chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme, Hypersensitivity, Injection site erythema, Injection site haematoma
Clinical narrative: The patient received the Pneumococcal Vaccine. The patient was informed of potential side effects such as flu-like symptoms or soreness at the injection site, and to report to any ER if adverse reactions occur (i.e SOB, rash). 0.5 ml of the vaccine was given Intramuscularly. Injection site: Left Deltoid. Patient Education Dialog: The patient needed instruction on this topic, preferred and received 1:1 verbal instruction (and written if pamphlet title included in note), had no barriers to learning and verbalized understanding. No F/U needs, further care/treatment/services or needs for information on additional resources were identified related to this education topic unless noted. January 6. 2011 5:50pm - veteran complained of pain to left upper arm in deltoid area noted 1/4cm bruising to area and beneath and 2 1/2 cm circular area of redness. Entry date Jan 08, 2011 at 16:40 Pt presented to (Nurses) station c/o arm itching, erythema had spread to cover the whole arm above the elbow. Pt received Pneumococcal vaccine on Thurs 1/6. Pt c/o pain at the site, 5 to 6 cm diameter redness at the injection site note on Thurs night. POD phone and instructed we continue to to watch the site. POD was phoned today and came to examine the site. Plans to prescribe diphenhydramine for itching and document allergic reaction to pneumococcal vaccine. 01/08/2011 17:14 - Patient seen and examined (by physician on call). He presents with redness on right arm at site of pneumococcal vaccine given 1/6/11. According to staff, redness has progressively worsened with spreading to elbow. Patient is afebrile with stable vs. Will order BENADRYL 25MG.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pruritus, Urticaria, Vaccination complication
Clinical narrative: The patient received the Pneumococcal Vaccine. The patient was informed of potential side effects such as flu-like symptoms or soreness at the injection site, and to report to any ER if adverse reactions occur (i.e SOB, rash). 0.5 ml of the vaccine was given Intramuscularly. Injection site: Left Deltoid. Patient Education Dialog: The patient needed instruction on this topic, preferred and received 1:1 verbal instruction (and written if pamphlet title included in note), had no barriers to learning and verbalized understanding. No F/U needs, further care/treatment/services or needs for information on additional resources were identified related to this education topic unless noted. January 6. 2011 5:50pm - veteran complained of pain to left upper arm in deltoid area noted 1/4cm bruising to area and beneath and 2 1/2 cm circular area of redness. Entry date Jan 08, 2011 at 16:40 Pt presented to (Nurses) station c/o arm itching, erythema had spread to cover the whole arm above the elbow. Pt received Pneumococcal vaccine on Thurs 1/6. Pt c/o pain at the site, 5 to 6 cm diameter redness at the injection site note on Thurs night. POD phone and instructed we continue to to watch the site. POD was phoned today and came to examine the site. Plans to prescribe diphenhydramine for itching and document allergic reaction to pneumococcal vaccine. 01/08/2011 17:14 - Patient seen and examined (by physician on call). He presents with redness on right arm at site of pneumococcal vaccine given 1/6/11. According to staff, redness has progressively worsened with spreading to elbow. Patient is afebrile with stable vs. Will order BENADRYL 25MG.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. c/o pain in (R) arm where injection was given. States it hurt when she received the shot. States it is difficult to raise (R) arm over her head. States it hurts to sleep.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Local site reaction to PREVNAR vaccine - redness, warmth, induration of whole upper leg x 3 days.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Food intolerance, Haematochezia, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Pt. had bloody stools 17 days after receiving ROTARIX, dx with intussusception. Went to hospital 12/31/10. Dx with formula intolerance - on ELECORE.
