chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Thyroiditis, Tinnitus, Tremor, Weight increased
Clinical narrative: Received Anthrax vacination and shortly developed symptoms of fatigue, joint pain, sleep disorder, eye cosmetic changes, vision & hearing loss, tinnitis, carpal tunnel, dry/course skin, loss of concentration, vasomotor rhinitis, weight gain, and essential tremor.  Symptoms developed slowly after the course of 8 vaccines and 8 years.  Was diagnosed with Hashimoto's Disease and Hypothyroidism.  Have no family disposition to explain symptoms or onset other than vaccinations. Additonal coStart Codes added on 06/13/2005 from Medical Record: cough, hyperholesteremia, dyspepsia, pharyngitis, pain chest. 01/04/10 Hashimoto's Thyroiditisi with hypothyroidism. Dry flaky skin and scalp, fatigue, weakness, lethargy, sleepiness, muscle cramps, joint pain, muscle aches, brain fog, loss of concentration, slow thinking, nasal congestion, post-nasal drip, heavy snoring; Vasomotor (hormonal) Rhinitis, cough, sore throat, enlarged thyroid, swollen lymph glands, continued weight gain>20lbs, frequent eye infection and styes, conjunctivitis, essential tremor, intolerance to heat or temperature changes, headaches, Aphthous ulcers, mouth sore, heart palpitiations and dizziness.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Convulsion, Headache, Medication error
Clinical narrative: Began experiencing HA following his first 3 anthrax vaccines. Seizure activity first witnessed in 09/02, but pt thinks he may have been having episodes as early as 1998.  30 year old ADA WM who contacted the healthcare center because  " the neurologist told him to contact the MD, because pt had all 6 (anthrax) shots and he thought there might be a relationship between the vaccines and the seizures... Pt saw on a web site that there were 4 known bad lot numbers and 3 of the shots I got were in the bad lots... I believe I have had these seizures since after the shots, but they were just never witnessed until about a year ago.. Pt is undergoing eval for a possible seizure disorder. He also reports that he is having HA at least 2x per week. He believes both started shortly after pt got his 3rd anthrax vaccine in 1998.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Pt states arm is sore and has been since received vaccine " hard to touch"
Age: 53.0
Sex: M
Vaccine: HEPA, IPV, TYP
Symptoms: Diarrhoea
Clinical narrative: Took 1 dose of oral typhoid on 06/02/03 at 7:00AM. Right arm 06/02/2005, diarrhea began aprroximately 8 times until 10:00 AM with cramping, liquid stools, Did not take any further pills.
Age: 4.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: OV 06/07/05- Multiple erythema lesions with central vesicles. Vesicles on penis, fever. TX with Acyclovir 800mg PO QID x5 Days.
Age: 1.03
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: OV 06/07/05: DX with breakthrough varicella. Has approximatelyu 20 lesions on trunk, arms, and several are vesiculated
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Broke out with Chicken pox, siblings + shingles.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: High-pitched crying, Screaming
Clinical narrative: Mom returned with infant  04/20/05 to receive vaccines. Reported high pitched crying for 26 hours afer vaccines administered on 01/14/2005. No MD visit or ER visit. Referred to Peditricain for eval.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Pt was immunized on 05/27/2005 with DTaP, IPV, Hib, and PCV-7. Hib vaccine was given to right upper thigh. Mom states pt developed a fever up to 104.0F 24 hours after receiving vaccines. 48 hours fever 103 F on 05/30 fever 99-100 F. Redness and swelling to RUT. 05/31/2005-low grade fever, 99F .
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash papular
Clinical narrative: 7-10 days- rash papulovesicular, mild chest and back pruritic. Received Hep A vaccine on 05/24/05.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Developed fever the evening of vaccines, then had a seizure. Seen in local ER. Blood culture, WBC done, f/u next 2 days in office.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Oedema peripheral, Vomiting
Clinical narrative: Vomiting and bilateral feet swelling on the evening following immunization administration.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Injection site hypersensitivity, Injection site induration, Oedema peripheral
Clinical narrative: Left arm was red, swollen, and felt hard to touch from elbow joint to shoulder.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Erythema multiforme
Clinical narrative: MMR given 05/24/05. Onset erythema multiforme 06/03/05.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Foetal distress syndrome, Medication error, Unintended pregnancy
Clinical narrative: Two days after receiving vaccine, client called and told RN she'd just found out she was pregnant. 8 Weeks per OB/Gyn (LMP stated to RN was 2/28/05).
