chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from an investigator concerning a 10 month old female child who received Prevnar on 12/22/00 and the next day, the child was taken to a clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree this event was 'possibly' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, the report has been downgraded to non-serious.
Age: 1.2
Sex: M
Vaccine: PNC
Symptoms: Angioneurotic oedema, Urticaria
Clinical narrative: A physician reported that a 14 month old male received his 2nd Prevnar on 9/12/00 and the next day, the child developed urticaria and angioedema. He was seen in a clinic and recovered. Angioedema is considered "Medically Important". Both the investigator and the medical monitor agree that the events are possibly related to vaccine administration. Follow up info received on 3/9/01 clarified that the pt did not experience angioedema as previously reported, he experienced urticaria only. Therefore, this report has been downgraded to "non-serious."
Age: 1.75
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from an investigator concerning a 21 month old male child who received his 1st dose of Prevnar on 12/8/00 and later that day, the child was taken to a local ER with urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that these events were 'probably' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, this report has been downgraded to non-serious.
Age: 33.0
Sex: M
Vaccine: LYME
Symptoms: Dizziness, Vision blurred
Clinical narrative: The pt received his 1st Lymerix injection on 1/24/01. Immediately, post vax, he became light-headed and dizzy and experienced blurred vision. He recovered "within moments", without treatment. The reporter stated that "it sounded like" the pt "had a problem with needles."
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 1/25/01 at 20:00, the site of injection was red and swollen and warm to the touch. The redness is 2 1/2" wide and 3" in length. On 1/26/01, doctor's office visit and leg was still swollen and red. Area was the same size as stated above.
Age: 1.25
Sex: F
Vaccine: HEP, IPV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythematous rash with mild induration of left mid-anterior thigh. 1st noted about 24 hours, post vax.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Edema, erythema and induration.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Pt had fever of 104.6F, 3-4 hours, post vax.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Eye swelling, Lacrimation increased, Sneezing
Clinical narrative: Had swelling of eyes, tearing and sneezing for 3 hours, post vax. Was seen ER and sent home. Follow-up done on 2/12/01. Was given Benadryl in ER.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Psychomotor hyperactivity
Clinical narrative: Was fine the day of the IZ, but became extremely active "could not sit still". He was running from room to room, unable to calm himself from the next afternoon at about 13:30 until about 20:00. He fell asleep at that time and woke up fine. Mother had felt that she had to almost restrain him, so he would not hurt himself.
Age: 1.4
Sex: M
Vaccine: PNC, PNC
Symptoms: Convulsion, Eye movement disorder, Hypotonia, Lethargy, Staring
Clinical narrative: This pt had a "spell", possibly a seizure. Child received Prevnar at 10:00 on 1/30/01. Around 17:00, suddenly became limp, while eating. Mom thinks he passed out for 1 minute. No abnormal movements. 2nd episode about 19:00, eyes rolled back, passed out for several minutes. Brought to ER, immediately. Regain consciousness but was dazed and lethargic X 2 hours. That night started low-grade fevers.
Age: 1.4
Sex: M
Vaccine: PNC, PNC
Symptoms: Convulsion, Eye movement disorder, Hypotonia, Loss of consciousness, Otitis media
Clinical narrative: This pt had a "spell", possibly a seizure. Child received Prevnar at 10:00 on 1/30/01. Around 17:00, suddenly became limp, while eating. Mom thinks he passed out for 1 minute. No abnormal movements. 2nd episode about 19:00, eyes rolled back, passed out for several minutes. Brought to ER, immediately. Regain consciousness but was dazed and lethargic X 2 hours. That night started low-grade fevers.
Age: 1.4
Sex: M
Vaccine: PNC, PNC
Symptoms: Pyrexia, Staring
Clinical narrative: This pt had a "spell", possibly a seizure. Child received Prevnar at 10:00 on 1/30/01. Around 17:00, suddenly became limp, while eating. Mom thinks he passed out for 1 minute. No abnormal movements. 2nd episode about 19:00, eyes rolled back, passed out for several minutes. Brought to ER, immediately. Regain consciousness but was dazed and lethargic X 2 hours. That night started low-grade fevers.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: I have received all 3 Lymerix vaccine shots. The last being on 11/17/00, within a few months of the 1st vaccinations on 12/99 and 11/99. I began experiencing soreness and stiffness in both wrists and my right elbow. It has continued and seems chronic.
