chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Diarrhoea, Rash
Clinical narrative: 10 days post immunization-2 raised dots on face-next day total body bumoy rash, diarrhea since 1-11-02. No treatment - advised desitin & oatmeal bath
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Face oedema, Oedema peripheral, Rash, Swelling, Urticaria
Clinical narrative: Rash, hives, swelling right leg, trunk, face, arms, MMR ON 1/17/02,  treatment-Benadryl po
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Neutropenia, Petechiae, Purpura, Pyrexia
Clinical narrative: Petechiae/ purpura, fever, neutropenia
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: 2 months old and was vaccinated on 01/24/2002. (DTaP #1, Hib #1, Hep B #1, IVP #1). Baby developed ful body rash, swelling, and fever.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Pyrexia, Skin ulcer
Clinical narrative: Chicken Pox lesions afater immunization with Varivax. Exposed to chicken pox 1/7/02. Varivax 1/9/02. Vesicles consistent with chicken pox and fever 1/20/2002. 20 lesions.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Feeling hot, Injection site reaction, Swelling
Clinical narrative: Pt had localized reaction to Trihibit injection with swelling from shoulder down to/including elbow area and red hot--Right arm.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash papular, Vomiting
Clinical narrative: fever to 103; vomiting; blanching red papular rash. 2 dozen papules primarily truncal developed 10 days after MMR.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Depersonalisation, Pyrexia, Tremor
Clinical narrative: Received DTaP/IVP on 1/22/2002. Had low grade fever that night. Began head shaking 1/23/2002 and change in behavior since then. Less content, not smiling as much. Also received Hib on 1/15/2002.
Age: 2.0
Sex: M
Vaccine: DTAPH, MMR
Symptoms: Depersonalisation
Clinical narrative: Pt became distant, regressed and lost milestones after the vaccine. Mom noted a change from mid October 2000 on.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: 5 cm diameter indurated area left deltoid, emanating from the deep tissue. It is slightly tender. No erythema and full range of motion of shoulder, no lymphadenopathy.
Age: 5.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash/pox developed sparce abd, face, arms
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Platelet count decreased, Purpura, Pyrexia
Clinical narrative: Patient about 8-9 days following the MMR II developed a fever of 103 and purpura on abdomen.  Platelet count went down to 130,000.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: Fever of 102 in the office. Parent reports temperature of 103 at home. Cold symptoms developed.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Screaming
Clinical narrative: Screamed for 4 hours after receiving vaccine. Continued to cry during the night.  Temperature was 100.5 on 01/31/2002.
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site reaction
Clinical narrative: It was reported that a male patient received a TD Adult vaccination on 31 Mar 2000. Reportedly sometime after the vaccination the patient developed a headache, fever (103F), joint aches and muscle stiffness. The next day, the patient developed chills and nausea, which are persisting, and a local reaction at the injection site with redness and swelling. Additional information is being requested.
Sex: M
Vaccine: TD
Symptoms: Injection site swelling, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: It was reported that a male patient received a TD Adult vaccination on 31 Mar 2000. Reportedly sometime after the vaccination the patient developed a headache, fever (103F), joint aches and muscle stiffness. The next day, the patient developed chills and nausea, which are persisting, and a local reaction at the injection site with redness and swelling. Additional information is being requested.
Age: 23.0
Sex: F
Vaccine: HEP, TD
Symptoms: Back pain, Erythema, Feeling hot, Injection site nodule, Pyrexia
Clinical narrative: It was reported that a 23 year old female patient received at TD-Adult and an Engerix Hepatitis B (SmithKline) vaccination on 21 Mar 2000. Reportedly in the morning of 22 Mar 2000, the patients left deltoid was red, hot and sore. The patient also experienced blurred vision, headache, upper back pain, fever, and chills. On 28 Mar 2000, the patients left deltoid was sore, firm and had a red area measuring 6.5 x 4.5cm. On 31 Mar 2000, the patient was seen at the hospital and given treatment for Keflex. On 4 April 2000, a firm, warm nodule measuring 5cm was located on the patients left deltoid. On 4 April 2000, the patient had prescription of Keflex filled. On 28 Apr 2000, the patients arm was better; scar was seen by RN, there was no soreness, swelling or discharge. The patient reportedly recovered from this experience. No new information was provided from additional correspondence received on 14 Jul 2000. No further information is anticipated for this report. This case is closed.
