chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: From initial information received on 11 MAY 2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 43 year old female patient received a TD ADS Adult vaccination administered IM in the left deltoid on 03 MAY 2004.  The same day the patient developed pain and swelling to which she applied a gel freeze pack.  She also developed a little area of blisters with a lot of tenderness, redness and swelling over a period of a couple of days; and low grade temperature.  She was seen in a walk-in clinic on 07 MAY 2004 and was being followed for cellulitis.  The patient's recovery status was not reported.    From additional information received on 20 AUG 2004 from the responsible physician it was reported that the patient recovered with Levaquin and Erythomycin in five to six days.  She received thsi dose of TD ADS Adult as a booster and had no previous reaction in the past.  The patient's illness at the time of vaccination were reported as well as her allergies.  Additional lab information was also provided.  No further information is anticipated this case is considered closed.  The reporter of this case is the same reporter as case 200401856
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Malaise, Pain, Pyrexia
Clinical narrative: From initial information received on 05/14/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received a TD ADS Adult vaccination, lot number U1017BA, administered intramuscularly in the right deltoid on 05/11/2004.  The next day, on 05/12/2004, the patient developed severe malaise, high fever, pain behind the knees and arthralgia.  Treatment included Tylenol and Motrin.  It is unknown if the patient recovered from these events.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Joint stiffness, Movement disorder, Myalgia
Clinical narrative: From initial information received on 05/14/2004 from a physician regarding an adverse event occurring in the USA, it was reported that following a heel laceration on 04/22/2004, a 40 year old female patient received a TD ADS Adult vaccination, lot number U1019AA, administered intramuscularly in the left deltoid on 04/23/2004.  A couple of days later the patient developed extreme fatigue, muscle aches and couldn't open her jaw for a few minutes.  The jaw stiffness was found to be resolved upon examination on 05/03/2004.  On 05/14/2004 the extreme fatigue and muscle aches were slowly resolving.  It is unknown if the patient recovered completely from these events.  From additional information received on 08/09/2004 from the reporting physician, the adverse event start date was reported as 04/25/2004.  No new medical information was provided.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Pain
Clinical narrative: From initial information received on 05/14/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a TD ADS Adult vaccination, lot number U1024AA, administered intramuscularly in the left deltoid on 05/11/2004.  The next day, on 05/12/2004, the patient experienced a local red area at the injection site.  She was seen in the office on 05/14/2004 with a 9.5 x 8 mm area of redness and a 7.5 x 5cm area of induration.  The area was also warm and painful to the touch.  It is unknown if the patient recovered from these events.  From additional information received on 09/22/2004 from a healthcare professional, it was reported that a nurse spoke with the patient on 09/15/2004.  At that time, the patient still had a dime-sized knot at the injections site, but stated that it was slowly getting smaller.  It was noted that there was no pain at the site.  Outcome for the rest of the reported events was not provided.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Fatigue, Lethargy, Muscle twitching
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 29 year old male patient received a TD Adult vaccination, lot number U1018BA, administered intramuscularly in the right deltoid on 01/18/2004.  Approximately ten days after vaccination the patient became lethargic, dizzy, tired and developed generalized muscle twitching.  The patient's recovery status is currently unknown.  From information received on 08/09/2004 from the initial reporter, the case was reviewed and there was no additional medical information at this time.  It was not reported whether the patient recovered from these events.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Difficulty in walking, Muscle spasms, Myalgia, Pain, Swelling
Clinical narrative: From initial information received on 05/20/2004 from the patient regarding an adverse event occurring in the USA, it was reported that the 38 year old female received a dose of TD ADS Adult, lot number U1014AA, administered in the left deltoid on 03/22/2004.  The route of administration was not reported.  Four days later, on 05/26/2004, the patient developed bilateral muscle aches and cramps in her legs, as well as pain and swelling in her left arm.  On 03/29/2004, she experienced a muscle constriction in her right leg and was barely able to walk.  On 03/30/2004, she was placed on prednisone and a medrol pack, which relieved the symptoms temporarily.  She was seen in the emergency room on 04/01/2004 for blood work and was administered baclofen for muscle spasms.  The patient was also seen by a neurologist and was placed on Klonopin and continued on 10mg of prednisone.  At the time of this report, the patient had not yet recovered, but had recently returned to work.  From additional information received on 08/18/2004 from the responsible physician, the patient was taking Zyrtec D at the time of vaccination.  The patient's recovery status was unchanged.  From additional information received on 04/21/2004 from the initial reporting facility, it was reported that the patient was last seen on 04/04/2004.  He has since been lost to follow up.  No further information is anticipated, this case is considered closed.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Erythema, Nausea, Pyrexia
