chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Erythema, Eyelid oedema, Hyperventilation, Injection site erythema, Lymphadenopathy
Clinical narrative: The pt experienced respiratory distress, nasal flaring, O2 sat at 94%, erythema at the injection site and abdomen, erythema and swelling of bilateral eyelids and neck. Respiratory rate is 60 with inspiratory and expiratory wheezing.
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Respiratory distress, Wheezing
Clinical narrative: The pt experienced respiratory distress, nasal flaring, O2 sat at 94%, erythema at the injection site and abdomen, erythema and swelling of bilateral eyelids and neck. Respiratory rate is 60 with inspiratory and expiratory wheezing.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: 5 days post vax the pt experienced arthralgias, myalgia's, fatigue, low grade fever persistent for 1 week. Symptoms resolved completely.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The pt experienced an upper left arm with redness and swelling from shoulder to elbow and under arm to axilla. Treated with Benadryl.
Age: 33.0
Sex: F
Vaccine: MMR, TD, MMR, TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The pt complained of pain and itching at the injection site on the left deltoid. The site was red and warm circle around injection site that was 20mm in width. No complaint of fever, chills and no drainage at site.
Age: 33.0
Sex: F
Vaccine: MMR, TD, MMR, TD
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: The pt complained of pain and itching at the injection site on the left deltoid. The site was red and warm circle around injection site that was 20mm in width. No complaint of fever, chills and no drainage at site.
Age: 31.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: The pt experienced a localized reaction at the left deltoid injection site with warmth to the touch, painful movement and localized deltoid swelling. Worsens each day. Has not tried anti-inflammatory or other over the counter medications or used heat/cold.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngitis, Pruritus, Pyrexia, Rash erythematous, Rhinitis
Clinical narrative: Following vaccination, the pt began to have cold symptoms on 4/20, 4/21. Then on 4/27/01 the pt began to have a rash and fever. Fever was present on 4/28 as well. On 5/1/01 was present with generalized red slight raised rash. The rash is itchy. Treated with Benadryl and Caladryl. BP was 124/80, T - 99.2, P-80, R-16.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Cold sweat, Convulsion, Eye movement disorder, Heart rate decreased, Hyperhidrosis
Clinical narrative: Within 1 minutes the pt exhibited a generalized seizure, eyes rolled back, BP 70/38 and pulse faint. The pt was cool and clammy with mild diaphoresis, and paleness. Seizure lasted 30-45 seconds, Pt was responsive. 911 and the parent called. The pt was taken to the ER.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Hypotension, Pallor
Clinical narrative: Within 1 minutes the pt exhibited a generalized seizure, eyes rolled back, BP 70/38 and pulse faint. The pt was cool and clammy with mild diaphoresis, and paleness. Seizure lasted 30-45 seconds, Pt was responsive. 911 and the parent called. The pt was taken to the ER.
Age: 21.0
Sex: M
Vaccine: MEN
Symptoms: Chills, Fall, Loss of consciousness, Rash, Tremor
Clinical narrative: Subsequent to receiving vax, the pt developed chills, shaking and a rash on his abdomen. The pt fell to the floor but there was no loss of consciousness. The pt was evaluated by a physician in the ER and treated with Benadryl and Epinephrine. The pt was discharged from the ER with oral Benadryl. Additional information reports that the pt recovered from this experience. No additional information was provided at the time of this report.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: It was reported that a 20 year old female received a Menomune A/C/Y/W-135 vaccination on 2/25/00 at 15:05. Reportedly, on 2/25/00 at 15:35, the pt developed itching around the injection site and a scattered rash on left arm, chest (shaped lake a butterfly), right post neck and back. The pt was seen by her family physician and was given Vistaril on 2/28/00. The pt reportedly, recovered from this experience.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Vasculitis
Clinical narrative: It was reported that a 19 year old male received a Menomune A/C/Y/W-135 vaccination on 12/28/99. Reportedly, on 1/11/00, the pt experienced persistent vasculitis. Pt was evaluated by a dermatologist.
Age: 18.0
Sex: M
Vaccine: HEP, MEN
Symptoms: Injury, Loss of consciousness
Clinical narrative: It was reported that an 18 year old male pt received a Menomune A/C/Y/W-135 vaccination on 8/17/00. Reportedly, post vax, the pt fell and hit his head in the reception area, resulting in a laceration requiring 6 stitches. Further information requested. From additional correspondence received on 10/30/00, it was reported that the pt recovered from this experience without side effect. No further information is expected, this case is closed.
Age: 25.0
Sex: M
Vaccine: MEN, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: It was reported that a 25 year old male received a Menomune A/C/Y/W-135 and a Pnu-Imune 23 (Lederle) vaccination on 3/21/00. Reportedly, on 3/22/00, the pt complained of erythema of the left deltoid and a 103F temperature. It was reported that the pt recovered.
