chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.33
Sex: F
Vaccine: DTAP, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt had red swollen upper thighs and warm to touch. Was told to put warm compresses to affected area.
Age: 35.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Dizziness, Headache, Injection site oedema, Pain
Clinical narrative: Redness, swelling, and pain around vaccination site, which began 6/9/03. Red streak extending from vaccination site, approximately 2 1/2" toward armpit. C/o pain in armpit area but no palpable lymph nodes. Headache, dizziness since 6/5 with limited relief from OTC medication.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt received the PneumoVax on 11/10/03. On 11/11/03 she noted redness, swelling and warmth, and pain at injection site. Took Benadryl with some relief. Seen at Dr's office on 11/12. Examined by CNP and Dr. Objective signs showed left arm erythema without induration 3/4 of deltoid region, tender to touch, mildly warm. Treatment included Benadryl for 2 days, ice packs and avoid PneumoVax in future. 11/14/03 spoke with pt by phone. Arm is much improved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Received telephone call from pt's mother 11/19/03 stating child's left arm was swollen from shoulder to elbow. Occurred gradually over 3 days. Denied fever, pain, no loss of movement, no tingling sensation. Instructed mother to take child to their physician for evaluation.
Age: 1.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC
Symptoms: Conjunctivitis, Erythema, Pyrexia, Rash papular, Upper respiratory tract infection
Clinical narrative: URI, low grade fever, conjunctivitis and severe rubella/measles-like rash covering entire body with red papules, worse no trunk, confluent on face.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash papular, Skin ulcer
Clinical narrative: 10/13/03 Seen for rash, 8 lesions, some crusted, some pustules, some papules, characteristic of chicken pox. Received vaccine 7/98. Follow up on 12/16/03: "Pt developed fever for 3 days prior to visit on 10/13/03.  Fever lasted 24 hours then developed a rash 2 days later characterized by papular vesicles and purpules. I do not know how many MD's have taken care of her before seen in my office the immunization events does not include Lot # or Manufacturer name it was given in 1998.  She was fine and sent home 10/01.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Myalgia, Pain
Clinical narrative: Pt had increased myalgia and fever of 103 degrees about 24 hours after dT vaccine. Right shoulder injection site, mild induration, slight erythema, warm to touch, +tender to palpation.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Pt had increased myalgia and fever of 103 degrees about 24 hours after dT vaccine. Right shoulder injection site, mild induration, slight erythema, warm to touch, +tender to palpation.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Fatigue, Flushing, Hyperhidrosis, Malaise
Clinical narrative: From telephone contact received at AP on 04/26/2002, it was reported that patient received first post exposure series of Imogram HT and Imovax on 04/08/2002.  Patient reported that he felt tired and achy after first dose.  After second dose of Imovax on 04/11/2002, he had chills and general malaise.  Patient also experienced chills and sweating after the third dose of Imovax on 04/15/2002.  Patient also reported that he is now flushed and very tired after the fourth dose of Imovax on 04/22/2002.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Pain
Clinical narrative: From telephone contact received at AP on 04/26/2002, it was reported that patient received first post exposure series of Imogram HT and Imovax on 04/08/2002.  Patient reported that he felt tired and achy after first dose.  After second dose of Imovax on 04/11/2002, he had chills and general malaise.  Patient also experienced chills and sweating after the third dose of Imovax on 04/15/2002.  Patient also reported that he is now flushed and very tired after the fourth dose of Imovax on 04/22/2002.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Globulins increased, Laboratory test abnormal, Petechiae
Clinical narrative: From information received via telephone on 10/31/2002 by AP it was reported that a 23 year old female student was vaccinated with Imovax Rabies, Lot # U8971 on 10/17/2002 (second dose in pre expose series).  On 10/26/2002, the patient developed low back pain and joint pain in her knees, ankles and elbows.  The patient self-medicated with ibuprofen.  The patient also reported taht she developed a rash on both lower legs.  She was evaluated by a physician and diagnosed with possible Immune Complex-like reaction and petechiae of both lower extremities.  Laboratory tests revealed that the patient had an elevated CR protein level, elevated globulin level, and sedimentation rate of 37.  Her basic chemistry was reportedly normal.  No further information was provided at this time.  It was not reported whether the patient recovered.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Red blood cell sedimentation rate increased
Clinical narrative: From information received via telephone on 10/31/2002 by AP it was reported that a 23 year old female student was vaccinated with Imovax Rabies, Lot # U8971 on 10/17/2002 (second dose in pre expose series).  On 10/26/2002, the patient developed low back pain and joint pain in her knees, ankles and elbows.  The patient self-medicated with ibuprofen.  The patient also reported taht she developed a rash on both lower legs.  She was evaluated by a physician and diagnosed with possible Immune Complex-like reaction and petechiae of both lower extremities.  Laboratory tests revealed that the patient had an elevated CR protein level, elevated globulin level, and sedimentation rate of 37.  Her basic chemistry was reportedly normal.  No further information was provided at this time.  It was not reported whether the patient recovered.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Dysphagia, Face oedema, Urticaria