Clinical narrative: From initial information received on 06/02/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 22 year old female patient received a TD ADS Adult vaccination, lot number U1024AA, administered intra-muscularly in the right arm on 05/30/2004.  Two days later, on 06/01/2004, the patient developed redness, low-grade fever and nausea.  she also experienced chest tightness the night of 06/01/2004.  She was treated with Slovent and her recovery status was reported as unknown.  The patient was pregnant at the time of vaccination and her past medical history was significant for asthma and allergies to citalopram and sulfa.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site pain, Urticaria
Clinical narrative: From initial information received on 06/10/2004 from a healthcare provider regarding an adverse event occurring in the USA, it was reported that a 25 year old female patient inadvertently received a 0.1ml dose of TD ADS Adult, lot number U101AA, administered intradermally instead of Tubersol 5tu, on 06/07/2004.  The site of administration was not reported.  The following day, on 06/08/2004, the patient developed a local reaction at the site of administration.  The reaction was described as a 2.5cm x 3cm wheal size area, which was warm and reddened.  The patient was seen in the emergency room on 06/09/2004 with complaints of pain at the site of the injection.  She was also scheduled for follow up at the reporting facility on 06/10/2004.  Reportedly, the patient had not recovered from these events at the time of this report.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Anxiety, Chills, Fatigue, Injury, Insomnia
Clinical narrative: From initial info received on 6/21/04 from the pt, regarding an adverse event occurring in the USA, it was reported that the 37 year old female pt received TD ADS Adult vaccination, lot U1184AA, IM, in the left arm on 6/14/04. Immediately following the vaccination, the pt developed chills and sweating without fever, had insomnia and observed "strange marks" on her hand, arms and feet. She reported the events to her physician by telephone, but has not yet been seen by her physician. The pt's recovery status is currently unknown. From additional info received on 9/21/04 from the responsible physician, it was reported that the pt had anxiety and finger laceration at the time of vaccination and was on concomitant therapy with Zyprexa. The physician reported that she saw the pt in her office on 6/16/04, 2 days after she had received the vaccination. At that time, the pt complained of fatigue, myalgias and night sweats since receiving the vaccine and reported to the physician that she had a similar reaction to Valium, with  a rash also, in 3/04. On 6/23/04, the physician removed 4 stitches from the pt's left fourth finger. The physician did not observe a rash at that time. On 7/9/04, the pt complained of insomnia, fatigue, anxiety and chills since her vaccination 3 weeks prior. She complained of "pits on her face" and rashes that came and went on her extremities, but were not viable upon the physicians exam. At that time, the pt was also being seen by her therapist for anxiety and delusions. It was not reported whether the pt had a history of delusions. The physician stated that she had not seen the pt since 7/19/04. It was not reported whether the pt recovered from these events. No further ino is anticipated, this case is considered closed.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Night sweats
Clinical narrative: From initial info received on 6/21/04 from the pt, regarding an adverse event occurring in the USA, it was reported that the 37 year old female pt received TD ADS Adult vaccination, lot U1184AA, IM, in the left arm on 6/14/04. Immediately following the vaccination, the pt developed chills and sweating without fever, had insomnia and observed "strange marks" on her hand, arms and feet. She reported the events to her physician by telephone, but has not yet been seen by her physician. The pt's recovery status is currently unknown. From additional info received on 9/21/04 from the responsible physician, it was reported that the pt had anxiety and finger laceration at the time of vaccination and was on concomitant therapy with Zyprexa. The physician reported that she saw the pt in her office on 6/16/04, 2 days after she had received the vaccination. At that time, the pt complained of fatigue, myalgias and night sweats since receiving the vaccine and reported to the physician that she had a similar reaction to Valium, with  a rash also, in 3/04. On 6/23/04, the physician removed 4 stitches from the pt's left fourth finger. The physician did not observe a rash at that time. On 7/9/04, the pt complained of insomnia, fatigue, anxiety and chills since her vaccination 3 weeks prior. She complained of "pits on her face" and rashes that came and went on her extremities, but were not viable upon the physicians exam. At that time, the pt was also being seen by her therapist for anxiety and delusions. It was not reported whether the pt had a history of delusions. The physician stated that she had not seen the pt since 7/19/04. It was not reported whether the pt recovered from these events. No further ino is anticipated, this case is considered closed.
