chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Swelling
Clinical narrative: 9/4/13 6 PM - Quarter size redness and rash - slight pain. 95/13 3:30 AM - Fever, complained of sore throat. Rash and redness size of palm - some pain - swelling. Mother gave Ibuprofen. 9/5/13 Night - More swollen - redness about 5" diameter. 9/6/13 AM - Not as active - Pt seen - Rx - KEFLEX 250/5 1 tsp TID for 10 days - warm compresses - BENADRYL PRN.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Lymph node pain
Clinical narrative: This spontaneous report as received from a Registered Pharmacist refers to a 55 year old female patient with no known pertinent medical history or drug reactions/allergies. On 25-AUG-2013, the patient was vaccinated with ZOSTAVAX (Lot # J003360; exp. date: 21-JUN-2014) 0.65 ml, subcutaneous. Concomitant therapies included influenza virus vaccine (manufacturer unknown). On 27-AUG-2013, the patient developed tenderness, redness and warmth at the site were ZOSTAVAX was injected. The patient also reported "pain in her lymph nodes". The patient sought medical attention, she went to see the pharmacist. No laboratory tests were performed. As treatment for the events, the patient was instructed to use ibuprofen (manufacturer unknown) and apply a cold compress to the injection site. The pharmacist reported that no rash and no fever was present. At the time of the report, the outcome of the events was not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Throat irritation, Tongue disorder
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 17-MAY-2013, the patient was vaccinated with a 0.5 ml dose of GARDASIL (Lot # H016960, expiration date 02-DEC-2013)intramuscularly. The nurse reported that on 27-MAY-2013, the patient experienced burning and stinging in back of throat. The patient's mother informed nurse that on 03-SEP-2013, the patient had a growth on the back of her tongue. The patient did not receive treatment for the adverse events. The nurse had not seen the patient. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction, Mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female diabetic patient with asthma and no known drug reaction/allergies. On 25-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J003359, expiring 21-JUN-2014, 0.65 ml, subcutaneous. In approximately August 2013 the patient experienced headache, injection site reaction and large lump big as an egg, after she received ZOSTAVAX. There was no evidence of any rash. The patient call pharmacy for medical attention. The patient was instructed to use ibuprofen as a treatment for the events. The outcome of the events was unknown. The causal relationship was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Haemorrhage, Laceration, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning a 40 year old male pharmacist. The patient's pertinent medical history, drug reactions/allergies were not provided. On 28-AUG-2013, upon opening a carton of ZOSTAVAX (Lot # J003483, expiration date 29-JUN-2014), the pharmacist found a broken vial of ZOSTAVAX and during handling of the vial, pharmacist had a cut from broken vial and minor bleeding occurred. A band-aid was put on as treatment. The patient did not seek medical attention. There were no laboratories performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner concerning a female patient of unknown age. On 15-JAN-2009, the patient was vaccinated with the first dose of GARDASIL. On 21-JUN-2011, the patient was vaccinated with the second dose of GARDASIL. No other co-suspect therapy was reported. Concomitant medications were not provided. At the time of the report, patient's outcome was unknown. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Fever for 2 days post vaccine with chills. Red area (R) arm where inj. given.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Full blood count, Injection site pain, Injection site swelling, Pain, Postictal state
Clinical narrative: Patient developed pronounced localized swelling at the injection site within 24 hrs. of the injection, and began complaining of pain radiating to the extremity distal to the injection site. Patient spontaneously displayed seizure-like behavior for 8-10 seconds during breakfast approximately 46 hours after injection. Patient was postical for 2 hours after event, and desired only to sleep. Patient was taken to lab for a blood panel draw, followed by an office with the pediatrician. Follow-up with a neurologist for an EEG was recommended.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Seizure like phenomena, Somnolence
Clinical narrative: Patient developed pronounced localized swelling at the injection site within 24 hrs. of the injection, and began complaining of pain radiating to the extremity distal to the injection site. Patient spontaneously displayed seizure-like behavior for 8-10 seconds during breakfast approximately 46 hours after injection. Patient was postical for 2 hours after event, and desired only to sleep. Patient was taken to lab for a blood panel draw, followed by an office with the pediatrician. Follow-up with a neurologist for an EEG was recommended.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Fatigue, Nasopharyngitis, Pyrexia, Wheezing
