chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Patient complained of redness at the site, vomiting, dizziness. The site of injection is swollen and hot. She went to urgent care and was prescribed an antibiotic.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Muscular weakness, Oedema peripheral, Rash
Clinical narrative: Pt noticed weakness in fingers of right arm 8/27/12. Patient noticed swelling in right hand 8/30/12. On 8/31/12 rash developed. No blisters but pain. Pt went to ER MD DX, as shingles. Treated pt as outpatient
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: 3 vaccines administered 8/30/12 pt. was in room passed out after third injection. Reported did not eat breakfast. VSS administered juice and re-evaluated by MD.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pain, Rash
Clinical narrative: States after getting vaccine day 1-5 arm became red and swollen. Then on day 8 ran temp and hurt all over on day 10 had a rash.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Patient received Tdap after burn injury 8/30/12. Patient returned to clinic 8/31/12 with complaints of fever of 100 degrees F, headache, and pain 4/10 at injection site. Patient does not remember having this type of reaction to tetanus vaccine in the past. Provider advised NSAID & cold compress. F/U phone call on 9/4/12 student reports symptoms resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, redness, hot to touch on (L) thigh.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, redness, area hot to touch. All symptoms at injection site .
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blepharospasm, Dizziness, Dyskinesia, Hypotension, Loss of consciousness
Clinical narrative: This spontaneous report is the second of two reports as received from a registered nurse concerning a 13 years old female patient with a history of previous vagal response to blood draw (date unspecified) who on 07-AUG-2012, was vaccinated with the first dose of GARDASIL (lot# 0459AE, exp 13-DEC-2014) (route not reported). Secondary suspect vaccine given on the same day included a dose of VAQTA (lot# 0535AE, ex 24-JAN-2015) (dose and route not reported). Concomitant medications included: ZOLOFT. The nurse reported that the patient had an episode of syncope following the first dose of GARDASIL. It was reported that the patient was sitting on the exam table following vaccination with GARDASIL and became lightheaded. The nurse had the patient lie down on the exam table. The patient lost consciousness for about 2 minutes with eye twitching and some mouth movements. The patient was reported to be pale and had low blood pressure during this time. The patient recovered quickly from all symptoms and was recovered with in a half hour and left the office. On 07-AUG-2012, the patient recovered. It was unknown if the patient sought medical attention. The relatedness for lost consciousness, low blood pressure, pale, some mouth movements, eye twitching, lightheaded and episode of syncope was unknown for VAQTA and GARDASIL. Upon internal review lost consciousness was considered to be medically significant. This is one of several report from the same source (report# 1208USA010653). Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: This spontaneous report is the second of two reports as received from a registered nurse concerning a 13 years old female patient with a history of previous vagal response to blood draw (date unspecified) who on 07-AUG-2012, was vaccinated with the first dose of GARDASIL (lot# 0459AE, exp 13-DEC-2014) (route not reported). Secondary suspect vaccine given on the same day included a dose of VAQTA (lot# 0535AE, ex 24-JAN-2015) (dose and route not reported). Concomitant medications included: ZOLOFT. The nurse reported that the patient had an episode of syncope following the first dose of GARDASIL. It was reported that the patient was sitting on the exam table following vaccination with GARDASIL and became lightheaded. The nurse had the patient lie down on the exam table. The patient lost consciousness for about 2 minutes with eye twitching and some mouth movements. The patient was reported to be pale and had low blood pressure during this time. The patient recovered quickly from all symptoms and was recovered with in a half hour and left the office. On 07-AUG-2012, the patient recovered. It was unknown if the patient sought medical attention. The relatedness for lost consciousness, low blood pressure, pale, some mouth movements, eye twitching, lightheaded and episode of syncope was unknown for VAQTA and GARDASIL. Upon internal review lost consciousness was considered to be medically significant. This is one of several report from the same source (report# 1208USA010653). Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram, Eye pain, Nausea, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 37 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SQ in the left arm with 0.5 ml MMR II (Lot number 1768AA, exp. date 10-NOV-2013) on 14-AUG-2012 at 07:45 a.m. No other co-suspects were reported. There were no concomitant medications. On 14-AUG-2012 (also reported as 24-AUG-2012) by 09:00 a.m., the patient was experiencing pain in her left arm, tingling, itchiness, nausea and her vision started going bad and hurting. The patient was admitted to the emergency room (ER) at unspecified hospital but no diagnosis or treatment was given besides BENADRYL. Magnetic resonance imaging (MRI) and computed tomography (CT) were performed (results not provided). At the time of the report, the patient had not recovered. The patient continued to have pain and partial loss of vision in her eye. The relatedness for pain in her left arm, tingling, itchiness, nausea, vision started going bad and hurting and partial loss of vision in her eye was unknown for MMR II. Pain in her left arm, tingling, itchiness, nausea, vision started going bad and hurting and partial loss of vision in her eye was considered to be disabling by the reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Pruritus, Visual acuity reduced, Visual impairment
