chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a healthcare worker (project manager at a clinical research organization) refers to her 62 year old husband. The patient had no pertinent medical history and no drug reactions/allergies. On 17-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX vial, subcutaneous, lot#, dose and frequency unspecified. Concomitant therapies included atenolol and unspecified statin. On 21-AUG-2013, the patient had shingles. The patient presented with a bubbly  blistered rash, located on the dermatome on midriff that followed a straight line. There was one cluster that hurts when the patient's shirt touched it. Ibuprofen was given as treatment for the event. The patient did not seek medical attention and no lab diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Skin lesion, Varicella
Clinical narrative: This spontaneous report as received from a 56 year old female hospital administrator via company representative refers to herself. Several months ago the patient was vaccinated with a dose of ZOSTAVAX vial (lot #, dose, frequency and route unspecified). A few weeks after administration of ZOSTAVAX the patient experienced lesion, shingles and chickenpox at the injection site, which lasted a few weeks. The result of the events was reported as recovered/resolved. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Dysgeusia, Dyspnoea, Fatigue, Somnolence
Clinical narrative: 8/28/13 2:30 pm TC from above client reporting possible adverse reaction to TWINRIX vaccine, dose #2 received at immunization clinic approximately 1:00pm on 8/27/13. States began to feel drowsy and tired on the way home from clinic. Fatigue persisted throughout day and evening. Woke up from sleep at 2am today gasping for breath. No swelling of mouth, lips, throat, eyes, no rash. Took BENADRYL, drank "a lot of water", as he reports had a "bad taste" in mouth and back of throat. Was eventually able to get back to sleep when sx improved 60 - 90 minutes later. Slept until about 11AM today. Felt normal upon rising. No prior h/o of SOB. Does have h/o bronchitis, is a smoker. To discuss with supervisor as to whether third TWINRIX will be considered. 8/29/13 8:15 am consult with SPHN; advised to complete VAERS report with clinic nurse. Nurse will follow up with client.
Age: 1.56
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: 8-8-13 (R) arm started swelling, hot to touch, after DTAP injection on 8-7-13. 8-9-13 Patient vomited x 2 this AM with fever 102. Mom gave TYLENOL and brought him in. Mother was instructed to apply cool compresses and give TYLENOL mor MOTRIN age appropriate dose. If no better or symptoms worsen, instructed to go to PCP. Child up and active, playful at HD today.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Mother called stating child had a mild rash and swelling of the glands behind ears, neck and the cheeks. Instructed caregiver to take pt to ER.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Movement disorder, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J000495 (exp: 14-APR-2014), 0.65 ml, subcutaneous in the left arm. A few weeks later, approximately in 2013 the patient had a "bad reaction" to ZOSTAVAX in the injection arm. The reaction included pain and weakness in the arm and a thumb that can no longer move properly. The patient sought medical attention either from her physician or from an unspecified emergency room. At time of report, the patient was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electromyogram abnormal, Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J000495 (exp: 14-APR-2014), 0.65 ml, subcutaneous in the left arm. A few weeks later, approximately in 2013 the patient had a "bad reaction" to ZOSTAVAX in the injection arm. The reaction included pain and weakness in the arm and a thumb that can no longer move properly. The patient sought medical attention either from her physician or from an unspecified emergency room. At time of report, the patient was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Radiculitis brachial, X-ray abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J000495 (exp: 14-APR-2014), 0.65 ml, subcutaneous in the left arm. A few weeks later, approximately in 2013 the patient had a "bad reaction" to ZOSTAVAX in the injection arm. The reaction included pain and weakness in the arm and a thumb that can no longer move properly. The patient sought medical attention either from her physician or from an unspecified emergency room. At time of report, the patient was not recovered. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Insomnia, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a 66 year old female consumer refers to herself. On 26-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose, route not reported). Concomitant therapy included "many" unspecified drugs. On 26-AUG-2013 ("at that night") the patient couldn't sleep due to "throbbing" arm pain. She had warmth, redness, and swelling all up and down injection site arm with redness that reached shoulder. The patient took BENADRYL, "steroids" and ibuprofen for treatment the events. The patient sought medical attention via visited her doctor. The outcome of the events was unknown. