chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Abasia, Cognitive disorder, Convulsion, Eye movement disorder, Muscle rigidity
Clinical narrative: This report describes the occurrence of developmental delay in a female child who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk) for prophylaxis. This report was received from the subject's grandmother and has not been verified by a physician or other healthcare professional. The subject's medical history and concurrent conditions were not reported. Reportedly, the subject received no concurrent medications at the time of vaccination. Reportedly, the subject experienced no adverse events following "other" immunizations. The grandmother reported that in March 2000, the subject received her first injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk). The grandmother reported that the child experienced increased tone (rigidity) in May 2000. She stated that the subject "started developing problems within two days after the injection but they didn't know what it was. The child would wake up out of a sound sleep and her arms would go straight above her head and she goes very stiff. her eyes roll back." The grandmother thought the infant was having a bad dream. "She was having them five to seven a day. It wasn't until she was five months old that they were diagnosed as seizures. The child is now on medication for seizures." It was reported that the subject experienced increased tone (rigidity) in May 2000. Reportedly, at an unknown time post-vaccination, the child experienced developmental delay characterized by the inability to walk, talk, and sit on her own; she is currently at the 6 month level of development. The grandmother stated that in April 2002, the child experienced hip displacement. The child was reportedly hospitalized for an unspecified period of time. The grandmother stated that the subject had "undergone numerous tests NOS and no underlying causes can be found for her symptoms." The events were reportedly treated with Trileptal, and baclofen. The events reportedly persisted as of 1/8/03. Additional information was received from the grandmother on 5/20/03. She stated that the subject did not receive any vaccine manufacturered by GSK. The manufacturer of the vaccine administered to the subject was not identified. Since no GSK vaccine was administered, this report has been voided.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Neurodevelopmental disorder
Clinical narrative: This report describes the occurrence of developmental delay in a female child who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk) for prophylaxis. This report was received from the subject's grandmother and has not been verified by a physician or other healthcare professional. The subject's medical history and concurrent conditions were not reported. Reportedly, the subject received no concurrent medications at the time of vaccination. Reportedly, the subject experienced no adverse events following "other" immunizations. The grandmother reported that in March 2000, the subject received her first injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk). The grandmother reported that the child experienced increased tone (rigidity) in May 2000. She stated that the subject "started developing problems within two days after the injection but they didn't know what it was. The child would wake up out of a sound sleep and her arms would go straight above her head and she goes very stiff. her eyes roll back." The grandmother thought the infant was having a bad dream. "She was having them five to seven a day. It wasn't until she was five months old that they were diagnosed as seizures. The child is now on medication for seizures." It was reported that the subject experienced increased tone (rigidity) in May 2000. Reportedly, at an unknown time post-vaccination, the child experienced developmental delay characterized by the inability to walk, talk, and sit on her own; she is currently at the 6 month level of development. The grandmother stated that in April 2002, the child experienced hip displacement. The child was reportedly hospitalized for an unspecified period of time. The grandmother stated that the subject had "undergone numerous tests NOS and no underlying causes can be found for her symptoms." The events were reportedly treated with Trileptal, and baclofen. The events reportedly persisted as of 1/8/03. Additional information was received from the grandmother on 5/20/03. She stated that the subject did not receive any vaccine manufacturered by GSK. The manufacturer of the vaccine administered to the subject was not identified. Since no GSK vaccine was administered, this report has been voided.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Meningitis aseptic
Clinical narrative: A physician described the occurrence of aseptic meningitis in a 29 year old male who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject's medical history and concurrent conditions were unknown. Havrix was the only new medication/vaccine given to the patient recently. Approximately the beginning of January 2003, the subject received an injection of Havrix; it was not known if he had received previous injections of Havrix. Ten days or less post-immunization, the physician made a diagnosis of aseptic meningitis. The subject was hospitalized for an unspecified period of time. As of 1/10/03, the outcome of the event was unknown.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal pain, Nausea, Pharyngolaryngeal pain, Throat tightness, Urticaria
Clinical narrative: The Menomune (meningococcal vaccine) was received on 1/14 afternoon. That evening, nausea and vomited once. next day, she had abdominal cramps. On 1/16 AM, she developed generalized hives; was seen in office at 1:15PM. Also complained of throat getting swollen, sore throat, tightness of throat. Was given SC Epinephrine shot; Benadryl IM; Oral steroid. Sent home on Zyrtec and Prednisone.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Vomiting
Clinical narrative: The Menomune (meningococcal vaccine) was received on 1/14 afternoon. That evening, nausea and vomited once. next day, she had abdominal cramps. On 1/16 AM, she developed generalized hives; was seen in office at 1:15PM. Also complained of throat getting swollen, sore throat, tightness of throat. Was given SC Epinephrine shot; Benadryl IM; Oral steroid. Sent home on Zyrtec and Prednisone.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, White blood cell count increased
Clinical narrative: Redness, swelling of right deltoid (site of shot), starting 5 hours, post vax. Required admission for cellulitis.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Pulmonary congestion, Pyrexia
Clinical narrative: 11/3/02, began to feel ill with fever, severe headache, coughing and chest congestion. 11/10/02, went to ER and got an injectable antibiotic and Legaquin 500mg, po q d.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash appeared on infant's abdomen, upper limbs and face. It was red, light and flat on 11/11/02 at 18:00.
