chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP, HIBV, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Reportedly a male infant (DOB 9/5/01) received an ActHIB (lot # UA648AA) and an IPOL (lot # U0426) vaccination administered in his left thigh on 1/14/01. The mother brought the patient back into physician's office a few hours later with the left thigh red, swollen and warm to touch. Hepatitis B injection site, administered on his right thigh, also becoming red and swollen. Physician prescribed Tylenol every 4 hours and cold compresses to the thighs.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Agitation, Insomnia, Screaming
Clinical narrative: From telephone contact received at Aventis Pasteur Inc. on 02/28/02, it was reported that a 4 month old with an ActHIB vaccine, lot # UA 623AA on 02/07/02. The patient experienced high pitched cry, fussiness and couldn't sleep on 02/07/02. Physician prescribed Tylenol and compresses. This case is closed.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Febrile convulsion, Laboratory test abnormal, Otitis media, Pyrexia
Clinical narrative: Temperature developed with temperature max of 105.4 and then febrile seizure x 2 on 11/23/02. Seen in ER and subsequently admitted. Febrile until 11/25. (unknown)LOM; (unknown) Pharyngitis. Medical records state otitis media, and pharyngitis.
Age: 1.4
Sex: M
Vaccine: DTPHIB, MMR, VARCEL
Symptoms: Blister, Rash
Clinical narrative: Approx in early morning with few vague rashes on back, chest, and stomach. More rashes developed am about 30 rashes. Developed blisters. No fever.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Visual disturbance
Clinical narrative: Employee received HBV #1 on 7/10/02, HBV #2 9/11/02. On 10/10/02 she developed symptoms of flashing light with a tan-brown spot to her R eye. The brown spot was a peanut shape. Due to visual loss, the employee went to see her optician. A diagnosis of acute posterior multifocal placoid pigment epitheriopathy as a result of HBV.
Age: 27.0
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Started feeling a little sick on 11/28. Missed one day of work. Still recovering from flu.
Age: 1.5
Sex: F
Vaccine: DTP, HEP, HIBV
Symptoms: Aphasia, Coma, Drug toxicity, Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: Information has been received regarding a case in litigation concerning an approximately 18 month old male who on was injection IM with vaccinations containing the mercury base preservative thimerosal. The alleged results of the vaccinations is the patient suffered mercury toxicity and permanent neurological injuries, and associated complications and sequelae with aggravation of other conditions directly through exposure via IM injections of mercury. In approximately 4/00, at approximately 18 months of age, the patient suddenly regressed developmentally, losing milestones of neurological development previously achieved specifically including but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior and loss of language skills, motor skills and affect. Immunization information indicated that the patient was injected with the following vaccines that contained thimerosal: Haemophilus B conjugate vaccine on 12/21/98, 2/22/99 and 2/10/00. Concomitant therapy included diphtheria toxoid/pertussis vaccine/teta on 12/27/98, 2/22/99, 4/24/99 and 2/10/00; and hepatitis B vaccine recombinant on 11/19/98 and 2/10/00. Upon internal review, the patient's mercury poisoning and neurological disorder were considered other important medical events. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a physician and an employee in a physician's office concerning a 69 year old white female with an allergy to aspirin and seasonal allergies who on approximately 10/18/02 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot 643782/0675M). Concomitant therapy included claritin, Rhinocort and enalapril maleate. Within 48 hrs on 10/18/02, the pt developed a rash and pruritis. Her arm was hot to the touch, she had edema and her arm and elbow were swollen to 4 times their normal site. Subsequently, the physician treated the pt with Benadryl, the rash and pruritis progressed, and the pt visited her physician's office. Upon examination, the pt had an erythematous rash extending above the below the injection site along the fascial planes, a hard indurated lesion at the site of injection, and pain was present on palpation. Subsequently, the pt's arm was only double in size and as of 10/21/02, her arm was still swollen. Indurated lesion, erythematous rash, edema, and pain were considered to be other important medical events by the physician. Addition info is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a physician and an employee in a physician's office concerning a 69 year old white female with an allergy to aspirin and seasonal allergies who on approximately 10/18/02 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot 643782/0675M). Concomitant therapy included claritin, Rhinocort and enalapril maleate. Within 48 hrs on 10/18/02, the pt developed a rash and pruritis. Her arm was hot to the touch, she had edema and her arm and elbow were swollen to 4 times their normal site. Subsequently, the physician treated the pt with Benadryl, the rash and pruritis progressed, and the pt visited her physician's office. Upon examination, the pt had an erythematous