chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Herpes zoster, Infection
Clinical narrative: Information has been received from a school nurse concerning a pt who was vaccinated "IM" with a dose of varicella virus vaccine live. It was reported that the child got shingles described as a small ring of papules on the back with a trail to the left or right. Unspecified medical attention was sought. No treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash papular, Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner and a registered nurse concerning a 4 year old female with an allergy to penicillin and cephalosporins and no known exposure to chicken pox who was vaccinated with a dose of varicella virus vaccine live. It was unknown if there was an illness at the time of vaccination. On 16-Nov-2003 the patient developed a flat, red papular rash on her chest and ankle with 15-25 red, flat, itchy lesions. She had no fever. She was taken to an urgent care center and was treated with diphenhydramine (Bendaryl) and calamine lotion. It was also reported that a prescription drug was required. On 18-Nov-2003 she was seen in the physician's office with the same symptoms. No diagnostic studies were performed. Subsequently, the patient recovered. It was noted that the vaccine was given at another office. No product quality complaint was involved. No further information is expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 30 year old female who was vaccinated with the first and second doses of varicella virus vaccine live. Subsequently, the patient showed a negative titer 4-6 weeks after the second dose. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional info has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 3 year old female with no past medical history and no known drug allergies who vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently the patient developed 7 spots. The reporter indicated that they were not vesicular and were on her waist and arms. No fever was noted. No URI was noted. There was no known contact with chickenpox, but the child does attend a day care part-time. Subsequently, the patient recovered. There were no diagnostic tests or laboratory date reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a child who was vaccinated with a dose of varicella virus vaccine live. Approximately two weeks later the child developed a rash. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. Follow up was received from the nurse practitioner which indicated that information regarding the name of the patient or any particulars of the event could not be recalled. No further information is expected.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular, Rash pruritic, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 25 year old female pt who is from another country and has no known allergies, who on 24OCT2003 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. The physician reported that on 18NOV2003 the patient had a chickenpox breakthrough. The physician reported the pt had developed itchy reddish papules and vesicles over her scalp (also
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician and a registered nurse concerning an 8 year old female student with no allergies and no past medical history who on 09JUN1998 was vaccinated with a dose of varicella virus vaccine live. It was not known if there was illness at the time of vaccination. On 10NOV2003, the pt returned to the office with "full blown" chickenpox. The pt was diagnosed with varicella and an onset date of 07NOV2003 was noted. On 17NOV2003, the pt recovered. The reporter mentioned that several of the pts classmates had chickenpox two weeks prior to her breakout. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old male patient with no allergies and no past medical history who on 06APR2001 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 07NOV2003, the pt began to develop spots. Four days later, the pt had a total of approximately 20 to 25 spots. "Itchy" was also noted. Medical attention was not sough. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female with no allergies or medical history who on 07AUG1998 was vaccinated with a first dose varicella virus vaccine live. There was no concomitant medication. It was noted that the pt had diarrhea at the time of vaccination. On 13NOV2003 the pt developed 10 to 20 papules on the back, legs and arm. There were also several small "welts." Atypical varicella was noted. A doctor visit was required and symptomatic treatment was provided. No diagnosticc laboratory tests were performed. The pt subsequently recovered. The reporter also indicated that neither the pt or her sibling had any adverse events following prior vaccination. No further info is expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female pt with no pre-existing medical conditions and no illness at the time of vaccination, who on 11OCT1996 was vaccinated in the left arm with a first dose of varicella virus vaccine live. On an unspecified day in November 2003, the pt was exposed to chicken pox and came down with the disease. The pt recovered on an unknown date. There were no laboratory or diagnostic tests performed, and the pt did not have adverse events following prior vaccinations. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Abdominal pain, Unintended pregnancy
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a registered nurse RN, through a manufacturer pregnancy registry, concerning a 24 year old female who on 20NOV2003 was vaccinated with a dose of varicella virus vaccine live (lot #640726/0221N). Concomitant vaccinations on that same day included diptheria toxoid + tetanus toxoid. The RN reported that on 20NOV2003, the pt experienced abdominal pain. On that same day, the pt was seen by a physician in the Emergency Room ER. A pregnancy test was positive (LMP-15-Oct-2003, EDD + 21-Jul-2004). At the time of this report, the outcome of the abdominal pain was unknown and the patient was noted to be lost to follow-up. Additional information is not expected.