Age: 0.4
Sex: M
Vaccine: IPV, PNC
Symptoms: Vomiting
Clinical narrative: Pt vomited 3 hours after injections and again at 3 1/2 hours.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: 2 days, post vax, noticed large red, hot and swollen area at site with a hardened lump. Not painful. MD recommended hot packs and thought it probably was not an allergic reaction but local reaction that was due to shot being put in posterior/lateral arm versus deltoid.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Went to ER on 1/15/03 with increased erythema and edema. Dx'd with cellulitis. Treated with antibiotic IV and oral antibiotics. F/U in office on 1/16/03 with decreased erythema on left thigh, decreased edema and warmth with scattered vesicles. F/U appt. 1/21/03. Finish Amoxil Rx. DX: Left thigh cellulitis.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Swollen upper right arm with redness, warmth and pruritic.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh red from top of thigh to knee, hot, left leg swollen to just below knee, twice the size of the right leg and skin taut. TX for left cellulitis with Keflex 200mg tid.
Age: 25.0
Sex: F
Vaccine: JEV
Symptoms: Arthralgia, Headache, Swelling, Urticaria
Clinical narrative: Pt presented with hives, urticaria, joint pain, swelling, low-grade fever and headache.
Age: 45.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pruritus, Rash papular
Clinical narrative: Papular rash began on lower legs and extended to upper back and shoulders (bilateral) with itching.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Pain
Clinical narrative: Had pain in arm from shoulder down to elbow.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, TTOX
Symptoms: Injection site pain, Pain
Clinical narrative: Had pain in arm from shoulder down to elbow.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Throat tightness
Clinical narrative: 30 minutes after vaccine was given, pt complained of itching and tightness of the throat.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Asphyxia, Coma
Clinical narrative: Baby was found unresponsive by mom at 8A 1/14/03 (per state police).
Age: 1.3
Sex: M
Vaccine: DT, HIBV, MMR, PNC
Symptoms: Irritability, Pruritus, Pyrexia, Rash, Vomiting
Clinical narrative: Friday 01/10/03 developed rash on torso/no fever. Mother called CDC  with instructions to take to hospital, was seen in ER @ 9:30 p.m. by that time the child was crnaky and itchy. Hospital in contact with CDC with instructions to put on prednisone and benadryl. On Sunday 01/12/03 3 am vomited with fever of 102. Mother gave tylenol on Monday 01/13/03 temp. was 99 and feeling better.
Age: 69.0
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Pain and numbness in finger joints and tips of fingers.
Age: 64.0
Sex: F
Vaccine: LYME
Symptoms: Hypoaesthesia, Pain
Clinical narrative: CONSTANT PAIN AND NUMBNESS IN FINGERTIPS, FINGER JOINTS AND TOES
Age: 14.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Erythema, Eye swelling, Hypersensitivity, Pharyngeal oedema
Clinical narrative: A nurse reported that a 14 year old female patient experienced itching, redness, swelling, difficulty breathing, and throat swelling during treatment with RabAvert therapy. The patient's medical history included allergies to penicillin and bee stings. She began her post-exposure vaccination series of RabAvert 1ml IM on 9/7/01. The patient received her first and second shots without any reported problems. She received her third shot on 9/14/01. On 9/16/01 the patient developed severe itching and redness around the face and neck area as well as some swelling around the eyes. On 9/17/01 the patient was treated with a Medrol Dose Pack and Benadryl cream PRN and the symptoms subsided. On the evening of 9/17/01 the patient was hospitalized for difficulty breathing and throat swelling. She was treated with epinephrine and adrenaline and the symptoms subsided. She was discharged on 9/19/01. The patient was scheduled to receive her fourth dose of RabAvert on 9/21/01, instead she received HDVC (rabies vaccine) on 9/22/01. The patient again experienced throat swelling and difficulty breathing and was treated with epinephrine and adrenaline. As of 9/26/01 the subject had discontinued RabAvert and the symptoms had resolved. The patient is scheduled to visit an allergist and dermatologist. The physician assessed this event as possibly related to RabAvert.
Age: 14.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus
Clinical narrative: A nurse reported that a 14 year old female patient experienced itching, redness, swelling, difficulty breathing, and throat swelling during treatment with RabAvert therapy. The patient's medical history included allergies to penicillin and bee stings. She began her post-exposure vaccination series of RabAvert 1ml IM on 9/7/01. The patient received her first and second shots without any reported problems. She received her third shot on 9/14/01. On 9/16/01 the patient developed severe itching and redness around the face and neck area as well as some swelling around the eyes. On 9/17/01 the patient was treated with a Medrol Dose Pack and Benadryl cream PRN and the symptoms subsided. On the evening of 9/17/01 the patient was hospitalized for difficulty breathing and throat swelling. She was treated with epinephrine and adrenaline and the symptoms subsided. She was discharged on 9/19/01. The patient was scheduled to receive her fourth dose of RabAvert on 9/21/01, instead she received HDVC (rabies vaccine) on 9/22/01. The patient again experienced throat swelling and difficulty breathing and was treated with epinephrine and adrenaline. As of 9/26/01 the subject had discontinued RabAvert and the symptoms had resolved. The patient is scheduled to visit an allergist and dermatologist. The physician assessed this event as possibly related to RabAvert.