rash extending above the below the injection site along the fascial planes, a hard indurated lesion at the site of injection, and pain was present on palpation. Subsequently, the pt's arm was only double in size and as of 10/21/02, her arm was still swollen. Indurated lesion, erythematous rash, edema, and pain were considered to be other important medical events by the physician. Addition info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a white female (45 years old at time of report), with no known allergies or reported medical history, who on unspecified date was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot 0675-invalid). There was no concurrent medication. Subsequently, 24-48 hrs post-vaccination, the pt developed an indurated lesion, erythematous rash, edema and pain. The injection site became hard, painful, warm, and erythematous "(abscess-like)" with continuing spread of erythema up and down fascial planes. The erythema was also pruritic. Prescription drug treatment was required. Subsequently, the pt recovered. As of 11/06/02, the pt was no longer being treated for the experience. "Indurated lesion; injection site became hard," "erythematous rash; also pruritic," "edema," "injection site became warm," "injection site became painful," and "injection site (abscess-like)" were considered to be other important medical events, by the reporting physician. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a white female (45 years old at time of report), with no known allergies or reported medical history, who on unspecified date was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot 0675-invalid). There was no concurrent medication. Subsequently, 24-48 hrs post-vaccination, the pt developed an indurated lesion, erythematous rash, edema and pain. The injection site became hard, painful, warm, and erythematous "(abscess-like)" with continuing spread of erythema up and down fascial planes. The erythema was also pruritic. Prescription drug treatment was required. Subsequently, the pt recovered. As of 11/06/02, the pt was no longer being treated for the experience. "Indurated lesion; injection site became hard," "erythematous rash; also pruritic," "edema," "injection site became warm," "injection site became painful," and "injection site (abscess-like)" were considered to be other important medical events, by the reporting physician. Additional info has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning his 70 year old Asian wife who on 6/14/02 at 8:50am was vaccinated SC in the left upper arm with 0.5mL of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). The physician reported that he gave his wife a dose of pneumococcal vaccine 23 polyvalent. He reported that she had a dose more than 5 or 6 years ago. On 6/14/02 after receiving the vaccine, the pt experienced swelling that started at the injection site and continued all the way down her arm. The physician reported that he gave his wife a few doses of prednisone and antihistamine and the swelling went down. The physician also reported that he had a slight reaction at the injection site after he vaccinated himself in the thigh with pneumococcal vaccine 23 polyvalent (lot 641130/1161L) (WAES0210USA01097). Additional info has been received from the physician. The physician reported that on 6/14/02 at 11:20am his wife developed swelling and redness at the injection site in her left upper arm which extended to her hand and fingers of the same arm. The pt was seen in her physician's office. She was treated with a cold compress to the injection site and oral prednisone (initial dose 60mg daily then 50mg daily, 40mg daily, 30mg daily, 20mg daily, 10mg daily and then stopped after a total of 6 days). The physician reported that his wife recovered. The reporting physician considered the injection site swelling, injection site erythema and peripheral swelling to be other important medical events (OMIC). No additional info is expected.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Headache, Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old white female with diabetes mellitus and allergies to codeine and IPV dye who on 10/23/02 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent in the right deltoid (lot 642749/0111M). On 10/25/02, the pt developed an area of redness at injection site that was hot from the top of arm to elbow. The pt was unable to move her arm. She also developed a fever, nausea and a headache. The pt was treated with Medrol.  It was reported the pt had a severe headache and her face was flushed from the methylprednisolone which stopped after 2-3 days. Additional info was received from the nurse and an ER report. The nurse reported that on 10/23/02, the pt's right arm was red and swollen. On 10/25/02, the pt contacted the office and reported that the pt's arm was swollen, red, and painful. The pt was told to go to the ER. The ER report indicated that in the ER, the pt denied any fever or chills. On the left arm, there was an area of erythema measuring 10cm x 8cm of the left arm. There was swelling with pain on movement of the left arm. The pt had an IV established and was given Rocephin 1g. It was reported that the pt did receive a flu shot on 10/23/02. The pt's symptoms were thought to be a localized reaction versus early cellulitis. The pt was treated for presumed early cellulitis and sent