chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Started to break out in red spots with small white tips. Increased and saw dermatologist who prescribed ointment with cortisone. No results - saw personal MD who prescribed stronger cortisone cream. No results. Red spots covered torso back and front - arms and legs and now rash on arms. Condition continues.
Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Started to break out in red spots with small white tips. Increased and saw dermatologist who prescribed ointment with cortisone. No results - saw personal MD who prescribed stronger cortisone cream. No results. Red spots covered torso back and front - arms and legs and now rash on arms. Condition continues.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site (size of 1/2 of a dollar bill), sore to touch, redness. Had pt treat w/ ice (or) APAP and BENADRYL (or) also to try cool or warm compress which ever felt better.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (+) Swelling, warm and redness @ injection site (L) deltoid (of arm). Advised to treat sx with ice pack to affected site BID-TID to reduce swelling and OTC TYLENOL for pain control.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inflammation, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Swelling, erythema and induration at local injection site ((L) lateral thigh). Sx control with BENADRYL liq soln, OTC TYLENOL/ADVIL for inflammation/pain control, and ice pack x 15 mins BID-QID.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: C-reactive protein, Carbon dioxide normal, Full blood count, Irritability, Metabolic function test
Clinical narrative: Papular rash buttocks, extensor surfaces arms/legs, purpuric lesions, nonblanching, pains/sores. No fever, slight irritability.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Pain, Purpura, Rash papular, Streptococcus test
Clinical narrative: Papular rash buttocks, extensor surfaces arms/legs, purpuric lesions, nonblanching, pains/sores. No fever, slight irritability.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Infection at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and pain at the injection site.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Fainted, seizure for approx 15 seconds.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: Redness back of arm and redness at injection site with itching, mom gave Benadryl, cool compresses.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster in 2-dose varicella vaccine recipient. Symptoms: rash on left side of belly. Duration: less than 4 weeks. No antiviral treatment.
Age: 1.29
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Aphasia, Childhood disintegrative disorder, Decreased appetite, Decreased eye contact, Dyskinesia
Clinical narrative: High fever of 104 the day of shot the fever lasted for 4 days then 10-14 days later red bumps from head to toe and a high fever ranging from 102-104, that lasted about a week she was very sick and tired she stopped eating, talking and making eye contact. She soon started shaking her head and flapping her right arm. We had to start her on baby foods again after being on solids for months. She also had regressed by 6 months when testing out at the doctors office. Before the vaccine she had always tested out as 3 months ahead of her age.
Age: 1.29
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Fatigue, Malaise, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: High fever of 104 the day of shot the fever lasted for 4 days then 10-14 days later red bumps from head to toe and a high fever ranging from 102-104, that lasted about a week she was very sick and tired she stopped eating, talking and making eye contact. She soon started shaking her head and flapping her right arm. We had to start her on baby foods again after being on solids for months. She also had regressed by 6 months when testing out at the doctors office. Before the vaccine she had always tested out as 3 months ahead of her age.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash generalised
Clinical narrative: Started with a fever that lasted about 3 days, loss of appetite and a few diarrhea diapers. On 7/28/2012 a rash appeared on the face and by the next morning it spread to the body.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Malaise, Nausea
Clinical narrative: Nausea, general malaise, at 1000, headache and dizzy that lasted 3 weeks.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Eye swelling, Laboratory test, Local swelling, Rash generalised
Clinical narrative: Rash over body, puffy (swelling) of feet, hands, eyes. Labs done to r/o other possibilities and instructed to take BENADRYL.
Age: 1.75
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Daycare sent child home for fever up to 100F and swollen thigh. Left thigh swollen about 3-4 inches in length and around thigh, warm to touch. Swelling stops above the knee. Lower leg normal. Cap refill on left big toe brisk. No swelling of toes. Right leg normal looking, no swelling.  Swelling started today at daycare. No symptoms noted the night of vaccinated day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Nasal congestion, Oropharyngeal pain
Clinical narrative: Large red welt at injection site "with head," itching at injection site, sore throat, sneezing, nasal congestion, mucousy cough.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Productive cough, Sneezing
Clinical narrative: Large red welt at injection site "with head," itching at injection site, sore throat, sneezing, nasal congestion, mucousy cough.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope - recovered within 10 minutes with some oral fluids.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Mobility decreased, Pain
Clinical narrative: Lots of pain don't have full function of right arm.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure decreased, Injection site nodule, Pyrexia, Syncope
Clinical narrative: Blood pressure drop/ fainting, fever. Large (3") firm nodule around injection site.
