chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site warmth, Otitis media, Pyrexia
Clinical narrative: On 1/17/01, approx. 12:15, mother complained of redness at child's injection site on right and left legs. No distress noted, happy affect and no respiratory problems noted. Ice packs were applied bilaterally and instructed mother to give Benadryl. At 14:00, per telephone call to mother, she verbalizes pt is doing well. On 1/18/01, father brought child to office. Examined by MD. Left leg had no redness noted. Right leg had redness and was warm to touch. MD instructed parents to give baby Benadryl. On 1/22/01, telephone call from parents, states per interpreter, baby not laughing and temperature 103F today. Instructed to go to ER. On 1/23/01, mother states she saw MD and he treated her for ear infection.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Ear disorder, Infection, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: On 1/17/01, approx. 12:15, mother complained of redness at child's injection site on right and left legs. No distress noted, happy affect and no respiratory problems noted. Ice packs were applied bilaterally and instructed mother to give Benadryl. At 14:00, per telephone call to mother, she verbalizes pt is doing well. On 1/18/01, father brought child to office. Examined by MD. Left leg had no redness noted. Right leg had redness and was warm to touch. MD instructed parents to give baby Benadryl. On 1/22/01, telephone call from parents, states per interpreter, baby not laughing and temperature 103F today. Instructed to go to ER. On 1/23/01, mother states she saw MD and he treated her for ear infection.
Age: 0.75
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Petit mal epilepsy
Clinical narrative: Approx. 4 hours, post vax, pt had 45 second interval of petit mal seizure.
Age: 1.2
Sex: F
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Herpes Zoster infection on nose.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Redness, sore, itchy and warm to touch at injection site on right buttocks. Was told to use Benadryl cream.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Chicken pox.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site for 72 hours. Child claimed entire arm hurt. Reaction began within 2 hours, post vax. Treated with Tylenol.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Screaming, Sleep disorder
Clinical narrative: Fever of 102F, within 6 hours, post vax, and 5 hours of non-stop crying, irritability and unable to sleep. Fever has been sporadic for nearly 10 days. Doses of children's Motrin used for fever.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Went to ER on 1/18/01 at 20:00, due to rash and hives all over body. Received a shot of Benadryl and Prednisone 20mg and 1 Pepcid AC and sent home that day. Denied dyspnea. Continues to have rash and itching.
Age: 36.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site urticaria, Nasopharyngitis, Pruritus, Rash, Skin atrophy
Clinical narrative: Received Havrix #1 in left deltoid on 1/22/01. Noted urticaria at injection site and began scratching area, immediately after injection. At home, noted she had broken skin when scratching. Area of itchy, fine, red rash has since spread to entire left upper arm, from elbow to shoulder. No fever, but did come down with a head cold the next day. No respiratory distress.
Age: 36.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Urticaria
Clinical narrative: Received Havrix #1 in left deltoid on 1/22/01. Noted urticaria at injection site and began scratching area, immediately after injection. At home, noted she had broken skin when scratching. Area of itchy, fine, red rash has since spread to entire left upper arm, from elbow to shoulder. No fever, but did come down with a head cold the next day. No respiratory distress.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: This AM, hands and feet were red and swollen. Hives were on face and torso; HEENT- unremarkable.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: On 02/08/01, this patient's right upper ext. is swollen, and tender. Prescribed Benadryl, Ice today, then warm compresses tid thereafter.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: This patient's left deltoid was swollen, red, warm to the touch, from the shoulder to the elbow to the entire upper arm. She was seen in the ER and prescribed Benadryl on 02/06/01. ON 02/07/01, the patient was seen in the office and given steroids and warm compresses. The local reaction is not resolved as yet on 02/08/01.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: On 02/08/01, this patient had a reaction 20-30 cm edematous and erythematous, warm area right upper arm. Prescribed warm compresses and steroids.
Age: 67.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Infection, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: On 02/02/01, this patient felt tenderness in her left arm. ON 02/03/01 , the patient's left upper arm was tender, swollen, with 1 quarter size spot (red) at the site of the injection. Another smaller red spot closer to the body. On 02/04/01, the spots got larger , area swollen, itching, and painful. She called the ER and was advised to use Benadryl, Ibuprofen and warm pads. On 02/04/01, the patient's sickness increased so the patient went in to the ER. The MD suspected an infection but he was not sure it wasn't a reaction to the vaccine. The patient received a prescription for Keflex, and she was advised to continue the Benadryl and Ibuprofen. On 02/06/01, the patient saw her own MD and she was advised to not have another TD vaccination and to continue the Keflex until gone. The swelling and inflammation are down but she can still feel a soreness in the upper arm.