Clinical narrative: From telephone correspondence received at AP on 11/05/2002, it was reported that a 28 year old female adult received the second dose of IMOVAX RABIES Lot # U098612, on 10/31/2002 as part of a pre-exposure series.  On 11/02/2002, patient experienced joint pain and pain in right arm and hand swelling.  In the middle of the night, patient broke out in hives on waist, followed by arms and legs.  She went to ER on 11/03/2002 and was prescribed hydroxyzine.  On 11/04/2002 patient was seen by her family physician but received no additional treatment.  On 11/05/2002, patient called the health department and reported swelling of her lips, huge generalized hives, chills, and difficulty swallowing.  There were no symptoms reported after the first dose and she has no history of antibiotic allergies.  It was not reported whether the patient recovered.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: From telephone call received at AP on 12/27/2002, it was reported that a 50 year old female patient received Imogam HT (Lot # U07062 expiration date 06/26/2003) and Imovax Rabies (Lot # U0815) vaccine administered on 12/24/2002.  Within 24 hours of vaccination, the patient complained of general body aches and a 100.6 degree F fever.  These symptoms were treated symptomatically.  It was not reported whether the patient recovered from the event.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Feeling hot, Hypersensitivity, Hypoaesthesia, Muscle spasms
Clinical narrative: 11/10/2002, it was reported that a 48-year-old female, DOB 08/10/1953, received Imovax Rabies and Imogam USP on 07/08/2002. Dose 2 of Imovax Rabies was given on 07/11/2002. The pt did not report any adverse events following either the first or second doses of the series. Dose 3 was administered on 07/15/2002 in the right deltoid and dose 4 was administered on 07/22/2002 in the left deltoid. After the 3rd and 4th doses of the vaccine, the pt stated that her arm felt like it was bubbling and went completely numb immediately upon receiving the vaccine. After 10 minutes, the numbness started to subside. The following day, her arm was red and warm over an area measuring approx 4" long and 2" wide. Her physician told her it was an allergic reaction and advised her not to complete the series. She then called the Center for Disease Control and was advised to have a titer done. She then went to her physician and her titer on 07/23/2002 measured greater than 1:5. In August, she began to experience muscle cramps and an aching sensation in her legs, which occurred with or without activity. The pt stated that she normally walked 10-12 miles per day, but was only able to walk 2 miles because it hurt too much to walk. She experienced muscle spasms in her neck, right shoulder, and left arm. as well as hip joint pain. The pt stated that she was not sure if this report was ever submitted to VAERS. She believes all doses were Imovax. The lot number provided is from doses 2, 3 and 4. The lot number for the initial dose was not available. Dose one was administered at ERl It was not reported whether the pt recovered from these adverse events.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Pain
Clinical narrative: 11/10/2002, it was reported that a 48-year-old female, DOB 08/10/1953, received Imovax Rabies and Imogam USP on 07/08/2002. Dose 2 of Imovax Rabies was given on 07/11/2002. The pt did not report any adverse events following either the first or second doses of the series. Dose 3 was administered on 07/15/2002 in the right deltoid and dose 4 was administered on 07/22/2002 in the left deltoid. After the 3rd and 4th doses of the vaccine, the pt stated that her arm felt like it was bubbling and went completely numb immediately upon receiving the vaccine. After 10 minutes, the numbness started to subside. The following day, her arm was red and warm over an area measuring approx 4" long and 2" wide. Her physician told her it was an allergic reaction and advised her not to complete the series. She then called the Center for Disease Control and was advised to have a titer done. She then went to her physician and her titer on 07/23/2002 measured greater than 1:5. In August, she began to experience muscle cramps and an aching sensation in her legs, which occurred with or without activity. The pt stated that she normally walked 10-12 miles per day, but was only able to walk 2 miles because it hurt too much to walk. She experienced muscle spasms in her neck, right shoulder, and left arm. as well as hip joint pain. The pt stated that she was not sure if this report was ever submitted to VAERS. She believes all doses were Imovax. The lot number provided is from doses 2, 3 and 4. The lot number for the initial dose was not available. Dose one was administered at ERl It was not reported whether the pt recovered from these adverse events.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Dizziness, Paraesthesia
Clinical narrative: From telephone call received at manufacturer on 08/08/2002 from pt it was reported that she received a dose of Imovax Rabies in her left deltoid on 07/25/2002. She experienced dizziness, diarrhea and parasthesia in both legs; tingling sensation that traveled up her legs, mainly in feet, pt stated it was uncomfortable to walk barefoot. She did not experience weakness or numbness. Pt experienced a slight tingling feeling in both hands. These symptoms persisted and became worse on 07/29/2002. on 07/30/2002 pt saw an infectious disease physician, he recommended stopping PEP treatment. The pt was afraid to continue with Imovax. Symptoms resolved 08/07/2002. Doses administered at hospital.
