to baseline by 8:30am.
Age: 11.0
Sex: F
Vaccine: TTOX
Symptoms: Tremor, Vomiting
Clinical narrative: TT given 8:05am L deltoid, 8:15am pt's vision went black and she fell to floor. Pt was unresponsive approximately 5 sec. Pt came to and vomited x 1 clear liquid. Skin cold, clammy, pallor. BP 110/58 and 110/62 (sitting and lying down). Denies HA, dizziness, or stomach ache c/o feeling "shaky." Pt back to baseline by 8:30am.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mother states onset 8/1/02 of redness and heat to L thigh following immunizations. States area getting larger each day 6" x 8". Mom went to ER at 10pm -didn't follow-up in office as ER Dr requested. Office closed at this time.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid red, swollen and hot. Time course, two days after injection. Treatment, Motrin prn.
Age: 1.9
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: R upper lateral thigh area redness noted approx. 2 inches in diameter around injection site. Area slightly warm, firm. No pain with palpation/pressure. Mom states redness started 7/31 is les today. Child ambulating with no noted problems, active, playful. No fever. Instructed on warm compresses. Tylenol for pain. Two follow-up calls, no response from mom.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Rec'd pneumonia vaccine to RD (pt had L breast surgery earlier in yr); pt developed large, reddened upper arm.
Age: 15.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Urticaria
Clinical narrative: Within minutes, hives, local redness noticed on left upper arm. Hive faded. Later evening arm redded 6 cm x 6 cm in office on 08/02/02 hard, tender, red.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: T 101 (on 09/03/02) for one day, Sore arm, Patient refused to come in to be checked.
Age: 1.75
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: Fever, local reaction/redness.
Age: 1.08
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Rash macular, Rash pustular
Clinical narrative: Maculopaustules on back, neck, scalp and few on lips/started 7/18/02. No meds.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Dyskinesia, Dyspnoea, Erythema, Irritability
Clinical narrative: Chicken pox vaccine given 6 days ago, ER visit 07/06/02, Has had fever "jerking" for 2 days, Slight jaundice cast to skin, ER reports says trouble breathing t 98.2 P 152, R 35, vaccinated 06/02/02, fever for 3 days , cough, fussy, skin rash,runny nose congested, red eyes, phargeal, erythema, tonsillar exudate
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Jaundice, Ocular hyperaemia, Pharyngitis, Pyrexia, Rash
Clinical narrative: Chicken pox vaccine given 6 days ago, ER visit 07/06/02, Has had fever "jerking" for 2 days, Slight jaundice cast to skin, ER reports says trouble breathing t 98.2 P 152, R 35, vaccinated 06/02/02, fever for 3 days , cough, fussy, skin rash,runny nose congested, red eyes, phargeal, erythema, tonsillar exudate
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rhinitis, Tonsillitis
Clinical narrative: Chicken pox vaccine given 6 days ago, ER visit 07/06/02, Has had fever "jerking" for 2 days, Slight jaundice cast to skin, ER reports says trouble breathing t 98.2 P 152, R 35, vaccinated 06/02/02, fever for 3 days , cough, fussy, skin rash,runny nose congested, red eyes, phargeal, erythema, tonsillar exudate
Age: 1.32
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site mass, Injection site warmth, Rash erythematous
Clinical narrative: 4th shot 15 X 15 cm red raised lump of 3 cm, hot.