Age: 66.0
Sex: F
Vaccine: YF
Symptoms: Dysphagia, Headache, Oropharyngeal pain, Tongue disorder
Clinical narrative: Sore throat, head ache, discomfort when swallowing, tongue felt "thick".  Denies any difficulty breathing.  Still has some throat soreness today. Benadryl helped some.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Dizziness postural, Nausea, Vomiting
Clinical narrative: Upon standing, pt complained of feeling dizzy and nauseated. Pt vomited. Vitals were assessed and PO fluids offered. Pt was monitored in clinic for 30 mins.
Age: 0.39
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site ulcer, Pyrexia, Screaming
Clinical narrative: Slept for 9 hours woke up with a big red sore on injection site fever of 104 and was letting out one big scream without hardly breathing in between screams he was givin Lortab and was in the ER for 5 hours to be checked on before it was ok to take him home.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Crying, Decreased appetite, Diarrhoea, Fatigue, Irritability
Clinical narrative: On 7/25 at 4 pm patient had a fever of 102.4 at which time I gave him 4 ml of acetaminophen. The fever subsided within 30 minutes to 99.0. He had a loss of appetite and would not eat but did take some fluids. (7/25) the fever returned around 9 pm, I gave another 4 ml of acetaminophen. He slept through the night until 8 am the next morning. On 7/26 he had no appetite and only ate 1/3 of what he normally eats. He had two bowel movements throughout the day which were both diarrhea. Around 6 pm the fever returned, I gave him 4 ml of acetaminophen and the fever subsided for the night. On 7/27 patient woke up very fussy and crying non-stop. His fever was at 100.2 so I gave 4 ml of acetaminophen and the fever subsided. He still had no appetite, diarrhea and was very tired. On the night of 7/27 patient woke up every hour crying and slept a total about about 6 hours. I gave him acetaminophen at 9pm and 4 am. 7/28 he was very tired throughout the day and would take naps for about 30 minutes at a time and wake up crying and go back to sleep. He had no bowel movements and still was eating about 1/3 of his normal food intake. He was still taking fluids (milk and water). On 7/28 around 3 pm I noticed a rash on his forehead. The rash was also on his back and stomach. At this time I called the nurse and was told it was a "viral rash". The symptoms and crying continued so I took him to urgent care around 7pm. The doctor informed me he was having an adverse reaction to the vaccine and to continue giving him Tylenol every 4 hours until the rash and fever subsided. As of 7/29 the rash is still present and he still has lack of appetite.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Middle insomnia, Pyrexia, Rash, Vaccination complication, Viral rash
Clinical narrative: On 7/25 at 4 pm patient had a fever of 102.4 at which time I gave him 4 ml of acetaminophen. The fever subsided within 30 minutes to 99.0. He had a loss of appetite and would not eat but did take some fluids. (7/25) the fever returned around 9 pm, I gave another 4 ml of acetaminophen. He slept through the night until 8 am the next morning. On 7/26 he had no appetite and only ate 1/3 of what he normally eats. He had two bowel movements throughout the day which were both diarrhea. Around 6 pm the fever returned, I gave him 4 ml of acetaminophen and the fever subsided for the night. On 7/27 patient woke up very fussy and crying non-stop. His fever was at 100.2 so I gave 4 ml of acetaminophen and the fever subsided. He still had no appetite, diarrhea and was very tired. On the night of 7/27 patient woke up every hour crying and slept a total about about 6 hours. I gave him acetaminophen at 9pm and 4 am. 7/28 he was very tired throughout the day and would take naps for about 30 minutes at a time and wake up crying and go back to sleep. He had no bowel movements and still was eating about 1/3 of his normal food intake. He was still taking fluids (milk and water). On 7/28 around 3 pm I noticed a rash on his forehead. The rash was also on his back and stomach. At this time I called the nurse and was told it was a "viral rash". The symptoms and crying continued so I took him to urgent care around 7pm. The doctor informed me he was having an adverse reaction to the vaccine and to continue giving him Tylenol every 4 hours until the rash and fever subsided. As of 7/29 the rash is still present and he still has lack of appetite.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pyrexia, Rash, Skin irritation
Clinical narrative: Local irritation and redness, mild fever and headache. Rash on arm and hands.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Gait disturbance, Visual impairment