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Infection, Pruritus, Rash papular
Clinical narrative: Vaccine breakthrough.  Had varicella vaccine on 06/22/2000. Diagnosed in office on 06/04/2005 with varicella.  Developed rash on trunk, face, arms, and legs on 06/03/2005.  No fever.  Rash was itchy, red papules.  Exposed to chickenpox at school.  Rash completely crusted by 06/06/2005.  Less than 50 lesions.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rash on right arm that itches.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Swelling
Clinical narrative: Swollen right thigh.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Flushing
Clinical narrative: Patient felt flushed, dizziness, 5 minutes after immunization.  Vital signs stable.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Menactra site, given 2 days ago on 06/7/05, 5 1/2 inches wide - 10 inches long at left arm, red/heat/swelling/pain.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Discomfort
Clinical narrative: Menactra site, given 2 days ago on 06/7/05, 5 1/2 inches wide - 10 inches long at left arm, red/heat/swelling/pain.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: 05/25/2005 - five maoular rash - prescription - vasiwound. 05/20/2005 - CBC with platelet # of 75K. 05/25/2005 - CBC with platelet - # of 208K.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: 05/02/2005 4 year old, immunizations given came in 05/04 for left thigh swelling, red with fever - 3 1/2 inches - 12.2 inches thigh area, site for DTAP and IPV.  Benadryl given only.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Received 2 months immunizations on 06/08/2005 at 9:30am, at 3PM on 06/08/2005 developed urticarial rash, no other symptoms.  Resolved with Benadryl.  Reoccurence on 06/08/2005 at 3PM.  Seen in doctor's office at 4:00 on 06/08/2005.  Except urticarial rash appeared well, no other known exposures, changes in skin products.  Mother recalled rash stared 06/09/2005 several hours after formula , given 1 times a day for past week, to change formula.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Nonspecific reaction
Clinical narrative: Telephone conversation with Mom.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Left deltoid swollen, red, patient febrile.  Treated with Keflex antibiotics.
Age: 1.11
Sex: M
Vaccine: DTAPH
Symptoms: Chest pain, Skin ulcer
Clinical narrative: 23 Spots last PM more today, no fever, not bothersome.  Awake, alert, bilateral tm's normal.  Spots on trunk, arms 5-6, eryth with vsical anterior upper back.  Chest pain?  Vaccine related?  No treatment.
Age: 1.46
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Hives - within 24 hours of immunizations.  Being treated with Benadryl.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Patient had high fever, 103-104, 6-8 hours after vaccine was given also red area on leg where vaccine was given.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Drug ineffective, Infection
Clinical narrative: Break through chickenpox.
Age: 13.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Fatigue, Nausea
Clinical narrative: Patient's Mom reports:  Patient took the first oral dose of Typhoid without problems.  Second dose taken at 11PM as directed with 2 glasses of water.  At 1PM the next day patient reported symptoms of abdominal pain, low back pain, fatigue with a temperature of 100F.  These symptoms lasted approximately 5 hours.  Third dose taken at 10:30PM as directed with 2 glasses of water.  At 9AM the next morning the patient reported stomach pain, nausea for 24 hours, and no fever.  Mom reported that these symptoms were worse than those after the second dose, prompting the father to call the clinic.  The nurse advised to discontinue the vaccine, continue to monitor symptoms and call if worse.  Patient's symptoms resolved after 24 hours.  Above was described to the vaccine manufacturer representative who recommended the filing of this report.
Age: 13.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: Patient's Mom reports:  Patient took the first oral dose of Typhoid without problems.  Second dose taken at 11PM as directed with 2 glasses of water.  At 1PM the next day patient reported symptoms of abdominal pain, low back pain, fatigue with a temperature of 100F.  These symptoms lasted approximately 5 hours.  Third dose taken at 10:30PM as directed with 2 glasses of water.  At 9AM the next morning the patient reported stomach pain, nausea for 24 hours, and no fever.  Mom reported that these symptoms were worse than those after the second dose, prompting the father to call the clinic.  The nurse advised to discontinue the vaccine, continue to monitor symptoms and call if worse.  Patient's symptoms resolved after 24 hours.  Above was described to the vaccine manufacturer representative who recommended the filing of this report.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Rash macular
Clinical narrative: Swelling, red, warm, blotchy raised rash, as soon has shot was given. Patient had to wait in office for 20 minutes, after 20 minutes rash begain to fade. Patient went home with mother. This is the third reaction like this in a month, to the MMR.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Flushing, Urticaria
Clinical narrative: Generalized flushing of skin over face and extremities.  Hives noted on both arms and lower back. 0.5ml Benadryl 50mg give IM.  Hives resolved. Client dismissed from clinc 35 minutes post-Benadryl administraion.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS - 3";  RAISED - 1 1/4". COOL COMPRESS APPLIED. REDDENED AND RAISED AREA BECAME SMALLER AND MORE LOCALIZED. CLIENT JUMPED DURING MMR INJECTION.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Right thigh with redness after DTaP vaccine given.
