chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTP, HIBV, IPV, PNC
Symptoms: Hypokinesia, Pyrexia
Clinical narrative: On 7/19/01 daycare reported to mom that temperature was 104. When mom took temperature it was 101. Pt reluctant  to move leg on left side. Mom to give Tylenol for temperature above 100 F and put warm pack on injection site during 1st 24 hours and then a cool pack on site for next day or two. On 7/23 Dad reports child was more comfortable and moving his leg well by late 7/20/01 and now temperature was 98.8 and child was doing fine.
Sex: F
Vaccine: PNC
Symptoms: Abnormal behaviour, Dyspnoea, Vomiting
Clinical narrative: After receiving vaccinations pt slept on the way home. Woke up at home and Mom gave her a snack. While eating it mom notiticed moaning, laying her head down frequently  and heavy breathing. Felt hot. Vomiting violently and repeatedly. Full body tremors at 30 sec. To ED vomiting repeatedly in minutes. Temperature was 106 in Tylenol given. Baby Kegan acting farily normal
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: No data provided...
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt developed a local area at left anterior thigh of redness and induration (2cm X 3cm) firm and tender about 36 hours, post vax. No fever, pain or limp. I prescribed cool compresses and ibuprofen. To reevaluate if worsens but expected to resolve with local care.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blister, Eye discharge, Nasopharyngitis, Pyrexia
Clinical narrative: 6 days, post vax, pt developed a high fever for 3 days and then a rash on body only. 8 days, post vax, pt had 1 small patch of tiny blister-like rash on stomach. The day after vaccines, the pt's eyes oozed green goo, but felt it might be related to a cold. (Never seen anything like it).
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Eye swelling, Headache, Musculoskeletal stiffness, Pharyngolaryngeal pain
Clinical narrative: Within 24 hours of 2nd injection, pt had a headache, neck stiffness, sore throat and a fever of 102F with chills and swelling of eye.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Within 24 hours of 2nd injection, pt had a headache, neck stiffness, sore throat and a fever of 102F with chills and swelling of eye.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: Approx. 15:10 on 7/13/01, noted intense itching on back, chest, arms and hives developing soon thereafter. Symptoms treated with Benadryl X 2 on 7/13/01 and X 1 on 7/15/01 and then no further symptoms.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Albuminuria, Blood cholesterol increased, Nephrotic syndrome, Proteinuria
Clinical narrative: Nephrotic Syndrome on prednisone and responding well.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Pruritus, Pyrexia, Rash macular, Rhinorrhoea
Clinical narrative: Pt developed a red, macular rash over entire body and face. No vesicles or papules, but did have pruritus. Also, with a low-grade fever and URI symptoms, rhinorrhea. Treated with Benadryl. Had 1 day of fever and rash was then better.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Rash macular, Rhinorrhoea
Clinical narrative: Pt developed a red, macular rash over entire body and face. No vesicles or papules, but did have pruritus. Also, with a low-grade fever and URI symptoms, rhinorrhea. Treated with Benadryl. Had 1 day of fever and rash was then better.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Cough, Erythema, Swelling face, Wheezing
Clinical narrative: Pt got 4 shots that day and as we left, she started crying. She was itchy, cranky and tired. We got 5 minutes down the road from the doctor's office and her whole face was swollen. She started coughing and was bright red all over. Her eyes well almost swollen shut. By the time we got back to the doctor's office, she was burning up. She started wheezing and her heart was pounding. Her body went stiff-like and she was calm. The doctor called EMS and she was rushed to the hospital. They gave her a shot of Epinephrine and Benadryl. They had her stay for about an hour or so and then discharged her that day. She had to be on steroids for 4 days and Benadryl as needed. That night she had a black eye from her eye being swollen. For 2 nights, she had a little rash on her face but now she is fine. This was the pt's 1st varicella shot.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Contusion, Cough, Crying, Fatigue, Feeling hot
Clinical narrative: Pt got 4 shots that day and as we left, she started crying. She was itchy, cranky and tired. We got 5 minutes down the road from the doctor's office and her whole face was swollen. She started coughing and was bright red all over. Her eyes well almost swollen shut. By the time we got back to the doctor's office, she was burning up. She started wheezing and her heart was pounding. Her body went stiff-like and she was calm. The doctor called EMS and she was rushed to the hospital. They gave her a shot of Epinephrine and Benadryl. They had her stay for about an hour or so and then discharged her that day. She had to be on steroids for 4 days and Benadryl as needed. That night she had a black eye from her eye being swollen. For 2 nights, she had a little rash on her face but now she is fine. This was the pt's 1st varicella shot.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Musculoskeletal stiffness, Palpitations, Pruritus, Rash, Somnolence