Age: 1.34
Sex: M
Vaccine: FLU3, HIBV, PNC13
Symptoms: Diet refusal, Pruritus, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Temp to 102 that lasted 2 days 12/24 - developed a rash with red lesions about 1/2 cm, slightly raised over the entire body except feet. He was scratching this. Slept all day after immunizations. Drank milk but would not eat for the 2 days of fever.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Pt's mother stated she developed a fever 102.6 the next day early AM accompanied with dizziness and body aches. Fever lasted 1 1/2 days. Treated with MOTRIN.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Infection, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Hot at shot site, fever, swelling, redness, hives, red streaks coming out of center for about 1 to 2 inches (4 to 6 of them) - hospital said infection flowing thru veins, arm hurt, couldn't raise arm up, shot site extremely painful.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Hot at shot site, fever, swelling, redness, hives, red streaks coming out of center for about 1 to 2 inches (4 to 6 of them) - hospital said infection flowing thru veins, arm hurt, couldn't raise arm up, shot site extremely painful.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Flu vaccine given 11/23/10. Pt still complains of arm pain and limited ROM. No erythema, induration son also has same sx.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: 10 days after flu vaccine, numbness feet hands & now into scalp no weakness referred to neurologist.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site swelling, Wheezing
Clinical narrative: Wheezing, coughing within hours of receiving vaccine. BENADRYL, MEDROL injection site size of baseball within 6 hrs. Over next 5 days continued wheezing - added Albuterol inhaler with steroids and antihistamine medications.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash after receiving flu shot on 12/20/10 reported by mom. Gave BENADRYL. Nurse instructed her to call MD.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Chest pain, Dyspnoea, Headache, Heart rate irregular
Clinical narrative: SEVERE HEADACHES, FAINTING, NAUSEA, IRREGULAR HEART BEATS, BLURRED VISION, BONES ACHING, TACHYCARDIA, SHORTNESS OF BREATH, RASHES, CHEST PAIN, IRRITABILITY, MOOD SWINGS, HOSPITALIZED NUMEROUS TIMES.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Irritability, Mood swings, Nausea, Rash, Syncope
Clinical narrative: SEVERE HEADACHES, FAINTING, NAUSEA, IRREGULAR HEART BEATS, BLURRED VISION, BONES ACHING, TACHYCARDIA, SHORTNESS OF BREATH, RASHES, CHEST PAIN, IRRITABILITY, MOOD SWINGS, HOSPITALIZED NUMEROUS TIMES.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia, Vision blurred
Clinical narrative: SEVERE HEADACHES, FAINTING, NAUSEA, IRREGULAR HEART BEATS, BLURRED VISION, BONES ACHING, TACHYCARDIA, SHORTNESS OF BREATH, RASHES, CHEST PAIN, IRRITABILITY, MOOD SWINGS, HOSPITALIZED NUMEROUS TIMES.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Coronary artery disease, Hyperlipidaemia, Hypertension
Clinical narrative: Admitted with right lower lobe pneumoina, bilateral leg weakness, COPD, CAD, hypertension, hyperlipidemia.  No deterioration of respiratory systems, spontaneous recovery started but IgD started for quick recovery. The weakness is almost gone on discharge 01/06/2011.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Lobar pneumonia, Muscular weakness
Clinical narrative: Admitted with right lower lobe pneumoina, bilateral leg weakness, COPD, CAD, hypertension, hyperlipidemia.  No deterioration of respiratory systems, spontaneous recovery started but IgD started for quick recovery. The weakness is almost gone on discharge 01/06/2011.
Age: 21.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Swelling, Urticaria, Vaccination complication
Clinical narrative: Severe allergic reaction requiring ER visit with epinephrine.  Had a Flu shot an Tdap at the same time. Not sure which was the cause. Hives, swelling, shortness of breath. Works in the ER, so was working when happened, quick response.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Woke with headache and stiff neck, had low grade temp (100.2). Consulted with physician by phone in evening, seen the following day in office, had improved by the time she came in with neck stiffness only on extension.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Malaise, Wheezing
Clinical narrative: Started wheezing, became SOB. Weak, malaise - difficulty breathing lasted several days - weakness.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Patient received flu shot and was told to stick around store for about 15 mins. About a half hour after vaccine administered, patient called saying he felt "weird in head", faint, and short of breath. Patient said he was closer to ER than store so he was heading to ER.
Age: 3.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: (L) leg pain - sens. to touch, could not walk on it. No redness, no swelling. Pt. was given MOTRIN -> to hosp. for X-ray in case injury -> pt. was better by the time he returned from X-ray.
Age: 31.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Angina pectoris, Cardiac enzymes normal, Electrocardiogram T wave inversion, Electrocardiogram normal, Full blood count normal
Clinical narrative: She relates to intermittent brief episodes of sharp "heart pains" and palpitations that last for 3 minutes at its longest duration. Usually can resolve with sitting upright, leaning forward, or standing upright/deep breathing. Denies dyspnea, n/v, diaphoresis, hx of same, fm hx of same, abd pain, fevers, chills, or recent illness. Given diagnosis of "Suspect Post Vaccinia Pericarditis" by the Working Group.
