chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea, Fatigue, Hypoxia, Insomnia, Malaise
Clinical narrative: Body temp increased (MEDI0003313 is a serious spontaneous case from a physician whose son required hospitalization for tracheitis. The reporter causality is Not related to FluMist. An 8 year old male received FluMist on 12Feb05 and on 06Mar05 the was hospitalized due to tracheitis. On 05Mar05, the pt complained of not feeling well, tired, and throat hurt. At 1:30AM on 06Mar05, the father noticed pt was awake and afebrile. At 3:30AM, he was unable to breathe and had stridor. The pt was taken to the ER on 06Mar05 and was able to breathe a bit better during the car ride. At the ER he was given breathing treatments which included steroids. A throat x-ray showed very little room to breathe for pt. He was diagnosed with tracheitis and a tracheostomy tube was inserted. Pt was taken to ICU on that Sunday 06Mar05 where he was intubated for five days. After 24 hrs in the ICU, his body temp increased and fluctuated to between 102-103.6 degrees F. His lungs were clear and he was heavily sedated with Propofol (diprivan) and Versed (midazolam). He was treated was clindamycin, to which he had an unspecified reaction and Benadryl (diphenhydramine). Throat culture during the hospital stay was positive for Influenza B. The pt was in the ICU for five days and the tracheostomy tube was removed Friday 11Mar05 after a normal x-ray finding. The pt was discharged on 11Mar05. The pt has recovered and is currently receiving daily Claritin (loratadine), Pepcid (famotidine), and Zantac (ranitidine). The reporter stated the pt is a big boy and could stand to lose some weight. He does not have any allergies nor was taking any medications prior to FluMist vaccination. The reporter does not believe tracheitis was due to FluMist vaccination.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Pyrexia, Sepsis, Stridor, Tracheitis
Clinical narrative: Body temp increased (MEDI0003313 is a serious spontaneous case from a physician whose son required hospitalization for tracheitis. The reporter causality is Not related to FluMist. An 8 year old male received FluMist on 12Feb05 and on 06Mar05 the was hospitalized due to tracheitis. On 05Mar05, the pt complained of not feeling well, tired, and throat hurt. At 1:30AM on 06Mar05, the father noticed pt was awake and afebrile. At 3:30AM, he was unable to breathe and had stridor. The pt was taken to the ER on 06Mar05 and was able to breathe a bit better during the car ride. At the ER he was given breathing treatments which included steroids. A throat x-ray showed very little room to breathe for pt. He was diagnosed with tracheitis and a tracheostomy tube was inserted. Pt was taken to ICU on that Sunday 06Mar05 where he was intubated for five days. After 24 hrs in the ICU, his body temp increased and fluctuated to between 102-103.6 degrees F. His lungs were clear and he was heavily sedated with Propofol (diprivan) and Versed (midazolam). He was treated was clindamycin, to which he had an unspecified reaction and Benadryl (diphenhydramine). Throat culture during the hospital stay was positive for Influenza B. The pt was in the ICU for five days and the tracheostomy tube was removed Friday 11Mar05 after a normal x-ray finding. The pt was discharged on 11Mar05. The pt has recovered and is currently receiving daily Claritin (loratadine), Pepcid (famotidine), and Zantac (ranitidine). The reporter stated the pt is a big boy and could stand to lose some weight. He does not have any allergies nor was taking any medications prior to FluMist vaccination. The reporter does not believe tracheitis was due to FluMist vaccination.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Viral infection
Clinical narrative: Body temp increased (MEDI0003313 is a serious spontaneous case from a physician whose son required hospitalization for tracheitis. The reporter causality is Not related to FluMist. An 8 year old male received FluMist on 12Feb05 and on 06Mar05 the was hospitalized due to tracheitis. On 05Mar05, the pt complained of not feeling well, tired, and throat hurt. At 1:30AM on 06Mar05, the father noticed pt was awake and afebrile. At 3:30AM, he was unable to breathe and had stridor. The pt was taken to the ER on 06Mar05 and was able to breathe a bit better during the car ride. At the ER he was given breathing treatments which included steroids. A throat x-ray showed very little room to breathe for pt. He was diagnosed with tracheitis and a tracheostomy tube was inserted. Pt was taken to ICU on that Sunday 06Mar05 where he was intubated for five days. After 24 hrs in the ICU, his body temp increased and fluctuated to between 102-103.6 degrees F. His lungs were clear and he was heavily sedated with Propofol (diprivan) and Versed (midazolam). He was treated was clindamycin, to which he had an unspecified reaction and Benadryl (diphenhydramine). Throat culture during the hospital stay was positive for Influenza B. The pt was in the ICU for five days and the tracheostomy tube was removed Friday 11Mar05 after a normal x-ray finding. The pt was discharged on 11Mar05. The pt has recovered and is currently receiving daily Claritin (loratadine), Pepcid (famotidine), and Zantac (ranitidine). The reporter stated the pt is a big boy and could stand to lose some weight. He does not have any allergies nor was taking any medications prior to FluMist vaccination. The reporter does not believe tracheitis was due to FluMist vaccination.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: VACCINE ADMINISTERED@ COUNTY HEALTH DEPT 10/18/2000 PRESENTED IN OFFICE 05/17/2005 WITH PAPULES DX;VARICELLA >50 LESIONS HAD MMR,DTAP,IPOL ON 11/09/2000
Age: 0.44
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Diarrhoea, Overdose, Vomiting
