chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Information has been received from an RN concerning a male who on 4/22/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 640744/0994L). Subsequently, the pt developed redness at the injection site. The pt sought unspecified medical attention. The reporter that the lot be checked. 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.  Follow up on 07/01/2003: "Information has been received from a registered nurse concerning a 71 year old male (also reported as 74 year old) who on 04/22/2002 at 10:00am was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 640744/0994L) (IM), in the left deltoid "with usual aseptic technique."  there was no illness at the time of vaccination.  On 04/22/2002, the patient developed redness at the injection site.  On 04/23/2002 the patient presented to the doctor's office and was diagnosed with "cellulitis that involved his whole left arm."  The patient was treated ceftriaxone sodium (Rocephin)(IM) and ciprofloxacin HCl (Cipro) (500mg) (BID).  On 04/26/2002 the patient was seen again in the office and "the cellulitis site appeared to be larger" (the patient was also reported as "better").   The patient was treated again with deftriaxone sodium (Rocephin)(IM) and was given cetirizine (Zyrtec).  On 04/28/2002 (also reported as 05/01/2002) the patient recovered.  The reporter requested that the lot be checked.  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.  The reporter considered cellulitis to be an other important medical event (OMIC).  Additional information is not expected."
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a pt who in approx. 4/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (dose series unk). The pt developed hives and an acute skin reaction with swelling and itching from the injection site to her elbow within minutes of receiving the vaccine (approx. 4/02). It was reported that the pt  was given a skin test for reactivity against pneumococcal vaccine 23 polyvalent. The pt tested positive for minute dilutions of 1:10,000 of pneumococcal vaccine 23 polyvalent and 2 controls were done which were negative. The physician planned on getting 8 more controls. The physician also noted that the pt has had a positive IgE to pneumococcal vaccine 23 polyvalent and will be published. It was unknown if the pt had any past medical history, concomitant therapies or had sought medical attention. A return visit was scheduled. The physician also reported that another pt developed bronchospasm after vaccination with pneumococcal vaccine 23 polyvalent (WAES 0204USA02764). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Injection site pain, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning her 60 year old hospitalized mother with an allergy to Duramorph and with a history of pneumonia NOS, cardiac failure congestive and septic shock who on 4/30/02 was vaccinated in her hip with pneumococcal vaccine 23 polyvalent. Concomitant therapy included cefepime (Maxipime) and gentamicin. The pt's daughter reported that her mother had been hospitalized since 4/6/02 with pneumonia and complication of CHF and septic shock. She reported that her mother seemed to have recovered from all complications and was fever free. On 4/30/02, she was administered pneumococcal vaccine 23 polyvalent in her hip. By that same evening, the pt was again febrile. The pt also had a severe local reaction to pneumococcal vaccine 23 polyvalent injection. It was reported that the injection site was so painful that the pt could not walk after receiving the injection. The pt's daughter reported that on 5/2/02, her mother was started on 2 antibiotics that she "thinks" were Maxipime and gentamicin. On 5/3/02, the pt still had a fever and now had a rash over most of her body. As of 5/6/02, the pt still had a fever and rash. The pt's highest temperature measurement was reported as 102.5F. Additional information had been received from a physician. The physician reported that during a "complicated hospitalization", the pt with pneumonia, primary pulmonary hypertension and an UTI received pneumococcal vaccine 23 polyvalent and then developed a fever 24 hours later. The pt recovered from the fever "days later". The physician reported that he doubted that the vaccine caused the fever. The physician reported that a UTI (concurrent condition) was suspected as the cause of the fever. Additional information is not expected.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Information has been received from a pharmacist and a pharmacy intern concerning a 41 year old male pt with HIV, bronchitis and on Bactrim therapy for prophylaxis of pneumocystis who on 5/1/02 at 11:00 was vaccinated SC with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641116/1160L). In approx. 