Clinical narrative: Fever, fatigue for 2 days followed by a head cold and wheezing. Then, symptoms appeared to lift for a few days, then high fever and ear pain.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection became purple, and very swollen and red..increased as day went on to 4 inches wide to 12 inches long. Very sore and arm fever went in to see doctor.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: Fever, fussiness, lethargic, loss of appetite.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Chills, violent shaking, fever (101), vomiting, diarrhea, muscle aches, anxiety.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Chills, violent shaking, fever (101), vomiting, diarrhea, muscle aches, anxiety.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypersensitivity, Local reaction
Clinical narrative: Pt returned to pharmacy with what appeared to be a local allergic reaction at the injection site on 9/4/13.  I recommended Benadryl and requested her to come in the next day so that I could take a look at it.  The reaction appeared slightly worse on 9/5/13 so I contacted her PCP and scheduled a same day appointment so that the office could take a look at it. Diagnosed as local allergic reaction and pt was recommended otc antihistamine therapy.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Asthenia, Flushing, Pyrexia
Clinical narrative: Fever of 102.2-102.6 for4 days, flushed, weak.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red rash in crotch area and underneath the armpit, near the rear. Itches and red rash has spread further. Outside of that, no adverse impact thus far. NOTE: I've never had an adverse reaction from a flu shot before. Right now, I'm guessing that the rash will eventually fade.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Arm very sore. 5:30pm. Fever began  8:30pm.  Fever at 100.6 at 9:00pm. Arm very sore. Large red, swollen, slightly hard bump about the size of a silver dollar over injection area and down the arm. 09/07/2013 9am.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hot flush, Pyrexia
Clinical narrative: Patient started getting hot flashes and chills around midnight the night the vaccine was administered. He had a fever of about 101*F on 9/7/2013 at 4pm.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Bradyphrenia, Dysarthria, Facial paresis, Muscular weakness
Clinical narrative: Anxiety, shaking, restless, progressing to marked weakness of extremeties and face, slurred speech, slow thoughts.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Restlessness, Tremor
Clinical narrative: Anxiety, shaking, restless, progressing to marked weakness of extremeties and face, slurred speech, slow thoughts.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Rash erythematous
Clinical narrative: Redness, swelling at injection site, irritation but no itching for 3-4 days. No fever. Red spots stay for 9 days.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left upper arm erythema and tenderness spreading around the arm in a band about 3 inches wide by 7 inches long.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Lethargy, Vomiting
Clinical narrative: Vomiting and diarrhea - overnight into next morning. Weak and lethargic.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Pt reported 2 inch long 3/8" inch wide red mark, reported that it did not hurt, only noticed in the mirror. Said it itched a little.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt reported 2 inch long 3/8" inch wide red mark, reported that it did not hurt, only noticed in the mirror. Said it itched a little.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt reported 2 inch long 3/8" inch wide red mark, reported that it did not hurt, only noticed in the mirror. Said it itched a little.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain, Lethargy, Pyrexia
Clinical narrative: Distended abdomen, severe abdominal pain, high fever, lethargy-lasted 1 week.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: 9/7/13 12pm - pt had rash 2 inches south of injection site that was hot, not itchy, but red 9/7/13 12pm - Rph recommended hydrocortisone cream and see MD on Monday if not resolved.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: About a day after vaccination, patient had bruise-like marking on her left arm at injection site. Looked bruised bluish/purple/reddish colored. But patient states she has no pain, no soreness, no swelling. Pt saw Dr and was told it's a bruise from vaccination but no infection. Everything is fine. Just wait for it to go away.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: After about one hour post vaccination, patient experienced feeling cold which progressed into shaking and chills.