Age: 0.4
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Chills, Choking, Eye movement disorder, Pallor
Clinical narrative: On the evening that the baby received IZ's, baby had choking type episode. The baby became pale, white lips and gums; eyes rolled back in head. Slight shivers often but no twitching. Father gave mouth to mouth breathing. Did not go to ER. Pt was seen in office on 1/14/00. Spoke with doctor on 1/12/00.
Age: 1.08
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: Seizure within 24 hours of vaccination.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: MMR; rash.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site discolouration, Rash macular, Urticaria
Clinical narrative: Urticarial type rash (erythema/blotchy and blanching rash) around areas of stick sites (legs), on arms and across chest. Mom reports, started around site of Prevnar injection.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Screaming
Clinical narrative: "Crying inconsolably, all night, following vaccine administration".
Age: 1.2
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Rash
Clinical narrative: 3 little dots on face on 2/4/01; 3 dots on arm on 2/5/01 and all over body on 2/6/01. Saw pediatrician on 2/6/01. Rash continues over body but not on palms of hands. Is fading at the present time. No fever.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Urticaria of right upper arm and left face. No wheezes or difficulty with breathing.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Screaming
Clinical narrative: Child began high pitched scream about 1 hour, post vax, lasting about 45 minutes. Later in the day, a red line was noted from the injection site followed by hot, red, local reaction. Local reaction persisted through 2/2/01 AM visit.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: At 15:00, gave injection of DTAP and HIB (2 different sites, same right thigh) leg became bright red in color, a few bumps noted; I got the doctors to look at baby and we administered 1/2 tsp Benadryl. The pt is to follow-up with an allergist.
Age: 72.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint stiffness, Pain
Clinical narrative: Pain in joints; elbow and shoulder; persistent ache; tender to touch at times with stiffness. Continued complaints but no worsening. There were 3 Lymerix given starting with 1st on 4/29/99, 2nd on 6/1/99 and 3rd on 5/1/00.
Age: 1.75
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fever of 104F within 24 hours, post vax. No local reaction.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Rash, (papulo-vesicular) on trunk, noticed on 1/28/01 and a fever. Exam on 1/29/01.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Hypokinesia
Clinical narrative: Left arm almost immovable due to massive swelling; left side, all the way down to hip is numb and almost immovable due to unbearable pain; rash and redness developed from top of shoulder to elbow with large lump, near injection site, the size of a tennis ball under muscle mass; several light-headedness and complete blackouts with rapid increase in heart rate; rapid heart rate/palpitations and profuse sweating onsets, while sitting stationary.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Loss of consciousness
Clinical narrative: Left arm almost immovable due to massive swelling; left side, all the way down to hip is numb and almost immovable due to unbearable pain; rash and redness developed from top of shoulder to elbow with large lump, near injection site, the size of a tennis ball under muscle mass; several light-headedness and complete blackouts with rapid increase in heart rate; rapid heart rate/palpitations and profuse sweating onsets, while sitting stationary.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Palpitations, Rash
Clinical narrative: Left arm almost immovable due to massive swelling; left side, all the way down to hip is numb and almost immovable due to unbearable pain; rash and redness developed from top of shoulder to elbow with large lump, near injection site, the size of a tennis ball under muscle mass; several light-headedness and complete blackouts with rapid increase in heart rate; rapid heart rate/palpitations and profuse sweating onsets, while sitting stationary.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site haemorrhage, Rash
Clinical narrative: At time of injection, the site of PCV, bled real bad. Was able to apply pressure and a bandaid. Child was seen on 1/31/01 for rash reaction. Mom states left thigh was worse. Child had complete body rash and was instructed to use OTC.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Gastrointestinal disorder, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea and vomiting, 24 hours, post vax. Resolved in 48 hours. Rx'd Motrin and fluids. May have been coincidental viral gastrointestinal.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash around injection site immediately after injection. Pt was instructed by physician to take Benadryl. Rash resolving before pt left the office.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Epistaxis, Injection site pain, Urticaria