Clinical narrative: CHILD CAME IN FOR WELL VISIT, BUT WAS ALSO HAVING SNEEZING, RUNNY NOSE AND WATERY EYES. NO FEVER OR LOW GRADE ONLY. TREATMENT PRESCRIBED WAS AN ANTIHISTAMINE DONATUSSSIN, HOWEVER PATIENT DID NOT GET PRESCRIPTION FILLED AND USED OTC MEDS INSTEAD, PER REPORT. CHILD HAD SOME VOMITING AND DIARRHEA THE NEXT EVENING AND AM OF DEATH. Received Autopsy Report which revealed COD as acetominophen poisoning.  Manner of death: accidental (inadvertent overmedication).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 48 hrs after immunization mother noticed L deltoid area red, warm & swollen.  Skin is very tight.  Brought child back to clinic =~72 hrs p imms.  L deltoid is as described above c ara extending from 1/2" down deltoid to approx. 1" below.  Afebrile, goo ROM.  will see PCP.  Has used ice & ibuprofen since yesterday.  PCP advises it is a local reaction.  Observe.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Bronchitis, Fatigue, Sinusitis
Clinical narrative: One week after flu vaccine, had fatigue and  sinusitis, and bronchitis. Treated with antibiotics, recovered and had recurrence of sinusitis in Feb.and bronchitis in late April. Has been in bed, off work with severe fatigue since February, 2005.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Bone pain, Injection site pain, Pain, Sleep disorder
Clinical narrative: Pain at injection site. Starting the night of injection.  Pain lasted one week. Pain has persisted on and off ever since. (3 months) "Deep throbbing ache that goes all the way to the bone,from the injection site.  Occasionally seems to radiate down the arm. Keeps her awake at night."  Denies reddness, swelling of fever.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Irritability, Rash, Vomiting
Clinical narrative: Child vomited once during the evening of 5/16, then awakened on 5/17 with "Little red bumps everywhere" according to Mother.  Upon questioning, Mom states that rash was on stomach, neck and back.  Rash was bright red upon awakening, but after child had played awhile with just diaper on, it became much fainter.  Child has also been fussy, but Mom says this could be attributed to teething. Mom denies fever.  On 5/18, child still had rash so Mom took her to Dr's office.  He told her rash was from MMR vaccine, and for her to use ibuprofen.  At this time, child still has rash.
Age: 4.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: Approximately 10:00 am on 5/18/05 patient's teacher noticed a large area of swelling with red splotches, a fever around the swelling, and patient complaining of itching. She also noticed the site was bleeding. I was called to pick her up at 11:00 am. Patient was also running a fever of 101.9 degrees and the swelling began to resemble the size and shape of a tennis ball in the shoulder area.
Age: 0.44
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Feeling hot
Clinical narrative: 5 minutes after patient was vaccinated both legs became very warm and red to the touch.  MD notified, he examined patient, patient was given Benadryl 8mg and Tylenol.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: From initial information received on 4/6/04 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 22 year old female patient received her second dose of IMOVAX RABIES, lot number W1419, administered IM in the left deltoid on 4/2/04 at 9:30 AM. Within two hours of vaccination the patient developed hives on her left deltoid. That evening, she also experienced malaise and lymphadenopathy. Reportedly, the hives have resolved, but lymphadenopathy continues. The patient received her first dose of IMOVAX RABIES, lot number W1004, administered IM in the left deltoid on 3/26/04, but no reaction was reported. At the time of vaccination, the patient was also taking birth control pills. Her pre-existing medical conditions include allergies to penicillin. The patient's recovery status is currently unknown. From return phone call from reporter on 4/21/04, she stated that indications were for pre-exposure. After reaction to second dose of IMOVAX RABIES, the patient was switched to RabAvert and experienced the same reaction. At this time, she has not recovered.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Influenza like illness, Myalgia
Clinical narrative: From initial information received on 13Apr04 from the pt, regarding an adverse event occurring, it was reported that a 31 year old female pt received Imovax Rabies, lot number W14193, administered IM in the left deltoid on 31Mar04. At 8:00AM the next morning, the pt experienced flu-like symptoms consisting of aches and fatigue. She took Advil. The pt reportedly did recover from this event.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Feeling hot, Hypersensitivity, Nausea, Urticaria
Clinical narrative: From initial information received on 4/16/04 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 26 year old female patient received an IMOVAX RABIES vaccination, lot number X0581, administered IM in the left arm on 4/13/04 at9:30AM. The same day, at 11:30 AM, the patient felt extremely nauseous, warm, and fatigued. Approximately 26 hours after the vaccination, she developed hives at the site of injection. 48 hours after the vaccination, she developed hives over her body but primarily in her back and arm. It is unknown whether the patient recovered from these events. From additional information received on 5/6/04, from a health care professional, it was reported that the patient was seen in the emergency room on 4/15/04. The names and contact information for the responsible physician and vaccine administrator were also provided. Reportedly, the patient recovered from this experience. No further information is anticipated, this case is considered closed.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Dysarthria, Hyperaesthesia, Lethargy, Nausea