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 an unknown date in 2011 the patient was vaccinated with first dose of GARDASIL, injection (route, dose, lot number and exp.date not provided). On an unknown date in May 2013 the patient had administered the second dose of GARDASIL, injection (route, dose, lot number and exp.date not provided) and on 27-AUG-2013 the patient received third dose of GARDASIL, injection (route, dose, lot number and exp.date not provided). No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood gases normal, Blood glucose normal, CSF glucose normal, CSF protein increased, CSF test abnormal
Clinical narrative: Status epilepticus requiring intubation and ICU admission, as well as antiepileptics to stop seizure activity.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF white blood cell count increased, Convulsion, Endotracheal intubation, Full blood count normal, Intensive care
Clinical narrative: Status epilepticus requiring intubation and ICU admission, as well as antiepileptics to stop seizure activity.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Red blood cells CSF positive, Status epilepticus, Traumatic lumbar puncture
Clinical narrative: Status epilepticus requiring intubation and ICU admission, as well as antiepileptics to stop seizure activity.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Diarrhoea, Eating disorder, Fatigue, Headache
Clinical narrative: Throwing up, diarrhea went on without stopping for 3 hours. Called doctor and she called in a prescription to stop the throwing up and told me to take an Imodium. Following that soreness, chills, sweating, headache. Next day 09/04/2013 still was unable to eat anything except bland food---headache, soreness in muscles. By the third day still felt fatique but other symptoms cleared to the point I could eat normally. I have been taking the flu shot for years and never a problem. This was the 1 MI Fluzone HD 2013-2014.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Hyperhidrosis, Myalgia, Pain, Vomiting
Clinical narrative: Throwing up, diarrhea went on without stopping for 3 hours. Called doctor and she called in a prescription to stop the throwing up and told me to take an Imodium. Following that soreness, chills, sweating, headache. Next day 09/04/2013 still was unable to eat anything except bland food---headache, soreness in muscles. By the third day still felt fatique but other symptoms cleared to the point I could eat normally. I have been taking the flu shot for years and never a problem. This was the 1 MI Fluzone HD 2013-2014.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Paraesthesia
Clinical narrative: Patient had a hard swollen muscle and redness where shot was administered. Patient also experienced tingling in the left hand and thumb and left forearm. Dr was notified and he prescribed prednisone.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Accidental exposure to product, Ophthalmological examination
Clinical narrative: As I was pulling out the needle from the vial, the yellow fever vaccine was squirted in my eye.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Nausea, Swelling
Clinical narrative: Swelling, abdominal cramping, diarrhea, nausea.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Pain, slight itching, swelling at injection site, increasing over time (day 1- 1inch to 3 inches in diameter - day 2) redness, fatigue, dull headache, knot in upper arm.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nodule
Clinical narrative: Pain, slight itching, swelling at injection site, increasing over time (day 1- 1inch to 3 inches in diameter - day 2) redness, fatigue, dull headache, knot in upper arm.
Age: 1.03
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Blister, Erythema, Pyrexia, Scab, Skin lesion
Clinical narrative: Lesion left deltoid region. Erythematous and developed central blister before crusting over about 5 days. Multiple new lesions (>30)over subsequent 4 days (mainly on Day 3 of symptoms). Also mild fever (100.5 degrees F rectal). Seen by MD on Sep 7 with no treatment or investigations recommended other than acetaminophen prn for fever.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Patient complained of painful swollen arm persisting for days after vaccine was administered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Bone lesion, Influenza like illness, Malaise
Clinical narrative: This spontaneous report as received from a consumer refers to her 63 year old mother. The patient had no pertinent medical history and no drug allergy. On 06-JUN-2013 the patient was vaccinated with ZOSTAVAX, 1 time vaccine, lot# reported as carpmpd A8135577911691, subcutaneous. There was no concomitant therapy. On 06-JUN-2013, the patient experienced multiple myeloma, which was diagnosed on 30-AUG-2013. The daughter stated that since the patient received the vaccine she had flu type symptoms, and generally not feeling well. Since July 2013 the patient had had pain in her right wrist. She stated an X-ray was performed and patient had a bone lesion in her right wrist. No treatment was given. Blood and urine test was done. No lab result was provided. At reporting time, the patient was not recovered from multiple myeloma. The patient sought unspecified medical attention. Upon internal review, multiple myeloma was determined to be medically significant event. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Plasma cell myeloma, Urine analysis, X-ray limb abnormal
Clinical narrative: This spontaneous report as received from a consumer refers to her 63 year old mother. The patient had no pertinent medical history and no drug allergy. On 06-JUN-2013 the patient was vaccinated with ZOSTAVAX, 1 time vaccine, lot# reported as carpmpd A8135577911691, subcutaneous. There was no concomitant therapy. On 06-JUN-2013, the patient experienced multiple myeloma, which was diagnosed on 30-AUG-2013. The daughter stated that since the patient received the vaccine she had flu type symptoms, and generally not feeling well. Since July 2013 the patient had had pain in her right wrist. She stated an X-ray was performed and patient had a bone lesion in her right wrist. No treatment was given. Blood and urine test was done. No lab result was provided. At reporting time, the patient was not recovered from multiple myeloma. The patient sought unspecified medical attention. Upon internal review, multiple myeloma was determined to be medically significant event. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient has been complaining of pain and soreness at the injection site for a longer period of time this year.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Her right arm still feeling sore after 10 days got flu shot (FLUZONE).
