chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: MEN
Symptoms: Musculoskeletal stiffness
Clinical narrative: From initial information received on 13Aug04 from a RN regarding an adverse event occurring, it was reported that a 25 year old female pt received a second dose of Menomune A/C/Y/W-135, lot number UE301AA, administered SC in the left upper arm on 13Aug04 at 9:20AM. 160 minutes later, at 12:00PM, the pt experienced stiffness to the back of her neck. The pt recovered from this event. From additional information received on 12Oct04 from the reporting facility, it was reported that the pt was monitored by the company physician. On presentation, she no longer had symptoms and was released back to work full duty. On initial presentation, the pt was treated with an over the counter dose of ibuprofen and returned back to work. Her symptoms lasted a few hours. No further information is anticipated, this case is considered closed.
Age: 29.0
Sex: M
Vaccine: MEN
Symptoms: Chills, Diarrhoea, Injection site oedema, Injection site pain, Lymphadenopathy
Clinical narrative: From initial information received from a health care professional on 18Aug04 regarding an adverse event occurring it was reported that a 29 year old male pt received his second dose of Menomune A/C/Y/W-135 vaccine, lot number UE301AA, administered SC in the left upper arm at 6:00PM on 16Aug04. The next day on 17Aug04 at 12:45AM, the pt experienced pain and swelling under his left armpit and his neck glands were sore and felt swollen. He also experienced nausea, vomiting, diarrhea, chills and felt like he had a fever. Reportedly, the pt recovered from these events. From additional information received on 18Nov04 from the initial reporter, it was reported that this case was reviewed and there is no additional information at this time. No further information is anticipated, this case is considered closed.
Age: 29.0
Sex: M
Vaccine: MEN
Symptoms: Nausea, Pyrexia, Similar reaction on previous exposure to drug, Vomiting
Clinical narrative: From initial information received from a health care professional on 18Aug04 regarding an adverse event occurring it was reported that a 29 year old male pt received his second dose of Menomune A/C/Y/W-135 vaccine, lot number UE301AA, administered SC in the left upper arm at 6:00PM on 16Aug04. The next day on 17Aug04 at 12:45AM, the pt experienced pain and swelling under his left armpit and his neck glands were sore and felt swollen. He also experienced nausea, vomiting, diarrhea, chills and felt like he had a fever. Reportedly, the pt recovered from these events. From additional information received on 18Nov04 from the initial reporter, it was reported that this case was reviewed and there is no additional information at this time. No further information is anticipated, this case is considered closed.
Age: 23.0
Sex: F
Vaccine: TD, YF, TD, YF, TD, YF
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Influenza like illness, Lethargy
Clinical narrative: From initial information received on 02Sep04 from a health care professional, it was reported that a 22 year old female pt received her sixth dose of TD ADS Adult vaccine, lot number U1282AA, administered IM in an unspecified site and her first dose of YF Vax vaccine, lot number UE180A, administered SC in an unspecified site at 1:00PM on 30Aug04. Two days later, on 01Sep04, the pt developed flu-like symptoms, became lethargic and her left axilla lymph nodes became enlarged. On 02Sep04 the pt was examined by a physician and no enlargement of lymph nodes were noted.  The pt recovered status is currently unk. From additional information received on 28Sep04 from a health care professional, it was reported that the pt's flu like symptoms consisted of diarrhea, stomach cramping, and fatigue. She also had arm aches. It was not reported whether the pt recovered from these events.
Age: 23.0
Sex: F
Vaccine: TD, YF, TD, YF, TD, YF
Symptoms: Lymphadenopathy, Pain
Clinical narrative: From initial information received on 02Sep04 from a health care professional, it was reported that a 22 year old female pt received her sixth dose of TD ADS Adult vaccine, lot number U1282AA, administered IM in an unspecified site and her first dose of YF Vax vaccine, lot number UE180A, administered SC in an unspecified site at 1:00PM on 30Aug04. Two days later, on 01Sep04, the pt developed flu-like symptoms, became lethargic and her left axilla lymph nodes became enlarged. On 02Sep04 the pt was examined by a physician and no enlargement of lymph nodes were noted.  The pt recovered status is currently unk. From additional information received on 28Sep04 from a health care professional, it was reported that the pt's flu like symptoms consisted of diarrhea, stomach cramping, and fatigue. She also had arm aches. It was not reported whether the pt recovered from these events.