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 37 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SQ in the left arm with 0.5 ml MMR II (Lot number 1768AA, exp. date 10-NOV-2013) on 14-AUG-2012 at 07:45 a.m. No other co-suspects were reported. There were no concomitant medications. On 14-AUG-2012 (also reported as 24-AUG-2012) by 09:00 a.m., the patient was experiencing pain in her left arm, tingling, itchiness, nausea and her vision started going bad and hurting. The patient was admitted to the emergency room (ER) at unspecified hospital but no diagnosis or treatment was given besides BENADRYL. Magnetic resonance imaging (MRI) and computed tomography (CT) were performed (results not provided). At the time of the report, the patient had not recovered. The patient continued to have pain and partial loss of vision in her eye. The relatedness for pain in her left arm, tingling, itchiness, nausea, vision started going bad and hurting and partial loss of vision in her eye was unknown for MMR II. Pain in her left arm, tingling, itchiness, nausea, vision started going bad and hurting and partial loss of vision in her eye was considered to be disabling by the reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Large, tender, tense erythematous patch on left thigh; warm to touch and weeping some transudate.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin tightness
Clinical narrative: Large, tender, tense erythematous patch on left thigh; warm to touch and weeping some transudate.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Needle issue, Pain
Clinical narrative: PM injection given into upper shoulder - needle stuck & was manipulated, but unable to inject vaccine. Needle removed with some resistance. Pain aching & shoot. Radiates moderate to severe pain with movement.
Age: 5.0
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Food intolerance, Functional gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a her 5 years old son who on an unknown date was vaccinated with a dose of oral ROTATEQ (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that while on oral ROTATEQ her son did not eat eggs any longer. He also had unspecified bowel issues. No treatment was given for the experience. At the time of the report, the patient had not recovered. The relatedness for patient did not eat eggs any longer and patient had unspecified bowel issues was unknown for oral ROTATEQ. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age who on "a year ago" in July 2011 was vaccinated with a dose 1 of GARDASIL (dose, route and lot # not reported). The consumer's mother, stated that her daughter took her first dose of GARDASIL a year ago and now their health care physician (HCP) was advising for her to take the 3 doses. The mother feels this would be a total of 4 doses of GARDASIL and called for asking if is this safe? The reporter did not want to provide any further information. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 years old female patient with no illness at time of vaccination, no adverse events following prior vaccination and no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (668051/1262AA) dose 3 GARDASIL, IM, left deltoid on 28-DEC-2011 at 10:16 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. There was no labs diagnostic performed. This is one of several reports from the same source. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 14 years old male patient with asthma and seasonal allergies. The patient was vaccinated with lot # (670048/0963AA) dose 2 GARDASIL, right deltoid on 03-JAN-2012 at 15:54. No other co-suspects were reported. Concomitant medications included: HAVRIX. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager and a medical assistant refers to a 5 years old female patient. The patient was vaccinated SQ with, 0.5 PROQUAD (Lot number 665512/0144Z is not a valid number for PROQUAD, expired in 27-APR-2012) on 19-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. There was no adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Pallor, Tinnitus
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a 15 years old female patient. On 10-AUG-2012, the patient was vaccinated intramuscularly with lot # (0459AE) GARDASIL exp date: 13-DEC-2014. The primary reporter stated that on 10-AUG-2012, the patient received GARDASIL, then 1.5 minutes later, she became pale, clammy, and had ringing in the ears, she had to lay down also. The patient experienced after 10 minutes. 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 registered pharmacist refers to a patient of unknown age who on 11-OCT-2011, was vaccinated with the first dose of GARDASIL and early on 08-NOV-2011, was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). It was reported that the patient had not received the third dose of GARDASIL and was not experiencing any known symptoms. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician refers to an adolescent female patient of unknown age who on an unknown date, was vaccinated with the second dose 0.5 ml dose of GARDASIL (route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that about a 1.5 weeks after vaccination on an unknown date, the patient developed a rash on her thigh and her shoulder. It was stated that it sounded that the patient's high and shoulder each had a different kind of rash. No treatment information was reported. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed a rash on her thigh and her shoulder was unknown for GARDASIL. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Food intolerance, Functional gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a her 5 years old son who on an unknown date was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that while on ROTATEQ her son did not eat eggs any longer. He also had unspecified bowel issues. No treatment was given for the experience. At the time of the report, the patient had not recovered. The relatedness for patient did not eat eggs any longer and patient had unspecified bowel issues was unknown for ROTATEQ. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a healthcare worker concerning a female patient of unknown age. On 17-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (lot #, dose and route were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date in the last year, in 2011, the patient received the first dose of GARDASIL and on 17-AUG-2012, she got the second dose. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 16 years old female patient with no illness at time of vaccination. The patient was vaccinated with lot # (668051/1262AA) dose 3 GARDASIL, IM on 30-DEC-2011 at 14:34. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received immunization that was stored at an improper range <32 degrees. There was no adverse reactions. This is one of several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 years old female patient with no illness at time of vaccination, no adverse events following prior vaccination and no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (668051/1262AA) dose 2 GARDASIL, IM, right deltoid on 28-DEC-2011 at 03:07 PM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. There was no labs diagnostic performed. This is one of several reports from the same source. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 years old female patient. The patient was vaccinated intramuscularly with a dose of lot # (672653/1860AA), 0.5 ml GARDASIL on 21-AUG-2012 into her left deltoid. No other co-suspects were reported. No concomitant medications were reported. The patient was 8 years an 2 months old at the time of administration. No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from an office manager refers to a 14 years old female patient. The patient was vaccinated with the first dose GARDASIL (lot # 667930/1561Z, exp 23-MAR-2013) on 10-MAY-2012, and the second dose on 31-JUL-2012 (lot# 0459AE, expiration date unknown). Vaccination route was not provided. It was reported that the patient developed plantar warts at an unknown date after either the first or second dose of GARDASIL. The patient present status was unknown. The patient's mother had called physician's office to seek medical attention. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a mother's consumer refers to approximately 4 months old male patient. On 1997, the patient was vaccinated with dose first, 0.5 ml MMR II. On 2001, the patient was vaccinated with dose second, 0.5 ml MMR II. On 2012, the patient was vaccinated with dose third, 0.5 ml MMR II. The patient's mother said that her son had received th MMR II vaccination three time since 1997. The patient received the vaccination in 1907, 2001 and 2012. No more information provided. At the time of the report the patient outcome was unknown. Action taken with MMR II was reported as discontinued. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age with no pertinent medical history. On 07-AUG-2012, the patient was vaccinated subcutaneously with, 0.65 ml ZOSTAVAX (lot # not reported). There was no concomitant medication. The pharmacist stated that a patient received ZOSTAVAX and on unspecified date, she had 2 tiny red spots 4 inches away from the injection site, injection site was red and the size of a quarter, and itching at the injection site. The patient sought medical attention by having a pharmacy visit. No treatment for the events was given. Laboratory and diagnostics was not performed. At the time of the report, the outcome of injection site red and the size of a quarter, itching at the injection site and 2 tiny red spots 4 inches away from the injection was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated 2 doses of RECOMBIVAX HB in one day. The date, lot# and route was not provided. The outcome of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on 20-AUG-2012, which had expired 18-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's sister on 24-APR-2012 at 10:00 AM, was vaccinated with a third dose of VARIVAX (Merck) in right upper arm, lot number reported as "143AA" (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an approximately 27-APR-2012 (3 days later), the patient's sister developed same rash (no vaccines) (reported as rash on trunk, rash not painful). No treatment information was reported. At the time of report, the outcome of the patient's event was unknown. The relatedness for the patient's event was not reported for VARIVAX (Merck). This is one of several reports from the same source. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning an 11 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot # unspecified). The nurse mentioned that on 06-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of VARICELLA (Merck) (lot # unspecified). The nurse mentioned that on 21-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 43 day old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 02-MAR-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 10 month old patient who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Merck) (lot# unspecified). The nurse mentioned that on 04-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 9 month old patient with on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 17-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 8 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot # not unspecified). The nurse mentioned that on 10-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested,