Age: 67.0
Sex: F
Vaccine: DT
Symptoms: Pain, Pruritus
Clinical narrative: On 02/02/01, this patient felt tenderness in her left arm. ON 02/03/01 , the patient's left upper arm was tender, swollen, with 1 quarter size spot (red) at the site of the injection. Another smaller red spot closer to the body. On 02/04/01, the spots got larger , area swollen, itching, and painful. She called the ER and was advised to use Benadryl, Ibuprofen and warm pads. On 02/04/01, the patient's sickness increased so the patient went in to the ER. The MD suspected an infection but he was not sure it wasn't a reaction to the vaccine. The patient received a prescription for Keflex, and she was advised to continue the Benadryl and Ibuprofen. On 02/06/01, the patient saw her own MD and she was advised to not have another TD vaccination and to continue the Keflex until gone. The swelling and inflammation are down but she can still feel a soreness in the upper arm.
Age: 1.75
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This child has redness and swelling at the site of injection.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Eye oedema, Laboratory test abnormal, Lung infiltration, Pleural effusion
Clinical narrative: This patient developed swelling of his eyes 27 days after his vaccine, followed by fever, arthralgia, and pleural effusion. She was hospitalized from 01/04 - 01/10/01 with uncertain diagnosis 1. Seronegative RA, 2. viral syndrome, 3. Adverse reaction to vaccine. She is improving. Still has joint pain.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Viral infection
Clinical narrative: This patient developed swelling of his eyes 27 days after his vaccine, followed by fever, arthralgia, and pleural effusion. She was hospitalized from 01/04 - 01/10/01 with uncertain diagnosis 1. Seronegative RA, 2. viral syndrome, 3. Adverse reaction to vaccine. She is improving. Still has joint pain.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Cardio-respiratory arrest
Clinical narrative: The pt experienced cardiopulmonary arrest. Was admitted to the hospital.
Age: 3.2
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dysphonia, Speech disorder, Swelling, Swelling face, Urticaria
Clinical narrative: Information has been received from a physician concerning a 4 year old caucasian male who on 2/12/98 received the 1st vaccination of MMR II. On 11/17/00, the pt received the 2nd MMR II in the right thigh. He also received DTAP + IPOL. On 11/17/00, later in the evening, the pt's parents called the physician to report the pt had changes in his voice, swelling of lips, edema, and hives. The pt's respiratory status was stable. The pt did not have wheezing or stridor. The pt was given hydroxyzine HC1 (Atarax) but "spit it out". The pt was then given Benadryl and his symptoms resolved. On 12/4/00, the pt's mother called the physician concerned about "lisp". The pt's mother was worried that the pt's speech change could be due to the vaccines. The pt was referred to speech therapy and the evaluation is pending. In further follow-up, the pt's physician did not feel that the lisp was related to the child's vaccinations. She indicated the child has been referred to speech therapy and that as far as she knows, the lisp is still present. The physician also reported that the child has "recovered completely" from his other symptoms. Additional information has been requested. The changes in voice, lisp, swelling of lips, edema and hives were considered to be "Other Medical Events". The changes in the pt's voice and lisp were considered to be disabling. Follow-up info corrected the date of vaccination and date of onset. Also, previous vaccination date was changed.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR, PNC
Symptoms: Convulsion, Hypotonia, Pyrexia, Vomiting
Clinical narrative: On 1/17/01 the pt went to bed at 8:30 PM, woke up at 10:30 PM with an elevated temp of 103.4 rectally. The pt was given Advil. At 2:15AM seizures started affecting body. The pt was taken to ER. Valium was given rectally, child then vomited, seizures stopped but the child was lying limp on left side of body, unable to hold up head. The child was transferred to a pediatric ICU at another facility. The pt was still unable to use the left side of body. All tests were negative. Child went home from hospital on 1/19/01.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR, PNC
Symptoms: Convulsion, Hemiplegia, Hypotonia, Pyrexia, Vomiting
Clinical narrative: On 1/17/01 the pt went to bed at 8:30 PM, woke up at 10:30 PM with an elevated temp of 103.4 rectally. The pt was given Advil. At 2:15AM seizures started affecting body. The pt was taken to ER. Valium was given rectally, child then vomited, seizures stopped but the child was lying limp on left side of body, unable to hold up head. The child was transferred to a pediatric ICU at another facility. The pt was still unable to use the left side of body. All tests were negative. Child went home from hospital on 1/19/01.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: It was reported that an 8 year old male pt received a Fluzone SV '00-'01 vaccination on 1/16/01. Reportedly, the pt experienced a seizure 20 hours, post vax. New onset of seizures; no fever. Pt was evaluated in ER and discharged home. Further information is requested. F/U correspondence rec'd on 4/18/01, additional pt vaccine,resposible physician vaccine administrator and lab data were provided. F/U rec'd on 5/7/01, the following information was provided: vaccine was given in the pt's deltoid. The pt had no history of seizures before the vaccination. The current medical condition of the pt is stable, no seizures.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Injury