Clinical narrative: From initial information received on 7/29/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 23 year old female patient received her first dose of IMOVAX RABIES, lot number X0581, administered in the left deltoid at 9:00 AM on 7/28/04. It was not reported whether the patient received the vaccine as part of a pre- or post-exposure series. 2.45 minutes post-administration, the patient developed slurred speech and became lethargic. 5.45 minutes post-administration, she developed hypersensitivity to touch. One hour after receiving the vaccine, her arm became swollen and painful. Two hours post-administration, the patient developed nausea, chills, and fever. The patient was advised by her private physician to take Tylenol and Benadryl. She slept for three hours and then felt better. Reportedly, the patient recovered for this experience. From additional information received on 9/13/04 from the initial reporter, it was reported that the patient received the vaccine as part of a pre-exposure series. The duration of the symptoms was five hours and 45 minutes, with the onset of slurred speech occurring two hours and 45 minutes after the injection. The original symptom did not subside while the subsequent symptoms developed, but rather continued for the five hours and 45 minutes until the patient fell asleep. After a three hour sleep, the patient awoke symptom free. The patient did not require an emergency room visit for these events, but rather received medical recommendations by phone from her personal physician. She did complete the series with pre-doses of Tylenol and Benadryl with no adverse effects. No further information is anticipated, this case is considered closed.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: From initial information received on 7/29/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 23 year old female patient received her first dose of IMOVAX RABIES, lot number X0581, administered in the left deltoid at 9:00 AM on 7/28/04. It was not reported whether the patient received the vaccine as part of a pre- or post-exposure series. 2.45 minutes post-administration, the patient developed slurred speech and became lethargic. 5.45 minutes post-administration, she developed hypersensitivity to touch. One hour after receiving the vaccine, her arm became swollen and painful. Two hours post-administration, the patient developed nausea, chills, and fever. The patient was advised by her private physician to take Tylenol and Benadryl. She slept for three hours and then felt better. Reportedly, the patient recovered for this experience. From additional information received on 9/13/04 from the initial reporter, it was reported that the patient received the vaccine as part of a pre-exposure series. The duration of the symptoms was five hours and 45 minutes, with the onset of slurred speech occurring two hours and 45 minutes after the injection. The original symptom did not subside while the subsequent symptoms developed, but rather continued for the five hours and 45 minutes until the patient fell asleep. After a three hour sleep, the patient awoke symptom free. The patient did not require an emergency room visit for these events, but rather received medical recommendations by phone from her personal physician. She did complete the series with pre-doses of Tylenol and Benadryl with no adverse effects. No further information is anticipated, this case is considered closed.
Age: 48.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Arthralgia, Atrial fibrillation, Blood cholesterol increased, Condition aggravated
Clinical narrative: Subject states that he made a VAERS submission in May 2005. Vaccinated on 10/08/2003, the following evening he experienced a severe HA and took Advil. The HA continued on until 10/10/03 he sought care at the clinic. He was given Tylenol for the HA and his BP was 160/120 at that time. Over the next 8 months the subject had continuing HA, fatigue, joint stiffness, and the feeling that his heart was racing. On 05/18/04- he went for a PE and was told that he was in atrial fibrillation with high BP (180/140). Over the next few days he experienced HA, chest tightness, chest pain, and in increased heart rate. On 05/22/04 he went to an emergency center where he was told he was in atrial fibrillation. On 06/11/04 a cardiac cath was done and he was told that he had a small blockage. He was put on Toprol 150mg QD, Lotrel 10mg/20mg QD, Benicar HCT 20/12.5 QD and Warfarin SOD 7.5 mg 1 1/2 tablets daily. Since that time the subject states the he easily gets indigestion. Over the past 6 months he has noticed short term memory loss.
Age: 48.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Electrocardiogram, Hypertension, Insomnia, Myalgia
Clinical narrative: Subject states that he made a VAERS submission in May 2005. Vaccinated on 10/08/2003, the following evening he experienced a severe HA and took Advil. The HA continued on until 10/10/03 he sought care at the clinic. He was given Tylenol for the HA and his BP was 160/120 at that time. Over the next 8 months the subject had continuing HA, fatigue, joint stiffness, and the feeling that his heart was racing. On 05/18/04- he went for a PE and was told that he was in atrial fibrillation with high BP (180/140). Over the next few days he experienced HA, chest tightness, chest pain, and in increased heart rate. On 05/22/04 he went to an emergency center where he was told he was in atrial fibrillation. On 06/11/04 a cardiac cath was done and he was told that he had a small blockage. He was put on Toprol 150mg QD, Lotrel 10mg/20mg QD, Benicar HCT 20/12.5 QD and Warfarin SOD 7.5 mg 1 1/2 tablets daily. Since that time the subject states the he easily gets indigestion. Over the past 6 months he has noticed short term memory loss.