Age: 23.0
Sex: F
Vaccine: HEP, TD
Symptoms: Vision blurred
Clinical narrative: It was reported that a 23 year old female patient received at TD-Adult and an Engerix Hepatitis B (SmithKline) vaccination on 21 Mar 2000. Reportedly in the morning of 22 Mar 2000, the patients left deltoid was red, hot and sore. The patient also experienced blurred vision, headache, upper back pain, fever, and chills. On 28 Mar 2000, the patients left deltoid was sore, firm and had a red area measuring 6.5 x 4.5cm. On 31 Mar 2000, the patient was seen at the hospital and given treatment for Keflex. On 4 April 2000, a firm, warm nodule measuring 5cm was located on the patients left deltoid. On 4 April 2000, the patient had prescription of Keflex filled. On 28 Apr 2000, the patients arm was better; scar was seen by RN, there was no soreness, swelling or discharge. The patient reportedly recovered from this experience. No new information was provided from additional correspondence received on 14 Jul 2000. No further information is anticipated for this report. This case is closed.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Arthritis, Back pain, Chest wall pain, Choroiditis, Hypoaesthesia
Clinical narrative: Reportedly on 27 Feb 2000, the patient experienced pain in shoulder and back, stiff neck and numbness in left hand. The patient was evaluated by doctor and diagnosed with costal chondritis. Doctor stated not vaccine related. A Neurologist evaluated patient, EMG was negative. MRI showed degenerative arthritis in her neck. From additional correspondence received on 11 Jul 2000, it was reported that the patient returned (2/29/00) four days after receiving TD complaining of pain in shoulder and left side. Did not complain of neck pain or numbness at injection site. Reproductable chest wall tenderness with palpation.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Palpitations, Shoulder pain
Clinical narrative: Reportedly on 27 Feb 2000, the patient experienced pain in shoulder and back, stiff neck and numbness in left hand. The patient was evaluated by doctor and diagnosed with costal chondritis. Doctor stated not vaccine related. A Neurologist evaluated patient, EMG was negative. MRI showed degenerative arthritis in her neck. From additional correspondence received on 11 Jul 2000, it was reported that the patient returned (2/29/00) four days after receiving TD complaining of pain in shoulder and left side. Did not complain of neck pain or numbness at injection site. Reproductable chest wall tenderness with palpation.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Joint range of motion decreased, Pain, Swelling
Clinical narrative: It was reported that a 38 year old male patient received a TD Adult vaccination on 20 Jun 2000. Immediately after receiving the vaccination the patient started to have increased pain of the left deltoid, worsening over the past 6 days. Experienced increased shooting pain from shoulder to left hand with abduction. Decrease in range of motion, abduction internal/external rotation limited by pain. Increase of swelling and redness of anterior of left deltoid, not present on exam today. Decrease sensation upper left arm, reflexes +2, strength 4/5 LA. Treatment of Prednisone tapered for 2 weeks was given. From additional correspondence received on 6 Sept 2000, it was reported, "Reviewed, no additional information at this time.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: It was reported that a 40 year old female received a TD Adult vaccination on 16 Jun 2000. Reportedly three days later after the vaccination the patient developed a sore arm and neck stiffness. Further information requested. From correspondence received on 17 Aug 2000, it was reported, "Reviewed, no additional information at this time."
Age: 46.0
Sex: M
Vaccine: HEP, TD
Symptoms: Hypokinesia, Injection site oedema, Injection site pain, Pain
Clinical narrative: It was reported that a 46 year old male patient received a Td Adult and Hepatitis B (Merck) vaccination on 22-Jun-2000. Reportedly, the patient complained of immediate pain and swelling at the site. For five days, the patient was "unable to move arm" very painful. The patient reportedly recovered from this experience.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: It was reported that a 42 year old female patient received a TD Adult vaccination on 16 Jun 2000. That same day the patient developed "sharp pain" of her right arm lasting for 2 weeks. Also experienced decrease in range of motion, internal rotation; painful to sleep on the affected side, decrease in strength and tingling. There was no swelling, no redness and no temperature. Reflexes +2. The patient was treated with Prednisone 60mgin tapered doses, heat and physical therapy. From additional correspondence received on 6 Sept 2000, it was reported, "Reviewed, no additional information at this time."
Sex: F
Vaccine: MMR, TD
Symptoms: Constipation, Diplopia, Dizziness, Facial palsy, Rash
Clinical narrative: It was reported that a female patient received a TD Adult and a MMR (Unspecified) vaccination on 12 Dec 1998. Reportedly sometime after the vaccinations the patient developed rash on her ankles. Three months later developed double vision, constipated, dizziness, Bell's Palsy. Patient had MRI's done and MS testing. Patient was diagnosed with Epstein-Barr virus.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Myalgia, Pyrexia
Clinical narrative: It was reported that a 45 year old female patient received the TD Adult vaccination on 6 Jul 2000. Reportedly that same day the patient developed erythema, edema at the injection site, myalgia, warmth over reflex, a fever to 102 deg F and diarrhea. No wheezing or shortness of breath. Further information requested. From additional correspondence received on 10/17/00, it was reported, "10/13/00 - Reviewed, no additional information at this time." No further information is expected. This case is closed.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Swelling, Syncope
Clinical narrative: It was reported that a 44 year old female patient received a TD Adult vaccination on 7 Jul 2000. Reportedly 2 hours after vaccination the patient's arm became swollen. The patient also developed weakness, syncope and extreme joint pain. Reportedly the patient recovered from this experience. From additional correspondence received on 2 Oct 2000 no additional information was provided. No further information is expected. This case is closed. From additional correspondence received on 7 Feb 2001, no additional information was provided. No further information is expected. Case is closed.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site rash, Nausea, Pyrexia, Tremor
Clinical narrative: It was reported that a 25 year old female patient received a TD Adult vaccination on 20 Jun 2000. Approximately 6 hours after the vaccination the patient developed redness and rash around the injection site. Patient also developed "shakes", nausea, and a low-grade fever. Reportedly the shakes, low-grade fever and nausea persist. Further information requested. From additional correspondence received on 26 Sep 2000, additional responsible physician, patient history and the county information was provided. No further information is anticipated for this report. The case is closed.