Age: 1.0
Sex: M
Vaccine: MMR, OPV, VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Developed chicken pox 07/02/2002, Diagnosis by PCP, Mom states @ least 150 lesion's on child's chest.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Developed chicken pox 7/12/02. 50+ lesions.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: 12x7cm indurated warm area at site of DTaP within 24 hours of imm. Happened with prev. shot.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Painful, hot, red area @ site of injection lasting 8-10 days.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Rash pruritic
Clinical narrative: Developed red, pruritic rash at injection site one week after administration.  Lasting several days, denies swelling.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Generalized hives, started immediately after receiving MMR continues 08/02/02
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site induration, Injection site warmth, Rash erythematous
Clinical narrative: 2 in diameter raised hard red wm area @ shot site.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left arm deltoid 11 cm X 9.5 cm, erythematous, warm firm, to left upper arm, first four doses
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4 in X 45 in red/warm area @ shot site of DTaP, 4 prior DTaP-Lederle vaccine
Age: 0.2
Sex: F
Vaccine: DTAP, HBPV, IPV
Symptoms: Flushing, Irritability, Musculoskeletal stiffness
Clinical narrative: Several episode of increased tone, or is this tonus, body stiff, arms extended, face red, fussy, 1 second of increased tone, 10 minutes fussy.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Myalgia, Rash, Urticaria
Clinical narrative: A rash started Fri 6/21 and has risen and faded all over for a week and 1/2. Experienced muscle pain in arches of feet, palm of hand and back of hem strings. Treatment with prednisone 60mg for 4 days, 40mg for 2 days, 20mg for 2 days. Persistent intermittent urticaria thru 7/17, given 3rd Rabavert.
Age: 72.0
Sex: M
Vaccine: MMR, PPV, TD
Symptoms: Medication error
Clinical narrative: None reported by pt. Unable to contact pt by phone (2 doses Td given on same day by two nurses at two visits).
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Hypersensitivity, Joint swelling
Clinical narrative: Joint pain and swelling that began the morning after first Hep B in a series of three required for job as vol. fire dept. worker. The vaccine was given May 15 and symptoms not reported until June 3/02. Tx with Celebrax but would not take. Seen at another provider. Hep B panel neg-put on prednisone x 6 days. 6/6/02. pt has hypersensitivity with adverse effect from hepatitis vaccine. Labs: drew hypatic profile.
Age: 4.9
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash, Urticaria
Clinical narrative: Four year old WF received DPT, IPV, MMR on 7/18/02, then developed generalized eruption no f/c, sob, lip swelling. Denies pruritus. Lesions not migrating. Mom and dad with pt. NO prior eruption with vaccination. PE: urticarial plagues trunk, face, generalized. Lips not swollen. Urticarial reaction 2 days immunization-no sign/symptoms of angioedema. Asymptomatic-may use po Benadryl prn itch wont' affect course of rash. May use OTC HC cream bid prn. Tz, sob, lip swelling occurs go to ER. Advised to get flu vaccination as scheduled. Risk of anaphalaxis/angioedema< risk of diseases that immunization protects against. Advised close observation at next immunization, if lip swelling or sob occurs need to get to ER immediately, risk of angioedema/death. Parents understood.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, redness, warm to touch 2-50 cent pieces.Treatment-water and check at clinic. ER if worse.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Red hard raised lump at size of lemon. Advised watch and let us know.
Age: 12.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Pain/redness L arm itchy 6cm x 8cm raised patch some streaking. Keflex 250mg tid x 7d.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site vesicles
Clinical narrative: Induration, swelling, redness, blistering over entire L deltoid area. 7/24 started on prelone, Augmentin.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Ascites, Pyrexia
Clinical narrative: 103 with rash.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cold sweat, Pyrexia, Respiratory disorder
Clinical narrative: Grandmother reports infant was being held by child care provider next day after imm. infant was asleep and stopped breathing. Rushed to hosp. turned blue, was breathing and OK again by the time they got to hosp. NO recommendations from DR. Grandmother states child felt hot-clammy the after of imm. but did not take temp. They gave Tylenol for that.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Large macular erythematous area on L thigh at site of DTaP injection.
Age: 4.3
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: 6/17/02 mother calls stating child given varicella 6/6/02 child now has red spot on legs, did not have last week. Advised child to be brought to office. Child not brought in. 6/19/02 mother calls pt child still with spot of redness, insists report be filed. Speaking with MD and advised mom use Benadryl it if spot still present in AM child to be seen.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: 6/17/02 mother calls stating child given varicella 6/6/02, child now has red spot on leg, did not have last week. Advised child to be seen in office today. Child not brought in . 6/19/02 mother calls and child still with spot on leg. Mother insists report be filed. Speaks with MD and advised mom use Benadryl it if spot still present in AM child to be seen.