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a 66 year old female consumer refers to herself. On 26-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose, route not reported). Concomitant therapy included "many" unspecified drugs. On 26-AUG-2013 ("at that night") the patient couldn't sleep due to "throbbing" arm pain. She had warmth, redness, and swelling all up and down injection site arm with redness that reached shoulder. The patient took BENADRYL, "steroids" and ibuprofen for treatment the events. The patient sought medical attention via visited her doctor. The outcome of the events was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report as received from a 50 year old female consumer refers to a her husband of unknown age. In July 2013 the patient's wife was vaccinated with a dose of ZOSTAVAX (lot number, dose number, dose and route were not reported). There was no concomitant medication of his wife. His wife had a pertinent medical history of skin nervous disorder and with no drug reactions or allergies. His wife called in to report that one month later, her husband developed a case of Shingles. No further AE information was provided. Outcome of the events was unknown. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 90 year old male patient, with no drug reaction/allergies and no other pertinent medical history. In October 2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, intramuscularly (site and lot number not provided). In October 2012, after he had ZOSTAVAX administered, the patient developed pain at the injection site. The pain came and went and the patient still had this pain presently. No lab diagnostic tests were performed. The patient was treated with OTC anti-inflammatory medications. The patient contacted pharmacist for medical attention. The causal relationship was not reported. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative refers to an unknown age male patient. On an unspecified date when the patient 12 months old, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified) (dose, route and location unspecified) and M-M-R II (lot# unspecified) (dose, route and location unspecified). The patient received a dose of PROQUAD (Merck) (lot# unspecified) dose, route and location unspecified in March 2013 ("5 months ago" as reported) and on 22-AUG-2013 the patient received another dose of PROQUAD (Merck). No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Erythema, Skin mass, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from the mother of a 3 year old male patient. On 28-AUG-2013 the patient was vaccinated with VARIVAX (Merck) injection (single dose injection, lot # J003223 exp 15-MAR-2015; route and dosage unknown). The reporter stated that the patient developed a "lump on the chest" after receiving th3e vaccine (28-AUG-2013). The reporter also stated that this lump was painful and red in color. The patient did not sought medical attention nor received treatment. No lab diagnostics studies were performed. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Erythema, Mass, Pain
Clinical narrative: This spontaneous report as received from the mother of a 3 year old male patient. On 28-AUG-2013 the patient was vaccinated with VARIVAX (Merck) injection (single dose injection, lot # J003223 exp 15-MAR-2015; route and dosage unknown). The reporter stated that the patient developed a "lump on the chest" after receiving th3e vaccine (28-AUG-2013). The reporter also stated that this lump was painful and red in color. The patient did not sought medical attention nor received treatment. No lab diagnostics studies were performed. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Mass
Clinical narrative: This spontaneous report as received from the mother of a 3 year old male patient. On 28-AUG-2013 the patient was vaccinated with VARIVAX (Merck) injection (single dose injection, lot # J003223 exp 15-MAR-2015; route and dosage unknown). The reporter stated that the patient developed a "lump on the chest" after receiving th3e vaccine (28-AUG-2013). The reporter also stated that this lump was painful and red in color. The patient did not sought medical attention nor received treatment. No lab diagnostics studies were performed. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Fainted after immunization.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: C-reactive protein, Cough, Full blood count, Mononucleosis heterophile test, Mononucleosis heterophile test negative
Clinical narrative: Fever for 5 days, coughing and wheezing. Mom alternated TYLENOL and MOTRIN for 5 days. Labs drawn CRP, CBC, sedimentation rate and mono.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Wheezing, White blood cell count decreased
Clinical narrative: Fever for 5 days, coughing and wheezing. Mom alternated TYLENOL and MOTRIN for 5 days. Labs drawn CRP, CBC, sedimentation rate and mono.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Apnoea, CSF glucose decreased, CSF lactate, Convulsion, Cyanosis