Sex: F
Vaccine: RAB
Symptoms: Muscle twitching
Clinical narrative: From telephone correspondence received at manufacturer on 08/21/2002, it was reported that the pt was vaccinated with a second dose of Imovax Rabies (lot #U0511-2) and began to experience muscle twitching in fingers, toes, neck and lower legs. Onset date was not reported. It is not reported whether the pt recovered from these adverse events.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Paralysis
Clinical narrative: From telephone contact received at manufacturer on 06/21/2002, it was reported that a 38-year-old female received dose one of Imovax Rabies vaccine in the left deltoid on 06/15/02 and dose two in the right deltoid on 06/18/02 for post exposure prophylaxis. Pt had superficial bite in right arm, RIG administered at wound site. On 06/20/02, pt developed complete paralysis from right elbow down to fingers with slight sensation in finger tips present. No sensation in forearm at all. No other signs and symptoms at this time. This case is closed.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Depressed level of consciousness, Tic, Tremor
Clinical narrative: From telephone contact received at manufacturer on 09/25/2002, it was reported that a 23-year-old male presented to the ER for post-exposure rabies Imogam USP and Imovax Rabies vaccine series at approximately 12:30 PM on 09/24/2002. Approximately 8 hours after vaccination the pt stated he experienced ticks, tremors, and a decreased level of consciousness lasted for approximately one hour. The pt then presented to the ER for evaluation. Assessment, vital signs and reflexes were normal, and no signs of symptoms were observed upon evaluation. Per physician, this is subjective info from the pt. It is not reported whether the pt recovered from these adverse events.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Nausea, Rash, Vomiting
Clinical narrative: From telephone contact received at Aventis Pasteur Inc. on 01/03/2003, it was reported that a 56-year-old female received 3 doses of Imovax Rabies (lot number U0971-3) for post exposure prophylaxis. The dates of vaccination were not reported. The pt experienced nausea, vomiting, headache and a rash inside her lips with swelling of the mouth, time and day not reported. It is not reported whether the pt recovered for the events.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Malaise, Myalgia
Clinical narrative: From telephone contact received at manufacturer on 08/14/2002 it was reported that a 48-year-old female received Imovax and Imogam started on 07/23/2002 as a post exposure treatment. The pt experienced generalized muscle aches, malaise after each dose. After third dose Imovax received on 07/30/2002, she developed bilateral facial pain (more right sided than left), generalized muscle and joint aches. After the 4th dose, on 08/16/2002, she experienced exacerbation of pain and tightness in face, which has not improved. The neurologist was contacted today, 08/14/02. The neurologist stated that it's not neurological in nature but most likely vaccine related. The pt contacted the CDC and was recommended to complete last dose of series with another rabies vaccine.
Sex: F
Vaccine: RAB
Symptoms: Face oedema, Injection site erythema
Clinical narrative: From telephone correspondence received at manufacturer on 05/10/2002, it was reported that a female received RIG (imogam) and first dose of Imovax on 04/06/2002. Several hours after vaccination, pt's lips and face became swollen, and generalized erythema noted. Pt was able to complete the series without event. Unable to determine if this was a reaction to the product or if some other etiology.
Age: 11.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Injection site erythema, Pain
Clinical narrative: From telephone contact received at manufacturer on 07/23/2002, it was reported that an 11-year-old female received 3 doses of Imovax IM to the deltoid for post exposure prophylaxis. The pt developed large local reactions at site of injection after each dose. The areas were red, warm, tender to touch, but size not reported. This report, phoned in by pt's mother, who is a nurse practitioner at a different facility from where the vaccines were administered. No lot number info available, doses were administered at family physician's office. Mother wasn't sure if this was reported to VAERS through her health department. A VAERS form was faxed to her requesting she obtain as much info as possible and return to manufacturer.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: From faxed correspondence received at manufacturer on 08/09/2002, it was reported that a 55-year-old male received his 4th dose of Imovax Rabies vaccine on 07/24/2002. The pt experienced low-grade fever and tingling sensation all over his body the day of vaccination. No other symptoms were reported. The first 3 doses were uneventful. The reporter refused to provide pt info at this time except for pt initials and DOB.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Pyrexia
Clinical narrative: From telephone contact received at manufacturer on 10/01/2002, it was reported that a 43-year-old female pt (DOB 12/17/1958) was administered the 4th dose of Imovax Rabies (lot #U0961-2) on 09/28/2002 for post-exposure prophylaxis. Sometime after vaccination (date unspecified), she experienced a fever of 102 degrees F and headache. She was prescribed acetominophen by her physician. The symptoms resolved as per reporter.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: From initial info received at manufacturer on 02/06/2003, it was reported that a 46-year-old female pt received Imovax Rabies, lot number U0595-2, given intra-muscular in the left deltoid as first booster on 01/30/2003. Pt experienced immediate nausea and lightheadedness. 24 hours later, pt reported having a severe headache and nausea that is still continuing. Nurse gave the vaccination reported that she obtained this info when returning to the pt's facility to administer vaccine to other patients. Pt received pre-exposure rabies series in past, had titer checked some point after series and titer was negative. The nurse stated that she did not have the dates of previous doses received on hand but could obtain them if requested. Pt was seen in ER/doctor's office, time and date not reported. Pt had no illnesses or pre-existing diagnosis at time of vaccination.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Dyspnoea, Headache, Nausea, Urticaria
Clinical narrative: From initial info received at manufacturer on 02/06/2003, it was reported that a 28-year-old female pt received Imovax Rabies, lot number T0122-2, given intra-muscular in the right deltoid, expiration date for this product is 02/16/2003, on 02/05/2003. On same day as vaccination, pt stated that she felt dizzy and nauseated right away. Pt developed a headache and by the next day she developed welts over her body. Pt took 4 Benadryl and used her inhaler for her breathing. Pt has allergies and an epinephrine, she used that. Pt still has dizziness and nausea.