Age: 33.0
Sex: F
Vaccine: MMR, TD
Symptoms: Facial palsy, Hypoaesthesia, Paraesthesia
Clinical narrative: From initial information received on 29/Mar/2004 from an osteopathic clinic employee, regarding an adverse event occurring in the U.S.A., it was reported that a 32-year-old female patient received a TD ADS ADULT vaccination, lot number U1021AA, administered in the left deltoid, and a MMR/MEASLES, MUMPS, RUBELLA vaccination, lot number 0950N, administered in the right arm on 26/Mar/2004. The next day, on 27/Mar/2004, the patient experienced Bell's palsy symptoms with numbness on the left side of her face, tingling and inability to close left eye. There was no facial pain. Recovery status at the time of the initial report was listed as not recovered. Patient's last TD booster was given in 1993-1994, at which time no local reaction was noted. No information was provided about patient's medical history, concomitant medications, and illness at time of vaccination. From additional information received on 09/Nov/2004 from the responsible physician, it was reported that the TD ADS ADULT vaccine was administered intra-muscularly and the MMR/MEASLES, MUMPS AND RUBELLA vaccine was administered subcutaneously. Additional information was provided during a telephone call with responsible physician on 16/Nov/2004, where it was reported that the patient received the vaccines for immigration purposes on 26/Mar/2004. The patient returned to the physician's office, where she was diagnosed with Bell's palsy. She was treated with oral prednisone 20 mg. As per the physician, the outcome of the symptoms is unknown and he has no further relevant information regarding this patient. No further information is anticipated, this case is considered closed.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Injection site nodule, Skin discolouration, Tenderness
Clinical narrative: From initial information received on 12/Mar/2004 from a HCP regarding an adverse event in the USA, it was reported that a 43 year old male pt received a dose of TD ADS Adult, lot number U1017BA, expiration date 04/May/2004, administered in the right arm (route of administration not reported) approximately one month ago. An unspecified time later, the pt developed tenderness, discoloration and a pea sized nodule at the site of injection as well as pain that begins at the injection site location and travels down his arm. The pt's pre-existing medical history includes a laceration injury, he has no other medical conditions  nor any known allergies. Currently the pt's recovery status is reported as not recovered. From additional information received on 11/Aug/2004 it was reported that the pt did not require an ER or doctor visit as previously reported. The onset date of the adverse events was provided as 11/Mar/2004, however, the date of vaccination was not provided. The pt recovered without sequelae. For the reporter, there is no additional information for this case. No further information is anticipated, this case is considered closed.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: From initial information received on 05/18/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a male patient received his sixth dose of TD ADS Adult vaccine, lot 40991AA, administered intra-muscularly in the left arm at 12:00PM on 05/17/2004.  Two minutes after vaccination the patient fainted, became diaphoretic and hypotensive.  Dizziness persisted after being in a Tredelenburg position for more than one hour.  The patient was very sleepy following the syncopal event.  Reportedly the patient fully recovered 3 to 4 hours later.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Feeling hot, Injection site erythema, Injection site pain, Nausea
Clinical narrative: From initial information received on 05/24/2004 from a registered nurse, it was reported that a 62 year old female patient received a TD ADS Adult vaccination, lot number U0842AA, administered intra-muscularly in the right deltoid on the morning of 05/18/2004.  Approximately eight hours after the injection, she developed redness and tenderness at the injection site, as well as fatigue.  The next day the patient stared with transient nausea and felt feverish although no temperature was taken.  All symptoms were continuing at the time of the report.  The patient was going to be seen by her primary doctor for evaluation.  From additional information received on 08/12/2004 from a healthcare professional, it was reported that no additional information is available at this time.  No new medical information was provided.  From additional information received on 09/24/2004 from a healthcare professional, it was reported that no additional information is available at this time.  No new medical information was provided and it was not reported whether the patient recovered from these events.  No further information is anticipated, this case is considered closed.
