chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Activities of daily living impaired, Catatonia, Gait disturbance, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and confined to a wheelchair" were considered to be disabling. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Speech disorder, Wheelchair user
Clinical narrative: This spontaneous report was received from an anonymous female attorney who reported seeing information on an unspecified web site on the effects of M-M-R II given at 3 year old. In the unspecified news source, an anonymous male patient (about 16 years ago) had been in perfect health prior to having received M-M-R II and "ten days later" after having received M-M-R II on an unspecified date, he "was no longer able to go to the bathroom by himself" and had speech impairment. This male had received M-M-R II sometime in the range of when he was "12-18 months old." He was reported to have been able to walk and to speak 20-30 words perfectly before getting M-M-R II and had trouble speaking and moving afterwards. He also was reported to have gotten a fever and a rash followed by a catatonic state" from which it was unspecified if he ever recovered. The male is now 18 years old, is "confined to a wheelchair" because of the effects of M-M-R II. He received vaccination with M-M-R II, by "injection" but whether it was administered subcutaneously was unspecified by reporter. The reporter also stated that the report stated there were events involving 500 other unspecified individuals who received M-M-R II (MARRS case # 1306USA011145). The events of "unable to go to the bathroom by himself", and confined to a wheelchair" were considered to be disabling. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Pallor, Pyrexia
Clinical narrative: Developed redness and induration at injection site and dx of cellulitis, also developed blanching maculopapular rash on trunk that spread to face and body, had subjective fever for 2-3 days, injection site redness resolved with course of cephalexin.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Developed redness and induration at injection site and dx of cellulitis, also developed blanching maculopapular rash on trunk that spread to face and body, had subjective fever for 2-3 days, injection site redness resolved with course of cephalexin.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative concerning a female patient of unknown age. On 09-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000436 and 10-APR-2014 respectively, dose and route unspecified). No concomitant medications were reported. On 19-MAY-2013, the patient experienced hives under their arms, under their breasts, and around their groin area after receiving the vaccination. The patient went to an unspecified hospital for an emergency room visit on two different unspecified days. It was unsure if the patient was admitted to the unspecified hospital on the two different unspecified days. The patient sought medical attention (contacted pharmacist by phone). It was unspecified if any treatment was given. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthma, Chills, Condition aggravated, Erythema, Heart rate increased
Clinical narrative: Moderate to severe allergic reaction, arm swelling, itching, redness, difficulty raising arm, fever, chills, nausea, elevated heart rate, and asthma attack.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hypersensitivity, Mobility decreased, Nausea, Oedema peripheral, Pruritus
Clinical narrative: Moderate to severe allergic reaction, arm swelling, itching, redness, difficulty raising arm, fever, chills, nausea, elevated heart rate, and asthma attack.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Moderate to severe allergic reaction, arm swelling, itching, redness, difficulty raising arm, fever, chills, nausea, elevated heart rate, and asthma attack.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Chest X-ray, Chest discomfort, Dysphagia, Dyspnoea, Oropharyngeal pain
Clinical narrative: 24 hours after injection, felt chest was tight, hurt to take deep breath, felt like he could not get a breath in and throat hurt and he could not swallow. No hives; no response at injection site. Painting the trampoline that day in yard with strong odor to paint. industrial paint.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Painful respiration
Clinical narrative: 24 hours after injection, felt chest was tight, hurt to take deep breath, felt like he could not get a breath in and throat hurt and he could not swallow. No hives; no response at injection site. Painting the trampoline that day in yard with strong odor to paint. industrial paint.
Age: 38.0
Sex: F
Vaccine: DTP
Symptoms: Headache, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: First adverse event was extreme arm soreness that worsened for the next 5 days to the point that I couldn't lift my arm to shoulder height.  I had a horrible headache starting the evening of the 21st as well as a fever.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: WOKE UP ON MORNING OF 23RD WITH FEVER, "BURNING SENSATION" REDNESS AND INDURATION 1/2" FROM SITE.  SHE TOOK IBUPROFEN 800 MG, APPLIED ICE TO SITE, REPORTS RESOLVED AFTER 24 HRS.