Age: 13.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anorexia, Gait disturbance, Hypoaesthesia, Vomiting
Clinical narrative: From correspondence received from Bayer Corp (200110163BBE) it was reported: "This report describes a 13 y.o. female treated with BAYRAB [RABIES IMMUNE GLOBULIN (HUMAN)] for rabies post exposure prophylaxis at a dose of 20 iu daily on 8/15/01. PT also received IMOVAX (rabies vaccine) for the indication rabies post exposure prophylaxis on 8/15/01. Relevant history includes reflex sympathetic dystrophy (RSD). "PT received BayRab and Imovax on 8/15/01 at 1 p.m. At 3:30 p.m., the PT experienced difficulty walking. She then fell asleep for 2 hours. At 6 p.m., PT experienced numbness in legs, could not stand or maneuver and vomiting. Stop date of the events were on 8/15/01. The PT is due for a 2nd vaccine shot 3 days later." "For the suspect drug BAYRAB [RABIES IMMUNE GLOBULIN (HUMAN)] (rabies immune globulin, human), difficulty walking, numbness in legs, could not stand or maneuver and vomiting was considered to have a possible relation to the drug. Rechallenge is unknown. Dechallenge is unknown. Outcome of events: improved." From add'l correspondence received on 12/3/01, it was reported at 8:30 p.m. on 8/15/01 the PT needed wheel chair, assistance walking. Seen by physician, recovered at this time. At 11:00 p.m. the PT was able to walk and had good color. The next day the PT slept all day, but couldn't eat, was force-fed. The day after the PT again experienced difficulty walking. The hospital did not provide the vaccine lot # info. The PT reportedly recovered from this experience. From add'l correspondence received at Aventis Pasteur, Inc. on 2/27/02 the lot # for the Rabies Imovax produce was provided (lot #R0885-2). No further info. is anticipated for this report. This case is closed.
Age: 13.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Gait disturbance, Hyperkinesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: From correspondence received from Bayer Corp (200110163BBE) it was reported: "This report describes a 13 y.o. female treated with BAYRAB [RABIES IMMUNE GLOBULIN (HUMAN)] for rabies post exposure prophylaxis at a dose of 20 iu daily on 8/15/01. PT also received IMOVAX (rabies vaccine) for the indication rabies post exposure prophylaxis on 8/15/01. Relevant history includes reflex sympathetic dystrophy (RSD). "PT received BayRab and Imovax on 8/15/01 at 1 p.m. At 3:30 p.m., the PT experienced difficulty walking. She then fell asleep for 2 hours. At 6 p.m., PT experienced numbness in legs, could not stand or maneuver and vomiting. Stop date of the events were on 8/15/01. The PT is due for a 2nd vaccine shot 3 days later." "For the suspect drug BAYRAB [RABIES IMMUNE GLOBULIN (HUMAN)] (rabies immune globulin, human), difficulty walking, numbness in legs, could not stand or maneuver and vomiting was considered to have a possible relation to the drug. Rechallenge is unknown. Dechallenge is unknown. Outcome of events: improved." From add'l correspondence received on 12/3/01, it was reported at 8:30 p.m. on 8/15/01 the PT needed wheel chair, assistance walking. Seen by physician, recovered at this time. At 11:00 p.m. the PT was able to walk and had good color. The next day the PT slept all day, but couldn't eat, was force-fed. The day after the PT again experienced difficulty walking. The hospital did not provide the vaccine lot # info. The PT reportedly recovered from this experience. From add'l correspondence received at Aventis Pasteur, Inc. on 2/27/02 the lot # for the Rabies Imovax produce was provided (lot #R0885-2). No further info. is anticipated for this report. This case is closed.
Age: 13.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anorexia, Gait disturbance, Hypoaesthesia, Vomiting
Clinical narrative: From telephone conversation with reporting pharmacist it was reported that a 13 y.o. female PT received Imovax Rabies (lot #R0885-2) administered on 8/15/01. Reportedly the PT developed a local reaction, it was also reported that the PT's legs felt like "jello" and she experienced numbness from waist to hips. From telephone contact w/PT's father it was reported that the PT received the Imovax Rabies as well as Bayer RIG at the emergency room of a hospital at 1 p.m. At approximately 3:30 p.m. the PT experienced trouble walking, by 6 p.m. PT experienced numbness and couldn't walk. PT was carried to camp's infirmary; PT also experienced nausea and vomiting. PT was taken back to emergency room, by 11 p.m. these symptoms resolved, treatment of Tylenol was recommended.