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Radiculitis brachial
Clinical narrative: There was no seriousness criteria reported in this case. Based upon appropriate medical judgment the reported event was considered serio8us: medically significant event. From initial information received on 17/Jun/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 25-year-old female patient received a TD ADS ADULT vaccination, lot number U1016AA, administered intra-muscularly in the right deltoid, on 21/May/2004. An unspecified amount of time later, the patient developed bilateral brachial plexus neuritis. She was seen by a physician, but no other information was provided. The recovery status of the patient was not reported. From additional information received from the responsible physician on 18/Oct/2004, it was reported that the patient was treated for this event by a neurologist and the reporter suggested contacting this physician for further information. It was not reported whether the patient recovered. No new relevant additional medical information was provided at this time for the adverse experience. This follow-up information is not submitted to the health authorities. 20/Jan/2005: Despite additional attempts at obtaining follow-up for this case, no more information has been received. The patient's recovery status remains unknown. Further information is not anticipated, this case is considered closed.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Encephalitis, Encephalopathy, Malaise, Pyrexia
Clinical narrative: There was no seriousness criteria reported in this case. Based upon appropriate medical judgement the reported event was considered serious: medically significant event (OMIC). From initial information received on 28/Jun/2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 35 year old female pt received a TD ADS ADULT vaccination for wound management after a laceration, lot number U1185AA, administered IM in the right deltoid on 21/Jun/2004. On 25/Jun/2004, the pt developed a fever of 101 degrees Fahrenheit, polyarthralgia, body tremors and generalized malaise. The pt was evaluated on 28/Jun/2004 and was diagnosed with encephalomyelopathy. The recovery status of the pt was reported as unknown. From phone call made to the reporter on 29/Jun/2004, it was confirmed that the preliminary diagnosis is encephalomyelopathy. The MRU was reportedly normal. This pt was not admitted to the hospital. It was the feeling of the emergency room doctor that her symptoms may have been psychogenic. She was treated with steroids. Recovery status is unknown at this time. Pt reported that her mother told her when she was age 10 years old that she was unable to walk after a Td shot. Also, the pt had a 4cm laceration of her right arm. From additional information received on 09/Aug/2004, it was reported that no additional information is available at this time. Per the reporter, the pt was lost to follow up. No further information regarding the pt's recovery status was reported. Further information is not anticipated, this case is considered closed.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Similar reaction on previous exposure to drug, Tremor
Clinical narrative: There was no seriousness criteria reported in this case. Based upon appropriate medical judgement the reported event was considered serious: medically significant event (OMIC). From initial information received on 28/Jun/2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 35 year old female pt received a TD ADS ADULT vaccination for wound management after a laceration, lot number U1185AA, administered IM in the right deltoid on 21/Jun/2004. On 25/Jun/2004, the pt developed a fever of 101 degrees Fahrenheit, polyarthralgia, body tremors and generalized malaise. The pt was evaluated on 28/Jun/2004 and was diagnosed with encephalomyelopathy. The recovery status of the pt was reported as unknown. From phone call made to the reporter on 29/Jun/2004, it was confirmed that the preliminary diagnosis is encephalomyelopathy. The MRU was reportedly normal. This pt was not admitted to the hospital. It was the feeling of the emergency room doctor that her symptoms may have been psychogenic. She was treated with steroids. Recovery status is unknown at this time. Pt reported that her mother told her when she was age 10 years old that she was unable to walk after a Td shot. Also, the pt had a 4cm laceration of her right arm. From additional information received on 09/Aug/2004, it was reported that no additional information is available at this time. Per the reporter, the pt was lost to follow up. No further information regarding the pt's recovery status was reported. Further information is not anticipated, this case is considered closed.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: From initial information received on 7/16/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 35 year old patient received a dose of TD ADS ADULT, lot number U1017BA, administered IM in the left deltoid on 7/13/04. The next day, on 7/14/04, the patient had developed slight erythema and two clear vesicles measuring 2-3mm in size at the injection site. The patient denied any itching, burning, fever, or respiratory symptoms. Reportedly he recovered from this experience. From additional information received no 8/19/04 from the initial report, the responsible physician's name was corrected. It was also reported that at the time of suture removal the patient reported the vesicles had resolved. No further signs or symptoms were reported. The sutures were removed and the patient was discharged from care. No further information is anticipated, this case is considered closed.