Age: 21.0
Sex: F
Vaccine: JEV
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: From initial info received on 7/6/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 21 year old female pt received her 2nd dose of JE-VAX, lot BJN213A, administered SC, in the left arm on 7/1/04. After receiving the 2nd dose at the beach by a relative, the pt reported (to this reporter who administered the 1st dose) that she experienced stomach pain, nausea and vomiting. The events resolved the same day without medical intervention. The pt recovered from these events.
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Cough, Injection site erythema, Pain, Pyrexia
Clinical narrative: From initial info received on 7/8/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 47 year old male pt received a TD ADS Adult vaccination, lot U1186AA, administered IM, in the left arm on 7/2/04. The same day, the pt developed redness at the injection site and flu-like signs and symptoms with chills, fever, hacky cough, aches and pain. He took Tylenol and reportedly fully recovered from these events. From additional info received on 8/19/04 from a health care professional, it was reported that there is no additional info at this time. No further info is anticipated, this case is considered closed.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Lymphadenopathy
Clinical narrative: From initial info received on 7/15/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 43 year old female pt received a dose of TD ADS ADULT, lot U1000AA, administered in the left deltoid on 7/8/04. Route of administration was not reported. Four days later, on 7/12/04, the pt experienced painful lymphadenopathy in the left clavicular region. The reporter provided the event onset date as 7/12/04, but reported that the event  occurred 2 days after vaccination. No infection, redness, warmth or drainage was noted at the injection site. Pt's pre-existing medical condintions include allergies to multiple antibiotics. The pt has hypertension at the time of vaccination. Reportedly, she recovered from the events.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: From initial information received on 7/19/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 65 year old male patient with second degree burns on the hand (extent and side not specified), received a TD ADS ADULT vaccination, lot number not provided, administered IM in the left arm on 4/4/04. About ten days post vaccination he developed intermittent tingling in his left shoulder, arm, and neck. At the time of the report the tingling was persisting. The patient's recovery status is unknown. From additional information received on 8/31/04 from the patient, he received no other products within four weeks of receiving the TD ADS ADULT vaccination. He has not recovered from this event. From additional information received on 11/22/04 from a registered nurse, it was reported that the patient was vaccinated on 4/19/04, not 4/4/04 as previously reported. The onset date of the adverse events is unknown. No relevant laboratory data or diagnostic tests were obtained. The physicain's office made two attempts to contact the patient on 11/16/04 in order to obtain additional information. Messages were left as well. Additional requests for information from the initial reporter were also attempted with no response. It is unknown whether the patient recovered from this event. Further information is not anticipated, this case is considered closed.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Muscle twitching, Neck pain, Pain in jaw
Clinical narrative: From initial information received on 7/22/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 30 year old female patient received a dose of TD ADS ADULT, lot number U0841AA, administered IM in the right deltoid at 10:00 AM on 7/20/04. Two hours later, the patient experienced pain at the injection site and pain in her entire arm, which radiated to her neck and jaw. The patient was seen by a physician on 7/22/04 and was prescribed unspecified pain medication and muscle relaxants. The patient's recovery status was reported as unknown. From additional information received on 8/30/04 from the initial reporter, additional patient, medication, adverse event and lab information was provided. It was reported that the patient was concomitantly taking Levothroid 25mcg and 5 units of Lantus for a history of hypothyroidism and type I diabetes. The unspecified pain medication and muscle relaxants previously reported were provided as Lortab 7.5/750, one every six hours for pain as needed, and Flexeril 10mg three times a day as needed for muscle spasms. The patient returned to the clinic on 7/28/04 for follow up. At that time the patient complained of neck muscles occasionally twitching and mild pain in the right arm. The patient has not reported any further problems or sought care from the  clinic since 7/28/04. The patient's recovery status was not provided. From additional information received on 10/28/04 from the responsible physician, it was reported that the case was reviewed and that there is no additional information available at this time. The patient's recovery status remains unknown. Further information is not anticipated, this case is considered closed.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Pain, Shoulder pain