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. Medical assistant reported that she administered a dose of M-M-R II on 31-JUL-2012 (from lot 666685/0742Z which had expired on 19-MAY-2012). No adverse effect was reported. No treatment information was reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 67 years old female patient with a history of allergies and no known drug reactions. On 08-AUG-2012, the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX. The pharmacist reported that on 09-AUG-2012 the patient experienced redness and itchiness at injection site after receiving ZOSTAVAX the patient sought medical attention by calling the pharmacist. No treatment for the adverse event was given. Laboratory and diagnostics were not performed. The outcome of itchiness at injection site and redness at injection site was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report an office manager refers to a pediatric patient of unknown age and gender who was vaccinated with the first dose of VAQTA on 09-FEB-2012. The office manager mentioned that the patient was vaccinated with second dose of VAQTA early on 01-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. Physician came to the phone and provided the patient's name, authorization to contact him for more information and that this was a pediatric patient. The patient was not experiencing any known symptoms. No treatment information was reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse concerning her 58 year old physician husband with no drug reactions or allergies and a history of positive tuberculosis skin test in 1979 who on 13-AUG-2012 in the morning, was vaccinated IM in the left deltoid with 0.5 ml dose of PNEUMOVAX 23 (lot # 1947AA, exp 20-OCT-2012). No concomitant medications were reported. A few hours later, the site of the injection was sore. By 7:30 PM that evening, the patient was pale, weak, felt feverish, had chills, and the injection site had a tennis ball-sized area of severe soreness, redness, swelling and was hot to touch. The patient self-treated with ADVIL. In the middle of the night on 14-AUG-2012, "the fever broke and he was sweating". That morning, the patient "felt washed out" but the injection site redness was resolved. At the time of the report, the patient's outcome for the site of the injection was sore/injection site had a tennis ball-sized area of severe soreness, feels washed out, hot to touch at the injection site, swelling at injection site, had chills, felt feverish, weak, pale and sweating were recovering/resolving. The relatedness for the site of the injection was sore/injection site had a tennis ball-sized are of severe soreness, feels washed out, hot to touch at the injection site, swelling at injection site, redness at injection site, had chills, felt feverish, weak, pale and sweating is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pallor, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse concerning her 58 year old physician husband with no drug reactions or allergies and a history of positive tuberculosis skin test in 1979 who on 13-AUG-2012 in the morning, was vaccinated IM in the left deltoid with 0.5 ml dose of PNEUMOVAX 23 (lot # 1947AA, exp 20-OCT-2012). No concomitant medications were reported. A few hours later, the site of the injection was sore. By 7:30 PM that evening, the patient was pale, weak, felt feverish, had chills, and the injection site had a tennis ball-sized area of severe soreness, redness, swelling and was hot to touch. The patient self-treated with ADVIL. In the middle of the night on 14-AUG-2012, "the fever broke and he was sweating". That morning, the patient "felt washed out" but the injection site redness was resolved. At the time of the report, the patient's outcome for the site of the injection was sore/injection site had a tennis ball-sized area of severe soreness, feels washed out, hot to touch at the injection site, swelling at injection site, had chills, felt feverish, weak, pale and sweating were recovering/resolving. The relatedness for the site of the injection was sore/injection site had a tennis ball-sized are of severe soreness, feels washed out, hot to touch at the injection site, swelling at injection site, redness at injection site, had chills, felt feverish, weak, pale and sweating is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of VARIVAX (lot number unknown) on 18-JUL-2012. The VARIVAX (merck) had an expiration date of 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. It was unspecified if the patient has sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route was not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient received ZOSTAVAX that did not look normal in terms of the lyophilized powder. No adverse event reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Rash locally - no treatment required.