Age: 68.0
Sex: F
Vaccine: HEP, TD
Symptoms: Blood pressure increased, Erythema, Heart rate increased, Pain
Clinical narrative: It was reported that a female pt received a TD Adult and a Hep B vaccination on 09/14/2000. Reportedly within 12 hours of vaccination the pt developed redness over entire body, stinging and burning in both legs. Pt was seen in the ER, had elevated blood pressure and pulse rate. The following Tuesday, the pt was seen in ER twice for same symptoms. continuous high blood pressure and pulse rate. An Allergist saw the pt for skin testing. Results were not provided. From additional correspondence received on 03/01/2001, it was reported that the pt recovered from this experience. Additional pt, vaccine, vaccine administrator and responsible physician information was also provided.
Age: 23.0
Sex: F
Vaccine: MEA
Symptoms: Asthenia, Conjunctivitis, Cough, Dizziness, Dysphagia
Clinical narrative: Information has been received from a health professional concerning a 23 year old white female with an ankle injury and hayfever, with no known drug allergies who on 03/26/2001 at 12:00 was vaccinated SQ in the left arm with a dose of measles virus vaccine live. There was no illness at the time of vaccination. concomitant therapy included an unspecified pain medication for the ankle injury. Other concomitant medication given on 03/24/2001 at 10:00, included a fifth dose Im in the left deltoid of diphtheria toxoid (+) tetanus toxoid. On 03/28/2001, at 8pm, the pt presented with the following symptoms: dizzy, weak, sores in mouth, difficulty swallowing, hurt to breath, stiffness, vomiting/nausea, red spots, non productive cough and itchy. It was noted that the pt's symptoms started on 03/27/2001. The nurse noted" it looked like a mild care of measles." On 03/30/2001, the pt presented feeling somewhat better but was still weak and her eyes were red, swollen, sensitive to light, diagnosed as conjunctivitis. Follow up info from a nurse indicated that the pt's condition had recovered as of 04/02/2001.
Age: 23.0
Sex: F
Vaccine: MEA
Symptoms: Eye swelling, Joint stiffness, Nausea, Ocular hyperaemia, Photophobia
Clinical narrative: Information has been received from a health professional concerning a 23 year old white female with an ankle injury and hayfever, with no known drug allergies who on 03/26/2001 at 12:00 was vaccinated SQ in the left arm with a dose of measles virus vaccine live. There was no illness at the time of vaccination. concomitant therapy included an unspecified pain medication for the ankle injury. Other concomitant medication given on 03/24/2001 at 10:00, included a fifth dose Im in the left deltoid of diphtheria toxoid (+) tetanus toxoid. On 03/28/2001, at 8pm, the pt presented with the following symptoms: dizzy, weak, sores in mouth, difficulty swallowing, hurt to breath, stiffness, vomiting/nausea, red spots, non productive cough and itchy. It was noted that the pt's symptoms started on 03/27/2001. The nurse noted" it looked like a mild care of measles." On 03/30/2001, the pt presented feeling somewhat better but was still weak and her eyes were red, swollen, sensitive to light, diagnosed as conjunctivitis. Follow up info from a nurse indicated that the pt's condition had recovered as of 04/02/2001.