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 11/3/00. Reportedly, 3 hours, post vax, the pt developed a red itchy rash over chest and upper back. No respiratory distress. Further information requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Apnoea, Coma, Epistaxis, Pulse absent
Clinical narrative: The pt was taken to health services on 4/26/01 at 8:00 am. The pt was unresponsive, not breathing, blood at nose. ACL protocol started immediately. No rhythm or pulse. Code stopped. Autopsy report states cause of death: changes suggestive of vaccine related death, however, rollover cannot be excluded and would have to be excluded by scene investigation; findings are not consistent with SIDS.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: Within 24 hours of Prevnar vaccine, this infant got a fever of 102 - 103 F, and hives all over her body.
Age: 0.4
Sex: F
Vaccine: HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash
Clinical narrative: a mother states her child got her shots on 04/06/01, Hep B #2, Hib #2, IPV #2, and Prevnar #2. At approximately 2 - 3 PM the infant had an elevated fever of 103, relieved with Tylenol and lasted 3 days, appetite decrease, and diarrhea and rash generalized all over her body on 04/07/01. reported here today for care.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: This infant received shots on 04/12/01. She had a fever of 102.7 2 - 3 days fluctuating degrees, with Tylenol. A rash was noted (hives) "all over her entire body". She received children's Benadryl on 04/14/10 through 04/15/01. The hives started  to disappear on Sunday and the hives were completely gone by Monday 04/16/01. The infant is to see a doctor today in the AM on 04/19/01. No problems noted instructed per doctor to inform us of a reaction. The mother  was instructed to have doctor write orders for DT next time.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Pyrexia, Rash
Clinical narrative: This infant received vaccines (listed below) on 04/18/01. Later that evening, he had a fever of 104 and possibly higher. He was taken to the ER after 12 midnight. The mother also noted " bumps on his chest". He was treated with Motrin and Tylenol in the ER and discharged at 4 AM. No explanation. On 4/23/01 the mom states the following day she noticed the infant making "jerking" movements. Denies fever or rash at this time. She states the jerking has continued since then. Instructed at this time to notify the child's pediatrician, explain to nursing personnel and ask for an appointment today. Will follow up in the AM. On 04/24/01, spoke with the mother today, she states the child saw a doctor on 04/23/01. She states that the baby is "fine". No problems noted on examination. The doctor stated some jerking movements are common after going to sleep. None noted excessively.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Erythema, Influenza like illness, Joint swelling
Clinical narrative: The pt is an orthopedic surgeon. He was reportedly "healthy". "Tests performed before and during the study showed no signs that the participants had Lyme disease." The pt received 2 doses of Lymerix on unspecified dates. Within 24 hours of the 2nd injection, he developed "severe swelling, redness and pain in his fingers". He also developed "acute disabling small and large joint symmetrical synovitis". A dx of "arthritis in his hands" was made. He also experienced flu-like symptoms, achiness, swelling in his toes, myalgia, and "severe pain in his shoulders." He was treated with "moderate doses of NSAIDS (NOS)" and recovered without sequelae, within 4 or 5 days. The guest physician stated, "And we have no reason to believe that it was anything but the vaccine involved in the development of the arthritis." He further stated, "We believe that the immune response to OspA is resulting in an auto reactive response."
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Synovitis
Clinical narrative: The pt is an orthopedic surgeon. He was reportedly "healthy". "Tests performed before and during the study showed no signs that the participants had Lyme disease." The pt received 2 doses of Lymerix on unspecified dates. Within 24 hours of the 2nd injection, he developed "severe swelling, redness and pain in his fingers". He also developed "acute disabling small and large joint symmetrical synovitis". A dx of "arthritis in his hands" was made. He also experienced flu-like symptoms, achiness, swelling in his toes, myalgia, and "severe pain in his shoulders." He was treated with "moderate doses of NSAIDS (NOS)" and recovered without sequelae, within 4 or 5 days. The guest physician stated, "And we have no reason to believe that it was anything but the vaccine involved in the development of the arthritis." He further stated, "We believe that the immune response to OspA is resulting in an auto reactive response."
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Erythema, Joint swelling, Pain
Clinical narrative: The pt is a Pulmonologist. He was reportedly "healthy". "Test performed before and during the study showed no signs that the participants hand Lyme disease". The pt received 2 doses of Lymerix on unspecified dates. Within 24 hours of 2nd dose, he developed "severe swelling, redness and pain in his fingers". He also developed "acute disabling small and large joint symmetrical synovitis". A dx of "arthritis in his hands" was made. He also experienced "pain throughout his body" and myalgia. He was unable to work for 3 days. He was treated with "moderate doses of NSAIDS (NOS)". However, the abstract indicated that he recovered without sequelae within 4 or 5 days. The guest physician stated, "And we have no reason to believe that it was anything but the vaccine involved in the development of the arthritis." He further stated, "We believe that the immune response to OspA is resulting in an auto reactive response." F/U acute symetrical polyarthritis, additional information was provided by the primary author. The pt rec'd his 1st SC injection of LYMerix (lot LY120B9)on 9/2/99, no adverse experiences occurred following this injection. He rec'd his 2nd SC injection of LYMErix (lot LY123B9) on 10/1/99, he experienced pain throughout his body. Two days post vaccine on 10/2/99 he developed severe swelling. A dx of acute symmetrical polyarthritis was made. The primary author reported that the polyarthritis resolved after 5 days. Acute symmetrical polyarthritis does not meet icm serious criteria.