Clinical narrative: Hives for 3 days; arm also sore for 3 days. Had shortness of breath and sinus problems (bloody).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Flu vaccine given and 24 hours later, pt noticed hives on legs. Went to Pharmacy and got Benadryl for hives. Three days later, 12/25/00, pt's arms and hands became swollen. Pt went to medical center where the doctor put her on steroids. Pt is doing fine now, 1/25/01. Pt also mentioned that husband got red spots and a fever blister, 12 hours, post flu vaccine.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Routine TD given in clinic. Returned, 2 days, later with erythemic area 5" X 3", just proximal to elbow. Tenderness, inflammation. No lesions, no drainage.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt states had chills and fever, the night of the injection of pneumonia and flu vaccines. Right arm was red and swollen the morning after injection but no fever.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 45 minutes, post vax, she had hives in both legs, lasted a few hours and was gone by morning. Told us about rash on 1/27/01.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt experienced redness, pain, swelling and warmth on left upper and lower arm, the night of the injection. RN was notified the next morning. Instructed pt to take ibuprofen and consult MD. On 12/18/00, she saw MD and was dx'd with cellulitis and placed on Keflex. Contact made on 12/20/00 and condition is much improved.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye oedema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Pronounced edema, redness and itching at injection site on right arm. Ice applied. Refused antihistamine. Arm checked in 30 minutes; at 45 minutes had swelling of right eye. Chlo-Amine tablets (4) given. Arm slowly improved. Continued with ice. Instructed to take Benadryl at home and call MD if condition worsens. At 16:00, arm checked and was much improved.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth and pain in right arm, noted on 12/16/00. Pt applied ice and took Tylenol on 12/16/00. Reaction lasted approx. 3 days. Required no medical attention. Follow-up call on 12/19/00, pt states fully recovered.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Upper respiratory tract infection, Vaccine positive rechallenge
Clinical narrative: Information was received from the physician concerning a 17 week old pt with upper respiratory infection, post vaccine in the left thigh. Pt was irritability and prolonged crying. Pt experienced injection site erythema (10x10) cm, pt was treated with Tylenol pt was monitored by physician. Pt was sleeping and the symptoms resolved. Mother also reported that pt has similar reaction at 2 months of age with redness on both legs. The pt also experienced red irritated site with another vaccine.
Age: 11.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site pain
Clinical narrative: Information received from a physician, pt received vaccine in right deltoid. Pt developed local tenderness. Treated with application of cold compress, pt recovered
Age: 0.4
Sex: F
Vaccine: HIBV, IPV, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 18 week old pt received vaccine in right leg. reports swelling at injection site, erythema and pain at injection site. Mother reports similar experience in January 2000 post vaccine.
Age: 0.3
Sex: F
Vaccine: HIBV, IPV
Symptoms: Crying, Feeling hot, Irritability
Clinical narrative: Physician reports pt irritable, crying, skin warm to touch post vaccine. Per physician pt recovered.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Injection site induration, Injection site warmth, Urticaria, Vaccine positive rechallenge
Clinical narrative: Reported induration at injection site, warmth at injection site, wheal at injection site. On June 5th 2000 the patient experienced a local reaction to vaccine, red welt on the arm that was warm to touch. The area was 1 1/2 x 2 1/2 cm and hard
Age: 0.2
Sex: F
Vaccine: DTOX, HIBV, IPV
Symptoms: Hyperkinesia, Injection site induration, Injection site swelling, Personality disorder, Psychomotor hyperactivity
Clinical narrative: Injection site swelling, hyperkinesia, personality change,pt was very hyper injection site induration.
Age: 0.17
Sex: U
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Injection site pain, Injection site reaction
Clinical narrative: Information received by a registered nurse concerning pt with reaction at injection site, crying, pain at injection site. Pt experienced similar reaction post other vaccine's.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Eye disorder, Pruritus, Swelling face
Clinical narrative: A nurse reported pt had facial swelling post injection, itchy eyes and sore neck and shoulders. She was treated with Prednisone. Follow-up info received on 04/17/2001 indicated that the pt also developed redness and swelling at the injection site. She recovered.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: A nurse reported a pt post vaccine she developed swelling, warmth,redness and a rash. The pt was treated in the ER.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash
Clinical narrative: A nurse reported that a 68 year old received a vaccine on Jan 12, 2000. Pt developed injection site reaction characterized by a 3 to 4cm area of redness and warmth. She was treated with Kelflex, on 1/19/2000, she was treated with Rocephin IM, after she developed little red spots and redness that extended down to the forearm. She was treated with Medrol dose pack.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Hypotension, Malaise, Nausea, Pyrexia
Clinical narrative: A nurse  reported that a pt received vaccine on 3/7/2000 and on 3/8/2000, the pt developed transient fever, malaise, hypotension, nausea, and arthralgia. The pt recovered.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reported that a pt received vaccine on 3/10/2000, later that night she experienced a reaction to the injection site, characterized by redness, heat, bruising and induration. Pt self treated with warm soaks. The physician treated with ice applications and ibuprofen. Follow-up info received from the reporter on 01/25/2001 indicated that the pt recovered.