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Patient was seen by me on 8/23/2013 due to rash x 3 day duration and low grade fever. Rash was classic chickenpox rash (diffuse). Had received Varicella vaccine 2 weeks prior at clinic on 8/9/2013.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 22 year old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with her first, second dose of M-M-R II (manufacturer unspecified) (dose, frequency, lot#, expiration date not reported) approximately in May 1992 ("at 18 months of age") and 1995 (about 4.5 and 5 years old respectively). There was no concomitant medication On 12-AUG-2013, the patient vaccinated with a booster dose of M-M-R II (dose, frequency, lot#, expiration date not reported). On 07-AUG-2013 ("an unspecified date 3 weeks ago") the patient showed low titer readings for the measles and mumps component during a routine test for immunity conducted for entry nursing school. Her titer for the rubella component was "good". As treatment for the low titer readings on the routine test conducted about three weeks ago, the patient received a booster dose of M-M-R II on 12-AUG-2013. She had not yet been retested on titer levels to determine her immune response. The outcome of the event was unknown. 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 healthcare worker (Certificate Medical Assistant) refers to an unspecified number of patients of unknown ages and genders. On unspecified dates the patients were vaccinated with PROQUAD (Merck) (dose, frequency, therapy route, lot# and expiration date unknown) that was exposed to refrigerator temperatures not greater than 46 Fahrenheit for an unknown period of time. No adverse symptoms reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Eyelid ptosis, IIIrd nerve paralysis, Inflammation, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of drooping eyelid in a 3-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). In August 2013, "approximately 2 weeks ago," the subject received a dose of FLUARIX (intranasal) and experienced intramuscular formulation administered by other route. The vaccine was administered intranasally when it is indicated to be given intramuscularly. In August 2013, "about" 1 week after vaccination with FLUARIX, the subject experienced drooping eyelid (described as "right eye lid droopiness"), unable to move eyes (described as "unable to turn right eye towards midline"), and eye swollen shut (described as "right eye that is swollen shut"). The subject was admitted to the hospital and per the physician "the eye has progressively worsened over the last 3 to 4 days." The subject was hospitalised and the physician considered the events were disabling. At the time of reporting the events were worse.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Eye movement disorder, Eyelid oedema, Eyelid ptosis, Incorrect route of drug administration
Clinical narrative: This case was reported by a physician and described the occurrence of drooping eyelid in a 3-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). In August 2013, "approximately 2 weeks ago," the subject received a dose of FLUARIX (intranasal) and experienced intramuscular formulation administered by other route. The vaccine was administered intranasally when it is indicated to be given intramuscularly. In August 2013, "about" 1 week after vaccination with FLUARIX, the subject experienced drooping eyelid (described as "right eye lid droopiness"), unable to move eyes (described as "unable to turn right eye towards midline"), and eye swollen shut (described as "right eye that is swollen shut"). The subject was admitted to the hospital and per the physician "the eye has progressively worsened over the last 3 to 4 days." The subject was hospitalised and the physician considered the events were disabling. At the time of reporting the events were worse.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: On Thursday 5Sep2013 at 4:30am awaken with fever oral temperature 102.0 chills, severe headache and right upper arm swollen, red, warm to touch and hard to move. Treated with ice packs to deltoid muscle and alternated tylenol & motrin for two days. Symptoms lasted two days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: On Thursday 5Sep2013 at 4:30am awaken with fever oral temperature 102.0 chills, severe headache and right upper arm swollen, red, warm to touch and hard to move. Treated with ice packs to deltoid muscle and alternated tylenol & motrin for two days. Symptoms lasted two days.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Clinic had issue with refrigerator, staff was initially told vaccines were okay to administer but later notified that small subset was not viable. No adverse symptoms in patient.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: Local reaction.
Sex: U
Vaccine: FLU3
Symptoms: Burning sensation, Fall, Guillain-Barre syndrome, Hypoaesthesia, Mobility decreased
Clinical narrative: Tingling and burning in legs and feet and numbness and tingling in hands and across back, muscle loss in legs and cause me to fall 3 times. Lost the use of my legs. Had hard time using my hands.