Clinical narrative: Report 2001003514-1 describes joint pain in a 52 year old male who received Lyme disease vaccine (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. Medical history included tick bite one week prior to receiving the first injection of Lymerix. The physician treated the patient with doxycycline. The patient received his first injection of Lymerix in April 2000. At some later, unspecified date, he developed "significant" joint pain, which made the patient feel as though he was "becoming like a cripple". The joint pain resolved after "a short time". The patient received his second injection of Lymerix on 05/04/00. At some later, unspecified date, the patient again experienced "significant" joint pain, which made him feel as though he was "becoming like a cripple". As of 02/01/01, the joint pain "had not totally resolved". The adverse experience of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 3.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Bronchitis, Otitis media, Pyrexia, Tonsillitis
Clinical narrative: On Tuesday morning at 10:30 AM, this child had a temperature of 101. Treated her with Tylenol / Motrin alternating. Temperature 104 by 9 PM, went to the ER. The patient was diagnosed with bronchitis, otitis media, and tonsillitis.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: Report 2001003418-1 describes arthritic-like joint pain in a female who received Lyme disease vaccine. The patient participated in a Lyme disease vaccine clinical trial; the protocol was not specified. The arthritic-like joint pain was reported spontaneously post-marketing. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient claims to have received placebo as part of a 1996 clinical trial of Lyme disease vaccine. After the blind had been broken, the patient reportedly was offered and accepted open-label Lyme disease vaccine in 1997. The number of injections of Lyme disease vaccine received by the patient was not specified. At some unspecified time after she had received Lyme disease vaccine, the patient began to experience arthritic-like joint pain. The study investigator reportedly told the patient that Lyme disease vaccine "had nothing to do with the pain". The outcome of this event was not provided. The adverse event of arthritic-like joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per June 28, 2000 letter.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Vomiting
Clinical narrative: This infant has 2 episodes of vomiting since her vaccination.
Age: 1.8
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This child has a large, red, raised area surrounding the injection site
Age: 0.5
Sex: M
Vaccine: DTAP, HBPV, HEP, IPV, PNC
Symptoms: Lethargy, Rash
Clinical narrative: The parent states the child was in the clinic on 01/18/01 to receive vaccines. On 01/19/01, the child became lethargic all day. On 01/20/01, the parent states she noted a rash on the child's face and trunk of body. On 01/21/01, the rash spread to his legs and buttocks. The parent called the physician on 01/21/01 and was instructed to give the child Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, VARCEL
Symptoms: Dizziness, Erythema, Pyrexia, Vomiting
Clinical narrative: Immunizations given at 7 PM. The patient complained of dizziness at 10 PM. At 3 AM the patient wet the bed (does not usually), Temp 103, vomiting. The patient's father called at 10:30 AM still vomiting, right arm reddened, no swelling. The mother reports on 01/22/01, the child is afebrile, eating well. The sister had vomiting on 01/17/01.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Rash erythematous
Clinical narrative: The patient woke up on Thursday night with a red rash, now raised or blistered, over the entire body. On 12/21/00, follow up phone call with the patient. Contacted the doctor per PHN recommendation on 12/01/00. was instructed to take OTC Benadryl which resolved the rash. Encourage follow up with the doctor before taking another Flu shot. Elevated symptoms next time.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Face oedema
Clinical narrative: This patient had bad swelling of her cheeks and lips. She received a shot on 01/05/01 at 12 noon. On 01/06/01 in the AM Benadryl every 6 hors 01/06/01 - 01/07/01.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: On 12/10/00 at 4 AM, the patient woke up with symptoms of diarrhea (approx 6 episodes) in a short time. Took Immodium. Same scenarios on Monday and Tuesday (12/11 & 12/12) of 2-3 episodes in the morning and early evening. Contacted HCP: informed them of many cases of diarrhea. Advised to take 3 doses of Immodium on Tuesday. No diarrhea today 12/13/00.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site hypersensitivity, Injection site induration, Oedema
Clinical narrative: On 12/05/00, Wednesday night, the patient's body ached, headache, arms red, swollen. Took Ibuprofen, Doxycycline ordered by the PMD. Today arm red all away around, swollen, itchy, painful encouraged to recall HCP. On 12/19/00 the patient states arm much better, less red and swollen, but still firm and itching at the injection site. To call for an appt with HCP when road conditions improve.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pruritus
Clinical narrative: On 12/05/00, Wednesday night, the patient's body ached, headache, arms red, swollen. Took Ibuprofen, Doxycycline ordered by the PMD. Today arm red all away around, swollen, itchy, painful encouraged to recall HCP. On 12/19/00 the patient states arm much better, less red and swollen, but still firm and itching at the injection site. To call for an appt with HCP when road conditions improve.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nerve injury, Pain
Clinical narrative: Vaccine was administered 11:45 on 12/19/00. At about 8 PM on 12/19/00 she had a slight numbness in her left hand. On 12/20/00, she experienced shoulder blade pain. The pain increased and varied in different parts on the left arm. She saw her primary MD on 01/02/01 or 01/03/01, because of pain and numbness in arm and fingers .The patient reported that she had "nerve damage all over her arm". Treatment continues with Vicodin, Tylenol, exercises, heating pad, follow up appointments.
