chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Memory impairment, Mobility decreased, Muscle disorder, Muscle fatigue, Muscular weakness
Clinical narrative: My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Myalgia, Photophobia, Pruritus, Rash
Clinical narrative: My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Renal pain, Somnolence, Temperature intolerance, Visual impairment, Weight decreased
Clinical narrative: My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Weight increased
Clinical narrative: My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Aggression, Crying, Diet refusal, Pyrexia, Rash generalised
Clinical narrative: She developed a fever almost immediately, she began acting aggressive and combative, the next day the rash began on her face then spread to her chest and hands and feet. She would not eat. She cried, and then stopped talking.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Speech disorder
Clinical narrative: She developed a fever almost immediately, she began acting aggressive and combative, the next day the rash began on her face then spread to her chest and hands and feet. She would not eat. She cried, and then stopped talking.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood culture negative, Chest pain, Computerised tomogram thorax normal, Echocardiogram normal, Haematuria
Clinical narrative: 6/10: Lethargy, cek pain, headache, hematuria.  6/14:  Chest pain and erythema at injection site.  6/14 To ED for chest pain and transferred to Medical Center for cardiology work up and infectious disease.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Injection site erythema, Lethargy, Pain, Troponin increased
Clinical narrative: 6/10: Lethargy, cek pain, headache, hematuria.  6/14:  Chest pain and erythema at injection site.  6/14 To ED for chest pain and transferred to Medical Center for cardiology work up and infectious disease.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiac stress test normal, Chest pain, Computerised tomogram thorax normal, Dyspnoea, Echocardiogram normal
Clinical narrative: 6/10: Lethargy, cek pain, headache, hematuria.  6/14:  Chest pain and erythema at injection site.  6/14 To ED for chest pain and transferred to Medical Center for cardiology work up and infectious disease.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: 6/10: Lethargy, cek pain, headache, hematuria.  6/14:  Chest pain and erythema at injection site.  6/14 To ED for chest pain and transferred to Medical Center for cardiology work up and infectious disease.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Neck pain, Troponin increased
Clinical narrative: 6/10: Lethargy, cek pain, headache, hematuria.  6/14:  Chest pain and erythema at injection site.  6/14 To ED for chest pain and transferred to Medical Center for cardiology work up and infectious disease.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Injection site erythema, Lethargy, Neck pain, Troponin I increased
Clinical narrative: 6/10: Lethargy, cek pain, headache, hematuria.  6/14:  Chest pain and erythema at injection site.  6/14 To ED for chest pain and transferred to Medical Center for cardiology work up and infectious disease.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Joint range of motion decreased, Myalgia, Oedema peripheral
Clinical narrative: Pain at injection insertion, administration, and following administration. On 8/14/13, patient noted redness/ swelling left upper forearm 26length x11cm. Decreased range of motion of arm. Tenderness along left trapezius muscle area. (improved range of motion 8/15/13).
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Received T-DAP, MENACTRA and HPV #1 at 3pm - became sick with fever 101 degrees lightheadedness, nausea and severe headache at 7pm.
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Foetal exposure during pregnancy, Polydactyly
Clinical narrative: Initial report received from a health care professional on 02 August 2013. A baby was exposed in utero to ADACEL, VALTREX, and Influenza vaccines. The baby was diagnosed with polydactyly. The outcome was not reported. This is linked to mother case 2012-09844. Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Hypersensitivity, Local reaction
Clinical narrative: Localized allergic reaction; early cellulitis dx at medical center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives approx 2 days post vaccination. Gave ZYRTEC and Allergist referral.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Localized erythematous reaction to entire upper arm where vaccine was given.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: 8" wide x 4" long red, raised, swollen, warm area. Two bruises noted. Itchy. Benadryl, Tylenol, icing.
Sex: U
Vaccine: ANTH, HEP, SMALL
Symptoms: Injection site pruritus, Scar, Swelling
Clinical narrative: The smallpox vaccine area becomes really itchy, and the scar area rises. Happened about 3-4 times, and lasts about a day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site infection, Injection site warmth
Clinical narrative: Redness, warmth, and infection at immunization site (LA).
Sex: U
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Localized reaction 2cm with 48 hours. Rx: warm compress Tylenol, benadryl as needed.
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injection site abscess, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Swelling and soreness at injection site, within 24 hr of immunization. Reaction was severe in nature and required immediate medical care.
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Swelling and soreness at injection site, within 24 hr of immunization. Reaction was severe in nature and required immediate medical care.