Sex: U
Vaccine: FLU3
Symptoms: Muscle atrophy, Paraesthesia
Clinical narrative: Tingling and burning in legs and feet and numbness and tingling in hands and across back, muscle loss in legs and cause me to fall 3 times. Lost the use of my legs. Had hard time using my hands.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Herpes zoster
Clinical narrative: Shingles
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Electrocardiogram normal
Clinical narrative: This study case was received from the investigator in a trial on 28 August 2013. A male subject (date of birth not reported) with no reported past medical history had received on 11 September 2012 ACAM2000 (lot number, route, site and date of administration not reported), Anthrax (lot number, route, site and date of administration not reported), FLUMIST (lot number, route, site and date of administration not reported) and Typhoid (lot number, route, site and date of administration not reported) and five days later on 16 September 2012, experienced moderate chest pain/pressure, shortness of breath and a dry cough while running. The subject stated the events continued intermittently for 48 hours. The subject was reported to have possible myopericarditis. Treatment included one time dose of TYLENOL. On 19 September 2012, Troponin I level was 0.23 ng/ml and an ECG was normal. A Troponin I level on 15 October 2012 was less than 0.10 ng/ml. No further information was available at the time of the report. The subject's outcome was recovered on 18 September 2012. According to the investigator, the event of possible myopericarditis was considered an other important event, possibly related to vaccination and severity of the event was moderate. Documents held by sender: none.
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 28 August 2013. A male subject (date of birth not reported) with no reported past medical history had received on 11 September 2012 ACAM2000 (lot number, route, site and date of administration not reported), Anthrax (lot number, route, site and date of administration not reported), FLUMIST (lot number, route, site and date of administration not reported) and Typhoid (lot number, route, site and date of administration not reported) and five days later on 16 September 2012, experienced moderate chest pain/pressure, shortness of breath and a dry cough while running. The subject stated the events continued intermittently for 48 hours. The subject was reported to have possible myopericarditis. Treatment included one time dose of TYLENOL. On 19 September 2012, Troponin I level was 0.23 ng/ml and an ECG was normal. A Troponin I level on 15 October 2012 was less than 0.10 ng/ml. No further information was available at the time of the report. The subject's outcome was recovered on 18 September 2012. According to the investigator, the event of possible myopericarditis was considered an other important event, possibly related to vaccination and severity of the event was moderate. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Electrocardiogram normal, Headache, Lymphadenopathy, Palpitations, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 28 August 2013. A 30 year-old female subject with a no past medical history had received on 15 October 2012 a ACAM2000 (lot number, route and site of administration not reported), a Typhoid vaccine (manufacturer, lot number, route and site of administration not reported) and an Anthrax vaccine (manufacturer, lot number, route and site of administration not reported) and on 23 October 2012 was found to have palpitations. The subject also reported headache and lymphadenopathy with a start date of 17 October 2012. On 24 October 2012, the subject had a Troponin I of <0.10 ng/mL and a normal ECG. No further information was available at the time of the report. The subject's outcome was recovered 23 October 2012. According to the investigator the event of palpitations was possibly related and the severity of the event was mild. Documents held by sender: medical records.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Electrocardiogram normal, Lymphadenopathy, Night sweats, Pyrexia
Clinical narrative: This study case was received from the investigator in a trial on 28 August 2013. A 24 year-old male subject with a past medical history of penicillin allergy had received on 27 August 2012 a ACAM2000 (lot number, route and site of administration not reported) and an Anthrax vaccine (lot number, route and site of administration not reported) and on 30 August 2012 was found to have possible myopericarditis. The investigator notes stated the subject had an onset during physical exertion of fever, chest pain and night sweats three days post vaccination which resolved on second day. The subject saw a medic and was diagnosed with "swollen glands". On 12 September 2012, the subject had a Troponin I of <0.10 ng/mL and a normal ECG. The subject's clinical evaluation was negative on 12 September 2012 and was returned to full duty. Treatments included aspirin. No further information was available at the time of the report. The subject's outcome was recovered 31 August 2012. According to the investigator the event of possible myopericarditis was possibly related and the severity of the event was mild. Documents held by sender: medical records.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 28 August 2013. A 24 year-old male subject with a past medical history of penicillin allergy had received on 27 August 2012 a ACAM2000 (lot number, route and site of administration not reported) and an Anthrax vaccine (lot number, route and site of administration not reported) and on 30 August 2012 was found to have possible myopericarditis. The investigator notes stated the subject had an onset during physical exertion of fever, chest pain and night sweats three days post vaccination which resolved on second day. The subject saw a medic and was diagnosed with "swollen glands". On 12 September 2012, the subject had a Troponin I of <0.10 ng/mL and a normal ECG. The subject's clinical evaluation was negative on 12 September 2012 and was returned to full duty. Treatments included aspirin. No further information was available at the time of the report. The subject's outcome was recovered 31 August 2012. According to the investigator the event of possible myopericarditis was possibly related and the severity of the event was mild. Documents held by sender: medical records.