home. The nurse reported that the primary care nurses in the practice always administer the pneumococcal vaccine in the right arm and the influenza vaccine in the left arm. She stated that she thought the documentation from the ER report was incorrect and should have read "in the right arm." On 10/26/02, the pt returned to the ER for follow-up. On physical examination, the cellulitis had receded from the outer margins of the previous day's visit. The pt stated that she was feeling somewhat better; however, she did continue to have mild pain in the left arm. The pt had no fever. The pt had an IV established and was given ceftriaxone 2mg IV. The pt was started on therapy with Duricef and was sent home. The nurse indicated that she followed up with the pt, and she had subsequently recovered. Upon internal review, the pt's cellulitis was considered an other medical event (OMIC). The nurse also reported that a pt developed injection site swelling, inflammation, erythema, pain and drug hypersensitivity (WAES0210USA02661) and another pt developed injection site erythema and inflammation (WAES0210USA02662) post-vaccination with pneumococcal vaccine 23 polyvalent. No additional info is expected.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site reaction, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old white female with diabetes mellitus and allergies to codeine and IPV dye who on 10/23/02 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent in the right deltoid (lot 642749/0111M). On 10/25/02, the pt developed an area of redness at injection site that was hot from the top of arm to elbow. The pt was unable to move her arm. She also developed a fever, nausea and a headache. The pt was treated with Medrol.  It was reported the pt had a severe headache and her face was flushed from the methylprednisolone which stopped after 2-3 days. Additional info was received from the nurse and an ER report. The nurse reported that on 10/23/02, the pt's right arm was red and swollen. On 10/25/02, the pt contacted the office and reported that the pt's arm was swollen, red, and painful. The pt was told to go to the ER. The ER report indicated that in the ER, the pt denied any fever or chills. On the left arm, there was an area of erythema measuring 10cm x 8cm of the left arm. There was swelling with pain on movement of the left arm. The pt had an IV established and was given Rocephin 1g. It was reported that the pt did receive a flu shot on 10/23/02. The pt's symptoms were thought to be a localized reaction versus early cellulitis. The pt was treated for presumed early cellulitis and sent home. The nurse reported that the primary care nurses in the practice always administer the pneumococcal vaccine in the right arm and the influenza vaccine in the left arm. She stated that she thought the documentation from the ER report was incorrect and should have read "in the right arm." On 10/26/02, the pt returned to the ER for follow-up. On physical examination, the cellulitis had receded from the outer margins of the previous day's visit. The pt stated that she was feeling somewhat better; however, she did continue to have mild pain in the left arm. The pt had no fever. The pt had an IV established and was given ceftriaxone 2mg IV. The pt was started on therapy with Duricef and was sent home. The nurse indicated that she followed up with the pt, and she had subsequently recovered. Upon internal review, the pt's cellulitis was considered an other medical event (OMIC). The nurse also reported that a pt developed injection site swelling, inflammation, erythema, pain and drug hypersensitivity (WAES0210USA02661) and another pt developed injection site erythema and inflammation (WAES0210USA02662) post-vaccination with pneumococcal vaccine 23 polyvalent. No additional info is expected.
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Cognitive disorder, Drug toxicity, Drug withdrawal syndrome, Nervous system disorder
Clinical narrative: Information has been received 11/15/02 via legal complaint from an attorney concerning a male child who received series of Tripedia, and Engerix B vaccines as well as Tetramune, Acel-Imune, and Hib-titer vaccines from 4/22/93 through 9/15/94 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae." Legal complaint states that at approximately 18 months of age, the pt was "neurologically devastated by the accumulation of mercury in his body, and has regressed developmentally, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, and the loss of language skills." Legal complaint also states that the pt has incurred "expenses of hospitalization."
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Neurodevelopmental disorder
Clinical narrative: Information has been received 11/15/02 via legal complaint from an attorney concerning a male child who received series of Tripedia, and Engerix B vaccines as well as Tetramune, Acel-Imune, and Hib-titer vaccines from 4/22/93 through 9/15/94 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae." Legal complaint states that at approximately 18 months of age, the pt was "neurologically devastated by the accumulation of mercury in his body, and has regressed developmentally, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, and the loss of language skills." Legal complaint also states that the pt has incurred "expenses of hospitalization."