Age: 13.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Gait disturbance, Hyperkinesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: From telephone conversation with reporting pharmacist it was reported that a 13 y.o. female PT received Imovax Rabies (lot #R0885-2) administered on 8/15/01. Reportedly the PT developed a local reaction, it was also reported that the PT's legs felt like "jello" and she experienced numbness from waist to hips. From telephone contact w/PT's father it was reported that the PT received the Imovax Rabies as well as Bayer RIG at the emergency room of a hospital at 1 p.m. At approximately 3:30 p.m. the PT experienced trouble walking, by 6 p.m. PT experienced numbness and couldn't walk. PT was carried to camp's infirmary; PT also experienced nausea and vomiting. PT was taken back to emergency room, by 11 p.m. these symptoms resolved, treatment of Tylenol was recommended.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Fatigue, Headache, Influenza, Musculoskeletal discomfort
Clinical narrative: It was reported that a 15 y.o. female PT received a Rabies Imovax IM series starting in July 00. Reportedly after the 2nd dose on day 3, the PT developed systemic immune-complex like side effect such as headache, nausea, flu-like symptoms with joint discomfort in back and shoulders. It is now 6 months since the series and she still has nausea and fatigue and problems with her back and joints. This event was classified as medically significant by AVP US on 4/25/01. From follow-up #1 mailed correspondence received on 7/2/01 additional PT, vaccine and vaccine administrator info. was provided.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Nausea
Clinical narrative: It was reported that a 15 y.o. female PT received a Rabies Imovax IM series starting in July 00. Reportedly after the 2nd dose on day 3, the PT developed systemic immune-complex like side effect such as headache, nausea, flu-like symptoms with joint discomfort in back and shoulders. It is now 6 months since the series and she still has nausea and fatigue and problems with her back and joints. This event was classified as medically significant by AVP US on 4/25/01. From follow-up #1 mailed correspondence received on 7/2/01 additional PT, vaccine and vaccine administrator info. was provided.
Age: 10.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Hypokinesia, Paraesthesia
Clinical narrative: From telephone contact with reporter it was stated that a 10 y.o. female PT received third dose of an Imovax Rabies vaccination intramuscularly on 3/22/01. W/in hours of the injection, the PT developed 1 hour of numbness in her legs. Was unable to walk. This was accompanied with a headache. Further info. is requested. From mailed correspondence received on 6/21/01, it was reported, "no further info. available except no numbness after 5/29/01 or 6/12/01 vaccines." The PT reportedly recovered from this experience.
Sex: F
Vaccine: RAB
Symptoms: Dysgeusia, Myalgia, Nausea
Clinical narrative: From telephone contact with reporting nurse stated that a female PT received an Imovax Rabies vaccination on 6/8/01 and 6/15/01. Shortly after each vaccination the PT experienced metallic bitter taste in her mouth, muscle aches and nausea. These symptoms are unresolved.
Age: 20.0
Sex: F
Vaccine: HEPA, RAB, TYP
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: From telephone contact with PT's mother it was stated that a 20 y.o. female PT received Imovax Rabies, a Typhim VI and a Hep A (mnft'r not specified) vaccination on 7/26/01. Reportedly w/in 24 hrs the PT developed a headache, chills, fever of 104F and muscle aches.
Sex: F
Vaccine: RAB
Symptoms: Headache, Malaise, Muscle twitching, Paraesthesia, Pharyngitis
Clinical narrative: From telephone contact w/PT it was stated that she received a Rabies Imovax vaccination on 6/30/01. Reportedly she developed a headache, general malaise, muscle tics, sore throat, numbness and tingling after receiving the first 2 doses of a post exposure series in the emergency dept. PT was not informed which vaccine was administered. She indicated aside from the rig, the vaccine received was clear and the 3rd one was pink. Indicated her symptoms intensified after receiving the 3rd dose in the series. PT was evaluated by the emergency dept physician and family physician.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Rash pruritic
Clinical narrative: From faxed correspondence received from vaccine provider it was stated that a 27 y.o. female PT received an Imovax Rabies vaccination on 7/6/01. Reportedly the next evening the PT developed an itchy red rash "like small hives" over arms and anterior trunk. PT denies systemic manifestations, feels generally well. She reportedly recovered from this experience. From add'l correspondence received on 9/6/01, it was reported, "Reviewed, no add'l info. at this time - 8/31/01" This case is closed.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Anxiety
Clinical narrative: From telephone contact on 8/7/01 it was reported that a 36 y.o. male PT went thru the Rabies Pre-Exposure series of 3 doses. He was fine after the first dose on day zero. After the 2nd dose, day 7, he noticed a change in himself in that he began to excessively worry about his job. After the last dose, his wife noticed a change in him and the anxiety attacks began. PT was placed on Lorazepam, which seems to be helping. From add'l correspondence received on 9/13/01, the PT's history, other medications and the responsible facility info. was provided. This case is closed.
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: It was reported by telephone that a 13 y.o. male PT received Imovax IM lot R0885-2 administered in the deltoid on 8/15/01. PT also received Bayrab-Rabies Immune Globulin lot #618W02A in left gluteal. PT experienced numbness and tingling from the waist to hip and down the left leg on the left side.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: It was reported by phone that a 46 y.o. female PT received Imovax IM lot #R0789-2, expiry 9/2/02, administered in the left deltoid as the 4th dose in a Rabies Post Exposure series. Administration date 8/4/01. PT developed reaction on 8/5/01. Left arm was red and swollen 3x3 cm area. Benadryl was administered w/success. Antibiotics started, 6 hrs later left arm again presented with redness & swelling, again Benadryl alleviated.