Age: 23.0
Sex: F
Vaccine: MEA
Symptoms: Pruritus, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 23 year old white female with an ankle injury and hayfever, with no known drug allergies who on 03/26/2001 at 12:00 was vaccinated SQ in the left arm with a dose of measles virus vaccine live. There was no illness at the time of vaccination. concomitant therapy included an unspecified pain medication for the ankle injury. Other concomitant medication given on 03/24/2001 at 10:00, included a fifth dose Im in the left deltoid of diphtheria toxoid (+) tetanus toxoid. On 03/28/2001, at 8pm, the pt presented with the following symptoms: dizzy, weak, sores in mouth, difficulty swallowing, hurt to breath, stiffness, vomiting/nausea, red spots, non productive cough and itchy. It was noted that the pt's symptoms started on 03/27/2001. The nurse noted" it looked like a mild care of measles." On 03/30/2001, the pt presented feeling somewhat better but was still weak and her eyes were red, swollen, sensitive to light, diagnosed as conjunctivitis. Follow up info from a nurse indicated that the pt's condition had recovered as of 04/02/2001.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Crying, Cyanosis, Pyrexia, Rash
Clinical narrative: Information has been rec'd for Infanrix and Engerix and was assigned manufacturer report number 2001028863-2. This was originally reported by a physician concerning a 9-week-old infant who on 11/15/01 was vaccinated with a dose(lot 639210/1311L) of haemophilus B conjugate vaccine (manufacturer unknown). Concomitant therapy on 11/15/01 included doses (lot number T1450)IM in the right thigh of poliovirus vaccine (IPOL), diphtheria toxoid/pertussis vaccine/ teta (Infanrix) and hepatitis B vaccine, recomb (Engerix-B).It was noted that the infant had an upper respiratory infection at the time of vaccination. Within five minutes post vaccination the infant began crying, turned blue, appeared to either fall asleep or pass out, and developed an urticarial rash on the face and body, experienced fussiness, and had a low-grade fever. The infant was observed in the physician's office for 2 hrs. It was reported that the rash lasted for 1.5 hrs, the other events resolved and the infant was sent home. The physician considered the events to be related to the therapy with diphtheria toxoid/ pertussis vaccine/ teta (Infanrix) and hepatitis B vaccine, recomb. (Engerix-B). Crying, cyanosis, syncope and rash were considered other important medical events. No further information is available. Additional info received on 3/19/01 indicated that the pt was currently healthy and medically stable. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Syncope
Clinical narrative: Information has been rec'd for Infanrix and Engerix and was assigned manufacturer report number 2001028863-2. This was originally reported by a physician concerning a 9-week-old infant who on 11/15/01 was vaccinated with a dose(lot 639210/1311L) of haemophilus B conjugate vaccine (manufacturer unknown). Concomitant therapy on 11/15/01 included doses (lot number T1450)IM in the right thigh of poliovirus vaccine (IPOL), diphtheria toxoid/pertussis vaccine/ teta (Infanrix) and hepatitis B vaccine, recomb (Engerix-B).It was noted that the infant had an upper respiratory infection at the time of vaccination. Within five minutes post vaccination the infant began crying, turned blue, appeared to either fall asleep or pass out, and developed an urticarial rash on the face and body, experienced fussiness, and had a low-grade fever. The infant was observed in the physician's office for 2 hrs. It was reported that the rash lasted for 1.5 hrs, the other events resolved and the infant was sent home. The physician considered the events to be related to the therapy with diphtheria toxoid/ pertussis vaccine/ teta (Infanrix) and hepatitis B vaccine, recomb. (Engerix-B). Crying, cyanosis, syncope and rash were considered other important medical events. No further information is available. Additional info received on 3/19/01 indicated that the pt was currently healthy and medically stable. No further information is available.
Age: 39.0
Sex: M
Vaccine: MEA
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a 39 year old male who in 1963 was vaccinated with measles virus vaccine live. The pt claims the vaccination was "inactive" and that he was "not sure if it was Attenuvax." Subsequently, the pt had a negative 0.84 titer. Unspecified medical attention was sought. Additional info has been requested.
Sex: U
Vaccine: MEA, MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with measles virus vaccine live (also reported as measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) MSD). It was reported that the pt was a low titer for measles. NO further information was available. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling
Clinical narrative: It was reported that a 38 year old female pt received a TD Adult vaccination on 02/29/2000 at 11:00am. Reportedly at 9:00pm that evening the pt experienced redness and swelling of the right arm, which required admission the hospital for four days
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Rash
Clinical narrative: It was reported that a female pt received a TD Adult vaccination on 3/9/00. Reportedly, within 12 hours, the pt developed a rash over her entire body. From correspondence received on 3/27/00, additional pt and responsible physician information was provided.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Oedema peripheral, Paraesthesia, Skin ulcer
Clinical narrative: It was reported that a 15 year old female pt received a TD Adult vaccination on 3/4/00. Reportedly, on 3/13/00, the pt complained of forearm swelling, numbness, tingling and weakness in fingers with flexion. The pt also developed a red, flat lesion 4-5mm on flexor surface of forearm. From correspondence received on 3/30/00, additional physician and vaccine information was provided.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Swelling
Clinical narrative: It was reported that a 47 year old female received a TD Adult  on 3/17/00. Reportedly, on 3/18/00, the pt complained of left deltoid soreness and left extremity swelling. The symptoms have reportedly subsided. From correspondence received on 4/10/00, additional pt and responsible physician information was provided.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: It was reported that a female pt received a TD Adult on 3/14/00. Reportedly, on 3/15/00, the pt complained of right deltoid redness, itchiness, tenderness and right extremity swelling. The pt received Keflex and Prednisone as treatment. Reportedly, the symptoms have subsided. From correspondence received on 4/10/00, additional pt, vaccine and responsible physician information was provided.