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: From telephone contact received on 3/1/02 at manufacturer, it was reported that an 18 month old male received Tripedia in the left thigh and IPOL in the right thigh on 2/28/02. Patient developed a rash with hives and welts all over his body. Both thighs were swollen. Seen by the doctor today, 3/1/02, Benadryl and Oraprez syrup prescribed. From additional correspondence received on 11/18/02, it was reported that the pt has one sibling, and weighed 7.15 pounds at time of vaccination. Pt received two previous doses of IPOL, this was his third. During data entry of the follow-up info, it was noted that the pt's age at the time of vaccination was 20 months and not 18 months as previously reported. No additional info was provided. It was  not reported whether the pt recovered.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Irritability, Lymphadenopathy
Clinical narrative: From telephone contact received on 3/7/02 at manufacturer, it was reported that a 5 year old male received 5th dose of Tripedia on 3/4/02. The patient complained of pain at injection site the next day and his mother noted redness from mid thigh down to the knee. On 3/6/02, local reactions: redness and warm to touch noted to the entire leg, from knee to upper leg. The patient is a little cranky but level of activity wasn't affected at that point. The redness has decreased on 3/7/02. Patient's left groin lymph node was swollen from 3/5/02 through 3/6/02.
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Feeling hot, Injection site erythema
Clinical narrative: From information received via the telephone at manufacturer on 3/8/02, it was reported that 2 children, a 15 month old and an 18 month old, developed large, local reddened areas at injection site after being vaccinated with Tripedia. The reddened areas were hot and warm to the touch. Both patient were treated symptomatically. One of the patients was treated with Keflex for possible cellulitis; however, the patient's identity was not specified. Reportedly both patients improved. This case is linked to U200200285.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site oedema, Injection site pain, Vasodilatation
Clinical narrative: From faxed correspondence received at Aventis Pasteur Inc. on 04/01/02, it was reported that a 4 year old male received DTAP (Tripedia) and IPV (IPOL) on 03/26/02. Patient's left arm became red, painful, swollen and hot to the touch on 03/28/02. Area measured 11cm X 10cm. patient treated with Biaxen 250 mg/5 1/2 tsp bid X 10 days
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: From information received via the telephone at Aventis Pasteur Inc. on 03/08/02, it was reported that 2 children,a 15 month old and an 18 month old developed large, local reddened areas at injection site after being vaccinated with Tripedia. the reddened areas were hot and warm to the touch. Both patients were treated symptomatically . One of the patients was treated with Keflex for possible celllulistis; however the patient's identity was not specified. Reportedly both patients improved. This case is linked  to U200200172.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: From telephone contact received at Aventis Pasteur Inc. on 04/22/02, it was  reported that a 16 month old child received Tripedia,HIB and prevnar on 04/16/02. Patient's right thigh became swollen, red and hot area almost covered the whole thigh. Temperature is 99.5 degree F axillary.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: From telephone contact received at manufacturer on 4/25/02, it was reported that a male patient received Tripedia on 4/22/02. Patient developed a pimply rash in the groin and on buttock area on 4/23/02. By 4/24/02, the pimply rash was on his chest and part of his face. Patient was evaluated and treated by physician on 4/25/02. Office filed a report.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: From telephone correspondence received at manufacturer on 5/3/02, it was reported that a 15 month old male received TRIPEDIA and ACTHIB on 5/2/02 in the left thigh. Patient developed localized redness, swelling and hardness approximately 2 inches in diameter.
Sex: F
Vaccine: RUB
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a lawyer concerning a post-partum female who on 9/19/01 at 10:30AM was vaccinated with rubella virus vaccine live (second generation) prior to discharge following the birth of her daughter (lot #1276K; expiration date 8/16/02; this is an invalid lot # for this product, it is a valid lot # for MMR (second generation)). The patient subsequently sustained scarring in her arm. At the time of this report, the lawyer was uncertain if the scarring was a result of negligence in administration or contamination within the medication. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: RUB
Symptoms: Congenital anomaly, Foetal distress syndrome, Premature labour, Torticollis
Clinical narrative: Information has been received from a physician concerning a 25 year old female with a history of no previous pregnancies who on 12/20/01 was vaccinated with rubella virus vaccine live (second generation). On 12/27/01, the patient found out she was pregnant. The date of last menstrual period (LMP) was 11/27/01. Her estimated delivery date was determined to be 09/02/02. During her pregnancy, the patient was placed on therapy with prenatal vitamins and ferrous sulfate (Slow FE. On approximately 07/19/02, at 33 weeks from LMP, the patient had premature labor. The patient was treated with terbutaline 5 mg every 6 hours. At 35.5 weeks from LMP, the patient had an ultrasound which revealed " +17 weeks normal". On 08/16/02, at 37 weeks from LMP, the patient delivered by casarean section a normal male weighting between 6- 8 lbs. The infant was delivered by cesarean section due to breach presentation. The infant had temporary torticollis with delivery and positional head deformation. It was reported that the infant had no congenital anomalies. No additional information is expected.