Age: 20.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a nurse practitioner concerning a "normal, healthy" 20 year old black male hospital employee with no significant medical history including no immunosuppression and no known recent exposure to varicella or other viruses, who on 12NOV2003 was vaccinated with a second dose of varicella virus vaccine live as part of his employment. Concomitant vaccination on the same day included a dose of hepatitis B virus vaccine. There was no other concomitant medication. On 01OCT2003 the pt was vaccinated with a first dose of variccella virus vaccine live. On 16NOV2003 the pt reported that he began to develop a rash. The pt was seen in employee health the following day. At that time, the nurse practitioner reported that the pt had approximately five lesions on his back, five on the trunk, and 10 in the "folds of his arm" (side unspecified). The lesions were described as macular/papular, but not vesicular. The reporter indicated that if there were any vesicles, they were extremely small/minimal, and she was not really able to discern if there was fluid in any of the lesions. The patient also reported that the lesions were itchy, but had no other complaints at the time. Diphenhydramine hydrochloride, benadryl, was prescribed. He was ordered to stay home from work until the lesions resolved/ crusted over if applicable. The pt had been ordered not to work in the hospital since his rash began on 16NOV2003. The pt was scheduled to be seen again on 24NOV2003. The nurse practitioner indicated that she would like to submit a specimen to the varicella zoster virus identification program if possible but ws not sure if she would have any viable specimens on 24NOV2003. On 24NOV2003 the nurse practitioner saw the patient in the office and indicated that his rash was macular/papular and she could not obtain any specimens. the reporter stated that the initial rash started just four days after the second vacciation. It was noted that the rash was resolving, however, a new macular/papular rash was developing on the patients thighs. The reporter planned to consult dermatology since she was not sure this was a post vaccination rash or something else. The nurse practitioner also planned to question the pt further regarding concomitant medication or concurrent conditions. The reporter did not feel the pt could return to work with a pediatric population at this point. She indicated that notification would be provided if a specimen should become available. A product quality complaint was not involved. Additional information has been requested. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a mother concerning her 12 month old son who has no pertinent medical history and from a physician who confirmed that the 12 month old male pt on 25JUN2003 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. The mother reported that within a "day or so" (approximately 26JUN2003) the pt developed a 104 degree fever. It was noted that the child was given acetaminophen and ibuprofen to treat the fever. It was noted that the fever lasted 6 days and on the seventh day, his temperature began to return to normal. There was no product quality complaint reported. The physician reported, "the pt needs the measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live and the mother is concerned about the child getting a fever again. Unspecified medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Family called doctor on 5/5 with c/o swelling on Right arm, instructed to apply cool compresses and to call back if further problems. Family called again with c/o redness and fever of 102.5 and increase in swelling. Seen by FMD on 5/6 Given Keflex 250/5ml 1 tsp.x 10 days. Instructed to call DOH and report which family did.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received DTaP in the Rt. Deltoid on Wed. May 19, 2004. Childs mother called today to report swelling redness & warmth to the Rt. Deltoid area. Also received polio sub Q in this arm, but this was administered below the deltoid and laterally. RN recommended to watch for fever, systemic symptoms and recommended a cool compress prn.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hyperhidrosis, Similar reaction on previous exposure to drug, Tachycardia
Clinical narrative: After recieving 4th Anthrax on 20 May 2004 member had episode of tachycardia and diaphoresis that  lasted for 2 1/2-3 hrs then resolved. Pulse was 113 b/p 153/89. Denied CP or SOB. Symptoms began approx 4 hrs after shot. Member did come to clinic but was told he needed to go to PCP or ER for treatment as this is not a treatment facility. Member did not seek care despite advice to do so.   Only problems with 3 previous Anthrax doses was headache which pt treated effectively with tylenol. Previous 3 doses were all in year 2000.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash morbilliform
Clinical narrative: afebrile morbilloform exanthem, cephalocaudal onset 7 days post vaccination no treatment
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Erythema
Clinical narrative: Large are of redness and blistering. States she now remember that she had a reaction like this when she little. She thinks that her brother had a reaction also.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: From initial information received on 28APR2003 from a nurse regarding an adverse event occurring in the US, it was reported that a 54 year old female pt received TD ADS ADULT, given intra muscular in the left deltoid at 10:30 AM on 21APR2003. A few hours after the injection, the pt began to develop backache, a headache,fever of 101-102 degrees, felt nausea and was vomiting. The pt has an allergy to the intravenous pyelogram dye. The recovery status was not reported.