Clinical narrative: On 8-18-13 staring spells with apnea, cyanosis, limp, irreg breathing to ER per ambulance - admitted with likely seizure. CSF glucose decreased at 34 while serum 7100. Episode captured on video EEG. Awaiting test results for GLUT 1. Home with pulse ox. No medication.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram abnormal, Glucose tolerance test, Hypotonia, Respiration abnormal, Staring
Clinical narrative: On 8-18-13 staring spells with apnea, cyanosis, limp, irreg breathing to ER per ambulance - admitted with likely seizure. CSF glucose decreased at 34 while serum 7100. Episode captured on video EEG. Awaiting test results for GLUT 1. Home with pulse ox. No medication.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Sometime in June 2013 the patient was vaccinated with ZOSTAVAX (lot #, expiration, route unspecified) at the right arm. In 2013 the patient had two hospitalizations for shortness of breath and neuropathy on the right side of (her) body after being administered ZOSTAVAX. The demographics for the hospital where the patient was admitted were unknown. The length of time that the patient spent in the hospital for both admissions were also unknown. At the time of report, the events outcome were unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient developed swollen arm/redness at site of injection lasting 1 week. Blk and blue and bruising still visible.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Red, swollen, used cool compresses swelling went down after couple of days, small knot.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Pain in extremity
Clinical narrative: Pt came to HC c/o sore (L) arm and a headache. Pt had 103 temp. - Given 600mg Ibuprofen within 30mins temp decreased 102.1 in 1 hour temp decreased to 100.7 Pt was feeling better H/A was gone.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Electroencephalogram, Feeling hot, Flushing, Gaze palsy, Glucose tolerance test
Clinical narrative: 8-23-13 Per mother, patient felt hot, flushed, and nauseated, called her mother, mother found her "shaking, and then her eyes rolled back in her head. This lasted just for a few seconds."  8-29-13, nurse noted rash on (L) deltoid, measuring 50 mm x 65 mm outside edges, no erythema in center.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Injection site rash, Nausea, Tremor
Clinical narrative: 8-23-13 Per mother, patient felt hot, flushed, and nauseated, called her mother, mother found her "shaking, and then her eyes rolled back in her head. This lasted just for a few seconds."  8-29-13, nurse noted rash on (L) deltoid, measuring 50 mm x 65 mm outside edges, no erythema in center.
Age: 43.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 43 year old patient (gender unknown). Information on medical history, drug reactions or allergies was not reported. On 26-AUG-2013, the patient was vaccinated with ZOSTAVAX, 0.5 ml, intramuscularly, (concentration and lot number were not reported). No concomitant medication was reported. The reporting physician stated that there were no adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to a patient of unknown gender and age who on an unknown date, was vaccinated with PROQUAD (Merck) (dose, route and lot # not provided). Nurse Practitioner reports that one children received dose of PROQUAD (Merck) that were stored at an unknown temperature for an unknown period of time. No adverse effect reported. No other information provided. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers two patients of unknown genders and ages who on an unknown date, were vaccinated with VARIVAX (Merck) (dose, route and lot # not provided) and on unspecified date vaccinated with M-M-R II (dose, route and lot # not provided). Nurse Practitioner reports that 2 children received doses of VARIVAX (Merck) and M-M-R II  that were stored at an unknown temperature for an unknown period of time. Two children each received a dose of VARIVAX (Merck) and dose of M-M-R II. No adverse effect reported. No other information provided. This is one of several reports from same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HEP, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant swelling redness and pain at injection site.
Age: 1.44
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Client had 101 Temp a few days before 09/01/2013 walk in clinic visit, unrelieved by ibuprofen. Walkin clinic told parent to go to Emergency Room temp at this time was 104 degrees. Emergency room did not insert IV or do lab work but they did give ibuprofen and prescribed a antibiotic. Child arrived at E.R. at 5:00pm and was discharged at 1:00 am. Monday 09/02/2013. Client was seen at MD on Tuesday and was told she must of recieved too many vaccines, client was given 7 vaccines on 08/26/2013.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Local swelling, Pain, Pain in extremity
Clinical narrative: Fever (101.8), chills, and terrible aches.  Her arm was extremely sore even to touch and it hurt to move it.  There was a large, red, hot, raised circle of about 4" in diameter that sort of even went under my arm pit.  The fever lasted till Monday, 9/2/13; by 9/2/13 was fine except the red circle is still there and arm is 'somewhat' sore (nothing like before though).