Age: 53.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia
Clinical narrative: From telephone contact received at manufacturer on 12/06/2002, it was reported that a 53-year-old male pt was administered Imovax Rabies, lot number U0448-2, intra-muscularly in the left deltoid on 11/22/2002. By the next day, 11/23/2002, the pt called to complain of painful joints in his fingers, wrist, elbow and knees. Reportedly, the symptoms went away on the 4th day without treatment. The case is closed.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Heat rash, Pyrexia, Vomiting
Clinical narrative: From info received at manufacturer on 12/02/2002, it was reported by the 42-year-old female pt that a stray cat bit her on 11/02/2002. She received a post-exposure series starting on 11/05/2002, she received Rabies Immune Globulin and 5 doses of Imovax Rabies, lot number U0971-3l She stated that she experienced vomiting and diarrhea continuously since first dose. After the third dose she had a high fever and a heat rash. Pt recovery status is unknown.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: From telephone contact received at manufacturer on 01/23/2003, it was reported that a 56-year-old female pt received 3rd dose of Imovax Rabies (PEP series) (lot #U0961-2) in the left deltoid at 12:00 PM on 01/15/2003. The pt also received 1st and 2nd doses of Imovax Rabies (lot numbers not reported) on 01/08/2003 and 01/11/2003 respectively. In the evening of 01/15/2003, the pt experienced pain at the injection site, no redness or swelling were reported. Additionally, the pt reported having a fever of 102-103 degrees F, which lasted for 3 hours. Info was reported when the pt came in for her 4th dose of Imovax Rabies appointment. The pt reportedly recovered from the event. No illnesses at time of vaccination were reported. Case is closed.
Age: 19.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Anxiety, Hallucination
Clinical narrative: From info received by telephone at manufacturer on 10/25/2002, it was reported by a pt's parent that her 19-year-old son received RIG Imovax post-exposure prophylaxis vaccination series at the ER. Her son was given Augmentin and a Tetanus immunization as well because of a dog bite (animal escaped). It was also reported by the parent that her son has a history of psychological problems and experienced signs and symptoms of hallucinations after the first 2 doses of the Imovax series. He was also very anxious. The parent stated that her medical doctor doesn't feel this is related to the vaccine, but she felt that it might be related. The series began on 06/08/2002 and all symptoms were experienced by the 2nd week of the series. Pt has a history of hallucinations and has taken Haldol. Mother does not have lot numbers for the products that were administered. It was not reported whether the pt recovered.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: From telephone contact received at Aventis Pasteur Inc. on 07/30/2002, it was reported that an 11-year-old male received 2 doses of Imovax in the thigh. Date of vaccination not specified. Pt experienced local soreness and muscle stiffness for approximately one hour after each dose. Also after first dose Imovax, pt experienced headache and continues daily, most severe in evenings.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: From telephone contact received at manufacturer on 07/31/2002, it was reported that a 19-year-old female received her last dose of the post exposure rabies series (Imovax Rabies) on 07/24/2002. The pt's mother called to report that her daughter had just completed her post exposure rabies series. Schedule was started on 06/26/2002, 06/29/2002, 07/03/2002, 07/10/2002 and last dose was on 07/24/2002. Mother stated that pt worked in office handling animals and had been exposed to a rabid raccoon. According to mother, pt did not wear gloves and probably did not wash her hand as she should have. Also reported that it took the office personnel at least 2 weeks to begin treatment if not as long as a month. On 06/30/2002, pt went to the ER with severe pain, rated a 10 on the scale of 1-10, in her legs and lower spine. Pt also had a fever. Physician in the ER gave her Motrin and antihistamine. Mother reported that a lot of blood work including test for rabies were done at the ER before discharged her to home. Mother asked, from what has read about rabies, does her daughter have rabies because of her signs and symptoms. Mother does not have any lot numbers and was too upset to ask more info.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms, Myalgia, Pain
Clinical narrative: From telephone contact received at manufacturer on 08/22/2002, it was reported by the pt, a 51-year-old female, that she had been vaccinated with Imovax Rabies. After the last dose, the pt experienced body aches, muscle aches and muscle spasms.
Sex: F
Vaccine: RAB
Symptoms: Arthritis, Skin discolouration
Clinical narrative: From telephone contact received, on 08/28/2002, an adult female reported that she had a severe reaction after administration of the 4th dose of Imovax post-exposure rabies series in March, 2002.  She reported she turned black and blue, developed severe arthritis and that both of her knees need surgery.  She stated she had filed a report with the CDC.