Sex: M
Vaccine: TD
Symptoms: Drug administration error, Erythema
Clinical narrative: From initial information received on 06/11/03 through e-mail correspondence from a pharmacist, regarding an adverse event occurring in the USA, it was reported that a total of 20 inmates, from a federal correctional institute, received TD ADS ADULT (Lot # route/sites were not reported) instead of Tubersol 5 TU on 06/06/03. They all experienced redness, site and date not specified. The recovery status of this pt was not reported.  From additional information received on 07/15/03 from the reporting pharmacist, it was reported that all of the 20 male inmate pt's were given 0.1 milliliters of TD ADS ADULT, SC in the arm on 06/06/03, by error by a staff nurse, instead of Tubersol 5 TU. The Lot # was not reported. One of the 20 pt's had a severe reaction on his arm and was diagnosed with cellulitis by a physician.  This pt was treated with Benadryl and Keflex and by the next morning the reaction had partly resolved. The pharmacist feels the event was not cellulitis, but an allergic reaction. It was reported that the pt had recovered as of 06/24/03.   01/16/04: No further information is anticipated. Case is closed.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Joint range of motion decreased
Clinical narrative: From initial information received on 06/11/03 from a physician, regarding an adverse event occurring in the US, it was reported that a 54 year old female pt received a dose of TD ADS ADULT, Lot # U0833AA, given IM in the left deltoid on 06/02/03.  The pt had initial pain at the injection site when the vaccination was given, but no symptoms thereafter until eight days later. On 01/10/03, eight days later, the pt awoke with swelling and pain at the injection site got better with improved shoulder range of motion at the time of the reporting. The pt also experienced a 15x7 cm area that had a red and warm patch with palpable spasms at the injection site. On an unspecified date, the pt was seen by a physician. Reportedly, the pt is improving. The pt suffered a dog bite around the time of vacciantion.  08/04/03: case 2003-01064 is a duplicate with case 2003-01068.  Case 2003-01064 is the case of record.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Chest discomfort, Influenza like illness, Pain, Pain in jaw
Clinical narrative: From initial information received on 10/Oct/203 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 43-year-old female patient received a dose of TD ADS Adult, lot number U0991AA, given intra-muscularly in the right deltoid at 11:30 AM on 18/Sep/2003. Nineteen and a half hours later, at 7:00 Am on 19/Sep/2003, the patient was feverish, had cold hands, jaw soreness, was unable to chew food, had left-sided face tenderness, tightness in her chest, aches in her back and legs, flu-like symptoms and had soreness in her right arm. On an unspecified date, the patient was seen by her primary medical doctor and was treated with Allegra for a tetanus-diphtheria reaction. The left jaw pain was continuing as of 26/Sep/2003 and the patient had not recovered.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Peripheral coldness, Pyrexia, Tenderness
Clinical narrative: From initial information received on 10/Oct/203 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 43-year-old female patient received a dose of TD ADS Adult, lot number U0991AA, given intra-muscularly in the right deltoid at 11:30 AM on 18/Sep/2003. Nineteen and a half hours later, at 7:00 Am on 19/Sep/2003, the patient was feverish, had cold hands, jaw soreness, was unable to chew food, had left-sided face tenderness, tightness in her chest, aches in her back and legs, flu-like symptoms and had soreness in her right arm. On an unspecified date, the patient was seen by her primary medical doctor and was treated with Allegra for a tetanus-diphtheria reaction. The left jaw pain was continuing as of 26/Sep/2003 and the patient had not recovered.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Malaise, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a PA concerning a 4 year old white male student, with asthma who on 04/11/00 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 632366/1458J).  Concomitant vaccination on 04/11/00 included a fourth IM dose in the right leg of Hib conj vaccine (Lot # 631481/0874J) and a first SC dose in the left arm with MMRII (Lot # 628007/1353H).  On 01/03/04, the pt developed "confirmed" breakthrough varicella with fever, malaise and classic rash. Medical attention was not sought. The pt recovered. The reporter mentioned that the pt's two brothers who were vaccinated at different times and with different lots of varicella virus vaccine live also developed breakthrough varicella post vaccination (WAES # 0401USA00690 & 0401USA00693).  No additional information is expected.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Malaise, Pyrexia, Rash