Age: 35.0
Sex: F
Vaccine: RUB
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an approximately 35 year old famale patient with no known drug allergies who was vaccinated with4 doses of rubella virus vaccine live (second generation) since childhood. Concomitant medication included levothyroxine  sodium (Synthroid). On 01/28/02, it was reported that a 'recent titer still does not show seroconverion". Unspecified medical attention was sought. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: RUB
Symptoms: Insomnia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 2 year old female who on 02/08/02 was vaccinated with a dose of rubella virus vaccine (second generation). On 02/11/2002, it was reported that the patient "has not slept since." The patient sought unspecified medical attention. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: RUB
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 34 year old female patient who was vaccinated with 5-6 doses of rubella virus vaccine live (second generation) over the last 10 years. In February 2002, a titer was drawn which did not show seroconversion. The patient sought unspecified medical attention. Follow-up information received from the physician indicated that a review of records revealed that the patient did not have rubella virus vaccine live (second generation) recently, as if was thought. No further information is available.
Sex: U
Vaccine: RUB
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the rubella virus vaccine live (second generation). The physician reported that the patient's mother reported that the patient's had a "bad experience with the rubella vaccine". The outcome of the patient's "bad experience" was unknown. Additional information has been requested.
Sex: F
Vaccine: RUB
Symptoms: Rash
Clinical narrative: Information has been received froma physician's office concerning a female patient who on on 05/05/02 was vaccinated with rubella virus vaccine live (second generation). It was reported that the patient developed a rash all over her body. Unspecified medical attention was sought. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: RUB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 52 year old female with no past neurological history, who on 06/08/02 was vaccinated with one dose of rubella virus vaccine live (second generation) (lot # not given). On 06/28/02,the patient developed tingling and numbness of her fingers and toes. Unspecified medical attention was sought and no treatment or medications were ordered. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: RUB
Symptoms: Drug ineffective
Clinical narrative: Information has been received on 07/23/02 from a physician concerning a 30 year old female who "in the past" was vaccinated with a dose of rubella virus vaccine live (second generation). On 07/23/02, it was reported that the patient's "titer is now negative." The patient sought unspecified medical attention. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: RUB
Symptoms: Arteritis, Myalgia, Rash
Clinical narrative: Information has been received from a 39 year old consumer with a history of Lyme disease in 1989 who on approximately 07/28/02 was vaccinated with a dose of rubella virus vaccine live (second generation). The patient was vaccinated by a nurse in the hospital following the delivery of her baby, On approximately 08/12/02, two weeks after vaccination, the patient experienced "pain in her joints and muscle, her knee felt it was exploding and she had a full rash over her body". The patient was also " extremely upset that she could be giving the baby rubella through her breast feeding. Unspecified medical attention was sought. Follow-up information from the consumer on 08/22/02 reported she had severe pain in her hands. She stated her knuckles felt like they were 'exploding" when she wakes up, and the pain sometimes travels up her arm. She also reported being unable to pick up her new baby because "the pain is bad". The patient reported being extremely upset that the hospital staff had given her this vaccine and not explaining the possible adverse reactions. It was also reported by the patient's father, who is a physician, that the patient is still experiencing arthritis fingers and knees, after being vaccinated with (rubella virus vaccine live (second generation)) post partum July 30th". Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: RUB
Symptoms: Anaphylactic reaction
Clinical narrative: Information ahs been received from a doctor of pharmacy concerning a 29 year old female with no prior medical history, no known drug allergies, and a latex allergy who in approximately August 2002, was vaccinated with a dose of rubella virus vaccine live (second generation) (lot #641025/0279M). Concomitant therapy included cefazolin sodium (ANCEF), famotidine (PEPCID), acetaminphen/oxycodone hydrochloride (PERCOCET) and ibuprofen. At the time of vaccination, the patient was hospitalized following the delivery of her child and had an "immediate classic anaphylactic reaction" post vaccination. Treatment included epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), and diphenhydramine hydrochloride (BENADRYL). The reported questioned whether "the patient's latex allergy may have been the cause."