Age: 65.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Hypoaesthesia, Pain
Clinical narrative: From information received on 11/25/2002, it was reported by a 65 year old female patient that she was bitten by a bat on 07/20/2002.  She received post-exposure prophylaxis on 07/23/2002, was given IMOGAM USP HT & IMOVAX RABIES, and completed the series on 08/20/2002.  She now has aches in her arms and legs.  She also has numbness in her legs, which feels like pins and needles.  She has a red area across her nose and cheeks and her face often turns beet red.  PEP series was given at a medical center outpatient pharmacy.  It is not known whether the patient recovered.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Convulsion
Clinical narrative: From telephone contact received  on 08/15/2002, it was reported that a female, born on 11/28/1999, received a dose of ActHIB, MMR and DTAP on 04/27/2002.  The patient developed seizures within 24 hours of vaccination.  On 08/08/2002, she received third dose of ActHIB and also developed seizure within 24 hours of vaccination and was rushed to the hospital on 08/09/2002.  No other vaccines administered on this occasion.  The patient appears fine at the present time.  From additional information received at AP on 12/18/2002, it was reported that the 2 year old patient also received a dose of MMR (manufacturer Merck, Lot # 0587K) given in the left upper arm and DTAP (manufacturer SKB, Lot # U0299AB) given in the right upper arm on 04/27/2001 at 10AM.  The patient was not taking any other medications or had any illnesses at time of vaccination.  The case is closed.
Age: 2.7
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: From telephone contact received on 06/11/2002, it was reported by a health care professional that a 2.5 year old female received 4th dose DTAP/HIB using Trihibit on 06/04/2002.  Two days later, patient had fever of 104 degree F. with swollen, and hot area at the injection site.  She went to ER and diagnosed with cellulitis.  Antibiotic Duraceft was prescribed for 10 days.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema, Irritability
Clinical narrative: From initial information received on 11/26/2002, it was reported that a 4 month old male infant received a second dose of ACTHIB, Lot # UA666AA, intra-muscularly in the right thigh, a second dose of IPOL, Lot # 1645-2, intra-muscularly in the left thigh and second dose of TRIPEDIA, Lot # U0582AA, intra-muscularly in the right thigh at 11:30 AM on 11/12/2002.  The patient experienced redness, puffiness, inconsolable crying and was fussy, at 12:00 PM on the same day as vaccination.  Patient recovered from these reactions.  It was reported that the patient had experienced an unspecified adverse event on 09/11/2002 at the age of 2 months following a second dose of Hepatitis B vaccine.  The case is closed.  Linked to cases: U2002-01099, U2002-01114, U2002-01117 & U2002-01138.
Age: 63.0
Sex: M
Vaccine: HIBV, MEN
Symptoms: Blood pressure increased, Flushing
Clinical narrative: From initial information received on 01/22/2003, it was reported that a 63 year old male patient received ACTHIB, Lot # UB405AA, given intra-muscular in the left arm and MENOMUNE A/C/Y/W - 135, Lot # UB256AA, given subcutaneous in the right arm on 01/22/2003.  Ten minutes after vaccination, patient's blood pressure increased from 142/78 to 182/100 and his face and neck were flushed.  Patient was administered with 50 milligrams of Benadryl-blood pressure-200/120, and also given 30-50 milligrams of Prednisone for 2 days.  It was reported that the patient did recover and had no illnesses at time of vaccination.  Patient had a pre-existing diagnosis of allergies and being anxious.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Irritability, Somnolence
Clinical narrative: From faxed correspondence received on 08/01/2002, it was reported that a 4 month old female received a dose of ACTHIB, Tripedia, IPOL and Prevnar on 07/11/2002.  Patient developed two hard areas with redness at the right leg injection site and one area on left leg injection site on 07/12/2002.  No fever noted.  Patient was fussy and sleeping a lot.  This reporter has two more patient's experienced same reactions after receiving these vaccines.  Linked with cases U2002-00607 & U2002-00608.  From additional information received at AP, Inc on 11/26/2002, it was reported that the patient was a 3 month old infant, who received ACTHIB, Lot # UB246AA, in the left leg as dose #2.  IPOL, Lot # U04252, in the right leg as dose #2, TRIPEDIA, Lot # U0544CA, in the left leg as dose #2, and PREVNAR (manufactured by Lederle), Lot # 484210, in the right leg as dose #2.  The patient had no illnesses at time of vaccination.  The patient recovered. Case is closed.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema
Clinical narrative: From initial information received on 11/26/2002, it was reported that a 2 month old female infant received ACTHIB, Lot # UA666AA, intra-muscularly in the right thigh, IPOL, Lot # 16452, intra-muscularly in the left thigh, TRIPEDIA, Lot # U0582AA, intra-muscularly in the right thigh and HEPATITIS B VACCINE (Merck manufacturer), Lot # 0513M, intra-muscularly in the left thigh on 11/14/2002.  All vaccinations were given as initial doses.  ON an unspecified date and time, the patient experienced inconsolable crying, redness and puffiness.  The patient recovered.  The case is closed.  Linked to cases: U2002-01099, U2002-01115, U2002-01117 & U2002-01138.  From faxed correspondence received at AP, Inc. on 12/17/2002, it was reported that the patient received the vaccinations at 11:30 AM on 11/14/2002.  The adverse reactions occurred on the same day.  This case is closed.
Age: 1.6
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: From telephone contact received on 06/17/2002, it was reported by the pediatrician's office that a 19 month old female received ACTHIB on 06/04/2002 to the right thigh.  Lot # UA704AA.  Patient's parent reported on 06/09/2002 to the pediatrician, Dr P, that there was redness and swelling.