Age: 48.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Atrial tachycardia, Atrioventricular block, Blood pressure increased, Blood triglycerides increased
Clinical narrative: Subject states that he made a VAERS submission in May 2005. Vaccinated on 10/08/2003, the following evening he experienced a severe HA and took Advil. The HA continued on until 10/10/03 he sought care at the clinic. He was given Tylenol for the HA and his BP was 160/120 at that time. Over the next 8 months the subject had continuing HA, fatigue, joint stiffness, and the feeling that his heart was racing. On 05/18/04- he went for a PE and was told that he was in atrial fibrillation with high BP (180/140). Over the next few days he experienced HA, chest tightness, chest pain, and in increased heart rate. On 05/22/04 he went to an emergency center where he was told he was in atrial fibrillation. On 06/11/04 a cardiac cath was done and he was told that he had a small blockage. He was put on Toprol 150mg QD, Lotrel 10mg/20mg QD, Benicar HCT 20/12.5 QD and Warfarin SOD 7.5 mg 1 1/2 tablets daily. Since that time the subject states the he easily gets indigestion. Over the past 6 months he has noticed short term memory loss.
Age: 48.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Chest discomfort, Chest pain, Coronary artery occlusion, Headache, Hypertension
Clinical narrative: Subject states that he made a VAERS submission in May 2005. Vaccinated on 10/08/2003, the following evening he experienced a severe HA and took Advil. The HA continued on until 10/10/03 he sought care at the clinic. He was given Tylenol for the HA and his BP was 160/120 at that time. Over the next 8 months the subject had continuing HA, fatigue, joint stiffness, and the feeling that his heart was racing. On 05/18/04- he went for a PE and was told that he was in atrial fibrillation with high BP (180/140). Over the next few days he experienced HA, chest tightness, chest pain, and in increased heart rate. On 05/22/04 he went to an emergency center where he was told he was in atrial fibrillation. On 06/11/04 a cardiac cath was done and he was told that he had a small blockage. He was put on Toprol 150mg QD, Lotrel 10mg/20mg QD, Benicar HCT 20/12.5 QD and Warfarin SOD 7.5 mg 1 1/2 tablets daily. Since that time the subject states the he easily gets indigestion. Over the past 6 months he has noticed short term memory loss.
Age: 48.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Joint stiffness
Clinical narrative: Subject states that he made a VAERS submission in May 2005. Vaccinated on 10/08/2003, the following evening he experienced a severe HA and took Advil. The HA continued on until 10/10/03 he sought care at the clinic. He was given Tylenol for the HA and his BP was 160/120 at that time. Over the next 8 months the subject had continuing HA, fatigue, joint stiffness, and the feeling that his heart was racing. On 05/18/04- he went for a PE and was told that he was in atrial fibrillation with high BP (180/140). Over the next few days he experienced HA, chest tightness, chest pain, and in increased heart rate. On 05/22/04 he went to an emergency center where he was told he was in atrial fibrillation. On 06/11/04 a cardiac cath was done and he was told that he had a small blockage. He was put on Toprol 150mg QD, Lotrel 10mg/20mg QD, Benicar HCT 20/12.5 QD and Warfarin SOD 7.5 mg 1 1/2 tablets daily. Since that time the subject states the he easily gets indigestion. Over the past 6 months he has noticed short term memory loss.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL, DTAP, HIBV, MMR, PNC, VARCEL, DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Dyskinesia, Eye movement disorder, Febrile convulsion, Hypoventilation, Pyrexia
Clinical narrative: Pt attended immunization clinic on 5/10/05. No previous history of untoward reactions noted. Mother reports seizure activity noted in the evening and early morning following the immunizations. Child seen at hospital treated and released.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL, DTAP, HIBV, MMR, PNC, VARCEL, DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: Pt attended immunization clinic on 5/10/05. No previous history of untoward reactions noted. Mother reports seizure activity noted in the evening and early morning following the immunizations. Child seen at hospital treated and released.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Pneumovax 5/11/05 lost energy 1 hr after shot, then moderate edema/redness/tenderness whole R upper arm. Saw 5/12 and improving.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Pyrexia
Clinical narrative: Felt tired and developed fever to 101.8 about 12 hrs after Td continued fever and exhausted 12 more hours and then symptoms resolved. Pt was seen by MD on 05/12/2005.