Clinical narrative: From initial information received on 7/28/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a dose of TD ADS ADULT, lot number not reported, administered IM in the right arm on 6/26/04. Six to eight hours after immunization, the patient developed pain in her right arm, which progressed to her right shoulder. The patient was seen in the office on 7/28/04. At the time of the report, her recovery status was unknown.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Malaise
Clinical narrative: From initial information received on 7/28/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of TD ADS ADULT, lot number U1185AA, administered in the left deltoid and a dose of TUBESOL 5 TU, lot number C1954AA, administered in the left forearm on 7/26/04. The patient had recently immigrated to the US and was administered the products because she had no documentation of her vaccination history and had to abide by the country's immigration laws. Five hours after vaccination, the patient developed fever, chills, general malaise, weakness, and paresthesia of her left arm and upper chest. She also experienced a local reaction (site not specified) of redness, swelling, and induration. Unknown length of time following administration of Tubersol, the patient's skin test was determined as positive with an area of induration, measuring 19 millimeters. As of 7/28/04, the events were resolving. From additional information received on 8/30/04 from the reporting physician, additional patient, vaccine, medication and lab information was provided. Per the patient, she has received unknown doses of BCG vaccine as childhood vaccinations. It was also reported that the TD ADS ADULT vaccination was administered IM, and the TUBERSOL skin test was administered ID. She had one positive TUBERSOL skin test with erythema, and induration 19 millimeters at the site of ID injection. The patient took over the counter ibuprofen (doses unknown) at the time of reaction with mild improvement. She was seen two days after the vaccination at which time she was approximately 60-80% better. From additional information received on 11/8/04 from a physician, it was reported that the patient was lost to follow up. No further information is anticipated. This case is considered closed.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Paraesthesia, Pyrexia
Clinical narrative: From initial information received on 7/28/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of TD ADS ADULT, lot number U1185AA, administered in the left deltoid and a dose of TUBESOL 5 TU, lot number C1954AA, administered in the left forearm on 7/26/04. The patient had recently immigrated to the US and was administered the products because she had no documentation of her vaccination history and had to abide by the country's immigration laws. Five hours after vaccination, the patient developed fever, chills, general malaise, weakness, and paresthesia of her left arm and upper chest. She also experienced a local reaction (site not specified) of redness, swelling, and induration. Unknown length of time following administration of Tubersol, the patient's skin test was determined as positive with an area of induration, measuring 19 millimeters. As of 7/28/04, the events were resolving. From additional information received on 8/30/04 from the reporting physician, additional patient, vaccine, medication and lab information was provided. Per the patient, she has received unknown doses of BCG vaccine as childhood vaccinations. It was also reported that the TD ADS ADULT vaccination was administered IM, and the TUBERSOL skin test was administered ID. She had one positive TUBERSOL skin test with erythema, and induration 19 millimeters at the site of ID injection. The patient took over the counter ibuprofen (doses unknown) at the time of reaction with mild improvement. She was seen two days after the vaccination at which time she was approximately 60-80% better. From additional information received on 11/8/04 from a physician, it was reported that the patient was lost to follow up. No further information is anticipated. This case is considered closed.
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Medication error
Clinical narrative: From initial information received on 8/2/04 from a physician regarding an adverse event occurring in the USA, it was reported that a male patient (age and date of birth not reported) received a dose of TD ADS ADULT vaccination, lot number U1024AA, inadvertently administered ID instead of TUBERSOL 5 TU on 7/30/04. The next day, on 7/31/04, the patient developed redness and swelling at the injection site. He was treated with a cool compress and improved slightly. The patient has not recovered from these events. From additional information received on 1/4/05 from a physician, it was reported that the patient experienced local irritation after immunization, but recovered from the events. No further information is anticipated. This case is considered closed.