Age: 59.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Patient developed hives a day after taking 4th dose. Ongoing.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Pt developed chicken pox rash post 2nd Varicella vac.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient reported to pharmacy 3 days after vaccines were given with a large, red, painful rash on his upper arm. (Left).
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Hypertension, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: World started spinning very fast. Very nauseous and vomiting. 4 times within 24 hours. Blood pressure went very high.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo, Vomiting, X-ray normal
Clinical narrative: World started spinning very fast. Very nauseous and vomiting. 4 times within 24 hours. Blood pressure went very high.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Multiple hives on trunk and upper extremities. Largest on (L) flank 14cm x 10cm. None surrounding injection site on (L) deltoid.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Pt. states that her arm was red, hot and swollen. She says her MD treated her for cellulitis though when she appeared at pharmacy 6 days after vaccination, no symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pruritus
Clinical narrative: Redness to Lt deltoid area 7 cm wide x 9 cm length - warm to touch - skin intact. Child c/o of itching and slight pain.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Pt. given PREVNAR 13 lot # G32487 0.5 ml IM Rt DLT on 8/22/2013. She called on 8/23 and reported redness - adv BENADRYL, ice, TYLENOL. Call back if not better. On 8/26, she presented w/ 16x9 area of redness, hot, tender.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Got vaccine on Monday 9/2/13 noted feeling itchy on Tues 9/3 later noted rash on bridge of nose noted on Wed 9/4 rash on forearm of left arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness, itching, no signs of infection.
Age: 71.0
Sex: F
Vaccine: PPV, PNC10
Symptoms: Erythema, Injection site pain, Joint swelling, Pain in extremity
Clinical narrative: Patient's arm was visibly red and slightly swollen around elbow. The patient was given a IM injection of Pneumovax in the left deltoid. Patient said the entire arm from shoulder to fingers was very painful but is better two days after. Patient purchased ibuprofen and benadryl.
Age: 71.0
Sex: F
Vaccine: PPV, PNC10
Symptoms: Erythema, Joint swelling, Pain in extremity
Clinical narrative: Patient's arm was visibly red and slightly swollen around elbow. The patient was given a IM injection of Pneumovax in the left deltoid. Patient said the entire arm from shoulder to fingers was very painful but is better two days after. Patient purchased ibuprofen and benadryl.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, warmth, swelling, some pain within 24 hrs of vaccine (R) arm.
Age: 1.3
Sex: U
Vaccine: PNC13
Symptoms: Convulsion, Crying, Cyanosis
Clinical narrative: Administered vaccine child started to cry. Lips turned blue, cried, mother picked up child. I went to call a provider child started to have a seizure. Took child and mother to ER.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Gait disturbance, Pain in extremity, Rash papular
Clinical narrative: 09/04/13 well visit received Dtap (4), HIB (4), Hep A (2), PCV13 (4) 12 hours later hand to toe papula rashy with bilateral leg pain. Did not want to walk.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen around proximal to injection.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from an unknown age male pharmacist refers to a lot of patients. There were a lot of patients experienced pain when they were vaccinated with ZOSTAVAX (lot#, expiration date, dose, route not reported). It was unknown whether the patients sought medical attention or not. The outcome of the event was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse reaction, Arthropod sting
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 13-AUG-2013 the patient was vaccinated with VARIVAX (Merck) (lot# unspecified). The patient was stung by a bee on an unspecified date in August 2013. The patient was treated with epinephrine at an unspecified urgent care facility for an unspecified reaction to the bee sting on an unknown date. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report refers to 8 to 10 patients of unknown gender and age. Medical history is not provided. On an unknown date in July 2013 the patients were vaccinated with PROQUAD (Merck) which was improperly stored. No symptoms were reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Local swelling, Pruritus, Urticaria
Clinical narrative: Received boostrix on 9-9-13; developed an itchy swollen area under the right jaw line that evening spread to neck and chest over the next 24 hours. Took benadryl regularly for 24 hours and symptoms improved - has couple hives remaining 9-9-13.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pruritus generalised, Skin lesion, Urticaria
Clinical narrative: Received boostrix on 9-9-13; developed an itchy swollen area under the right jaw line that evening spread to neck and chest over the next 24 hours. Took benadryl regularly for 24 hours and symptoms improved - has couple hives remaining 9-9-13.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Breast swelling, Injection site pain, Local swelling, Neck pain
Clinical narrative: 9/5 - Soreness around inj. site - iced; 9/6 - Day-five - PM- took Ibuprofen - slept fine; 9/7 - About 11 AM swelling began R upper arm, breast and up into neck pain. got antibiotics.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after 1st capsule.