Age: 8.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Rash generalised, Rash pruritic, Vaccination complication
Clinical narrative: Broke out with pin dot rash on face, neck, chest, back, and shoulders. Took patient to see Dr. that afternoon, and he blamed the rash on her drying w/ a bathing suit on after swimming. The rash was nowhere under the areas that her bathing suit was on though. After researching it myself at home, I found that the reaction had to have come from the MMR vaccine she had just received. The doctor thought it would have come the day after the immunization if it was a reaction, but research shows that it can come anywhere up to 28 days out. Obviously this was a reaction!!! It has now been 8 days since the immunization was given and she still has the itchy bumps all over!
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Adverse reaction, Incorrect dose administered
Clinical narrative: Hepatitis B 40mcg administered to the patient in lew of Hepatitis B 20mcg. No adverse reaction at time of administration. Received report from supervisor that the patient verbalized complaints of adverse reaction following disclosure of medication error.
Age: 73.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT STATES LARGE SORE AREA AT INJECTION SITE APPROXIMATELY 2 INCHES BY 1 INCH, RED AND SWOLLEN THAT BURNS.
Age: 46.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TYP, YF
Symptoms: Arthralgia, Insomnia, Myalgia, Pyrexia
Clinical narrative: Began having a low grade temp on 6/23/2013, no exact temperature data available, on 06/24/2013 around 5 or 6 pm, began to have an ache in left hip joint and left thigh muscle. Achiness became worse at bedtime and he couldn't sleep, so he took 2 ibuprofen and medication did relieve aches. Aches continue today, but he rates achiness as 1 or 2 on scale of 0-10 pain scale. Reports he also continues with low grade temperature.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash erythematous, Skin warm, Varicella post vaccine
Clinical narrative: 3" x 1" red raised rash that was hot to the touch. Progressively less heat and redness, but turned into 2 clusters of pox blisters 3 days later.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: Redness and swelling noted. Fever, chills, diarrhea, lasted all night. Pt felt weak and fatigued.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Redness and swelling noted. Fever, chills, diarrhea, lasted all night. Pt felt weak and fatigued.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Erythema, Injection site pruritus, Oedema peripheral
Clinical narrative: Patient woke up in the AM and left arm was red and swollen the size of a tennis ball with associated itching to site. Also had mild dizziness.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash vesicular, Skin lesion
Clinical narrative: Large area of swelling below injection site. Next day began with varicella like rash on neck, chest and both arms. About 20 lesions in all over a 4 day period. Still had some more break out today.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Agitation, Feeding disorder neonatal, Immediate post-injection reaction, Irritability, Poor sucking reflex
Clinical narrative: Baby was extremely fussy/agitated immediately following vaccination for several days. Also began to have breastfeeding issues (poor latch/suckling) which were not apparent prior to vaccination. Weight gain halted after vaccination.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Weight gain poor
Clinical narrative: Baby was extremely fussy/agitated immediately following vaccination for several days. Also began to have breastfeeding issues (poor latch/suckling) which were not apparent prior to vaccination. Weight gain halted after vaccination.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Mass, Pain, Rheumatoid arthritis
Clinical narrative: This spontaneous report as received from a patient's sister refers to a 79 year old female patient with no drug reactions/allergies and a pertinent medical history of "rheumatic fever". Sometime in February 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # was not reported), subcutaneous. Concomitant therapies included LIPITOR and lisinopril (manufacturer unknown). The reporter stated the patient developed the following adverse reactions "four to six months" after ZOSTAVAX was administered: a lump on her collarbone that created pain, and rheumatoid arthritis. The patient sought medical attention by an office visit on an unspecified date. The patient was prescribed prednisone (unspecified dose, frequency and manufacturer) and methotrexate (unspecified dose, frequency and manufacturer). The patient also underwent "blood work". At the time of reporting, the patient was not recovered. Additional information is not expected.