Age: 8.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: It was reported by phone on 8/20/01 that an 8 y.o. female PT received an Imovax rabies vaccine (lot # not reported) and Rabies Immune Globulin [Imogam] (lot # not reported) on 8/17/01. PT experienced headache, nausea, malaise and low-grade fever, which started 24 hrs, post vaccination and continued for 48 hrs. PT treated symptomatically w/Tylenol. From add'l correspondence received on 9/18/01 it was reported that the PT also experienced dizziness. The symptoms resolved and the PT recovered. Add'l PT, vaccine and responsible physician info. was provided. This case is closed.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: From phone conversation w/reporting pharmacist it was stated that a 46 y.o. female PT received an Imovax Rabies Vaccination (dose #4) on 8/3/01. Reportedly on 8/4/01 the PT developed a local reaction near the inject site of her left arm. The area became red and swollen and measured approximately 3cm x 3cm. The PT returned to the care center on 8/4/01 and on 8/5/01 for evaluation. The reaction has resolved and PT has had her 5th dose of Imovax Rabies w/out incident.
Sex: M
Vaccine: RAB
Symptoms: Myasthenic syndrome, Salivary hypersecretion
Clinical narrative: It was reported that an adult male PT received a post exposure Rabies Imovax IM after exposure in mid-June 01. PT experienced weakness in his legs and excess salivation started approximately 1 month ago (Sept. 01).
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: It was reported by the PT that she was just exposed and had the 2 Imovax Rabies IM vaccinations administered Day 0 on 11/30/01 and again on Day 3 [12/03/01]. 5 days later [12/8/01] she developed hives on her face, then w/in 8 hrs all over her body. Physician treated her w/Zyrtec and Hydroxine. They are not working well.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Somnolence
Clinical narrative: From telephone contact received at manufacturer, on 2/15/02, it was reported that a 22 y.o. female PT received an Imovax Rabies vaccine lot #T0863-2 on 2/8/02. The PT reported to physician on 2/15/02 that she was very tired all the time and was falling asleep in class and sleeping long hrs at night. From add'l correspondence received from physician on 2/19/02 it was reported that the PT has mono and is the reason has her tiredness.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Arthritis, Dermatitis bullous, Influenza, Pain
Clinical narrative: From telephone contact on 3/6/02 at a manufacturer, it was reported that a 41 y.o. female PT received Rabies Post Exposure back in October 2001. A few days after her 4th dose she developed achy flu-like symptoms which lasted about 2 weeks. She never completed the series. At 3 mts she was diagnosed w/arthritis and in her words: bubbles or blisters behind her knees that the doctor told her was the onset of arthritis. She wanted to know how long this pain from the vaccine will last. She did not want to do this report. She said her doctor put her on anti-inflammatory drug called Feldine and also pain medication which she did not know the name of. Her back, arms, knees and shoulders are involved but not her hands.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Tremor
Clinical narrative: From fax correspondence received at a manufacturer, it was reported that 3 county employees had reactions to the Imovax vaccine. All 3 women are improving as of 2/7/02. B) 1 had chills, shaking same day as vaccine. Remained tremulous thru 2/1/02.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain
Clinical narrative: From telephone contact received at a manufacturer on 4/3/02, it was reported that a 40 y.o. female received Rabies Imovax series for post exposure prophylaxis. After 3rd and 4th dose of rabies Imovax series, PT reported sharp abdominal pains w/a burning sensation lasting 2 days after each dose. 3rd dose received on 3/22/02 and 4th dose received on 3/29/02. Signs and symptoms started w/in 24 hrs of receipt of dose. No other signs and symptoms noted.
Age: 3.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Hyperhidrosis, Injection site oedema, Injection site pain, Nausea
Clinical narrative: From phone contact received at a manufacturer on 4/22/02, it was reported that a 3 y.o. male began post exposure treatment on 4/12/02. PT's mother reported that PT received RIG and Imovax given in gluteal region. Approximately 3 hrs after doses received, PT was nauseated, began vomiting which persisted for 2 hrs. Inject site was very swollen and sore (not sure if RIG or vaccine). PT was cold and sweaty. PT received 2nd dose treatment on 4/18/02. Inject site (gluteal) was sore. He also experienced cold sweats and pale for approximately 2 hrs later, and continues throughout the day. Another report needed for PT's sister who also has had local irritation, redness, warmth, and swelling at inject site (gluteal). PT's mother called in report. This case is linked w/U2002-00336.
Age: 3.0
Sex: M
Vaccine: RAB
Symptoms: Pallor, Vomiting
Clinical narrative: From phone contact received at a manufacturer on 4/22/02, it was reported that a 3 y.o. male began post exposure treatment on 4/12/02. PT's mother reported that PT received RIG and Imovax given in gluteal region. Approximately 3 hrs after doses received, PT was nauseated, began vomiting which persisted for 2 hrs. Inject site was very swollen and sore (not sure if RIG or vaccine). PT was cold and sweaty. PT received 2nd dose treatment on 4/18/02. Inject site (gluteal) was sore. He also experienced cold sweats and pale for approximately 2 hrs later, and continues throughout the day. Another report needed for PT's sister who also has had local irritation, redness, warmth, and swelling at inject site (gluteal). PT's mother called in report. This case is linked w/U2002-00336.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal discomfort, Headache, Nuchal rigidity, Paraesthesia
Clinical narrative: From phone contact received at a manufacturer on 4/25/02, it was reported that a 29 y.o. female received Imovax IM - 2nd dose for pre-exposure series administered on 4/11/02. PT developed tingling and numbness in right arm where vaccination given. Also experienced neck problems on left side, headache and abdominal discomfort w/in 24 hrs.