Age: 0.1
Sex: F
Vaccine: HIBV, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: From telephone contact received on 06/25/2002, it was reported that a 7 week old infant received ACTHIB in the right thigh and IPOL in the left thigh on 06/21/2002.  Patient developed a local reaction of redness and swelling in the right thigh.  Physician prescribed cool packs to be applied to right thigh and infant Tylenol.  Reactions resolved as of 06/22/2002.  Patient also received Recombivax in the left thigh on 05/16/2002.  Linked with case U2002-00472.
Age: 0.1
Sex: F
Vaccine: HIBV, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: From telephone contact received on 06/25/2002, it was reported that a 7 week old female received ACTHIB in the right thigh and IPOL in the left thigh on 06/21/2002.  Patient developed a local reaction of redness and swelling in the right thigh.  Patient treated with cool packs and infant Tylenol. Reactions resolved.  Patient also had a case of oral thrush at time of immunization and was being treated with Nystatin.  Patient was vaccinated with Recombivax Hepatitis B in the left thigh on 05/21/2002.  Case linked with U2002-00470.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema
Clinical narrative: From information received on 12/04/2002, it was reported that a 2 month old female patient was vaccinated with first dose of TRIPEDIA (Lot # U582AA) given intra-muscularly in the right thigh, ACTHIB (Lot # UA735AA) given intra-muscularly in the right thigh, IPOL (Lot # W00632) given intra-muscularly in the left thigh and HEPATITIS B VACCINE (manufacturer Merck Lot # 0513M) given intra-muscularly in the left thigh at 11:00 AM on 12/02/2002.  TRIPEDIA was administered within a 2 week span, from the same lot numbers as 4 other children.  At 12:00PM on the same day as vaccination, the patient experienced redness and swelling at the injection site and unconsolable crying lasted 2-4 hours.  The patient was not taking any other medication at time of vaccination.  No other vaccines were given within 4 weeks of vaccination date.  It is not reported whether the patient recovered.  The case is closed.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema
Clinical narrative: From initial information received on 11/26/2002, it was reported that a 4 month old female infant received second doses of ACTHIB, Lot # UA666AA, intra-muscularly in the left leg, IPOL, Lot # W00632, intra-muscularly in the right leg and TRIPEDIA, Lot # U0582AA, intra-muscularly in the left leg at 9:00 on 11/19/2002.  The patient experienced redness and puffiness at the injection site and inconsolable crying at 11:00 on the day of vaccination.  The patient recovered.  Linked to cases: U2002-01099, U2002-01114, U2002-01115 & U2002-01138.  The case is closed.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema
Clinical narrative: From faxed correspondence received at manufacturer on 11/26/2002, it was reported that a 1-month-old female infant was vaccinated with ACTHIB, Aventis manufacturer, lot #UA666AA, IM in the right thigh, IPOL, Aventis manufacturer, lot #1645-2, IM in the left thigh, TRIPEDIA, Aventis manufacturer, lot #U0582AA, IM in the right thigh and HEPATITIS B VACCINE, Merck manufacturer, lot #0513M, IM in the left thigh at 11:00 a.m. on 11/14/2002. All of the vaccinations given on this date were primary doses, except for the Hepatitis B vaccine, which was the 2nd dose. The pt received a 1st dose of HEPATITIS B VACCINE, Merck manufacturer, lot #0513M, IM in the right thigh on 10/17/2002. The pt experienced redness and puffiness at the injection site and inconsolable at 12:00 p.m. on the same day as vaccination. The pt recovered. Linked to cases: U2002-01114, U2002-01115, U2002-01117 and U2002-01138.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema, Irritability
Clinical narrative: From faxed correspondence received at Aventis Pasteur Inc. on 08/01/2002, it was reported that a 4-month-old male received a dose of ACTHIB, Tripedia, IPOL, and Prevnar on 07/12/2002. Pt developed redness and swelling at injection site and was irritable on 07/15/2002. This reporter has 2 more patients who experienced similar reactions after receiving these vaccines. Linked with cases U2002-00607 and U2002-00525. From additional correspondence received at Aventis Pasteur Inc. on 11/26/2002, the lot #'s and administration sites for the vaccinations were provided. The pt received ACTHIB, lot #UA708AA, in the right leg as dose #2, IPOL, lot #U0425, in the left leg as dose #2, TRIPEDIA, lot #U0544CA, in the right leg as dose #2 and PREVNAR (manufacturer Lederle), lot #484-210, in the left leg as dose #2. The pt recovered. From additional correspondence received at Aventis Pasteur Inc. on 12/18/2002, it was reported that the pt had no pre-existing diagnosis and no illnesses at time of vaccination. The pt had no previous adverse reactions following prior vaccinations. No further info was reported. Case is closed.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia, Screaming, Somnolence, Tremor
Clinical narrative: From telephone contact received at manufacturer on 06/24/2002 regarding 3 patients who received Tripedia vaccine (lot #U0532AA), IPOL (lot #T12942-2) and Prevnar on 04/05/2002. The mother of the 3 patients called to report that all 3 of her children had reactions to vaccines administered. She reported that one month later all 3 had seizure like activity, high fever and screaming and shaking. Twins and another younger baby. She reported that she could not awake the youngest all night. Twins also slept unusually long. One twin on 05/13/2002 was limping and taken to the ER, had an ear infection, and on 05/16/2002 had spell in high chair which mom said he was unconscious for 1 hour. Other twin on 05/18/2002 had a seizure. She still awakes at night screaming and shaking. Youngest still has shakes and tremors. A neurologist has evaluated them all and attributes to immature immune systems. Linked with cases: U2002-00475 and U2002-00476.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia, Screaming, Somnolence, Tremor