Age: 33.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 33-year old male patient who was HIV positive. On 07-JUN-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not provided). The patient was outside the age range. Reported patient has had no adverse effects. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a physician refers to a 9 month old patient. On an unknown date the patient was vaccinated with a dose of ROTATEQ, (lot# not reported), oral. On an unknown date the patient experienced contracted rotavirus after received the ROTATEQ. The patient sought medical attention with physician and was prescribed dextrose, PEDIALYTES. Not lab diagnostic studies were performed. The patient was recovered and the AE improved due to the virus and symptoms subsiding on its own. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ, oral. On an unknown date the patient experienced contracted rotavirus after received ROTATEQ, (lot# not reported). The patient sought medical attention with physician and was prescribed dextrose, PEDIALYTE. Not lab diagnostic studies were performed. The patient was recovered and the AE improved due to the virus and symptoms subsiding on its own. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 66 year old female patient. The patient's medical history included shingles. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) vial. On an unknown date, six weeks after receiving ZOSTAVAX the patient had a second case of shingles. The reporter stated that this second outbreak of shingles was just as bad as her first case of shingles. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 07-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous), instead of VARIVAX. No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 13 year old patient. On 20-JUN-2013, the patient was vaccinated with an adult dose (first dose) of VAQTA, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 38 year old male patient. On 20-JUN-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23, (lot # 672074/1502AA, expiry date 19-MAY-2013, route was not reported). Concomitant medications were not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch in left arm. Redness and swelling lasted about a week and a half.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states felt as skin was burning, face became flushed. Had very bad headache the next morning. Injection site lightly red and swollen, painful to touch.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Skin burning sensation
Clinical narrative: Patient states felt as skin was burning, face became flushed. Had very bad headache the next morning. Injection site lightly red and swollen, painful to touch.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Hypoaesthesia
Clinical narrative: Chest pain, trouble taking a deep breath, numbness in forearms.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: Abdominal discomfort, Pruritus, Sensation of pressure
Clinical narrative: 6/25/13 Father called today, 2 days ago patient developed itching on her hands and feet. Pretty extensive itching so was given Benadryl with good results. However, the itching returned after Benadryl wore off.  She also c/o stomach upset and feeling like a "pressure" in her abdomen, that comes and goes.  She is not c/o diarrhea, nausea or vomiting.  She is able to eat. No fever and no rash at this time. Will file a VAERS today. Encouraged father to push fluids, continue to use either Benadryl and/or Claritin (antihistamine) for the itching. Discussed if itching progresses to throat, hives develop or if client becomes short of breath it would be a medical emergency and she would need to be seen right away. He stated his sister is a PA and he has been discussing with her as well.  Will monitor closely and keep me posted.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Angiogram normal, Blood test normal, Computerised tomogram normal, Dizziness, Dysarthria
Clinical narrative: Feeling sickish, dizzy 'said felt funny and then started stuttering and now is worst then the beginning in speech can not understand him.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Dysphemia, Echocardiogram normal, Feeling abnormal, Malaise, Nuclear magnetic resonance imaging normal
Clinical narrative: Feeling sickish, dizzy 'said felt funny and then started stuttering and now is worst then the beginning in speech can not understand him.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's medical history included Lyme disease and unspecified upper respiratory tract infections. The patient had no drug allergy. On 17-MAY-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. At reporting time, the patient had been prescribed prednisone (route unspecified), doxycycline and an unspecified inhaler for treatment of an unspecified condition. The outcome of the unspecified condition was reported as not recovered/not resolved. The patient sought medical attention via unspecified method. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: This spontaneous report as received from an 89 year old female consumer refers to herself. The patient had acid reflux and papaya allergy (caused stomach ache). On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant therapies included PRILOSEC. It was reported that in March 2013, the patient developed a rash around her waist and tenderness on her waist after receiving ZOSTAVAX. The patient did not seek medical attention. Her doctor prescribed an anti viral medication (medication name and dosage unspecified) but the patient stated that the anti-viral was hard on her stomach. Lab diagnostics studies performed were reported as none. The patient continued to have this rash. The outcome was reported as not recovered. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a physician refers to a 3 years old patient. On an unknown date the patient was vaccinated with a dose of ROTATEQ (lot# not reported), oral liquid, orally. On an unknown date the patient experienced contracted rotavirus after received the ROTATEQ. The patient sought medical attention with physician and was prescribed PEDIALYTE Solution. Not lab diagnostic studies were performed. The patient was recovered and the AE improved due to the virus and symptoms subsiding on its own. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Repeated episodes of cold sore outbreaks beginning in 12/12 in my nasal passages - most recent outbreak 6/05/13 and recurrence of cold sore outbreak in nasal passage on 6/25.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Rash red and light and fading slowly by the day. Approximately 3inches by 3 inches in area.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient experienced aches and pains and a general feeling of malaise. In addition, felt tingling in her hands and lips.