Age: 43.0
Sex: M
Vaccine: LYME
Symptoms: Polyarthritis, Synovitis
Clinical narrative: The pt is a Pulmonologist. He was reportedly "healthy". "Test performed before and during the study showed no signs that the participants hand Lyme disease". The pt received 2 doses of Lymerix on unspecified dates. Within 24 hours of 2nd dose, he developed "severe swelling, redness and pain in his fingers". He also developed "acute disabling small and large joint symmetrical synovitis". A dx of "arthritis in his hands" was made. He also experienced "pain throughout his body" and myalgia. He was unable to work for 3 days. He was treated with "moderate doses of NSAIDS (NOS)". However, the abstract indicated that he recovered without sequelae within 4 or 5 days. The guest physician stated, "And we have no reason to believe that it was anything but the vaccine involved in the development of the arthritis." He further stated, "We believe that the immune response to OspA is resulting in an auto reactive response." F/U acute symetrical polyarthritis, additional information was provided by the primary author. The pt rec'd his 1st SC injection of LYMerix (lot LY120B9)on 9/2/99, no adverse experiences occurred following this injection. He rec'd his 2nd SC injection of LYMErix (lot LY123B9) on 10/1/99, he experienced pain throughout his body. Two days post vaccine on 10/2/99 he developed severe swelling. A dx of acute symmetrical polyarthritis was made. The primary author reported that the polyarthritis resolved after 5 days. Acute symmetrical polyarthritis does not meet icm serious criteria.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Pruritus
Clinical narrative: This patient's mother stated her child started breaking out with chicken pox on 04/28/01. He had six in total pox, itchy. PPD is all that was listed.
Age: 38.0
Sex: F
Vaccine: TTOX
Symptoms: Swelling
Clinical narrative: This patient had swelling.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This patient had a rash.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Infection
Clinical narrative: This child had Varicella in mouth and on body. No vaccine listed . States vaccine was given at another facility.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: This patient received Varivax 10/21/97; he has recently been around a cousin with clinical varicella, a sibling (also previously vaccinated) developed varicella 2 weeks ago and today this patient has clinical symptoms of varicella.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Anorexia, Blood chloride decreased, Blood sodium decreased, Fatigue, Headache
Clinical narrative: Had TD after having laceration sutured on 4/8/01 in ER. Had anorexia, fatigue, felt feverish the next day. Two days later, had a fever of 104.3F. Continued to have fevers especially in the evenings, headache, myalgia, anorexia and 15 lb weight loss for 2 1/2 weeks. No specific symptom of viral syndrome. Recovering
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Injury, Myalgia, Pyrexia, Red blood cell sedimentation rate increased, Weight decreased
Clinical narrative: Had TD after having laceration sutured on 4/8/01 in ER. Had anorexia, fatigue, felt feverish the next day. Two days later, had a fever of 104.3F. Continued to have fevers especially in the evenings, headache, myalgia, anorexia and 15 lb weight loss for 2 1/2 weeks. No specific symptom of viral syndrome. Recovering
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: States see attached sheet, but "attached sheet" not available.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Brain oedema, Cerebral atrophy, Cerebral haemorrhage, Dysphagia, Irritability
Clinical narrative: Child seen on 2/28/01 for well child 2 month exam. Received DTAP, HIB, Prevnar and HEP-B. Child seen on 4/12/01 for "fussy and stiff with decreased smile X 2 weeks". Child hospitalized. (+) RSV (bronchiolitis) on 2/16/01, treated with Augmentin. After exam, it was revealed spasticity and abnormal eye movements. She was seen by neurosurgery, neurology, development and genetics. The present concensus is that pt may have a metabolic disease. Parents state child is waking up more at night and screaming. Child was put on apnea monitor for swallowing disorder. Shows signs of cerebral palsy/eye movement disorder. Has persistent URI. He was also found to have bilateral otitis media and treated with Amoxil. Annual report dated 05/02/2003: Diag death 2 hours to genetic mitochondrial Dz. Date of death: 10/03/2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Musculoskeletal stiffness, Nervous system disorder, Otitis media, Sleep disorder, Staring
Clinical narrative: Child seen on 2/28/01 for well child 2 month exam. Received DTAP, HIB, Prevnar and HEP-B. Child seen on 4/12/01 for "fussy and stiff with decreased smile X 2 weeks". Child hospitalized. (+) RSV (bronchiolitis) on 2/16/01, treated with Augmentin. After exam, it was revealed spasticity and abnormal eye movements. She was seen by neurosurgery, neurology, development and genetics. The present concensus is that pt may have a metabolic disease. Parents state child is waking up more at night and screaming. Child was put on apnea monitor for swallowing disorder. Shows signs of cerebral palsy/eye movement disorder. Has persistent URI. He was also found to have bilateral otitis media and treated with Amoxil. Annual report dated 05/02/2003: Diag death 2 hours to genetic mitochondrial Dz. Date of death: 10/03/2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Upper respiratory tract infection