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Fever (101.8), chills, and terrible aches.  Her arm was extremely sore even to touch and it hurt to move it.  There was a large, red, hot, raised circle of about 4" in diameter that sort of even went under my arm pit.  The fever lasted till Monday, 9/2/13; by 9/2/13 was fine except the red circle is still there and arm is 'somewhat' sore (nothing like before though).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Unevaluable event
Clinical narrative: Adv eff viral vacc NEC on 2013-07-16.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-07-18.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-08-02.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphonia, Dyspnoea, Eye discharge, Nasal congestion
Clinical narrative: Tightness in chest, discharge from eyes, difficulty to breath, hoarseness. Lasted through 4:00 AM. Still having some symptoms of nasal congestion, tightness in chest, yellowish mucous discharge from eyes at 11:23 AM on 09/05/2013.
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a current 36 year old male patient of unknown age who on an unknown dates, when he was a child was vaccinated with two doses of M-M-R II (therapy specifications not provided). The nurse stated that on an unknown date the patient had titers drawn on unspecified date and the results came back as equivocal for mumps. The outcome of patient had titers results as equivocal for mumps was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-08-17.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Headache, Pyrexia, Vomiting
Clinical narrative: High fever over 102, shivering, sever headache, vomiting, mild chest pain. Lasted until 6:00 AM. When vomiting ceased treated with 2 aspirins every 4 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: Other anaphylactic react on 2013-08-28, clinician comment: This child has had each of the component vaccines before and did not have an immediate reaction this time.  Nevertheless, as patient started showing systemic allergic response within 24hrs of vaccination, adverse reaction to vaccines must be considered as possible cause of anaphylaxis.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Body temperature increased, Rash erythematous, Rash generalised
Clinical narrative: Had Temp. for 1 week ranging from 99 to 101degrees. Then when temp broke developed red spots on face and over body. It did go away, but does return if she gets hot. Went to Dr. was told it may be 5th disease.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Pyrexia, Rash erythematous
Clinical narrative: Had Temp. for 1 week ranging from 99 to 101degrees. Then when temp broke developed red spots on face and over body. It did go away, but does return if she gets hot. Went to Dr. was told it may be 5th disease.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Muscular weakness, Oedema peripheral, Pyrexia
Clinical narrative: FEVER NORTH OF 102, AND RIGHT ARM AND ARMPIT SWELLING. I HAD TO USE MY LEFT HAND TO PICK UP MY RIGHT ARM.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TD
Symptoms: Communication disorder, Fall, Immediate post-injection reaction, Loss of consciousness, Somnolence
Clinical narrative: As reported on occurrence report by nurse in Local Health Unit:  Client received vaccines and immediately fell forward off of chair and was unresponsive.  Regained consciousness, but kept going in and out.  Layed her on the floor with feet elevated, cold cloths and cold water to drink.  Began to fall asleep, unresponsive to ammonia capsule activated and passed under her nose.  Asked to sit up after a few minutes, but kept falling asleep and had difficulty communicating.  B/P and pulse were stable.  Epinephrine 0.5ml given SQ.  Alert and communicative within 7 minutes.  Walked out on her own with mother with instructions to see her physician for further problems.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TD
Symptoms: Unresponsive to stimuli
Clinical narrative: As reported on occurrence report by nurse in Local Health Unit:  Client received vaccines and immediately fell forward off of chair and was unresponsive.  Regained consciousness, but kept going in and out.  Layed her on the floor with feet elevated, cold cloths and cold water to drink.  Began to fall asleep, unresponsive to ammonia capsule activated and passed under her nose.  Asked to sit up after a few minutes, but kept falling asleep and had difficulty communicating.  B/P and pulse were stable.  Epinephrine 0.5ml given SQ.  Alert and communicative within 7 minutes.  Walked out on her own with mother with instructions to see her physician for further problems.
