chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin reaction, Skin warm
Clinical narrative: Pt describes a localized skin reaction as a 2" by 1" area that was raised and hot.  The next morning her "entire upper arm was raised to a 5" by 5" raised, itchy and burning hot area".  She also reports feeling "light-headed".   Today, 4/7/14, she reports the site is not swollen or hot just "very itchy" with a "light bruise".
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Rash at the site of injection. The doctor described it as a cellulitis rash.  Started small and is now from elbow to shoulder.
Age: 29.0
Sex: M
Vaccine: FLU3, HEP, HEPA, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 22.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash on left anterolateral thigh, possible adverse reaction to band aid or vaccines.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to a 1 year old infant patient (gender unknown). On 20-JUL-2013, the 1 year old patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot #, expiry not reported), intramuscularly. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed hives all over arms and legs three hours after vaccine. Itchy. No fever. No other symptoms or side effects reported.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Blood test, Computerised tomogram, Computerised tomogram head, Dizziness, Fall
Clinical narrative: Within about 5-10 min felt nauseated and dizzy fainted and fell on the floor at Dr. office. Ambulance came took her to Hospital. (Did blood work and CT of head and back).
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Nausea, Syncope
Clinical narrative: Within about 5-10 min felt nauseated and dizzy fainted and fell on the floor at Dr. office. Ambulance came took her to Hospital. (Did blood work and CT of head and back).
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy kidney abnormal, Blood creatinine increased, Cryoglobulinaemia, Glomerulonephritis membranoproliferative, Hypersensitivity
Clinical narrative: Baseline health till 2 days after immunization. He got flu shot 10/2013 by outside provider. Shortly got sick developed rash and persistent leg swelling. Hosp 11/15 - 11/23/2013 outside hosp for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. Cr 2.5. Limited response to prednisone trial - readmit 1/3 - 1/10/2014 and has pulmonary/renal symptom and positive RF.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Local swelling, Lung disorder, Malaise, Protein urine present, Rash
Clinical narrative: Baseline health till 2 days after immunization. He got flu shot 10/2013 by outside provider. Shortly got sick developed rash and persistent leg swelling. Hosp 11/15 - 11/23/2013 outside hosp for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. Cr 2.5. Limited response to prednisone trial - readmit 1/3 - 1/10/2014 and has pulmonary/renal symptom and positive RF.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Renal disorder, Renal failure acute, Rheumatoid factor positive, Vasculitis
Clinical narrative: Baseline health till 2 days after immunization. He got flu shot 10/2013 by outside provider. Shortly got sick developed rash and persistent leg swelling. Hosp 11/15 - 11/23/2013 outside hosp for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. Cr 2.5. Limited response to prednisone trial - readmit 1/3 - 1/10/2014 and has pulmonary/renal symptom and positive RF.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy kidney abnormal, Blood creatinine increased, Cryoglobulinaemia, Glomerulonephritis membranoproliferative, Local swelling
Clinical narrative: Baseline health till 2 days after immunization. He got flu shot 10/2013 by outside provider. Shortly got sick developed rash and persistent leg swelling. Hosp 11/15 - 11/23/2013 outside hosp for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. Cr 2.5. Limited response to prednisone trial - readmit 1/3 - 1/10/2014 and has pulmonary/renal symptom and positive RF.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Protein urine present, Rash, Renal failure acute, Rheumatoid factor positive
Clinical narrative: Baseline health till 2 days after immunization. He got flu shot 10/2013 by outside provider. Shortly got sick developed rash and persistent leg swelling. Hosp 11/15 - 11/23/2013 outside hosp for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. Cr 2.5. Limited response to prednisone trial - readmit 1/3 - 1/10/2014 and has pulmonary/renal symptom and positive RF.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Type IV hypersensitivity reaction, Vasculitis
Clinical narrative: Baseline health till 2 days after immunization. He got flu shot 10/2013 by outside provider. Shortly got sick developed rash and persistent leg swelling. Hosp 11/15 - 11/23/2013 outside hosp for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. Cr 2.5. Limited response to prednisone trial - readmit 1/3 - 1/10/2014 and has pulmonary/renal symptom and positive RF.
Age: 61.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Abdominal pain, Activities of daily living impaired, Adverse drug reaction, Helicobacter infection, Hyperaesthesia
Clinical narrative: Following the administration of a Hepatitis B and a Zoster vaccine (both administered 9/3/2013), both in the left deltoid, the patient developed pain and hyperesthesia in a dermatomal distribution in the (L) rib region that was felt to be similar to a post-herpetic neuralgia. There was, however, no vesicular rash or skin eruption preceding the pain. This was first reported by the patient 9/30/13 - it is an ongoing issue. The patient does not recall developing any kind of rash preceding the skin discomfort. Since the development of the pain, the patient has tried gabapentin with nortriptyline, tramadol, and capsaicin cream without relief. The symptoms have steadily become worse, and the patient is unable to do activities he normally enjoys. The patient had a neurology consult in November 2013 resulted in a diagnosis of neuropathic pain.