Clinical narrative: Pt got 4 shots that day and as we left, she started crying. She was itchy, cranky and tired. We got 5 minutes down the road from the doctor's office and her whole face was swollen. She started coughing and was bright red all over. Her eyes well almost swollen shut. By the time we got back to the doctor's office, she was burning up. She started wheezing and her heart was pounding. Her body went stiff-like and she was calm. The doctor called EMS and she was rushed to the hospital. They gave her a shot of Epinephrine and Benadryl. They had her stay for about an hour or so and then discharged her that day. She had to be on steroids for 4 days and Benadryl as needed. That night she had a black eye from her eye being swollen. For 2 nights, she had a little rash on her face but now she is fine. This was the pt's 1st varicella shot.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTP, MMR, OPV, VARCEL
Symptoms: Swelling face, Wheezing
Clinical narrative: Pt got 4 shots that day and as we left, she started crying. She was itchy, cranky and tired. We got 5 minutes down the road from the doctor's office and her whole face was swollen. She started coughing and was bright red all over. Her eyes well almost swollen shut. By the time we got back to the doctor's office, she was burning up. She started wheezing and her heart was pounding. Her body went stiff-like and she was calm. The doctor called EMS and she was rushed to the hospital. They gave her a shot of Epinephrine and Benadryl. They had her stay for about an hour or so and then discharged her that day. She had to be on steroids for 4 days and Benadryl as needed. That night she had a black eye from her eye being swollen. For 2 nights, she had a little rash on her face but now she is fine. This was the pt's 1st varicella shot.
Age: 75.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Condition aggravated, Dyspnoea, Obstructive airways disorder, Palpitations
Clinical narrative: Information has been received from an investigator regarding a 75 year old male who received a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation) on 12/1/98 as part of the study, "A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial". On 12/5/98, the pt developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/11/98. The investigator believed that exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) was "Medically Important" and "possibly" related to study vaccine administration. The medical monitor's assessment is unknown. Follow-up information received on 6/14/01, indicated that the pt received an injection of Fluvirin along with a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation). On 12/5/98, he developed increased shortness of breath. On 12/8/98, the pt experienced palpitations with exertion. He was seen in an ER where a chest x-ray and an EKG show "no acute changes". The assessment remained unchanged. Additional follow-up received on 8/1/01, indicated that the pt was treated with Augmentin (amoxicillin clavulanate) and prednisone. There was no change in the original assessment. This was a nasal solution.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Decreased appetite, Electroencephalogram abnormal, Infantile spasms
Clinical narrative: Infantile spasms: "Salaam Seizures" treated with ACTH-Klonopin. The follow-up states that the child was well up until the vaccinations. Post-vaccination, the parents noted episodes of dropping head forward, extending arms and bringing legs up to chest and it became more frequent 4-5 times a day and tend to occur in clusters so that has 1-3 spasms in one cluster. Other types of seizures head/eye deviation and tonic-clonic. He has also been very irritable and not breast feeding as well as before this incident.
Age: 62.0
Sex: M
Vaccine: TTOX
Symptoms: Hypokinesia, Injection site pain, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Started with normal sore shoulder but within days, should got worse (couldn't raise arm), soreness and stiffness spread across shoulder blades, other shoulder then became affected (couldn't get dressed or sleep at night). Then about 2-3 weeks later, spread into neck (much stiffness). I have lived with this for 11 months now and condition is slightly better, but still bad. Doc 204222, 60-Day follow up states that patient seems to be recovering slowly, but still do not have full mobility, still has stiffness in both shoulders, cannot do certain movements like lifting slightly heavy objects. Patient honestly thinks that she is getting better.