Clinical narrative: Information has been received from a PA concerning a 4 year old white male student, with asthma who on 04/11/00 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 632366/1458J).  Concomitant vaccination on 04/11/00 included a fourth IM dose in the right leg of Hib conj vaccine (Lot # 631481/0874J) and a first SC dose in the left arm with MMRII (Lot # 628007/1353H).  On 01/03/04, the pt developed "confirmed" breakthrough varicella with fever, malaise and classic rash. Medical attention was not sought. The pt recovered. The reporter mentioned that the pt's two brothers who were vaccinated at different times and with different lots of varicella virus vaccine live also developed breakthrough varicella post vaccination (WAES # 0401USA00690 & 0401USA00693).  No additional information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a PA concerning a 9 year old male pt with asthma who on 11/06/98 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 627333/1244H).  On 12/23/03, the pt developed a breakthrough varicella infection. The pt was seen to confirm the breakthrough varicella infection. Subsequently, the pt recovered.  The reporter mentioned that the pt's two brothers also developed varicella post vaccination with varicella virus vaccine live (WAES # 0401USA00690& 0401USA00691).  Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a PA concerning a 9 year old male pt with asthma who on 11/06/98 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 627333/1244H).  On 12/23/03, the pt developed a breakthrough varicella infection. The pt was seen to confirm the breakthrough varicella infection. Subsequently, the pt recovered.  The reporter mentioned that the pt's two brothers also developed varicella post vaccination with varicella virus vaccine live (WAES # 0401USA00690& 0401USA00691).  Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a PA concerning a 7 year old male pt with asthma who on 09/22/98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 626399/0654H).  There was no illness at the time of vaccination. On 01/02/04, the pt developed a "verified" varicella infection. Medical attention was not sought. Subsequently, the pt recovered.  The reporter mentioned that the pt's two brothers also developed varicella post vaccination with varicella virus vaccine live (WAES # 0401USA00691 & 0401USA00693).  Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a PA concerning a 7 year old male pt with asthma who on 09/22/98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 626399/0654H).  There was no illness at the time of vaccination. On 01/02/04, the pt developed a "verified" varicella infection. Medical attention was not sought. Subsequently, the pt recovered.  The reporter mentioned that the pt's two brothers also developed varicella post vaccination with varicella virus vaccine live (WAES # 0401USA00691 & 0401USA00693).  Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Coordination abnormal
Clinical narrative: Information has been received initially from a physician, and follow up from a registered nurse concerning an otherwise healthy 12 month old white female patient with no pre-existing conditions or other history, who on 1/6/04 at 10:00 AM was vaccinated SC in the left thigh (also reported by physician as one thigh) with a first dose of varicella virus vaccine live (lot # 644248/1145M). Concomitant therapy administered on the same day, 1/6/04 at 10:00 Am in the right thigh (also reported by physician as other thigh) included a SC first dose of MMR (lot # 644982/1236M). By late afternoon, 17:30 PM on the same day of vaccination, 1/6/04, the patient developed ataxia. The patient is neurologically intact except for the ataxia. The physician reported he had contacted and spoken with the treating physician for additional case information. The treating physician informed him that the child was improving/recovering from the ataxia. The physician reported that at present there were no plans to do a lumbar puncture so there will be no cerebrospinal fluid specimen forthcoming. The reporting physician indicated the treating physician will provide follow up information. In the follow up information received from the registered nurse, she indicated the patient's ataxia lasted approximately 48 hours and then resolved without treatment. The patient recovered on 1/8/04. The patient was afebrile, had no edema, ecchymosis, or tenderness at the injection site. It was noted the patient was not ill at the time of vaccination. Upon internal review ataxia was considered to be an important medical event (OMIC). No additional information is expected.
Age: 13.0
Sex: M
Vaccine: HEP, TD, HEP, TD
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: From initial information received on 09/Sep/2003 from manufacturer (reference number A0419993A) regarding an adverse event occurring in the U.S.A., it was reported by a nurse that a 13-year old male patient received a first dose of Engerix-B, lot number ENG355A2, manufacturer, administered intra0muscularly in the right arm, and a dose of TD ADS Adult, lot number unknown, administered intra-muscularly in the left arm on 05/Aug/2003. Later that day, at an unspecified time, the patient experienced a fever of 103 degrees Fahrenheit, pain in both arms, vomiting and headache. The patient's mother treated him with ibuprofen (Motrin). The nurse considered the events were possibly related to the vaccinations. The Engerix-B immunization series was discontinued. The events resolved on 08/Aug/2003 and the patient recovered.