Age: 23.0
Sex: F
Vaccine: TD, YF, TD, YF, TD, YF
Symptoms: Influenza like illness, Lethargy, Lymphadenopathy
Clinical narrative: From initial information received on 02Sep04 from a health care professional, it was reported that a 22 year old female pt received her sixth dose of TD ADS Adult vaccine, lot number U1282AA, administered IM in an unspecified site and her first dose of YF Vax vaccine, lot number UE180A, administered SC in an unspecified site at 1:00PM on 30Aug04. Two days later, on 01Sep04, the pt developed flu-like symptoms, became lethargic and her left axilla lymph nodes became enlarged. On 02Sep04 the pt was examined by a physician and no enlargement of lymph nodes were noted.  The pt recovered status is currently unk. From additional information received on 28Sep04 from a health care professional, it was reported that the pt's flu like symptoms consisted of diarrhea, stomach cramping, and fatigue. She also had arm aches. It was not reported whether the pt recovered from these events.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: From initial information received on 03Sep04 from a health care professional regarding an adverse event occurring, it was reported that an 18 year old male pt received a Menomune A/C/Y/W-135 vaccination, lot number UE158AA, administered SC in the right arm on 19Aug04. Two days later, the pt experienced intense muscle pain, fever of 100 F, severe headache and neck stiffness. Reportedly the symptoms lasted for 48 hours and subsequently. From additional information received on 11Oct04 from a health care professional, the pt's full name was provided. Per the reporter the information has been reviewed and no additional information is available at this time. No further information is anticipated. This case is considered closed.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Arthralgia, Medication error, Myalgia, Pyrexia
Clinical narrative: From initial information received from a pharmacist regarding an adverse event occurring, it was reported that the pharmacy dispensed a dose of Menomune A/C/Y/W-135 to the pt's grandmother. The vaccine was left out of refrigeration for five days and was then administered to a male pt by his grandmother on an unspecified date. The pt now complains of a fever, muscle aches and joint pain. No specifics were provided regarding the pt's age, the lot number, route, site or vaccination date of the product administered or the onset date of the adverse events. The pt's recovery status is currently unk. From additional information received on 25Oct04, it was reported that the pt is an 18 year old male. The responsible physician's name was also provided. Per the reporter the case was reviewed and there is no additional information at this time. The pt's recovery status was not reported.
Sex: F
Vaccine: MEN
Symptoms: Laboratory test abnormal
Clinical narrative: From initial information received on 09/21/04 from a physician regarding an adverse event occurring in the USA, it was reported that a female patient (age and date of birth not reported) received a dose of Menomune A/C/Y/W-135, lot number UE239aa, administered on 09/20/04. The route and site of administration were not reported. During routine blood work the following day, it was noted that the patient had elevated white blood cell count of 16.4. No other signs or symptoms were noted. It was not reported whether the patient recovered from this event.
Age: 37.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Blister, Rash erythematous
Clinical narrative: From initial information received on 12Oct04 from a health care professional regarding an adverse event occurring, it was reported that a 36 year old male pt received a dose of Menomune A/C/Y/W-135, lot number UE301AA, site of administration not reported, as well as a dose of TD ADS adult, lot number U1283AA, administered in the left deltoid, on 08Oct04. Routes of administration were not reported. The following day, the pt developed patchy red areas measuring approx five millimeters in size on one side of his buttocks bilaterally extending up his torso with approximately 30 in number on his torso. The red areas were also noted on his left arm and right elbow. Some of the sites were blistered and opened. No drainage was noted. The pt denied pruritus. Reportedly Benadryl was ordered. Per a physician, the symptoms persist. The pt also previously received Twinrix, on 08Sep04 with no reaction reported. He also received IPOL, Typhoid vaccine, manufacturer unk , Yellow fever vaccine, manufacturer unk and Measles Mumps and Rubella vaccine, on an unspecified date in August with no reactions reported. Lot numbers as well as routes and sites of admin for these vaccines were not reported. Reportedly, the pt did not recover from these events.
Age: 37.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Erythema, Rash
Clinical narrative: From initial information received on 12Oct04 from a health care professional regarding an adverse event occurring, it was reported that a 36 year old male pt received a dose of Menomune A/C/Y/W-135, lot number UE301AA, site of administration not reported, as well as a dose of TD ADS adult, lot number U1283AA, administered in the left deltoid, on 08Oct04. Routes of administration were not reported. The following day, the pt developed patchy red areas measuring approx five millimeters in size on one side of his buttocks bilaterally extending up his torso with approximately 30 in number on his torso. The red areas were also noted on his left arm and right elbow. Some of the sites were blistered and opened. No drainage was noted. The pt denied pruritus. Reportedly Benadryl was ordered. Per a physician, the symptoms persist. The pt also previously received Twinrix, on 08Sep04 with no reaction reported. He also received IPOL, Typhoid vaccine, manufacturer unk , Yellow fever vaccine, manufacturer unk and Measles Mumps and Rubella vaccine, on an unspecified date in August with no reactions reported. Lot numbers as well as routes and sites of admin for these vaccines were not reported. Reportedly, the pt did not recover from these events.