Age: 48.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Rash papular
Clinical narrative: This patient had a red area, swollen, hot about 4 inches in diameter. On the 5th day the area became very hard and reported to Health Dept on the 6th day for advice. Pinpoint papule noted with appearance of whitehead. The patient was sent to PMD. The patient had been using cold compresses and taking Ibuprofen. The PMD reports possible cellulitis, patient put on Keflex.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin nodule
Clinical narrative: This patient developed black and blue left arm and into left wrist 5 cm size lump above left collar bone. Called HCP and will be seen today.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: After receiving injection Pt developed immediate aching and pain at site. Pt has experienced aching at site extending down arm.  Pt reports limitation in motion, problem on going. Pt being sent to PMD for evaluation and work-up.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: After receiving injection Pt developed immediate aching and pain at site. Pt has experienced aching at site extending down arm.  Pt reports limitation in motion, problem on going. Pt being sent to PMD for evaluation and work-up.
Age: 1.94
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Otitis media, Pyrexia
Clinical narrative: Pt has fever of 103-104 for 2 days. Diagnosed with otitis media, seen in office 2/1 9:20-10:30am - treated with Amoxil, also received 2nd influenza vaccine, has history of reactive airway disease. Pt presented on 2/1 at 14:30 to ER with 103 temp, febrile seizure lasting 7-8 minutes stiffening of extremities, eyes rolled upward. Pt received IM Rocephin for otitis media. Pt discharged from ER at 0045 2/2/2001, alert, nontoxic.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Myalgia, Neck pain, Pain
Clinical narrative: 12 hours post vax for flu had substantial muscle soreness, pain in arm at injection site and most of all in whole body side, shoulder, back neck back, Got massage therapy which helped reduce pain. 3 weeks post still having residual effects.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Pt's mother called 1/16/01 to report her daughter received Varivax 1/11/1. She developed facial and neck rash on 1/14/2001, which resolved. She developed trunk rash on 1/15/01, which resolved by 1/16/01.She called family MD who told her to report to health department. Rash was red/raised but not pustules or drainage. None at injection site.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt's mother called 1/16/01 to report her daughter received Varivax 1/11/1. She developed facial and neck rash on 1/14/2001, which resolved. She developed trunk rash on 1/15/01, which resolved by 1/16/01.She called family MD who told her to report to health department. Rash was red/raised but not pustules or drainage. None at injection site.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Agitation, Chest pain, Cough, Injection site haemorrhage, Injection site pain
Clinical narrative: This child complained immediately of extreme burning in arm. Bleeding when needle was pulled out of skin but there was no blood when plunger pulled back prior to injecting vaccine. One hour at home, the child was complaining that her chest hurt and she started coughing. I advised the mother to give her Tylenol and apply ice to injection site. Never complained of shortness of breath to my knowledge, but the mother called back in about thirty minutes and reported severe arm pain, crying, crying, more chest pain along with coughing. Advised to call private physician or go immediately to the ER. Two hours later the child was seen at the ER and was given a cough medicine that contained Codeine and the mother reported the doctor said that the child had a cold starting. The mother also said that after the child got back home she had taken the cough medicine and relaxed that she felt better. The child went to school the day after the episode, the mother said that she still had a "sore arm", then. NOTE: the client before this child was extremely loud when given his immunizations and required most of the clinic staff.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Nasopharyngitis
Clinical narrative: This child complained immediately of extreme burning in arm. Bleeding when needle was pulled out of skin but there was no blood when plunger pulled back prior to injecting vaccine. One hour at home, the child was complaining that her chest hurt and she started coughing. I advised the mother to give her Tylenol and apply ice to injection site. Never complained of shortness of breath to my knowledge, but the mother called back in about thirty minutes and reported severe arm pain, crying, crying, more chest pain along with coughing. Advised to call private physician or go immediately to the ER. Two hours later the child was seen at the ER and was given a cough medicine that contained Codeine and the mother reported the doctor said that the child had a cold starting. The mother also said that after the child got back home she had taken the cough medicine and relaxed that she felt better. The child went to school the day after the episode, the mother said that she still had a "sore arm", then. NOTE: the client before this child was extremely loud when given his immunizations and required most of the clinic staff.