Age: 62.0
Sex: M
Vaccine: TTOX
Symptoms: Sleep disorder
Clinical narrative: Started with normal sore shoulder but within days, should got worse (couldn't raise arm), soreness and stiffness spread across shoulder blades, other shoulder then became affected (couldn't get dressed or sleep at night). Then about 2-3 weeks later, spread into neck (much stiffness). I have lived with this for 11 months now and condition is slightly better, but still bad. Doc 204222, 60-Day follow up states that patient seems to be recovering slowly, but still do not have full mobility, still has stiffness in both shoulders, cannot do certain movements like lifting slightly heavy objects. Patient honestly thinks that she is getting better.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right thigh with pink 4-5 cm area. Augmentin and Motrin prescribed.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MEN, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: Father reports seizure at home at 4:00 AM, and was taken to Medical Center in Scottsville.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: DTAP, HIB, IPV and Prevnar were given on3/30/01 with > 3 hours screaming inconsolable.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had erythema, increased in warmth noted on left thigh less than 1 minute after vaccines. Benadryl given po.
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large area of swelling and redness on left upper leg-onset 7/25/01. Pt evaluated on 7/26/01 at 15:40- 7.0 X 9.0 cm area of erythema, warm and swelling left upper thigh.
Age: 1.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Herpes zoster
Clinical narrative: A few vesicle/lesions noted on trunk, legs, arms, face. Positive test result for varicella zoster.
Age: 57.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Laboratory test abnormal
Clinical narrative: Pt developed joint pain after vaccination. This report was received from the pt's spouse and has not been verified by a physician or other health care professional. The vaccinee works as a contractor and is expose to ticks. He reportedly had Lyme disease in 1995, 1996, and 1997. The pt had no adverse experiences following receipt of the first two injections of Lymerix. His spouse reports that she developed Lyme disease after receiving 3 injections of Lymerix. Additional info was received from the treating physician on 10/17/2001. The physician indicated that the vaccinee developed pain in his right shoulder in April 2001. He then experienced pain in his left shoulder. The physician evaluated the vaccinee once for the shoulder pain, on 07/03/2001. No warm or swollen joints were observed on physical examination. No joint fluid was obtained. Erythrocyte sedimentation rate was 5mm/hr., rheumatoid factor was negative, and antinuclear antibody titer was negative. Lyme antibodies by ELISA werre positive at 1.26. Lyme IgM by western blot revealed 39kD and 41kD bands. The physician made a diagnosis of arthralgia and prescribed Celebrax 200mg daily. The physician considered the arthralgia to be mild in intensity and possibly related either to LYMErix administration or exposure to an infected tick. The physician reported thatt the arthralgia persisted as of 07/10/2001. The physician did not confirm the report of headache and fatigue.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Chills, Dizziness, Ear pain, Fatigue
Clinical narrative: Pt appears to be in second or third stage of Lyme disease, numbness and pain in arm or legs, pt has both. She is having severe headaches and neck creaks and cracks with stiffness. Fatigue has worsened to point she can't say awake during public meetings, feels drained. Chills and sweats off and on for a year or more. Muscle and joint pains, shooting pains, burning, tingling and numbness and burning in feet. Feeling light headed and woozy by midday to remaining of day. Left eye twitching and bumping into things from feeling disoriented or perception is off. Reported to friend that I was seeing light spots shooting across room (floater), and restlessness, reoccurring ear pain and sensitive to any thing loud. I have been dx with fibromayalgia.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Fibromyalgia, Headache, Hyperhidrosis, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Pt appears to be in second or third stage of Lyme disease, numbness and pain in arm or legs, pt has both. She is having severe headaches and neck creaks and cracks with stiffness. Fatigue has worsened to point she can't say awake during public meetings, feels drained. Chills and sweats off and on for a year or more. Muscle and joint pains, shooting pains, burning, tingling and numbness and burning in feet. Feeling light headed and woozy by midday to remaining of day. Left eye twitching and bumping into things from feeling disoriented or perception is off. Reported to friend that I was seeing light spots shooting across room (floater), and restlessness, reoccurring ear pain and sensitive to any thing loud. I have been dx with fibromayalgia.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Myalgia, Pain, Paraesthesia, Restlessness, Skin burning sensation
Clinical narrative: Pt appears to be in second or third stage of Lyme disease, numbness and pain in arm or legs, pt has both. She is having severe headaches and neck creaks and cracks with stiffness. Fatigue has worsened to point she can't say awake during public meetings, feels drained. Chills and sweats off and on for a year or more. Muscle and joint pains, shooting pains, burning, tingling and numbness and burning in feet. Feeling light headed and woozy by midday to remaining of day. Left eye twitching and bumping into things from feeling disoriented or perception is off. Reported to friend that I was seeing light spots shooting across room (floater), and restlessness, reoccurring ear pain and sensitive to any thing loud. I have been dx with fibromayalgia.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Viral infection, Vitreous floaters