Age: 41.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Urticaria
Clinical narrative: From initial information received on 22Oct04 from a RN regarding an adverse event occurring, it was reported that a 40 year old female pt received her first dose of Menomune A/C/Y/W-135, lot number UE348AA, administered SC in the left arm on 20Oct04. She also received her first dose of Pneumonia vaccine, lot number 0986N, administered intramuscularly in the left deltoid on 21Oct04 at 3:45PM. At 5:00PM on 21Oct04, the pt developed hives on upper arms, legs, chest and eye lids. Per pt, she did not develop shortness of breath or any other symptoms. Reportedly, the symptoms mostly resolved the following morning on 22Oct04 and completely resolved by 11:00AM. Pt's pre-existing medicl conditions include hypothyroidism, Hashimoto's  and angioedema. At the time of vaccination, the pt also took Atenolol, Levoxyl and Epipen. She had no illnesses at the time of vaccination.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, TTOX, YF
Symptoms: Medication error
Clinical narrative: Pt inadvertently received an extra dose of Twinrix (Hep A and B). Denies any symptoms.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anorexia, Diarrhoea, Drug ineffective, Hypoglobulinaemia, Leukopenia
Clinical narrative: Information has been received from a physician concerning an approximately 13 month old male who in early October 2004, was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included a dose of MMR. The physician reported that the patient was thought to be well and without any known underlying condition. It had since been determined that the patient had a primary immune deficiency that could not be classified easily and that he had an antiviral T-cell function that was defective clinically. Three weeks after vaccination, the patient began to have chicken pox lesions appear followed by protracted diarrhea and profound malnutrition. The patient was treated as an outpatient with oral acyclovir and was not getting better. The patient was then admitted to a hospital and was not getting any better. The patient was then transferred to another hospital on 12/8/04 where he was treated with IV acyclovir and for 10 days prior to the report, foscarnet. The patient was reported to have hypogammaglobulinemia with leukopenia. He had a normal mitogen response. At the time of the report, the patient remained hospitalized. Although he was improving, through out the sixth week post vaccination course he has had new crops of chicken pox and was not healing normally from the lesions. At the time of the report, the patient had had lesions of chicken pox for four weeks and the reporter believed this was a case of antiviral induced resistance from acyclovir. The physician noted that he had specimens that tested positive for varicella zoster virus on 12/8/04 and that he though that the strain was the Oka strain that had a mutated gene. The physician also had specimens from the second reoccurrence of the chicken pox. The physician indicated an interest in sequencing the thymidine kinase gene to determine if a mutation exists or if there had been a reversion to the WTV. A product quality complaint was not involved. Additional information has been requested. Per follow up report received on 06/14/2005:  Patient still has not recovered. 10/5/06 Received Death Certificate which reveals COD as measles inclusion body encephalitis & immunodeficiency/ss
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning an approximately 13 month old male who in early October 2004, was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included a dose of MMR. The physician reported that the patient was thought to be well and without any known underlying condition. It had since been determined that the patient had a primary immune deficiency that could not be classified easily and that he had an antiviral T-cell function that was defective clinically. Three weeks after vaccination, the patient began to have chicken pox lesions appear followed by protracted diarrhea and profound malnutrition. The patient was treated as an outpatient with oral acyclovir and was not getting better. The patient was then admitted to a hospital and was not getting any better. The patient was then transferred to another hospital on 12/8/04 where he was treated with IV acyclovir and for 10 days prior to the report, foscarnet. The patient was reported to have hypogammaglobulinemia with leukopenia. He had a normal mitogen response. At the time of the report, the patient remained hospitalized. Although he was improving, through out the sixth week post vaccination course he has had new crops of chicken pox and was not healing normally from the lesions. At the time of the report, the patient had had lesions of chicken pox for four weeks and the reporter believed this was a case of antiviral induced resistance from acyclovir. The physician noted that he had specimens that tested positive for varicella zoster virus on 12/8/04 and that he though that the strain was the Oka strain that had a mutated gene. The physician also had specimens from the second reoccurrence of the chicken pox. The physician indicated an interest in sequencing the thymidine kinase gene to determine if a mutation exists or if there had been a reversion to the WTV. A product quality complaint was not involved. Additional information has been requested. Per follow up report received on 06/14/2005:  Patient still has not recovered. 10/5/06 Received Death Certificate which reveals COD as measles inclusion body encephalitis & immunodeficiency/ss
Age: 46.0
Sex: F
Vaccine: MMR, TD
Symptoms: Disturbance in attention, Eye swelling, Fatigue, Memory impairment, Oedema peripheral
Clinical narrative: Woke up with swollen eyes the following morning. Then, the nightmare began. Feet, ankles and legs (almost twice their sizes) were swollen. Extreme exhaustion and fatigued. Lack of concentration in class and after class causing me to do poorly in school. Dark rash under my chin and stomach. Medical Records received on 3/11/2005 states pain. Per follow up report received 06/10/2005:  Patient still has not recovered. 12/30/2009 I am still not back to normal. I am still experiencing problems with my memories. I must study the classwork material over, and over, and over again (and still there are times when I do not remember or comprehend what I have studied). The nightmare continues because I have problems remembering formulas and some complicated definitions. Please make certain what happened to me does not happen to anyone else. Thank you for caring.