Age: 13.0
Sex: M
Vaccine: HEP, TD, HEP, TD
Symptoms: Headache, Injection site reaction, Pain, Pyrexia, Vomiting
Clinical narrative: From initial information received on 09/Sep/2003 from manufacturer (reference number A0419993A) regarding an adverse event occurring in the U.S.A., it was reported by a nurse that a 13-year old male patient received a first dose of Engerix-B, lot number ENG355A2, manufacturer, administered intra0muscularly in the right arm, and a dose of TD ADS Adult, lot number unknown, administered intra-muscularly in the left arm on 05/Aug/2003. Later that day, at an unspecified time, the patient experienced a fever of 103 degrees Fahrenheit, pain in both arms, vomiting and headache. The patient's mother treated him with ibuprofen (Motrin). The nurse considered the events were possibly related to the vaccinations. The Engerix-B immunization series was discontinued. The events resolved on 08/Aug/2003 and the patient recovered.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal stiffness, Night sweats, Paraesthesia
Clinical narrative: From initial information received on 26/Jan/2004 from a physician, regarding an adverse event occurring in the U.S.A., it was reported that a 42-year-old female patient received TD ADS Adult, lot number U1015AA, administered intra-muscularly in the left deltoid on 24/Dec/2003 at 3:48 PM. At the time of vaccination, the patient had a deer tick bite on her anterior chest wall. On 28/Dec/2003, the patient experience a fever, which lasted until 30/Dec/2003. She was seen by her physician on 04/Jan/2004 and she complained of pain at the the injection site, which spread to the back of the arm and into forearm. She also experienced numbness, tingling, stiff neck and night sweats. She was given a steroid injection into her back for a muscle spasm. On a return visit on 05/Jan/2004, the patient complained of the same symptoms. She was referred to an orthopedic doctor. The patient met with the orthopedic doctor on 07/Jan/2004 and physical therapy was ordered. The patient was getting treatment at the time of this report, however, her recovery status is unknown.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia
Clinical narrative: From initial information received on 26/Jan/2004 from a physician, regarding an adverse event occurring in the U.S.A., it was reported that a 42-year-old female patient received TD ADS Adult, lot number U1015AA, administered intra-muscularly in the left deltoid on 24/Dec/2003 at 3:48 PM. At the time of vaccination, the patient had a deer tick bite on her anterior chest wall. On 28/Dec/2003, the patient experience a fever, which lasted until 30/Dec/2003. She was seen by her physician on 04/Jan/2004 and she complained of pain at the the injection site, which spread to the back of the arm and into forearm. She also experienced numbness, tingling, stiff neck and night sweats. She was given a steroid injection into her back for a muscle spasm. On a return visit on 05/Jan/2004, the patient complained of the same symptoms. She was referred to an orthopedic doctor. The patient met with the orthopedic doctor on 07/Jan/2004 and physical therapy was ordered. The patient was getting treatment at the time of this report, however, her recovery status is unknown.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypoaesthesia, Injection site pain, Muscle spasms, Musculoskeletal stiffness, Night sweats
Clinical narrative: From initial information received on 26/Jan/2004 from a physician, regarding an adverse event occurring in the U.S.A., it was reported that a 42-year-old female patient received TD ADS Adult, lot number U1015AA, administered intra-muscularly in the left deltoid on 24/Dec/2003 at 3:48 PM. At the time of vaccination, the patient had a deer tick bite on her anterior chest wall. On 28/Dec/2003, the patient experience a fever, which lasted until 30/Dec/2003. She was seen by her physician on 04/Jan/2004 and she complained of pain at the the injection site, which spread to the back of the arm and into forearm. She also experienced numbness, tingling, stiff neck and night sweats. She was given a steroid injection into her back for a muscle spasm. On a return visit on 05/Jan/2004, the patient complained of the same symptoms. She was referred to an orthopedic doctor. The patient met with the orthopedic doctor on 07/Jan/2004 and physical therapy was ordered. The patient was getting treatment at the time of this report, however, her recovery status is unknown.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: From initial information received on 26/Jan/2004 from a physician, regarding an adverse event occurring in the U.S.A., it was reported that a 42-year-old female patient received TD ADS Adult, lot number U1015AA, administered intra-muscularly in the left deltoid on 24/Dec/2003 at 3:48 PM. At the time of vaccination, the patient had a deer tick bite on her anterior chest wall. On 28/Dec/2003, the patient experience a fever, which lasted until 30/Dec/2003. She was seen by her physician on 04/Jan/2004 and she complained of pain at the the injection site, which spread to the back of the arm and into forearm. She also experienced numbness, tingling, stiff neck and night sweats. She was given a steroid injection into her back for a muscle spasm. On a return visit on 05/Jan/2004, the patient complained of the same symptoms. She was referred to an orthopedic doctor. The patient met with the orthopedic doctor on 07/Jan/2004 and physical therapy was ordered. The patient was getting treatment at the time of this report, however, her recovery status is unknown.