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injection site swelling, Muscular weakness, Pain
Clinical narrative: Swelling and soreness at injection site, within 24 hr of immunization. Reaction was severe in nature and required immediate medical care.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Pt had fever of 103.0 nausea, chills, and red around injection site aprox 3cm.  Ibuprofen given by next morning feeling better fever down and redness down to 1cm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 8/14/13 3:00PM seen in office: Swollen, warm, tender, upper right arm. Advised children's ibuprofen and Benadryl. Go to urgent care if worsens.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Eye swelling
Clinical narrative: SWOLLEN LEFT EYE, PATIENT RETURNED ONE HOUR POST VACCINATION. GIVEN OVER THE COUNTER BENADRYL.
Age: 26.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever, aches, pain, swollen lymph nodes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash
Clinical narrative: C/o localized rash at injection site right thigh.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient given adult dose Hepatitis A vaccine instead of Pediatric dose of stated vaccine. No reaction / adverse event. Talked to RN - form faxed - she stated it is not necessary to call manufacturer unless our facility requires us to do so.
Age: 14.0
Sex: M
Vaccine: HPV4, PNC13, HPV4
Symptoms: Emotional distress, Fall
Clinical narrative: He kept falling over, slipping and very emotional for 24 hours after HPV #1.
Age: 14.0
Sex: M
Vaccine: HPV4, PNC13, HPV4
Symptoms: Coordination abnormal, Dizziness, Emotional distress
Clinical narrative: He kept falling over, slipping and very emotional for 24 hours after HPV #1.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Unmeasured fever, headache, redness/swelling, itching/burning at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Unmeasured fever, headache, redness/swelling, itching/burning at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Pt received Proquad on 8.12.13 9AM. On Wednesday 8.14.13  swelling of left leg 50 cent size and cellulits about 4" across.
Age: 1.49
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature, Contusion, Irritability
Clinical narrative: Bruising below injection site of PREVNAR. Cranky, running temp based on mother's guess. Today temp without meds is 98.2. Mother has been giving ADVIL every 8-12 hrs.
Age: 68.0
Sex: F
Vaccine: MMR, TYP, YF
Symptoms: Guillain-Barre syndrome, Paraesthesia, Paralysis
Clinical narrative: Husband states that 3 days after administration of travel vaccines pt. experienced tingling in feet and legs, leading to progressive paralysis up the body. Diagnosed as Guillain-Barre' syndrome. Pt. being treated at hospital.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Influenza like illness, Injection site warmth, Pyrexia
Clinical narrative: Fever, site warm to the touch, joint pain, mild flu-like sx.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head injury
Clinical narrative: Patient experienced dizziness about 10 minutes after receiving the HPV (Gardasil) vaccine. The patient hit her head.
Age: 13.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Lethargy, Muscle spasms
Clinical narrative: Patient's mother reported lethargy, diarrhea and cramps following the third self administered dose of VIVOTIF. Symptoms treated with loperamide and oral hydration. Symptoms resolved within 24 hours and the fourth self administered dose was taken on schedule with no adverse events.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Mother stated child woke up with arm where injections given with rash, hard, swollen, and warm to touch.
Age: 21.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site scab, Injection site swelling
Clinical narrative: Left deltoid red, swollen, and hard to the touch.  Measures ~40mm in diameter.  Center of swelling is scabbed w/ lesion ~ 2mm in diameter.  Client reports swelling was much worse.  Reports no treatment.
Age: 21.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Skin lesion
Clinical narrative: Left deltoid red, swollen, and hard to the touch.  Measures ~40mm in diameter.  Center of swelling is scabbed w/ lesion ~ 2mm in diameter.  Client reports swelling was much worse.  Reports no treatment.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swelling, warmth, redness.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm with redness, swelling, warm to touch.  Apply ice, and take Tylenol.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Localized itching & rash.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Decreased appetite, Fatigue, Irritability, Lethargy
Clinical narrative: Child not hungry at lunch time, very tired. After nap is unusually cranky all afternoon. Very tired/sleeping late afternoon, wants to nurse but not eat solids. Has a rectal temperature of 102.9 F. around 6pm. (I administered child Tylenol). Goes to bed early and sleeps through the night as usual. In the morning he was lethargic and cranky and had a rectal temperature of 103.5 F mid morning. He ate a little and we gave him Tylenol again. He had a nap as usual and the fever was gone in the afternoon. He was acting back to normal after two days.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Somnolence
Clinical narrative: Child not hungry at lunch time, very tired. After nap is unusually cranky all afternoon. Very tired/sleeping late afternoon, wants to nurse but not eat solids. Has a rectal temperature of 102.9 F. around 6pm. (I administered child Tylenol). Goes to bed early and sleeps through the night as usual. In the morning he was lethargic and cranky and had a rectal temperature of 103.5 F mid morning. He ate a little and we gave him Tylenol again. He had a nap as usual and the fever was gone in the afternoon. He was acting back to normal after two days.