Age: 46.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pain, Rash
Clinical narrative: Woke up with swollen eyes the following morning. Then, the nightmare began. Feet, ankles and legs (almost twice their sizes) were swollen. Extreme exhaustion and fatigued. Lack of concentration in class and after class causing me to do poorly in school. Dark rash under my chin and stomach. Medical Records received on 3/11/2005 states pain. Per follow up report received 06/10/2005:  Patient still has not recovered. 12/30/2009 I am still not back to normal. I am still experiencing problems with my memories. I must study the classwork material over, and over, and over again (and still there are times when I do not remember or comprehend what I have studied). The nightmare continues because I have problems remembering formulas and some complicated definitions. Please make certain what happened to me does not happen to anyone else. Thank you for caring.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Pain
Clinical narrative: 01/18/2005 - 5:20pm Onset of severe dizziness and "lightheadedness" extreme fatigue. 01/19/2005 - Upon awakening - severe pain at posterior mid-thoracic with movement - "felt like pleurisy" dizziness continued. 01/12/2005 - Symptoms worsened with myalgia of neck, headache.  Saw physician received Tamiflu.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pleurisy
Clinical narrative: 01/18/2005 - 5:20pm Onset of severe dizziness and "lightheadedness" extreme fatigue. 01/19/2005 - Upon awakening - severe pain at posterior mid-thoracic with movement - "felt like pleurisy" dizziness continued. 01/12/2005 - Symptoms worsened with myalgia of neck, headache.  Saw physician received Tamiflu.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: 01/18/2005 - Fatigue 01/19/2005 - Upon awakening severe dizziness "unable to drive" fatigue, headache. 01/20/2005 - Malaise, myalgia ankles, fever, continued dizziness headache.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 01/18/2005 - Fatigue 01/19/2005 - Upon awakening severe dizziness "unable to drive" fatigue, headache. 01/20/2005 - Malaise, myalgia ankles, fever, continued dizziness headache.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Myalgia, Pyrexia, Upper respiratory tract infection
Clinical narrative: 01/18/2005 - Extreme dizziness onset and upper respiratory congestion. 01/19/2005 - Upon awakening myalgia neck, shoulders, continued respiratory congestion, temperature 100.4 - symptoms continued all day. 01/20/2005 - Increase in myalgia to lower body, headache, continued respiratory congestion - saw physician received Tamiflu.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Anaphylactic reaction, Anxiety, Chest pain, Dyspnoea
Clinical narrative: Anxiety, itching, watering eyes, agitation, anaphylaxis, chest pain, congestion, nasal, dyspnea.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Nasal congestion, Pruritus
Clinical narrative: Anxiety, itching, watering eyes, agitation, anaphylaxis, chest pain, congestion, nasal, dyspnea.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MEN, MMR
Symptoms: Medication error, Overdose
Clinical narrative: Patient inadvertently received an extra dose of pneumococcal vaccine, denies any symptoms.
Age: 1.72
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Erythema, Injection site induration, Pyrexia, Swelling
Clinical narrative: Fever, erythema, induration and swelling on right thigh, redness and induration 3 x 2.5 CM.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Red rash and itching covering entire back, along incision from back surgery and wrist, and under breast.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Rash on arms and legs - not itchy, mild irritation.  No prior reactions to shots.  No treatment given.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Complained of redness, and swelling of left arm with mild pain for duration of 2 days following administration of pneumonia shot.  To MD on  10-22-04.  Diagnosis of cellulitis. Prescription given for Augmentin XR times 5 days.  Treated with warm compresses.