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse at a health department concerning a 12 month old male pt, a triplet brother, with no pertinent medical history who on 30DEC2003 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 07JAN2004 the pt developed a chicken pox like rash with some nasal congestion. No other information was available. There was no product complaint reported. Unspecified medical attention was sought. Additional information has been requested. The reporter also mentioned that the pt's brothers also developed a chickenpox like rash with some nasal congestion following vaccination with varicella virus vaccine live.  Follow up information received.  Concomitant vaccine therapy included a fourth dose given intramuscularly in the right leg of Hib conj vaccine (tst toxoid) (ACTHIB) (batch #UEII3AB), a fourth dose given intramuscularly in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot #494382), and a first dose given subcutaneously in the right leg of measles virus vaccine live (Moraten) (*) mumps virus vaccine live (Jeryl Lynn) (*) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #645626/0396N). Concomitant therapy included carbinoxamine meleate (SILDEC-DM). The patient was noted to have a runny nose and dry skin at the time of vaccination. On Jan 6, 2004 the patient was also vaccinated intramuscularly in the left leg with a fourth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (*) tetanus toxoid (Infanrix) (lot #DTPa589A2), a third dose given subcutaneously in the left leg of poliovirus vaccine inactivated (Vero) (IPOL) (batch #WI582) and a second dose given intramuscularly in the right leg of influenza virus split virion vaccine inactivated (Fluzone) (batch #UUI3AA). On Jan 7, 2004 at 0800 the patient's mother called the physician's office noting that her sone had a generalized rash described as a chicken pox-like rash (also described as a macular-papular rash). There was no pruritus, vesicles, or pustules noted, only a fine rash. The patient also developed nasal congestion. No diagnostic studies were performed. No treatment was required. The mother was advised to observe the patient and treat him as needed for a fever or pruritus, not to give him aspirin (ASA), and to consider making an MD appointment. On Jan 9, 2004 the patient was seen by a physician. The physician noted "something viral". It was noted that the patient had not yet recovered. There was no product quality complaint reported. Additional information is not expected.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Nasal congestion, Rash generalised, Viral infection
Clinical narrative: Information has been received from a registered nurse at a health department concerning a 12 month old male pt, a triplet brother, with no pertinent medical history who on 30DEC2003 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 07JAN2004 the pt developed a chicken pox like rash with some nasal congestion. No other information was available. There was no product complaint reported. Unspecified medical attention was sought. Additional information has been requested. The reporter also mentioned that the pt's brothers also developed a chickenpox like rash with some nasal congestion following vaccination with varicella virus vaccine live.  Follow up information received.  Concomitant vaccine therapy included a fourth dose given intramuscularly in the right leg of Hib conj vaccine (tst toxoid) (ACTHIB) (batch #UEII3AB), a fourth dose given intramuscularly in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot #494382), and a first dose given subcutaneously in the right leg of measles virus vaccine live (Moraten) (*) mumps virus vaccine live (Jeryl Lynn) (*) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #645626/0396N). Concomitant therapy included carbinoxamine meleate (SILDEC-DM). The patient was noted to have a runny nose and dry skin at the time of vaccination. On Jan 6, 2004 the patient was also vaccinated intramuscularly in the left leg with a fourth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (*) tetanus toxoid (Infanrix) (lot #DTPa589A2), a third dose given subcutaneously in the left leg of poliovirus vaccine inactivated (Vero) (IPOL) (batch #WI582) and a second dose given intramuscularly in the right leg of influenza virus split virion vaccine inactivated (Fluzone) (batch #UUI3AA). On Jan 7, 2004 at 0800 the patient's mother called the physician's office noting that her sone had a generalized rash described as a chicken pox-like rash (also described as a macular-papular rash). There was no pruritus, vesicles, or pustules noted, only a fine rash. The patient also developed nasal congestion. No diagnostic studies were performed. No treatment was required. The mother was advised to observe the patient and treat him as needed for a fever or pruritus, not to give him aspirin (ASA), and to consider making an MD appointment. On Jan 9, 2004 the patient was seen by a physician. The physician noted "something viral". It was noted that the patient had not yet recovered. There was no product quality complaint reported. Additional information is not expected.
Age: 43.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Discomfort, Hypoaesthesia, Muscular weakness, Paraesthesia, Renal pain
Clinical narrative: From initial information received on 21/JUL/2003 from a registered nurse regarding an adverse event occurring in USA, it was reported that a 43 year old male pt received a Menomune vaccination, administered subcutaneously in the left arm, and a TD ADS Adult vaccination in the left deltoid on 17/JUL/2003 at 9:00PM. Two days later at 8:00AM in the morning, the pt developed numbness and tingling in the left arm, weakness in the left hand, and bilateral kidney aching and discomfort. The recovery status of the pt was reported as unknown. From additional information received on 20/JAN/2004 from a registered nurse, it was reported that there was no additional information at this time. No further information is anticipated, this case is considered closed.