5/02, the pt developed flu-like symptoms described as muscle ache, fever, and weakness. In follow-up, the pharmacy intern described the pt's symptoms as fever/chills, myalgia, arthralgia and malaise. The pharmacist reported that the flu-like symptoms lasted 3 days after administration of the vaccine. The pharmacist also reported that since the vaccination, the pt developed the same flu-like symptoms after every dose of Bactrim, which was taken 3 X weekly. In follow-up, the pharmacy intern reported that the pt has had no previous problems with Bactrim therapy. The outcome of the pt's flu-like symptoms was not known. Unspecified medical attention was sought. No further information is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an MA concerning a 78 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a local reaction which included swelling, redness and heat. The MA reported that the reaction was more pronounced than she thought "was customary". The outcome of the pt's local reaction was unknown. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 48 year old male with no known allergies who on 5/7/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included Prevacid (30mg BID); morphine and  Librium. There were no other reported vaccinations that day. On 5/7/02, the pt developed a bad local reaction. It was reported that "by the evening of the day of administration", the pt developed redness (about 15cm in diameter), mild induration and soreness on the right arm, following the injection (slightly below the deltoid) and a fever of 103F. The reporter indicated that there may be other causes of the fever, but did not clarify. It was noted that the pt was unable to take any NSAIDS. On 5/9/02, it was reported that "at this time, the condition appears to be getting worse". The pt sought unspecified medical attention. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site oedema, Medication error, Pain
Clinical narrative: Information has been received from an MA concerning a 36 year old female with no chronic illnesses and a cephalexin (Keflex) allergy with hives and a shellfish allergy who in the morning of 5/8/02, was inadvertently vaccinated with pneumococcal vaccine 23 polyvalent, ID, 0.1ml, instead of a PPD ordered for work. Concomitant therapy included desogestral/ethinyl estradiol (Ortho-Cept), vitamins (unspecified), 50mg, 4 X a day. The pt was scheduled to be rechecked on 5/9/02. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: On 05/08/2002 at 15:15 the pt called and returned to the medical office with site swelling, tenderness and warmth (no neuropathy). The pt was treated with diphenhydramine (BENADRYL) 50 mg, 4 times a day. The pt was scheduled for a re-check on 05/09/2003. Follow up info was received frm the medical assistant who reported that the pt was also treated with ice. The medical assistant reported that the pt had recovered from her site swelling and tenderness.  Additional follow up information was received from the medical assistant who confirmed that the medication error resulted from a procedural error in their office. The nurse intended to administer the PPD tuberculin skin test to the patient but inadvertently vaccinated the patient with pneumococcal vaccine 23 polyvalent, using the "mantoux" administration procedures (0.1 mL of liquid injected IM). The reporter confirmed that there was no confusion regarding the appearance or name of the product and the error did not result from any confusion as to the proper dosing of the product.  No additional info is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician and his 73 year old white female pt who on 4/19/02 was vaccinated IM with a 0.5cc dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Concomitant therapy included atorvastatin calcium (Lipitor) (20mg X 1 daily); lisinopril (reported as Prinivil and Zestril (20mg 1 daily), metoprolol succinate (Toprol XL Tablets) (25mg 1 daily); aspirin and amlodipine besylate (Norvasc) (5mg 1 daily). On approx. 4/21/02 (also reported as 4/22/02 and 4/26/02), the pt developed welts and "terrible itching" all over her body. Medical attention was sought and the physician confirmed urticaria and pruritus. The experience was treated with prednisone (5mg "as directed"); cetirizine hydrochloride (Zyrtec) (10mg 1 daily); halobetasol propionate (Ultravate Cream) ("as directed") and permethrin (Elimite Cream) ("as directed"). At the time of report, the experience was still being treated and the pt had not recovered. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Headache, Injection site swelling, Urticaria
Clinical narrative: Information has been received on 5/23/02 from an RN concerning a 62 year old female with no known drug allergies who "2.5 months" prior to "last week" and "last week" was vaccinated with the 1st and 2nd dose of pneumococcal vaccine 23 polyvalent, respectively. This dose not comply with the recommended dosage schedule. It was reported that the pt was re-vaccinated since there was a temperature instability issue with the 1st dose. Concomitant therapy the day of the 2nd dose included Hep-B vaccine recombinant (yeast). Within hours, after the 2nd dose, the pt developed a headache, hives, and swelling at both injection sites. The pt sought unspecified medical attention. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: (malaise added to reactions following 2nd dose). It was reported that 30 minutes after leaving the clinic the pt began complaining of headache and tenderness around the injection site. The pt had requested that both injections be given on the same arm due to pre-existing muscle soreness on the right deltoid. By 1:00 PM that afternoon, the pt developed a rash on the left arm and the injection site was swollen about the size of a half dollar. The pt notified her son who is an ER physician. He prescrived diphenhydramine HCl (Benadryl) and ibuprofen (Motrin) for the pain, inflammation and rash, and also moist soaks and elevation of the left arm. It was noted that the pt did not receive any tests with the prescribed treatment. The pt's husband notified the reporter that she had decreased pain and swelling of her left arm and her rash disappeared. It was also noted that the pt had no other adverse events following prior vaccinations. It was reported that the pt recovered on 05/23/2002. No further info is expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 48 year old white female, with allergies to tetracycline and "gold shots", who on 12/18/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641115/1159L), administered SC, in the left arm. The pt had pharyngitis and an upper respiratory infection at the time of vaccination. Subsequently, on 12/20/01, the pt developed a swollen, red and hot arm. The pt stated that she had a "large, red, hot area due to pneumonia injection". She was in no distress, but stated it was "painful". Unspecified medical attention was sought. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from an RN concerning a pt (demographics unknown) who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (from either lot 641532/1353L or 641130/1161L). Subsequently, the pt developed an injection site reaction. The reaction involved the "entire upper arm from the elbow to the shoulder" and was characterized by redness, warmth and fever. The pt sought unspecified medical attention and was treated with an antibiotic. The reporter expressed a concern with the lots. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: She was seen in the physician's office on 05/31/2002. At that time, she stated that she could not raise her arm above her head "one day ago". She had circumferential erythema, described as pink, circumscribed from the top of the deltoid to 4 cm below the elbow. Her arm was very warm to the touch and tender. She had good range of motion and pulses. Her temperature was 99.7 degrees. The pt was treated with an antibiotic. On 06/18/2002, the pt complained of mild discomfort in the right axillary area. No adenopathy was noted and pt had normal use of muscles. On 09/09/2002, it was reported that there was "no notation of problems in following office visits". The reporter expressed a concern with the lot. It was noted that she had previously been vaccinated with pneumococcal vaccine 23 polyvalent in 1995. 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. No further info is expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Pain
Clinical narrative: Information has been received from an RN concerning a pt (demographics unknown) who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (from either lot 641532/1353L or 641130/1161L). Subsequently, the pt developed an injection site reaction that involved "one-half the circumference" of the arm. The pt sought unspecified medical attention and was treated with an antibiotic. The reporter expressed a concern with the lots. Additional information has been requested. A 15-day follow report received 8/5/2003 adds: She developed pain and swelling of the right arm and was seen by the physician on 05/31/2002. At the time, she had right upper arm swelling, erythema, and tenderness involved 2/3 of the upper arm. The erythematous area extended from her shoulder to 2 inches above the right elbow. Laboratory testing revealed the following: WBC and blood culture normal. The pt was treated with an antibiotic. On 06/07/2002, the white blood cell count was noted as normal, the right upper arm erythema and swelling had resolved, and there was a "little bit" of pain. The reporter indicated that there was "no notation of any further problems in following office visits." The reporter expressed a concern 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: 9.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Information has been received from an RN concerning a 9 year old female with no known drug allergies, with a history of splenectomy in 1973 who in 1973 was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced fever and "bad" local reaction. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning his wife who in 1981 was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. Subsequently, she developed a sore arm. Unspecified medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician who in 1981 was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. Subsequently, the physician developed a sore arm. It was noted that the physician, "did not want to report adverse event for his sore arm, said no big deal". Unspecified medical attention was sought. Further information is expected.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Coordination abnormal, Pyrexia, Rash
Clinical narrative: Fever 8/1/02-8/7/02(103F-105F) Rash 8/5/02 Ataxia developed 8/5/02.  Follow up:  child had trouble with balance 08/07/2002.  Parents to bring child back to office if problem worsens.