Age: 0.41
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Hypokinesia, Irritability, Laboratory test abnormal, Pain, Pyrexia
Clinical narrative: Within an hour of the vaccines, mother recalls her being fussy and shortly thereafter developing a fever.  She had a fever up to 103 and noticably stopped using her legs voluntarily.  She normally puts her feet in her mouth and she was not even flexing her hips much.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Received Pnuemovax Vaccine in her right arm at approx 11 am on Jan 12,2005. At approx. 3PM had swelling  and pain around vaccine site with erythema encompassing entire upper arm. Site was hot and endurated. Applied cold packs to site. Did not seek medical attention. Reported reaction on 1/20/05. Still has some redness around site, complains of itching around site and upper arm. Advised pt. to contact her primary physician for follow up.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Received Pnuemovax Vaccine in her right arm at approx 11 am on Jan 12,2005. At approx. 3PM had swelling  and pain around vaccine site with erythema encompassing entire upper arm. Site was hot and endurated. Applied cold packs to site. Did not seek medical attention. Reported reaction on 1/20/05. Still has some redness around site, complains of itching around site and upper arm. Advised pt. to contact her primary physician for follow up.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Complained of swelling and knot at shot site on right arm tmes 4 days.  Good ROM.  No MD visit.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 10/20/04 Client complained of painful, red, swollen right arm after PPV23 immunization given on 10/19/04.  Good ROM and blanching.  Saw MD on 10/21/04.  Rx: Ibuprofen; Benedryl.  Tx: cold compresses
Age: 0.82
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Convulsion, Pyrexia, Urinary tract infection
Clinical narrative: She had been in for her 9mo well exam on 12/28/04 and was to receive her 6mo immunizations.  She received the Pediarix, Prevnar, Hib, and the Fluzone for influenza. That evening, at approximately 2100, she was taken to the local ED for a possible seizure and a fever up to 103.  With her evaluation at the ED she had a urine sample obtained by catheter that showed her to have a urinary tract infection.  It was unclear as to whether she had a primary seizure, or a seizure from the fever from the shots or a seizure from a febrile urinary tract infection.   She was fine on the day recheck in the office on 12/30/04.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: 1 hr. after receiving vaccine, developed itching on left wrist, no hives; developed swelling in left hand that continued to the following day.
Age: 23.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: 1/13/05 Developed swelling, redness, itching of entire left upper arm along with heat (hot to touch) 1/15/05 Developed what patient describes as a dime-sized lump in left axilla. By 1/16/05 it was about the size of a nickel along with nausea and vomiting.  As of 1/18 still persists. As per annual follow up report 04/25/2005 lump in left axilla persists, non painful. Family physician recommends removal and believes this is a result of the immunization. If patient decides to have it removed, will contact the local public health agency with pathology report.  NOTE: the patient states that she had a tetnus shot three years ago, but did not have record of it and needed this for school program.
Age: 23.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Pruritus, Vomiting
Clinical narrative: 1/13/05 Developed swelling, redness, itching of entire left upper arm along with heat (hot to touch) 1/15/05 Developed what patient describes as a dime-sized lump in left axilla. By 1/16/05 it was about the size of a nickel along with nausea and vomiting.  As of 1/18 still persists. As per annual follow up report 04/25/2005 lump in left axilla persists, non painful. Family physician recommends removal and believes this is a result of the immunization. If patient decides to have it removed, will contact the local public health agency with pathology report.  NOTE: the patient states that she had a tetnus shot three years ago, but did not have record of it and needed this for school program.
Age: 0.69
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever up to 103F for 4 days following the Influenza vaccine.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Mucous membrane disorder, Pyrexia, Skin ulcer
Clinical narrative: Possible vaccine failure. Began lesions erupting 1/3/05 and continued to break out until 1/9/05. Lesions from top of head down to feet. Excess of 50 lesions. Mucous membranes affected by lesions. Low grade temp. elevation prior to lesions appearing. (Another child in school with possible vaccine failure.)
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Pyrexia, Skin ulcer
Clinical narrative: Possible vaccine failure. Varicella lesions appeared 1/6/05 and continued to erupt for 4 - 5 days. 50 plus lesions. Low grade fever 4 - 5 days.  (Another child in same school with possible vaccine failure.)
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Cardiomegaly, Chest discomfort, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: This is a serious post marketed study case from a physician who reports a pt required hospitalization for viral pericarditis after receiving FluMist vaccination. The reporter assessed the events to be possibly related to FluMist study vaccine. On 10Dec04, a 23 year old female received FluMist or Placebo and on 27Dec04 developed acute pericarditis with moderate pericardial effusion while participant in an investigator initiated randomized, double-blinded, placebo-controlled, experimental, epidemiological study. The pt developed trouble breathing on 10Dec04 some time after receiving FluMist. She indicated this to be mild on her daily post vaccination report form from 10Dec04 and moderate on 16Dec04 and 17Dec04. The pt reported feeling chest pain 16Dec04 and constant pressure as well as couldn't take a deep breath. She also had a sinus cold. The pt attributed her chest pain to the cold and her 5 cigarette per day smoking. The pt developed a fever of 100.5 degrees F on 25Dec04. On 26Dec04, the pt had 5-6 bouts of