Sex: M
Vaccine: HEP
Symptoms: Jaundice
Clinical narrative: This case was reported by a nurse and described the occurrence of yellow skin in an adult male subject who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date before 13May05, the subject received the first dose of Engerix B. At an unspecified time following the first dose of Engerix B, on an unspecified date before 13May05, the subject experienced yellowing of the skin. The nurse reported that the subject never contacted a physician and it was never evaluated by a physician. The yellowing of the skin resolved on an unspecified date on or before 13May05. Yellowing to the skin was assessed as medically serious by manf.
Age: 1.17
Sex: F
Vaccine: DTAP, PNC
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: TC 5/16/05 from mother, that pt had fever of 103, chills, diarrhea, and vomiting that started Friday evening 5/13/05. Still has symptoms today with fever of 102. TC 5/18/05 Saw Dr, not imm. related, still vomiting, no diarrhea or fever.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Paraesthesia, Similar reaction on previous exposure to drug, Throat tightness
Clinical narrative: This is a 55 year old white female with past medical history of allergic reactions who states, "I'm having another one". She states that she had a Pneumovax given to her a couple days ago and that she initially developed redness at the site, but now she is getting a hive on her right arm and tingling down her complete right side and the spreading to her left side. This is consistent with other allergic reactions she has had in the past. She states she has been taking Benadryl and Zyrtec since this started last night. She states that she feels tight in the throat but has had no trouble swallowing or difficulty breathing. No wheezing. She states she would prefer not to get any epinephrine, as she has had it before and she thinks she does not need it now. All other pertinent review of systems is negative.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This is a 55 year old white female with past medical history of allergic reactions who states, "I'm having another one". She states that she had a Pneumovax given to her a couple days ago and that she initially developed redness at the site, but now she is getting a hive on her right arm and tingling down her complete right side and the spreading to her left side. This is consistent with other allergic reactions she has had in the past. She states she has been taking Benadryl and Zyrtec since this started last night. She states that she feels tight in the throat but has had no trouble swallowing or difficulty breathing. No wheezing. She states she would prefer not to get any epinephrine, as she has had it before and she thinks she does not need it now. All other pertinent review of systems is negative.
Age: 0.23
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pallor
Clinical narrative: Pt turned white face to feet within seconds of IPV, Dtap, Comvax given. Prevnar was given 4th but by then pt turned white.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: From initial information received on 5/7/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 43 year old female patient received second dose of IMOVAX RABIES vaccination, lot number W1419, administered IM on 1/12/04 (on or about 2:00 PM). Six days later on 1/18/04 at6:00 PM the patient developed facial itching and a reddened rash and hives which progressed over the entire body. The patient did not have tongue swelling. She began using 1% Cortaid creme locally on Saturday morning. She felt immediately hot then the itchiness stopped. She popped some Benadryl Q4 hours over the weekend and by Sunday evening, the rash was subsiding and the itchiness resolved. By Monday, the rash was fading and lighter. The patient did not experience any fever throughout the episode. The patient recovered from these events.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: From initial information received on 5/10/04 from the patient, regarding an adverse event occurring in the USA, it was reported that a female patient (age not reported) received her third dose of IMOVAX RABIES on 3/15/04 as part of a post exposure series. The lot number, route and site of administration were not reported. Per the patient, the hospital did not maintain records of the lot numbers. One day after vaccination, on 3/16/04, the patient developed a temperature of 102.8 degrees F, severe body aches and chills. She received a fourth dose of IMOVAX RABIES on 3/22/04 and a fifth dose on 4/5/04 and experiernced the same symptoms. The lot numbers, routes and sites of administration for the fourth and fifth doses were not reported. She was on an unspecified antibiotic at the time of vaccination with the fourth dose. Reportedly, the patient recovered from these events and no residual effects were noted. She no longer has any symptoms. The patient denied experiencing any adverse events after receiving her first and second dose. From additional information received on 6/21/04 from the patient, her full address and telephone number were provided. She also provided her date of birth, which indicated that the patient was 30 years old at the time of this event. No other information was provided at this time.
Sex: F
Vaccine: RAB
Symptoms: Chills, Disturbance in attention, Fatigue, Medication error
Clinical narrative: From initial information received on 5/12/04 from the patient regarding an adverse event occurring in the USA, it was reported that the female patient (age not reported) received her first dose of pre-exposure IMOVAX RABIES, lot number not reported, route and site of administration not reported, on 4/1/04 in preparation for a stay abroad. The patient also received four additional doses of IMOVAX RABIES (a total of five doses) as well as a dose of IMMUNOGLOBULIN HUMAN ANTIRABIES on unspecified dates. Lot numbers, routes and sites of administration of these vaccines were not reported. An unspecified amount of time after receipt of each dose, the patient experienced chills and fatigue. Reportedly, the first dose of the vaccine was the first injection out of a series of three, which was given from a re-called lot. Because of this, the patient was given four additional shots. The patient stated that with each time she received the shot, she was unable to study and learn at her usual pace and was unable to engage in any moderate physical activities for the rest of the day after the shot was given. The patient's recovery status was not reported.