Age: 19.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Mobility decreased, Muscle twitching, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: I began having some soreness in the arm a few hours after receiving the vaccination. On 8/15, today, I woke up in severe pain. As an athlete, I certainly know the difference between soreness and pain and this is definitely pain. I can barely move my arm despite my best efforts and the pain is not even slightly relieved by over-the-counter medications. Neither hot or cold compresses have any effect on the pain. In the evening on 8/15, around 9:15 PM, my arm began twitching uncontrollably and I developed a fever. I have record tetanus vaccines before, but never had a reaction like this before. I only got this vaccine because it was required by my college to move into the dorm, but I certainly willd everything in my power to never get it again. I am currently uninsured and cannot afford an emergency room or doctor's office visit, but I would go if I were financially able. Having a swollen, nearly nonfunctional arm is certainly not a normal response to a vaccination.
Age: 42.0
Sex: F
Vaccine: HPVX
Symptoms: Abasia, Asthenia, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Difficulty breathing, Sore Throat, pain throughout the body. Mild fever, loss of appetite, chills, muscle pain, weakness, and unable to walk due to pain in legs. Lasted for 1wk 1/2.
Age: 42.0
Sex: F
Vaccine: HPVX
Symptoms: Myalgia, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Difficulty breathing, Sore Throat, pain throughout the body. Mild fever, loss of appetite, chills, muscle pain, weakness, and unable to walk due to pain in legs. Lasted for 1wk 1/2.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a few patients of unknown age and gender. The reporter stated that for last few months, few patients experienced burning sensation for a second after the administration of ZOSTAVAX (subcutaneous, dosage and site of administration not reported). No treatment for burning sensation was given. The outcome of burning sensation was unknown. The patients did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 05-AUG-2013 the patient was vaccinated with the first dose of PNEUMOVAX23 lot # 671416/1241AA (reported as 1241AA) with expiry date 12-APR-2013. Route of administration, anatomical location and indication were not reported. This dose was expired when the patient was vaccinated with it on 05-AUG-2013. No product quality complaint was filed, no adverse symptoms were reported. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 86 year old male patient. On 23-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported, dose not reported, "injection"). On August 6th or 7th, the patient contact the pharmacist reporting experienced "red bumps" about one inch above the injection site, the bumps were said to be "smaller than a dime and somewhat hard". The patient did not seek the medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no drug reactions/allergies. On 24-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # were not reported), subcutaneous. The patient experienced an unspecified allergic reaction to an unspecified substance ZOSTAVAX (could not be ruled out) on an unspecified date following the ZOSTAVAX administration and was prescribed MEDROL dose pak for treatment. The patient sought unspecified medical attention. The outcome of event was unknown. Additional information has been requested.
Age: 22.0
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 22 year old female patient. The patient was administered the first dose in GARDASIL (dose, route, lot # not specified) series on an unspecified date in 2007. On 17-JUL-2013 patient was in the physician's office to receive her second dose in the GARDASIL series (dose, route, lot # not specified). No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified 17 year old female patient. The first dose of the GARDASIL, injection was given on an unspecified date in 2008, the second dose in the series was administered on an unspecified date in 2010 and the third dose in the series was given on an unspecified date in 2012. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient in his sixties years. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported to the field employee that the patient developed shingles at an unspecified time after receiving ZOSTAVAX. The patient might also have developed postherpetic neuralgia (PHN) after experiencing shingles. The patient had been prescribed VICODIN possibly related to pain associated with postherpetic neuralgia (PHN). It was unknown if the patient sought medical attention. At the time of reporting, the outcome of above events was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
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 GARDASIL dose 2, intramuscular. The patient was administered his first dose in the GARDASIL series in "August of 2012". On 13-AUG-2013, the patient was administered the second dose in the series today (13-AUG-2013). On 2013, the patient experienced no adverse effect. The outcome of was administered the second dose in the series today (13-AUG-2013) and no adverse effect is unknown. The reporter considered was administered the second dose in the series today (13-AUG-2013) and no adverse effect to be not related to GARDASIL. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site pruritus, Rash
Clinical narrative: This spontaneous report as received from   a pharmacist refers to an 83 year old male patient with no known pertinent medical history and no known drug reactions/allergies. There was no concomitant medication. On 29-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001010, exp date 24-APR-2014), subcutaneous. The pharmacist reported that the patient presented to the pharmacy on 02-AUG-2013 with "7 randomly placed (no pattern) shingles-like vesicles on his abdomen". The pharmacist reported that the patient was not experiencing any symptoms at the site of the vesicles but did experience "a great deal of itching" at the injection site immediately following the ZOSTAVAX administration. No lab diagnostics studies were performed. The pharmacist reported that the injection site itching had disappeared but the rash on the abdomen remains. VZVID packet faxed. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm erythematous non tender at site of injection.