Age: 4.0
Sex: F
Vaccine: DTP, HEPA, IPV, MMR
Symptoms: Contusion, Periorbital oedema, Purpura, Urticaria
Clinical narrative: Hives developed two days after vaccination on her belly and back.  They spread out to her legs, arms, feet, and face.   On Tuesday 8/6 I took her back to the Dr.  They perscribed Clariten and Benadryl.  The hives disappeared until Sunday 8/11 when they reappeared.  The hives then turned into a big red spot (like dried blood under the skin, and then into big dark bruises.  Her eyes were red and swollen and her face was swollen.  On Monday I called the Dr again...they did not see us intil Tuesday.  They did a urine sample to see if there was blood in her kidneys.  No blood.  They diagnosed the condition as an overactive immune system making her vessel ooze blood.  Called something like Purpara.  The said this was not related to the immunization, but I don't believe that.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Pain
Clinical narrative: A female consumer reported that she received Flu Shield vaccine on 1/22/01 in her left arm. Concomitant with vaccine administration, she experienced inflammation with stiffness on her left arm. Two hours post-immunization she "felt a know (nodule" under her left arm. After awhile (exact time unk) she felt two more knots under her left arm, toward her back, she has also experienced tingling and pulling sensations in her left arm. Once while driving her left arm "gave out" and she was seen by her physician. She now has Carpal Tunnel Syndrome, nerve damage at the left elbow and burning sensation around the left shoulder blade. She was treated at the ER with a "steroid shot (medication name and dose not identified by consumer). Currently she goes to physical therapy and is on a "muscle relaxant" (medication not identified by consumer). This case was serious since Carpal Tunnel Syndrome and nerve damage were considered medically important in this case. No additional info was available as of the date of this report.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Carpal tunnel syndrome, Injection site inflammation, Musculoskeletal stiffness, Nerve injury, Paraesthesia
Clinical narrative: A female consumer reported that she received Flu Shield vaccine on 1/22/01 in her left arm. Concomitant with vaccine administration, she experienced inflammation with stiffness on her left arm. Two hours post-immunization she "felt a know (nodule" under her left arm. After awhile (exact time unk) she felt two more knots under her left arm, toward her back, she has also experienced tingling and pulling sensations in her left arm. Once while driving her left arm "gave out" and she was seen by her physician. She now has Carpal Tunnel Syndrome, nerve damage at the left elbow and burning sensation around the left shoulder blade. She was treated at the ER with a "steroid shot (medication name and dose not identified by consumer). Currently she goes to physical therapy and is on a "muscle relaxant" (medication not identified by consumer). This case was serious since Carpal Tunnel Syndrome and nerve damage were considered medically important in this case. No additional info was available as of the date of this report.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Skin nodule
Clinical narrative: A female consumer reported that she received Flu Shield vaccine on 1/22/01 in her left arm. Concomitant with vaccine administration, she experienced inflammation with stiffness on her left arm. Two hours post-immunization she "felt a know (nodule" under her left arm. After awhile (exact time unk) she felt two more knots under her left arm, toward her back, she has also experienced tingling and pulling sensations in her left arm. Once while driving her left arm "gave out" and she was seen by her physician. She now has Carpal Tunnel Syndrome, nerve damage at the left elbow and burning sensation around the left shoulder blade. She was treated at the ER with a "steroid shot (medication name and dose not identified by consumer). Currently she goes to physical therapy and is on a "muscle relaxant" (medication not identified by consumer). This case was serious since Carpal Tunnel Syndrome and nerve damage were considered medically important in this case. No additional info was available as of the date of this report.
Age: 56.0
Sex: F
Vaccine: TTOX, TD
Symptoms: Asthenia, Chest pain, Headache, Hypoacusis, Hypoaesthesia
Clinical narrative: Allergic reaction to tetanus shot; left arm swelling; tenderness; pain radiates up into neck and across upper back.
Age: 56.0
Sex: F
Vaccine: TTOX, TD
Symptoms: Injection site erythema, Injection site swelling, Migraine, Nasal congestion, Pyrexia
Clinical narrative: Allergic reaction to tetanus shot; left arm swelling; tenderness; pain radiates up into neck and across upper back.
Age: 56.0
Sex: F
Vaccine: TTOX, TD
Symptoms: Back pain, Injection site pain, Injection site reaction, Injection site swelling, Neck pain
Clinical narrative: Allergic reaction to tetanus shot; left arm swelling; tenderness; pain radiates up into neck and across upper back.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Eye disorder, Hemiparesis, Myocardial infarction, Pneumonia
Clinical narrative: A 79 year male consumer received Flu Shield vaccine on 12/01/01. One week post-immunization, he developed pneumonia. In early Jan 2002, he experienced a heart attack and was hospitalized. In early Mar 2002, he experienced a stroke and was also hospitalized at that time. The stroke caused left sided weakness and speech impairment. He states his left eye in now larger. He is now taking warfarin sdium. No additional info was available as of the date of this report.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: A 79 year male consumer received Flu Shield vaccine on 12/01/01. One week post-immunization, he developed pneumonia. In early Jan 2002, he experienced a heart attack and was hospitalized. In early Mar 2002, he experienced a stroke and was also hospitalized at that time. The stroke caused left sided weakness and speech impairment. He states his left eye in now larger. He is now taking warfarin sdium. No additional info was available as of the date of this report.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Autism, Convulsion
Clinical narrative: Developed seizure and now has autism.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: 8/8/02 mother called and states "RT arm (injection site)sl. red and hot to touch." She described a "uarter-sized area." Dr. notified and told to use Benadryl and cold compresses-if sx persist or worsen to f/up with him. Mother verbalized understanding. 8/9/02 child came to see Dr. Rt arm red, warm to touch and inflammed arm about the size of a lemon noted. Child in no distress and no c/0 pain. Meds/instructions given per Dr.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had local swelling and redness at site of DTaP right arm. Mom instructed to use warm compresses and give Ibuprofen. Mom to call in 24 - 48 hours if no improvement.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Mom called 08/05/2002 reporting MD visit because left arm of pt; increased redness circling arm with hard raised knot. Treated with Benadryl.