diarrhea. The pt went to urgent care and was subsequently referred to the ER. She presented to the ER on 27Dec04 and was hospitalized with general malaise for the past week that had progressed into substernal chest pressure resulting in difficulty breathing. On the same day she presented to the ER, she also had 5-6 bouts of runny stool as well as low grade fever of 100.5 degree range at home every night over an unspecified date. The hospital discharge summary relates a diagnosis of pericardial effusion, possibly secondary to viral pericarditis. Pulmonary embolism was ruled out due to lack of contraceptive use, no recent travel, no calf symptoms, and the insidious onset of symptoms. The pt's elevated white blood cell count, erythrocyte sedimentation rate, and C-reactive protein indicated an inflammatory process. The discharge summary states the pt's clinical presentation is most consistent with acute viral pericarditis. Chest x-ray indicated an enlarged heart border. A bedside echocardiogram showed results consistent with a moderate sized pericardial effusion but no frank tamponade. Cardiac consultation decided to defer pigtail drainage of effusion in light of the pt's stable clinical findings. A repeat echocardiogram on day of discharge continued to demonstrate a moderate effusion but no change in appearance from 27Dec04. The pt was discharged on 29Dec04 with instructions to continue around the clock NSAIDS for two weeks. As of 04Jan05, the pt claims she feels better but that mild physical exertion such as climbing stairs still causes her to feel chest pressure. The pt will follow up with general medicine on 07Jan05 and cardiology on 27Jan05. Additional information has been requested in terms of infectious agent.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Laboratory test abnormal, Malaise, Pericardial effusion, Pericarditis, Pyrexia
Clinical narrative: This is a serious post marketed study case from a physician who reports a pt required hospitalization for viral pericarditis after receiving FluMist vaccination. The reporter assessed the events to be possibly related to FluMist study vaccine. On 10Dec04, a 23 year old female received FluMist or Placebo and on 27Dec04 developed acute pericarditis with moderate pericardial effusion while participant in an investigator initiated randomized, double-blinded, placebo-controlled, experimental, epidemiological study. The pt developed trouble breathing on 10Dec04 some time after receiving FluMist. She indicated this to be mild on her daily post vaccination report form from 10Dec04 and moderate on 16Dec04 and 17Dec04. The pt reported feeling chest pain 16Dec04 and constant pressure as well as couldn't take a deep breath. She also had a sinus cold. The pt attributed her chest pain to the cold and her 5 cigarette per day smoking. The pt developed a fever of 100.5 degrees F on 25Dec04. On 26Dec04, the pt had 5-6 bouts of diarrhea. The pt went to urgent care and was subsequently referred to the ER. She presented to the ER on 27Dec04 and was hospitalized with general malaise for the past week that had progressed into substernal chest pressure resulting in difficulty breathing. On the same day she presented to the ER, she also had 5-6 bouts of runny stool as well as low grade fever of 100.5 degree range at home every night over an unspecified date. The hospital discharge summary relates a diagnosis of pericardial effusion, possibly secondary to viral pericarditis. Pulmonary embolism was ruled out due to lack of contraceptive use, no recent travel, no calf symptoms, and the insidious onset of symptoms. The pt's elevated white blood cell count, erythrocyte sedimentation rate, and C-reactive protein indicated an inflammatory process. The discharge summary states the pt's clinical presentation is most consistent with acute viral pericarditis. Chest x-ray indicated an enlarged heart border. A bedside echocardiogram showed results consistent with a moderate sized pericardial effusion but no frank tamponade. Cardiac consultation decided to defer pigtail drainage of effusion in light of the pt's stable clinical findings. A repeat echocardiogram on day of discharge continued to demonstrate a moderate effusion but no change in appearance from 27Dec04. The pt was discharged on 29Dec04 with instructions to continue around the clock NSAIDS for two weeks. As of 04Jan05, the pt claims she feels better but that mild physical exertion such as climbing stairs still causes her to feel chest pressure. The pt will follow up with general medicine on 07Jan05 and cardiology on 27Jan05. Additional information has been requested in terms of infectious agent.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Sinus congestion
Clinical narrative: This is a serious post marketed study case from a physician who reports a pt required hospitalization for viral pericarditis after receiving FluMist vaccination. The reporter assessed the events to be possibly related to FluMist study vaccine. On 10Dec04, a 23 year old female received FluMist or Placebo and on 27Dec04 developed acute pericarditis with moderate pericardial effusion while participant in an investigator initiated randomized, double-blinded, placebo-controlled, experimental, epidemiological study. The pt developed trouble breathing on 10Dec04 some time after receiving FluMist. She indicated this to be mild on her daily post vaccination report form from 10Dec04 and moderate on 16Dec04 and 17Dec04. The pt reported feeling chest pain 16Dec04 and constant pressure as well as couldn't take a deep breath. She also had a sinus cold. The pt attributed her chest pain to the cold and her 5 cigarette per day smoking. The pt developed a fever of 100.5 degrees F on 25Dec04. On 26Dec04, the pt had 5-6 bouts of diarrhea. The pt went to urgent care and was subsequently referred to the ER. She presented to the ER on 27Dec04 and was hospitalized with general malaise for the past week that had progressed into substernal chest pressure resulting in difficulty breathing. On the same day she presented to the ER, she also had 5-6 bouts of runny stool as well as low grade fever of 100.5 degree range at home every night over an unspecified date. The hospital discharge summary relates a diagnosis of pericardial effusion, possibly secondary to viral pericarditis. Pulmonary