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Muscle atrophy, Muscle spasms, Muscular weakness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Provisional diagnoses: Brachial neuritis or Complex regional pain syndrome. From initial information received on 17/Aug/2004 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 49-year-old male patient received a dose of TD ADS ADULT, lot number U1025AA, administered intra-muscularly in the left upper arm on 19/Apr/2004 in the PM. The following day, on 20/Apr/2004, the patient experienced pain in the left upper arm. 15 days later, the pain in his left arm became severe and worsened to involve neck stiffness and spasm to the supraspinatus. He also had atrophy and weakness of the left upper arm. The patient has no history of shoulder pain problems. He was sent for an MRI of the cervical spine and the left shoulder, however, no results were provided. Per the reporter, complex regional pain syndrome or brachial neuritis is suspected, probably due to the intra-muscular injection on 19/Apr/2004. The patient did not recover from the events and may be permanently disabled. From additional information received on 15/Oct/2004 from a physician, it was reported that the patient has had low neck pain for the past four years. He was told that he had a herniated disc while in Argentina and his symptoms resolved with exercise. Per the reporting physician, the pre-existing significant compromise to the region by the disc possibly predisposed the patient to the adverse reactions he experienced after receiving TD DAS ADULT. The patient's weakness and atrophy were reported as new conditions. The patient attended two sessions of physical therapy and his condition worsened. He was treated with Vicodin ES as needed for pain as well as Xanax. Consultation with a pain clinic and a neurosurgeon were also recommended and he was to follow-up with the reporting physician. From additional information received on 01/Nov/2004 from a physician, it was reported that he has had no further contact with this patient. He stated that the patient's symptoms were likely due to complications from pre-existing reflex sympathetic dystrophy and were not related to the vaccine. The patient's recovery status is unknown. No further information is anticipated, this case is considered closed.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Pain, Radiculitis brachial, Shoulder pain
Clinical narrative: Provisional diagnoses: Brachial neuritis or Complex regional pain syndrome. From initial information received on 17/Aug/2004 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 49-year-old male patient received a dose of TD ADS ADULT, lot number U1025AA, administered intra-muscularly in the left upper arm on 19/Apr/2004 in the PM. The following day, on 20/Apr/2004, the patient experienced pain in the left upper arm. 15 days later, the pain in his left arm became severe and worsened to involve neck stiffness and spasm to the supraspinatus. He also had atrophy and weakness of the left upper arm. The patient has no history of shoulder pain problems. He was sent for an MRI of the cervical spine and the left shoulder, however, no results were provided. Per the reporter, complex regional pain syndrome or brachial neuritis is suspected, probably due to the intra-muscular injection on 19/Apr/2004. The patient did not recover from the events and may be permanently disabled. From additional information received on 15/Oct/2004 from a physician, it was reported that the patient has had low neck pain for the past four years. He was told that he had a herniated disc while in Argentina and his symptoms resolved with exercise. Per the reporting physician, the pre-existing significant compromise to the region by the disc possibly predisposed the patient to the adverse reactions he experienced after receiving TD DAS ADULT. The patient's weakness and atrophy were reported as new conditions. The patient attended two sessions of physical therapy and his condition worsened. He was treated with Vicodin ES as needed for pain as well as Xanax. Consultation with a pain clinic and a neurosurgeon were also recommended and he was to follow-up with the reporting physician. From additional information received on 01/Nov/2004 from a physician, it was reported that he has had no further contact with this patient. He stated that the patient's symptoms were likely due to complications from pre-existing reflex sympathetic dystrophy and were not related to the vaccine. The patient's recovery status is unknown. No further information is anticipated, this case is considered closed.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site swelling, Medication error, Paraesthesia
Clinical narrative: From initial info received on 8/19/04 from a health care professional regarding an adverse event occuring in the USA, it was reported that a 15 month old female pt received a dose of TD ADS ADULT vaccine administered ID in the forearm instead of Tuberculin PPD vaccine on 8/16/04. That same day, the pt developed a local reaction of redness and swelling 4 x 6 cm in diameter. She also developed vomiting lasting  1 day; tingling in her hand and a mild headache that lasted for 2 days. From additional information received on 10/1/04 from a health care professional, the pt's full name and address were provided. Reportedly, the pt does not take any medications. Per the reporter, the pt was vaccinated at a public health clinic/hospital. From additional info received on 10/28/04 from an RN, the recovery status was reported as unknown. From additional info received on 12/28/04 from an RN, it was reported that the pt received 0.5cc dose of TD ADS ADULT (U1185AA), ID in the left forearm in error instead of a 0.1cc dose of Tuberculin PPD on 8/16/04 at 10:24 AM. The onset of the of the symptoms was reported as being immediately after vaccination. Per the reporter, the pt has not been visually assessed by the staff at the health dept, but was seen by a physician for her symptoms. The pt recovered. No further info is anticipated, this case is closed.