chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling hot, Vision blurred
Clinical narrative: Patient returned to class at 11:25 am and at 11:35 am got up and told the teacher that she was feeling woozy hot, and things were blurry. She also claimed to have difficulty breathing. Ambulance came at 11:55 am and patient received IV BENADRYL and a nebulizer. In the hospital she was admitted and given IV BENADRYL.
Age: 1.13
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash erythematous, Rash papular, Urticaria
Clinical narrative: Patient presented to office after having vaccines with erythematous papular urticaric rash. Treatment was Benadryl.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Injection site swelling, Pain, Rash, Rash macular
Clinical narrative: PATIENT DEVELOPED A RASH ON THE LEFT ARM 4 HOURS AFTER THE INJECTION. THE INJECTION SITE WAS A LITTLE SWOLLEN AND THE RASH ON THE ARM WAS SLIGHTLY PAINFUL (BURNING SENSATION). THE FOLLOWING DAY THE PATIENT HAD RED BLOTCHES ON THE FACE THAT RESOLVED WITHIN 24 HOURS.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Computerised tomogram, Cough, Facial pain, Fatigue
Clinical narrative: Sore throat, followed by coughing and fatigue for two weeks. Three weeks after the vaccine, I developed facial pain, arm tingling, and neck pain.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Oropharyngeal pain, Paraesthesia
Clinical narrative: Sore throat, followed by coughing and fatigue for two weeks. Three weeks after the vaccine, I developed facial pain, arm tingling, and neck pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Arm turned red, warm and tender. Area of approximately 70mm x 140mm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Myalgia, Pain in extremity, X-ray
Clinical narrative: Arm was sore from time of onset and got progressively worse as time went on. No redness or swelling; only soreness and aching in muscle and continues to this day.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Discomfort, Injection site pain, Joint range of motion decreased
Clinical narrative: Vaccine administered in left deltoid hurt more than usual upon administration.  I had the anticipated sore/tender feeling that I have had in the past after immunization, but it persisted past the normal 2-3 days.  The discomfort has persisted daily.  Now, 10 weeks later, I am struggling with decreases in strength and range of motion.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ, PPV, TYP
Symptoms: C-reactive protein increased, Cellulitis, Headache, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid swelling pain, fevers 102.6, myalgias, headache, vomiting for 2 days than (L) arm swelling cellulitis, pain for one week.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ, PPV, TYP
Symptoms: Local swelling, Myalgia, Pain in extremity, Pyrexia, Ultrasound scan normal
Clinical narrative: Left deltoid swelling pain, fevers 102.6, myalgias, headache, vomiting for 2 days than (L) arm swelling cellulitis, pain for one week.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ, PPV, TYP
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Left deltoid swelling pain, fevers 102.6, myalgias, headache, vomiting for 2 days than (L) arm swelling cellulitis, pain for one week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection. 2 1/2 " x 1 1/2" - Dr gave her BENADRYL and cimetidine.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Haematoma, Mobility decreased, Pain
Clinical narrative: Patient received FLUVIRIN and PNEUMOVAX-23 in left arm 12/7/2013. Called back 12/9/13 and 12/11/13 to complain of pain and limited movement, (no swelling, redness numbness).
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient has pain in arm injected with FLUCELVAX. Has difficulty raising arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient complains that she has occasional/sporadic pain going up her arm after she got the vaccine.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neck pain, Pain, Pain in extremity, Rash macular, Skin warm
Clinical narrative: Started on inside of left arm - spread out and around to bicep - about 1/3 of upper arm affected. 8 small hives. 3 medium hives. 1 large hive. None are itchy. Skin is warm and blotchy. Arm is throbbing. No open skin. Pain in arm has spread. Now neck hurts. Advised pt to get immediate medical care.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Started on inside of left arm - spread out and around to bicep - about 1/3 of upper arm affected. 8 small hives. 3 medium hives. 1 large hive. None are itchy. Skin is warm and blotchy. Arm is throbbing. No open skin. Pain in arm has spread. Now neck hurts. Advised pt to get immediate medical care.