Age: 43.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Arthralgia, Discomfort, Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: From initial information received on 21/JUL/2003 from a registered nurse regarding an adverse event occurring in USA, it was reported that a 43 year old male pt received a Menomune vaccination, administered subcutaneously in the left arm, and a TD ADS Adult vaccination in the left deltoid on 17/JUL/2003 at 9:00PM. Two days later at 8:00AM in the morning, the pt developed numbness and tingling in the left arm, weakness in the left hand, and bilateral kidney aching and discomfort. The recovery status of the pt was reported as unknown. From additional information received on 20/JAN/2004 from a registered nurse, it was reported that there was no additional information at this time. No further information is anticipated, this case is considered closed.
Age: 43.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Paraesthesia
Clinical narrative: From initial information received on 21/JUL/2003 from a registered nurse regarding an adverse event occurring in USA, it was reported that a 43 year old male pt received a Menomune vaccination, administered subcutaneously in the left arm, and a TD ADS Adult vaccination in the left deltoid on 17/JUL/2003 at 9:00PM. Two days later at 8:00AM in the morning, the pt developed numbness and tingling in the left arm, weakness in the left hand, and bilateral kidney aching and discomfort. The recovery status of the pt was reported as unknown. From additional information received on 20/JAN/2004 from a registered nurse, it was reported that there was no additional information at this time. No further information is anticipated, this case is considered closed.
Age: 0.6
Sex: M
Vaccine: IPV, PNC, DTAPHEPBIP, IPV, PNC
Symptoms: Lung disorder, Sudden infant death syndrome
Clinical narrative: A consumer reported that a 7 month old male patient received an injection of Prevnar on 4/19/04 and experienced SIDS. The patient also received the first dose of poliomyelitis vaccine inactivated on 4/19/04. Indication for Prevnar was immunization. Product was administered on 4/19/04 at 6:00 PM. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 4/22/04, at 3:00 PM, the patient died. The cause of death was reported as SIDS. According to the reporter, the child had no apparent adverse effects from the vaccination. An autopsy was performed; the results showed nothing. No additional information was available at the time of this report. This report of a serious, labeled event, is being submitted in a 15-day time frame as requested.
Age: 0.6
Sex: M
Vaccine: IPV, PNC, DTAPHEPBIP, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: A consumer reported that a 7 month old male patient received an injection of Prevnar on 4/19/04 and experienced SIDS. The patient also received the first dose of poliomyelitis vaccine inactivated on 4/19/04. Indication for Prevnar was immunization. Product was administered on 4/19/04 at 6:00 PM. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 4/22/04, at 3:00 PM, the patient died. The cause of death was reported as SIDS. According to the reporter, the child had no apparent adverse effects from the vaccination. An autopsy was performed; the results showed nothing. No additional information was available at the time of this report. This report of a serious, labeled event, is being submitted in a 15-day time frame as requested.
Age: 0.6
Sex: M
Vaccine: IPV, PNC, DTAPHEPBIP, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: A consumer reported that a 7 month old male patient received an injection of Prevnar on 4/19/04 and experienced SIDS. The patient also received the first dose of poliomyelitis vaccine inactivated on 4/19/04. Indication for Prevnar was immunization. Product was administered on 4/19/04 at 6:00 PM. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 4/22/04, at 3:00 PM, the patient died. The cause of death was reported as SIDS. According to the reporter, the child had no apparent adverse effects from the vaccination. An autopsy was performed; the results showed nothing. No additional information was available at the time of this report. This report of a serious, labeled event, is being submitted in a 15-day time frame as requested.
Age: 50.0
Sex: F
Vaccine: UNK, TD
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Severe hives 4/5 cm. controlled with 2nd generation antihistamines and occassionaly with 1st generation. New address for reporter.