Clinical narrative: Child seen on 2/28/01 for well child 2 month exam. Received DTAP, HIB, Prevnar and HEP-B. Child seen on 4/12/01 for "fussy and stiff with decreased smile X 2 weeks". Child hospitalized. (+) RSV (bronchiolitis) on 2/16/01, treated with Augmentin. After exam, it was revealed spasticity and abnormal eye movements. She was seen by neurosurgery, neurology, development and genetics. The present concensus is that pt may have a metabolic disease. Parents state child is waking up more at night and screaming. Child was put on apnea monitor for swallowing disorder. Shows signs of cerebral palsy/eye movement disorder. Has persistent URI. He was also found to have bilateral otitis media and treated with Amoxil. Annual report dated 05/02/2003: Diag death 2 hours to genetic mitochondrial Dz. Date of death: 10/03/2001.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red, warm, tender and swollen. Pt was fatigued. Symptoms started 24 hours, post vax and resolved with Zyrtec 10mg, once a day.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA, TD, TYP, YF
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Had immunizations on 1/2/01 and noticed swelling of lymph nodes under left arm on 1/4/01 and tenderness under left arm although enlarged nodes were not painful. States no increase in lump or other symptoms. Referred to MD.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4cm reddened area with swelling on left leg.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Coordination abnormal
Clinical narrative: Ataxia
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling, pain and redness.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Diarrhoea, Hypersensitivity, Urticaria
Clinical narrative: Child was at school. Mother reports child broke out in hives especially on trunk and also had hives in groin areas and a few on arms and face. He had diarrhea several times. Mother took child to doctor and he gave him a steroid shot and sent him home on Benadryl and prednisone. Reports improved within 15 minutes after injection. Pt had a reaction at his Hep-B #2. He is to receive no more Hep-B vaccinations per his PMD.
Age: 59.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Dyspnoea, Injection site erythema, Rash macular
Clinical narrative: Pt called on 4/20/01 at 10:30 and stated her right arm was red and blotched and complaining of mild difficulty breathing. She was told to see MD. She stated she was going to MD and was to call clinic with results. Also, given another telephone # to call. Tried to call pt on 10/23/01 and only answering machine picked up, so left a message for her to call clinic.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: The pt experienced a red, edematous, macular rash at the injection site. (left proximal thigh) with pain and mile warmth with palpation.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash macular
Clinical narrative: The pt experienced a red, edematous, macular rash at the injection site. (left proximal thigh) with pain and mile warmth with palpation.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Subsequent to receiving vax the pt developed muscle aches, joint pain and fatigue. Additional information received reports that the pt recovered from this experience on 12/20/1999.
Age: 56.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema
Clinical narrative: Subsequent to receiving vax, the pt complained of redness from injection site to elbow.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema
Clinical narrative: Subsequent to receiving vax, the pt developed a mild local reaction which consisted of localized erythema.
Age: 21.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Nausea, Night sweats
Clinical narrative: It was reported that a 21 year old female pt received a Menomune A/C/Y/W-135 and a Fluzone SV '99-'00 vaccination on 11/11/99. Reportedly, on 11/12/99, the pt complained of night sweats, dizziness and nausea that lasted 1 day. The pt reportedly, recovered from this experience.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: It was reported that a 20 year old female pt received a Menomune A/C/Y/W-135 vaccination on 11/30/99. Reportedly, the pt was running a fever initially after the vaccination. Approx. 1 week, post vax, on 12/6/99, the pt developed a hard-reddened area of her left upper arm about the size of an orange. Reportedly, the pt recovered from this experience.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site swelling, Malaise, Nausea, Paraesthesia
Clinical narrative: It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 10/3/99. Reportedly, 4 hours, post vax, the pt developed vertigo, nausea, tingling in her arm, malaise, fever and her arm became swollen with a red rash. The pt was given Benadryl and Tylenol as treatment. The pt reportedly, recovered from the experience. *F/UP report on 3/4/03: From correspondence received at manufactorer on 2/22/00, add'l PT history info was provided. F/UP #1 (6/19/02): During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event Coding (Added Fever and Paresthesia).
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Pyrexia, Rash, Vertigo
Clinical narrative: It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 10/3/99. Reportedly, 4 hours, post vax, the pt developed vertigo, nausea, tingling in her arm, malaise, fever and her arm became swollen with a red rash. The pt was given Benadryl and Tylenol as treatment. The pt reportedly, recovered from the experience. *F/UP report on 3/4/03: From correspondence received at manufactorer on 2/22/00, add'l PT history info was provided. F/UP #1 (6/19/02): During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event Coding (Added Fever and Paresthesia).
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Pyrexia
Clinical narrative: It was reported that a 19 year old male received a Menomune A/C/y/W-135 vaccination on 1/25/00. Reportedly, on 1/27/00, the pt developed a headache and a fever. The pt took Tylenol and was effective. The pt was not evaluated by a physician. From additional correspondence, it was reported that the pt was evaluated by a nurse practitioner. "No other symptoms consistent with 'flu', i.e.: 'aches', sore throat, cough, etc."