Clinical narrative: From telephone contact received at manufacturer on 06/24/2002 regarding 3 patients who received Tripedia vaccine (lot #U0532AA), IPOL (lot #T12942-2) and Prevnar on 04/05/2002. The mother of the 3 patients called to report that all 3 of her children had reactions to vaccines administered. She reported that one month later all 3 had seizure like activity, high fever and screaming and shaking. Twins and younger baby. She reported that she could not awake youngest all night. Twins also slept unusually long. One twin on 05/13/2002 was limping and taken to the ER, had an ear infection and on 05/16/2002 had spell in high chair which mom said he was unconscious for 1 hour. Other twin on 05/18/2002 had a seizure. She still awakes at night screaming and shaking. Youngest still has shakes and tremors. A neurologist has evaluated them all and attributes to immature immune systems.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia, Screaming, Somnolence, Tremor
Clinical narrative: From telephone contact received at Aventis Pasteur Inc. on 06/24/2002 regarding 3 patients who received Tripedia vaccine (lot #U0532AA), IPOL (lot #T12942-2) and Prevnar on 04/05/2002. The mother of the 3 patients called to report that all 3 of her children had reactions to vaccines administered. She reported that one month later all 3 had seizure like activity, high fever and screaming and shaking. Twins and younger baby. She reported that she could not awake youngest all night. Twins also slept unusually long. Male twin on 05/13/2002 was limp and taken to the ER, had an ear infection and on 05/16/2002 had spell in high chair which mom said he was unconscious for 1 hour. Female twin on 05/18/2002 had a seizure. She still awakes at night screaming and shaking. The youngest still has shakes and tremors. A neurologist has evaluated them all and attributes to immature immune systems. Linked with cases: U2002-00476 and U2002-00467.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Irritability, Pyrexia
Clinical narrative: From telephone correspondence received at manufacturer on 11/05/2002, pt's mother reported that 2-month-old female infant received ACTHIB (lot #UA720AA), TRIPEDIA (lot #U0549AA), IPOL (lot #U01275) and Prevnar on 09/09/2002. Tylenol was administered right after vaccination. That evening, the pt had a fever of 101.5 F and was extremely agitated and fussy compared to how she normally was. Breastfeeding was difficult and fussiness lasted for approximately 5 days. Mother was not sure if this was reported to VAERS by her doctor.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Injection site oedema, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: From telephone contact received at manufacturer on 05/28/2002, it was reported that a 15-month-old male received ActHIB to the left thigh and MMR to the right thigh on 05/21/2002. Two days after vaccination, pt developed fever of 101.5 degrees F rectally. Pt's left thigh was swollen 25% more than the right thigh with splotchy red rash 2-3 inches around injection site (left thigh). CBC was normal and Amoxicillin administered.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Dyspnoea, Febrile convulsion
Clinical narrative: A 15 month old male received injections of Prevnar (third dose), MMR II, and ActHIB on 1/5/02. The infant had pre-existing upper airway congestion and nasal drainage. Concomitant therapy included Phenergan VC syrup. Approximately 12 hours post vaccination, the infant developed fever and a seizure. He needed valium to breathe. Magnetic resonance imaging, electroencephalogram and lumbar puncture results were negative. The infant was hospitalized for 3 days. The diagnosis was atypical febrile seizure. From additional correspondence received on 9/4/02, no further medically significant information provided. Case is closed.
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Nasal congestion, Pyrexia, Rash erythematous, Rhinorrhoea
Clinical narrative: Flu Vaccine (Aventis #U1264AA) 0.25 cc given IM at 1655 on November 20, 2003.  Mom reports that about 24 hours later, he developed a raised red rash on his forehead, but no other symptoms.  No fever and no apparent itching; no difficulty breathing.  The next 48 hours, the rash became lighter on his forehead and then appeared on his chest, arms, and legs.  On November 25th mother reports that he now is having nasal congestion with green nasal discharge and a temperature of 100.5; says that he may have had a runny (watery) nose the day of the vaccine.  She has contacted her physician's office and says that they advised her the child should not have the second dose of the flu vaccine.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Pharyngitis
Clinical narrative: Approx 5-15min after shot, pt c/o while in care with wife "sensation in arm- felt medicine gown arm, tongue felt "funny" throat scratchy", Patient not with her when wife called and gave the report.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Paraesthesia
Clinical narrative: I TOOK THE FLU SHOT AT ABOUT 10:00 AM ON NOVEMBER 10, 2003.  THAT AFTERNOON ABOUT 1:00 I STARTED TO HAVE SEVERE STOMACH CRAMPS WHICH CONTINUE ALL AFTERNOON AND NIGHT.  I DID NOT GO TO THE DOCTOR AT THIS TIME. ON WEDNESDAY MORNING THE 12TH MY FINGERS ON MY RIGHT HAND BEGAN TO TINGLING. THIS EVENTALLY CONSUMED MY WHOLE RIGHT HAND WITH THIS SENSATION AND THEN I START TO FILL IT IN THE RIGHT SIDE OF MY FACE.  AT THIS POINT I HAVE BEEN TO THE EMERGENCY ROOM, A CLINIC, FAMILY PHYSICAN AND A NEUROLOGIST.  I AM SCHEDULED TO HAVE A SPINAL TAP DONE ON MONDAY TO CHECK FOR MS AND I SUGGESTED ALSO TO CHECK FOR GBS.