Age: 72.0
Sex: F
Vaccine: RAB, RAB, TD
Symptoms: Fatigue, Injury, Nausea, Pain
Clinical narrative: From initial information received on 8/2/04 from the patient's husband, who is a physician, and from the patient on 8/3/04, regarding an adverse event occurring in the USA, it was reported that the 72 year old female patient received a first dose of IMOGAM USP HT; a dose of TD ADS ADULT; and a first dose of RABAVERT, lot number 330011,  administered in the right hip on 5/24/04. The lot numbers and routes and administration were not reported for the IMOGAM USP HT and TDS ADULT. The patient received the products as part of a post-exposure prophylaxis. Three to four hours after receiving the products, the patient experienced nausea, which lasted for several hours. She also developed aches all over her body, especially in her legs and has also experienced fatigue, which has lasted for five weeks. The patient's status was reported as not recovered. From additional information received on 9/16/04 from a health care professional, it was reported that the 72 year old female patient had no illnesses at the time of vaccination. She has allergies to epinephrine and flu vaccine. On 5/23/04, the day before receiving the IMOGAM treatment, the patient finished taking a Z pack for oral surgery. On 5/24/04, the patient had a bat land on her arm, a red scratch mark was noted on her right lower arm. Reportedly the bat got away. That same day the patient received IMOGAM USP HT, administered IM in an unspecified site, a TD ADS ADULT vaccination administered IM in the gluteus maximus and a RABAVERT vaccination, administered IM in the gluteus maximus. On 5/27/04, the patient received her second dose of RABAVERT, lot number 330011 administered in an unspecified site. On 5/31/04, the patient received her third dose of RABAVERT, lot number 330011 administered in the left hip and on 6/7/04, the patient received her fourth dose of RABAVERT, lot number 330011 administered in the left deltoid. It was not reported if the patient experienced any adverse events following the administration of the last three RABAVERT vaccinations. The patient's recovery status is currently unknown.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: From initial information received on 8/6/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 57 year old female patient received a third dose of TD ADS ADULT, lot number U1025AA, administered IM in the left deltoid on 7/29/04. Later that same day, the patient's left arm was sore. Two days alter, she experienced redness of the site of injection. The patient's left arm continued to be sore and on approximately 8/4/04 the patient started to experience a burning and tingling sensation from the left shoulder to her finger tips and the arm felt hot at the injection site. The injection site was red with a 4cmx3cm area of induration. The patient's recovery status was reported as unknown. From additional information received on 9/24/04 from a health care professional, it was reported that the patient's physician stated that the adverse event appeared to be cellulitis at the injection site. He also reported that the patient works at a nursing home and that possibly the site was not cleaned well at the time of vaccination. The physician stated that he thought the reaction was vaccine related. The patient's recovery status was not reported. From additional information received on 10/13/04 from the patient's physician, it was reported, "No new information. Patient never followed up. Uncertain whether the infection was vaccine related, but rather I expressed that infection may have been introduced at time of the injection. There definitely was cellulitis developing around the site that resolved (apparently) on Biaxin XL 500mg daily for seven days." No further information is anticipated, this case is considered closed.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth, Paraesthesia, Thermal burn
Clinical narrative: From initial information received on 8/6/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 57 year old female patient received a third dose of TD ADS ADULT, lot number U1025AA, administered IM in the left deltoid on 7/29/04. Later that same day, the patient's left arm was sore. Two days alter, she experienced redness of the site of injection. The patient's left arm continued to be sore and on approximately 8/4/04 the patient started to experience a burning and tingling sensation from the left shoulder to her finger tips and the arm felt hot at the injection site. The injection site was red with a 4cmx3cm area of induration. The patient's recovery status was reported as unknown. From additional information received on 9/24/04 from a health care professional, it was reported that the patient's physician stated that the adverse event appeared to be cellulitis at the injection site. He also reported that the patient works at a nursing home and that possibly the site was not cleaned well at the time of vaccination. The physician stated that he thought the reaction was vaccine related. The patient's recovery status was not reported. From additional information received on 10/13/04 from the patient's physician, it was reported, "No new information. Patient never followed up. Uncertain whether the infection was vaccine related, but rather I expressed that infection may have been introduced at time of the injection. There definitely was cellulitis developing around the site that resolved (apparently) on Biaxin XL 500mg daily for seven days." No further information is anticipated, this case is considered closed.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site vesicles, Medication error
Clinical narrative: From initial information received on 8/17/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 38 year old female patient received 0.1ml of TD ADS ADULT vaccine administered ID in error instead of TUBERSOL. The site of administration was not reported. Approximately three and a half weeks alter, the  patient reported that she had developed an 8mm pustule with a white center at the administration site. At the time of this report, the patient was scheduled to be seen by a dermatologist. It is not known if she recovered from these events. From additional information received on 12/23/04 from a health care professional, it was reported that the patient received the vaccine in the forearm. Reportedly, the patient never went to see a dermatologist, but was seen in the emergency department instead as she could not get a clinic or her own primary care physician to treat her. Per the reporter, the patient went to the emergency department inappropriately and was later admitted to the psychiatric unit for behavioral/drug seeking problems. The reporter also stated that the report is unreliable as it was never verified by the vaccine administrator that the event occurred as stated by the patient. It has been presumed that the patient recovered from the event, which never progressed beyond a pustule and was considered to be a minor event. Vaccine administrator and responsible physician information was also provided.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Fatigue, Gingival bleeding, Thrombocytopenia
Clinical narrative: From initial information received on 8/17/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 15 year old female patient received a dose of TD ADS ADULT, lot number U1015AA, administered on 7/8/04. The route and site of administration were not reported. Three days later, on 7/11/04, the patient experienced fatigue, bruising and bleeding of her gums when brushing her teeth. On 7/20/04, her platelet count was at 80 and she was diagnosed with thrombocytopenia. As of 8/4/04, her platelet count had increased to 148. Reportedly, the patient recovered from these events.