Age: 2.6
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: 6/17/02 mother calls states child given varicella 6/6/02. Child now has red spot on leg  it did not have last week. States did have child ran out in high grass day prior (6/16/02). Advised child to be seen , child not brought in. 6/18/02 child seen by the MD. 6/19/02 mother calls with insisting report be filed. Spoke with MD and advised to use Benadryl if still present child to be seen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Child doing well. R deltoid area with redness and edema x 2 days. ROM intact. 6/8/02 Sx: mild, getting better. Tx: Motrin as directed/cold compress, RTC if Sx not better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: 4 year old left shoulder swelling, redness, and itching after was immunized the next day. PE L deltoid area erythema, swelling, prior to treat, non tender. Plan Benadryl 125m po tid, recommend cold compresses.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warm, pain, swelling above elbow. No prior reaction to DTaP. Examined by provider 5/22/02. Put on Tylenol after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: About 2 inches around vaccinated area was red and hot to touch.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Joint swelling, Lymphadenopathy, Malaise, Oedema
Clinical narrative: Received vac. 4/11/02. Began running fever-feeling ill 4/19/02. Fever spiked 105 degrees 4/21/02 resulting in ER visit. Headache, swollen glands and joints-all over body.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Received vac. 4/11/02. Began running fever-feeling ill 4/19/02. Fever spiked 105 degrees 4/21/02 resulting in ER visit. Headache, swollen glands and joints-all over body.
Age: 4.5
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Red, hot, lump, hard R leg, itches local reaction. Treat Zyrtec, cool compresses, on Septra.
Age: 4.5
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Pruritus
Clinical narrative: Red, hot, lump, hard R leg, itches local reaction. Treat Zyrtec, cool compresses, on Septra.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Local reaction=erythema, pruritis at injection site=erythema 3cm around injection site. Currently on Benadryl prn. Recovering.
Age: 5.2
Sex: M
Vaccine: HEP, HEPA, IPV, MMR
Symptoms: Anxiety, Arrhythmia, Cold sweat, Hyperhidrosis
Clinical narrative: Pt became cool, clammy and diaphoretic, BP 110/60, 120/70. O2 given accur 89, EM scaled, taken to ER for further eval. MD tx: arrhythemia, anxiety
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Erythema, Rash macular
Clinical narrative: Infant had blood transfusion 5/17/01 received MMR and varicella 3/13/02. Infant broke out in a macular red rash covering trunk arms and thighs 3/27/02. Had a fever or sick contacts prior to rash. Rash rechecked on 4/4/02-faintly present. Child in registry twice with two different birth dates. NOte in one file that child had transfusion and that MMR should not be given until 4/19/02. The second record was complete and had no notation. On screening questionnaire mother marked that the child had not had a transfusion in the past 11 months. Live vaccine given at HD. Provider called about duplicate records in computer. Records have since been combined and duplicate record deleted.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site inflammation, Swelling
Clinical narrative: Information has been received from a man in a drug store concerning a female nurse who on approximately 12/21/01 was drawing up pneumococcal vaccine 23 polyvalent and poked herself. Subsequently, her finger swelled. It was unknown if the patient sought medical attention. Follow up information received from medical records indicated that on 12/18/01 the registered nurse inadvertently poked herself in the left middle finger with a clean, sterile needle. That night, the finger began to throb and became red with some inflammation. On 12/19/01, the patient presented to the physician and it was noted that she appeared healthy and was in no acute distress. The physician reported that on 12/19/01 it was even worse. On the flexor aspect of her left hand, particularly in the region just distal to the left middle finger metacarpophalangeal joinct (MCP), was swelling, redness and some streaking back up over the palmar aspect of the left hand. There was a very tiny puncture wound, which represented the needle. On 12/19/01 the patient was assessed as having cellulitis secondary to the needle stick. It was noted that the nurse was 100% sure that this was a clean, unused needle. On gram of ceftriaxone sodium (ROCEPHIN) IM was given in the office. She was prescribed cephalexin (KEFLEX) 500 mg PO QID x 10 days. She was sent home and advised to elevate her arm. On 12/20/01 the patient returned for a follow up visit and her finger was more swollen, though less red. She found it very difficult to flex the finger. The physician observed that the left middle finger was swollen from the MCP distally. There was good coloration at the very proximal portion of the finger, and there was less redness than yesterday, but overall more swelling. There was no streaking up the hand towards the arm. On 12/20/01 the patient was assessed as having cellulitis, less likely would be an allergic reaction, but I cannot exclude it. The patient continued with the cephalexin (KEFLEX) as prescribed. Another gram of ceftriaxone sodium (ROCEPHIN) was