Age: 35.0
Sex: U
Vaccine: TD
Symptoms: Headache, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: A nurse reported that a 35 year old pt received vaccine and developed fever and headache. Pt also developed large reaction to injection site characterized by redness, swelling and warmth, extending from shoulder to elbow.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: A nurse reported that pt received vaccine, the next day he developed a reaction, which the reporter did not describe. He recovered.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Chills, Chromaturia, Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: A nurse reported pt received vaccine on 10/30/2000, subsequently he developed nausea, chills, sleepiness, achiness, dark colored urine and was unable to get warm. Also developed reaction at injection site, reaction characterized by 3" by 4" area of redness, swelling, inflammation and warmth.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Somnolence
Clinical narrative: A nurse reported pt received vaccine on 10/30/2000, subsequently he developed nausea, chills, sleepiness, achiness, dark colored urine and was unable to get warm. Also developed reaction at injection site, reaction characterized by 3" by 4" area of redness, swelling, inflammation and warmth.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reports pt received vaccine 3/21/2000, he was seen by physician on 3/23/2000 for injection site reaction characterized by a 5cm area of induration, warmth and pain. He did not require treatment.
Sex: U
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A pharmacist reported that a pt received vaccine on 5/1/2000, or 5/2. 15 to 30 minutes later pt developed severe cellulitis at the injection site. Pt was seen by physician who prescribed a single IV dose of Cefazolin.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Anxiety, Cellulitis, Dyspnoea, Injection site induration, Injection site reaction
Clinical narrative: A nurse reported a pt received a vaccine on 4/6/2000 and subsequently developed a severe injection site reaction characterized by a hive-like area of swelling, redness and  induration which resembled cellulitis. Pt also developed swollen lymph nodes under the left arm. On 4/11 pt was treated with Prednisone. On 4/11/2000 pt developed shortness of breath, anxiety, malaise, general achiness,arm pain and fever.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: A nurse reported a pt received a vaccine on 4/6/2000 and subsequently developed a severe injection site reaction characterized by a hive-like area of swelling, redness and  induration which resembled cellulitis. Pt also developed swollen lymph nodes under the left arm. On 4/11 pt was treated with Prednisone. On 4/11/2000 pt developed shortness of breath, anxiety, malaise, general achiness,arm pain and fever.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: A nurse reported a pt received a vaccine on 4/6/2000 and subsequently developed a severe injection site reaction characterized by a hive-like area of swelling, redness and  induration which resembled cellulitis. Pt also developed swollen lymph nodes under the left arm. On 4/11 pt was treated with Prednisone. On 4/11/2000 pt developed shortness of breath, anxiety, malaise, general achiness,arm pain and fever.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Fibromyalgia, Hypoaesthesia, Oral intake reduced, Pain
Clinical narrative: Medical Assistant reported a pt with history of chronic pain and possible fibromyalgia received a vaccine on 6/7/2000. The next day pt developed severe arm pain, arm numbness and weakness. In the following day the pt experienced pain almost everywhere had difficulty sleeping and eating and lost 9 pounds.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Sleep disorder, Weight decreased
Clinical narrative: Medical Assistant reported a pt with history of chronic pain and possible fibromyalgia received a vaccine on 6/7/2000. The next day pt developed severe arm pain, arm numbness and weakness. In the following day the pt experienced pain almost everywhere had difficulty sleeping and eating and lost 9 pounds.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Skin disorder
Clinical narrative: A nurse reported a pt received a vaccine on 3/23/2000, on 4/26/2000 she developed an injection site reaction characterized by redness, warmth and indented skin. Pt recovered
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: Pt reports she received vaccine on 4/21/2000. Post vaccine she developed rash on her arm. The rash then became generalized; itched and burned. The rash persisted as of 7/6/2000.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: A pharmacist reported a pt received a vaccine on 4/20/2000. The next day pt developed a fever of 103 deg F, reaction characterized by redness and swelling. The fever ad injection site reaction resolved after 3 days.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: a pharmacist reported that a pt received a vaccine on 6/27/2000. Two days post vaccine she developed fever and flu like symptoms, which lasted more than 36 hours. Pt also developed a 15 cm area of soreness at injection site. On 7/1/2000 pt was treated by physician.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: A pharmacist reports a pt received vaccine 7/4/2000, that same day she developed a fever and flu like symptoms which lasted more than 36 hours. The pt also developed a 15cm area of soreness at the injection site.