Clinical narrative: Patient ligthheaded after vaccines; vision went fuzzy while walking past waiting room with mom. (She did not tell mother). She stumbled and recalls waking up on floor. Dr. examined pt. normal findings. Pt waited 20 minutes without dizziness before discharged again. (1st time to visit our office).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient in his mid-sixties. Within the last two weeks, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). The patient suffered an immediate injection site reaction to red and swollen to the size of goose egg. It was given BENADRYL as a treatment for the adverse effect. The outcome of injection site reaction of red and swollen to the size of goose egg was unknown. The casual relationship was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: This spontaneous report as received from a B.S.N. refers to a 60 year old female patient with tetracycline and amoxicillin allergy. On 19-JUN-2013, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # not reported) IM. The nurse reported that in 2013 after receiving PNEMOVAX23, the patient experienced swelling and redness of her left arm at the injection site. The affected area extended from her elbow to her neck. The patient did not seek medical attention, but treated the area by applying ice packs to her arm. At the time of the report, the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female registered pharmacist of unknown age with high blood pressure, sulfa allergy and erythromycin allergy reporting on herself. On 20-APR-2012, the pharmacist was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapies included DIOVAN HCT and verapamil. The pharmacist reported that on 21-APR-2012, the day after vaccination with ZOSTAVAX, she developed shingles and lasted for about 10 days. The patient went to her physician for treatment. The patient was treated with VALTREX. There were no lab diagnosis or studies performed. The outcome of shingles was reported as recovered/resolved on approximately 30-APR-2012.  This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: Left deltoid with 2" x 2" red area over immunization site given antibiotic and antihistamine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown demographics. On an unknown date, patients were vaccinated with a dose of VARIVAX (Merck) (lot number and expiry date reported as H020601 and 13-NOV-2014 respectively, dose and route unspecified) (expiry date was also reported as 03-NOV-2014) which was stored in the refrigerator at 41 degrees Fahrenheit (F) for 49 days. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. in clinic for Immunization update on 7/16/13, receive Tdap and MCV, 0.5 ml, IM, (R) deltoid given. Pt waited in lobby for 20 mins on 7/16/13 w/o any s/s of adverse reactions. Pt and mother returned to clinic on 7/18/13 w/ c/o site pain. Pt. was checked in to clinic for PCM evaluation of site. PCM noted site redness, warm to touch, 7cm to 9cm area noted on (R) deltoid site. Pt's mother was advised to continue to use cool compresses, MOTRIN 600mg, PO, every 6 hrs w/ food per PCM order.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist (R.Ph) via a company representative refers to 3 patients of unknown age and gender. On an unknown date of year 2012 the patients were vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). Concomitant medication was not reported. On an unknown date the patient experienced rash, after receiving ZOSTAVAX, described as worse than normal, in comparison to flu vaccine over the past year. The outcome of rash was unknown. Patient was advised to contact pharmacist if rash worsened; however there was no further contact from the three patients. No identifying patient information was provided. VZVIP packet was faxed. This is one several cases reporting from same source.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 14-JUN-2013, the patient was vaccinated with a dose of M-M-R II, (lot # H010135, expiry date 17-MAY-2014, route was not reported) which may have been improperly stored at 8.5 degrees Celsius and 9.1 degrees Celsius for 720 hours. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient with no medical history or drug reactions or allergies who received two doses of ZOSTAVAX. In May 2010, the patient was vaccinated with the first 0.65 ml dose of ZOSTAVAX (lot# and expiration date unspecified) subcutaneously. On 19-JUL-2013, the patient was vaccinated with the second 0.65 ml dose of ZOSTAVAX (lot # J001729, expiration date 20-OCT-2013) subcutaneously. There was no concomitant medication. On 20-JUL-2013, the patient developed redness underneath an unspecified armpit after receiving his second dose of ZOSTAVAX. The patient was not given treatment for the event. No labs/diagnostics studies were performed. The patient did not seek medical attention. At the time of reporting, the outcome of redness underneath an unspecified armpit was unknown. This is one of several reports received from the same source (linked with Case# 1307USA014767). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 68 year old female patient. On an unknown date in 2006, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported), 0.65 ml, subcutaneously. On an unknown date in 2013 (reported as recently within this year), the patient was diagnosed with shingles on her neck by a referring dermatologist. The patient sought medical attention (unspecified). No treatment was given to patient. The physician reported that the patient's condition resolved itself (also reported as recovering). Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 18 year old patient. On 25-JUL-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (Lot#, dose and route not reported) in error instead of a second dose of M-M-R II (Wistar RA 27-3). No adverse event was reported. It was not known if the patient sought medical attention. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Local swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 69 year old male patient with hypertension. On 10-JUL-2013 the patient was vaccinated with PNEUMOVAX23 injection with valid lot # H013847 (expiry date 15-MAR-2014), intramuscularly. Concomitant therapy included hydrochlorothiazide, triamterene. On 10-JUL-2013 in the evening, the patient developed redness and tenderness at the injection site with swelling in the entire arm down to his fingertips. He could not lift his arm. The patient called the physician's office for medical attention and was prescribed TYLENOL for treatment. On an unspecified date the patient recovered. No causality assessment was provided. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20 year old female patient with no pertinent medical history and no drug reactions/allergies. There was no concomitant medication. The patient was administered three doses in the pediatric RECOMBIVAX HB (lot# not reported) series on 28-DEC-1992, 27-JAN-1993 and 27-SEP-1993 intramuscular respectively. The patient had titers for hepatitis B drawn on 15-JUL-2013 and the results came back as indeterminate. The patient was subsequently administered a 5 mcg (0.5 ml) dose of RECOMBIVAX HB on 18-JUL-2013. The patient sought medical attention by seeing in the office and no treatment was given. No lab diagnostics studies were performed. At the time of reporting, the outcome of patient was not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a medical assitant refers to currently 13 year old female patient with eggs allergy and no other pertinent medical history. On 30-MAR-2012 the patient was vaccinated with the first dose of GARDASIL (intramuscular, 0.5 ml) lot number: 670049/1171AA, exp. date 11-NOV-2013. No further doses have been administered. There was no concomitant medication. Reporting medical assistant did not have further details of what the specific symptoms were. On an unknown date the patient experienced injection site reaction. No lab test reported. There was no treatment given for the patient's event. The outcome of injection site reaction was reported as recovered/resolved (date unspecified). The relatedness for GARDASIL was not reported. The patient did not sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age. On 22-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). On an unknown date in July 2013, the patient developed an injection site reaction described as itchy, red, rash with swelling at the injection site. Patient sought medical attention (unspecified). The outcome of itchy, red, rash with swelling at the injection site was reported as not recovered.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 11-JUN-2013, the patient was vaccinated with a dose of ROTATEQ, (lot # H011439, expiry date 01-DEC-2013, route was not reported) which may have been improperly stored at 8.5 degrees celsius to 9.1 degrees celsius for 720 hours. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 14-JUN-2013, the patient was vaccinated with a dose of VARIVAX (Merck), (lot # H016578, expiry date 05-SEP-2014, route was not reported) which may have been improperly stored (also reported as that went through an unsupported temperature excursion). No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Seizure like phenomena, Syncope
Clinical narrative: Fainted with seizure like movements in body.  Blood pressure went extremely low and took about 1 hour to come back up.