Age: 31.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: It was reported that a 31 year old female pt received a TD Adult and a Fluzone UNSP '99-'00 vaccination on 3/20/00. Reportedly, on 3/21/00, the pt complained of redness, itching, soreness, warmth to touch and an induration of the left deltoid. From correspondence received on 3/29/00, it was reported that the pt recovered from this experience.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a 28 year old female received a TD Adult vaccination on 3/14/00. Reportedly, on 3/15/00, the pt developed erythema, swelling and a bruise at the injection site. The pt reportedly recovered from this experience.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Eye disorder, Muscle spasms, Opisthotonus
Clinical narrative: It was reported that a 14 year old male received a TD Adult vaccination on 3/9/00. Reportedly, 17 days post vax, on 3/26/00, the pt developed severe muscular tightening of his left shoulder and then right shoulder which lasted approx. 3 minutes, each side. In the evening of 3/28/00, the pt experienced severe tightening in the lower back which caused arching of his back and his left leg to go out to the left side, unable to put down, pt actually fell out of bed. This entire episode lasted approx. 7 minutes, then totally resolved. The pt denies any muscle weakness or soreness. Shortly after the muscle spasm on the 28th, the pt noticed an area under his right eye could produce "squeaking" sound, which persisted for the rest of the evening. This experience resolved in the morning of 3/29.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: It was reported that an 11 year old female received a TD-Adult vaccination in her left arm on 3/29/00. Reportedly, sometime after the vaccination, the pt developed a 3" red area, raised and warm at the area of the injection. From correspondence received on 4/19/00, additional pt information was provided.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: It was reported that a female pt received a TD Adult on 3/30/00. Sometime, post vax, the pt developed a swollen, red, hard nodule at the injection site. Additional information is being requested. From correspondence received on 5/4/00, additional pt, vaccine, responsible physician and vaccine administrator information was provided.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: It was reported that a female pt received a TD Adult on 3/30/00. Sometime, post vax, the pt developed a swollen, red, hard nodule at the injection site. Additional information is being requested. From correspondence received on 5/4/00, additional information was provided.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: It was reported that a pt who rec'd TD adult vaccination on 4/3/00. Reportedly on 4/4/00 the pt experienced extreme fatigue, body aches, fever 100F and chills. From correspondence rec'd on 5/1/00, it was reported no treatment was necessary, symptoms resolved on own. No localized reaction noted. Additional pt, vaccine and responsible physician information were also provided.
Age: 22.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: It was reported that a pt who rec'd TD adult vaccination on 3/13/00, reportedly sometime after the vaccination the pt developed erythema and a local induration. The pt reportedly recovered from this experience. From correspondence rec'd on 5/30/00, it was reported. Reviewed , no additional information at this time. 4/28/00 Dr reports no further information is anticipated for this report, the case is closed.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a pt rec'd a TD adult vaccination on 4/7/00. Reportedly after that vaccination the pt experienced swelling and redness of the L arm at the injection site. From correspondence rec'd on 5/5/00, it was reported that the pt recovered from this experience. Additional pt, vaccine and responsible physician information was also provided.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: It was reported that a pt rec'd a TD adult vaccine on 4/7/00. Reportedly sometime after the vaccination the pt developed a large red area, very painful, hard knot at the injection site. From correspondence rec'd on 5/2/00 additional pt, vaccine administrator and responsible physician information was provided.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: It was reported that a pt rec'd a TD adult vaccination on 4/6/00. Reportedly sometime after the vaccination the pt developed a swollen painful area at the injection site that was warm to the touch, the pt also developed pain traveling up toward the shoulder. From correspondence rec'd on 5/5/00, additional pt and vaccine information was provided.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: It was reported that a pt who rec'd a TD adult vaccination on 4/4/00. Reportedly on 4/7/00, the pt developed a local reaction of redness, warmth and induration.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: It was reported that a pt who rec'd TD adult vaccination on 4/10/00. Reportedly on 4/11/00, the pt developed a local reaction of redness, warmth and induration.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: It was reported that a pt rec'd TD adult vaccination on 3/20/00. Reportedly on 3/24/00, the pt developed a local reaction of redness, warmth, induration.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: It was reported that a pt rec'd a TD adult vaccination on 4/10/00. reportedly on 4/11/00, the pt developed a local reaction of redness, warmth and induration.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: It was reported that a pt rec'd a TD adult vaccination on 4/25/00. Reportedly on 5/2/00, the pt developed a nodular density of the injection site with redness and swelling. Further information requested. From correspondence rec'd on 1/7/00, additional pt, vaccine and responsible physician information was provided.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Nausea
Clinical narrative: It was reported that a 41 year old female received a TD Adult vaccination on 11 Apr 2000. Reportedly on 12 Apr 2000, the patient complained of pain and redness at the injection site of the left deltoid, as well as nausea. The left arm pain and redness was diagnosed as cellulitis. The patient was placed on antibiotics, pain-killers and something for the nausea (not specified). The symptoms seemed to become better in a few days. The patient returned on April 14th for checkup. Further information requested. From additional information received on 7 Jun 2000, it was reported that the patient recovered from this experience. Additional vaccine, patient and responsible physician information was also provided.