administered, and it was recommended that she try fexofenadine (ALLEGRA) 60 mg BID to see if the antihistamine effect would reduce some of the swelling. The physician noted that they were gathering all the pneumococcal vaccine 23 polyvalent vials that they had, would not be using them, and were concerned about the possibility of contamination. On 12/21/01 the patient returned again for a follow up visit. It was noted that her finger was still swollen, but was improving. The redness and inflammation was less than it was the day before. There was no streaking up the palm or the forearm. The physician's final assessment was an acute inflammatory reaction following a needle stick injury. It was reported that the needle was clean as noted that the reaction was either allergic or infectious. The patient continued with the cephalexin (KEFLEX) and antihistamines as needed. She was to keep her finger elevated. Additional information has been requested. A 15-day follow up report received 8/5/03 adds no new info.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 60 yr old caucasian female pt with hypertension, no known allergies and no past medical history who on 12/19/2001 was vaccinated IM in the left deltoid with the second 0.5ml dose (lot number 64115/1159L) of pneumococcal vaccine 23 polyvalent. There was no concomitant medication or illness at the time of vaccination. That same evening, the pt developed localized redness, swelling, and heat at the injection site. The pt was seen in the physician's office on 12/21/2001 and treated with diphenhydramine hydrochloride (Benadryl), ibuprofen (Advil), fexofenadine (Allegra) (180 mg QD), celecoxid (Celebrax) (200g, up to BID) and warm compresses. The pt never returned for a follow-up visit, but it was reported that the event lasted for three days and the pt recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a patient (demographics unknown) who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 641115/1159L). Subsequently the patient developed a swollen, red and hot arm. Unspecified medical attention was sought. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction, Pain, Swelling
Clinical narrative: Informaton has been received from a health professional concerning a 63 year old female who on 12/13/01 was vaccinated with one dose of pneumococcal vaccine 23 polyvalent. Eight hours post vaccination, the patient experienced severe local reaction. According to the reporter, the reaction began as pain and swelling and progressed to cellulitis. On 12/17/01, the patient was seen by her physician and was trated with an antibiotic. The patient again saw her physician on 12/24/01 for a follow up visit and the reaction was reported as resolving. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Infection, Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a manager of a physician's office concerning a 79 year old male with no allergies and a history of coronary bypass surgery and recurrent pleural effusions who on 12/19/01 was vaccinated in the arm with a first dose of pneumococcal vaccine 23 polyvalent (lot # 640577/0995L). It was reported that the patient had quite an extensive medical history of being unwell. Concomitant therapy included warfarin sodium (Coumadin) lisinopril (Zestril), atorvasdtatin calcium (Lipitor), levothyroxine na (synthroid), pantoprazole sodium (Protonix) and hydrochlorothiazide (Hydrochlorithiazide Tablets (USP)). On 12/21/01, the patient called the office complaining of redness and itching at the  injection site. It was also reported that there was swelling at the injection site. The physician instructed the patient to keep an eye on the area and that if it became worse to go to the emergency room. The patient went to the ER where he was diagnosed with a staff infection, given antibiotics and released. It was reported that no cultures were done and the diagnosis was made on the visual appearance of the arm. It was noted that the patient was instructed not to receive a booster dose in the future. It was also noted that this was a multidose vial of 5 and that the other two patients who were given doses from this vial have not reported any problems. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Feeling hot, Injection site oedema
Clinical narrative: Information has been received from a medical assistant concerning a 49 yr old white female with no known drug allergies who on 11/30/2001 was vaccinated with a first dose of pneumococcal vaccine-23 polyvalent intramuscularly in the right deltoid (lot number 641530-1351L). Post vaccination, the pt developed a local site reaction. The pt's arm was swollen, hot to touch, and bruised. Ice was applied and the pt declined intramuscular diphenhydramine (Benadryl). The pt was advised to go to the emergency rm if the problem worsened. On 12/05/2001, the pt recovered. The reporter requested a lot check of lot 641530/1351L. The records of testing prior to release had been checked by GMP Compliance and found to be satisfactory. The lot complied with the standards of the Center for Biologics Evaluation and Research and was re;eased. The pt's husband also developed injection site swelling and warmth post vaccination with pneumococcal vaccine 23 polyvalent (see WAES01120220). No additional information is expected.