Age: 1.05
Sex: F
Vaccine: HEP, HEPA, MMR, PPV, VARCEL
Symptoms: Injection site rash, Irritability
Clinical narrative: Developed rash on left outer thigh at site of injections (PCV-13 and Varicella).  Patient irritable, no fever, eating well, sleeping well.  Rash doubled in size by 9/05/13 at time of presentation to the ER.  No medication/treatment given in time prior to arrival.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Headache, fever 102 F, body aches, painful injection site to left arm, nausea treated with ibuprofen.
Age: 60.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Orthostatic hypotension, Vertigo
Clinical narrative: Light-headedness, vertigo, orthostatic hypotension.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Severe local reaction - red, raised approx 2 inches wide - warm to touch  lasted 5 days - resolving slowly.
Age: 1.24
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Wheezing
Clinical narrative: Within 2 hours I laid down and felt as though my lungs were half full of air and had to sit up. I had slight wheezing and kept trying to clear my throat. I drank a hot liquid - used menthol cough drops and deep breathing techniques.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a patient of unknown age and gender. The nurse reported that the physician's office had a patient who were administered GARDASIL (lot# unspecified) route, dose and location unspecified on an unspecified date and experienced syncope. The physician inquired "Is there increased risk of syncope associated with unspecified lot# GARDASIL". At the time of report, the outcome of syncope was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Pt had routine blood drawn and was given GARDASIL vaccine. While waiting to give urine specimen (standing) he passed out - hitting head on floor.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Pt had routine blood drawn and was given GARDASIL vaccine. While waiting to give urine specimen (standing) he passed out - hitting head on floor.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Heart rate irregular, Injection site erythema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 65 year old female patient with atrial fibrillation, cardiac arrhythmia and no listed drug reaction/allergies. On 12-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J001694, expiring 08-MAY-2014, 0.65 ml, subcutaneous in the left arm. Concomitant therapies included digoxin, metoprolol and sotalol hydrochloride. On 14-AUG-2013, the patient reported to the pharmacy with an elevated blood pressure and heart rate increased. The patient's heart rate was 102 and irregular. The pharmacist measured the patients blood pressure and it was 162/88. The patient demonstrated a reddened area at the injection site, which the pharmacist stated had no evidence of being rash-like. The patient was not short of breath or exhibiting any sign of distress. No treatment was given for the adverse events. No other lab diagnostic tests were performed. The patient consulted the pharmacist for medical attention. The outcome of the events was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
Age: 1.43
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: 9/5/13 office visit for attenuated varicella - started breaking out 9-3-13. Not aware of source of exposure.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Incorrect dose administered, Pain
Clinical narrative: This spontaneous report as received from a 64 year old female patient regarding herself. Patient's medical history was breast cancer and current condition included high blood pressure. The patient had no drug reaction/allergies. On 17-FEB-2013, the patient was vaccinated with a first dose of ZOSTAVAX and on 13-MAR-2013, the patient received a second dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported for both). Concomitant therapies included COREG and DIOVAN HCT. On 13-MAR-2013, the patient experienced body aches, dizzy spells and excessive sweating that usually lasted from one hour to two hours and one time the symptoms lasted all day. The patient sought no medical attention and no treatment was given for the events. No lab diagnostics studies were performed. The outcome of body aches and dizzy spells with excessive sweating was reported as not recovered/not resolved. The outcome of received two injections of the ZOSTAVAX vaccine was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 01-AUG-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and route was not reported). On 21-MAR-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date and route was not reported). On 16-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date and route was not reported). No adverse effects reported was reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Hypotension, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 67 year old female patient with no reported medical history. On 07-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (route dose and lot number unknown). No other suspect therapy or concomitant medication was reported. On 07-AUG-2013 the patient experienced severe swelling and severe pain in the arm where PNEUMOVAX23 was administered. The nurse practitioner reported that the patient's blood pressure is a little low and the patient feels a little fatigued. No treatment information was reported. The outcome of severe swelling and severe pain   in the arm where PNEUMOVAX23 was administered, a little fatigued and blood pressure is a little low was reported as not recovered/not resolved. The reporters relatedness of severe swelling and severe pain in the arm where PNEUMOVAX23 was administered, a little fatigued and blood pressure is a little low to PNEUMOVAX23 is unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II, (lot number, expiry date and route was not reported). No adverse effects were reported. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, IPV, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a patient's mother via Registered Nurse, refers to an 11 year old, female patient with none pertinent medical history and drug reaction/allergy to amoxicillin. On 20-APR-2013 (start date of the therapy also reported as 30-APR-2013) the patient was vaccinated with the first dose of GARDASIL (lot # H021608, expiry date: 13-AUG-2015) (dose, route not reported). The first dose of GARDASIL was concomitantly administered with Tdap (manufacture unknown), IPV (unspecified) and MENACTRA. On 17-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (lot # H021346, expiry date: 01-OCT-2015) (dose, route not reported). It was reported that patient developed hives on the top of the thighs about one week after the first (approximately on 27-APR-2013) and second dose of GARDASIL (approximately on 24-JUN-2013). The outcome of hives on the top of the thighs was reported as recovered/resolved, on unknown date in 2013. Relatedness between the therapy with GARDASIL and hives on the top of the thighs was not assess by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Hypomenorrhoea, Metrorrhagia
Clinical narrative: This spontaneous report was received from the patients grandmother refers to a 12 year old female patient. The patient who had been menstruating for "about two years" normally has "very heavy" periods. Shortly after the GARDASIL (lot # expiry not reported) was administered on an unknown date in July 2013 (reported as mid July) the patient experienced a usual, normal menstrual period. On an unknown date in August 2013 the patient experienced only "a few days of spotting" and felt "bloated". Her period was much shorter and lighter than normal. No treatment was given to the patient. No medical attention sought. The outcome of felt bloated, her  period was much shorter and lighter than normal and a few days of spotting was unknown. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test abnormal, Dehydration, Electrocardiogram normal, Fall, Syncope
Clinical narrative: Fainting (Syncope) at home while teaching piano to student. Fell into corner near furniture, woke up after 30 seconds; husband transported to ER at hospital.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound Doppler, Ultrasound scan normal
Clinical narrative: Fainting (Syncope) at home while teaching piano to student. Fell into corner near furniture, woke up after 30 seconds; husband transported to ER at hospital.
Age: 0.07
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Asthenia, Barium swallow, Biopsy, Blood test, Convulsion
Clinical narrative: Swelling, seizure, rash, lethargy, bloody stool, fever, pain, weakness, lump at injection site.
Age: 0.07
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Endoscopy, Exploratory operation, Haematochezia, Injection site mass, Lethargy
Clinical narrative: Swelling, seizure, rash, lethargy, bloody stool, fever, pain, weakness, lump at injection site.
Age: 0.07
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Pain, Pyrexia, Rash, Swelling
Clinical narrative: Swelling, seizure, rash, lethargy, bloody stool, fever, pain, weakness, lump at injection site.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain L deltoid after injection, radiating to fingers with numbness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm very swollen, red and hot to the touch. Patient saw doctor on 9/4/13 and has been applying ice.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Eating disorder, Loss of consciousness, Malaise, Myalgia
Clinical narrative: Pt got chills, muscle aches, 103 fever, pt could not eat and passed out. Pt was ill for 5 days.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt got chills, muscle aches, 103 fever, pt could not eat and passed out. Pt was ill for 5 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Burning sensation, Cough, Erythema, Headache
Clinical narrative: Extreme swelling, large red area, burning, itching, pain underarm, and down length of arm.  The day after a slight fever, headache, cough.  Still a large red area on arm 10 days later.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Extreme swelling, large red area, burning, itching, pain underarm, and down length of arm.  The day after a slight fever, headache, cough.  Still a large red area on arm 10 days later.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Dysarthria, Laboratory test, Loss of consciousness, Memory impairment
Clinical narrative: Patient received HPV at 4:30 p.m., given juice, observed for 15 minutes, left clinic without incident. Later that night, at softball practice, blacked out, slurred speech, couldn't remember incident. Taken to ER and CT, xray, labs done per mom. Referred to neurologist for possible seizure.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray
Clinical narrative: Patient received HPV at 4:30 p.m., given juice, observed for 15 minutes, left clinic without incident. Later that night, at softball practice, blacked out, slurred speech, couldn't remember incident. Taken to ER and CT, xray, labs done per mom. Referred to neurologist for possible seizure.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Patient felt faint after vaccine was administered right away. She reported arm pain the day after immunization to the pharmacy on 9-5-13.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Disorientation, Grand mal convulsion, Unresponsive to stimuli
Clinical narrative: Received the Tdap, Varicella, MCV4, Hepatitis A, and first HPV vaccine. Client was unresponsive for approx. 10 seconds, followed by what appeared to be a 8-10 second tonic-clonic seizure. Provided safe environment. Was disoriented for approx. 2 minutes, then alert and oriented X4. Contacted physician, who stated that client should go to the ER to be assessed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Paraesthesia, Pruritus
Clinical narrative: Enlarged red area under the arm, tingling, burning, itching.  Patient self medicated with Benadryl tablets, Aloe Vera Gel for 3-4 days and reddened area decreased in size.  Patient did not contact MD because she felt like there was nothing more they can do.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age. On an unknown date the patient was inadvertently vaccinated with ZOSTAVAX (dose, route and lot # not provided) instead of VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner (N. P), refers to a patient of an unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unspecified date, the patient was on Prednisone (dosages and manufacturer unspecified) because of rash on both arms that developed after she received ZOSTAVAX. The outcome of rash on both arms was unknown. This case is related with  MARRS 1309USA000504. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse practitioner (N. P), refers to a 63 year old female patient. On 26-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported). Concomitant therapies was not reported. On 29-AUG-2013, the patient developed a severe headache and injection site reactions after receiving ZOSTAVAX. The patient sought medical attention with the nurse and it was unknown if any treatment was given for the adverse events.  The outcome of severe headache and injection site reactions were unknown. This case is related with MARRS 1309USA002243. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Nausea, Retching
Clinical narrative: Within 1 minute of being given injection, patient reported feeling light headed, and nauseated. Patient started clutching chest, and dry heaved several times. Patient was given 16oz orange juice, and rested for 10 minutes. The patient reported they felt fine after the rest, and left the facility under their own power.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose increased, Cold sweat, Diarrhoea, Faecal volume increased, Fatigue
Clinical narrative: Frequent large bowel movements, feeling of nausea, painful muscles, fatigue, possible fever (felt cold & clammy and sometimes sweaty.  Headache at base of neck. Diarrhea a couple of times.  And RIDICULOUSLY high blood sugars (which usually occur when I get sick).
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Frequent bowel movements, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Frequent large bowel movements, feeling of nausea, painful muscles, fatigue, possible fever (felt cold & clammy and sometimes sweaty.  Headache at base of neck. Diarrhea a couple of times.  And RIDICULOUSLY high blood sugars (which usually occur when I get sick).
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Frequent large bowel movements, feeling of nausea, painful muscles, fatigue, possible fever (felt cold & clammy and sometimes sweaty.  Headache at base of neck. Diarrhea a couple of times.  And RIDICULOUSLY high blood sugars (which usually occur when I get sick).
Age: 82.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: INJECT SITE REACTION - ENTIRE DELTOID.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Left deltoid pain and swelling around injection site. Erythema of 5 cm around injection site. Fever of 38.5. Chills.
Age: 12.0
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Tdap was ordered but DTaP was given.
Age: 0.23
Sex: F
Vaccine: HIBV
Symptoms: Hypersomnia, Somnolence
Clinical narrative: Extreme sleepiness and sleeping more than 20 hours in one 24 hour timeframe.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation in arm and fingers of arm injected (left). Referred guest to call physician to assess if further treatment should be considered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus, Pyrexia
Clinical narrative: Patient first experienced a fever on day 1, which was then followed by swelling of her arm. The arm continued to swell and was red in color. Patient claimed that it also itched, and took Benadryl for the itching.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient began to feel numbness in her face and arms.  She was advised to seek medical attention but declined.
Age: 1.03
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Aggression, Malaise, Viral infection
Clinical narrative: Child began throwing temper tantrums, erratic behavior, and showing aggressiveness within 1 week of MMR/V Vaccine. Infant became ill with viral symptoms within a week and lasted for 2 months following vaccine. Child continues to have unusual aggression and tantrums at age of 3 now.