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Infection, Irritability, Lethargy, Pyrexia
Clinical narrative: On 12/18/00, the patient had an office visit, parent complained of child being cranky, irritable, lethargic with fever on and off since immunizations. Temperature 103 on Saturday. When seen at the office the temperature was 96.5; rash just started on his chest, back and groins. TM's slight redness, Tympanometry R72, L115, right thigh was red. On 12/19 called the patient crying and pulling on ears. On 12/22, the patient was doing better  not on Zithromax, but Claritan.
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash
Clinical narrative: On 12/18/00, the patient had an office visit, parent complained of child being cranky, irritable, lethargic with fever on and off since immunizations. Temperature 103 on Saturday. When seen at the office the temperature was 96.5; rash just started on his chest, back and groins. TM's slight redness, Tympanometry R72, L115, right thigh was red. On 12/19 called the patient crying and pulling on ears. On 12/22, the patient was doing better  not on Zithromax, but Claritan.
Age: 15.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This patient had a red raised warm 5 cm in diameter.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness
Clinical narrative: Pt did not want to get Anthrax shot but did comply as directed. 5 minutes, post vax, he reported to Flight Med front desk complaining of dizziness. Orthostatics were wnl, no respiratory symptoms. Neuro exam was wnl. After 15 minutes, pt felt better. Released from duty and deployed to air base the next AM.
Age: 1.4
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Unevaluable event
Clinical narrative: A father reported that his 17 month old son received Tri-Immunol, Hib-Titer and Orimune vaccines on 11/19/91. On 11/20/91, the child passed away. The reporter noted that the police had investigated the cause of death and determined that the heater in the room was too hot; however, the reporter had 3 different independent medical people look into it, and they said it was the shot. This report of a discontinued product is being sent in a 15 day time frame, as requested by FDA.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Myalgia
Clinical narrative: Report 2001003417-1 describes joint pain in a 43 year old male who received Lyme disease vaccine. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient received his first injection of Lymerix on 03/01/99 and his second injection on 03/29/99. No adverse experiences were reported following receipt of these injections. The patient received his third injection on 04/26/99. The third injection was administered approximately one month, rather than the recommended one year, following receipt of the second injection. At some later, unspecified time the patient experienced " severe, pervasive, persistent and acute joint and muscle pain." The outcome of the joint muscle pain was not provided. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dysuria, Pneumonia, Sepsis
Clinical narrative: A physician reported that a 30 year old female received an injection of vaccine, in November, 1990. In January, 2001, the patient was hospitalized for the diagnosis of pneumococcal sepsis, serotype 9N. While hospitalized, the patient was ventilator dependent for 3 days and had no urine output for 2 days. The reporter did note that the patient had received and injection of pneumococcal vaccine in September, 2000. Follow up information received on 04/04/2001, indicated that this patient was 31 years old and was hospitalized for more than 30 days. Upon further medical review the code of intubation NOS was removed from the case.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Infection, Muscle spasms, Myalgia
Clinical narrative: After the 2nd vaccine, this patient had joint and muscle pain, generalized muscle spasms, onset of illness 12/00. Pain medication, anti-anxiety, depressants, and sleeping medication given.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: Report 2001003496-1 describes joint pain in a male who received Lyme disease vaccine. The patient participated in a Lyme disease clinical trial; the protocol was not specified. The adverse event was reported spontaneously post-marketing. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient claims to have received placebo as part of a Lyme disease clinical trial. After the blind had been broken, the patient reportedly was offerred and accepted open-label Lyme disease vaccine. He received his first injection of Lyme disease vaccine in March 1997. No adverse experience was reported following this injection. He received his second injection of Lyme disease vaccine in 04/97. In 11/97, three months following receipt of the second injection, he began to experience slight pain in his arm joints. The patient received his third injection of Lyme disease vaccine in the spring of 1998. Within one week of receiving the third injection, his joint pain became severe and affected all of his joints. The joint pain was described as "burning and cramping". He had "the sensation of a hundred razor blades poking his knee joints, hips, ankles, wrists and elbows." The outcome of the joint pain was not provided. The adverse event of joint pain does not meet ICH serious criteria, but os being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Age: 32.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Report 2001003650-1 describes joint aches in a 32 year old male who received Lyme disease vaccine. The patient received his first injection of Lymerix on 10/12/00. At some later, unspecified date, he experienced "severe" joint aches involving his entire body. The joint aches persisted. The patient did not report this event to his physician. On 11/17/00, the patient received his second injection of Lymerix. The "severe" joint aches involving his entire body persisted. The patient's spouse notified the physician of the joint aches. The patient has not been seen by the physician for evaluation of the joint aches. The adverse event of joint aches does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: 12/5/00 immunized, 12/8/00. No second page attached