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Vasodilation procedure
Clinical narrative: From telephone contact received at a manufacturer on 4/22/02, it was reported that a female received Imovax vaccine in the gluteal area. Date of vaccination unknown. PT experienced local irritation, redness, warmth and swelling at inject site (gluteal). PT's mother called in report. This case is linked w/U2002-00292.
Age: 62.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Chills, Dizziness, Myalgia, Pain
Clinical narrative: From telephone correspondence received at a manufacturer on 5/10/02, it was reported that a 62 y.o. male received Imovax and Imogam on 4/11/02 after a bat exposure. After the first dose, PT's left hand pinky and index fingers felt sore and this soreness persisted through entire series and is still present. No problems after 2nd dose. 3rd dose Imovax given on 4/18/02. 3 hours later, PT felt tired, slight photophobia and slight dizziness. PT experienced muscle pain in both arms after received fourth dose on 4/25/02. PT received 5th dose on 5/9/02. Approximately 3 hrs later, PT developed significant aching in hips and both arms, fingers hurt when extended, also experienced shaking, chills and some photophobia. No fever present. On 5/10/02, PT continues to experience significant body aches in arms, hips and elbows, other symptoms no longer present. PT is a veterinarian. The lot #'s of the first 4 doses are not available at this time.
Age: 62.0
Sex: M
Vaccine: RAB
Symptoms: Photophobia, Tremor
Clinical narrative: From telephone correspondence received at a manufacturer on 5/10/02, it was reported that a 62 y.o. male received Imovax and Imogam on 4/11/02 after a bat exposure. After the first dose, PT's left hand pinky and index fingers felt sore and this soreness persisted through entire series and is still present. No problems after 2nd dose. 3rd dose Imovax given on 4/18/02. 3 hours later, PT felt tired, slight photophobia and slight dizziness. PT experienced muscle pain in both arms after received fourth dose on 4/25/02. PT received 5th dose on 5/9/02. Approximately 3 hrs later, PT developed significant aching in hips and both arms, fingers hurt when extended, also experienced shaking, chills and some photophobia. No fever present. On 5/10/02, PT continues to experience significant body aches in arms, hips and elbows, other symptoms no longer present. PT is a veterinarian. The lot #'s of the first 4 doses are not available at this time.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Arthritis
Clinical narrative: From mailed correspondence received at a manufacturer on 4/11/02, it was reported that a 41 y.o. female donor who was involved with the rabies program at a medical facility. This donor received 4 out of the 5 scheduled rabies shots during enrollment in the rabies program in October 01. She was dropped from the program when she failed to show up for the scheduled 5th immunization. In March 02, she was presented as a normal source plasma donor, and was deferred at the time due to arthritis medications she was taking. On 3/5/02, she was questioning if the Imovax Rabies vaccine that was received in October 01 has precipitated this arthritis episode.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Rash erythematous, Rash follicular
Clinical narrative: Fine, discrete, erythematous, follicular pustules scattered over back and chest.
Age: 26.0
Sex: M
Vaccine: FLU3, TYP, YF
Symptoms: Overdose
Clinical narrative: Pt. died 2 days after receiving vaccines. Autopsy resutls pending. Specimens to be sent to CDC for testing. Autopsy report received on 2/12/2003 indicates overdose.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash erythematous, Skin ulcer
Clinical narrative: Discrete, Agminated, blanchable, slightly raised 3-5mm erythematous, slightly raised papules, some with pale haloes. Lesions were located on extensor knees, elbows, dorsal hands, and ventral wrists. slight associated pruritus.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Rash erythematous, Rash follicular, Rash macular, Tenderness
Clinical narrative: Discrete follicular erythematous macules and small pustules scattered over chest and back. Associated with mild lymphadenopathy and skin tenderness.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Infection, Injection site hypersensitivity, Pain, Pyrexia
Clinical narrative: Day 3: slight swelling at site,red and itchy, low grade fever and diarrhea. Day 4,5,6,7,8: increased swelling and redness at site,hot to touch, persistant low grade fever and diarrhea. Day 9:Severe swelling at site, hot to touch,severe pain in arm and lymph nodes of underarm and left side of neck, fever of 101.4,pt sent to ER and diagnosed with skin infection,sent home with rx for Keflex 500mg
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: 1/2 hour after receiving Td shot, patient did not feel good, and the room was swimming.  The next day, she could not move her arm. On 8/21/02 it was red, hot and swollen.  The patient developed chills and a fever of 102 F.  She took Tylenol.  