Age: 2.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Swelling, Urticaria
Clinical narrative: Dime size welt and redness where MMR injection was administered. Iced area x 15 min and given ibuprofen. Swelling did resolve. (Kept patient at office for 15-20 minutes).
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Client received Tdap vaccine at 2:49 PM Rt. deltoid IM and Depo Provera injection IM Lt. deltoid. Client fainted post administration. V/S: B/P 118/69, HR 67, RR 16, alert and oriented x3 at discharge. Client is diabetic, taking pills to   control. States last meal at 10:00 AM.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness, Fall, Headache, Nausea, Screaming
Clinical narrative: Vaccines listed below given at approx 3:15 pm, pt then walked to lab waiting area and sat down. At approx 3:20 mother of pt started screaming. Nurses found pt slumped over in chair, unresponsive. Pt carried to exam table/room by MD - pt unresponsive for less than 1 minute. BP's stable. Pt recovered after 15 mins had some nausea, HA, dizziness. Pt reported she has passed out before with blood work, but never shots.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Vaccines listed below given at approx 3:15 pm, pt then walked to lab waiting area and sat down. At approx 3:20 mother of pt started screaming. Nurses found pt slumped over in chair, unresponsive. Pt carried to exam table/room by MD - pt unresponsive for less than 1 minute. BP's stable. Pt recovered after 15 mins had some nausea, HA, dizziness. Pt reported she has passed out before with blood work, but never shots.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hyperhidrosis, Pyrexia, Rash
Clinical narrative: Pt received initial HPV vaccine on 8/29/12 was told to wait 15 minutes after receiving it. Pt did mention that had a headache and sweats for a few minutes, but then subsided. Pt comes in a week later for another vaccine and mention had fever x 4 days, headache as well. Developed rash on 3rd day subsided. Treated fever w/Tylenol which helped a little w/cool showers. Pt ok on 5th day.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Vaccine positive rechallenge
Clinical narrative: 13 yo received 2nd Gardasil 8/27, had sz on 9/4/13. Pt previously healthy though also had 1st sz on 7/28/13 after receiving Gardasil on 6/27/13.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Wheezing
Clinical narrative: Within 24h, patient started coughing and wheezing. Was hospitalized approximately 48h after vaccination with FLUMIST. She was not a known asthmatic.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal rigidity, Crying, Diet refusal, Irritability
Clinical narrative: Child crying non stop since 4 mo shots this morning. Child refusing bottle, fussy, crying. Abdomen taut. Increased crying when supine. Child sent to ER via ambulance for evaluation.
Age: 50.0
Sex: M
Vaccine: VARCEL
Symptoms: Acne, Body temperature fluctuation, Pain, Skin lesion, Varicella post vaccine
Clinical narrative: On a Sunday, 1 week after receiving vaccination, patient reports to have had body aches, fluctuating body temperature, and "pimples" on his face. The "pimples" progressed into a self-diagnosed chicken pox. Patient never sought medical attention and quarantined himself for the past two weeks. Lesion is apparent on face upon returning to pharmacy on 9/5/13, but patient states that it is now in remission. Still in recovery (getting better).
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Polyarthritis
Clinical narrative: This spontaneous report was received from a 55 year old female patient regarding herself. Approximately on an unknown date in 1993 (reported as 20 years ago), the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On an unknown date in 1993 (reported as 20 years ago), the patient experienced generalized arthritis symptoms especially in her legs. The symptoms lasted about 3 weeks and then subsided. The outcome of generalized arthritis symptoms especially in her legs was recovered (reported as subsided). It was unknown if patient sought medical attention. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Adult Hep A vaccine administered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient reported to be in her late 60's to early 70's. The patient's medical history included naturally occurring shingles. On an unknown date (4 or 5 months after recovering from the original case of shingles) the patient was vaccinated with ZOSTAVAX injection (route, dosage and lot number not reported). Upon follow-up at her Physician's office, the patient was found to have developed a painless rash in unspecified locations of the body. The patient sought medical attention (doctor visit) but received no treatment. The outcome of the event was reported as recovered (unspecified date).  Additional information is not expected.