Age: 13.0
Sex: M
Vaccine: HEP, TD
Symptoms: Dizziness, Injection site erythema, Injection site reaction, Injection site swelling, Nausea
Clinical narrative: A nurse reported pt received vaccine on 7/10/2000, on 7/11 pt awoke with injection site reaction characterized by redness, swelling, and tenderness at the injection site. Pt was also nauseous, then became dizzy and pale and had blurred vision these symptoms lasted approximately 5 minutes. Pt felt feverish, but did not take his temperature. His mother treated him with dihenhydramine, acetaminophen, and applications of ice to the injection site. By 07/12/2000, only the injection site swelling and tenderness remained. The pt's last injection of diphtheria and tetanus toxoids was in 1992. Concomitant vaccine given on 07/10/2000 is Engerix-B.
Age: 13.0
Sex: M
Vaccine: HEP, TD
Symptoms: Pallor, Pyrexia, Tenderness, Vision blurred
Clinical narrative: A nurse reported pt received vaccine on 7/10/2000, on 7/11 pt awoke with injection site reaction characterized by redness, swelling, and tenderness at the injection site. Pt was also nauseous, then became dizzy and pale and had blurred vision these symptoms lasted approximately 5 minutes. Pt felt feverish, but did not take his temperature. His mother treated him with dihenhydramine, acetaminophen, and applications of ice to the injection site. By 07/12/2000, only the injection site swelling and tenderness remained. The pt's last injection of diphtheria and tetanus toxoids was in 1992. Concomitant vaccine given on 07/10/2000 is Engerix-B.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A HCP reported a pt received a vaccine 6/23/2000, on 6/26 he developed an injection site reaction characterized by 6cm by 8cm area of warmth, erythema, swelling and tenderness. He was treated in the ER and diagnosed with cellulitis. He recovered
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Injection site warmth
Clinical narrative: A HCP reported a pt received a vaccine 6/23/2000, on 6/26 he developed an injection site reaction characterized by 6cm by 8cm area of warmth, erythema, swelling and tenderness. He was treated in the ER and diagnosed with cellulitis. He recovered
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Chills, Heart rate irregular, Injection site pain, Injection site reaction
Clinical narrative: A nurse reported a pt received vaccine on 7/24/2000 and subsequently developed an irregular heart beat, chills, and chest pain which resolved within 24 hours. Pt also developed an injection site reaction characterized by swelling and pain. She reported these events to her MD on 7/28/00 when the injection site remained mildly tender. Additional info received from the reporter on 01/25/2001 indicated that the pt recovered
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Tenderness
Clinical narrative: A nurse reported a pt received vaccine on 7/24/2000 and subsequently developed an irregular heart beat, chills, and chest pain which resolved within 24 hours. Pt also developed an injection site reaction characterized by swelling and pain. She reported these events to her MD on 7/28/00 when the injection site remained mildly tender. Additional info received from the reporter on 01/25/2001 indicated that the pt recovered
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reported pt received vaccine on 7/19/200 and subsequently developed an injection site reaction characterized by redness, festering, swelling and pain.
Age: 21.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A pharmacist reported a pt received vaccine on 8/1/00, later that day he developed injection site reaction characterized by redness, swelling and pain.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction, Injection site swelling, Tenderness
Clinical narrative: A HCP reported post vaccine pt developed an injection site reaction characterized by 2cm palpable area of swelling and tenderness. Pt was treated in the ER and diagnosed with cellulitis, a moderate amount of pus was removed from the right arm an Penrose drain was inserted and sutured in place.
Sex: U
Vaccine: TD
Symptoms: Blister, Contusion, Injection site erythema, Injection site hypersensitivity, Injection site induration
Clinical narrative: A nurse reported post vaccine pt reported the next day, developed injection site reaction characterized by a 4.5 to 5cm area of redness, warmth, itching, induration, tiny blisters and pain described as feeling bruised on the inside.
Sex: U
Vaccine: TD
Symptoms: Injection site infection, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: A nurse reported post vaccine pt reported the next day, developed injection site reaction characterized by a 4.5 to 5cm area of redness, warmth, itching, induration, tiny blisters and pain described as feeling bruised on the inside.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A pharmacist reported that a received a vaccine on 7/2000, Pt subsequently developed cellulitis at injection site. Pt treated with antibiotics and recovered. Follow-up info received on 01/23/2001 from the reporter indicated that the pt was immunized on 07/25/2000. The cellulitis, requiring a physician visit, occurred the following day on 07/26/2000. The pt has a histroy of pcn allergy and allergy to "environmental agents."