Age: 4.9
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left arm increased redness; raised harness circling arm and extending posterior shoulder.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Right leg swelling with circumference 9 1/2" thigh; left leg circumference 9 1/4" thigh.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red and warm to touch.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Irritability, Lymphadenopathy, Pain, Pyrexia, Rash morbilliform
Clinical narrative: Measles rash X 1 day. Had swollen gland, all over achiness X 7 days, very cranky and fussy X 6 weeks. Temperature up to 100F X 3 days.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Eye pain, Injection site swelling, Injection site warmth, Oral intake reduced, Pruritus
Clinical narrative: On 7/29/02, pt reports arm swelled to twice it's normal size the day after shot. Had fever and was unable to eat over the weekend. Eyes hurt and had itchy face. Slept OK last night (7/28/02) and back to eating normally. Right arm no longer swollen but still a bit warm to the touch. No fever. Eyes and face feel normal now.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Pyrexia
Clinical narrative: On 7/29/02, pt reports arm swelled to twice it's normal size the day after shot. Had fever and was unable to eat over the weekend. Eyes hurt and had itchy face. Slept OK last night (7/28/02) and back to eating normally. Right arm no longer swollen but still a bit warm to the touch. No fever. Eyes and face feel normal now.
Age: 0.7
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Injection site swelling
Clinical narrative: Day after vaccines were administered mother noticed a raised red streak down the arm of the infant in the arm the IPV was administered.  The streak lasted about 2 weeks and faded into a scar which remains.  Visited doctor 2 days after streak appeared - doctor was unsure of cause of streak.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site vesicles, Irritability, Pruritus, Rash, Restlessness
Clinical narrative: Received Varicella vaccination on 04/25/02.  Next day, vesicles noted around injection site.  1-2 days later, rash developed on back, trunk, legs, and scalp.  Itching noted.  Restless and irritability noted that evening and for approximately three days after injection.  Rash lasted approximately 10 days.  Follow uP: no report of reaction at Prevnar site.  No prescription. Seen by pediatrician 4 days after injection and was diagnosed with a possible allergic reaction to varicella vaccine.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: prolonged generalized seizure (approx 45mins) requiring treatment in ER including ativan and dilantin to arrest seizure activity, followed by 2 day admission in hospital; this event occurred at approximately 9am on the day following vaccination (vaccines were administered in the afternoon); temperature upon arrival at ER was 38.2C; following resolution of seizure activity and after a post-ictal perios the patients' exam returned to baseline
Age: 2.0
Sex: U
Vaccine: DTAP, HEPA, MMR
Symptoms: Oedema
Clinical narrative: Local swelling of LEFT arm around injection site to elbow and on to chest per mother's description. Resolved in 24-48 hours. not seen by physician
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: A physician reported via a company representative that a 2 month old infant received Prevanr vaccine (date not specified) along with three other vaccines (not identified). The following day, the infant died from SIDS. The reporting physician did not think that the vaccines had anything to do with the death. No additional information was available as of the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested. Follow up information via telephone contact was obtained from the physician on 10/03/02. She clarified the infant's age (4 months rather than 2 months) and reported that the child died as a result of co-sleeping with the parents. (Initial report)A physician reported via a company representative that a 2 month old infant received Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine (date not specified) along with 3 other vaccines (not identified).The following day, the infant died from SIDS. The reporting physician did not think the vaccines had anything to do with the death. No additional information was available as of the date of this report.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing 30 minutes after injection with dizziness, Symptoms subsided but reoccurred at 3 hrs and 6hrs. Dizziness continued sporadically  for the next 3 days.
Sex: F
Vaccine: DTAP, PNC
Symptoms: Bacterial infection, Contusion, Injection site erythema, Pruritus, Pyrexia
Clinical narrative: Shot given 2 pm-next am -Erythema that looked like it would bruise around injection site- Got 3 inches in diameter - The next day rash started, looked like hives (trunk) 4d later serpiginous and target lesions on trunk, face, upper arms and legs - Itchy-Temp. 99.9
Sex: F
Vaccine: DTAP, PNC
Symptoms: Rash, Skin ulcer, Urticaria
Clinical narrative: Shot given 2 pm-next am -Erythema that looked like it would bruise around injection site- Got 3 inches in diameter - The next day rash started, looked like hives (trunk) 4d later serpiginous and target lesions on trunk, face, upper arms and legs - Itchy-Temp. 99.9
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy, Flat affect
Clinical narrative: On 11/10/98, sudden onset of loss of feeling right side of face with right sided facial muscle paralysis. Dx as Bell's palsy. Treated with tapered course of oral Prednisone. Symptoms improved gradually over the next several months. Still with residual symptoms that when tired.