Clinical narrative: Pt appears to be in second or third stage of Lyme disease, numbness and pain in arm or legs, pt has both. She is having severe headaches and neck creaks and cracks with stiffness. Fatigue has worsened to point she can't say awake during public meetings, feels drained. Chills and sweats off and on for a year or more. Muscle and joint pains, shooting pains, burning, tingling and numbness and burning in feet. Feeling light headed and woozy by midday to remaining of day. Left eye twitching and bumping into things from feeling disoriented or perception is off. Reported to friend that I was seeing light spots shooting across room (floater), and restlessness, reoccurring ear pain and sensitive to any thing loud. I have been dx with fibromayalgia.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Hypoaesthesia
Clinical narrative: Pt c/o left sided facial numbness that persisted for approximately 12 hours.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Dysphagia, Gastrointestinal disorder, Laboratory test abnormal, Weight decreased
Clinical narrative: Pt began experiencing chest discomfort approximately 3 months after 1st anthrax shot. The frequency of the discomfort increased to one a month. In Oct 2000 the severity of the chest discomfort increased. In Dec 2000 the episodes began to include dysphagia and odynophagia, now occurring 2-3 X per day. Pt has lost 25 pounds.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Laboratory test abnormal
Clinical narrative: Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD.
Age: 87.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Laboratory test abnormal
Clinical narrative: Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10cm-11cm redness and induration on left thigh.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Dyskinesia, Electroencephalogram abnormal, Loss of consciousness, Syncope
Clinical narrative: Child became dizzy within 5 minutes and collapsed to the ground. Unconscious for 1 minute. Had some jerking movements in both upper extremities, lasting for a minute.
Age: 10.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash
Clinical narrative: Pt developed generalized rash with itching and was treated with Benadryl.
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Laboratory test abnormal
Clinical narrative: Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: Pt had numbness on left leg X 3 days, muscle fatigue (general) X 7 days and overall physical fatigue X 2 weeks. No treatment given.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Pt had a headache, low-grade fever of 99.8F, malaise, "tingling all over" and dizzy. At the area of injection, it was swollen and warm. No treatment except Tylenol and rest.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Pt had a headache, low-grade fever of 99.8F, malaise, "tingling all over" and dizzy. At the area of injection, it was swollen and warm. No treatment except Tylenol and rest.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Laboratory test abnormal
Clinical narrative: Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Received varivax at health dept on 10/10/00. Broke out with varicella rash on 7/28/01. Seen in ER and dx'd as varicella (for another reason).
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: Pt had a fever of 100.5F yesterday, post vax. Today it was 101F and left deltoid had a 6cm erythematous, firm nodule at site of Hib and DTAP. Was told to give pt Benadryl, 1 tsp every 6 hours prn and Tylenol, 1 tsp po prn.
Age: 1.7
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt developed swelling of right leg (thigh) area with redness and was also febrile.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Cardiovascular disorder, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 7/31/01, pt had pain in upper right arm, down to fingers of right hand with swelling in upper right arm, down to fingers of right hand. This began, post vax, yesterday. Applied ice the evening of 7/30/01 and had less swelling in arm today (7/31/01) but hot and hand still swollen. Referred to PMD for follow-up today. Pt went to ER on 8/1/01, due to hand swelling and states had loss of use of hand and area of hand with decreased blood flow. Calan 40mg Rx given and referred to surgeon.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Pain, Swelling
Clinical narrative: On 7/31/01, pt had pain in upper right arm, down to fingers of right hand with swelling in upper right arm, down to fingers of right hand. This began, post vax, yesterday. Applied ice the evening of 7/30/01 and had less swelling in arm today (7/31/01) but hot and hand still swollen. Referred to PMD for follow-up today. Pt went to ER on 8/1/01, due to hand swelling and states had loss of use of hand and area of hand with decreased blood flow. Calan 40mg Rx given and referred to surgeon.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site induration, Rash papular
Clinical narrative: 3 papules with indurated base at site of varivax vaccine on left anterior lateral upper thigh.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Pt had swelling of thigh with slight erythematous rash.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Hypercholesterolaemia, Hypertension, Infection, Injection site erythema