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Bradycardia, Hypoventilation, Syncope vasovagal
Clinical narrative: It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 2/8/00. Reportedly, the pt experienced a vasovagal reaction, post vax. BP-120/60, P-52, R-16. Resolution of symptoms after elevation of legs, ammonia ampule inhalant and ingestion of orange juice. The pt completely recovered from this experience.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: It was reported that a 20 year old female received a MENOMUNE  vaccination on 2/15/00. Reportedly, post vax, the pt developed erythema, urticaria and itching. Pt denies dyspnea. Treatment of 50mg BENADRYL was given at 13:15. The pt reportedly, recovered from this experience.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Blood pressure increased, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 02/10/00 at 14:30 and felt fine and left the office. The pt returned at 18:00, complaining of general weakness, nausea, chest tightness, hives and itching. The pt did not experience shortness of breath, BP-left 140/84-100-20; right 150/84-100-20. Treatment of Benadryl 50mg per oral was given. At 18:30, the pt's BP was left 140/84-100-20, right 150/84-100-20. The pt reportedly recovered from this experience. From correspondence received, it was reported that the pt did not experience chest tightness, hives and itching as previously reported, however, did experience diaphoresis.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Hypotension, Nausea, Pallor
Clinical narrative: It was reported that a 19 year old female pt received a Menomune A/C/Y/W-135 vaccination on 2/7/00 at 12:05. The pt did not eat since early in the morning. Approx. 12:20, the pt became pale, weak and nauseated, BP 60/42. The pt's feet were elevated and she was given juice and crackers. After a half an hour of rest, the pt's BP was 94/62. The pt reportedly, recovered from this experience. *F/UP report on 3/4/03: F/UP #1: During internal auditing of all files, it was necessary to amend the report by updating the adverse event coding (added pallor & hypotension).
Age: 25.0
Sex: M
Vaccine: MEN
Symptoms: Blood pressure increased, Dizziness, Fall, Heart rate increased, Loss of consciousness
Clinical narrative: It was reported that a 25 year old male pt received a Menomune A/C/Y/W-135 vaccination on 2/7/00 at 12:00. Reportedly, at 12:10, the pt stated he felt lightheaded, fell forward and the left side of his face hit the floor. The pt experienced a brief loss of consciousness, ammonia inhalant was effective. The pt lost a left upper tooth, had an abrasion and swelling of left cheek, abrasion of chin on left side and a small amount of blood in mouth. The pt had no recall of passing out. The pt was awake, alert, oriented, BP 162/84-164-20, rechecked 10 minutes later and BP 156/86-150-20. "I feel okay", pt sitting in chair, was given juice and remained oriented. The pt was instructed to see family doctor. Reportedly, the pt recovered from this experience. On 5/17/00, an error was amended in the actual onset time of the adverse event. The correct time was 12:10, not 12:02, as previously reported.
Age: 25.0
Sex: M
Vaccine: MEN
Symptoms: Mouth haemorrhage, Tooth disorder
Clinical narrative: It was reported that a 25 year old male pt received a Menomune A/C/Y/W-135 vaccination on 2/7/00 at 12:00. Reportedly, at 12:10, the pt stated he felt lightheaded, fell forward and the left side of his face hit the floor. The pt experienced a brief loss of consciousness, ammonia inhalant was effective. The pt lost a left upper tooth, had an abrasion and swelling of left cheek, abrasion of chin on left side and a small amount of blood in mouth. The pt had no recall of passing out. The pt was awake, alert, oriented, BP 162/84-164-20, rechecked 10 minutes later and BP 156/86-150-20. "I feel okay", pt sitting in chair, was given juice and remained oriented. The pt was instructed to see family doctor. Reportedly, the pt recovered from this experience. On 5/17/00, an error was amended in the actual onset time of the adverse event. The correct time was 12:10, not 12:02, as previously reported.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: It was reported that a pt received a Menomune A/C/Y/W-135 vaccination and sometime, post vax, the pt developed a headache, fever and possible viral symptoms. Additional information is being requested. From correspondence received, it was reported on 3/25/00, the pt developed a fever (100F-101F), chills and pain in the head. Pt went to the ER at 19:30. A fever of 99F persisted until 3/29/00. The pt reportedly, recovered from this experience. Doctor dx'd idiosyncratic reaction to vaccine or an "exagena normal response" and nothing to be concerned about.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Condition aggravated, Cyst, Dementia, Headache
Clinical narrative: It was reported that an 18 year old male pt was dx'd with an Asymptomatic Arachnoid Cyst, 6 years ago, discovered by chance after an accident. This cyst was smaller at the time and did not need any intervention. Reportedly, the pt received a Menomune A/C/Y/W-135 vaccination on 1/21/00 and several weeks later, the pt developed severe headaches, rating a 10 on a scale of 1 to 10. Neurologist saw pt and had a MRI done which showed the Arachnoid Cyst was enlarged. Vioxx and Biofeedback was tried, which seemed to help slightly but headaches have continued. A Neurosurgeon has suggested possible surgery. From correspondence *received at manufacturer on 5/1/00,* it was reported that the pt continues to be treated with a non-steroidal anti-inflammatory. As of 4/12/00, the pt's headaches have subsided. He is scheduled for a return visit in 6/00 to the Neurologist. *F/UP report on 3/4/03: Amendments in the narrative and add'l PT and responsible MD info was also provided. (also added adverse event coding Aggravation Rx).*
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Stridor
Clinical narrative: It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 3/31/00. Reportedly, sometime after the vaccination, the pt developed stridor. Additional information is being requested. It was reported that the pt recovered from this experience.