embolism was ruled out due to lack of contraceptive use, no recent travel, no calf symptoms, and the insidious onset of symptoms. The pt's elevated white blood cell count, erythrocyte sedimentation rate, and C-reactive protein indicated an inflammatory process. The discharge summary states the pt's clinical presentation is most consistent with acute viral pericarditis. Chest x-ray indicated an enlarged heart border. A bedside echocardiogram showed results consistent with a moderate sized pericardial effusion but no frank tamponade. Cardiac consultation decided to defer pigtail drainage of effusion in light of the pt's stable clinical findings. A repeat echocardiogram on day of discharge continued to demonstrate a moderate effusion but no change in appearance from 27Dec04. The pt was discharged on 29Dec04 with instructions to continue around the clock NSAIDS for two weeks. As of 04Jan05, the pt claims she feels better but that mild physical exertion such as climbing stairs still causes her to feel chest pressure. The pt will follow up with general medicine on 07Jan05 and cardiology on 27Jan05. Additional information has been requested in terms of infectious agent.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Cardiomegaly, Cough, Dyspnoea, Hypoxia
Clinical narrative: This is a serious case from a physician involving pulmonary vascular congestion: unlabelled. The reporter causality is not provided. A 15 year old female, who received FluMist on 22Oct04, experienced difficulty breathing, wheezing and coughing on 30Oct04. The pt was seen at the physician's office where she was given Xopenex (levalbuterol) nebulizer treatments and Decadron (dexamethasone) IM injection. Despite the treatments, the pt went into severe respiratory distress and was brought to the ER and was subsequently admitted on 30Oct04 with a principal diagnosis upon admission of asthma. During the four day hospitalization, the pt received nebulizer treatments, steroids and chest physiotherapy. Chest x-ray revealed pulmonary vascular congestion and cardiomegaly. Peak flow rates were monitored and had an average of 360. The pt was discharged home on 02Nov04 in stable condition with discharge medications of albuterol MDI, prednisone, Seroquel (quetiapine). The pt's clinical outcome is unk. The reporter did not assess relationship between events and FluMist vaccination. Information from missing data report states 04/22/05 per reporter at physician's office, they do not have a record of the Flumist lot number.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Pulmonary congestion, Respiratory distress, Wheezing
Clinical narrative: This is a serious case from a physician involving pulmonary vascular congestion: unlabelled. The reporter causality is not provided. A 15 year old female, who received FluMist on 22Oct04, experienced difficulty breathing, wheezing and coughing on 30Oct04. The pt was seen at the physician's office where she was given Xopenex (levalbuterol) nebulizer treatments and Decadron (dexamethasone) IM injection. Despite the treatments, the pt went into severe respiratory distress and was brought to the ER and was subsequently admitted on 30Oct04 with a principal diagnosis upon admission of asthma. During the four day hospitalization, the pt received nebulizer treatments, steroids and chest physiotherapy. Chest x-ray revealed pulmonary vascular congestion and cardiomegaly. Peak flow rates were monitored and had an average of 360. The pt was discharged home on 02Nov04 in stable condition with discharge medications of albuterol MDI, prednisone, Seroquel (quetiapine). The pt's clinical outcome is unk. The reporter did not assess relationship between events and FluMist vaccination. Information from missing data report states 04/22/05 per reporter at physician's office, they do not have a record of the Flumist lot number.
Age: 1.53
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure the night after 18 months vaccines.
Age: 1.0
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous, Erythema, Otitis media, Rash maculo-papular, Upper respiratory tract infection
Clinical narrative: Patient with erythopapular scattered blanching rash, changing now with raised central small whitish papule on erythema base on same. Mostly on trunk, abdomen, face and scalp. Also with upper respiratory infection symptoms and right otitis media. Appears like a varicella rash a mild case.
Age: 1.48
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Erythema, Hypokinesia, Swelling, Urticaria
Clinical narrative: Patient has hives, redness, swelling and would not walk on leg.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: DTaP given in the right lateral thigh on 01/18/05, later that day the injection site became inflammed, red and warm to touch. The area became bigger over time. The patient was seen on 01/21/05 and the area was 7 cm wide, red and warm to touch. Patient instructed to apply heat and given a script for Augmentin.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Pruritus
Clinical narrative: Mother complained of dry itchy patches on face and arms after vaccines.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: On 12/16/04, called to report swelling from shoulder to elbow where received pneumococcal vaccine on 12/15/04. Visited ER on 12/16/04 as swelling increased to wrist area, no pain reported. Ice and Motrin recommened by physician.
Age: 1.01
Sex: F
Vaccine: BCG, MMR
Symptoms: Rash morbilliform
Clinical narrative: Patient came in 11 days after vaccine with rash to body. Patient was taking Cephalexin and cough medicine. The rash was measle like. The doctor prescribed Atarax for 5 days and follow up in 72 hours.  1/20/05 Diagnosis: Vaccine sided effect MMR Afebrile
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Patient came in 11 days after vaccine with rash to body. Patient was taking Cephalexin and cough medicine. The rash was measle like and the patient was afebrile. The doctor prescribed Atarax for 5 days and to follow up in 72 hours. 1/20/05 Diagnosis: Vaccine side effect to MMR.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Infection, Oedema peripheral, Pain
Clinical narrative: Entire left thigh swollen and painful. No fever or redness noted. Diagnosed as an infection and treated with Keflex.