Sex: U
Vaccine: TD
Symptoms: Erythema, Injection site inflammation, Injection site pain
Clinical narrative: It was reported that a patient received a TD Adult vaccination. Reportedly within 24 hours of vaccination the patient developed a local reaction or redness, inflammation and soreness to the elbow. Further information requested.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: It was reported that a 31 year old male patient received a TD-Adult vaccination on 8 May 2000. Reportedly within 5 hours the patient developed a fever, chills, myalgia and a sore throat. The patient still experiences chills and fever at night. Further information requested. From additional information received on 7 Jun 2000, it was reported that the symptoms lasted for 72 hours and then resolved completely. The patient recovered from this experience.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: It was reported that a 54 year old male patient received a TD Adult vaccination on 18 May 2000. Reportedly three days after the vaccination the patient developed an induration at the injection site, a fever and swelling of the arm from elbow to shoulder. Further information requested. From additional information received on 19 Jun 2000, it was reported that the patient recovered from this experience. Additional patient and responsible physician information was also provided.
Sex: U
Vaccine: TD
Symptoms: Erythema, Injection site inflammation, Injection site reaction
Clinical narrative: It was reported that a patient received a TD Adult vaccination. Reportedly within 24 hours of vaccination the patient developed a local reaction or redness, inflammation and soreness to the elbow. Further information requested.
Age: 0.2
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Cyanosis, Loss of consciousness, Rash
Clinical narrative: Information has been rec'd for diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) and hepatitis B vaccine recombinant (Engerix-B) and concerns a 2 month old infant who on 11/15/01 was vaccinated with one dose of haemophilus B conjugate vaccine (manufacturer unknown). concomitant vaccinations that day included one dose each of poliovirus vaccine (IPOL), hepatitis B vaccine, recombinant (Engerix-B) and diphtheria toxoid/  pertussis vaccine/tetanus (Infanrix. Within 5 min. post vaccination the infant began crying, turned blue, appeared to either fall asleep or pass out, and developed a rash on the face and body. The infant was observed in the physicians office for 2 hrs. The rash lasted 1.5 hrs. The other events had also resolved and the infant was sent home. The reporting physician considered the events to be related to the diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Infanrix) and hepatitis B vaccine recombinant (Engerix-B). The pt's experience were considered to be other important medical events. Additional information has been requested. Other business partner numbers include F2002-00175 and U2002-00035.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome
Clinical narrative: Progressive generalized weakness which began approx 7-10 days after administration of influenza vaccine. (Guillain Barre).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Guillain-Barre syndrome, Hypoaesthesia, Pneumonia
Clinical narrative: The pt received a flu vaccine on 10/17/01. She had no problems until around Thanksgiving, at which time, she was dx'd with pneumonia and bronchitis. Shortly after this, she began experiencing a feeling of numbness in her feet, hips, arms, face and mouth. She told her doctor about these symptoms and was hospitalized in order to figure out what was going on. Her doctor could not find anything wrong. Even though she was discharged from the hospital, she continued to have problems. At this time, the pt's daughter took her to see another doctor and according to her daughter, the dx was confirmed as Guillain-Barre after obtaining the results of a spinal tap. The pt is currently recovering in the home of her daughter.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Sluggishness, Vomiting
Clinical narrative: Shot Thursday, sluggish on Friday, vomited on Saturday, Monday weak, rundown, no fever.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: The pt had a fever of 102 degrees F. Took extra strength tylenol. Gait unsteady so he was taken to the ER which they gave him more tylenol and some fluids. Temp went down to 99 degrees and then he was released.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: The pt had a reaction to pneumococcal vaccine. Left arm got red, hot and swollen for five days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Faint for 1 hour by noon feeling fine.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Hyperhidrosis, Vomiting
Clinical narrative: Late Tuesday stomach cramps, vomited, sweats along with vomiting. On 10/23/2001 Wednesday sipped water, tea, ate little in the evening and had no problems.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anorexia, Chest pain, Muscular weakness, Myalgia, Nausea
Clinical narrative: Monday-soreness, put on ice pack, achiness on arm, weakened. Tuesday, wiped out chest aching, nausea, loss of appetite.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Monday-soreness, put on ice pack, achiness on arm, weakened. Tuesday, wiped out chest aching, nausea, loss of appetite.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Oedema peripheral