Age: 31.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Laboratory test normal, Palpitations, Pericarditis, Post vaccination syndrome, QRS axis abnormal
Clinical narrative: She relates to intermittent brief episodes of sharp "heart pains" and palpitations that last for 3 minutes at its longest duration. Usually can resolve with sitting upright, leaning forward, or standing upright/deep breathing. Denies dyspnea, n/v, diaphoresis, hx of same, fm hx of same, abd pain, fevers, chills, or recent illness. Given diagnosis of "Suspect Post Vaccinia Pericarditis" by the Working Group.
Age: 31.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: She relates to intermittent brief episodes of sharp "heart pains" and palpitations that last for 3 minutes at its longest duration. Usually can resolve with sitting upright, leaning forward, or standing upright/deep breathing. Denies dyspnea, n/v, diaphoresis, hx of same, fm hx of same, abd pain, fevers, chills, or recent illness. Given diagnosis of "Suspect Post Vaccinia Pericarditis" by the Working Group.
Age: 31.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Angina pectoris, Cardiac enzymes normal, Drug screen negative, Electrocardiogram T wave inversion, Electrocardiogram abnormal
Clinical narrative: She relates to intermittent brief episodes of sharp "heart pains" and palpitations that last for 3 minutes at its longest duration. Usually can resolve with sitting upright, leaning forward, or standing upright/deep breathing. Denies dyspnea, n/v, diaphoresis, hx of same, fm hx of same, abd pain, fevers, chills, or recent illness. Given diagnosis of "Suspect Post Vaccinia Pericarditis" by the Working Group.
Age: 31.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Full blood count normal, Laboratory test normal, Palpitations, Pericarditis, QRS axis abnormal
Clinical narrative: She relates to intermittent brief episodes of sharp "heart pains" and palpitations that last for 3 minutes at its longest duration. Usually can resolve with sitting upright, leaning forward, or standing upright/deep breathing. Denies dyspnea, n/v, diaphoresis, hx of same, fm hx of same, abd pain, fevers, chills, or recent illness. Given diagnosis of "Suspect Post Vaccinia Pericarditis" by the Working Group.
Age: 1.3
Sex: M
Vaccine: HEPA
Symptoms: Diet refusal, Fatigue, Insomnia, Lethargy, Pyrexia
Clinical narrative: 24 hours after Hep A on 7/1/10 child had fever of 103 degrees lethargy, fatigue, insomnia, did not want to eat Mom gave TYLENOL and MOTRIN but it would not work fever and other symptoms went away after about 3 days. Mom reported this after we contacted her to bring child in for 2nd dose of Hep A.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Throat irritation
Clinical narrative: Less than 30 minutes after receiving PNEUMOVAX IM she came back c/o of an itchy throat - skin. Immediately assessed lungs clear, no facial or throat swelling, VS stable. Given po BENADRYL, then BENADRYL 25 mg IM, & ZYRTEC po. Symptoms resolved within 15 min.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pt c/o fatigue, chills, malaise, redness, swelling & pain at injection site on (L) arm (deltoid); c/o swollen lymph node in (L) axilla; also c/o nausea, HA.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site swelling, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Pt c/o fatigue, chills, malaise, redness, swelling & pain at injection site on (L) arm (deltoid); c/o swollen lymph node in (L) axilla; also c/o nausea, HA.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Pt reported a mild case of chickenpox diagnosed by her primary care physician. It was brought to my attention 1-4-2011 and she still had a few small lesions on her trunk. Patient was not particularly concerned but wanted me to know about event.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Lg area of redness 4 x 2" around vaccine site warm, non tender, no lump, no pain.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Dermatitis, Pain of skin, Paraesthesia, Pruritus, Skin burning sensation
Clinical narrative: Dermatitis for 3 days, he had tingling, burning, and pruritis with little pain pt given VALTREX and Hydrocodone.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Diet refusal, Dizziness, Gastrointestinal disorder, Injection site swelling
Clinical narrative: Pts arm felt very heavy and sore, also broke out in cold sweat, nauseated, felt like passing out.  Did not eat for two days because of GI symptoms.  Small raised area at site of injection.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Sensation of heaviness
Clinical narrative: Pts arm felt very heavy and sore, also broke out in cold sweat, nauseated, felt like passing out.  Did not eat for two days because of GI symptoms.  Small raised area at site of injection.