The following day, her fever was 101.4 and she had body  Follow up information received 08/30/2002. Pt complained of a fever of 100.2 degrees F and continued to complain of a sore arm, muscle aches and joint aches. Pt went to the doctor on 08/29/2002. Pt had a normal white blood count, but it was left shifted, meaning infection. Pt refused contact with PMD. Follow up information received 09/04/2002, pt said she is terrible and that she continues to have a low grade fever and seizure muscle weakness. She stated the weakness is generalized, involving her legs and neck, and that she is fatigued. She stated that her sore arm went away in 2 days, but that the generalized aches and fatigue and low grade fever had continued. She said that last week at her doctor's, she had normal blood workk and chemistrics, but her poly were high on her white blood count. The pt stated that she is very sensitive to things and she developed an allergy to penicillin, she has to take Benadryl before getting a manicure or hair perm, she has a severe allergy to morphine. Was asked what her doctor thought of her symptoms, and what he recommended. the pt said her doctor told her to stay indoors and drink fluids and that this is probably related to vaccine. She again mentioned that she did not want to involve her own doctor with this report. She asked for our medical directors phone number in case she needed to call to report more.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity, Hypokinesia, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: 1/2 hour after receiving Td shot, patient did not feel good, and the room was swimming.  The next day, she could not move her arm. On 8/21/02 it was red, hot and swollen.  The patient developed chills and a fever of 102 F.  She took Tylenol.  The following day, her fever was 101.4 and she had body  Follow up information received 08/30/2002. Pt complained of a fever of 100.2 degrees F and continued to complain of a sore arm, muscle aches and joint aches. Pt went to the doctor on 08/29/2002. Pt had a normal white blood count, but it was left shifted, meaning infection. Pt refused contact with PMD. Follow up information received 09/04/2002, pt said she is terrible and that she continues to have a low grade fever and seizure muscle weakness. She stated the weakness is generalized, involving her legs and neck, and that she is fatigued. She stated that her sore arm went away in 2 days, but that the generalized aches and fatigue and low grade fever had continued. She said that last week at her doctor's, she had normal blood workk and chemistrics, but her poly were high on her white blood count. The pt stated that she is very sensitive to things and she developed an allergy to penicillin, she has to take Benadryl before getting a manicure or hair perm, she has a severe allergy to morphine. Was asked what her doctor thought of her symptoms, and what he recommended. the pt said her doctor told her to stay indoors and drink fluids and that this is probably related to vaccine. She again mentioned that she did not want to involve her own doctor with this report. She asked for our medical directors phone number in case she needed to call to report more.
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: A legal complaint was received from an attorney concerning a male child who received injections of ORIMUNE, DTP/ACTHIB, MMR II, Recombivax HB, Varivax, polio virus, DTaP, and DTP/HIB vaccines as well as tine/PPD from October 1995 through September 1999. The legal complaint states that the child was poisoned by the cumulative doses of mercury in the thimerosal and suffers from the toxic neurological effects of mercury poisoning. Mercury poisoning was considered medically important. No further information was available at the date of this report.
Age: 0.2
Sex: F
Vaccine: DTPHIB, MMR, OPV
Symptoms: Autism
Clinical narrative: A father reported that his daughter, now 11 years of age, received series of Orimune, Hib-Titer, Tetramune, DTP/DTaP, and MMR II vaccines from May 1991 through 9/21/95. On an unspecified date in 1995, the child was diagnosed with autism. The father stated that he thinks there may be a potential link between her autism and administration of vaccines. Autism was considered medically important (OMIC). This report was received from manufacturer.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Bacterial infection, Cerebral infarction, Convulsion, Drug ineffective, Hemiparesis
Clinical narrative: A pediatrician reported via a company representative that an 11 month old male received his third dose of Prevnar along with HIbTITER and Tripedia vaccines on 7/12/02 at 6 months of age. On 12/23/02, the infant developed lethargy and a fever of 104.3 degrees F. On 12/27/02, he was seen by a physician. On examination, his temperature was 101.7 degrees F. He was hospitalized. Laboratory tests results were as follows: CSF WBC 187; CSF and blood cultures positive for pneumococcus (serotype 6B isolated); IgG, IgM, IgA, and CH50 normal; HIV negative. Pneumococcal antibodies by ELISA were as follows: serotype 4, 0.38 mcg/mL; serotype 6B, 0.25 mcg/mL; serotype 9V, 0.56 mcg/mL; serotype 14, 1.36 mcg/mL; serotype 18C, 0.28 mcg/mL; serotype 19F, 1.13 mcg/mL; serotype 23F, 0.14 mcg/mL; interpretation: non-responder. The infant was treated with IV vancomycin and cefotaxime. Vancomycin was discontinued following receipt of sensitivity results (sensitivity to penicillin). Subsequently, the infant developed seizures. An MRI was performed and showed an infarct. Weakness in the left arm was noted, and the infant was not walking or sitting up normally. On 1/9/03, he was transferred to another hospital facility. No further information was available at the date of this report. ON 1/22/03, he was discharged. The physician indicated that the child recovered and noted that the child was crawling and "cruising" but not walking; some weakness in his left upper extremity persisted.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Lethargy, Pyrexia