Age: 48.0
Sex: M
Vaccine: HEPA, TD, TYP
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Chills, Disorientation
Clinical narrative: Abdominal upset, bloating, nausea, sharp severe pain in lower back/kidney area, disorientation, unable to forms thoughts, feverish, shivers, headache and unusally tired.
Age: 48.0
Sex: M
Vaccine: HEPA, TD, TYP
Symptoms: Fatigue, Headache, Incoherent, Nausea, Pyrexia
Clinical narrative: Abdominal upset, bloating, nausea, sharp severe pain in lower back/kidney area, disorientation, unable to forms thoughts, feverish, shivers, headache and unusally tired.
Age: 48.0
Sex: M
Vaccine: HEPA, TD, TYP
Symptoms: Renal pain, Speech disorder
Clinical narrative: Abdominal upset, bloating, nausea, sharp severe pain in lower back/kidney area, disorientation, unable to forms thoughts, feverish, shivers, headache and unusally tired.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Exposed to varicella 2 weeks ago. Broke out in rash on trunk, arms, legs and face. There were about 25 to 30 lesions. Was given Benpadryl and Calamine lotion for itching.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Apnoea, Coma, Drooling, Electrocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Hypoventilation, Staring
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Blepharospasm, Coma, Convulsion, Fatigue, Gaze palsy
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Laboratory test abnormal
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Convulsion, Cyanosis, Hypotonia
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Coma, Convulsion, Crying, Cyanosis
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Drooling, Feeling abnormal, Gaze palsy, Hypotonia, Hypoventilation
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Screaming
Clinical narrative: In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Eye disorder, Somnolence
Clinical narrative: Received vaccine 10:15 am. Tylenol and bottle at 11 am and napped. Up at around 01:15 pm jerking extremities, wide eyed. Increased solutions at 01:30 pm - then sleepy. Seen at doctor's at 02:30 pm. No color change.
Age: 0.47
Sex: F
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Reported crying and intermittent screaming reaction of short duration and responsive to Tylenol and distraction. Symptoms resolved in 2 days time.
Age: 1.03
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Rash papular
Clinical narrative: Rash noted on trunk, arms and genitalia ( approximately 30 papular red bumps ). Low grade fever and "fussy". Calamine lotion as needed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration
Clinical narrative: Localized induration at injection site approximately 7 by 13 cm. Zyrtec 5 cc administered and to take 5 cc daily until resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema
Clinical narrative: Redness and in duration of left shoulder 9cm x 9cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Injection site erythema, Irritability, Pyrexia, Vomiting
Clinical narrative: Temp 102.0 evening of shot.  Now fever 101.  Both thighs hurt red and inflamed where shots were.  All 3 shots normal looking now.  Spit up x1.  C/O stomach ache - no emesis yet, cranky too.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin disorder
Clinical narrative: Mom states child had varivax vaccine but has now been diagnosed with chicken pox 1-10-2005.  Call mom for further info.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Petechiae, Pyrexia, Rash morbilliform
Clinical narrative: New pt presented on 01/04/05 at our office with fever and morbilliform rash over entire body and hands and palms of hands; around neck beginning of petechiae.
Age: 1.51
Sex: M
Vaccine: HIBV, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever 101 Tylenol
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Fever of 105 degrees and inconsolable crying from greater than 2 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: 7x8 cm on left thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Red, swollen and hot left arm from mid to elbow.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthma, Dyspnoea
Clinical narrative: Client reported on 01/21/05 that she had asthma attack (could not breathe) for few minutes after receiving 1st Twinrix on 12/08/04. Took inhaler and did not require further medical attention.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Developed erythema and induration at site 24hr later. Treated with ice, Motrin and Benadryl.
Age: 1.05
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Vaccine given Monday01/10/2005, mo called 01/12/05. 5 areas poss. chicken pox abd and by L arm pit area.
Age: 1.53
Sex: F
Vaccine: HIBV
Symptoms: Feeling hot, Pharyngitis
Clinical narrative: 01/07/2005 got immunizations, 1/05 felt warm, child won't let mom take her temp, 01/11/05 seen in office T98 pharyngitis.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Migraine
Clinical narrative: Pt received Twinrix2 on 1/6/05. Received phone call from pt on 01/12/05; client states he had been having migraine headaches since 1/8/05 or for the last five days. Has been self medication with OTC remedies. Recommended client see his family doctor for evaluation. Received Twinrix 1 on 12/9/04 with no ill effects.