Sex: U
Vaccine: HBHEPB, HPV4, PPV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with GARDASIL, COMVAX, PNEUMOVAX 23, or ROTATEQ stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Body temperature increased, Injection site bruising, Irritability
Clinical narrative: Approx. 4-5 hours after baby received vaccines became increasing fussy, temp. up to 101, injection sites bruised appearing. Checked by physician in office 8/28/13.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Menactra vaccine given 9/19/13 to left arm IM w/11 yo well check on 8/20/13 at 11:30 AM. MOC called with red and warm to touch and swollen and painful where Menactra was given. Advil given per nurse advise. Seen in office 9/20/13 by PA w/10x15 cm area erythema warm to touch. Keflex Rx given. On 8/21 with increase to 12x13 cm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Menactra vaccine given 9/19/13 to left arm IM w/11 yo well check on 8/20/13 at 11:30 AM. MOC called with red and warm to touch and swollen and painful where Menactra was given. Advil given per nurse advise. Seen in office 9/20/13 by PA w/10x15 cm area erythema warm to touch. Keflex Rx given. On 8/21 with increase to 12x13 cm.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Culture stool, Haematochezia, Occult blood positive
Clinical narrative: Bloody stools started day after vaccination and continued intermittently for 6 days - culture is pending but neg so far.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Irritability, Occult blood positive
Clinical narrative: Bloody stools started day after vaccination and continued intermittently for 6 days - culture is pending but neg so far.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: The next day after getting the vaccination - client developed high fever up to 102 degrees Farenheit and L deltoid became swollen, red and very hot to touch. Mom gave her Motrin and fever only last for 1 day. Soreness last 2-3 days and child able to go to school. 9/3/13 Tuesday of follow up call today and Mom verbalized she is doing great!
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: R arm swollen, erythematous and feels hard to touch - Fever 101 degrees. ER physician called it "allergic reaction". Recomm. Tylenol and Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMRV, PNC13
Symptoms: Injection site movement impairment, Injection site pain, Injection site warmth
Clinical narrative: Pt got immunizations on 27 Aug 13 R leg - Hib and PCV-13 L leg MMRV and DTap-IPV. FOC called 28Aug13 stated pt complaining of pain in R leg, warm to touch, will not put pressure on leg. Father stated symptoms started about an hour after they got home. Pt was seen by PCM and was instructed to take ibuprofen every 6-8 hours for approx 24 hours. As well as instruction to walk on leg.