Age: 19.0
Sex: F
Vaccine: HEPA, MNQ, YF
Symptoms: Dizziness, Pallor, Syncope, Tremor
Clinical narrative: Pt turned white at 11:29. Asked if she was ok and she responded she was feeling light headed and dizzy. Told her to breathe and she fainted and had muscle shakes. She awoke 1 minute later. She was given some water and rested comfortably in the chair for 45 minutes and felt much better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received a large rash on arm near injection site. Patient was started on cephalexin 250mg four times daily on 6/24/13 and rash started to resolve.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 10 cm diameter area of red, warmth, firm at injection site.
Age: 1.27
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None at time of vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: The patient described an "apple" sized rash and swelling at the injection site.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chest pain, Heart rate increased, Lip discolouration, Nausea, Pallor
Clinical narrative: Per mom, 10 mins after vaccine child complained of chest pain, elevated heart rate, nausea, hands shaky, child looked pale to face and lips were white. Ringing to ears and not able to hear with blurr vision. Child was very anxious and nervous before vaccine child was fasting.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Per mom, 10 mins after vaccine child complained of chest pain, elevated heart rate, nausea, hands shaky, child looked pale to face and lips were white. Ringing to ears and not able to hear with blurr vision. Child was very anxious and nervous before vaccine child was fasting.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Angina pectoris, Asthenia, Hypoacusis, Lip discolouration, Nausea
Clinical narrative: Per mom, 10 mins after vaccine child complained of chest pain, elevated heart rate, nausea, hands shaky, child looked pale to face and lips were white. Ringing to ears and not able to hear with blurr vision. Child was very anxious and nervous before vaccine child was fasting.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pallor, Tinnitus, Tremor, Vision blurred
Clinical narrative: Per mom, 10 mins after vaccine child complained of chest pain, elevated heart rate, nausea, hands shaky, child looked pale to face and lips were white. Ringing to ears and not able to hear with blurr vision. Child was very anxious and nervous before vaccine child was fasting.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray normal, Lymphocyte percentage decreased, Metabolic function test normal, Neutrophil percentage increased, Pain
Clinical narrative: Fever and body aches started day after vaccine given. She went to ER, temp. of 102.1 degrees F. Tx: TYLENOL, MOTRIN, IV fluids. Sx fully resolved within 24 hr.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urine analysis normal, White blood cell count normal
Clinical narrative: Fever and body aches started day after vaccine given. She went to ER, temp. of 102.1 degrees F. Tx: TYLENOL, MOTRIN, IV fluids. Sx fully resolved within 24 hr.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, IPV, VARCEL
Symptoms: Cold sweat, Dizziness, Hypotension, Lethargy, Nausea
Clinical narrative: Patient was administered with GARDASIL (1st dose 0.5 ml, IM, (L) deltoid) at 340 pm. 5 min after patient developed hypotension, cold clammy skin, dizziness, nausea. Provider stayed with patient - lethargic. The patient responsive. Suddenly vomited after 10 minutes and recovered. BP after 10 min was 71/62 -> 5 min 77/65 -> 81/65 -> 81/65 after 30 min; HR 77; O2 sat 100%.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, IPV, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient was administered with GARDASIL (1st dose 0.5 ml, IM, (L) deltoid) at 340 pm. 5 min after patient developed hypotension, cold clammy skin, dizziness, nausea. Provider stayed with patient - lethargic. The patient responsive. Suddenly vomited after 10 minutes and recovered. BP after 10 min was 71/62 -> 5 min 77/65 -> 81/65 -> 81/65 after 30 min; HR 77; O2 sat 100%.