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Information has been received from a health professional and a women in a physician's  office concerning an 82 yr old white male with an allergy to the "flu vaccine" who on 12/18/2001 in the am was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (lot number 640981-1050L) in the right deltoid. Concomitant therapy included clopidogral bisulfate (Plavix), amlodipine besylate (+) benazepril hydrochloride (Lotrel) and cetirizine hydrochloride )Zyrtec). On 12/19/2001 in the am, the pt developed swollen right arm, red down to the elbow, painful, very warm to the touch and apprx. 7in oval red mark right above the elbow (below the injection site). It was noted that the pt had initially been seen for a routine office visit. The pt sought unspecified medical attention. The outcome was not reported. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: Follow-up info received indicated that the pt had fully recovered. No further info is available.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health care professional concerning a 66 year old white male with no known allergies who on 1/8/02 was vaccinated in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy included Manair, albuterol, Advair, and Flovent. On 1/10/02 (previously reported as 1/9/02) the pt developed a red, swollen, hot and painful left arm from two inches above the wrist to two inches below the armpit. Unspecified medical attention was sought. Additional info has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a woman in a doctor's office, a registered pharmacist and a registered nurse, concerning a 78  year old white female who on 10/24/01 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent in the right deltoid (Lot # 635892/1197K). There was no illness at the time of vaccination. On 10/26/01 (previously reported as within 12 hours of administration of the vaccine), the patient developed an injection site reaction with enlarged , red, hot and painful areas. It was also reported that the patient developed redness and swelling at the injection site, a slight fever and was tired. It was reported that the arm "appears to have reaction similar to cellulitis". The patient was treated with cephalexin (Keflex) (previously reported as ciprofloxacin hydrochloride (CIPRO), acetaminophen (Tylenol) and warm packs. The patient was seen at the physician's office on 10/29/01 and he documented that the injection site was getting better and that the warm packs made the reaction worse. The patient was instructed to use cold packs. It was noted that the patient had since recovered. The pharmacist who supplied the physician's office with the pneumococcal vaccine 23 polyvalent was worried about using the last vial. The records of testing prior to release of this lot (635892/1197K have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a woman in a doctor's office, a registered pharmacist and a registered nurse, concerning a 78  year old white female who on 10/24/01 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent in the right deltoid (Lot # 635892/1197K). There was no illness at the time of vaccination. On 10/26/01 (previously reported as within 12 hours of administration of the vaccine), the patient developed an injection site reaction with enlarged , red, hot and painful areas. It was also reported that the patient developed redness and swelling at the injection site, a slight fever and was tired. It was reported that the arm "appears to have reaction similar to cellulitis". The patient was treated with cephalexin (Keflex) (previously reported as ciprofloxacin hydrochloride (CIPRO), acetaminophen (Tylenol) and warm packs. The patient was seen at the physician's office on 10/29/01 and he documented that the injection site was getting better and that the warm packs made the reaction worse. The patient was instructed to use cold packs. It was noted that the patient had since recovered. The pharmacist who supplied the physician's office with the pneumococcal vaccine 23 polyvalent was worried about using the last vial. The records of testing prior to release of this lot (635892/1197K have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Oedema, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 66 yr old male who was vaccinated with his first dose of pneumococcal vaccine 23 polyvalent. Subsequently, within two days  of receiving the vaccine, the pt experienced paresthesia in his hands and developed unspecified swelling. The nurse reported that this was the first time that the pt had ever received a pneumococcal vaccine. The nurse also reported that she was from the health dept and that the pt did not ever receive his vaccine at the health dept. Unspecified medical information was sought. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was "recently" vaccinated with pneumococcal vaccine 23 polyvalent in the left arm (lot number 641115/1159L). The pt developed redness from her left shoulder to her elbow, and she complained that her arms was very tender. The pt sought unspecified medical attention. The nurse also reported that 3 other pt developed erythema and pain post vaccination with pneumococcal vaccine 23 polyvalent (see WAES 0202USA01474). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with pneumococcal vaccine 23 polyvalent two days after it had expired. Subsequently, the patient experienced a headache, felt tired and experienced a local reaction. Unspecified medical attention was sought. No further details were provided and at the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 77 yr old caucasian female pt with diabetes mellitus, hypertension, hyperlipidemia, palpitations, cataracts, xerosis, and no known drug allergies who on 01/16/2002 at 1300 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent intramuscularly in the left deltoid (lot number 641116/1160L). On 01/17/2002, at 1430, the pt developed a local reaction which occurred "8 cm below the injection site" and was characterized by pain, swelling, erythema, and warmth. The pt was treated with celecoxib (Celebrax) 200mg daily for 5 days. Subsequently, the pt recovered. No additional information is expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site oedema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 45 year old white asplenic female with a history of splenectomy in 1993 for hemolytic anemia who on 1/15/02 was vaccinated with pneumococcal vaccine 23 polyvalent in the left deltoid. Concomitant therapy included sulfasalazine and folate. On 1/15/02, hours after administration, the patient developed pain, swelling, redness, and tennis ball sized induration at the injection site. The patient had a fever to 103 F for 3 days with increased inflammation at the injection site. The patient was treated for possible pyrogenic infection with cephalexin for 7 days with good results. No additional information is expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 45 year old white asplenic female with a history of splenectomy in 1993 for hemolytic anemia who on 1/15/02 was vaccinated with pneumococcal vaccine 23 polyvalent in the left deltoid. Concomitant therapy included sulfasalazine and folate. On 1/15/02, hours after administration, the patient developed pain, swelling, redness, and tennis ball sized induration at the injection site. The patient had a fever to 103 F for 3 days with increased inflammation at the injection site. The patient was treated for possible pyrogenic infection with cephalexin for 7 days with good results. No additional information is expected.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Joint range of motion decreased
Clinical narrative: Information has been received from a health professional and a 52 year old Caucasian male consumer with no known allergies and diabetes mellitus, stomach problems, cardiovascular disease and hypercholesterolemia and a history of a reaction to Trimax used in dental surgery and slight reaction to flu shots through the years who on 12/13/01, at approximately 11:45 am, was vaccinated in the right deltoid with pneumococcal vaccine 23 polyvalent (lot #641531/1352L). There was no illness at the time of vaccination. Concomitant therapy included atorvastatin calcium (LIPITOR), alprazolam (XANAX), atenolol, ranitidine hydrochloride (ZANTAC) and glipizide (GLUCOTROL). On 12/13/01, at approximately 13:30 pm, the patient called the local ER and they suggested using hot packs. It was reported that his seemed to make it worse and the upper arm continued to swell through 2/15/01. The second day, on 2/14/01, he called the health department and they suggested cold packs which seemed to help. There was no laboratory work done. It was reported that this lasted 2.5 days. The patient was unable to elevate his arm until 2/16/01. By 2/17/01 the patient reported the arm is normal. It was also noted that the patient had the influenza vaccine about a month and a half prior and did not have any reaction. Unspecified medical attention was sought.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female in her 60's with suspected immunodeficiency who received a dose of pneumococcal vaccine 23 polyvalent in approximately 1998. She received a second dose in November 2001 to assess the immunity response to the vaccine; results were equivocal. In December 2001 the patient received a third dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient experienced an injection site reaction with redness, induration and warmth. No details were provided concerning duration or treatment. No adverse symptoms were reported after the first and second doses. Unspecified medical attention was sought. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Asthma, Lacrimation increased, Swelling face, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 34 year old Native American female with asthma and urticaria (dx'd at visit on 1/22/02) and allergies to acetaminophen (+) propoxyphene Napsylate (Darvocet), loratadine (Claritin) and doxycycline who on 1/22/02, at 11:00 AM, was vaccinated IM, in the left deltoid, with pneumococcal vaccine 23 polyvalent (lot 641116/1160L). Concomitant medication included estrogens conjugated (Premarin), cyproheptadine hydrochloride (Periactin), flunisolide (Aerobid) and albuterol. It was reported that the pt experienced an anaphylactic reaction. The symptoms onset at the pt's home and she went to the local ER. The symptoms were described as severe swelling on the left side of her face and lips and excessive tearing in her eyes. She was treated in the ER with epinephrine and steroids and released. The symptoms resolved the same day. Another pt (WAES 0201USA03094) experienced swelling, redness and warmth at the injection site after vaccination with the same lot. The reporter "questioned the stability" of 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. Anaphylactic reaction was considered to be an "Other Important Medical Event".