Age: 67.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site vesicles, Underdose
Clinical narrative: Provider ordered Zostavax 0.65mL. RN gave patient 0.1mL of Zostavax since RN noted a bubble near injection site with redness. RN stopped injection and there was 0.5mL of Zostaax left in the syringe. RN informed provider and provider determined it was an allergic reaction. Provider ordered 25mg of Benadryl by mouth. Patient was observed for 20minutes before provider said he can go.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dizziness, Dizziness postural
Clinical narrative: Patient began to get lightheaded and dizzy. Patient was laid down and feet elevated. Patient begin to have beginning signs of a seizure but mom intervened by talking with patient and patient begin to talk to mom and patient responded by. Patient was unable to stand without being lightheaded so patient was sent to the ER.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Chromaturia
Clinical narrative: Dark urine occurring over 36-48 hours after vaccine administration. No other symptoms.
Age: 1.13
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash appeared 7/19, spreading. Fever. Irritable bright confluent erythematous rash on face and trunk and extremities but not palms and soles, maculopapular.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TD, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Painful, swollen red, hot to touch noticed vaccine 1-2 hours after receiving vaccine.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Injection site erythema, Injection site nodule, Nausea, Vomiting
Clinical narrative: Nausea and vomiting, approx 45 min post injection, vital signs stable,  Rt deltoid slightly red and injection site has small knot, lightheaded.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Blood alkaline phosphatase, Electrocardiogram
Clinical narrative: High blood pressure (190/100 when highest); Tachycardia; Headache; Fatigue; Brief Fainting; Weakness.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Haematology test, Headache, Hypertension, Syncope
Clinical narrative: High blood pressure (190/100 when highest); Tachycardia; Headache; Fatigue; Brief Fainting; Weakness.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Tachycardia, Troponin I, Urine analysis
Clinical narrative: High blood pressure (190/100 when highest); Tachycardia; Headache; Fatigue; Brief Fainting; Weakness.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 25-JUN-2013, the patient was vaccinated with a dose of GARDASIL,(lot # H012973, expiry date 05-MAR-2015, route was not reported) which may have been improperly stored at 8.5 degrees celsius to 9.1 degrees celsius for 720 hours. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 12 year old female patient. The patient's pertinent medical history was reported as none and she did not have any drug allergies. On 17-AUG-2001, the patient was vaccinated with the first and only dose of VARIVAX (Merck). The patient did not take any concomitant medications. On an unknown date in 2012, the patient developed shingles. The nurse stated that the patient was not treated at her office for the shingles and she was unsure if any treatment was given. The shingles resolved on an unspecified date. A causality assessment between VARIVAX (Merck) and the shingles was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender (no demographic information was provided). No information regarding the patients medical history was provided. On an unknown date the patient was vaccinated with ZOSTAVAX while under the age of 50 years old. No concomitant medication was reported. No adverse effect was reported. No outcome was reported. 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 a healthcare worker, who reported that VARIVAX (Merck) was exposed to 40F for an unspecified amount of time longer than 72 hours. Healthcare worker was unsure if any doses were administered. No adverse effects reported. This case is linked to case 1307USA012731 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that on an unknown date, the patients was vaccinated with a dose of RECOMBIVAX HB (lot # H018691, Exp. date: February 2015), dose and route unspecified) which was exposed to 10 degrees Fahrenheit (F) for 8 hours, which was an excursion that was unsupported by in-house stability data. No concomitant medications were reported. No adverse symptoms were reported. This is one of the three reports from the  same source.  Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old patient (gender not reported). No information regarding the patient's medical history was provided. On 20-JUN-2013 the patient was vaccinated with GARDASIL, valid lot # H021608, 0.5 ml, intramuscularly. No concomitant medication was reported. The patient was 5 years old when receiving the vaccine. No adverse effect was reported. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, who reported that ZOSTAVAX was exposed to 40F for an unspecified amount of time longer than 72 hours. Healthcare worker was unsure if any doses were administered. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient noticed raised, itchy rash at site of injection 7 days post injection.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Generalised vaccinia, Rash pustular
Clinical narrative: 22 y/o male with suspected generalized vaccinia vs postvaccinia nonviral pustulosis. Multiple pustules on trunk, upper arms, thighs 10 days after immunization.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Ear swelling, Eye swelling, Flushing, Swelling face, Urticaria