Sex: F
Vaccine: VARZOS
Symptoms: Myositis, Pruritus
Clinical narrative: This spontaneous report as received from a female patient of unknown age with penicillin allergy refers to herself. The patient did not remember what else she was allergic to. About 3 years ago, in approximately October 2010 the patient was vaccinated with a dose of ZOSTAVAX to help with prior case of shingles (dosage and route was not reported). Concomitant therapy included nabumetone. The patient reported that she had a prior case of shingles was not sure of exact date it started but it was about 3 years ago and she took the vaccine as advised. She stated that her shingles symptoms did not get better she still had itching. The side where she had been diagnosed was her left shoulder and she advised it was spreading. She stated that her muscle tissues were inflamed and she was taking medication for that. The patient sought medical attention. At the time of the report, the outcome of events was reported as not recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date in approximately June 2012 (reported as a year and half ago), the patient was vaccinated with GARDASIL dose 1. The patient had received the second dose approximately in June 2013, reported as a year after the first. Dose, lot and expiry date were not reported for both doses. The physician stated that the patient has not reported any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer refers to unspecified family members whose children. On an unknown date the patients were vaccinated with M-M-R II, (strength, dose, lot# and indication were not provided). The patients had unspecified reaction to the M-M-R II vaccine. The outcome of event and action taken with M-M-R II were not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Insomnia, Musculoskeletal pain, Neck pain, Spinal pain
Clinical narrative: Patient comes in accompanied by her mother with ongoing back, upper shoulder, and neck pain. She states about 1 1/2 week after receiving her second HPV vaccine in early October she developed achiness in the neck, periscapular area and down the thoracic spine to the low back. The achiness has been persistent and is quite bothersome when she is sitting for a long period of time. She is not currently taking gym. She is doing dance, which she has been able to do, but the pain does keep her up at night. They have been seeking chiropractic care and despite multiple chiropractic modalities, she has had no relief of symptoms. She denies any fever, chills, or sweats. She denies any other joints or pains. Her wrists, knees, and hand have been spared. There is no family history of any inflammatory arthritis according to the mother. She has had no skin rash. No fever, chills, or sweats. No mouth ulcers associated with this. No change in bowel or bladder habits. She has not missed any school with it, but she has been quite uncomfortable she tells me.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Lip pruritus, Pruritus
Clinical narrative: Approx 11:05 A shot given as a Nurse only Visit. 11:20 A pt voiced feeling OK no reactions. Discharge into given to her and husband. Pt left went to lobby BR and came out talking of allergic reaction. Itching at lips, face and head v/s taken 98.50 20 56 102/62 O2 Sat 100%. Dr notified. He ordered BENADRYL 25 mg IM. given in (L) buttock Pt A and O sent to c/o just itching. 11:55 pt voiced feeling better.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Amnesia, Anxiety, Arthralgia, Condition aggravated, Depression
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Exercise tolerance decreased, Fight in school, Fine motor delay, Grip strength decreased
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Headache
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Adjustment disorder with mixed anxiety and depressed mood, Alanine aminotransferase normal, Amnesia, Arthralgia
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Aspartate aminotransferase normal, Asthma, Astigmatism, Blood albumin normal, Blood calcium normal
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood lactate dehydrogenase normal, Blood magnesium normal
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood phosphorus increased, Blood potassium normal, Blood sodium decreased, Blood thyroid stimulating hormone normal, Blood urea normal
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood uric acid normal, C-reactive protein normal, Carbon dioxide normal, Central nervous system lesion, Cerebellar ataxia
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Condition aggravated, Coordination abnormal, Culture urine negative, Decreased appetite, Dizziness
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyslexia, Dysphagia, Electroencephalogram normal, Fall, Fatigue
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fine motor delay, Free thyroxine index normal, Gait disturbance, Grip strength decreased, Hallucination, visual
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Headache, Hyperacusis, Hypophagia, Hyporesponsive to stimuli, Lumbar puncture normal
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Mastication disorder, Mental status changes, Metabolic function test normal, Muscular weakness, Neurological examination
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination normal, Photophobia, Protein total normal, Red blood cell sedimentation rate normal
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Speech disorder, Thyroxine normal, Tremor, Tri-iodothyronine uptake normal, Upper motor neurone lesion
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Urinary incontinence, Urine analysis normal, Urine output decreased, Visual impairment
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Computerised tomogram, Dysarthria, Dysphagia, Headache, Mental status changes
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: Headache, mental status change, slurred speech, generalized pain, difficulty swallowing.
Age: 45.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Eyelid oedema
Clinical narrative: Pt. called pharmacy at 5:45 PM 12/13 to report continual eye irritation and slight swelling since vaccine. Pt is fearful that because she is allergic to dogs and FLUCELVAX is cultured in dog kidney cell, this is the reason for her rxn. Pt reports that BENADRYL helps, but she doesn't want to continually take.