Age: 20.0
Sex: F
Vaccine: IPV, MEN, TYP
Symptoms: Eye swelling, Ocular hyperaemia, Pruritus
Clinical narrative: It was reported that a 20 year old female received a Menomune A/C/Y/W-135, a Typhim VI and an IPOL vaccination on 4/19/00. Reportedly, about 4-5 hours, post vax, the pt developed red, swollen and itchy eyes. This resolved fully with antihistamine. No further information is anticipated for this report. The case is closed.
Sex: F
Vaccine: MEN
Symptoms: Condition aggravated, Convulsion
Clinical narrative: It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 4/20/00. Reportedly, on 4/24/00, the pt experienced a seizure. The pt is a known epileptic on Lamictal. Further information requested.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Injection site reaction, Malaise, Mononucleosis syndrome, Pyrexia
Clinical narrative: It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 6/12/00. Reportedly, on 6/13/00, the pt developed a headache, fever, general malaise and a mild local reaction. Recovery status unknown. Further information requested. From additional correspondence received on 7/12/00, it was reported that on 6/15/00, the pt was dx'd with mono. Reportedly, the pt recovered from this experience. No further information is expected, case is closed.
Sex: U
Vaccine: FLUX, MEN, TD
Symptoms: Arthritis
Clinical narrative: It was reported that a pt (1 of 2) received a Menomune A/C/Y/W-135, a TD adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of 6/8/00 and 6/10/00 (exact date not specified). Reportedly, sometime after the vaccinations, the pt developed reactive arthritis. Further information requested. On 9/6/00, additional correspondence was received from the responsible physician, no additional information was provided.
Sex: U
Vaccine: FLUX, MEN, TD
Symptoms: Arthritis
Clinical narrative: It was reported that a pt (2 of 2) received a Menomune A/C/Y/W-135, a TD Adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of 6/8/00 and 6/10/00 (exact date not specified). Reportedly, sometime post vax, the pt developed reactive arthritis. Further information requested. On 9/6/00, additional correspondence was received from the responsible physician, no additional information was provided.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Dizziness, Pyrexia
Clinical narrative: It was reported that an 18 year old male pt received a Menomune A/C/Y/W-135 vaccination and a PPD-Tubersol skin test on 6/27/00. Reportedly, on 6/28/00, the pt developed a temperature of 100F and dizziness. A physician did not evaluate the pt. Further information requested. From correspondence received on 8/8/00, it was reported that the pt recovered from this experience. No further information is expected, this case is closed.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Dyskinesia, Eye movement disorder, Fatigue, Hearing impaired, Movement disorder
Clinical narrative: It was reported that a female patient received a Menomune A/C/Y/W-135 vaccination on 07/07/00 at 2:00 PM. Reportedly 30 hours after the injection the patient became severely nauseated, pale and developed shaking and jerking of her arms and legs, eyes were open but rolling, no loss of bladder or colon. When the patient came to she could see but not hear, could sit up but couldn't move legs. The patient experienced muscle fatigue for the rest of the day. Patient recovered from this experience and was okay the following day. From additional correspondence received on 10/10/00, the county were the vaccine was administered was provided. No further info is expected, this case is closed. *F/UP report 3/4/03: ....It was deemed necessary to amend the report by updating the adverse event coding - added Pallor, Nystagmus, Paralysis.*
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Nausea, Nystagmus, Pallor, Paralysis, Tremor
Clinical narrative: It was reported that a female patient received a Menomune A/C/Y/W-135 vaccination on 07/07/00 at 2:00 PM. Reportedly 30 hours after the injection the patient became severely nauseated, pale and developed shaking and jerking of her arms and legs, eyes were open but rolling, no loss of bladder or colon. When the patient came to she could see but not hear, could sit up but couldn't move legs. The patient experienced muscle fatigue for the rest of the day. Patient recovered from this experience and was okay the following day. From additional correspondence received on 10/10/00, the county were the vaccine was administered was provided. No further info is expected, this case is closed. *F/UP report 3/4/03: ....It was deemed necessary to amend the report by updating the adverse event coding - added Pallor, Nystagmus, Paralysis.*
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Abscess
Clinical narrative: It was reported that an 18 year old male pt received a Menomune A/C/Y/W-135 vaccination on 6/2/00. Reportedly, on 6/13/00, the pt developed a possible sterile abscess, no specifics provided. Further information requested.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Nausea, Pain, Pharyngolaryngeal pain, Pyrexia, Viral infection
Clinical narrative: It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 7/29/00. Reportedly, on 8/1/00, the pt developed a sore throat, a temperature of 101F, nausea and general aches. The pt was evaluated by a physician and was dx'd with a viral illness and her symptoms per the Adverse Event report, were not related to the vaccine. From additional correspondence received on 10/4/00, it was reported, "As per our telephone conversation of 9/26/00, this form was never started. Once this individual had gone to her physician, it was determined that she had a viral infection, which had nothing to do with the vaccine. Upon talking with our director and pharmacist in charge, it was determined that this was not an event to be reported." This case is closed. *F/UP report on 3/4/03: Viral infection added as adverse event coding*