Clinical narrative: Arm red and swollen, felt lump at injection site. Went to see the doctor the next day (10/15/2001) and was prescribed Alegra, took it twice only because it made her drowsy.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Flu shot on 10/10/2001. Went to the doctor's on the 14th for fever, vomiting, aches and pains. The doctor said that it's the virus, no Rx, but did blood work.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site rash
Clinical narrative: Warm red flat rounded 2 inch area at right arm deltoid within 3 hours of vaccination. Next day flat round rash on both legs, nausea.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Diarrhoea, Dyspnoea, Pruritus, Rash
Clinical narrative: Lesion on back, swollen for 2 and a half months, chills everyday up to now, extreme rash, itching, difficulty breathing, vomiting, diarrhea.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Skin ulcer, Swelling, Vomiting
Clinical narrative: Lesion on back, swollen for 2 and a half months, chills everyday up to now, extreme rash, itching, difficulty breathing, vomiting, diarrhea.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site reaction, Injection site swelling, Rash
Clinical narrative: Lesion on back, swollen for 2 and a half months, chills everyday up to now, extreme rash, itching, difficulty breathing, vomiting, diarrhea.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Diarrhoea, Dyspnoea, Injection site reaction, Pruritus
Clinical narrative: Lesion on back, swollen for 2 and a half months, chills everyday up to now, extreme rash, itching, difficulty breathing, vomiting, diarrhea.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Rash, Vomiting
Clinical narrative: Lesion on back, swollen for 2 and a half months, chills everyday up to now, extreme rash, itching, difficulty breathing, vomiting, diarrhea.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Developed orange size swelling at injection site after vaccine dose number two. Site was red but not painful. No fever reported, no lost work or limitation of activities. Swelling began to resolve 9 days post vaccine, now not noticeable.
Age: 1.4
Sex: F
Vaccine: HIBV, MMR
Symptoms: Feeling hot, Injection site induration, Tenderness
Clinical narrative: The pt developed 8cm by 6cm indurated area; tender; warm to touch.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Pt noted with temperature of 105 degrees 3-4 hours after the vaccinations. He vomited, chills stated.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Oedema, Pruritus, Tongue paralysis, Urticaria
Clinical narrative: Noted pruritis webs of left hand progressed to numbness up to both elbows, tongue felt funny, numbness chin and jaw line. Given Benedryl and after one hour relief of numbness, hives, wheeze, SOB, edema noted. remained stable, released.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Jaundice, Malaise, Pyrexia, Vomiting
Clinical narrative: Fever and malaise same day. vomiting three times the next day. Jaundice noted on 01/27.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Blood bilirubin increased, Chromaturia, Eye disorder, Hepatomegaly, Jaundice
Clinical narrative: Fever and malaise same day. vomiting three times the next day. Jaundice noted on 01/27.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Pyrexia, Yellow skin
Clinical narrative: Fever and malaise same day. vomiting three times the next day. Jaundice noted on 01/27.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Pt presented to ER with rash. Vaccine for "chicken pox" received about 10 days earlier. Follow up states: Lot number information not available.
Age: 0.17
Sex: F
Vaccine: DTAP, FLUX, IPV
Symptoms: Agitation, Crying, Psychomotor hyperactivity
Clinical narrative: Very hyper and agitated the day after vaccination. Four days later she started crying and crying until no apparent reason which she never used to do that before.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: It was reported that an 11-year-old boy received a TD-Adult vaccination on 12-Jun-2000. Reportedly that same day, the patient developed hives. Further information requested.
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site mass
Clinical narrative: It was reported that a female patient received a TD Adult and a Pneumococcal (Unspecified) vaccination on 7 Jun 2000. Reportedly sometime after the vaccinations the patient developed a hard nodule at the injection site. Further information requested. From follow-up received 10/15/01 it was reported, "No additional information at this time." This case is closed.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: It was reported that a female patient received a TD Adult vaccination on 3 Jul 2000. Reportedly within 24 hours the patient developed pain at the injection site, fever, chills, headaches, and general malaise. Further information requested. From correspondence received 7 Aug 2000, it was reported that the patient recovered from this experience. Additional patient, vaccine, responsible physician and the vaccine administrator information were also provided.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site reaction
Clinical narrative: Reportedly the patient was seen by a physician 4 days later, the patient had developed a large local reaction, red/purple area that was warm to the touch from elbow to shoulder. Further information requested. From additional correspondence received on 28 Jan 2000, additional patient, vaccine, concomitant medications and responsible physician information was provided. No further information expected, this case is closed.