Age: 1.3
Sex: F
Vaccine: HBHEPB
Symptoms: Contusion
Clinical narrative: Information has been received from a medical assistant concerning a 16 month old female with no past medical history and no known allergies who on 11/6/01 was inadvertently vaccinated with a fourth dose of haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot #638136/1589K), IM in the right thigh. There was no illness at the time of vaccination. It was reported that on 11/6/01 at 2:00PM the patient developed a bruise at the injection site. The mother described the bruise as the size of her hand. The patient sought unspecified medical attention. No further information is expected.
Age: 0.2
Sex: U
Vaccine: HBHEPB
Symptoms: Pyrexia
Clinical narrative: This is in follow up to report (s) previously submitted on 11/26/02. Information has been received from a physician concerning a 2 month old child who was vaccinated IM with the first dose of haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Subsequently, following the two month vaccination, the child developed a high fever which lasted over 48 hours. At the time of this report, the outcome of the event was unknown. No further information was provided. The patient sought unspecified medical attention. Additional information has been requested.  Follow up 02/04/04: "This is an amended report. The date received by manufacturer was changed from 11/07/02 to 11/07/01.  The report type listed as Follow-up (1) should have been a report type of Initial. The sentence, this line is in follow-up to report(s) previously submitted on 11/26/02 was entered in error.  This report is corrected as amended."
Sex: U
Vaccine: HBHEPB
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an infant with a hepatitis B positive mother who was vaccinated with a first, second, and third dose of haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) at birth, one month, and 6 months. At 10-11 months, the physician took two different titers, and the patient had no protection. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: It was reported in a published abstract that a 9 month old female was vaccinated with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant vaccine therapy included diphtheria toxoid/ pertussis vaccine/teta and poliovirus vaccine. It was noted that the poliovirus vaccine was given IM. Subsequently the patient experienced a generalized urticarial rash. She was referred for allergy testing regarding the completion of her immunization series. It was reported that a skin prick and intradermal testing at 1:100 dilution to HIB wand the Hep B vaccines individually with negative results, and hence subsequent vaccine administration with success. However, further testing resulted in positive intradermal skin test results to 1:100 dilution of DTaP, DT and tetanus vaccines, DTaP vaccines of two different pharmaceutical companies were used, both resulting in positive reactions. A blood sample was subsequently drawn from the patient and sent for measurement of tetanus-specific IgE antibody which resulted in a level of 5.10 kU/L (class 03 or high positive) as measured test. Considering the clinical history, skin test and the above elevated antibody level, we conclude the presence of tetanus hypersensitivity in this patient. The patient had a tetanus IgG antibody of 0.88 IU/ml which is greater than 0.10 IU/ml, and hence considered to be above the protective level. It was therefore decided to withhold desensitization and administration of tetanus vaccine at this time and serially follow the tetanus IgG level. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a healthy 15 month old white female with amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN) allergy and cefprozil (CEFZIL) allergy and a history of urticaria (reported as AUGMENTIN and CEFZIL = hives) who on 3/25/02 at 10:30 was vaccinated IM in the right outer aspect thigh with the third dose (lot # 641323/1389L) of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy on 3/25/02 included a dose IM in the left thigh of diphtheria toxoid/pertussis vaccine/teta (manufacturer not reported). Additional concomitant therapy included a dose of Streptococcus pneumoniae vaccine (PREVNAR). The patient was afebrile and had no complaints at the time of injection. During the evening of 3/27/02, the patient developed a rash. She presented to the physicians office the next morning (3/28/02).  The patient's mother reported no new foods or detergents. At the office, the patient was noted to have red, raised hives at the site of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) injection (also reported as right anterior thigh). The area involved was 4cmx9cm, which started at the site of injection and headed toward the inner part of the thigh. It was reported that the injection site was towards the top of the area. The patient was afebrile at the visit. Subsequently, on a unspecified date, the patient recovered. No further information is available.
Age: 1.25
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Information has been received from a physician and the mother of a 15 month old white female with no relevant medical history who on 4/17/02 was vaccinated with a third dose of Haemophilus B conjugate vaccine (+) Hepatitis B vaccine recombinant (yeast) IM in the right deltoid (lot 641319/1366L). On 4/17/02, the patient was concomitantly vaccinated with a fourth dose of Streptococcus pneumoniae vaccine (PREVNAR) IM in the right deltoid (lot # 484208). The patient had no illnesses at the time of vaccination. On 4/18/02, the patient woke up with eye swelling and redness. The patient was to see a physician on 4/18/02. The physician reported that the patient's symptoms were gone a few hours later on 4/18/2002 without treatment. No additional information is expected.