Age: 6.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Rash
Clinical narrative: 06/29/2002 8;30 Child woke up with a rash on his back, No itching or fever, Has gotten worse but has not spread beyond his back, Mom reporting has not seen referred to ER if needed, Child out of town, To call if worsens.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Shot (DTaP) given 07/08/02 with mom noticed red rash, No raised @ site of injection, On 07/10/02, Afebrile, No other symptoms, No swelling @ site, On 07/12/02, child w/out symptoms, No redness.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Injection site inflammation, Injection site oedema, Injection site warmth
Clinical narrative: 07/11/02 am, parent present to clinic with child, 3" X 2" area of inflammation edema@ site of injection site RAT. Apparent insect bite adjacent to affected area, Skin warm to touch, Mother  relates she is allergic to pertussis component of DPT, 07/11/02, mother phones to relate she thinks afflicted area due to insect bite. 07/12/02, mom reports about red, no fever, Child Active.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Cardiac valve disease, Contusion, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: Mother phoned 07/17/02 reporting fever 100.8 ax, Not feeling well, c/o sore left arm, Slept Ok, Using Tylenol and cool packs locally, Saw PMD as advised (07/18/02), 07/19/02-P.C to mother who states child seen by PMD, 07/18/02-was told it was a local reactions-had redness, swelling, rash and bruising of left arm.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site rash, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Mother phoned 07/17/02 reporting fever 100.8 ax, Not feeling well, c/o sore left arm, Slept Ok, Using Tylenol and cool packs locally, Saw PMD as advised (07/18/02), 07/19/02-P.C to mother who states child seen by PMD, 07/18/02-was told it was a local reactions-had redness, swelling, rash and bruising of left arm.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: 7/9/02 received TD at 4pm-began with fever and chills on 7/10/02 at 10pm. Wed pm arm became red, feverish from shoulder to arm and pain (was extremely sore). Talked with dr's nurse and dr, recommended Benadryl po for Tx-Motrin 400mg Q 6-8 hrs and this helped pain. Are a of arm some redness still present/site of injection.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt reports tenderness to site and when observed, noted large area of redness from shoulder to elbow. Reports area was hot to touch and was seen in ER where doctor gave tx of Rocephin IM>
Age: 0.6
Sex: F
Vaccine: DTAP, HEP
Symptoms: Cough, Dry skin, Listless, Skin warm, Staring
Clinical narrative: Infant came in for immunizations. No illnesses. Rec DTaP #3 and hep B #3. Cried for few minutes, mother gave bottle, infant coughed, cried some, mother placed her on car seat. Nurse talking to infant, infant developed blank stare and would not focus to doll or look. Removed from car seat, stimulated took deep breth-skin warm and dry to touch, no breaking out on rash or hives. Pulse rate 200, respiration 38. 7/11/02 infant acted listless at times but would arouse. Monitored, talked with pediatrician and he felt not allergic reaction but possibly vasovagal or something. Pulse 150, R 32, no respiratory-MD felt that parents just needed to monitor her but if any change take to ER. Infant remained at clinic for approx. 1 hr and stable when left pulse rate 120, R 30, skin remained warm and dry to touch, alert when leaving. Talked with mother at 6pm and infant okay. Talked at 11am on 7/12/02, infant has had no further problems appear to be normal.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP
Symptoms: Syncope vasovagal
Clinical narrative: Infant came in for immunizations. No illnesses. Rec DTaP #3 and hep B #3. Cried for few minutes, mother gave bottle, infant coughed, cried some, mother placed her on car seat. Nurse talking to infant, infant developed blank stare and would not focus to doll or look. Removed from car seat, stimulated took deep breth-skin warm and dry to touch, no breaking out on rash or hives. Pulse rate 200, respiration 38. 7/11/02 infant acted listless at times but would arouse. Monitored, talked with pediatrician and he felt not allergic reaction but possibly vasovagal or something. Pulse 150, R 32, no respiratory-MD felt that parents just needed to monitor her but if any change take to ER. Infant remained at clinic for approx. 1 hr and stable when left pulse rate 120, R 30, skin remained warm and dry to touch, alert when leaving. Talked with mother at 6pm and infant okay. Talked at 11am on 7/12/02, infant has had no further problems appear to be normal.