Age: 1.27
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 104.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Headache, Hepatitis B antibody, Injection site swelling, Lymph node pain
Clinical narrative: 6/22/13 Headache, swelling at injection site. 6/23-6/24 Dizziness / lightheadedness. 6/25 Tender lymph nodes, axillary.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Measles antibody, Mumps antibody test, Rubella antibody test, Varicella virus test
Clinical narrative: 6/22/13 Headache, swelling at injection site. 6/23-6/24 Dizziness / lightheadedness. 6/25 Tender lymph nodes, axillary.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Mom noticed a golfball sz. knot, redness, and warm to touch to (L) arm at injection site.
Age: 1.01
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash papular, Skin lesion
Clinical narrative: Papulovesicular rash various stages of healing less than 30 lesions total.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Burning sensation, Chest pain, Feeling abnormal, Injection site erythema
Clinical narrative: Over 3 days. Tdap given 06/04/2013 = L. deltoid. All lymph nodes swollen; nodes under (L) arm to (L) chest burning. Burning sensation. Neck stiff; All joints swollen. General weakness. Injection site mod. Redness/soreness. As of 06/19/20 still not feel 100% better.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Joint swelling, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Over 3 days. Tdap given 06/04/2013 = L. deltoid. All lymph nodes swollen; nodes under (L) arm to (L) chest burning. Burning sensation. Neck stiff; All joints swollen. General weakness. Injection site mod. Redness/soreness. As of 06/19/20 still not feel 100% better.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Myalgia, Pyrexia
Clinical narrative: Developed fever 103 with dizziness and myalgias. Reduced to 100 with ADVIL. Fever spiked back up to 102. Finally reduced to 100. Symptoms x3-4 days.
Age: 1.66
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Measles antibody, Rash, Rubella antibody test
Clinical narrative: Extreme rash.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Underdose
Clinical narrative: Patient was given ADACEL subcutaneously in left forearm. Tuberculin was given intramuscular left deltoid. ADACEL was 0.1 mL and Tuberculin was 0.9 cc.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an adult patient of unknown age and gender. On an unknown date the patient was vaccinated with (Merck) VARIVAX (lot number and expiration date unknown), dose, route and anatomical location unspecified. Concomitant medications were not reported. It was reported that the patient with (Merck) VARIVAX at the age of 1 and developed shingles at the age of 8. Nurse practitioner reported that the patient is an adult now. The outcome of shingles at the age of 8 was unknown. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 year old female patient who yesterday on 18-JUN-2013, was vaccinated with a dose of PROQUAD (Merck) (dose and lot number not reported) due to human error. No adverse effect was reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site dryness, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient presented to the clinic at approximately 4:25 PM with her spouse and son. She needed a PPD for an application. Employee administered a PPD in the patient's left forearm. She noticed the bleb disappeared immediately so she placed another PPD 2" away from the first site. Patient and spouse returned to the clinic 07 June 2013 in the afternoon to have myself and employee check the site for her PPD pos/neg status. Upon exam, the site was extremely greasy as if the patient had placed an emmollient of some kind on the site. The site (both sites) were red and dry kin. There was no induration. Only redness and what appeared to be a rash. There was a language barrier as the patient could not speak english well. The husband stated that she felt itching of the site the evening it was placed. The spouse said that the pt had placed some kind of cream on the site to help with the discomfort, I put in a TCON for the patient to speak with a nurse as she did not have a provider assigned to her yet. I was informed the nurse contacted them.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Seborrhoea