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: From initial info received on 8/19/04 from a health care professional regarding an adverse event occuring in the USA, it was reported that a 15 month old female pt received a dose of TD ADS ADULT vaccine administered ID in the forearm instead of Tuberculin PPD vaccine on 8/16/04. That same day, the pt developed a local reaction of redness and swelling 4 x 6 cm in diameter. She also developed vomiting lasting  1 day; tingling in her hand and a mild headache that lasted for 2 days. From additional information received on 10/1/04 from a health care professional, the pt's full name and address were provided. Reportedly, the pt does not take any medications. Per the reporter, the pt was vaccinated at a public health clinic/hospital. From additional info received on 10/28/04 from an RN, the recovery status was reported as unknown. From additional info received on 12/28/04 from an RN, it was reported that the pt received 0.5cc dose of TD ADS ADULT (U1185AA), ID in the left forearm in error instead of a 0.1cc dose of Tuberculin PPD on 8/16/04 at 10:24 AM. The onset of the of the symptoms was reported as being immediately after vaccination. Per the reporter, the pt has not been visually assessed by the staff at the health dept, but was seen by a physician for her symptoms. The pt recovered. No further info is anticipated, this case is closed.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Injection site erythema, Injection site inflammation, Medication error
Clinical narrative: From initial information received on 12/2804 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received in error a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at10:40 AM. Soon after vaccination, over the next several hours, the patient developed injection site inflammation and redness with increasing discomfort. The following day, the patient reported that a red area measuring approximately the size of a 50 cent piece. Reportedly, the patient previously received a dose of Td vaccine in August of 1990 with no reactions reported. The patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404036, 200404037, 200404038, 200404039, 200404040, 200404041 and 200404042.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Medication error
Clinical narrative: From initial information received on 12/28/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received in error a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:31 AM. An unspecified amount of time later, the patient developed redness and swelling at the site of injection. Per the reporter, the patient was not visually assessed by a nurse. The patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404036, 200404037, 200404038, 200404039, 200404041, 200404042 and 200404043.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: From initial information received on 8/19/04 from the patient's parent, who is a health care professional, regarding an adverse event occurring in the USA, it was reported that a 14 year old patient received a TD ADS ADULT vaccination, lot number U1185AA, administered in the left forearm on 8/16/04 in error instead of a TUBERCULIN PPD skin test. Later that same day, the patient developed a 2-inch by 4-inch area of redness, swelling, pain, and itching. She also experienced formation of a granuloma. The patient's parent treated her with four 50mcg doses of Benadryl, Claritin and a steroid cream. At the time of this report, the events were resolving. From additional information received on 11/8/04 through a telephone call from a health care professional, it was reported that the patient has recovered from the events and no additional information is available. Additional information was also received on 12/28/04 from a registered nurse, who reported that the patient received a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm in error instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:25 AM. Later that same day, the patient developed edema, redness, and pain at the site of injection. The symptoms were treated with cool compresses as well as Benadryl and Tylenol for discomfort. Per the reporter, the patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Medication error, Pruritus
Clinical narrative: From initial information received on 8/19/04 from the patient's parent, who is a health care professional, regarding an adverse event occurring in the USA, it was reported that a 14 year old patient received a TD ADS ADULT vaccination, lot number U1185AA, administered in the left forearm on 8/16/04 in error instead of a TUBERCULIN PPD skin test. Later that same day, the patient developed a 2-inch by 4-inch area of redness, swelling, pain, and itching. She also experienced formation of a granuloma. The patient's parent treated her with four 50mcg doses of Benadryl, Claritin and a steroid cream. At the time of this report, the events were resolving. From additional information received on 11/8/04 through a telephone call from a health care professional, it was reported that the patient has recovered from the events and no additional information is available. Additional information was also received on 12/28/04 from a registered nurse, who reported that the patient received a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm in error instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:25 AM. Later that same day, the patient developed edema, redness, and pain at the site of injection. The symptoms were treated with cool compresses as well as Benadryl and Tylenol for discomfort. Per the reporter, the patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: From initial information received on 12/28/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 15 year old female patient received a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm in error instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:08 AM. Later that same day, the patient developed a red and sore area at the site of injection. Per the patient's mother, the area was treated with cool compresses, Benadryl, and Tylenol. It was reported that the patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404036, 200404038, 200404039, 200404041, 200404042 and 200404043.