Sex: U
Vaccine: TD
Symptoms: Granuloma, Headache, Medication error, Paraesthesia, Syncope
Clinical narrative: From initial information received on 8/19/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that 15 patients (13 students and two teachers) received a TD ADS ADULT vaccination, lot number U1185AA, administered in the forearm on 8/16/04 in error instead of a TUBERCULIN PPD skin test. Later that same day, the patients experienced injection site redness, swelling, and granuloma formatino. Some of the patient's experienced headache, vomiting, syncope, tingling of the arm and hand where the product was administered and decreased used of the arm where the product was administered. All of the patients were taken to a local clinic, where the reactions were measured and photographed. The DOH and CDC were contacted. The recovery status of the patients was reported as unknown. The reporter of this case is the same reporter of cases 200402848 and 200402849.
Sex: U
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: From initial information received on 8/19/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that 15 patients (13 students and two teachers) received a TD ADS ADULT vaccination, lot number U1185AA, administered in the forearm on 8/16/04 in error instead of a TUBERCULIN PPD skin test. Later that same day, the patients experienced injection site redness, swelling, and granuloma formatino. Some of the patient's experienced headache, vomiting, syncope, tingling of the arm and hand where the product was administered and decreased used of the arm where the product was administered. All of the patients were taken to a local clinic, where the reactions were measured and photographed. The DOH and CDC were contacted. The recovery status of the patients was reported as unknown. The reporter of this case is the same reporter of cases 200402848 and 200402849.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction, Medication error
Clinical narrative: From initial info received on 8/27/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 51 year old female pt received a dose of TD ADS ADULT, lot U1020AA, administered ID in error, in the left arm on 7/20/04. That same day, the pt developed cellulitis of the left arm at the site of injection. No treatment was required and the pt recovered from this event. From additional info received on 10/1/04, from an RN, the pt's full name, address and telephone number were provided. Reportedly, the pt did not have any illnesses at the time of vaccination. The reporter had no additional info at this time. No further info is anticipated. This case is considered closed.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: From initial info received on 8/27/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 45 year old female pt received a dose of TD ADS ADULT, lot U1020AA, administered ID in error, in the left arm on 7/29/04. That same day, the pt developed cellulitis of the left arm at the site of injection. She was treated with dicloxacillin 125mg every 6 hours for 2 days. The pt recovered from this event. From additional info received on 10/1/04 from an RN, the pt's full name, address and telephone number were provided. Per the reporter, the pt did not have any illnesses at the time of vaccination. The reporter had no additional info at this time. No further info is anticipated. This case is considered closed.