Age: 10.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Contusion, Diarrhoea, Headache, Injury
Clinical narrative: From initial information received on 4/10/04 from the patient's mother, regarding an adverse event occurring in the USA, it was reported that a 10 year old female patient started her 5-dose post exposure series with RIG, and IMOVAX RABIES on 12/31/03. The lot number, route and site information for these products were not provided. The next day, the patient experienced a fever of 101 degrees F. In mid January, the patient experienced vomiting, diarrhea, headache, stomach pains, and an intermittent sore throat. Antibiotics were prescribed on and off six times. The patient had multiple wounds from head to toe and bruises that are still present. Her right arm is numb at the wound sit from an attack from an unspecified animal that occurred on 12/22/03. The signs and symptoms still persist. It was not reported if the suspect animal had been captured and/or tested. It was not reported if the patient continued with the vaccination series. It was reported the patient reportedly did not recover from this event.
Age: 10.0
Sex: F
Vaccine: RAB
Symptoms: Pharyngolaryngeal pain, Pyrexia, Vomiting
Clinical narrative: From initial information received on 4/10/04 from the patient's mother, regarding an adverse event occurring in the USA, it was reported that a 10 year old female patient started her 5-dose post exposure series with RIG, and IMOVAX RABIES on 12/31/03. The lot number, route and site information for these products were not provided. The next day, the patient experienced a fever of 101 degrees F. In mid January, the patient experienced vomiting, diarrhea, headache, stomach pains, and an intermittent sore throat. Antibiotics were prescribed on and off six times. The patient had multiple wounds from head to toe and bruises that are still present. Her right arm is numb at the wound sit from an attack from an unspecified animal that occurred on 12/22/03. The signs and symptoms still persist. It was not reported if the suspect animal had been captured and/or tested. It was not reported if the patient continued with the vaccination series. It was reported the patient reportedly did not recover from this event.
Age: 50.0
Sex: M
Vaccine: RAB
Symptoms: Injection site rash, Injury, Pruritus
Clinical narrative: From initial information received on 4/14/04 from the patient regarding an adverse event occurring in the USA, it was reported that a male patient (age not reported) received his fourth dose of IMOVAX RABIES on 3/15/04 due to a dog bite to his ankle. The lot number of the vaccine as well as route and site of administration were not reported. The following day, the patient experienced rash at the site of injection as well as intermittent itching like ant bites all over his body. Reportedly, the patient did not recover from these events. He received his first dose of IMOVAX RABIES as well as a dose of IMMUNOGLOBULIN HUMAN ANTIRABIES vaccine on 2/27/04 with no reaction reported. From additional information received on 4/26/04 from the patient, the patient's date of birth was provided. It was also reported that the dose administered was from a post-exposure series. The patient was vaccinated at a pubic health clinic/hospital and purchased the vaccine with public funds. The telephone number for the responsible facility was provided. Reportedly, the patient experienced a very swollen arm with the fourth dose of vaccination and two days later complained of pruritus throughout the entire body. The patient had also previously received a dose of TD ADS ADULT with no reaction reported. It was also reported that the patient has gone for a doctor's visit and still complains of pruritus.
Age: 50.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Injection site pain, Insomnia, Mood altered, Nervousness
Clinical narrative: From initial information received on 4/15/04 from a workman's compensation representative regarding an adverse event occurring in the USA, it was reported that a 50 year old male patient received a dose of IMOVAX RABIES in the left arm on 3/31/04. The lot number, route and dose number were not reported. It was not reported whether the patient received the product as part of a pre- or post-exposure series. On 4/7/04, the patient complained of headache and sleeplessness. It was reported that he felt nervous and edgy and became argumentative. He also had a very sore left arm at the site of injection. He was seen by a physician and had not yet recovered from these events at the time of this report.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Pharyngolaryngeal pain
Clinical narrative: From initial information received on 4/13/04 from the patient regarding an adverse event occurring in the USA it was reported that a 48 year old female received her fifth dose of IMOVAX RABIES vaccine, lot number W1419-3, administered IM at 3:30 AM on 4/2/04. The next day the patient developed a sore throat for three days. Reportedly the patient recovered from this experience.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Pain
Clinical narrative: From initial information received on 4/27/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 45 year old female received her second dose of IMOVAX RABIES, lot number W1004-2, administered IM in the deltoid on an unspecified date. An unspecified amount of time later, the patient's arm became very sore and she was achy all over. She also developed slight redness at the injection site. She took Advil and Vioxx for two days to sleep. Reportedly the patient recovered from this experience. The reporter of this case is the same as for case 200401728.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Influenza like illness, Pain