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 8/1/00. Reportedly, within 24 hours, the pt developed a fever of 102F, headaches and neck pain. Further information requested. *F/UP report on 3/4/03: It was reported per the PT that the Sx's resolved after 1-2 days and the PT recovered. This case is closed.*
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Headache, Myalgia, Vomiting
Clinical narrative: It was reported that a female pt (twin A) received a MENOMUNE vaccination on 8/30/00. Reportedly, sometime after the vaccination, the pt developed vomiting, headache, dizziness and muscle aches for 3 days. Further information requested. F/UP report on 3/4/03: From add'l info received on 1/22/01, add'l responsible MD, PT and Lab info were provided. Reportedly, there were no other medications, illnesses at time of vax or pre-existing conditions. No further info was provided. This case is closed.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Headache, Myalgia, Vomiting
Clinical narrative: It was reported that a female pt (twin b) received a MENOMUNE A/C/Y/W-135 vaccination on 8/30/00. Reportedly, sometime after the vaccination, the pt developed vomiting, headache, dizziness and muscle aches for 3 days. Further information requested. F/UP report on 3/4/03: From follow-up info received on 1/22/01, add'l PT, vax administrator, responsible MD, lab data, PT illness at time & medical history were provided. There were reportedly no other PT medications. There were no adverse events reported for previous vax's. This case is closed.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Migraine
Clinical narrative: It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 5/26/00. Reportedly, the pt developed migraine headaches, 1 week, post vax. From additional information received on 1-DEC-2000, additional information for the Reporter, Vaccine Administrator and Responsible Physician were received. The patient's recovery status was reported as unknown.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 9/29/00. Reportedly, on 9/30/00, the pt complained of severe headache, a temperature of 102F, nausea and vomiting and malaise. Further information requested.
Age: 0.2
Sex: F
Vaccine: DTP, HEP, HIBV, OPV
Symptoms: Ecchymosis, Haemolytic anaemia, Infection, Platelet disorder, Pyrexia
Clinical narrative: It was reported that a female infant received vaccines on 7/25/96. Reportedly, on 7/25/96, the pt developed a high fever, bruised thighs and high pitched crying. The reporter states her daughter has had reoccurring infection and fever ever since. Child received total of 4 doses of DTP. Last dose was administered in 11/97. Pt's mother refused the 5th dose and any and all vaccinations since. In 6/98, the child presented with signs and symptoms of leukemia, which has been ruled out. The child has been dx'd with hemolytic anemia; splenomegaly and platelet disorder, which she feels, based on her research, is the result of receiving DTP vaccine. The pt is currently under the care of MD. From follow-up telephone conversation with the physician, the correct pt's name was provided. It was reported that the pt was born in May 1996. Since the pt has an autoimmune disease requiring weekly lab work a faxed request was sent to the physician's office asking for specific lab info.
Age: 0.2
Sex: F
Vaccine: DTP, HEP, HIBV, OPV
Symptoms: Screaming, Splenomegaly
Clinical narrative: It was reported that a female infant received vaccines on 7/25/96. Reportedly, on 7/25/96, the pt developed a high fever, bruised thighs and high pitched crying. The reporter states her daughter has had reoccurring infection and fever ever since. Child received total of 4 doses of DTP. Last dose was administered in 11/97. Pt's mother refused the 5th dose and any and all vaccinations since. In 6/98, the child presented with signs and symptoms of leukemia, which has been ruled out. The child has been dx'd with hemolytic anemia; splenomegaly and platelet disorder, which she feels, based on her research, is the result of receiving DTP vaccine. The pt is currently under the care of MD. From follow-up telephone conversation with the physician, the correct pt's name was provided. It was reported that the pt was born in May 1996. Since the pt has an autoimmune disease requiring weekly lab work a faxed request was sent to the physician's office asking for specific lab info.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTP, IPV, PNC
Symptoms: Cold sweat, Depressed level of consciousness, Hypotension, Pallor, Respiratory depression
Clinical narrative: A pediatric pt exhibited hypertonic hyper-responsive spell and went limp for 20 minutes without seizures and became unresponsive. The pt was admitted to the hospital for observation and recovered without treatment. F/U per physician there was no history of seizures, febrile or otherwise, no family history of seizures,no other disorders. The pt was not on any medication before the vaccines.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTP, IPV, PNC
Symptoms: Stupor
Clinical narrative: A pediatric pt exhibited hypertonic hyper-responsive spell and went limp for 20 minutes without seizures and became unresponsive. The pt was admitted to the hospital for observation and recovered without treatment. F/U per physician there was no history of seizures, febrile or otherwise, no family history of seizures,no other disorders. The pt was not on any medication before the vaccines.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTP, IPV, PNC
Symptoms: Coma, Hypertonia, Hypotonia
Clinical narrative: A pediatric pt exhibited hypertonic hyper-responsive spell and went limp for 20 minutes without seizures and became unresponsive. The pt was admitted to the hospital for observation and recovered without treatment. F/U per physician there was no history of seizures, febrile or otherwise, no family history of seizures,no other disorders. The pt was not on any medication before the vaccines.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Rash
Clinical narrative: Went to ER for assessment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: Went to ER for assessment.