Age: 41.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Injection site pain, Neck pain, Sleep disorder
Clinical narrative: One week after administration of vaccine pt. complained of pain in the right deltoid area that radiated into right lateral and frontal neck area. She described it as a sharp, intermittent pain. She also stated that she has been unable to sleep on the right side. Has not had treatment, advised to see private provider.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abasia, Areflexia, Blister, Cast application, Facial pain
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fibula fracture, Gait disturbance, Herpes zoster, Hypoaesthesia, Insomnia
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nerve injury, Pain, Pain in extremity, Scab, Skin lesion
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tibia fracture
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Arthropathy, Back pain, Bone operation
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depression, Fall, Fibula fracture, Frustration, Gait disturbance
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Joint swelling, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tibia fracture, Weight bearing difficulty
Clinical narrative: Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin decreased, Dizziness, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no drug allergies and irregular menses and a history of abnormal "low grade squamous" pap in February 2008, who on 03-FEB-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not provided). There was no concomitant medication. On 16-FEB-2009 the patient sought medical attention for prenatal care at physician's office for a confirmed pregnancy. On 19-MAR-2009 the patient phoned physician's office and complained of bleeding. Therefore a quantitative Human Chorionic Gonadotropin (HCG) was drawn with a result was "61, 811". On 21-MAR-2009 the patient had a repeat quantitative Human Chorionic Gonadotropin (HCG) level drawn with a result of "46, 393". On 23-MAR-2009 the patient went to her primary care physician's office and had a "cytotech" procedure performed there for a miscarriage. On 04-APR-2009 the patient visited an emergency room for complaints of cramping and bleeding following the "cytotech" procedure. On 14-APR-2009 the patient came to physician's office and complained of dizziness. On 21-APR-2009 the patient met with the nurse practitioner at physician's office when her second dose of GARDASIL was due, but it was not given at that time. On 28-DEC-2010 the patient came to physician's office and received the second dose of GARDASIL (therapy route and lot # not provided) late. At the time of reporting, the patient's status was recovered. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Prostatic acid phosphatase abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no drug allergies and irregular menses and a history of abnormal "low grade squamous" pap in February 2008, who on 03-FEB-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not provided). There was no concomitant medication. On 16-FEB-2009 the patient sought medical attention for prenatal care at physician's office for a confirmed pregnancy. On 19-MAR-2009 the patient phoned physician's office and complained of bleeding. Therefore a quantitative Human Chorionic Gonadotropin (HCG) was drawn with a result was "61, 811". On 21-MAR-2009 the patient had a repeat quantitative Human Chorionic Gonadotropin (HCG) level drawn with a result of "46, 393". On 23-MAR-2009 the patient went to her primary care physician's office and had a "cytotech" procedure performed there for a miscarriage. On 04-APR-2009 the patient visited an emergency room for complaints of cramping and bleeding following the "cytotech" procedure. On 14-APR-2009 the patient came to physician's office and complained of dizziness. On 21-APR-2009 the patient met with the nurse practitioner at physician's office when her second dose of GARDASIL was due, but it was not given at that time. On 28-DEC-2010 the patient came to physician's office and received the second dose of GARDASIL (therapy route and lot # not provided) late. At the time of reporting, the patient's status was recovered. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Haematochezia, Irritability, Urinary system X-ray
Clinical narrative: Abdomen pain, bloody stools, Fussy.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Haematochezia, Irritability, Vomiting
Clinical narrative: Vomiting, Bloody stools, Fussy
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Pruritus, Rash
Clinical narrative: Pt called 1/10, reporting having symtoms of Shingles.  Rash, itchy, pain on opposite side of shot, under breast, unilateral around to back. Going to see PCP.