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This child had erythema 8 x 10 am at the injection site with induration, 48 hours after injection.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Injection site reaction, Injection site swelling, Shoulder pain
Clinical narrative: Pt reports left shoulder pain and swelling after 3rd Rabies vaccine injection. Did experience mild reaction to 1st and 2nd doses, temp of 97.4- pt denies breathing or swallowing difficulties. Localized reaction.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This infant had a rash and a fever.,
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: The patient had a vaccine, ten days later, the mother noted red "specks" not raised, on the child's face, arm, and stomach. The child also had a fever of 100.6.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Chest discomfort, Dyspnoea, Face oedema, Hypersensitivity, Oedema peripheral
Clinical narrative: The patient complained of a "popping" sensation in his throat and chest about 1 hour after receiving immunization. He did not go to the school nurse. The school nurse contacted 10/24/00 by the mother of the child stating that for the past week he had hives; they started at his ankles and then became generalized. She treated him with Benadryl on and off. She did not want him to have a second shot. This reaction was brought to my attention 10/30/00 and I talked with the parent who stated that on the morning of 10/30/00 the patient again complained of "tightness" (same as popping according to the mother) in his throat and "wheezing". The mother had an appointment scheduled for 11/01/00 with the patients primary physician. Telephone call from the mother on 11/02/00 to report that at midnight 10/30/00 the child's lips were swollen and so was his right big toe. She had talked with someone from 1-703-938-DPT3 who advised her that Hepatitis B vaccine can damage the immune system. The patient was seen on 10/31/00 by his primary provider who has recommended that he be seen by an allergist. Note- the hives persist. On 11/19/00, the mother called the RN today to report that her son continues to have allergic symptoms. They were in Buffalo on 11/08/00 and her son developed difficulty breathing and his feet and hands swelled "3 times their normal size". She took him to the hospital in Buffalo. He was given steroids. Required Benadryl this AM. Some swelling of the hands persists.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: The patient complained of a "popping" sensation in his throat and chest about 1 hour after receiving immunization. He did not go to the school nurse. The school nurse contacted 10/24/00 by the mother of the child stating that for the past week he had hives; they started at his ankles and then became generalized. She treated him with Benadryl on and off. She did not want him to have a second shot. This reaction was brought to my attention 10/30/00 and I talked with the parent who stated that on the morning of 10/30/00 the patient again complained of "tightness" (same as popping according to the mother) in his throat and "wheezing". The mother had an appointment scheduled for 11/01/00 with the patients primary physician. Telephone call from the mother on 11/02/00 to report that at midnight 10/30/00 the child's lips were swollen and so was his right big toe. She had talked with someone from 1-703-938-DPT3 who advised her that Hepatitis B vaccine can damage the immune system. The patient was seen on 10/31/00 by his primary provider who has recommended that he be seen by an allergist. Note- the hives persist. On 11/19/00, the mother called the RN today to report that her son continues to have allergic symptoms. They were in Buffalo on 11/08/00 and her son developed difficulty breathing and his feet and hands swelled "3 times their normal size". She took him to the hospital in Buffalo. He was given steroids. Required Benadryl this AM. Some swelling of the hands persists.
Age: 1.0
Sex: M
Vaccine: DTP, HBHEPB, MMR, PNC
Symptoms: Depressed level of consciousness, Face oedema, Fall, Rash
Clinical narrative: A few hours post vax the child was difficult to arouse, his face was swollen, and a body rash was present. He was taken to the ER, examined and sent home. That night the child was not able to be aroused and fell on his face while crawling. He was admitted to the hospital. Subsequently the pt's condition resolved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Difficulty in walking, Injection site reaction, Pain
Clinical narrative: On November 8, 200, at 2:30 PM, the patient received Hep B vaccine. The patient complained of his legs being sore in the evening of 11/08/00. He woke up on 11/09/00, with extreme soreness in his legs and pain with walking. The mother describes son "walking like an old man". The mother was advised by PHN to take the child to the MD for evaluation. The patient was seen by the family MD on 11/09/00 who felt the child had a "mild" reaction to the Hepatitis B vaccine but still advised to continue with the series. The MD ordered the patient to rest with legs elevated and use Tylenol if needed.