Age: 38.0
Sex: U
Vaccine: TD
Symptoms: Thermal burn
Clinical narrative: From initial information received on 8/30/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 38 year old female received a booster dose of TD ADS ADULT, lot number U1186AA, administered in the left deltoid on 7/22/04. Several days post-vaccination (exact date not reported), the patient experienced an unusual burning sensation in her body. Her recovery status was not reported. From additional information received on 11/1/04 from a health care professional, it was reported that the route of administration for the TD ADS ADULT product was not documented and the nurse administered the vaccine is no longer employed at the facility due to retirement. The adverse event onset date was reported as 7/24/04 at 11:10 AM. The patient required an emergency room or doctor's visit due to the symptoms. It was not reported whether the patient recovered from this event.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Flushing, Injection site nodule, Musculoskeletal stiffness
Clinical narrative: From initial information received on 9/7/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a female patient (age unknown) received a TD ADS ADULT vaccination, lot number U1347AA, administered in the left upper deltoid on 9/30/04. The same day, the patient developed soreness and stiffness of the left arm and neck. She also experienced a flushed face and a local reaction of a granuloma formation at the injection site. From additional information received on 10/19/04 from the responsible physician, it was reported that the patient was 39 years old at the time of the event. No new medical information was provided and it was not reported whether the patient recovered from these events. The reporter of this case is the same reporter as case 200402989.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site mass, Neck pain, Pyrexia, Urticaria
Clinical narrative: From initial information received on 9/7/04 from a registered nurse who is also the patient, regarding an adverse event occurring in the USA, it was reported that a 44 year old female patient received a TD ADS ADULT vaccination, lot number U1347AA, administered in the left upper deltoid on 9/3/04. The same day, the patient developed a sore neck and arm, a local reaction of knot formation at the injection site, fever of 101 degrees F, chills and hives on her back and chest. She self-medicated with Advil. The patient recovered from these events within 12 hours. From additional information received on 10/19/04 from a physician, the patient's full name address and telephone number were provided. No further information is anticipated. This case is considered closed. The reporter of this case is the same reporter as case 200402988.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Neck pain
Clinical narrative: From initial information received on 9/30/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an elderly female patient (exact age not reported) received TD ADS ADULT vaccination, lot number U1347AA, administered in the right deltoid on 9/23/04. An unspecified amount of time later, the patient experienced swelling, redness, and induration measuring 14cmx12cm at the site of injection. She also developed pain in the right axilla and neck area. She was seen by a physician and prescribed Decadron and Zyrtec. At the time of this report, the patient had not recovered from these events. The reporter of this case is the same as for case 200403263.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Medication error
Clinical narrative: From initial information received on 10/6/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 24 year old male patient received TD ADS ADULT vaccination, lot number U1347AA, administered in the right forearm, and a TUBERSOL 5 TU skin test, lot number C1602AA, administered ID in the right forearm on 10/4/04. Two days later on 10/6/04, the patient developed redness, warmth to the touch, induration the size of a nickel and slight itching. The TD ADS ADULT was inadvertently administered ID. It is unknown if the patient recovered from these events.
Age: 23.0
Sex: M
Vaccine: HEPA, IPV, JEV, RAB, TD, TYP
Symptoms: Abdominal pain, Diarrhoea, Erythema, Face oedema, Pyrexia
Clinical narrative: From initial information received on 10/12/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 23 year old male patient received a dose of IPOL, lot number X1191; his first dose of JE VAX, lot number EJN213A, administered IM in the right arm; a dose of TD ADS ADULT, lot number U1340AA; a dose of TYPHIM VI, lot number X0850; a dose of RABAVERT, lot number 336011; and a dose of HEPATITIS A VACCINE, lot number AHAVA020BA, administered on 10/5/04. The routes and sites of administration for all products except for JE VAX were not reported. Five days later, on 10/10/04, the patient experienced crampy abdominal pain, diarrhea, rash, hives, facial tightness, redness and felt feverish. Reportedly the symptoms resolved within a few hours without intervention and the patient recovered from these events.