Clinical narrative: From initial information received on 4/28/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 34 year old female patient received her fourth dose of IMOVAX RABIES from a post-exposure series, administered in the right upper arm on 2/25/04 PM. The vaccine lot number and route of administration were not reported. One and a half hour later, the patient developed flu-like symptoms as well as redness and soreness in her right arm. The patient received her third dose of IMOVAX RABIES, administered in the right upper arm in January of 2004 with no reactions reported. She also received her fifth dose of the vaccine, administered in the left upper arm on 2/28/04 and experienced the same reaction as after her fourth dose. Lot numbers and routes of administration for the third or fifth doses of IMOVAX RABIES were not reported. Reportedly, the patient recovered from these events.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Malaise, Nausea, Vomiting, Weight increased
Clinical narrative: From initial information received on 7/13/04 from the patient's mother regarding an adverse event occurring in the USA, it was reported that a 29 year old male patient was bit by a wild cat and received a post-exposure IMOVAX RABIES vaccination, lot number W1419, and an IMOGAM USP HT, lot number W1367 (routes and sites of administration were not reported) on 2/26/04. Soon after the vaccinations (exact onset unknown), the patient began to not feel well and experienced nausea, vomiting, extreme fatigue, and a large weight gain. The patient gained approximately 60 pounds since February 2004. He was scheduled to see a doctor on 7/13/04. The patient's recovery status was not reported. From follow up phone call from a hospital pharmacist on 7/15/04, she stated that the reported adverse event was not due to the rabies vaccine or the rabies IMOGAM USP HT. She has agreed to fax the dates of all the rabies vaccine given. Patient did complete the series of five doses. From additional information received on 10/19/04 from a telephone contact with  the patient's mother, it was reported that the patient has not yet fully recovered from these events. No other information was provided at this time.
Age: 25.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: From initial information received on 3/30/04 from a physicians office regarding an adverse event occurring in the USA, it was reported that a 25 year old female patient received IMOVAX RABIES, lot number X0581-2, administration information not reported; and JE-VAX, lot number EJN205B, administered in the left arm, on 3/30/04. Three hours later the patient complained of mild numbness, tingling, and soreness in her left hand, arm and shoulder; and tingling in the right side of her face. The patient did seek medical attention, however, details were not provided. The patient's recovery status was not reported. From additional correspondence received on 5/10/04 from the initial reporter, no further information could be provided. Further information is not anticipated, this case is considered closed.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Injection site mass, Injection site swelling, Lymphadenopathy, Oedema peripheral, Pain
Clinical narrative: From initial information received on 4/5/04 from a health professional regarding an adverse event occurring in the USA, it was reported that a 26 year old female patient received her third dose of IMOVAX RABIES vaccine, lot number W1419, administered IM in the left deltoid at 3:00 PM on 4/2/04. Four hours later, the patient felt pain and heaviness in her left arm, felt a lump over tricep, experienced swelling of the arm and swelling of fingers in left hand. Patient also experienced swelling of the lymph glands in her left axilla. Tylenol was taken as needed for treatment. The patient's recovery status is currently unknown. Follow up phone call to reporter on 4/21/04 to learn indication for vaccine series which was prophylactic since she is veterinary technician. Also, this patient has recovered and continued with the vaccine series without any reaction reported. From additional information received on 5/3/04 from a health care professional, the patient received his first dose of IMOVAX RABIES, lot number W1419, administered IM in the left  deltoid on 3/12/04 and his second dose of IMOVAX RABIES, lot number W1419, administered IM in the left deltoid on 3/19/004. The patient did not have any illnesses at the time of vaccination. No additional information is expected, therefore this case is considered closed.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Sensation of heaviness
Clinical narrative: From initial information received on 4/5/04 from a health professional regarding an adverse event occurring in the USA, it was reported that a 26 year old female patient received her third dose of IMOVAX RABIES vaccine, lot number W1419, administered IM in the left deltoid at 3:00 PM on 4/2/04. Four hours later, the patient felt pain and heaviness in her left arm, felt a lump over tricep, experienced swelling of the arm and swelling of fingers in left hand. Patient also experienced swelling of the lymph glands in her left axilla. Tylenol was taken as needed for treatment. The patient's recovery status is currently unknown. Follow up phone call to reporter on 4/21/04 to learn indication for vaccine series which was prophylactic since she is veterinary technician. Also, this patient has recovered and continued with the vaccine series without any reaction reported. From additional information received on 5/3/04 from a health care professional, the patient received his first dose of IMOVAX RABIES, lot number W1419, administered IM in the left  deltoid on 3/12/04 and his second dose of IMOVAX RABIES, lot number W1419, administered IM in the left deltoid on 3/19/004. The patient did not have any illnesses at the time of vaccination. No additional information is expected, therefore this case is considered closed.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Discomfort, Palpitations