Clinical narrative: A pediatrician reported via a company representative that an 11 month old male received his third dose of Prevnar along with HIbTITER and Tripedia vaccines on 7/12/02 at 6 months of age. On 12/23/02, the infant developed lethargy and a fever of 104.3 degrees F. On 12/27/02, he was seen by a physician. On examination, his temperature was 101.7 degrees F. He was hospitalized. Laboratory tests results were as follows: CSF WBC 187; CSF and blood cultures positive for pneumococcus (serotype 6B isolated); IgG, IgM, IgA, and CH50 normal; HIV negative. Pneumococcal antibodies by ELISA were as follows: serotype 4, 0.38 mcg/mL; serotype 6B, 0.25 mcg/mL; serotype 9V, 0.56 mcg/mL; serotype 14, 1.36 mcg/mL; serotype 18C, 0.28 mcg/mL; serotype 19F, 1.13 mcg/mL; serotype 23F, 0.14 mcg/mL; interpretation: non-responder. The infant was treated with IV vancomycin and cefotaxime. Vancomycin was discontinued following receipt of sensitivity results (sensitivity to penicillin). Subsequently, the infant developed seizures. An MRI was performed and showed an infarct. Weakness in the left arm was noted, and the infant was not walking or sitting up normally. On 1/9/03, he was transferred to another hospital facility. No further information was available at the date of this report. ON 1/22/03, he was discharged. The physician indicated that the child recovered and noted that the child was crawling and "cruising" but not walking; some weakness in his left upper extremity persisted.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Multiple sclerosis, Vision blurred
Clinical narrative: Information has been received from a 42 year old female consumer. In Nov-2001, she received a dose of Flu-shield (2001-2002 formula). Six weeks post-vaccination, she developed blurry vision. In Jun-2002, at 43 years of age, she was diagnosed with multiple sclerosis. She indicated that she has received injections of influenza vaccine in 1999 and 2000 without problems. No further info was available at the date of this report. These events were considered medically important (OMIC).
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Pain, Swelling
Clinical narrative: Night received vaccine, arm swollen size of tennis ball. Within 48 hours, shortness of breath, aching, became worse. Client asthmatic, so used Advair Inhaler. Saw allergist 12/30/02; said bronchial tubes still swollen.
Age: 21.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Circulatory collapse, Diplopia, Fatigue, Headache
Clinical narrative: Severe headaches, back tightness and pain, tingling, pneumonia, tired, swollen glands, double vision, paralysis, mono. 11/19/01 flu shot. 12/17/01 collapsed. 12/18/01-12/12/24/01 critical care. 12/25/01-1/3/02 intermediate care. 1/4/02-1/17/02 rehab. hospital out patient. 1/18/02-3/18/02 rehab. Thorocic nerve continues to heal.
Age: 21.0
Sex: M
Vaccine: FLUX
Symptoms: Lymphadenopathy, Musculoskeletal discomfort, Paraesthesia, Paralysis, Pneumonia
Clinical narrative: Severe headaches, back tightness and pain, tingling, pneumonia, tired, swollen glands, double vision, paralysis, mono. 11/19/01 flu shot. 12/17/01 collapsed. 12/18/01-12/12/24/01 critical care. 12/25/01-1/3/02 intermediate care. 1/4/02-1/17/02 rehab. hospital out patient. 1/18/02-3/18/02 rehab. Thorocic nerve continues to heal.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Coordination abnormal, Dysarthria, Injection site inflammation, Laboratory test abnormal
Clinical narrative: Ataxia and dysarthria with brain stem and cerebellar inflammation. No other etiology found with exam. Annual follow up on 02/09/04: "Pt did not recover from adverse events.  Improved, remains ataxic with dysarthria.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea and vomiting, muscle ache, headache and general malaise. Off work X 1 day, 1/17/03. Signs and symptoms less today.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain
Clinical narrative: Lower back pain and groin area, Wednesday 1/7/03, 20:30-03:00.
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Dizziness, Vomiting
Clinical narrative: Pt became shaky, lightheaded and vomited X 1. Reports chills. No chest pain or arm pain. Remained alert but shaking chills continued X 10 minutes. 911 called and was transported to ED.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Right deltoid area with a rash, papules, erythema on area of vaccine administration, with pruritus, 3 days after vaccine administered. Physical exam compatible with delayed type hypersensitivity.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: 2 days after Anthrax, the pt developed torso rash which lasted 1 day. No blisters and completely resolved. No fever at that time.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Left upper arm swollen with redness. Hot to touch. Two days lapse from initial shot. Sent to ER given Keflex 500 QID. Recheck in two days. Dx: cellulitis.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Redness and swollen right upper arm. Tender to touch. Two days lapse from initial shot sent to ER and given Keflex 500mg QID. Dx: cellulitis.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 43 y/o female with localized reaction to anthrax vaccination, approximately 5 1/2 inch area of erythema (+) increase warmth. No other symptoms.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling/redness at injection site.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pain and decreased mobility that is continuing.
Age: 30.0
Sex: F
Vaccine: FLU3, MMR, TD
Symptoms: Contusion, Injection site oedema, Pyrexia
Clinical narrative: 1/10/03 elevated temp 102.4 and headache, left deltoid swollen and purple. 1/11/03 still elevated temp 103.5 came down with Tylenol and Motrin. 1/12/03 temp normal and arm normal by pm.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: Received flu vaccine Oct-2002 L DIM-client states in two days that pain and couldn't lift his arm.