Age: 50.0
Sex: F
Vaccine: UNK, TD
Symptoms: Enzyme abnormality, Urticaria
Clinical narrative: Severe hives 4/5 cm. controlled with 2nd generation antihistamines and occassionaly with 1st generation. New address for reporter.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Laboratory test abnormal, Medication error, Unintended pregnancy
Clinical narrative: Information has been received from a 36 year old white female who on 3/19/04 was vaccinated with the second dose of varicella virus vaccine live (lot number could not be provided). There was no concomitant medication. It was noted that the patient was receiving fertility treatments at the time of vaccination. The patient's LMP was 3/15/04. The patient became pregnant shortly after vaccination. unspecified medical attention was sought. There was no laboratory diagnostic studies performed. There was no product quality complaint. Follow up information received from the patient indicated that the patient was tested for varicella antibodies before vaccination with varicella virus vaccine live and the results were negative. The patient was not vaccinated for immigration purposes. The patient had no previous pregnancies. There was no local reaction at the vaccination site, no varicella symptoms post vaccination, and no herpes zoster (shingles) symptoms post vaccination. On 5/3/04, the patient had a spontaneous abortion. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Face oedema, Pharyngeal oedema, Tongue oedema
Clinical narrative: Information has been received from a vaccine specialist from another company concerning a patient in his customer's medical practice who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647271/1138N). Subsequently after vaccination, the patient developed a swollen throat, swollen tongue, and swollen face. The patient was treated in the emergency room, but was not hospitalized. The patient's outcome was unknown. There was no product quality complaint involved. Upon internal review, the patient's swollen throat, swollen tongue and swollen face were considered to be other important medical events. The reporter also indicated that another patient also had an adverse experience following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Autism, Speech disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a 25 month old male who on 12/29/00 at approximately one year of age was vaccinated with MMR, diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid, and poliovirus vaccine inactivated. On 1/10/00 the patient was vaccinated with hepatitis B immune globulin. On 2/11/00 the patient received diphtheria toxoid (+) Hib conj vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid and poliovirus vaccine inactivated. On 4/17/00 the patient was vaccinated with poliovirus vaccine inactivated and poliovirus vaccine inactivated. On 1/14/00 the patient was vaccinated with HIB conj vaccine, diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid; hepatitis B virus vaccine; poliovirus vaccine inactivated. On 12/29/01 the patient was vaccinated with HIB conj vaccine. On 2/4/02 at 25 months of age, the patient was diagnosed with delayed receptive and expressive language skills, with an auditory comprehension age of 15 months, an expressive communication age of 16 months, and a total language equivalent of 16 months. On 1/3/02 at the age of 29 months, the patient was tested on the Peabody Developmental Motor Scales and was evaluated at a gross motor age of 18 to 25 months and a fine motor age of 20 months. On 8/22/02 at the age of 33 months, the patient was administered the Childhood Autism Rating Scale test and was diagnosed with Autism Spectrum Disorder. The patient's autism and delayed receptive and expressive language skills were considered important medical events (OMIC). Additional information is not expected.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema multiforme, Rash
Clinical narrative: 45 minutes after vaccines given, broke out in a rash all over body. Hospitalized for observation.
Age: 1.0
Sex: F
Vaccine: DTAP, DTAPHEPBIP, HIBV, IPV, VARCEL
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site pain, Laboratory test abnormal, Oedema peripheral
Clinical narrative: Patient had immunization on 5/13/04. On 5/16/04, left leg became swollen the progressed to knee and then to ankle. The area looks like a 3rd degree burn. Temp 104.5. On 5/17/04, mother states she had a fever on 5/15 and 5/16 but didn't have a thermometer. While in hospital she is on Solumedrol 4mg every six hours and Rocephin 400mg IV.  Nurse follow up on 06/21/04 states: "Review of discharge summary indicates diagnosis of cellulitis vs severe immunization reaction.  Additional symptoms were pain due to reaction and vomiting."
Age: 1.0
Sex: F
Vaccine: DTAP, DTAPHEPBIP, HIBV, IPV, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient had immunization on 5/13/04. On 5/16/04, left leg became swollen the progressed to knee and then to ankle. The area looks like a 3rd degree burn. Temp 104.5. On 5/17/04, mother states she had a fever on 5/15 and 5/16 but didn't have a thermometer. While in hospital she is on Solumedrol 4mg every six hours and Rocephin 400mg IV.  Nurse follow up on 06/21/04 states: "Review of discharge summary indicates diagnosis of cellulitis vs severe immunization reaction.  Additional symptoms were pain due to reaction and vomiting."
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Irritability, Petechiae
Clinical narrative: 3pm. Child fussy but not warm to touch. Scattered petechial type rash on abdomen and head: only a few, light faint. Called child's doctor who advised .2mg tylenol and monitoring. Advised aunt to take child to her doctor who stated he would see her. Advised the aunt to call this clinic for any concerns.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Feeling hot, Screaming, Swelling
Clinical narrative: Non stop crying. Erythematous, swollen, warm 2x3.5 inch area on right thigh. Rx: Clindamycin (75/5) 6cc po tidx 10days.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Rash
Clinical narrative: Client states he broke out in a rash all over his body. Client reported this on 03/04 clinic visit.