Clinical narrative: Patient presented to the clinic at approximately 4:25 PM with her spouse and son. She needed a PPD for an application. Employee administered a PPD in the patient's left forearm. She noticed the bleb disappeared immediately so she placed another PPD 2" away from the first site. Patient and spouse returned to the clinic 07 June 2013 in the afternoon to have myself and employee check the site for her PPD pos/neg status. Upon exam, the site was extremely greasy as if the patient had placed an emmollient of some kind on the site. The site (both sites) were red and dry kin. There was no induration. Only redness and what appeared to be a rash. There was a language barrier as the patient could not speak english well. The husband stated that she felt itching of the site the evening it was placed. The spouse said that the pt had placed some kind of cream on the site to help with the discomfort, I put in a TCON for the patient to speak with a nurse as she did not have a provider assigned to her yet. I was informed the nurse contacted them.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Skin mass
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient with iodine allergy, shellfish allergy and codeine allergy. The patient's medical history included prior case of shingles. On 14-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001009, expiry: 24-APR-2014) subcutaneously. Concomitant therapies included PRISTIQ. On 14-JUN-2013, the patient experienced hives at injection site with symptoms of redness and itching that resolved by the next day (15-JUN-2013). On 15-JUN-2013, the patient detected a knot underneath the skin at the injection site that was the size of a fifty cent piece. On 16-JUN-2013, the knot under her skin was smaller on day 3, about the size of a quarter, but the site was now red and puffy with swelling at the injection site as large as her hand. The pharmacist reported that the patient had not seen her physician yet. No treatment was received by the patient. No laboratory diagnostic tests were performed. Patient sought medical attention (unspecified). The outcome of knot underneath the skin at the injection site and the site was now red and puffy with swelling at the injection site was unknown. The outcome of hives at injection site was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-JUN-2013 the patient was vaccinated with an expired dose of ZOSTAVAX, (dose, route and site of administration were not reported; lot number 672428/1599AA, expiration date:). No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On 17-JUN-2003, the patient was vaccinated with the first dose of (pediatric dose) of Hepatitis A Vaccine, (manufacturer unknown) (lot number and expiry date unspecified) and on an unknown date she developed hives. No concomitant medications were reported. On an unknown date, the patient recovered from the hives. On an unknown date, the patient became an adult but received the second dose of VAQTA (lot number and expiry date unspecified), a pediatric dose instead of an adult dose due to a human error. The patient did not have a reaction with the second dose. It was unspecified if the patient sought any medical attention. It was unspecified if any treatment was given or if any lab tests were performed. The relatedness for hives was unknown for Hepatitis A Vaccine, (manufacturer unknown). Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Colitis ulcerative, Condition aggravated
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 63 year old male patient. Patient has no drug allergies or reactions. The patient's medical history included ulcerative colitis. On 13-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported), subcutaneously. No concomitant medications were reported. On an unknown date in June 2013, the patient experienced a flare up of his ulcerative colitis shortly after receiving the ZOSTAVAX. Patient sought medical attention (called the pharmacist). The outcome of flare up of his ulcerative colitis was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 71 year old female patient with drug reactions and allergies to several unspecified narcotics. In May 2010 the patient was vaccinated with ZOSTAVAX (route, lot number and expiration date not reported). There was no concomitant medication reported. On 30-MAY-2013 the patient experienced abdominal pain. On 03-JUN-2013 the patient experienced shingles. On 10-JUN-2013 the patient visited doctor. The patient was given TYLENOL as a treatment for the shingles. The outcomes of shingles and abdominal pain were unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 53 year old female patient. No medical history and drug allergies were reported. On 17-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001010, expiry: 24-APR-2014), 0.65 ml, subcutaneously in the left arm. No concomitant medications were reported. On 18-JUN-2013, the patient experienced a 2 inch by 1 inch area that was red, raised and warm to touch at the injection site. Patient sought medical attention: saw pharmacist. The pharmacist suggested the patient use Hydrocortisone cream for the reaction. Pharmacist also stated she had another patient that experienced the same reaction when given ZOSTAVAX from the same Lot #. Laboratory diagnostics studies performed was none. The outcome of the events was reported as not recovered. This is one of 2 reports from the same reporter. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a female patient with no pertinent medical history and no drug reactions or allergies, who, on 20-MAY-2013, was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # J001002, expiry date 25-APR-2014). It was reported that, on 21-MAY-2013, the patient developed a red, itchy, varicella like rash all over the arms, legs and back, that was still continuing to present (the pharmacist saw the patient on 18-JUN-2013, "two days ago"). The pharmacist reported that the patient went to their physician on an unspecified date and was given BENADRYL and unspecified steroids as treatment, but the treatment did not help. The patient did not recover from red, itchy, varicella like rash all over the arms, legs and back at the time of the report. Relatedness for the patient's rash was not reported for ZOSTAVAX. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: New hire received a MMR 5/11/13 (susceptible to measles) at local store near her home.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Injection site rash, Pyrexia
Clinical narrative: Rash right thigh, lateral, fever, diarrhea.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 25-FEB-2011 the patient the first dose of GARDASIL, 0.5ml, intramuscularly (lot number not reported), second dose of GARDASIL, 0.5ml, intramuscularly (lot number not reported) on 25-MAY-2011, and was receiving a third dose of GARDASIL, 0.5ml, intramuscularly (lot number not reported) on 18-JUN-2013. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone abnormal, Burning sensation, Full blood count abnormal, Metabolic function test abnormal, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 63 year old female patient with hypertension. Reporter stated no drug reactions or allergies. On approximately 30-APR-2013, reported as "end of April 2013", the patient was vaccinated with ZOSTAVAX (dose, route, lot number and indication were not provided). Concomitant medications included an unspecified high blood pressure medication. Physician assistant reported that on approximately 14-MAY-2013 the patient developed "a rash noted as pinpoint erosions and little pink scabs" on both arms and across her lower back and generalized itching "about two weeks" after received ZOSTAVAX. The patient saw her physician after developing these symptoms and was prescribed prednisone (manufacturer unknown) on an unspecified date for five days. The physician assistant reports that the prednisone (manufacturer unknown) helped the patient a little bit with the itching. The patient was then started on a second course of prednisone (manufacturer unknown) "about a week or two later after the first course of prednisone" because the symptoms were still not resolved. The physician assistant reported that the patient was started on gabapentin (unspecified) "within the last week or two" on approximately 29-MAY-2013 due to developing pain in the arms that the patient described to the physician assistant as a "burning sensation when she goes out into the sun and exercise makes it worse." The physician assistant reports that the patient was informed by her physician that she probably never had chickenpox before. Physician assistant reported that the following lab diagnostics studies were performed: complete blood count (CBC), basic metabolic panel (BMP), and Thyroid-stimulating hormone (TSH) were drawn on an unspecified date after the patient developed symptoms in approximately May 2013. The physician assistant reports that the labs showed "minor abnormalities but nothing major." The outcome of the patient at the moment of the report was reported as not recovered. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash, Scab
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 63 year old female patient with hypertension. Reporter stated no drug reactions or allergies. On approximately 30-APR-2013, reported as "end of April 2013", the patient was vaccinated with ZOSTAVAX (dose, route, lot number and indication were not provided). Concomitant medications included an unspecified high blood pressure medication. Physician assistant reported that on approximately 14-MAY-2013 the patient developed "a rash noted as pinpoint erosions and little pink scabs" on both arms and across her lower back and generalized itching "about two weeks" after received ZOSTAVAX. The patient saw her physician after developing these symptoms and was prescribed prednisone (manufacturer unknown) on an unspecified date for five days. The physician assistant reports that the prednisone (manufacturer unknown) helped the patient a little bit with the itching. The patient was then started on a second course of prednisone (manufacturer unknown) "about a week or two later after the first course of prednisone" because the symptoms were still not resolved. The