Clinical narrative: Cellutlitis - Information has been received from a physician concerning a 79 year old white male patient with hypertension and hypercholesterolemia who on 08 Jun 2000 was vaccinated IM with the one dose pneumococcal vaccine 23 polyvalent in the right deltoid.  On 09-Jun 2000 the patient developed pain redness and swelling at the injection site.  The patient went to a physican's office and was diagnosed with cellulitis.  The patient was treated with cephalexin monohydrate Keflex.  The reporter had a concern about the lot of vaccine administered 633102/1217J.  An additional patient waes 00061283 had a similar experienced following exposure to pneumoccal vaccine 23 polyvalent.  follow up information from the physicain indicated the patient recovered from his experience.  No further information is expected.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Cellutlitis - Information has been received from a physician concerning a 79 year old white male patient with hypertension and hypercholesterolemia who on 08 Jun 2000 was vaccinated IM with the one dose pneumococcal vaccine 23 polyvalent in the right deltoid.  On 09-Jun 2000 the patient developed pain redness and swelling at the injection site.  The patient went to a physican's office and was diagnosed with cellulitis.  The patient was treated with cephalexin monohydrate Keflex.  The reporter had a concern about the lot of vaccine administered 633102/1217J.  An additional patient waes 00061283 had a similar experienced following exposure to pneumoccal vaccine 23 polyvalent.  follow up information from the physicain indicated the patient recovered from his experience.  No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Information has been received from an RN concerning a black female who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced redness and swelling of the injection site with edema to the elbow. In follow-up, the RN indicated that a caregiver reported that the pt who was resident of a "Rest Home" was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 630095/0044J), IM, in the left deltoid, at 14:30 on 10/25/00. On the day of the vaccination at 17:00, the pt was noted to have red blotches over  her body which the pt had scratched. Blotches were flat, maculopapular in appearance. No other sign or symptom with onset was reported. The physician ordered diphenhydramine hydrochloride (Benadryl) 25mg to 50mg po 4 X daily for symptoms. Symptoms resolved within 4 to 5 days without complication. No further information was available.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: After being vaccinated the pt experienced left arm cellulitis and had a fever of 103.2 F for 2 1/2 days post vaccination. The symptoms disappeared after one week.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Pyrexia
Clinical narrative: Information has been received concerning a pt who post vaccination had a fever of 100-101 F. There was a .5 inches of and swelling of right arm at the injection site, tenderness and limited range of motion. The pt went to the emergency room and was given Motrin and Amoxicillin and Augmentin. On 12/11/2000 the pt recovered.
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Pain
Clinical narrative: On an unspecified date, the pt experienced neck pain and shoulder pain. The pt recovered from her experiences after two weeks. The pt did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Shoulder pain
Clinical narrative: On an unspecified date, the pt experienced neck pain and shoulder pain. The pt recovered from her experiences after two weeks. The pt did not seek medical attention. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL, HEPA, VARCEL
Symptoms: Headache, Infection, Insomnia, Pharyngolaryngeal pain, Pruritus
Clinical narrative: The patient complained of a headache 2 days post VZV. The rash started on 07/01/2001. The patient had severe itching and was unable to sleep. The patient had varicella like lesions from the waist down covering her legs and feet and a few on her arms. The patient had no lesions in her mouth, though she did complain of a sore throat. The patient was treated with Zyrtec and advised to use Aveeno bath. The patient reports varicella like lesions continuously since last in on 07/03/2001 with cycles of eruptions, drying and reappearing. The patient's strept throat was treated with Amoxicillin. The patient also has sinusitis, otitis media, and severe itching of leasions covering arms and legs
Age: 38.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL, HEPA, VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: The patient complained of a headache 2 days post VZV. The rash started on 07/01/2001. The patient had severe itching and was unable to sleep. The patient had varicella like lesions from the waist down covering her legs and feet and a few on her arms. The patient had no lesions in her mouth, though she did complain of a sore throat. The patient was treated with Zyrtec and advised to use Aveeno bath. The patient reports varicella like lesions continuously since last in on 07/03/2001 with cycles of eruptions, drying and reappearing. The patient's strept throat was treated with Amoxicillin. The patient also has sinusitis, otitis media, and severe itching of leasions covering arms and legs
Age: 38.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL, HEPA, VARCEL
Symptoms: Headache, Insomnia, Otitis media, Pharyngolaryngeal pain, Pruritus
Clinical narrative: The patient complained of a headache 2 days post VZV. The rash started on 07/01/2001. The patient had severe itching and was unable to sleep. The patient had varicella like lesions from the waist down covering her legs and feet and a few on her arms. The patient had no lesions in her mouth, though she did complain of a sore throat. The patient was treated with Zyrtec and advised to use Aveeno bath. The patient reports varicella like lesions continuously since last in on 07/03/2001 with cycles of eruptions, drying and reappearing. The patient's strept throat was treated with Amoxicillin. The patient also has sinusitis, otitis media, and severe itching of leasions covering arms and legs
Age: 38.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL, HEPA, VARCEL
Symptoms: Rash, Sinusitis, Skin ulcer