Sex: M
Vaccine: TD
Symptoms: Hypotension, Nausea, Syncope, Vomiting
Clinical narrative: It was reported that a male patient received a TD Adult vaccination on 25 Jul 2000. Reportedly about 18 hours after the vaccination the patient developed nausea, vomiting, hypotension and syncope. Further information requested.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Headache, Nausea, Syncope, Tinnitus
Clinical narrative: It was reported that a 39 year old female pt received a TD Adult vaccination on 08/04/2000. Reportedly the pt received the vaccination at noon on Friday, developed headache several hours after. The next day the pt developed dizziness, nausea, and vomiting and unrelieved headache. On Sunday the pt experienced dizziness, ringing in ears and fainted. The pt was not seen by a physician.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: It was reported that a 39 year old female pt received a TD Adult vaccination on 08/04/2000. Reportedly the pt received the vaccination at noon on Friday, developed headache several hours after. The next day the pt developed dizziness, nausea, and vomiting and unrelieved headache. On Sunday the pt experienced dizziness, ringing in ears and fainted. The pt was not seen by a physician.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: It was reported that a 29 year old female pt received a TD Adult vaccination on 08/23/2000. Reportedly on 08/25/2000, the pt developed redness, warmth, swelling and an induration of 7cm x 10cm at the injection site. Reportedly the pt recovered from this experience. From additional info received on 12/01/2000, pt identifier information was updated.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Headache, Palpitations, Tremor
Clinical narrative: It was reported that a 42 year old male pt received a TD Adult vaccination on 08/28/2000. Reportedly a half an hour later the pt developed a headache, became lightheaded, dizzy, shaky and his heart began to race. Treatment-observed for approx. 30 mins. Reportedly the pt recovered from this experience. From correspondence received on 11/21/2000, it was reported, "Reviewed, no additional info." No further info is expected, thi case is closed.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Headache, Palpitations, Throat tightness, Tremor
Clinical narrative: It was reported that a 44 year old female pt received a TD Adult vaccination on 08/28/2000. Reportedly within 30 mins after the injection the pt developed shakiness, heart racing, tightness in throat and headache. Treatment-observation only. Reportedly the pt recovered from this experience.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Dizziness, Injection site pain, Myasthenic syndrome, Nausea
Clinical narrative: It was reported that a 34 year old male pt received a TD Adult vaccination on 09/05/2000. Reportedly that same day the pt experienced nausea, vomiting, diarrhea and light-headness. he also experienced pain at the injection site with numbness and weakness of the left hand. The pt was evaluated by a nurse practitioner not physician. From additional info received on 12/05/2000, additional pt and responsible physician info was provided.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia, Vomiting
Clinical narrative: It was reported that a 34 year old male pt received a TD Adult vaccination on 09/05/2000. Reportedly that same day the pt experienced nausea, vomiting, diarrhea and light-headness. he also experienced pain at the injection site with numbness and weakness of the left hand. The pt was evaluated by a nurse practitioner not physician. From additional info received on 12/05/2000, additional pt and responsible physician info was provided.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: It was reported that a 35 year old female pt received a TD Adult vaccination on 08/24/2000. Reportedly on 08/26/2000, the pt developed a severe localized reaction of redness, warmth and induration. Reportedly the pt recovered from this experience.
Sex: U
Vaccine: TD
Symptoms: Throat tightness
Clinical narrative: It was reported that a patient (1 of 2) received a TD Adult vaccination on 08/28/2000. Reportedly that same day, the pt complained of tightness in their throat. No specific provided. Further info requested.
Sex: U
Vaccine: TD
Symptoms: Throat tightness
Clinical narrative: It was reported that a patient (2 of 2) received a TD Adult vaccination on 08/28/2000. Reportedly that same day the pt complained of tightness in the throat. No specifics provided. Further info requested.
Age: 12.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Anorexia, Injection site reaction, Osteoarthritis
Clinical narrative: It was reported that a male pt received a TD Adult (right arm), a MMR (left arm) and a Hep B (left arm) vaccinations on 08/28/2000. Sometime after the vaccinations the pt developed a "Arthrus reaction." No specifics were provided, further info requested. From additional info received on 11/14/2000, it was reported that the pt developed swelling of the right arm into armpit, increased pain, loss of appetite, no vomiting, no fever. Reportedly the pt recovered from his experience. No further info is expected, this case is closed.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: It was reported that a male pt received a TD Adult vaccination on 08/31/2000. Reportedly 2 days after the vaccination the pt developed redness and pain below the injection site. No specifics were provided. From additional info received on 10/31/2000 it was reported that the pt also received a PPD Tubersol skin test. Reportedly the pt recovered from this experience. No further info is expected; this case is closed.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: It was reported that an 18 year old male pt received a TD Adult on 9/8/00 and on 9/11/00, the pt developed a local reaction of redness and pain at the injection site. Physician treated as cellulitis with Cefadroxil 500mg twice a day for 10 days.