Clinical narrative: From initial information received on 4/5/04 from the vaccine provider regarding an adverse event occurring in the USA, it was reported that a 33 year old female patient received a third dose of IMOVAX RABIES vaccination, lot number W0136, route and site of administration unknown, on 3/10/04. Two days later, on 3/12/04, the patient experienced palpitation and discomfort. Her titers reached 1:50 on 3/17/04. It was reported that her signs and symptoms resolved and that she recovered from these events. The patient receievd the first dose of an IMOVAX RABIES vaccination, lot number U0971, route and site of administration unknown, on 3/4/04. The only known information on the second dose is the lot number, which was provided as 330011, manufacturer and route and site of administration unknown, on 3/7/04. From follow up information received on 4/7/04 from the reporting physician through a telephone contact, it was reported that the patient admits to drinking several cups of coffee on 3/12/04 and for this reason the physician felt the palpitations were more likely caused by the caffeine and not the vaccine. The lot number for the third dose of vaccine was also confirmed as W0136, dose two was given in the emergency room, therefore she was not able to verify the lot number at this time, but she has requested the emergency room records from the hospital. The rabies vaccine was administered because the patient's dog was attacked by a unknown wild animal in a rural area and because she sleeps with her dog, this made her very anxious. The patient requested the rabies series be given, even though the physician did not feel it was needed. The physician agreed to call back when the hospital records were obtained. No other information was reported. From information received on 5/5/04 from a health care professional, no additional information was provided. No further information is anticipated, this case is considered closed. A correction to the date of vaccination was made in box 10 of the report. The date of vaccination was reported as 5/10/04, but entered in error as 3/30/04.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Tremor
Clinical narrative: From initial information received on 4/9/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 55 year old female patient received her fourth dose of IMOVAX RABIES, lot number W1419, administered in the left deltoid (route of administration not reported) on 3/8/04. Ten days later, the patient experienced trembling in her hands, which stopped only if when she sat on them. Reportedly, the patient's children also noticed that her head was shaking. The symptoms lasted seven days. The patient received a fifth dose of IMOVAX RABIES, lot number X0581, administered in the right deltoid on 3/22/04. The patient went to see a doctor on 4/8/04 and was told that it might be Parkinson's disease or her thyroid, but was not given any medication. The patient stated that the symptoms occurred half way through her vaccination series. Reportedly, she feels fine otherwise. The patient's recovery status is currently unknown. From additional information received from the reporter on 4/12/04, it was reported that the patient did not think the tremors were related tot he vaccine. It is unknown whether any diagnostic test were performed. The reporter had contacted the physician regarding this question but has not yet received a response. She agreed to forward this information when it becomes available. From additional information received on 5/7/04 from the initial reporter, the patient's physician said that the events had resolved and that he did not feel that it was a vaccine reaction. No testing was performed. The patient received a fifth dose of IMOVAX RABIES, lot number 0581, in the right deltoid on a unspecified date. No adverse event was reported following this vaccination.
Age: 53.0
Sex: M
Vaccine: RAB
Symptoms: Feeling cold, Speech disorder, Tremor
Clinical narrative: From initial information received on 4/13/04 from a consumer regarding an adverse event occurring in the USA, it was reported that a 52 year old male patient received an IMOVAX RABIES vaccination, lot number W1419, administered IM in the right arm on the morning of 4/4/04. The patient also received IMMUNOGLOBULIN HUMAN ANTIRABIES on an unspecified date. The indication for the vaccination was not reported. On the evening of 4/1/04, the patient complained of slowed speech described as difficulty getting words out. This has continued since his first injection. He also experienced shaking and felt cold, which lasted for two days. No other information was provided. The patient did not recover from these events. A new version of this case was created to correct the date of administration of IMOVAX RABIES from 4/4/04 to the reported date of 4/1/04. The case was not medically confirmed, as it was reported by the patient. NO new information was reported. From additional information received on 5/20/04, the report has been medically confirmed by a physician where the patient was vaccinated. It was reported that the lot number for this first dose of IMOVAX RABIES (given on 4/1/04) was W1419. The patient received a second dose of RABIES VACCINE and a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES on 4/7/04. The lot numbers and manufacturers were not reported. On 4/10/04, the patient received a third dose of RABIES VACCINE. He received his fourth dose of IMOVAX RABIES on 4/14/04, a fifth dose on 4/21/04 and a sixth dose on 4/28/04. The lot number for the last three doses was X0581. All doses of IMOVAX RABIES and RABIES VACCINE were given IM. No adverse events were reported following subsequent doses and per the physician there is no additional information. The patient's recovery status was not reported. Further information is not anticipated, this case is considered closed.
Age: 14.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Headache, Paraesthesia
Clinical narrative: From initial information received on 4/12/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 14 year old male patient received a post-exposure IMOVAX RABIES vaccination, lot number W0023, route and site of administration unknown, on 1/7/04. An unspecified time after receiving the vaccination, the patient complained of a stomach ache. On 1/14/04, the patient complained of tingling in the ears. On 1/30/04, he still complained of tingling in the ears and experienced a headache. On 4/8/04, the headache resolved, but the ear tingling still persisted. It is unknown whether the patient fully recovered. From additional information received on 5/27/04 from a physician, the physician stated that she was not the responsible physician at the time the vaccine was administered. No further information is anticipated, this case is considered closed.