Age: 17.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Medication error, Pruritus
Clinical narrative: From initial information received on 12/28/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received in error a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm instead of a dose of TUBERCULIN PPD on 8/16/04 at 10:20 AM. The following morning, the patient developed redness, swelling, and itching at the site of injection. The patient followed up with a physician and labs were drawn. She had cold symptoms at the time of vaccination which were treated with over the counter cold medicine. Reportedly, the patient previously received a dose of  Td vaccine on 2/9/04 with no reactions reported. The patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404036, 200404037, 200404038, 200404039, 200404040, 200404042 and 200404043.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Medication error
Clinical narrative: From initial information received on 12/28/04 from an RN regarding adverse event occurring in the USA, it was reported that a 16 year old male pt received in error, a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID, in the left forearm instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:33 AM. The following day, the pt developed redness, swelling and pain at the injection. The pt followed-up with a physician and will continue to do so as now both arms are painful. Reportedly, the pt recovered from the events. The reporter of this case is the same reporter of cases 2004-02848, 2004-02849, 2004-02850, 2004-04036, 2004-04037, 2004-04038, 2004-04039, 2004-04040, 2004-04041 and 2004-04043.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Medication error
Clinical narrative: From initial information received on 12/28/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received in error a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:18 AM. Later that day, the patient developed increasing swelling, redness, and pain at the site of injection. The patient was to follow up with a physician. Reportedly, the patient previously received a dose of Td on 12/3/98 with no reactions reported. The patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404036, 200404037, 200404039, 200404040, 200404041, 200404042 and 200404043.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Medication error
Clinical narrative: From initial information received on 12/28/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 15 year old female patient received in error a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:35 AM. Later that day, the patient developed edema, redness and discomfort at the site of injection. Treatment included cool compresses as well as Benadryl and Tylenol for discomfort. Per the reporter, the date of the last Td vaccination is unknown. The patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404036, 200404037, 200404040, 200404041, 200404042 and 200404043.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Dizziness, Erythema, Injection site erythema, Injection site pain
Clinical narrative: From initial information received on 9/10/04 from a health care facility regarding an adverse event occurring in the USA, it was reported that a 14 year old male patient received a TD ADS ADULT vaccination, lot number U1340AA, administered IM on 8/25/04. The site of administration was not reported. Within two days of receiving the vaccine (reported as approximately on 8/27/04, the patient complained of soreness, swelling, redness and warmth at the injection site. He was seen in the emergency room and diagnosed with cellulitis. He was treated with Keflex. At some point, the patient also developed nausea and dizziness, but the exact date of onset was unknown. At the time of this report, the patient's symptoms were still persisting, although the local reaction at the injection site had improved. The patient's recovery status was not reported. From additional information received on 10/13/04 from the initial reporter, it was reported that the lot number was U1347AA (previously reported as U1340AA). The injection was administered in the patient's left arm. Approximately five days after the vaccination, the patient developed erythema of the arm extending from the elbow to the shoulder with swelling. He was also given IM Benadryl in the emergency room. One week later the shoulder area improved, but the swelling continued to the elbow. He was seen in the emergency room again on 9/1/04 by a private physician. By 9/3/04, the events resolved. The patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: From initial information received on 9/10/04 from a health care facility regarding an adverse event occurring in the USA, it was reported that a 14 year old male patient received a TD ADS ADULT vaccination, lot number U1340AA, administered IM on 8/25/04. The site of administration was not reported. Within two days of receiving the vaccine (reported as approximately on 8/27/04, the patient complained of soreness, swelling, redness and warmth at the injection site. He was seen in the emergency room and diagnosed with cellulitis. He was treated with Keflex. At some point, the patient also developed nausea and dizziness, but the exact date of onset was unknown. At the time of this report, the patient's symptoms were still persisting, although the local reaction at the injection site had improved. The patient's recovery status was not reported. From additional information received on 10/13/04 from the initial reporter, it was reported that the lot number was U1347AA (previously reported as U1340AA). The injection was administered in the patient's left arm. Approximately five days after the vaccination, the patient developed erythema of the arm extending from the elbow to the shoulder with swelling. He was also given IM Benadryl in the emergency room. One week later the shoulder area improved, but the swelling continued to the elbow. He was seen in the emergency room again on 9/1/04 by a private physician. By 9/3/04, the events resolved. The patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Convulsion