Age: 1.08
Sex: M
Vaccine: IPV, MMR, PNC, IPV, MMR, PNC
Symptoms: Irritability, Pyrexia, Rash morbilliform
Clinical narrative: The mother states "on 04/13/01, this patient was very cranky and wanted to be held most of the day. He had a fever, mom did not take his temp with the thermometer, she stated he felt very warm. Gave him Tylenol every 4 - 6 hours. On 04/14/01, he woke up with a pink rash on his face, arms, chest, back, and legs. No fever on 04/14/01. The patient was even "acting better". The rash lasted 4-5 days. Did not take the child to the doctor because the father in law visited and said "he had the measles, he knew the rash because he had the measles as an adult".
Age: 1.08
Sex: M
Vaccine: IPV, MMR, PNC, IPV, MMR, PNC
Symptoms: Feeling hot, Irritability, Pyrexia, Rash, Rash morbilliform
Clinical narrative: The mother states "on 04/13/01, this patient was very cranky and wanted to be held most of the day. He had a fever, mom did not take his temp with the thermometer, she stated he felt very warm. Gave him Tylenol every 4 - 6 hours. On 04/14/01, he woke up with a pink rash on his face, arms, chest, back, and legs. No fever on 04/14/01. The patient was even "acting better". The rash lasted 4-5 days. Did not take the child to the doctor because the father in law visited and said "he had the measles, he knew the rash because he had the measles as an adult".
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Cardiac arrest, Cerebral haemorrhage, Cough, Dehydration, Dyspnoea
Clinical narrative: Heavy breathing and pulling at ears the night before carrying her to the ER, some cough. In the ED, T to 40.2 on the evening of 04/27/01. Normally uses 0.5 L prn O2 at home, in ED pulse ox 94% on R.A. coffee ground material from G-tube. Initially hemoccult neg, but later when rechecked was hemoccult positive. Initially tachycardia, became SVT after albuterol, developed diminished respiratory effort, cardiac arrest and death at 9:10 PM. Autopsy report states cause of death as medical complications of prematurity: dehydration, bronchopulmonary dysplasia and edema, s/p Nissen fundoplasty for esophageal reflux, gliosis and extensive neuronal necrosis of the brain (brain atrophy) , small subdural hemorrhage (manner of death - natural). Cause of death-medical complications of prematurity.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Ear disorder, Gastrointestinal haemorrhage, Gastrooesophageal reflux disease, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Heavy breathing and pulling at ears the night before carrying her to the ER, some cough. In the ED, T to 40.2 on the evening of 04/27/01. Normally uses 0.5 L prn O2 at home, in ED pulse ox 94% on R.A. coffee ground material from G-tube. Initially hemoccult neg, but later when rechecked was hemoccult positive. Initially tachycardia, became SVT after albuterol, developed diminished respiratory effort, cardiac arrest and death at 9:10 PM. Autopsy report states cause of death as medical complications of prematurity: dehydration, bronchopulmonary dysplasia and edema, s/p Nissen fundoplasty for esophageal reflux, gliosis and extensive neuronal necrosis of the brain (brain atrophy) , small subdural hemorrhage (manner of death - natural). Cause of death-medical complications of prematurity.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Hypoxia, Laboratory test abnormal, Necrosis, Nervous system disorder, Pulmonary oedema
Clinical narrative: Heavy breathing and pulling at ears the night before carrying her to the ER, some cough. In the ED, T to 40.2 on the evening of 04/27/01. Normally uses 0.5 L prn O2 at home, in ED pulse ox 94% on R.A. coffee ground material from G-tube. Initially hemoccult neg, but later when rechecked was hemoccult positive. Initially tachycardia, became SVT after albuterol, developed diminished respiratory effort, cardiac arrest and death at 9:10 PM. Autopsy report states cause of death as medical complications of prematurity: dehydration, bronchopulmonary dysplasia and edema, s/p Nissen fundoplasty for esophageal reflux, gliosis and extensive neuronal necrosis of the brain (brain atrophy) , small subdural hemorrhage (manner of death - natural). Cause of death-medical complications of prematurity.