Age: 45.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Eye irritation, Swelling
Clinical narrative: Pt. called pharmacy at 5:45 PM 12/13 to report continual eye irritation and slight swelling since vaccine. Pt is fearful that because she is allergic to dogs and FLUCELVAX is cultured in dog kidney cell, this is the reason for her rxn. Pt reports that BENADRYL helps, but she doesn't want to continually take.
Age: 9.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site swelling
Clinical narrative: (R) arm swelling/? cellulitis.
Age: 9.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Local swelling
Clinical narrative: (R) arm swelling/? cellulitis.
Sex: U
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a patient of unknown age and gender. In 2013 (date unspecified) the patient was vaccinated with a dose of PNEUMOVAX23, injection (strength, dose, route, lot number and expiration date not provided). The nurse reported that the patient had adverse reactions (type of reaction unspecified) with in the last couple of weeks (in 2013, date unspecified) to PNEUMOVAX23. The patient sought medical attention and was hospitalized (reason and duration of hospitalization was unspecified) following vaccination with PNEUMOVAX23. The outcome of adverse reactions was not reported. The relatedness between vaccination with PNEUMOVAX23 and adverse reactions was not reported. The adverse event had been provided to the Vaccine Adverse Event Reporting System (VAERS). This is one of two reports from the same source (#1312USA005018). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a patient of unknown age and gender. In 2013 (date unspecified) the patient was vaccinated with a dose of PNEUMOVAX23, injection (strength, dose, route, lot number and expiration date not provided). The nurse reported that the patient had adverse reactions (type of reaction unspecified) with in the last couple of weeks (in 2013, date unspecified) to PNEUMOVAX23. The patient sought medical attention and was hospitalized (reason and duration of hospitalization was unspecified) following vaccination with PNEUMOVAX23. The outcome of adverse reactions was not reported. The relatedness between vaccination with PNEUMOVAX23 and adverse reactions was not reported. The adverse event had been provided to the Vaccine Adverse Event Reporting System (VAERS). This is one of two reports from the same source (#1312USA005018). Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: This study case was received from the investigator in a trial on 03 December 2013. A 49 year-old male subject had received on 12 November 2013 ACAM2000 (lot number, route, site and date of administration not reported) and Anthrax (lot number, route, site and date of administration not reported) and two days later on 14 November 2013, experienced shortness of breath and palpitations. On 18 November 2013, the subject developed a dry cough. The subject was diagnosed with possible myopericarditis. On 21 November 2013, the subject had a normal Troponin I and an abnormal ECG that showed a first degree atrioventricular (AV) heart block. The subject was evaluated by cardiologists who feel symptoms may be related to vaccination but no diagnosis and subject was cleared. According to the subject, the cardiologist ran cardiac enzymes and did an echo and ruled out a murmur. According to the subject, the cardiologist the palpitations and shortness of breath could have been related to the vaccine since symptoms were not there in the past. The subject also wore a Holter monitor for 24 hours and has not received the results. According to the investigator, the subject was reluctant to divulge results and suspects no further information. No treatments were received. No further information was available at the time of the report. The subject's outcome was still present, being treated (not recovered). According to the investigator, the event of possible myopericarditis was considered mild, an "other important event" and probably related to vaccination. Documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Atrioventricular block first degree, Cardiac enzymes normal, Cough, Dyspnoea, Echocardiogram normal
Clinical narrative: This study case was received from the investigator in a trial on 03 December 2013. A 49 year-old male subject had received on 12 November 2013 ACAM2000 (lot number, route, site and date of administration not reported) and Anthrax (lot number, route, site and date of administration not reported) and two days later on 14 November 2013, experienced shortness of breath and palpitations. On 18 November 2013, the subject developed a dry cough. The subject was diagnosed with possible myopericarditis. On 21 November 2013, the subject had a normal Troponin I and an abnormal ECG that showed a first degree atrioventricular (AV) heart block. The subject was evaluated by cardiologists who feel symptoms may be related to vaccination but no diagnosis and subject was cleared. According to the subject, the cardiologist ran cardiac enzymes and did an echo and ruled out a murmur. According to the subject, the cardiologist the palpitations and shortness of breath could have been related to the vaccine since symptoms were not there in the past. The subject also wore a Holter monitor for 24 hours and has not received the results. According to the investigator, the subject was reluctant to divulge results and suspects no further information. No treatments were received. No further information was available at the time of the report. The subject's outcome was