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, MMR
Symptoms: Injection site mass, Injection site pain, Pyrexia
Clinical narrative: 7/20/02 8mm size knot in RAT-no redness-usual ADL-tender to touch. 7/17/02 temp of 102 degrees on 7/17/02 pm-resolved by mid morning of 7/18/02.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Laryngeal oedema
Clinical narrative: Felt like throat was swelling, sought treatment, was given Epinephrine and Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Sleep disorder
Clinical narrative: Last night child's arm swelled, didn't sleep good. Mom applied cold compresses L deltoid swollen, hot to touch and firm, red approx. 3" in diameter. Advised warm compresses today and Tylenol or Advil.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: R upper arm was swollen, reddened and warm to the touch. Advised Ibuprofen B10, cool compresses to area-elevate arm. RTC PRN.
Age: 4.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: L arm swollen, red and hot from elbow to shoulder. Received DTaP 7/17/02. Onset edema 7/18/02. Seen at family practice 7/19/02. Treated with Amoxicillin and Motrin. 7/22-mother says edema decreased.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness from shoulder to elbow warm to touch, firm @ injection site.
Age: 4.25
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Nausea, Vomiting
Clinical narrative: Redness began 7-11 from shoulder to elbow, hot, firm-nausea, vomiting 7-12.
Age: 4.7
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm swollen red, hot.
Age: 4.2
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: L upper deltoid slightly swollen-area as big as adult palm, slightly red and warm to touch. Advised to apply cool compress to area per RN.
Age: 4.08
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 7/25/00 2" in diameter redness Lt arm swollen warm to touch. DTaP given 7/23/00.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large area on left arm red, warm to touch , and sore
Age: 4.2
Sex: F
Vaccine: DTAP, MMR, PPV
Symptoms: Injection site erythema, Skin irritation
Clinical narrative: Vaccines admin afternoon of 7/22. Pt remained at office for 15 mins. No adverse reaction noted. Mother called afternoon of 7/25 and reported area red, and hot to touch. Advised to bring child in. N-P checked area, reviewed interval from 7/22 to 7/25. NO serious c/o except redness. Prophylactic Omnicef 125mg BID x 7 days prescribed for irritation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pyrexia, Vomiting
Clinical narrative: 8/1/02 child had 102 deg F temperature that broke around 12:30pm on 8/1/02 11pm says started with temperature at 6:30pm on day of shots. Gave 1tsp of Motrin  till fever broke. Notified red area on arm 12:30pm 8/1/02. Area of redness became large until about 2pm on 8/2/02, 11am took child to ER at 10:30pm on 8/1/02 because he vomited and due to redness on arm. No fever that time. ER did not register client was told by physician to pt ice to arm and follow-up with health dept. Today arm-red below injection site to elbow. No swelling, hot to touch. No soreness or knot at site. Child active-climbing, jumping, moving arm freely.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Questionable reaction to DTaP,Swelling and warmth at site, Given Zyrtec and Duricef
Age: 0.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Headache, Mononucleosis syndrome, Myalgia, Oedema
Clinical narrative: Client received Hep B injection on Thur 8/1/02. in the evening of the same day her mother noticed red, pruritic, rash on her neck and back. On Friday 8/2/02 the rash her arms, legs, stomach. On Sat 8/3/02 muscle aches , heaches, general swelling. Referred to physician client went to Dr who facts that the rash was d/t vaccine .Gave Benadryl inj. Dr questioning of client has mononucleosis.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Client received Hep B injection on Thur 8/1/02. in the evening of the same day her mother noticed red, pruritic, rash on her neck and back. On Friday 8/2/02 the rash her arms, legs, stomach. On Sat 8/3/02 muscle aches , heaches, general swelling. Referred to physician client went to Dr who facts that the rash was d/t vaccine .Gave Benadryl inj. Dr questioning of client has mononucleosis.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Urticaria
Clinical narrative: 3 hours after immunization, developed hives on right arm, progressed across chest and abdomin. Examined at ER at 8:30pm. Given Zantac and Benadryl. No lab work done. Hives resolved by 2am 7/31/02.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Dizziness, Fatigue, Flushing, Gait disturbance
Clinical narrative: During drive home from HD, client experienced a numb or tingling feeling in left armpit, Stated that the seatbelt caused discomfort as it pressed against her left arm. By the time she reached home, her arm was sore, limp and she felt flushed, woozy, fatigued. She napped off and on throughout the day, Symptoms diminished the following am but not gone, Client denied, elevated temp., Reported symptoms to physician 24 hours after injection.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Pyrexia
Clinical narrative: During drive home from HD, client experienced a numb or tingling feeling in left armpit, Stated that the seatbelt caused discomfort as it pressed against her left arm. By the time she reached home, her arm was sore, limp and she felt flushed, woozy, fatigued. She napped off and on throughout the day, Symptoms diminished the following am but not gone, Client denied, elevated temp., Reported symptoms to physician 24 hours after injection.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Child received DTaP, HBV, HIB, MMR, VAR on 5/7/02. The next day-child had welts at injection sites on arms on Thursday. The child had welts all over. Mom took him to Dr's office-was told to use OTC Benadryl. Sat night child developed fever and hives con't. Taken to ER-put on oral steroids. TC 5/13- child con't with hives and under medical care.