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female patient with a penicillin allergy and no significant medical history who on 1/21/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 1/22/02 patient reported she developed a fever of 101 and a 5-6 cm raised red spot at the injection site. On 1/24/02, she called the physician's office and reported that her temperature was 98 degrees. The patient recovered from the fever and the outcome of the raised red spot at the injection site was unknown. Unspecified medical attention was sought. Additional information has been requested. A 15-day follow up report received 08/05/2003 adds: Info has been received from a woman at a family practice office concerning a 57 year old female pt with a penicillin allergy and no significant medical history who on 01/21/2002 was vaccinated in the right deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #637487/1071K). There was no illness at the time of vaccination. On 01/22/2002 pt reported she developed a fever of 101 and a 5-6 cm raised red spot at the injection site. On 01/24/2002, she called the physician's office and retported that her temperature was 98 degrees. Follow-up info indicated that the pt experienced a fever and sore arm. The pt recovered from the fever and the outcome of the raised red spot at the injection site and sore arm were unknown. Unspecified medical attention was sought. Additional info has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 47 yr old Native American woman with hypertension,Type 2 diabetes mellitus and low back pain and no other known medical history who on 01/16/2002, at 0900 was vaccinated IM in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot number 641116/1160L) also reported as 1106L-invalid. It was reported that the pt experienced a quick onset of swelling, redness, pain, and warmth at the injection site. The pt returned to the clinic on 01/17/2002 for a precription for pain and was advised to use a cold pack occasionally to the site. The pt returned again to the clinic on 01/21/2002 and the symptoms had resolved. Another pt (WAES0201USA02698) had a similar experience with vaccination with the same lot. The reporter "questioned the stability" of the lot. The records of testing prior to release of this lot 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.
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an RN concerning a female with sinusitis who on 1/21/02 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641027/1051L), in the upper arm. Concomitant therapy included Lorabid. On 1/25/02, the pt had localized bruising, redness, pain, skin warm to touch, tenderness and swelling. The pt sought unspecified medical attention. It was reported that 2 weeks later, the pt was "fully recovered". Two other pts had a similar experience (WAES 0202USA00145 and 0202USA00146). It was also reported that 1 of these 3 pts had "swelling down to her elbow, 6" or more", and as of 1/31/02, is still experiencing tenderness and redness. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received on 1/31/02 from an RN concerning a female who "last week" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt had warmth, tenderness and swelling. The pt sought unspecified medical attention. Two other pts had a similar experience (WAES 0202USA00011 and 0202USA00146). It was also reported that 1 of these 3 pts had "swelling down to her elbow, 6" or more" and as of 1/31/02, is still experiencing tenderness and redness. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received on 1/31/02 from an RN concerning a pt (demographics unspecified) who "last week" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt had warmth, tenderness and swelling. The pt sought unspecified medical attention. Two other pts had a similar experience (WAES 0202USA00011 and 0202USA00145). It was reported that 1 of these pts had "swelling down to her elbow, 6" or more" and as of 1/31/02, is still experiencing tenderness and redness. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a male consumer with a Vicodin Tablet allergy and a history of fungus growth in the lung (1997) who on 1/31/02 at 09:00 was vaccinated with the 1st dose (lot 640577/0995L) of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 1/31/02 included Lipitor, Zestril, omeprazole; Zyban; nicotine patch; Viagra; Atrovent; Slo-Bid and vitamins (unspecified). On 1/31/02, about 4 hours after vaccination, the pt's arm began to hurt. He reported that this became worse later in the afternoon. His arm also became swollen later that day. He noted that as of 2/1/02, the swelling and pain were somewhat reduced. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain
Clinical narrative: Information has been received from a health professional concerning a female pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637345/1449K). Subsequently, the pt experienced significant body aches, a large area of erythema, redness and pain (at least 3" X 3"). Unspecified medical attention was sought. It was reported that 2 other pts (WAES 0202USA00635 and 0202USA00633) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female with a history of eggs allergy as a child and previous reaction to flu vaccination "many years ago" who was vaccinated in the deltoid muscle with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a severe injection site reaction with swelling down to wrist. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Unevaluable event
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female who on 12/5/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (invalid lot 8030L reported) (site unknown). Concomitant therapy on 12/5/01 included a dose of influenza virus vaccine (site unknown). The pt developed a local reaction that same day, the pharmacist referred to the reaction as an injection site reaction. It was noted that she was afebrile. No past vaccination information was available. No treatment was needed, but the pt sought unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 60 year old pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included tetanus toxoid in the same arm. Subsequently, the pt experienced redness and swelling. The physician questioned whether it could be related to the pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an RN concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 637487/1071K). Subsequently, the pt developed redness, warmness, swelling and cellulitis. The pt went to the local ER and was treated with warm soaks. The pt was not admitted to the hospital. Subsequently, the pt recovered. The nurse had requested a lot check of lot 637487/1071K. The records of testing prior to release of this lot had been checked by GMP Compliance and found to be satisfactory. The lot complied with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP, DTP, HIBV, IPV
Symptoms: Crying, Irritability, Somnolence
Clinical narrative: My child became very sleepy, and slept for five hours straight. She has also become very fussy cranky and has also been crying for no reason.
Age: 36.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Lymphopenia, Monocytosis, Pain, Pyrexia
Clinical narrative: Report 2002000879-1 describes muscle aches in a 36 year old male who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix). Medical history, concurrent condition, and concurrent medications were not specified. The vaccinee received his first injection of Twinrix on 01/04/2002. Later that day, he experienced muscle aches, followed by fever and joint pain. He presented for medical attention on 1/14/02, stating that he had experienced muscle aches, fever, and joint pain continuously since 1/4/02. He reported that his temperature ranged from 101 to 103 degrees F; in the physician's office, his temperature was 102.1 degrees F. The physician also noted that the vaccinee had a rash. Treatment and outcome of these events was unknown.
Age: 36.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Rash, Red blood cell sedimentation rate increased, Viral infection, White blood cell count increased
Clinical narrative: Report 2002000879-1 describes muscle aches in a 36 year old male who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix). Medical history, concurrent condition, and concurrent medications were not specified. The vaccinee received his first injection of Twinrix on 01/04/2002. Later that day, he experienced muscle aches, followed by fever and joint pain. He presented for medical attention on 1/14/02, stating that he had experienced muscle aches, fever, and joint pain continuously since 1/4/02. He reported that his temperature ranged from 101 to 103 degrees F; in the physician's office, his temperature was 102.1 degrees F. The physician also noted that the vaccinee had a rash. Treatment and outcome of these events was unknown.
Age: 36.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Myalgia, Pyrexia, Rash
Clinical narrative: Report 2002000879-1 describes muscle aches in a 36 year old male who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix). Medical history, concurrent condition, and concurrent medications were not specified. The vaccinee received his first injection of Twinrix on 01/04/2002. Later that day, he experienced muscle aches, followed by fever and joint pain. He presented for medical attention on 1/14/02, stating that he had experienced muscle aches, fever, and joint pain continuously since 1/4/02. He reported that his temperature ranged from 101 to 103 degrees F; in the physician's office, his temperature was 102.1 degrees F. The physician also noted that the vaccinee had a rash. Treatment and outcome of these events was unknown.