Age: 56.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swollen and feverish.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: On evening of 11/18/03, patient reports vaccine site was red, swollen and tender to touch; he reports a knot about the size of a 50-cent piece at the site. Also, c/o fatigue and generalized muscle aches that evening; denies fever, chills or headaches.                                   On 11/19/03, swelling and redness at vaccine site had increased; patient continued to c/o fatigue and generalized muscle aches; later that afternoon, he c/o chills, generalized weakness, and left shoulder pain; he also said that it took extra effort to lift his left upper extremity above his head. He self-treated that night with ice to the vaccine site and to his left shoulder.                                       On 11/20/03, the swelling and redness surrounding his vaccine site had increased; he continued to have left shoulder pain, fatigue, generalized muscle aches and weakness. He sought evaluation; on exam, an area of approximately 80x80mm was indurated, and an area of approximately 160x100mm was erythematous surrounding the vaccine site; he had (+) axillary lymphadenopathy; temp 97.3; FROM of shoulder, elbow and wrist; he rated his level of pain as a 3 of 10 on pain scale; he was treated with Allegra q a.m., Benadryl q hs, and Motrin tid.                                     On 11/25/03, vaccine site with dime-sized knot; no redness or swelling; axillary lymphadenopathy dimished. Fatigue and weakness persist, but diminished.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: On evening of 11/18/03, patient reports vaccine site was red, swollen and tender to touch; he reports a knot about the size of a 50-cent piece at the site. Also, c/o fatigue and generalized muscle aches that evening; denies fever, chills or headaches.                                   On 11/19/03, swelling and redness at vaccine site had increased; patient continued to c/o fatigue and generalized muscle aches; later that afternoon, he c/o chills, generalized weakness, and left shoulder pain; he also said that it took extra effort to lift his left upper extremity above his head. He self-treated that night with ice to the vaccine site and to his left shoulder.                                       On 11/20/03, the swelling and redness surrounding his vaccine site had increased; he continued to have left shoulder pain, fatigue, generalized muscle aches and weakness. He sought evaluation; on exam, an area of approximately 80x80mm was indurated, and an area of approximately 160x100mm was erythematous surrounding the vaccine site; he had (+) axillary lymphadenopathy; temp 97.3; FROM of shoulder, elbow and wrist; he rated his level of pain as a 3 of 10 on pain scale; he was treated with Allegra q a.m., Benadryl q hs, and Motrin tid.                                     On 11/25/03, vaccine site with dime-sized knot; no redness or swelling; axillary lymphadenopathy dimished. Fatigue and weakness persist, but diminished.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Shoulder pain
Clinical narrative: On evening of 11/18/03, patient reports vaccine site was red, swollen and tender to touch; he reports a knot about the size of a 50-cent piece at the site. Also, c/o fatigue and generalized muscle aches that evening; denies fever, chills or headaches.                                   On 11/19/03, swelling and redness at vaccine site had increased; patient continued to c/o fatigue and generalized muscle aches; later that afternoon, he c/o chills, generalized weakness, and left shoulder pain; he also said that it took extra effort to lift his left upper extremity above his head. He self-treated that night with ice to the vaccine site and to his left shoulder.                                       On 11/20/03, the swelling and redness surrounding his vaccine site had increased; he continued to have left shoulder pain, fatigue, generalized muscle aches and weakness. He sought evaluation; on exam, an area of approximately 80x80mm was indurated, and an area of approximately 160x100mm was erythematous surrounding the vaccine site; he had (+) axillary lymphadenopathy; temp 97.3; FROM of shoulder, elbow and wrist; he rated his level of pain as a 3 of 10 on pain scale; he was treated with Allegra q a.m., Benadryl q hs, and Motrin tid.                                     On 11/25/03, vaccine site with dime-sized knot; no redness or swelling; axillary lymphadenopathy dimished. Fatigue and weakness persist, but diminished.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Infection, Pyrexia, Thrombosis
Clinical narrative: Patient had been in good health previously, except for some ear infections, and tympanostomy tubes 8/2003.  Seemed to be fine the day of the vacination 10/08/03. Four days later she had a fever of 103 and small old bruises on her shins tripled and quadrupled in size.  The next day she was seen in pediatric office by the doctor who saw blood clots in her ears by tympanostomy tubes but no ear infection.  A platelet count was done and the results were normal however she developed another bruise under her eye where she was rubbing it because she was crying during the blood draw
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 11/12/03  RAN LO GRADE FEVER; 11/13/03  RED PATCHES, SLIGHTLY RAISED, ON FACE AROUND EYES & CHEEKS; SPREADING TO WHOLE FACE; STILL RUNNING LO GRADE FEVER
Age: 0.5
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Sudden infant death syndrome, Vomiting
Clinical narrative: Throwing up, high fevers, diarrhea, crying, no sleeping.