Clinical narrative: The patient complained of a headache 2 days post VZV. The rash started on 07/01/2001. The patient had severe itching and was unable to sleep. The patient had varicella like lesions from the waist down covering her legs and feet and a few on her arms. The patient had no lesions in her mouth, though she did complain of a sore throat. The patient was treated with Zyrtec and advised to use Aveeno bath. The patient reports varicella like lesions continuously since last in on 07/03/2001 with cycles of eruptions, drying and reappearing. The patient's strept throat was treated with Amoxicillin. The patient also has sinusitis, otitis media, and severe itching of leasions covering arms and legs
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a woman from a physician's office concerning a pt who on 5/31/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629883/0042J). Subsequently, the pt experienced a temperature of greater that 101F. Unspecified medical attention was sought. Another pt was reported with an adverse event following vaccination with this same vaccine (WAES 00061850). The pt was lost to follow-up. No further information is expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a health care professional concerning a 74 year old female who on 6/13/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. In 6/00, the pt experienced redness and warmth at the injection site. The pt sought unspecified medical treatment. On an unspecified date, the pt recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a woman from a physician's office concerning a pt who on 5/31/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629883/0042J). Subsequently, the pt experienced redness, swell and pain at the injection site. Another pt was reported with an adverse event following receipt of the same vaccine (WAES 00060352). The pt was lost to follow-up. No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: Information has been received from a healthcare facility concerning an unidentified pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced shoulder and elbow pain. The pt sough unspecified medical attention. An additional pt (WAES 00062102) had a similar experience following exposure to this same vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been requested from a healthcare professional concerning a pt who on approx. 6/9/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J). Subsequently, the pt experienced cellulitis at the injection site that extended all the way down the arm. The pt was treated with antibiotics in the ER but not admitted. Another pt (WAES 00062248) had a similar experience. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Malaise, Myalgia
Clinical narrative: Information has been received from a physician concerning a 66 year old white female with a history of a (+) PPD tuberculosis test, a seizure disorder and hyperlipidemia who on 6/14/00 was vaccinated, IM, with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J) in the right deltoid. Subsequently, the pt developed extensive edema and erythema in her right arm, malaise and myalgia. A dx of injection site cellulitis was determined. The pt was treated with rest, analgesics and oral cephalexin (Keflex). On 6/27/00, the pt recovered. It was also noted that another pt (WAES 00071379) experienced a similar reaction after vaccination with this same vaccine. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: Information has been received from a healthcare facility concerning an unidentified pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced shoulder and elbow pain. The pt sought unspecified medical attention. An additional pt (WAES 00061872) had a similar experience following exposure to the same vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a healthcare professional concerning a pt who was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J). Subsequently, the pt experienced cellulitis at the injection site that extended all the way down the arm. The pt was seen in the physician's office for examination and treated with antibiotics. It was noted that the pt was afebrile. Another pt (WAES 00061885) had a similar experience. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a healthcare professional concerning a 69 year old male who in 6/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. It was noted that the pt was schedules for surgery in 6/00 and that routine blood work revealed "anti-D (anti-RBC) antibodies". The pt did receive gamma-globulin. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Around 8 PM post vaccination, the pt developed a large, local, red, warm, area at the injection site which spread from the upper arm to her elbow. The physician also added that the subcutaneous tissue is indurated to a size of 16 cm X 30 cm if spread out and there is no fever or lymphadenitis. The pt sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Nausea, Pruritus
Clinical narrative: The day after vaccination, the pt woke up with a two inch diameter lump in the injection site area. The pt experienced itching and was nauseated the entire day. The nausea resolved by the next evening and the itching continued for the 2 or 3 days post vaccination. The pt is recovered and did not experience any other symptoms or rxn's.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site inflammation, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female patient with no known allergies who on 04/09/00 was vaccinated in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (lot #630097/0045J)/ On 04/24/00, the patient experienced a severe local reaction in the left deltoid region. It was noted that the estimated area was approximately 4-5 cm and warm and firm,but not fluctant. The patient's temperature was 99.5 degrees fahrenheit and she had been taking Tylenol. On an unspecified date,the patient recovered. Two other patients (WAES numbers 00051264 & 00070168) had similar experiences. No furhter information is available.