still present, being treated (not recovered). According to the investigator, the event of possible myopericarditis was considered mild, an "other important event" and probably related to vaccination. Documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory, Palpitations, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 03 December 2013. A 49 year-old male subject had received on 12 November 2013 ACAM2000 (lot number, route, site and date of administration not reported) and Anthrax (lot number, route, site and date of administration not reported) and two days later on 14 November 2013, experienced shortness of breath and palpitations. On 18 November 2013, the subject developed a dry cough. The subject was diagnosed with possible myopericarditis. On 21 November 2013, the subject had a normal Troponin I and an abnormal ECG that showed a first degree atrioventricular (AV) heart block. The subject was evaluated by cardiologists who feel symptoms may be related to vaccination but no diagnosis and subject was cleared. According to the subject, the cardiologist ran cardiac enzymes and did an echo and ruled out a murmur. According to the subject, the cardiologist the palpitations and shortness of breath could have been related to the vaccine since symptoms were not there in the past. The subject also wore a Holter monitor for 24 hours and has not received the results. According to the investigator, the subject was reluctant to divulge results and suspects no further information. No treatments were received. No further information was available at the time of the report. The subject's outcome was still present, being treated (not recovered). According to the investigator, the event of possible myopericarditis was considered mild, an "other important event" and probably related to vaccination. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain
Clinical narrative: Employee with stated complaint that left arm has been hurting since receipt of an influenza vaccine. Describes the discomfort to be in the area of where the injection was given, pain with movement limiting range of motion and functional ability and difficulty lying on the affected side. Employee has received the influenza vaccine voluntarily for years.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain, Pain in extremity
Clinical narrative: Employee with stated complaint that left arm has been hurting since receipt of an influenza vaccine. Describes the discomfort to be in the area of where the injection was given, pain with movement limiting range of motion and functional ability and difficulty lying on the affected side. Employee has received the influenza vaccine voluntarily for years.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Burning sensation, CSF protein increased, Hyporeflexia
Clinical narrative: Patient complained of pain/weakness in legs.  Spinal tap confirmed case of Guillain-Barre syndrome.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Metabolic function test, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Patient complained of pain/weakness in legs.  Spinal tap confirmed case of Guillain-Barre syndrome.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Restless legs syndrome
Clinical narrative: Patient complained of pain/weakness in legs.  Spinal tap confirmed case of Guillain-Barre syndrome.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness, Pain in extremity
Clinical narrative: Patient complained of pain/weakness in legs.  Spinal tap confirmed case of Guillain-Barre syndrome.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Acne, Bacterial test, Rash erythematous
Clinical narrative: Broke out in red rash all over chest, arms, back, neck.  Turned into having acne breakout as well.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Two days following administration, patient reported a red, raised area around the injection site. Area had slight burning and itching and was hot to the touch.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 62 year old male patient with pain in his left shoulder. The patient had not known drug reactions/allergies. On 26-OCT-2013, the patient received a dose of ZOSTAVAX, 0.65 ml, subcutaneous in the left arm (Lot # and expiration date were not provided). There was no concomitant medication. It was reported that the patient had pain in his left shoulder which began about a year ago (approximately in December 2012), and she has not seen a physician about this shoulder pain and it's etiology was unknown. The reporter stated that he received the dose of ZOSTAVAX in his left arm on 26-OCT-2013, and the pain in his shoulder increased. It was stated that he has not yet seen a physician, but was planning to. The patient had not received any treatment for the event and no laboratory diagnostic test has been performed. The patient sought medical attention by pharmacy visit. At the time of the report, the patient had not recovered from the event. The relatedness between the event and the suspect therapy was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a certified medical assistant concerning to a 16 year old female patient with historical vaccination with the first dose of MMR (unspecified) on 22-MAR-1999 and the first dose of VARIVAX (unspecified) on 18-MAY-2007. On 25-NOV-2013, the patient was vaccinated with PROQUAD (Merck), (dose, lot# and route not reported). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with first dose of GARDASIL. On 23-OCT-2013 and on 22-NOV-2913 the patient received a second and third doses of GARDASIL, respectively. It was reported that patient received the third dose of GARDASIL too early. No adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Monoplegia, Muscular weakness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. On 21-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, route not reported, one dose). On an unknown date in October 2013 the patient developed left upper arm paralysis and weakness after receiving one dose of GARDASIL. The patient went for a doctor's visit on 25-OCT-2013 and 31-OCT-2013. A physical exam was performed and it was "normal". The physician referred the patient to a neurologist, and the neurologist performed a physical exam and it was "normal". The neurologist tests could not be performed on the patient due to insurance reasons. There was no treatment given for the events. The outcome of the events was unknown. Upon internal review, left upper arm paralysis was considered as medically significant. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 16 year old male patient. Medical history and drug reactions/allergies were not reported. On 15-NOV-2012, the patient was vaccinated with GARDASIL lot # J007354 expiry date 20-FEB-2016 first dose, 0.5 ml, intramuscular in the left deltoid. On 19-NOV-2013, the patient was vaccinated with GARDASIL second dose, (lot, dose and route not reported). Concomitant medication was not reported. On 19-NOV-2013, the patient was vaccinated with improperly stored GARDASIL, this was the patient second dose in the series. No adverse effects. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed mood, Thinking abnormal
Clinical narrative: This spontaneous report as received from a patients mother refers to her daughter of 13 year old. The patient just started her period two months ago. On an unknown date in 2013, the patient was completed her full series of vaccination with GARDASIL dose 3, intramuscular for routine vaccination. The patient received her first and second doses some time in 2012. No concomitant therapy was used. On an unknown date in October 2013 (about 2 months), the patient began to exhibit sadness and sad thoughts. The patients mother spoke to physician. No treatment was given and no lab diagnostics were performed. The outcome of began to exhibit sadness and sad thoughts was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to 3 patients of unknown age and gender. On an unknown date the 3 patients were vaccinated with GARDASIL, 0.5 ml, intramuscular. The GARDASIL administered were exposed to temperature conditions that Merck cannot support. No adverse effects reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Drug administered at inappropriate site, Local reaction, Pruritus
Clinical narrative: This spontaneous report as received from a nurse practitioner who is also the 61 year old female patient with gastroesophageal reflux disease secondary to non steroidal anti-inflammatory drugs, hypertension, low potassium, fibromyalgia, sensitive to latex and has drug reactions/allergies to sulfa. The patient's medical history included back soreness, joints aching and recent back surgery repair. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX in the left arm. Dose, expiry date were not reported. Concomitant therapies included NORCO. The patient had received vaccine in her left arm, not in deltoid, below deltoid, toward later, above elbow and it was a funny angle to get there. Within 24 hours (02-DEC-2013 approximately), she developed a baseball sized local reaction. The patient said though she had fibromyalgia, last night and day before (03-DEC-2013 approximately) she experienced joints aching, back soreness much more than she had before. The patient took TYLENOL and MOBIC as treatment and informed that she did not normally take these medications. The patient had contacted her physician regarding the reaction. The patient informed that last 2 days had been horrid and had started to itch last night (04-DEC-2013) but not quite as red as it was initially and there was no other rash anywhere on her body. The event of redness was resolving at the time of report, outcome of joints aching and back soreness was unknown and outcome of rest of the events were not resolved. No lab studies were performed. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound abdomen
Clinical narrative: Information has been received from a nurse (L.P.N), for GARDASIL, a Pregnancy Registry product, concerning a 15 year old white female with drug allergy to ZITHROMAX and amoxicillin and no history of pregnancy who on 08-AUG-2011 was vaccinated IM with the first dose of GARDASIL(Lot # 666596/0766Z). On 26-OCT-2011 the patient was vaccinated IM with the second dose of GARDASIL (Lot # 670048/0963AA). Concomitant therapy included prenatal vitamins, "PHENERGAN" and albuterol. On 11-NOV_2011 the patient presented to the office and was determined to be "11 weeks pregnant by HCG test and ultrasound (performed on 15-NOV-2011)". Her LMP was 24-AUG-2011 (reported as September 2011) and EDD was 30-MAY-2012. Follow up information received. The reporter's office was called at, for the pregnancy outcome information but they had no additional information to provide. The pregnancy outcome and case was to be considered lost to follow up. All telephone attempts to obtain follow up information had been unsuccessful. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients (no patient names or demographics known). The an unspecified amount of patients might had been administered with a dose of MMR II (lot#, dose, route and strength not reported) that were out of temperature range and may of not been supported by Merck's stability data on unspecified date. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age. On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX dose 1, subcutaneously in the back, or triceps region, of the arm. No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse, for HPV rL1 6 11 16 18, a Pregnancy Registry product, concerning a 20 year old female with no drug reaction and with a LMP of late April who on 02-APR-2012 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 (lot # 672193/1524AA, Exp Date 23-AUG-2014). On 672233/1561AA, Exp Date 26-AUG-2014). There was no concomitant medication. The patient sought medical attention by office visiting. There was no lab diagnostics studies performed. All telephone attempts to obtain follow-up information have been unsuccessful. This case is lost to follow up and pregnancy outcome is to be considered lost to follow up. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Information has been received from a consumer for HPV, a Pregnancy Registry product; concerning a 14 year old daughter with no pertinent medical history, no drug reactions/allergies, who on 16-FEB-2012 was vaccinated with a first dose of HPV vaccine (Lot # not reported). Concomitant therapy included Singulair. The consumer reported that the patient received 1st shot of HPV vaccine series and did not know she was pregnant, she only found out on 01-MAR-2012 by an ultrasound. The patient would not be continuing with the vaccination series. Patient's last menstrual period was on approximately 08-SEP-2011 and her estimated delivery date was on 14-JUN-2012. Follow up information received from physician via phone call. Patient had delivered a baby on 08-JUN-2012. Follow up information received from physician via phone call. Patient had delivered a baby on 08-JUN-2012. There were no problems. The baby was normal, healthy and has been seen at the reporters practice. Additional information is not expected.
Age: 22.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 22 year old patient. Nurse reported that patient of 22 years age was administered PROQUAD (inappropriate age) on 12-OCT-2013, subcutaneously. No adverse effects were reported. This case is linked to 1312USA005814 and 1312USA006027 due to same reporter link. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, lot and expiry date unknown). On an unknown date the patient developed rash, redness and swelling after receiving ZOSTAVAX. The outcome of events was reported as not resolved. Follow-up information was received from the physician concerning the 53 year old female patient with no allergies and a history of chicken pox, who on 16-NOV-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# reported as 5006832) in her left arm. There was no concomitant medication. On an unknown date in November 2013 the patient experienced redness and swelling after receiving ZOSTAVAX (as previously reported). On 16-NOV-2013, 2 days after vaccination, the patient experienced red, hot and blistery rash only at injection site (multiple lesions) and painful arm. The maximum temperature was 99.6. The patient did not recent exposure to chicken pox or shingles. On an unknown date in November 2013, the patient recovered from the events. This is one of the several reports from the same source. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Rash, Swelling
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, lot and expiry date unknown). On an unknown date the patient developed rash, redness and swelling after receiving ZOSTAVAX. The outcome of events was reported as not resolved. Follow-up information was received from the physician concerning the 53 year old female patient with no allergies and a history of chicken pox, who on 16-NOV-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# reported as 5006832) in her left arm. There was no concomitant medication. On an unknown date in November 2013 the patient experienced redness and swelling after receiving ZOSTAVAX (as previously reported). On 16-NOV-2013, 2 days after vaccination, the patient experienced red, hot and blistery rash only at injection site (multiple lesions) and painful arm. The maximum temperature was 99.6. The patient did not recent exposure to chicken pox or shingles. On an unknown date in November 2013, the patient recovered from the events. This is one of the several reports from the same source. Additional information is not expected.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a18 year old patient. On 12-OCT-2013, the patient was vaccinated with PROQUAD, subcutaneous. Nurse reported that patient of 18 years age was administered PROQUAD (inappropriate age). No adverse effects were reported. This case is linked to 1312USA005814 and 1312USA006026 due to same reporter link. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative and a pharmacist who was informed by the physician refers to a 69 year old female patient. On 03-DEC-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J010654, expire date: 17-OCT-2014) injection, 0.5 ml, subcutaneous. On 03-DEC-2013, the patient experienced her arm swelled up, within a few hours, after receiving PNEUMOVAX 23. The patient sought medical attention by visiting the physician, who was also the patient's husband. Prednisone (manufacturer unknown) and BENADRYL were given to treat the adverse event. The outcome of the event was unknown. Additional information has been requested.