Age: 1.02
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash locally - no treatment required.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Blood calcium increased, Blood magnesium increased, Blood phosphorus normal, Blood urea normal, Chest X-ray normal
Clinical narrative: Pt started feeling dizzy 4 hrs after vaccines administration. Pt was indoor and mother noticed pt becoming pale and passing out for about 4 seconds. Lethargic period 10 - 15 mins after syncopal episode.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Crying, Cyanosis, Hypotonia, Laboratory test, Loss of consciousness
Clinical narrative: Pt started feeling dizzy 4 hrs after vaccines administration. Pt was indoor and mother noticed pt becoming pale and passing out for about 4 seconds. Lethargic period 10 - 15 mins after syncopal episode.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Pallor, Platelet count normal, Syncope, Vomiting, White blood cell count normal
Clinical narrative: Pt started feeling dizzy 4 hrs after vaccines administration. Pt was indoor and mother noticed pt becoming pale and passing out for about 4 seconds. Lethargic period 10 - 15 mins after syncopal episode.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Dizziness, Lethargy, Loss of consciousness, Pallor, Syncope
Clinical narrative: Pt started feeling dizzy 4 hrs after vaccines administration. Pt was indoor and mother noticed pt becoming pale and passing out for about 4 seconds. Lethargic period 10 - 15 mins after syncopal episode.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood glucose, Laboratory test, Metabolic function test, Mononucleosis heterophile test, Musculoskeletal discomfort
Clinical narrative: Fever up to 102. Strange sensations of "feathers and ice" of muscles. Vomiting.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pyrexia, Thyroxine, Vomiting
Clinical narrative: Fever up to 102. Strange sensations of "feathers and ice" of muscles. Vomiting.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Laboratory test
Clinical narrative: This spontaneous report was received from a physician refers to a 1 year old male patient without any medical history and drug reactions/allergies. The patient was vaccinated SQ with single 0.5 ml dose of M-M-R II (lot# not reported) on 20-AUG-2012. Second suspect medications included VARIVAX (Merck) (dose, route, lot# not reported) and concomitant therapy included PREVNAR 13 (dose, route, lot# not reported) on 20-AUG-2012. On 22-AUG-2012 the patient developed a febrile seizure after concomitant administration of VARIVAX (Merck) and M-M-R II. The patient was taken to the ER for the event, and given ROCEPHIN. Unspecified test was performed (result not reported). The AE was improved. At the time of reporting, the patient had recovered on an unspecified date. Upon internal review, febrile seizure was considered as an other important medical event. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Pallor, Vomiting
Clinical narrative: After vaccines were given infant became very pale and lethargic. Vomited after vaccines. Infant was monitored for O2 and heart rate. Provider checked lungs and refluxes. Infant ok after 1 hour 15 min observation. Went home.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Cellulitis, Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: 7/26/12 Pt seen NP Dx with cellulitis. Rash on left upper arm - described as erythematous macular, painful, confluent in arrangement. Warm and exquisitely tender to palpation 3" x 3" area. No discharge or bleeding. Told to use hot compress on site, continue ibuprofen, Rx'd KEFLEX qid x 10d. Seen at hospital and given IV antibiotics.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Rash macular
Clinical narrative: 7/26/12 Pt seen NP Dx with cellulitis. Rash on left upper arm - described as erythematous macular, painful, confluent in arrangement. Warm and exquisitely tender to palpation 3" x 3" area. No discharge or bleeding. Told to use hot compress on site, continue ibuprofen, Rx'd KEFLEX qid x 10d. Seen at hospital and given IV antibiotics.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Laboratory test
Clinical narrative: 7/26/12 Pt seen NP Dx with cellulitis. Rash on left upper arm - described as erythematous macular, painful, confluent in arrangement. Warm and exquisitely tender to palpation 3" x 3" area. No discharge or bleeding. Told to use hot compress on site, continue ibuprofen, Rx'd KEFLEX qid x 10d. Seen at hospital and given IV antibiotics.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP, TYP, PPV
Symptoms: Local reaction, Pyrexia
Clinical narrative: 7/26/12 Pt seen NP Dx with cellulitis. Rash on left upper arm - described as erythematous macular, painful, confluent in arrangement. Warm and exquisitely tender to palpation 3" x 3" area. No discharge or bleeding. Told to use hot compress on site, continue ibuprofen, Rx'd KEFLEX qid x 10d. Seen at hospital and given IV antibiotics.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis reaction requiring hospitalization.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Administering FLUZONE in (L) deltoid muscle & vaccine liquid squirted back out, the injection did not go in.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Patient developed low grade fever on 12SEP2011 with no associated signs & symptoms. Fever started a few hours after receiving her third GARDASIL shot. This resolved spontaneously the same day.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood creatinine increased, Kidney transplant rejection