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: A nurse reported that a pt received vaccine 1/6/00, several days post vaccine pt developed an injection site reaction characterized by redness and induration. Pt recovered.
Sex: F
Vaccine: TD
Symptoms: Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: A pharmacist reported that a female in her 40's received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 12/01/99. On 12/02/99, the patient developed an injection site reaction characterized by swelling and tenderness "more severe than usual". The patient was treated with Vioaxx and Claritin. She recovered on 12/09/99.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A territory representative reported that a pt received vaccine and subsequently developed a severe injection site reaction characterized by swelling and redness.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: A nurse reported that a female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined (Wyeth) on 03/09/00. She subsequently developed an injection site reaction characterized by a "baseball" size area of swelling, redness, and tenderness. Follow up info received from the physician on 10/06/00, indicated that the patient was a 48 year old female who experienced the adverse event on 03/11/00. The patient recovered.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: A physician reported that a pt received vaccine on4/7/00, on 4/10/00 pt developed a 18cm by 10cm area of redness and was treated and recovered. Follow-up info received from the physician on 04/02/2001 indicated that this pt has a medical history inclusive of hypertension. The pt remained recovered.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Pruritus, Urticaria
Clinical narrative: A medical assistant reported that a 36 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined (Wyeth) on 04/18/00. On 04/23/00, the patient developed a large hive which was described as red, sore, and itchy.
Age: 75.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site reaction, Pain
Clinical narrative: A medical assistant reported that a 75 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined and Pnu-Imune 23 vaccines on 05/02/00. One week later, the patient developed an injection site reaction characterized by redness and soreness at the site of the TD administration.
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Tenderness
Clinical narrative: A nurse reported a pt received vaccine on 3/9/00, he subsequently developed an injection site reaction characterized by a baseball size area of swelling, redness and tenderness.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Pruritus
Clinical narrative: A pharmacist reported a pt received a vaccine 5/1 or 5/2/00, 15 minutes later the pt developed an injection site reaction characterized by induration, severe pruritus and redness.
Age: 70.0
Sex: M
Vaccine: HEPA, TD, YF, HEPA, TD, YF
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Pt reports post vaccine on 5/15/00, on 5/25/00 he developed hives. The pt recovered. Follow up #1 (5/15/02): during internal auditing of all files, it was deemed necessary to amend the report by updating the adverse coding (corrected vesiculobullos rash to maculopapular rash).
Age: 70.0
Sex: M
Vaccine: HEPA, TD, YF, HEPA, TD, YF
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Pt reports post vaccine on 5/15/00, on 5/25/00 he developed hives. The pt recovered. Follow up #1 (5/15/02): during internal auditing of all files, it was deemed necessary to amend the report by updating the adverse coding (corrected vesiculobullos rash to maculopapular rash).
Sex: U
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: A physician reported that 4-5 patients "over the last 4 months" developed "severe localized reactions" following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined Lot # 4998366.  MANUFACTURERS COMMENT: The reporter was unable to specify the number of patients involved.  Additional reports will be generated when identifying information is provided.  This report was received from Medeva (Ref # MPI-2000-04566).
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: A medical assistant reported pt received a vaccine and1 week later developed injection site reaction characterized by redness, and soreness.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A medical assistant reported that a pt received vaccine on 4/21/00, one week later she developed and injection site reaction characterized by large area of redness, swelling.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: A pharmacist reported a pt received a vaccine on 5 26/00, the next day she developed a fever of 103 deg F and an injection site reaction characterized by pain and swelling. She recovered after 3 days
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site oedema, Joint range of motion decreased, Pain
Clinical narrative: A physician reports a pt received vaccine on 7/6/00, she awoke on 7/14/00 with an injection site reaction characterized by a 5cm area of induration, swelling and tenderness that made it difficult to raise her arm. She was treated and recovered.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A medical supplier reported a pt received vaccine and subsequently developed a bad injection site reaction characterized by redness and swelling.