Age: 1.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Dermatitis bullous, Pyrexia, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 10 days after varicella vaccine, pt had low grade fever & developed a varicella-like rash, Smaller lesions then wild-type varicella. Positive Pruritus, Involved palms and soles, Symptoms relieved with Tylenol, Calamine Lotion, Generalized erythema papular rash, (?) Mostly on anterior abdomen and back, Some on extremities and microvesicular lesions
Age: 1.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: 10 days after varicella vaccine, pt had low grade fever & developed a varicella-like rash, Smaller lesions then wild-type varicella. Positive Pruritus, Involved palms and soles, Symptoms relieved with Tylenol, Calamine Lotion, Generalized erythema papular rash, (?) Mostly on anterior abdomen and back, Some on extremities and microvesicular lesions
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Quarter size knot on LA with redness, hot.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Eye movement disorder, Pyrexia, Syncope, Tremor
Clinical narrative: Fainted 10-15 minutes after vaccine fever and had shaking of arms, rolling up of eyeballs lasting 10-15 seconds. Had another similar episode half an hour later.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule
Clinical narrative: DTaP given 8/5/02 to child's left thigh. On 8/7/02, mother noted redness to area. On 8/8/02 described by private MD as "6x7cm, unusual, firm nodular center, local inflammatory reaction". No fever.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Grand mal convulsion, Injection site mass, Pyrexia
Clinical narrative: On 7/19/02, had a seizure, lasting 10 minutes. Went to ER with a fever of 103.9F (Grand Mal). On 7/28/02, had a seizure lasting 27 minutes. Went to ER with fever of 100F (Grand Mal). Left arm with nickel-size lump on 7/19/02, down to pea-size by 7/30/02.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Infection
Clinical narrative: Pt with mild case of varicella despite having been vaccinated.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 days later, had red and swollen upper arm; hot; 10cm X 8cm; not very tender. It's ok.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Angioneurotic oedema, Asthma, Condition aggravated, Urticaria
Clinical narrative: Hives, asthma exacerbation and angioedema requiring ER evaluation and treatment. Referral to allergist.
Age: 18.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Dizziness, Musculoskeletal stiffness, Staring
Clinical narrative: About 32 hours, post vax, had sudden dizziness followed by hyper-extension of hand, tight jaw, arms flexed, eyes staring straight ahead X 5 minutes. Resolved spontaneously.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Immunization of DTAP (lot 567A2( on 8/0/02 to left thigh, IM. That evening, started a 3cm blotchy, red area. On 8/10/02, it was 6cm in diameter. On 8/11/02, it was 8-9cm in diameter of swelling. On 8/12/02, 6cm X 8cm reaction with blotchy/warm/erythema on left lateral thigh localized reaction. Treated with Benadryl 1 tsp q 4-6 hours and cold compresses. Seen by a physician.
Age: 0.7
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea, Musculoskeletal stiffness, Pallor
Clinical narrative: About 1 hour, after shot, pt could not breathe. EMT's came. During his gasping for air, he stiffened and became very, very white. Following 48 hours, after the shot, he had another episode of difficulty breathing.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Positive for chickenpox. Vaccine given on 1/14/00.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large erythematous, swollen area approx. 7cm over deltoid.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site rash, Skin discolouration
Clinical narrative: Mild firmness under papule where shot given, 3 days after administration. Treat by monitoring. Mom reported that it was larger mass and blue appearing.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Nausea, Urticaria
Clinical narrative: Onset of nausea about 10 minutes after receiving vaccines. On the way home, she complained "can't get it in". Mom thinks she was short of breath. Mom noticed hives at home (about 45 minutes after getting shots) and gave Benadryl po and was referred to ER. Given Epi X 1 and Benadryl po q 4 hr prn.
Age: 4.4
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right arm with red and warm induration.