Clinical narrative: After receiving MMR-V, KINRIX was at lab and noted (L) periorbital swelling --> (L) facial swelling --> flushed skin abdomen/arms --> hives face and more swelling face and swelling ears. No wheezing or trouble breathing --> received offer BENADRYL orally and EPI IM.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 76 year old female consumer (reporting on herself). On 03-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX (Lot # not reported) (dose not reported, injection route). Concomitant therapy was not reported. On 08-JUL-2013, the patient experienced a rash after receiving the ZOSTAVAX vaccine. The patient did not sought medical attention. The outcome of rash after receiving the ZOSTAVAX vaccine was reported as recovering. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: Patient was sent to the Emergency room.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Mobility decreased, Myopathy
Clinical narrative: Patient was sent to the Emergency room.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Patient was sent to the Emergency room.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 75 year old patient. The patient's medical history included shingles. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J001005, expiration date 24-APR-2014) in the arm, dose and route unspecified. Soon after ZOSTAVAX vaccination, the patient developed "bump or lump" at the injection site where shingles had in the past. The outcome of the patient was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients. The Nurse reported that a medical office might had administered GARDASIL (lot # unspecified), injection which may have under went an unsupported excursion, to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: MNQ
Symptoms: Joint swelling, Local swelling, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Pt began experiencing pain in legs the evening of vaccination. He stated his feet, ankles, knees and legs are swollen. He also began to feel itchy and had broken out in hives on his back, chest, and arms. Pt was advised to take BENADRYL.
Age: 1.52
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Ear swelling, Rash, Rash papular, Urticaria
Clinical narrative: Swelling of external ear and rash to torso approx 2 hours after vaccines. Hives vs. papular appearance. BENADRYL given.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pallor, Syncope, Tremor
Clinical narrative: ADministered vaccines and within 5 min of administration pt. became very pale and proceeded to faint. When coming to she began to shake for 15 sec and then was alert. Applied oxygen to pt and had pt stay at clinic 45 min for observation.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 14 year old patient. On 17-JUL-2013 the patient received a dose of ZOSTAVAX instead of VARIVAX (Merck). Lot# was not provided. The pharmacist did not have patient or physician details available at the time of the call but she was agreeable to follow up. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 25-JUL-2013, the patient was inadvertently vaccinated with dose of (Merck) VARIVAX, subcutaneous who was actually supposed to receive ZOSTAVAX. Patient had no adverse effects. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 50 year old male patient. On 11-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J000493, exp. date on 14-APR-2014, subcutaneous. The patient's clothing had felt wet after having been administered ZOSTAVAX and asked that if that was normal. It was found that the wetness was because the ZOSTAVAX was "partially sprayed on the patient's clothing." About 60% of a full dose was administered to the patient. The patient reported no adverse effects from the improper administration of ZOSTAVAX. The reporter also asked if less than a full dose of ZOSTAVAX was administered, was that a valid dose of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a facility nurse via a company representative regarding two patients of unknown age and gender. On an unknown date, the two patients were vaccinated with a dose of PROQUAD (Merck) (lot # J001054, expiry: 28-JUL-2014). On an unknown date, the two patients developed confirmed cases of cellulitis after receiving the PROQUAD vaccine. It was unspecified if the patients sought medical attention. The outcome of cellulitis was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist (Pharm. D.) refers to a patient of unknown age. On 16-JUL-2013 the patient was vaccinated subcutaneously with a 0.5 ml dose of M-M-R II (lot # 1119AA, expiry date: 12-JUL-2013). No adverse effects reported. The outcome of events was unknown. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 year old patient. On unknown date (as a child) the patient received 2 doses of VARIVAX (Merck) and 3 doses of RECOMBIVAX HB. The reporter stated that the patient recently had titer's drawn for varicella (reported in MARRS# 1307USA013285) and hepatitis B both of which came back negative. Treatment for this consisted of booster doses of VARIVAX (Merck) and RECOMBIVAX HB. The outcome was not reported. The relatedness RECOMBIVAX HB and the event was not reported. Same patient link 1307USA013285. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a female patient of unknown age. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX (vial, lot# H018091, strength, formulation, dose/frequency, route and duration were unspecified). Pharmacist reported that the patient developed shingles after receiving ZOSTAVAX (unspecified date in 2013). Patient had sought medical attention by going to an emergency room. The outcome of shingles was reported as recovered/resolved(unspecified date in 2013). Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Echocardiogram, Electrocardiogram, Lumbar puncture, Myocarditis, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2013. A 20 year-old male subject with no significant past medical history was found to have idiopathic myocarditis 12 days after the subject had received the following vaccines on 26 August 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Influenza live intranasal (manufacturer, lot number, route and site of administration not reported). The Troponin I result, ECG and Echocardiogram, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2013. A 20 year-old male subject with no significant past medical history was found to have idiopathic myocarditis 12 days after the subject had received the following vaccines on 26 August 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Influenza live intranasal (manufacturer, lot number, route and site of administration not reported). The Troponin I result, ECG and Echocardiogram, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Encephalitis post immunisation
Clinical narrative: This study case was received from the investigator in the trial on 18 July 2013. An 37 year-old female subject whose past medical history included headaches was found to have encephalitis following immunization procedures 11 days after the subject had received on 23 September 2009 an injection of ACAM2000 (lot number, route and site of administration not reported. Troponin I result, ECG and Echocardiogram, Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: HEP, SMALL
Symptoms: Echocardiogram, Electrocardiogram, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2013. A 39 year-old female subject was found to have unspecified disease of the pericardium 28 days after she had received on 12 September 2009 an injection of ACAM2000 (lot number, route and site of administration not reported) and Hepatitis B vaccine (other manufacturer, lot number, route and site of administration not reported). The subject also received on 22 August 2009 an injection of Anthrax 1 (other manufacturer, lot number, route and site of administration not reported) and TYPHIM VI (lot number, route and site of administration not reported). Results from Troponin I, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and lumbar puncture were not available. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: HEP, SMALL
Symptoms: Nuclear magnetic resonance imaging thoracic, Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2013. A 39 year-old female subject was found to have unspecified disease of the pericardium 28 days after she had received on 12 September 2009 an injection of ACAM2000 (lot number, route and site of administration not reported) and Hepatitis B vaccine (other manufacturer, lot number, route and site of administration not reported). The subject also received on 22 August 2009 an injection of Anthrax 1 (other manufacturer, lot number, route and site of administration not reported) and TYPHIM VI (lot number, route and site of administration not reported). Results from Troponin I, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and lumbar puncture were not available. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Echocardiogram, Electrocardiogram, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2013. A 29 year-old male subject with a history of chest pain was found to have acute pericarditis unspecified 10 days after he had received on 29 September 2009 an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (other manufacturer, lot number, route and site of administration not reported), and Influenza Live Intranasal (other manufacturer, lot number not reported). Results from Troponin 1, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and lumbar puncture were not available. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Nuclear magnetic resonance imaging thoracic, Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2013. A 29 year-old male subject with a history of chest pain was found to have acute pericarditis unspecified 10 days after he had received on 29 September 2009 an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (other manufacturer, lot number, route and site of administration not reported), and Influenza Live Intranasal (other manufacturer, lot number not reported). Results from Troponin 1, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and lumbar puncture were not available. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Encephalitis post immunisation
Clinical narrative: This study case was received from the investigator in a trial on 16 July 2013. A 32-year-old male subject with a past medical history of elevated cholesterol and headaches was found to have encephalitis following immunization procedures 11 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 08 April 2010. Troponin I, ECG, echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram, Pericardial disease
Clinical narrative: This study case was received from the investigator in a trial on 16 July 2013. A 28-year-old male subject with a past medical history of asthma (including exercise induced) was found to have unspecified disease of pericardium 24 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 23 May 2010. Echocardiogram on 15 June 2010 was abnormal. ECG was not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.