Age: 0.9
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Erythema multiforme, Face oedema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning an otherwise healthy 11 month old female with no known drug allergies who has never been sick and has only come into the office for well visits, who on 5/29/02 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # not given). Concomitant therapy that same day included diptheria toxoid/pertussis vaccine/teta and poliovirus vaccine. On 6/10/02 the patient presented to the doctor's office with a classic MMR type reaction with erythema multiforme, swollen face and hands and fever (patient has not received MMR vaccination yet). There were no other signs of viral infection. The report noted that although the patient received DTP and Polio the same day, the doctor believes it was the Comvax. Additional information has been requested. Follow up on 12/05/2003: "Follow up information received from a registered nurse indicated that on 06/10/02 the pt developed hives x 1 day.  swollen face and hands.  The reporter wrote that the MD had stated "thinks reaction to HIB part of Comvax."  The pt recovered from hives, swollen face and hands on 06/2/2002.  There were no relevant diagnostic or lab tests performed.  Follow up information from the RN indicated that the pt transferred to another MD office and has not been seen in their office since 06/10/2002.  Additional info is not expected."
Age: 1.4
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site mass
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 month old female with no know drug allergies who on 5/30/02 was vaccinated in the leg with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 642243/0170M) and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (site not reported). The nurse reported that the patient developed a knot, about the size of a quarter, at the injection site of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). The child was treated with warm soaks to the affected area. The nurse reported that the patient's knot stayed hard for about one month. The patient sought unspecified medical attention. The nurse reported that several patients have had the same experience after vaccination with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (WAES0207USA00219). Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, DTP, HBHEPB, HIBV
Symptoms: Hypersensitivity, Infection, Laboratory test abnormal, Skin nodule
Clinical narrative: Information has been received from a health professional concerning an approximately 21 week old male patient who on 10/29/01 was vaccinated with the first 0.5 ml dose of Haemophilus b conjugate vaccine (+) hepatitis B vaccine (yeast). Concomitant therapy on 10/29/01 included a dose of diphtheria toxoids/pertussis vaccine/tetanus toxoid (manufacturer not reported) HIB conjugate vaccine (manufacturer unknown) and poliovirus vaccine (manufacturer not reported). On 01/07/02, the patient was vaccinated with the first 0.5 ml dose of Hepatitis B vaccine recombinant (yeast) (manufacturer unknown). Concomitant therapy on 01/07/02 included the second dose of 0.5 ml dose of HIB conjugate vaccine (manufacturer unknown), the second 0.5 ml dose of diphtheria toxoid/pertussis vaccine/ tetanus toxoids (manufacturer not reported) and the first 0.5 ml dose of poliovirus vaccine (manufacturer unknown). It was reported that the the patient had his shots at 2 months and 4 months and about 2 days later, developed nodules on both of his legs. The reporter's office thought that the patient might have an infection,and they gave him an "INO" procedure. The physician at the office sent the patient to a dermatologist to see if he had an allergic reaction to the vaccine. The dermatologist then sent the patient to a university, where they thought the patient was allergic's to the alumnium in the vaccines. It was reported that the patient sought medical attention (physician's office). No other information was provided. Additonal information has been requested.
Sex: F
Vaccine: HBHEPB, HIBV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer on 07/30/02 concerning his daughter with acid reflux and no known allerigies, who "recently" (date not specified) was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # not given). The father reported that concomitant therapy that same day included "two shots" of Haemophilus b conjugate vaccine (HIBTITER). Other concomitant therapy included an  unnamed medication for acid reflux. Subsequently, the patient developed a slight fever. No medical attention was sought. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Dysphonia
Clinical narrative: Information has been received from a health professional concerning a 4 month old male who on 5/24/02 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot 642221/0040M). On 5/24/02, the patient was concomitantly vaccinated with a dose of Streptococcus pneumoniae vaccine (PREVNAR) (lot 485997). The patient developed hoarseness 1 to 3 days post vaccination. Unspecified medical attention was sought. The hoarseness lasted for 3 to 4 days and the patient subsequently recovered. The patient's parents reported to the office that there seemed to be no residual effects. The parents also stated that the patient did not cry excessively after the injection. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HBHEPB
Symptoms: Hepatitis
Clinical narrative: Information has been received from a physician concerning his 6 year old daughter with no known drug allergies who was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) a number of years ago. on 8/23/02 it was reported that recent lab work seems to show a Hepatitis B infection. The lab  data showed a positive core antibody and was negative for surface antigen. Additional information has been requested.