Age: 58.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Patient developed hives a day after completing 4th dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Induration, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Within 30 seconds of receiving vaccine, redness from site of injection to inner arm, swelling over band aid, nausea, dry heaves, weakness. Day after vaccine, no redness but large area of induration, vertigo and tinnitus L ear. No redness 8/26 or 8/27. Redness with pressing returned 8/27/13.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Tinnitus, Vertigo
Clinical narrative: Within 30 seconds of receiving vaccine, redness from site of injection to inner arm, swelling over band aid, nausea, dry heaves, weakness. Day after vaccine, no redness but large area of induration, vertigo and tinnitus L ear. No redness 8/26 or 8/27. Redness with pressing returned 8/27/13.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Headache, Hot flush, Hyperhidrosis, Vision blurred
Clinical narrative: Sweating, headache, blurry vision, hot flash. Checked blood pressure and sugar all normal.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pruritus, Lacrimation increased, Muscle spasms, Nasal congestion
Clinical narrative: Coughing, itchy and runny eyes, body aches, stuffed nose, muscle cramps.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Coughing, itchy and runny eyes, body aches, stuffed nose, muscle cramps.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Unable to raise arm, very painful (hadn't hurt at time of injection), decreased ROM--deltoid muscle. Symptoms gradually improved over one week's time.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Complains of having reaction to injections of fever of 102 through 09/07/13, no other complaints.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt reports deep red area at injection site that measured 3-4" in length.  Now smaller and down to 2" in length. Has lighter red area around deep red section. Feels warm to touch and with hard lump at site. Pt noted that the pink area has small little bumps (like "goosebumps). Area itches intensely despite taking daily antihistamine. Pt noted low grade temp of 99.2 on Saturday with some muscle aches and pains as well. Pt noted that the pink area is almost her entire upper arm. She will begin using Benadryl topical on the site to help with the itch. Advised pt to follow-up with MD if not better or resolving in 2 more days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pt reports deep red area at injection site that measured 3-4" in length.  Now smaller and down to 2" in length. Has lighter red area around deep red section. Feels warm to touch and with hard lump at site. Pt noted that the pink area has small little bumps (like "goosebumps). Area itches intensely despite taking daily antihistamine. Pt noted low grade temp of 99.2 on Saturday with some muscle aches and pains as well. Pt noted that the pink area is almost her entire upper arm. She will begin using Benadryl topical on the site to help with the itch. Advised pt to follow-up with MD if not better or resolving in 2 more days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm where ProQuad was given with swelling, 4x5cm redness and warm to touch. Dx with shot reaction vs early cellulitis. Treated with 7 days Augmentin and ibuprofen.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Diarrhoea, Migraine, Nausea, Vomiting
Clinical narrative: N/V/D later at night Migraine headache.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Arthralgia, Asthenia, Chills, Conjunctivitis, Cough
Clinical narrative: N/V/D later at night Migraine headache.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Diarrhoea, Headache, Malaise, Migraine, Myalgia
Clinical narrative: N/V/D later at night Migraine headache.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Nausea, Oropharyngeal pain, Scotoma, Vomiting
Clinical narrative: N/V/D later at night Migraine headache.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Diarrhoea, Migraine, Nausea, Vomiting
Clinical narrative: Dry cough, sore throat, bilateral conjunctivitis, feeling sick, nausea, profuse vomiting, diarrhea, shivers, weakness, myalgia, arthralgia, subfebrile (37.8C), visual field loss/scotoma (migraine), severe headache.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Arthralgia, Asthenia, Chills, Conjunctivitis, Cough
Clinical narrative: Dry cough, sore throat, bilateral conjunctivitis, feeling sick, nausea, profuse vomiting, diarrhea, shivers, weakness, myalgia, arthralgia, subfebrile (37.8C), visual field loss/scotoma (migraine), severe headache.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Diarrhoea, Headache, Malaise, Migraine, Myalgia
Clinical narrative: Dry cough, sore throat, bilateral conjunctivitis, feeling sick, nausea, profuse vomiting, diarrhea, shivers, weakness, myalgia, arthralgia, subfebrile (37.8C), visual field loss/scotoma (migraine), severe headache.
Age: 31.0
Sex: F
Vaccine: HEP, MM, FLU3
Symptoms: Nausea, Oropharyngeal pain, Scotoma, Vomiting
Clinical narrative: Dry cough, sore throat, bilateral conjunctivitis, feeling sick, nausea, profuse vomiting, diarrhea, shivers, weakness, myalgia, arthralgia, subfebrile (37.8C), visual field loss/scotoma (migraine), severe headache.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Malaise, Odynophagia, Oral discomfort, Wheezing
Clinical narrative: Weezy, flushed, extremely painful to swallow, general maliase; symptoms are lessened after taking Benadryl. Taste buds seem burned for approximately 24 hours after symptoms commenced. Similar reaction occurred after receiving the flu vaccine three years ago.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dizziness postural, Fatigue, Nausea, Somnolence
Clinical narrative: Fatigue, drowsy; vertigo with nausea (very dizzy at rest, with position changes and when walking); on 09/08/2013 called personal physician and began taking Antivert 25 mg once a day; vertigo lessening on 09/09/2013; unable to leave home to symptoms from 09/06/2013 5:00 p.m. through 09/09/2013.