Sex: M
Vaccine: RV5
Symptoms: Abnormal sensation in eye, Accidental exposure to product, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous report as received from a male certified medical assistant (C.M.A.) (reporting on himself), age not reported, with none pertinent medical history or drug reaction allergies. It was reported that he was administering ROTATEQ (lot # J004393, exp date 26-JUL-2014) to an infant, and the infant sputtered while receiving the last of the dose (MARRS XXXXX). He stated the infant did not vomit or regurgitate the dose, but the infant sputtered drops out of his mouth. The reporter stated that a drop of ROTATEQ landed in his eye. He stated that it felt sticky and burned slightly. He stated that he washed his eye with normal saline and the burning went away. The reporter stated that then his eye felt fine. The patient did not sought medical attention and laboratory diagnostic studies were not performed. The outcome of it felt sticky was reported as recovering and the outcome of burned slightly was recovered. This case is related with MARRS 1308USA006801. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Nodule
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 54 year old female patient with no pertinent medical history or drug reactions or allergies. On 05-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J000446, expiration date 11-APR-2014) (0.65 ml, subcutaneous). No other suspect therapies were reported. Concomitant medications included unspecified eyedrops. On 07-AUG-2013 the patient experienced an injection site reaction that was red and warm. The patient also reported to the pharmacist that she had a small nodule "in her arm pit". The outcome for injection site reaction that was red and warm and small nodule in her arm pit was reported as not recovered. No treatment was given for the above mentioned events. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by calling to the pharmacy. The reporting pharmacist did not assess the causality between the above mentioned events and ZOSTAVAX. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fungal infection, Headache, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer (patient's mother), refers to a 17 year old female patient with none pertinent medical history or drug reaction allergies. On 01-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # H018755, exp date 21-MAR-2015) (1 shot, intramuscular route). Concomitant therapy was not reported. On 03-AUG-2013, the patient developed a bad headache followed by body aches and a fever that had remained between 100 and 102 degrees Fahrenheit. The patient still had the fever, which began about a week ago. The patient had also been having bad stomachaches, such that the stomach hurt sometimes when she ate. The patient experienced vomiting and last night (08-AUG-2013) the patient woke in the middle of the night with hives. The patient was reported to had developed a yeast infection at an unspecified time around the administration date of GARDASIL. The patient sought medical attention with the physician, and began therapy of DIFLUCAN for the yeast infection on an unspecified date, a day or so after 03-AUG-2013. She was administered BENADRYL as treatment for the hives. The reporter requested a lot check on the GARDASIL. Laboratory diagnostic studies were not performed. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a consumer (patient's mother), refers to a 17 year old female patient with none pertinent medical history or drug reaction allergies. On 01-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # H018755, exp date 21-MAR-2015) (1 shot, intramuscular route). Concomitant therapy was not reported. On 03-AUG-2013, the patient developed a bad headache followed by body aches and a fever that had remained between 100 and 102 degrees Fahrenheit. The patient still had the fever, which began about a week ago. The patient had also been having bad stomachaches, such that the stomach hurt sometimes when she ate. The patient experienced vomiting and last night (08-AUG-2013) the patient woke in the middle of the night with hives. The patient was reported to had developed a yeast infection at an unspecified time around the administration date of GARDASIL. The patient sought medical attention with the physician, and began therapy of DIFLUCAN for the yeast infection on an unspecified date, a day or so after 03-AUG-2013. She was administered BENADRYL as treatment for the hives. The reporter requested a lot check on the GARDASIL. Laboratory diagnostic studies were not performed. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Carpal tunnel syndrome
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to himself. No medical history or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot # and dose not provided) one time vaccine injection. On an unknown date, 12 hrs after receiving ZOSTAVAX the patient developed carpal tunnel syndrome in her right hand. The outcome of developed carpal tunnel syndrome in her right hand was unknown. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from registered nurse (R.N.) refers to a 55 year old female patient. On 13-AUG-2013 the patient was suppose to receive VARIVAX (Merck), but was inadvertently given the ZOSTAVAX (Lot #, 0.66ml, subcutaneous route). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and gender. The pharmacist reported that on an unknown dates at least a half-dozen patients were vaccinated with a dose of ZOSTAVAX (route, dose and lot number not provided). On an unknown dates the patients experienced injection site reaction. The outcome of injection site reaction was unknown for all the patients. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a patient's mother concerning her child of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (route, dose, lot number and expiration date were not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The patient's mother reported that her child had received a vaccine against chickenpox but had developed a mile case of chickenpox after receiving the vaccine. At the time of reporting, patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 09-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not provided), on 11-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not provided) and on 06-AUG-2013, the patient was vaccinated with the third dose of GARDASIL (dose, route, and lot number were not provided). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy doctor refers to a 66 year old female patient with chronic pain, hypertension, unspecified cardiac condition and no drug reaction/allergies. On 16-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000446, expiring 11-APR-2014, 0.65 ml, subcutaneous in the right tricep. Concomitant therapies included lisinopril, LASIX, carbamazepine and simvastatin (manufacturer unknown). On 18-APR-2013 morning, the patient reported that her injection site was slightly itchy, swollen, red, firm to touch and tender to palpation. The patient described the size of her injection site as the size of two half dollars. No treatment was given for the adverse event. The patient consulted the pharmacist for medical attention. By 22-APR-2013 the patient's symptoms had resolved. It was noted that there was never any rash that developed. This is one of several reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 75 year old female consumer reporting on herself who two years ago in approximately August 2011, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that she was 6 weeks on 02-JUL-2013 into shingles. At the time of the report, the consumer's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 23 year old patient of unknown gender. In 2012 the patient was vaccinated with the second dose of VARIVAX (Merck) (dose, route and lot number not provided). The pharmacist stated that for an unspecified reason, patient had varicella titers drawn on an unspecified date which were negative. The outcome of the event was unknown. The casual relationship was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date was vaccinated subcutaneously with one dose of ZOSTAVAX (dose and lot number not reported). The physician reported that on an unknown date the patient experienced zoster like rash at the injection site after receiving ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for zoster like rash at the injection site and ZOSTAVAX was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after immunizations pt presented with 4cm x 5cm area on (L) Ant thigh with erythema, swelling and increased warmth. No fevers or chills. Tx consisted of reassurance and ice to thigh TID x 20 min. Sx improved on 2 day follow up.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to 13 year old patient (unknown gender). On 30-JUL-2013 the patient was vaccinated with a first dose of VARIVAX (route, lot number and expiration date not reported). There was not concomitant medication reported. On 07-AUG-2013 the patient was vaccinated with a second dose of VARIVAX (route, lot number and expiration date not reported. No adverse symptoms reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 17 or 18 year old twin male patient. On 06-AUG-2013 the patient was vaccinated with GARDASIL lot # H020002, expiring 08-AUG-2015 dose 1 (dose, route and site not provided). On 06-AUG-2013, about 10 minutes following GARDASIL vaccination, the patient experienced syncope with tonic-clonic movements; however the patient remained awake and alert during the syncope. The syncope lasted about 15 minutes. No lab diagnostic tests were performed. The patient sought medical attention by office visiting. On 06-AUG-2013, the patient recovered from the events. The casual relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager to a patient of unknown age. After VARIVAX (Merck) (reported lot#J006109, expiration date 21-May-2015) underwent an unsupported temperature excursion, it was administered to the patient on 12-JUL-2013. (Dose, route, indication not reported). No adverse event was reported. this is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was administered 3 separate doses of  M-M-R II injection (lot number, dose, route and injection site were not reported) on three separate unspecified dates. Post-vaccination titers were performed on an unspecified date in 2012 and the results were negative to measles, mumps and rubella antibodies. The action taken was not provided. The outcome was unknown. The patient has seen at the physician's office for medical attention. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, IPV, RV5