physician assistant reported that the patient was started on gabapentin (unspecified) "within the last week or two" on approximately 29-MAY-2013 due to developing pain in the arms that the patient described to the physician assistant as a "burning sensation when she goes out into the sun and exercise makes it worse." The physician assistant reports that the patient was informed by her physician that she probably never had chickenpox before. Physician assistant reported that the following lab diagnostics studies were performed: complete blood count (CBC), basic metabolic panel (BMP), and Thyroid-stimulating hormone (TSH) were drawn on an unspecified date after the patient developed symptoms in approximately May 2013. The physician assistant reports that the labs showed "minor abnormalities but nothing major." The outcome of the patient at the moment of the report was reported as not recovered. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Feeling hot, Herpes zoster, Neuralgia, Swelling
Clinical narrative: This spontaneous report as received from a 80 year old female patient concerning on herself with no drug reactions or allergies. In 2007 the patient had been vaccinated with ZOSTAVAX (route, lot number and expiration date not reported). Concomitant therapies included famciclovir, capsaicin and tramadol hydrochloride. On 08-JUN-2013 the patient got a case of the shingles. The episode came on her legs above the knee, ran from the knee to the torso. swelling, hotness. Got 2 blisters on each leg, mostly was nerve pain. Unspecified treatment was given for the event. No lab diagnostic studies were performed. The patient sought for unspecified medical attention. The outcome of the events were unspecified. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist regarding a 76 year old female patient with hypertension and no known drug reactions/allergies. On 08-JUN-2013, the patient received a dose of ZOSTAVAX, 0.65 ml, subcutaneously for vaccination purposes. (Lot # J000432, expiration date 04-OCT-2014). Co-suspect therapy was not provided. Concomitant therapies included SYNTHROID, DIOVAN, ALPRAZOLAM and FLECTOR patch. In June 2013, the patient experienced an injection site reaction of redness about 3 inches in length. There was no rash. At the time of the report, the patient had not recovered from injection site reaction of redness. The patient sought medical attention by visiting the pharmacy and was treated with unspecified ointment and BENADRYL. There were no laboratories performed. Relationship between the event ad therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist regarding a 76 year old female patient with hypertension and no known drug reactions/allergies. On 08-JUN-2013, the patient received a dose of ZOSTAVAX, 0.65 ml, subcutaneously for vaccination purposes. (Lot # J000432, expiration date 04-OCT-2014). Co-suspect therapy was not provided. Concomitant therapies included SYNTHROID, DIOVAN, ALPRAZOLAM and FLECTOR patch. In June 2013, the patient experienced an injection site reaction of redness about 3 inches in length. There was no rash. At the time of the report, the patient had not recovered from injection site reaction of redness. The patient sought medical attention by visiting the pharmacy and was treated with unspecified ointment and BENADRYL. There were no laboratories performed. Relationship between the event ad therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patient may have received improperly stored VARIVAX (Merck) and PROQUAD (Merck) over an unspecified time frame that could have been up to a year. No adverse event were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant (PA) refers to a patient of unknown age and gender. The patient received 1st dose of GARDASIL, 0.5 ml, subcutaneously in February 2012 and her second dose of GARDASIL, 0.5 ml, subcutaneously in March 2012 and on 18-JUN-2013 was in the office to receive her third dose of GARDASIL. PA reported that the third dose of GARDASIL had not been administered yet. No adverse effect was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Rash macular, Swelling
Clinical narrative: Extreme pain in arm, swelling, redness, blotching, then fever of over 102 for three days. Took OTC pain and fever reducing medicine, applied ice.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chest pain, Heart rate increased, Lip discolouration, Nausea, Pallor
Clinical narrative: He put his hand over his chest and said, "It must have just reached my heart. I have a pain in my heart." He was quite pale, lips white, and said, "I feel like I'm going to throw up." He felt weak and his hands were very shaky. He said that his heart was racing, his ears were ringing, making it hard to hear, and his vision became slightly blurry. I had him take deep breaths. The symptoms gradually subsided over about 30 minutes.