Age: 8.0
Sex: M
Vaccine: TD
Symptoms: Injection site induration
Clinical narrative: A physician reported a pt received vaccine on 7/11/00 and subsequently developed induration at the injection site. The child's previous dose of Tetanus toxoid was administered when the child was two years of age. Additional info received on 03/01/2001 from the reporter provided the pt's date of birth, county of administration, recovery status, product lot number, concurrent illness, and concomitant medication. The reporter noted that at the time of immunization the child received Tetanus and Diphtheria toxoids adsorbed, Ultrafined,a nd that he was suffering from allergic rhinitis for which he was prescribed Dimetapp. The child recovered from the event.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A territory representative reported that several children received an injection of Acel-Imune and subsequently developed an injection site reaction characterized by "severe" swelling, redness and warmth.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Tenderness
Clinical narrative: A pt's mother reported that her son received vaccine on 9/5/00, the vaccine was administered closer to the elbow than the deltoid and may have been SQ. On 9/6/00 the pt developed an injection site reaction characterized by swelling, hardness, redness, tenderness, and a bump.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Discomfort, Fatigue, Hyperhidrosis
Clinical narrative: A nurse reported a pt  with a history of sensitivity to egg whites inadvertently received an injection of Acel-Imune on 8/28/00. She also received vaccine of PPD. Later that day she developed achy joints, profuse sweating and a feeling of being tired. The reporter indicated that the reaction was similar to the one the pt has when she eats egg whites. The pt was treated and recovered; however still had some leg discomfort now and again but felt better.
Sex: U
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: A territory representative reported that a pt received vaccine and subsequently developed swelling at the injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site swelling, Urticaria
Clinical narrative: A nurse reported that pt received vaccine 7/11/00, approximately 10 minutes post vaccine the pt developed hives and swelling at the injection site, with hives all over the leg.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling
Clinical narrative: A territory representative reported that a pt received vaccine. On 9/23/00, the pt developed swelling at the injection site.
Age: 1.9
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling
Clinical narrative: A territory representative reported that a pt received vaccine. On 9/23/00 pt developed swelling at injection site. Follow-up received from the physician on 01/25/2000 indicated that the child received both Acel-Imune and IPV vaccines on 09/28/2000. On 09/30/2000, he developed swelling at an unspecified injection site. He was treated with amoxicillin/clavulanic acid and diphenhydramine. He recovered.
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported pt received vaccine on 11/13/00, the next day pt developed injection site reaction characterized by a 4" area of redness, warmth, and swelling.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV, HBHEPB, PNC
Symptoms: Infection, Laboratory test abnormal
Clinical narrative: A pharmacist reported a pt received vaccine 11/8/00. A nasopharyngeal culture was performed; the result was positive for pertussis. Additional info received from the reporter on 01/25/2001 indicated that the pt concomitantly received IPV on 11/08/2000, on 11/09/2000 Prevnar and Comvax. The reporter noted that the pt has a concurrent history of Hirschsprung's disease.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV, HBHEPB, PNC
Symptoms: Cough, Infection
Clinical narrative: A pharmacist reported a pt received vaccine 11/8/00. A nasopharyngeal culture was performed; the result was positive for pertussis. Additional info received from the reporter on 01/25/2001 indicated that the pt concomitantly received IPV on 11/08/2000, on 11/09/2000 Prevnar and Comvax. The reporter noted that the pt has a concurrent history of Hirschsprung's disease.
Sex: U
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: A pharmacist reported a pt received a vaccine, shortly after injection the pt developed a raised hive at the injection site.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported that a pt received vaccine on 11/13/00, the next day she developed an injection site reaction characterized by a 4" area of redness, warmth and swelling.
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: A nurse reported that pt received a vaccine and subsequently developed an injection site reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Physician reported pt received vaccine on 10/6/00, on 10/8 he developed a generalized rash over his upper body. As of 10/18, the rash persisted. Pt did recover.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Physician reported pt received vaccine on 10/6/00, on 10/8 he developed a generalized rash over his upper body. As of 10/18, the rash persisted. Pt did recover.
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: A physician reported a pt received vaccine and subsequently developed a rash.
Age: 0.4
Sex: M
Vaccine: DTAP
Symptoms: Otitis media, Pyrexia
Clinical narrative: A physician reported that his grandson received a vaccine on 5/24/00, on 5/25/00 he developed an ear infection and fever. The reporter indicated that he was not able to determine if the ear infection was present at time of vaccination. The pt recovered.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A Nurse reported that a pt received a vaccine 8/14/00, on 8/16/00 pt developed plugged sinuses and an injection site reaction characterized by 115mm by 90mm area of warmth, mild swelling, redness, soreness, and a quarter size lump.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Sinus congestion
Clinical narrative: A Nurse reported that a pt received a vaccine 8/14/00, on 8/16/00 pt developed plugged sinuses and an injection site reaction characterized by 115mm by 90mm area of warmth, mild swelling, redness, soreness, and a quarter size lump.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received vaccine on 1/31/00, on 2/1/00 she developed an injection site reaction characterized by redness, swelling.