Clinical narrative: From initial information received on 22 SEP 2004 from a nurse practitioner regarding an adverse event occurring in the USA, it was reported that a female patient (age at time of event not reported) received a booster dose of TD ADS ADULT administered in the right deltoid and a Tuberculin PPD skin test, administered in the right forearm on an unspecified date.  Following the administration of the products the patient also had blood drawn.  Approximately ten minutes after receiving the TD product the patient experienced a generalized seizure with rigidity and tonic spasms in her legs, arms and neck.  After a minute the patient became cloin and arched her back.  The duration of the symptoms was reported as five minutes.  Emergency services was contact but eh patient refused to go to the emergency department.  The patient was fine when seen for a 48 hours follow-up visit and she was scheduled to follow-up with a neurologist.  It was reported that the patient recovered from these events.    From additional information received on 28 OCT 2004 from the initial reporter it was reported that the TD ADS ADULT was administered IM and the TB PPD was administered intradermally.  Both products were administered on 14 SEP 2004 at 11:00am.  The patient reported having a couson with an adult onset seizure disorder.  No other information was provided at this time.    A new version of this case was created on 05 NOV 2004 to amend the route of administration of the TB PPD product, which was correctly enterred in the product screen as intramuscularly, not intradermally as reported.  No new medical information was provided at this time.    From additional information received on 12 NOV 2004 from a nurse practitioner it was reported that the patient denied further seizure-like activity.  Reportedly the patient has not yet made an appointment with a neurologist.  The reporter stated that because this facility is not the patient's primary care site their contact with the patient is limited.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Abscess, Arthralgia, Chills, Injection site erythema, Injection site induration
Clinical narrative: From initial information received on 10/05/04 from a health care professional, it was reported that a 31 year old male patient received a TD ADS ADULT vaccination, lot number U1283AA, administered ID in the right anterior forearm at 2:30 PM on 10/1/04. It was intended for the patient to receive PPD instead. Reportedly within 24 hours the patient developed an induration, erythema, and tenderness at the injection site which progressed to his wrist and elbow. He developed arthralgia, increased swelling and a red streak to his elbow crease. He also developed chills, body aches, nausea, emesis and malaise within 48 hours of administration. The patient was sent to the emergency room where he was treated with Biaxin for the abscess on his left arm and fever which he had at the time of vaccination. The patient was rescheduled to be re-evaluated later that same day. The patient's recovery status is currently not recovered.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Malaise, Medication error, Nausea, Pain
Clinical narrative: From initial information received on 10/05/04 from a health care professional, it was reported that a 31 year old male patient received a TD ADS ADULT vaccination, lot number U1283AA, administered ID in the right anterior forearm at 2:30 PM on 10/1/04. It was intended for the patient to receive PPD instead. Reportedly within 24 hours the patient developed an induration, erythema, and tenderness at the injection site which progressed to his wrist and elbow. He developed arthralgia, increased swelling and a red streak to his elbow crease. He also developed chills, body aches, nausea, emesis and malaise within 48 hours of administration. The patient was sent to the emergency room where he was treated with Biaxin for the abscess on his left arm and fever which he had at the time of vaccination. The patient was rescheduled to be re-evaluated later that same day. The patient's recovery status is currently not recovered.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Skin striae, Vomiting
Clinical narrative: From initial information received on 10/05/04 from a health care professional, it was reported that a 31 year old male patient received a TD ADS ADULT vaccination, lot number U1283AA, administered ID in the right anterior forearm at 2:30 PM on 10/1/04. It was intended for the patient to receive PPD instead. Reportedly within 24 hours the patient developed an induration, erythema, and tenderness at the injection site which progressed to his wrist and elbow. He developed arthralgia, increased swelling and a red streak to his elbow crease. He also developed chills, body aches, nausea, emesis and malaise within 48 hours of administration. The patient was sent to the emergency room where he was treated with Biaxin for the abscess on his left arm and fever which he had at the time of vaccination. The patient was rescheduled to be re-evaluated later that same day. The patient's recovery status is currently not recovered.