Sex: F
Vaccine: RUB
Symptoms: Drug effect decreased, Laboratory test abnormal
Clinical narrative: Information has been received from a female consumer who was vaccinated with rubella virus vaccine live (manufacturer unknown) when she was a small child. When the patient became pregnant, she was checked for antibodies. Laboratory evaluations revealed there were no antibodies. The patient had to get re-vaccinated. The patient sought unspecified medical attention. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Drug effect decreased, Laboratory test abnormal
Clinical narrative: Information has been received from a female registered nurse who as a child, in 1974, at approximately 9 years old was vaccinated with rubella virus vaccine live. The nurse reported that she immediately experienced severe pain in all her joints which lasted for 3 years. At that time, she was taken to an orthopedic doctor who performed blood work and tests and stated that the patient had a reaction to the vaccine (results not provided). The nurse did not remember what, or if, there was intervention to treat the reaction. The nurse also reported that a titer was drawn and she was not immune to rubella. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: RUB
Symptoms: Hallucination, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her husband with no medical history and no allergies who in approximately 1976, when the patient was 5 or 6 years old, was vaccinated with rubella virus vaccine live. There was no concomitant medication. In approximately 1976, the patient experienced hallucinating and developed a fever. it was unknown whether the patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Pyrexia
Clinical narrative: Pts mother, called reporting on 11/18/02 that patient was very weak and had temp of 102.5 over the weekend of the 15th through 17th.  On 11/19/02 Dr. called to report patient was ok.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Infection
Clinical narrative: PATIENT RECIEVED AN MMR VACCINE ON 11-15-02 AND THEN ON 11-28-02 WAS TREATED FOR MUMPS
Age: 17.0
Sex: M
Vaccine: FLUX, TD
Symptoms: Blood pressure decreased, Cardiomegaly, Cough, Heart rate increased, Hepatomegaly
Clinical narrative: Given Td/Influenza (same syringe)on 11/6, already had flu like symptoms at time of vacination. 11/9 showed increased signs of flu like symptoms, pain in neck and chest. 11/10 began vomiting, complained of chest pain rapid heart beat, had fever. 11/11 was given antibiotics at job corp center and sent home w/complaints of chest pain and coughing up green and black "stuff". Continued to vomit thru 11/12, had appointment to go to private doctor on 11/13. 11/13 0500 am collapsed. Taken to emergency room. BP low and continued to decrease. Showed enlarged heart and liver, kidneys shutting down. Dignosed with myocarditus, inflamation of heart muscle. Placed on ventilator for three days. Survived illness at this point heart functioning at 30%. Continued treatment indefinite at this point in time.
Age: 17.0
Sex: M
Vaccine: FLUX, TD
Symptoms: Influenza like illness, Myocarditis, Pain, Pyrexia, Renal failure
Clinical narrative: Given Td/Influenza (same syringe)on 11/6, already had flu like symptoms at time of vacination. 11/9 showed increased signs of flu like symptoms, pain in neck and chest. 11/10 began vomiting, complained of chest pain rapid heart beat, had fever. 11/11 was given antibiotics at job corp center and sent home w/complaints of chest pain and coughing up green and black "stuff". Continued to vomit thru 11/12, had appointment to go to private doctor on 11/13. 11/13 0500 am collapsed. Taken to emergency room. BP low and continued to decrease. Showed enlarged heart and liver, kidneys shutting down. Dignosed with myocarditus, inflamation of heart muscle. Placed on ventilator for three days. Survived illness at this point heart functioning at 30%. Continued treatment indefinite at this point in time.
Age: 17.0
Sex: M
Vaccine: FLUX, TD
Symptoms: Syncope, Vomiting
Clinical narrative: Given Td/Influenza (same syringe)on 11/6, already had flu like symptoms at time of vacination. 11/9 showed increased signs of flu like symptoms, pain in neck and chest. 11/10 began vomiting, complained of chest pain rapid heart beat, had fever. 11/11 was given antibiotics at job corp center and sent home w/complaints of chest pain and coughing up green and black "stuff". Continued to vomit thru 11/12, had appointment to go to private doctor on 11/13. 11/13 0500 am collapsed. Taken to emergency room. BP low and continued to decrease. Showed enlarged heart and liver, kidneys shutting down. Dignosed with myocarditus, inflamation of heart muscle. Placed on ventilator for three days. Survived illness at this point heart functioning at 30%. Continued treatment indefinite at this point in time.