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: Pt given IPV rather than PCV, along with his PEDIARIX, so received double dose of IPV.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 17 or 18 year old twin male patient. On 06-AUG-2013 the patient was vaccinated with GARDASIL lot # H020002, expiring 08-AUG-2015 dose 1 (route and site not provided). On 06-AUG-2013, about 10 minutes following GARDASIL vaccination, the patient experienced syncope with tonic-clonic movements; however the patient remained awake and alert during the syncope. The syncope lasted about 15 minutes. No lab diagnostic tests were performed. The patient sought medical attention by office visiting. On 06-AUG-2013, the patient recovered from the events. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 month old female patient. The patient did not have any relevant medical history. On 10-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004058)0.5 ml, intramuscular. No other co suspects were reported. No concomitant therapy was reported. The physician reported that on 10-AUG-2013, the patient was accidentally administered PNEUMOVAX23. The physician reported that the patient will be revaccinate with PREVNAR13. The outcome of the patient was accidentally administered PNEUMOVAX23 was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a License Practical Nurse (LPN) concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (route, dose, lot number and expiration date were not provided). Other suspect therapies included a dose of M-M-R II (route, dose, lot number and expiration date were not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The LPN reported that in approximately 2013, the patient's recent titers were negative for VARIVAX (Merck) and M-M-R II. The patient might had gotten the vaccines in the past but the vaccination record could not be located. At the time of reporting, the outcome the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. On an unknown date in September 2011, the patient was vaccinated with the first dose of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. On an unknown date in January 2012, the patient was vaccinated with the second dose of, 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. On an unknown date in October 2012, the patient was vaccinated with the third dose of, 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 10-AUG-2013, the patient was vaccinated with an extra dose of, 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself with a history of shingles diagnosed on 25-APR-2010 and who on 21-JUL-2010 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that a few days ago in approximately August 2013, she came down with a shingles but this time there were only seven small sores which were more itchy than painful and which had resolved themselves without any need of professional medical attention or drugs. The consumer reported that she believed that ZOSTAVAX was responsible for the minor of this shingles attack. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself with a history of shingles diagnosed on 25-APR-2010 and who on 21-JUL-2010 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that a few days ago in approximately August 2013, she came down with a shingles but this time there were only seven small sores which were more itchy than painful and which had resolved themselves without any need of professional medical attention or drugs. The consumer reported that she believed that ZOSTAVAX was responsible for the minor of this shingles attack. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old female patient who on 29-JUL-2013, was vaccinated with a dose of ZOSTAVAX (lot # J001003, expiration date 24-APR-2014) 0.65 ml, subcutaneously. This pharmacist noted that the patient experienced an injection site reaction after being vaccinated with ZOSTAVAX. The patient returned to the pharmacy today 31-JUL-2013, to informed this pharmacist that there was a red, painful, raised area where the ZOSTAVAX was administered. This patient noticed this reaction started yesterday 30-JUL-2013. The pharmacist stated that she told the patient to administer IBUPROFEN to herself to manage the pain. The outcome of injection site reaction not recovered/not resolved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pallor, Vomiting
Clinical narrative: After patient received his 3rd immunization he became very pale and eyes closed and started to lean over this nurse grabbed client and hollered for help he was then lower to the ground. Ft elevated and put a couple fans on him to increase air flow. He then vomited, he was turned to his side and cleaned up. He remained at our facility about 1 ht w/ft elevated and air blowing on him.
Age: 63.0
Sex: F
Vaccine: YF
Symptoms: Activities of daily living impaired, Balance disorder, Dizziness, Fall, Head injury
Clinical narrative: On 8/1/13 began to have photo sensitivity and felt off balance while out hiking; felt dizzy when turning head. Took a fall and hit head. On 8/7/13 became nauseous/vomiting headache, hands and elbows became tingling - went to DR immediately - DR. felt it was a migraine related event. Sent home - continued to have photo sensitivity, balance problems. Returned to doctor 8/13/13. Improving slowly - remains off work.
Age: 63.0
Sex: F
Vaccine: YF
Symptoms: Headache, Migraine, Nausea, Paraesthesia, Photosensitivity reaction
Clinical narrative: On 8/1/13 began to have photo sensitivity and felt off balance while out hiking; felt dizzy when turning head. Took a fall and hit head. On 8/7/13 became nauseous/vomiting headache, hands and elbows became tingling - went to DR immediately - DR. felt it was a migraine related event. Sent home - continued to have photo sensitivity, balance problems. Returned to doctor 8/13/13. Improving slowly - remains off work.