Age: 0.75
Sex: M
Vaccine: DTP
Symptoms: Anorexia, Apnoea, Circulatory collapse, Crying, Eye movement disorder
Clinical narrative: Information has been received on 7/16/01 from an internet site through a consumer, concerning a 9 month old male who received his 3rd dose of DTP on 8/22/84. He immediately began vomiting. The next day, he stopped eating. He reportedly, stayed alert but was no longer active. That night, he cried out every 15 to 30 minutes. He was seen in the pediatrician's office where the pediatrician immediately noted "obvious circulation collapse". His eyes rolled back in his head an he stopped breathing. He was taken to an ER. Resuscitative efforts failed and he was pronounced dead.
Age: 0.75
Sex: M
Vaccine: DTP
Symptoms: Somnolence, Vomiting
Clinical narrative: Information has been received on 7/16/01 from an internet site through a consumer, concerning a 9 month old male who received his 3rd dose of DTP on 8/22/84. He immediately began vomiting. The next day, he stopped eating. He reportedly, stayed alert but was no longer active. That night, he cried out every 15 to 30 minutes. He was seen in the pediatrician's office where the pediatrician immediately noted "obvious circulation collapse". His eyes rolled back in his head an he stopped breathing. He was taken to an ER. Resuscitative efforts failed and he was pronounced dead.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Urticaria, Wheezing
Clinical narrative: Information has been received from a health professional concerning a pt who was vaccinated with MMRII and subsequently, the pt experienced an anaphylactic reaction. No further information was available. Upon internal review, anaphylactic reaction was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states: Information has been received from a health professional concerning a 5 year old Caucasian male pt who, on 5/1/01, at 13:00, was vaccinated in the right arm with a 2nd dose of MMRII (lot 0168L-invalid lot). The pt returned to the office about 1/2 hour, after the injection, complaining of wheezing and covered with hives, consistent with an anaphylactic reaction. The pt was treated with albuterol nebulizer, antihistamines and epinephrine. It was noted that the pt recovered on 5/1/01. Upon internal review, anaphylactic reaction was considered to be an "Other Important Medical Event". Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Bradycardia, Cellulitis, Coma, Fall, Injection site erythema
Clinical narrative: Information has been received from an RN concerning a 90 year-old male assisted living pt with Alzheimer'd disease, cardiac problems and no known allergies and a history of atrial fibrillation and dementia who on 7/16/01 was vaccinated IM on the right deltoid with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent. On 7/17/01, the pt was found unresponsive and bradycardic on the bathroom floor at the assisted living facility. The pt was transferred to the ER. In the ER, it was noted that the pt's right arm was red, swollen and warm to touch. The pt was treated for cellulitis with IV amoxicillin trihydrate (+) clavulanate potassium (Augmentin). He was admitted to the hospital for his cardiac condition and was discharged from the hospital on 7/23/01 to a nursing home facility. The nurse reported that the pt's unresponsiveness was not related to the pneumococcal vaccine 23 polyvalent, it was related to his cardiac problems. The pt was discharged on PO amoxicillin trihydrate (+) clavulanate potassium (Augmentin) and it was noted that his arm swelling had greatly improved. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was reported that another pt (WAES 01072423) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). FOLLOW-UP information indicated that the pt was hospitalized for five days and subsequently, recovered. Upon internal medical review, the pt's cellulitis was considered to be another important medical event. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an RN concerning a 90 year-old male assisted living pt with Alzheimer'd disease, cardiac problems and no known allergies and a history of atrial fibrillation and dementia who on 7/16/01 was vaccinated IM on the right deltoid with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent. On 7/17/01, the pt was found unresponsive and bradycardic on the bathroom floor at the assisted living facility. The pt was transferred to the ER. In the ER, it was noted that the pt's right arm was red, swollen and warm to touch. The pt was treated for cellulitis with IV amoxicillin trihydrate (+) clavulanate potassium (Augmentin). He was admitted to the hospital for his cardiac condition and was discharged from the hospital on 7/23/01 to a nursing home facility. The nurse reported that the pt's unresponsiveness was not related to the pneumococcal vaccine 23 polyvalent, it was related to his cardiac problems. The pt was discharged on PO amoxicillin trihydrate (+) clavulanate potassium (Augmentin) and it was noted that his arm swelling had greatly improved. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was reported that another pt (WAES 01072423) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). FOLLOW-UP information indicated that the pt was hospitalized for five days and subsequently, recovered. Upon internal medical review, the pt's cellulitis was considered to be another important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Difficulty in walking, Fall, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Information has been received from an MA concerning a 5 year old male who on 7/17/01 was vaccinated with a 1st dose in the left leg of varicella virus vaccine live and a 1st dose, in the left leg, of diphtheria toxoid/pertussis vaccine/tetanus. There were no other concomitant medications. That night, the pt's leg became very swollen and stiff and he was unable to bend it. He went to the ER on 6/18/01 and they did a tap on the knee to make sure that there was no bacteria in the knee. The cultures were reported as negative. It was noted that the pt did not stay overnight at the hospital. The pt was seen in the doctor's office on 7/19/01 and seemed better and on 7/20/01, the day of this report, the pt was seen again in the physician's office. The swelling had gone down slightly, however, it was still swollen and he was still unable to bend his knee. The physician recommended continuing treatment with ibuprofen. The reporter stated that the lower extremity edema and muscular-skeletal stiffness was a reaction to the varicella virus vaccine live and the diphtheria toxoid/pertussis vaccine/tetanus. Follow-up information from a nurse, indicated that the pt reported to his mother that he had fallen on the left leg around the same time as the vaccination. It was reported that the swelling and stiffness were "documented to be probably related to the Varivax administration". The nurse indicated that the office has not heard from the pt's mother and they are "assuming the child is OK". Upon internal review, the pt's experience was considered an "Other Important Medical Event". Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a female assisted living pt over the age of 65 who on 7/16/01 was vaccinated, IM, with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent (lot 637369/1187K). On 7/18/01, the pt was taken to the ER for cellulitis with symptoms of swelling, redness and a warm to touch arm from the site of the injection down to her fingers. She was treated with IV ceftriaxone sodium (Rocephin) and was released back to the assisted living facility, hospital admission was not needed. It was reported that the pt has subsequently recovered. The reporter expressed a concern with the lot. It was reported that another pt (WAES 0107128) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). Upon internal medical review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Headache, Neck pain, Pain, Paraesthesia
Clinical narrative: A 50 year old female student, attending a veterinary school of medicine, who was being treated for pre-exposure prophylaxis, developed diffuse pain on the entire left arm which resulted in a tingling sensation and paresthesia, 24 hours, post vax, of a 2nd pre-exposure dose of RabAvert. Each dose was 1ml and given IM. (Batch 277011). The 1st dose of RabAvert was on 7/3/01 and the 2nd was on 7/10/01. The pt continued to have left shoulder pain, joint pain, finger joint pain, left-sided neck pain, and is tender to touch on the left side of the body. There was no erythema at the injection site. A neurologic work-up was normal and the pt was afebrile. The pt complained of a headache, 3 days, post vax of the 2nd dose. It was reported by the PA, that as of 7/23/01, the condition of the pt was improving. The PA assessed this event as possibly related to the RabAvert injection.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from an MA concerning a 75 year old white male who on 12/5/00 was vaccinated, IM, with pneumococcal vaccine 23 polyvalent (lot 637094/0945K). Subsequently, on 12/6/00, the pt experienced increased swelling and erythema of the upper arm that was considered an "Other Medical Event". Subsequently, the pt recovered "spontaneously". This was the pt's booster dose. The pt had no reaction with previous dose. Unspecified medical attention was sought. No further information is not expected.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 7 year old son who on 10/24/00 was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent. Within 6 hours, post vax, the child's injection site arm swelled from his elbow to his shoulder to 3 times it's normal size. He also developed a fever of 103F. The fever "went down" as of 20:00 on 10/25/00. The child was seen by a physician who put him on a steroid and an antihistamine. It was noted as of 10/26/00, the child still has pain and swelling in his arm. Upon medical review, the pt's experiences were considered to be "Other Medical Events". No further information is available.