Clinical narrative: Patient was enrolled in the GARDASIL vaccine study on 12JAN12 a month after receiving the second shot of GARDASIL, his creatinine was found to be elevated. Work-up done and found to have developed acute kidney rejection.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain & swelling on injection site, mild in severity on his first 2 shots of GARDASIL. There were no accompanying sign & symptoms. Events resolved in a day or two spontaneously. First vaccine given on 01APR2011 while the second vaccine was given on 07JUN2011. This was part of the GARDASIL vaccine study.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: After vaccine, pt became "a little lightheaded". Pt. was given TDAP (BOOSTRIX) pt asked to remain seated for approx 10-15 min. Dr came in to evaluate pt. before leaving. Sxs lasted approx 15 min.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Per mom: Itchy, red rash under neck, on abdomen, under arms and back of knees. Appeared within 24hrs after vaccines administered. Pt saw PCP who prescribed rx for reaction.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram normal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 15 July 2009 an elevated Troponin, central laboratory level of 0.15 ng/ml (also with a reported date of 20 July 2009). The subject had a rapid Troponin I level on 15 July 2009 that was within normal limits (negative). A repeat Troponin on 20 July 2009 was < 0.10 ng/mL and an ECG on the same date was normal "Repeat test normal". The subject had no concomitant medications. No treatments were reported. No other reported visits, no chest x-ray, no echo and no labs. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered on 20 July 2009. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 15 July 2009 an elevated Troponin, central laboratory level of 0.15 ng/ml (also with a reported date of 20 July 2009). The subject had a rapid Troponin I level on 15 July 2009 that was within normal limits (negative). A repeat Troponin on 20 July 2009 was < 0.10 ng/mL and an ECG on the same date was normal "Repeat test normal". The subject had no concomitant medications. No treatments were reported. No other reported visits, no chest x-ray, no echo and no labs. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered on 20 July 2009. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 23 September 2009 an elevated Troponin, central laboratory level of 0.12 ng/ml. The subject had a rapid Troponin I level on 23 September 2009 that was within normal limits (negative). No ECG was performed. No other reported visits, no chest x-ray, no echo and no labs. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was not reported. According to the investigator, the event of elevated Troponin was considered an other important event and was possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Electrocardiogram normal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 08 December 2009 an elevated Troponin, central laboratory level of 0.11 ng/ml. The subject had a rapid Troponin I level on 08 December 2009 that was within normal limits (negative). An ECG was performed on 11 December 2009 which was normal. A repeat Troponin on 11 December 2009 was < 0.10 ng/mL reported as normal. On study day 14, the subject had a left knee x-ray due to atraumatic pain that was within normal limits (WNL). The subject had no concomitant medications, no chest x-ray, no echo and no labs. No further information was available at the time of the report. The subject's outcome was not reported. According to the investigator, the event of elevated Troponin was considered an other important event and was possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: X-ray limb normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 08 December 2009 an elevated Troponin, central laboratory level of 0.11 ng/ml. The subject had a rapid Troponin I level on 08 December 2009 that was within normal limits (negative). An ECG was performed on 11 December 2009 which was normal. A repeat Troponin on 11 December 2009 was < 0.10 ng/mL reported as normal. On study day 14, the subject had a left knee x-ray due to atraumatic pain that was within normal limits (WNL). The subject had no concomitant medications, no chest x-ray, no echo and no labs. No further information was available at the time of the report. The subject's outcome was not reported. According to the investigator, the event of elevated Troponin was considered an other important event and was possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Electrocardiogram normal, Gastrooesophageal reflux disease, Injection site pain, Pyrexia
Clinical narrative: A 22-year-old male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 25 March 2010 (also with a reported date of 01 April 2010) an elevated central laboratory Troponin level of 0.13 ng/ml and on 13 April 2010 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 13 April 2010. The subject had a rapid Troponin I level on 25 March 2010 that was within normal limits (negative). On 13 April 2010, the subject had a normal ECG reading. On 13 March 2010 (also with a reported date of 25 March 2010), the subject experienced AEs including intermittent fevers (recovered 15 March 2010), soreness on right smallpox site (ongoing), acid reflux (recovered 24 March 2010), and painful joints left and right legs "both legs" (ongoing). The subject's concomitant medications included ALEVE and TUMS. No further information was available at the time of the report. The subject's outcome was not recovered. According to the Investigator, the event of elevated central lab Troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.