Age: 1.3
Sex: U
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Infants cause of death SIDS
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Cardio-respiratory arrest, Encephalopathy
Clinical narrative: This infant died of cardiopulmonary arrest of unknown etiology; at this time autopsy is pending. Autopsy stated cause of death as  acute encephalopathy.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This patient has Guillain Barre' Syndrome, He was hospitalized.  Follow up 07/06/2001: "Final diagnosis was GBS.  Patient experienced other previous illnesses or medical conditions before the onset of GBS, however, it was not stated.  Patient was previously vaccinated with INfluenza prior."
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Anxiety, Injury, Rash
Clinical narrative: A pharmacist reported that a 16 year old male received Antivenin Polyvalent, Equine following a snake bite on 10/26/00 and subsequently, developed a total body rash and became anxious. A second dose of Antivenin Polyvalent, Equine was administered following treatment with diphenhydramine and methlprednisolone; however, the infusion was discontinued because of rash progression. Additional information received 01/17/2001 indicated that the patient was hospitalized for 2 days.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 63 year old female who on 9/22/00 was vaccinated with pneumococcal vaccine 23 polyvalent in the deltoid. On 9/24/00, the pt's arm was swollen, tender and very red from elbow to back. The pt was seen and treated at urgent care. The pt's experience was considered an "Other Medical Event" by the reporter. On 9/28/00, still not feeling well with a low-grade fever, no temperature elevation or swelling was noted. The physician notes stated "multiple constitutional symptoms, most likely secondary to pneumococcal vaccine 23 polyvalent (MSD)". Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Breath holding, Convulsion, Crying, Hypoglycaemia, Influenza
Clinical narrative: The child was seen by a doctor for a viral illness and diagnosed with the flu. The father requested a flu shot for the child. The child screamed, held breath, left side tonic clonic seizure lasting 2-3 minutes, post ictal axillary temp during seizure of 101.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Screaming, Viral infection
Clinical narrative: The child was seen by a doctor for a viral illness and diagnosed with the flu. The father requested a flu shot for the child. The child screamed, held breath, left side tonic clonic seizure lasting 2-3 minutes, post ictal axillary temp during seizure of 101.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Ear disorder, Hypertension, Viral infection
Clinical narrative: On 11/9 the pt experienced dizziness and the pt was sent to the ER. Treated for high blood pressure. Stated fluid behind ear. On 11/10 began medication for elevated blood pressure. On 11/16 and 17. went to ER, blood pressure still elevated. Sent to the ER for a 3rd time treated by neurology for "viral infection".
Sex: U
Vaccine: DTP
Symptoms: Unevaluable event
Clinical narrative: A physician reported that an unidentified person may have inadvertently received an expired dose of DTP. The physician declined to proved any further information. Follow up information has been received from the reporter on 2/6/01. The physician explained that an unidentified attorney called to inquire if there are any known adverse effects of receiving an expired DTP vaccine. The physician states "I do not know who the pt is, nor what company produced the vaccine". It is unknown if the pt experienced any adverse event from this vaccine.
Age: 66.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Condition aggravated, Hepatocellular damage, Thyroid disorder, Tinnitus
Clinical narrative: The pt reports ringing in her ears which has gotten worse after each vaccine. She has completed the series. She also states that she has liver damage, her liver enzymes are high. Since receiving the vaccine, she has had to increase her thyroid medication to 3 times the dose.  Follow up 03/20/2001: "On 01/24/2001, patient had first Hep A & B shot.  That night patient's ears began ringing.  In years past (2 times) patient taken 1 or 2 Tylenol and got both times, ringing in the ears for 3 weeks.  Patient told a nurse and she said that it was a severe reaction and to never take Tylenol and that kind of product ever again and patient hasn't.  On 04/07/2000, patient had the second Hep B shot and the ringing got much louder.  On 08/03/2000 when patient went to finish the series, patient thought if ringing in the ears was a side effect of the Hep A and B shots.  The nurse looked at her materials and said "no".  So patient had the shot-regrefully.  The ringing is very much louder, louder than the TV, road noise-it's terrible and has gone on all this time, never stopping.  Sometimes the right ear is 2 times lower than the left ear but usually it's the same.  Shots caused liver disfunction and thyroid mediccal event from 1 pick to 3.  It's now down to 2 and seems to have stabalized.  A former allergist told me that people with severe allergies and hydrocarbon & petrochemical sensitivity were not tested when the Hep A & B were studied.  Patient has been badly affected by these shots.  Patients liver disfunction is a great worry, patient is tired all the time and the ringing of the ears is rotten to put up with.  Patient surely hopes you can help.  You know, patient doesn't know what else those shots disrupted."