Age: 43.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 43 year old patient. Nurse reported that patient of 43 years age was administered PROQUAD (inappropriate age) on 12-OCT-2013, subcutaneously. No adverse effects were reported. This case is linked to 1312USA006026 and 1312USA006027 due to same reporter link. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a female patient of unknown age. Medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL. Concomitant medication was not provided. It was reported that on an unknown date the patient experienced drug reactions/allergies to GARDASIL. No further details were reported. The outcome of vaccine hypersensitivity is unknown. This case was linked to case 1312USA004322. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. On an unknown date in approximately November 2012, at the age of 2 months, the patient was vaccinated with the first dose of PEDVAXHIB (dose, route and lot number not reported). The patient received the second dose of PEDVAXHIB (dose, route and lot number not reported) on an unknown date in approximately January 2013, at the age of 4 months. The patient received the third dose of PEDVAXHIB (dose, route and lot number not reported) on an unknown date in approximately March 2013, at the age of 6 months. On 06-DEC-2013, at the age of 15 months the patient received the fourth dose of PEDVAXHIB (dose, route and lot number not reported). No adverse events were reported. This is one of two reports received from the same source (linked MARRS#: 1312USA006089). Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of 6 month old patient of unknown gender. It was reported that on an unspecified dates the patients were vaccinated with the first, second, third and fourth doses of LIQUID PEDVAXHIB (dose, route and lot number not reported), respectively at the 2 months, 4 months, 6 months of age and the fourth dose at an unspecified age. No adverse events were reported. This is one of two reports received from the same source (linked MARRS#: 1312USA003666). Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G normal, Varicella post vaccine, Varicella virus test positive
Clinical narrative: 11/7 - 11/10/13 Pt. may have been exposed to Varicella. His IgG titer was neg. Pt. developed varicella on 11/26/13. Was sent to hospital. Pt was treated for a mild case of varicella with Acyclovir and returned to jail on 12/3/13.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient with drug reaction/allergies to penicillin. On 08-NOV-2013 the patient was vaccinated with PNEUMOVAX 23, dose 0.5 ml, route intramuscular. Dose, lot and expiry date were not reported. Concomitant therapies included unspecified flu shots (manufacturer unknown) and blood pressure medication. On 09-NOV-2013, one day after receiving the first dose of PNEUMOVAX 23, the patient experienced severe swelling of the hand and arm. The patient was seen at the hospital emergency room but not admitted. The patient was diagnosed with cellulitis and was started on BACTRIM and cephalexin. The patient had fully recovered from events on an unknown date. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: PT was over the age limit for the vaccine. No adverse reaction occurred. Pt was given HPV in lieu of HBV vaccine.
Age: 1.03
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Culture stool positive, Diarrhoea, Pyrexia, Salmonella test positive
Clinical narrative: High fever up to 105 within 24 hours of receiving 12 mos vaccines.  Evaluated by ED.  Tests and work up as cause for fever negative.  On day 10 of fever, developed diarrhea. Fever defervesced but diarrhea continued.  Stools cultures sent- positive for Salmonella.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Cough, Increased upper airway secretion, Influenza virus test negative, Injection site erythema
Clinical narrative: Sore throat, cough, green, yellow phlegm from nose and chest. Low grade fever. Injection sight red and swollen. Pain in chest.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, cough, green, yellow phlegm from nose and chest. Low grade fever. Injection sight red and swollen. Pain in chest.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt received vaccine 11/18/13, noticed pimple-like rash on torse where waistband of pants & bra sits (per pt).  Pt states rask started 11/28/13 & is itchy.  Per pt, as of 12/5/13, rash is resolving.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients (no patient names or demographics known). The an unspecified amount of patients might had been administered with a dose of GARDASIL (lot#, dose, route and strength not reported) that were out of temperature range and may of not been supported by Merck's stability data on unspecified date. No adverse effects reported. No product quality compliant (PQC) was reported. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients might have been vaccinated with PNEUMOVAX 23 (dose, lot and expiry date were not reported) that have been expose to unsupported temperature excursions. No adverse effect was reported. This is 3 of 3 reports from same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 53 year old female patient with no pertinent medical history or drug reactions/allergies. On 22-NOV-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J006827, EXP date 14-SEP-2014), subcutaneously. Concomitant therapies included ZYRTEC. On 25-NOV-2013, 4 days after onset of therapy the patient presented to the office with local redness and swelling of her left arm at the injection site area. Patient sought medical attention by contacting physician and patient was given treatment by being advised to use MOTRIN. There was no lab diagnostics studies performed. The outcome of events was reported as recovering/resolving. Additional information has been requested.