Sex: F
Vaccine: TDAP
Symptoms: Drug exposure during pregnancy, Jaundice neonatal
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of jaundice in a male neonate subject exposed to BOOSTRIX (GlaxoSmithKline) taken by the subject's mother during pregnancy. The mother's date of last menstrual period was 01 December 2009. Concurrent medications included Prenatal vitamins. On 20 August 2010 at 13:30 the mother of the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, left arm). The baby experienced drug exposure in utero (third trimester). The mother's estimated delivery date was 14 September 2010. Follow-up information was received on 04 January 2011 via a physician. Conception was normal. The mother delivered a male neonate on 07 September 2010, at 39 weeks gestation via normal vaginal delivery. The neonate weighed 7 pounds and 2 ounces and was 18.5 inches in length. It was noted that the baby was born with jaundice. He was hospitalized for a day and was treated (unspecified). The outcome of the event and attribution of the event to BOOSTRIX was not provided. For details concerning the mother case, refer to case number A0879124A.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose abnormal, Chondrocalcinosis pyrophosphate, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional (wife of the subject) and described the occurrence of injection site reaction in a 76-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 22 September 2010 the subject received a dose of FLULAVAL in the left arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced an injection site reaction described as pseudogout causing his hand to be almost paralyzed. It was reported that the subject had experienced a similar reaction to Merck's flu vaccine previously (year not specified). It was noted that the subject may have possibly forgotten about his history and the new doctor's office did not have the documentation. These events required the subject to receive prednisone, which was reported to be affecting his blood sugars. The doctor that the subject visited to received treatment for the reaction thought that this condition may have possibly been Guillain Barre, but then determined that not to be the case. According to the reporting nurse (wife of the subject), the subject should have been admitted to the hospital, but was not as of yet. It was noted to be a possibility given the subject's condition. In the reporter's opinion, the subject should receive intravenous antibiotics in the hospital. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 1/9/11 at 12pm - Pt called to say she had a reaction to the BOOSTRIX vaccine. Symptoms included red, swollen, hot & raised at the site of injection (left upper arm). Pt also complained of headache. These sx start to occur on Friday night 1/7/11. Per pt her sx is worsening.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Convulsion, Electroencephalogram, Gastrointestinal disorder, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Received vaccines at well check 1/3/11, that night developed seizures x 2/short, few hours later along with fever and then severe worsening of GI symptoms.
Age: 48.0
Sex: M
Vaccine: FLUX, MMR, PPV, TD
Symptoms: Abdominal pain, Asthenia, Coordination abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: ABDOMINAL CRAMPS LOSS OF SENSITIVITY (LOWER AND UPPER LIMBS) NO COORDINATION TO WALK AND WEAKNESS ALL OVER THE BODY
Age: 48.0
Sex: M
Vaccine: FLUX, MMR, PPV, TD
Symptoms: Sensory loss
Clinical narrative: ABDOMINAL CRAMPS LOSS OF SENSITIVITY (LOWER AND UPPER LIMBS) NO COORDINATION TO WALK AND WEAKNESS ALL OVER THE BODY
Age: 7.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: Mother stated she had hives in mid section that got worse with warm bath. Took her to private physican 2 days later. He said reaction was probably from immunizations.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: There was some swelling at site of injection after this HPV vaccine and it went away in days. There is now a bump at injection site that appeared weeks later and its tender.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Auricular swelling, Crying, Erythema, Oropharyngeal pain, Pruritus
Clinical narrative: Child crying vigorously prior to vaccination. Calmed down immediately after given. After sister received immunizations, he began crying again, he complained of sore throat, vomited, he complained of his hands and feet being itchy, no redness or swelling noted at injection sites. At 3:15 PM he complained of itchy hands, feet, and ears. Ears were red and mildly swollen. No respiratory stress noted. Blotchy red area noted on chest. Gave 1/2 teaspoon Benadryl, mom refused full dose. Left the waiting room-walking and talking.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Rash macular, Vomiting
Clinical narrative: Child crying vigorously prior to vaccination. Calmed down immediately after given. After sister received immunizations, he began crying again, he complained of sore throat, vomited, he complained of his hands and feet being itchy, no redness or swelling noted at injection sites. At 3:15 PM he complained of itchy hands, feet, and ears. Ears were red and mildly swollen. No respiratory stress noted. Blotchy red area noted on chest. Gave 1/2 teaspoon Benadryl, mom refused full dose. Left the waiting room-walking and talking.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered
Clinical narrative: ADVISED TO GO TO ER BECAUSE HE WAS PT HAVING UPPER ABDOMINAL PAIN.  PT GIVEN 5X ADULT DOSE (1/9/11) INSTRUCTIONS IN COMPLIANCE WITH DR. (POISON CONTROL) ADVICE FROM CASE #4570825.  PT WENT TO HOSPITAL FOR TREATMENT.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered, Pain in extremity
Clinical narrative: ADVISED TO GO TO ER BECAUSE HE WAS PT HAVING UPPER ABDOMINAL PAIN.  PT GIVEN 5X ADULT DOSE (1/9/11) INSTRUCTIONS IN COMPLIANCE WITH DR. (POISON CONTROL) ADVICE FROM CASE #4570825.  PT WENT TO HOSPITAL FOR TREATMENT.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered, Laboratory test normal, Pain in extremity
Clinical narrative: ADVISED TO GO TO ER BECAUSE HE WAS PT HAVING UPPER ABDOMINAL PAIN.  PT GIVEN 5X ADULT DOSE (1/9/11) INSTRUCTIONS IN COMPLIANCE WITH DR. (POISON CONTROL) ADVICE FROM CASE #4570825.  PT WENT TO HOSPITAL FOR TREATMENT.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Ear pain, Eye pain, Fatigue, Headache
Clinical narrative: Localized swelling, tenderness over injection site, also generalized fatigue, headache, joint pain, sore throat/ears/eyes
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Local swelling, Oropharyngeal pain
Clinical narrative: Localized swelling, tenderness over injection site, also generalized fatigue, headache, joint pain, sore throat/ears/eyes
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Laboratory test normal, Pain, Pyrexia, Vaccination complication
Clinical narrative: Fever, chills by 7 pm.  Felt better until Sunday 10/24/2010.  Fever returned, severe body aches.  Went to hospital 10/26/2010.  Released next evening.  Severe pain continued for 5 days returned to Dr.  Further test performed.  Results all negative.  Dr. felt it was still the reaction to flu shot.  Aches much improved but still continue as of this date.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Fever, chills by 7 pm.  Felt better until Sunday 10/24/2010.  Fever returned, severe body aches.  Went to hospital 10/26/2010.  Released next evening.  Severe pain continued for 5 days returned to Dr.  Further test performed.  Results all negative.  Dr. felt it was still the reaction to flu shot.  Aches much improved but still continue as of this date.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Had two dot-like..spider bite looking bumps on right chest above nipples...next day small rash under right arm within the same horizontal line and the first two dots had exploded into tiny bumps......called pediatric office and was told to give Benadryl. The next day after was Jan 30 and was still not any better and there were two new dots on his back; so I called the pediatric office again and was told to come in. Did not see Dr. saw the Nurse and she diagnosed it as Shingles after she had a second opinion from another Dr....then they told me there was nothing else to do and sent me on my way with no further questions about my son or information about what to do.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Injection site discolouration, Injection site swelling, Personality change
Clinical narrative: Entire upper arm and shoulder area swelled to more than twice the normal size.  The injection site turned black.  the doctor prescribed Zyrtec and said not to report issues.  After five days the swelling went down.  The child's behavior changed with/after the vaccination.  No follow up was done.  No labs.  Doctor believed it was related to family situation, blew off concerns.  My child's personality changed after this event.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: High fever, body aches, sore throat, runny nose, sore arm from injection (red and swollen).
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: High fever, body aches, sore throat, runny nose, sore arm from injection (red and swollen).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 1 1/2" reddened area, slightly firm at injection site. Non tender, no itching, just noticed after shower.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt complaint of marked pain left upper arm/shoulder area immediately after injection continued for 5 hours requiring TORADOL injection, arm sling. Arm exam by doctor unremarkable.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity, X-ray normal
Clinical narrative: Severe left shoulder & arm pain s/p PCV-23 injection 1/5/11. Pt seen at ER for eval with (-) shoulder xray. Believe to have been injected into shoulder joint at time of vaccine. At f/u visit with decreased ROM due to pain (+) ttp shoulder/arm.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt given 2nd HPV - within 5 minutes - pt. complained of dizziness, lightheadedness - "blacking out". Pt helped to a chair in hallway of office; elevated feet - gave pt water, orange juice, crackers - wet washcloth- pt "felt fine" after 15 minutes. BP checked - pt released with mother.
Age: 19.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Muscle spasms
Clinical narrative: 12/7/10 Redness, swelling in left deltoid within 15 minutes after injections. 12/7/10 Leg spasms Wed. evening. 12/9/10 Muscle spasms - entire body per mom taken to Urgent Care - given antibiotics 12/14/10 Follow up with M.D. - improving.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Hypotonia, Pallor
Clinical narrative: 40 hrs post immunization emesis then pallor, limp. Improved 15 minutes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 40 hrs post immunization emesis then pallor, limp. Improved 15 minutes.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: About 4 days after flu shot, she developed rash on outer thighs & hives on inner thighs. She has taken ZYRTEC & rash is clearing up.