Age: 23.0
Sex: M
Vaccine: HEPA, IPV, JEV, RAB, TD, TYP
Symptoms: Rash, Urticaria
Clinical narrative: From initial information received on 10/12/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 23 year old male patient received a dose of IPOL, lot number X1191; his first dose of JE VAX, lot number EJN213A, administered IM in the right arm; a dose of TD ADS ADULT, lot number U1340AA; a dose of TYPHIM VI, lot number X0850; a dose of RABAVERT, lot number 336011; and a dose of HEPATITIS A VACCINE, lot number AHAVA020BA, administered on 10/5/04. The routes and sites of administration for all products except for JE VAX were not reported. Five days later, on 10/10/04, the patient experienced crampy abdominal pain, diarrhea, rash, hives, facial tightness, redness and felt feverish. Reportedly the symptoms resolved within a few hours without intervention and the patient recovered from these events.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Medication error
Clinical narrative: From initial information received on 10/21/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that two patient's (age and gender not reported) received TD ADS ADULT, lot number U0840AA, administered ID in error instead of TUBERCULIN PPD on 10/19/04 or 10/20/04. An unspecified amount of time later, the patients developed redness at the test site. The recovery status of the patients is unknown. The reporter of this case is the same as for cases 200403440 and 200403441.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: From initial information received on 10/21/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that two patients (no individual identification provided) received TD ADS ADULT, lot number U0840AA, administered ID in error on 10/19/04 or 10/20/04 instead of TUBERCULIN PPD. An unspecified amount of time later, the patients developed redness and pain at the site of administration. The recovery status of the patients was reported to be unknown. The reporter of this case is the same as for cases 200403439 and 200403441.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Medication error
Clinical narrative: From initial information received on 10/21/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a cluster of six patients (dates of birth, ages, and genders not reported) inadvertently received a dose of TD ADS ADULT, lot number U0640AA, administered ID instead of TUBERCULIN PPD with three vaccination given on 10/19/04 and three given on 10/20/04. Sites of administration were not reported. An unspecified amount of time later, all six patients developed redness at the site of injection. Two out the six patients also developed injection site pain. In additions, two other patients out of the six also developed injection site induration. It is unknown whether any of the patients recovered from these events. The reporter of this case is the same reporter as cases 200403439 and 200403440.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Myalgia
Clinical narrative: From initial information received on 12/8/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 46 year old male patient received a dose of TD ADS ADULT, lot number U1347AA, administered IM in the left deltoid on 12/3/04 for travel purposes. The patient was not sure how many previous doses he received prior to the last booster. An unspecified amount of time later in December of 2004, the patient developed a deep muscle pain rated as a 7 on a scale of 1 to 10 with 10 being the worst. Per the reporter, the pain is persistent and still continues. The patient previously received a dose of TYPHIM VI, lot number X0771, administered in the right deltoid, a dose of IPOL, lot number X0521, administered in the right arm and a dose of Hepatitis A vaccine, lot number AHAVA020BA, administered in the left deltoid on 11/5/04. Per the reporter, the patient did not recover from this event.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Medication error, Vomiting
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 26 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 10:10 AM. Later that same day, the patient developed redness, swelling and itching at the site of injection. On 8/19/04, she also developed vomiting and diarrhea. It was reported that the patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404037, 200404038, 200404039, 200404041, 200404042 and 200404043.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Medication error, Pruritus
Clinical narrative: From initial information received on 12/28/04 and 12/30/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 20 year old female patient received a 0.1cc dose of TD ADS ADULT, lot number U1356AA, administered ID in the left forearm in error instead of TUBERCULIN PPD on 12/28/04 at 10:00 AM. 140 minutes later, at 12:20 PM, the patient developed itching at the site of injection. At the time of this report, the patient had not recovered from this event.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: From initial information received on 1/11/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a cluster of four patients received a dose of TD ADS ADULT, lot number U1282AA, administered on an unspecified date. Routes and sites of administration were not reported. An unspecified amount of time later, all four patients developed red swollen areas at the site of injection. One of the patients also developed systemic body aches. It was not reported whether any of the patients recovered from these events.
Sex: U
Vaccine: TD
Symptoms: Influenza like illness, Injection site pain, Myalgia
Clinical narrative: From initial information received on 1/19/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a cluster of five patients received a dose of DECAVAC, lot number U1206BA, administered IM on 1/13/05. The site of administration was not reported. The following day, on 1/14/05, all five patients experienced pain at the injection site, as well as extreme muscle pain and flu-like symptoms. The patient's recovery status was reported as unknown.
Sex: U
Vaccine: TD
Symptoms: Hypokinesia, Pain
Clinical narrative: From initial information received on 2/18/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a total of seven patients received a dose of DECAVAC, lot number U1206DA, administered IM in the deltoid on an unspecified date. An unspecified amount of time later, five of the patients experienced arm soreness and some pain, resulting in decreased mobility in the arm that the vaccine was given. The patients all recovered from these events.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Pain
Clinical narrative: From initial information received on 3/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 53 year old patient received a dose of DECAVAC, lot number U1206DA, administered IM in the left deltoid on 2/22/05. Seven days later, on 3/1/05, the patient experienced a deep throbbing sensation in her left arm with limited movement. Per the reporter, the patient had been moving furniture that week. Upon examination, no tenderness or inflammation was noted. The patient self-medicated with ibuprofen and was to follow up with an orthopedic specialist. Her recovery status was reported as unknown.