Age: 31.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Asthenia, Malaise, Pyrexia, Rash
Clinical narrative: A physician reported a pt received vaccine on 8/8/00, approximately 1 hr post vaccine she developed a fever of 102F and a flat irregular rash on her trunk, the pt also felt ill and weak. Pt recovered.
Sex: F
Vaccine: TYP
Symptoms: Lymphadenopathy
Clinical narrative: A pt reported that she received a vaccine 12/99 and subsequently developed lymphadenopathy in her groin. The pt is being seen by the physician; the lymphadenopathy persists.
Age: 44.0
Sex: F
Vaccine: HEPA, TTOX, TYP, HEPA, TD, TYP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt received vaccine 7/19/99 and subsequently developed an injection site reaction characterized by pain and swelling.
Age: 44.0
Sex: F
Vaccine: HEPA, TTOX, TYP, HEPA, TD, TYP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reported a pt received vaccine's on 7/19/99. The pt subsequently developed an injection site reaction characterized by pain and swelling.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A mother reported that her son received vaccine on 2/26/00 and on 2/27/00 he developed an injection site reaction characterized by redness and swelling, reportedly the size of a softball. His symptoms have persisted.
Age: 19.0
Sex: M
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Influenza like illness, Injection site reaction, Swelling
Clinical narrative: A nurse  reported that a pt received a vaccine on 2/23/00 and within 24 hrs developed flu like symptoms and an injection site reaction the size of an orange, characterized by a red swollen arm.
Age: 19.0
Sex: M
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Influenza like illness, Injection site erythema, Injection site oedema
Clinical narrative: A nurse  reported that a pt received a vaccine on 2/23/00 and within 24 hrs developed flu like symptoms and an injection site reaction the size of an orange, characterized by a red swollen arm.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, TYP, HEP, HEPA, TYP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: A nurse reported a pt received vaccine's on 2/22/00, within 24 hrs she developed a fever of 101.1F, headache and generalized body aches. She recovered.
Age: 71.0
Sex: M
Vaccine: HEPA, IPV, TYP
Symptoms: Laboratory test abnormal, Musculoskeletal stiffness, Oedema peripheral, Red blood cell sedimentation rate increased
Clinical narrative: A physician reported a pt received vaccine's first wk of Feb, 2000. Within a week the pt developed muscle stiffness, knee pain and swelling in both hands.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR, TYP
Symptoms: Injection site pain
Clinical narrative: A nurse reported a pt received vaccines on 10/4/00. The next day the child developed soreness at injection site.
Sex: F
Vaccine: TYP
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Pt received vaccine 3/30/00 and subsequently developed an injection site reaction characterized by redness and warmth.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The pt developed and injection site reaction characterized by redness and swelling.
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Lymphadenopathy
Clinical narrative: Subsequently pt developed swollen lymph nodes in the groin area which lasted several weeks, she also developed an injection site reaction characterized by swelling and soreness which lasted 4 days.
Age: 1.2
Sex: F
Vaccine: TYP
Symptoms: Crying, Cyanosis, Tremor
Clinical narrative: Approximately 1.5 hrs post vaccine pt awoke crying and shaking. Mother noticed while child was sleeping that her lips were blue and she was trembling.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Injection site swelling
Clinical narrative: Pt reported injection site swelling within hrs developed local swelling on arm the size of a baseball.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pt reports approximately 2 hrs post vaccine she developed an injection site reaction characterized by redness and swelling, she then developed a fever and muscle aches.
Sex: U
Vaccine: HEPA, TYP
Symptoms: Injection site swelling
Clinical narrative: Pt reported injection site swelling the size of an egg.
Age: 45.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Diarrhoea, Injection site induration, Injection site nodule, Nausea, Tenderness
Clinical narrative: Pt experienced nausea and diarrhea post vaccine, also fever. She reports she has lost 6 to 7 lbs, she also developed induration and tenderness in L3 area. Pt also has nodule at injection site. Pt recovered.
Age: 45.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Vomiting, Weight decreased
Clinical narrative: Pt experienced nausea and diarrhea post vaccine, also fever. She reports she has lost 6 to 7 lbs, she also developed induration and tenderness in L3 area. Pt also has nodule at injection site. Pt recovered.