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Diarrhoea, Fatigue, Heart rate increased, Insomnia, Irritability
Clinical narrative: This patient in less than 72 hours after vaccines, began vomiting, diarrhea, fever, irritability, restless sleep, fat heartbeat, tired. The pediatric doctor refused to examine the patient and refused to file a report.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: This patient in less than 72 hours after vaccines, began vomiting, diarrhea, fever, irritability, restless sleep, fat heartbeat, tired. The pediatric doctor refused to examine the patient and refused to file a report.
Age: 51.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Pain
Clinical narrative: Report 2001003774-1 describes "achy knees" in a 51 year old male who received Lymerix for the prevention of Lyme disease. This report was received from the vaccinee and has not been verified by a physician or other health care professional. During the spring of 1999, the vaccinee received his first and second dose of Lymerix. In autumn, 2000, he received his third dose of Lymerix. Subsequently, he experienced "achy knees". The vaccinee has not been evaluated for this event, and no treatment has been given. As of 02/12/01, the outcome of this event is ongoing. The adverse event of "achy knees" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Report 2001003649-1 describes joint pain in a male (age not provided) who received Lyme disease vaccine (Lymerix). The patient received an injection of Lymerix in October 2000. At some later, unspecified date, he experienced knee joint pain. The pain persisted as of 02/08/01. Additional information has been requested. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Report 2001003541-1 describes joint pain in a 53 year old male who received Lyme disease vaccine (Lymerix). This report was received from the patient and has not been verified by a physician or other health care professional. The patient reported receiving injections of Lymerix in May 1999, June 1999, July 1999, May 2000, and June 2000; this is greater than the recommended number of Lymerix injections. At some later, unspecified date, the patient experienced bilateral knee joint pain. No redness, edema, or heat was noted in the knees. The patient has not sought medical attention. The outcome of this event was not provided. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Palpitations, Rash
Clinical narrative: Report 2001003522-1 describes joint pain in a 54 year old female who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health professional. In the summer of 1998, the vaccinee was treated for Lyme disease. On 03/29/99, she was reported to be 100% better, except for some stiffness of the left hand. On that date she was given a prescription for Celebrex for her continued hand stiffness, and received the first injection of Lymerix. The hand stiffness reportedly continued, without changes, until the vaccinee received her second injection of  Lymerix on 04/03/99. Following a dose of Lymerix, the vaccinee experienced joint pain, vision impairment, palpitations, chills and a bull's eye rash over the injection site. As of 02/01/01, the vaccinee continued to experience "significant joint pain, stiffness, fatigue, swelling of her hands and an impaired vision field in her left eye." The adverse events of "joint pain" and "stiffness" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Visual acuity reduced
Clinical narrative: Report 2001003522-1 describes joint pain in a 54 year old female who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health professional. In the summer of 1998, the vaccinee was treated for Lyme disease. On 03/29/99, she was reported to be 100% better, except for some stiffness of the left hand. On that date she was given a prescription for Celebrex for her continued hand stiffness, and received the first injection of Lymerix. The hand stiffness reportedly continued, without changes, until the vaccinee received her second injection of  Lymerix on 04/03/99. Following a dose of Lymerix, the vaccinee experienced joint pain, vision impairment, palpitations, chills and a bull's eye rash over the injection site. As of 02/01/01, the vaccinee continued to experience "significant joint pain, stiffness, fatigue, swelling of her hands and an impaired vision field in her left eye." The adverse events of "joint pain" and "stiffness" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: Report 2001003518-1 describes arthritic symptoms in a 47 year old male who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. On 09/22/99 and 10/23/99, the vaccinee received his first and second doses of Lymerix, respectively. Reportedly, by January, 2000, he began experiencing "severe joint pain of acute onset which worsened through February, 2000." As of 02/01/01, these arthritic symptoms "have not resolved, despite the prescription of rofecoxib (Vioxx), Prednisone, Methotroxate, and hydroxychloroquine phosphate (Plaquenil)." The adverse event of "arthritic symptoms" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.