Age: 61.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Musculoskeletal chest pain, Myalgia, Neuralgia, Pain of skin, Post herpetic neuralgia
Clinical narrative: Following the administration of a Hepatitis B and a Zoster vaccine (both administered 9/3/2013), both in the left deltoid, the patient developed pain and hyperesthesia in a dermatomal distribution in the (L) rib region that was felt to be similar to a post-herpetic neuralgia. There was, however, no vesicular rash or skin eruption preceding the pain. This was first reported by the patient 9/30/13 - it is an ongoing issue. The patient does not recall developing any kind of rash preceding the skin discomfort. Since the development of the pain, the patient has tried gabapentin with nortriptyline, tramadol, and capsaicin cream without relief. The symptoms have steadily become worse, and the patient is unable to do activities he normally enjoys. The patient had a neurology consult in November 2013 resulted in a diagnosis of neuropathic pain.
Age: 61.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Rib fracture, Skin discomfort
Clinical narrative: Following the administration of a Hepatitis B and a Zoster vaccine (both administered 9/3/2013), both in the left deltoid, the patient developed pain and hyperesthesia in a dermatomal distribution in the (L) rib region that was felt to be similar to a post-herpetic neuralgia. There was, however, no vesicular rash or skin eruption preceding the pain. This was first reported by the patient 9/30/13 - it is an ongoing issue. The patient does not recall developing any kind of rash preceding the skin discomfort. Since the development of the pain, the patient has tried gabapentin with nortriptyline, tramadol, and capsaicin cream without relief. The symptoms have steadily become worse, and the patient is unable to do activities he normally enjoys. The patient had a neurology consult in November 2013 resulted in a diagnosis of neuropathic pain.
Age: 47.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: Pain over the left shoulder and deltoid muscle since he received the Tdap vaccine per patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Pt. called 4/3/14, (1 month post vax) to report an area of rash, redness, itch at site of injection. Unsure when it began. Has not seen a doctor as yet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. The patient's medical history included history of shingles. On 17-MAR-2014 the patient was vaccinated with ZOSTAVAX lot # J011338, dose 1, subcutaneous in the left arm. On 21-MAR-2014 the patient called the pharmacy to report she developed redness and soreness at the injection site. The patient was advised to apply cold compresses and take BENADRYL. The outcome of redness at injection site and soreness at the injection site was reported as recovering/resolving. The causal relationship was not provided. No consent for follow up. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unspecified demographics. On 22-JAN-2008, the patient was vaccinated with ZOSTAVAX, dose, frequency was unspecified. Concomitant medication was unspecified. Approximately on an unknown date in 2014 (reported as recently), the patient was recently seen in the office and had developed shingles. No product quality complaint was involved. The outcome of event shingles was unknown. The reporters causality for the event shingles with the therapy of ZOSTAVAX was not reported. No further information was provided. 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 pharmacist refers to a patient of unknown age and gender. On 01-APR-2014 the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, lot# and expiration date not reported) exposed to 19F for 30 minutes (date of exposition was unspecified). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Patients medical history was unspecified. On 02-APR-2014 (also reported as yesterday), the patient received a dose of PNEUMOVAX 23, (dose, frequency and route of administration were unspecified) in a unspecified hospital setting. Concomitant medication was unspecified. Approximately in April 2014, the patient has developed lump and redness on her arm at the injection site with the therapy of PNEUMOVAX 23 was not reported. No other information was available at the time of report. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Aphagia, Asthenia, Fatigue, Grip strength decreased
Clinical narrative: Vaccine given at 10 AM - later that afternoon she started feeling wiped out, couldn't walk, couldn't use hands, weak, couldn't eat, no SOB. Rested all weekend feels better now.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 8 week old patient (unknown gender). On 03-APR-2014 the patient was vaccinated with the first dose of ROTATEQ (Lot # reported as H017721 and exp date 01-APR-2014, 2 ml, oral). No adverse effect reported. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure that occurred on 4/2/14. No treatment except for Ibuprofen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Rash macular, Skin warm, Tenderness
Clinical narrative: Grapefruit sized induration.  Splotchy, warm, red, and tender.
Age: 50.0
Sex: F
Vaccine: FLUR3
Symptoms: Arthralgia, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Towards the end of December, patient started feeling generalized pain in her fingers. 50 yo female childbirth educator presents to Occupational Health with c/o "pain in fingers after receiving a shot, worsening with movement." She stated, symptoms occurred 30 days after giving the flu vaccine. On 11/22/13, employee was convinced to obtain the flu vaccine (Flublok) after being exempt in 2012 due to pain she experienced in her finger she attributed to receiving the flu vaccine in 2011. She stated she experiences an "arthritic - like" reaction everytime she has received the flu vaccine. She has received the flu vaccine 3 time. The only time she has not experienced this "arthritic - like" reaction was in 2012 when she did not receive the vaccine.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Injection site pain, Irritability, Pyrexia
Clinical narrative: Pain and soreness at injection site (both thighs).  Fever ranging from 100 - 102.5 for approx. 2 days.  Fussiness for approx 3-4 days.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash pruritic
Clinical narrative: Circular rash in varying sizes started around ankles and wrists. Has spread to tops of feet and up legs to knees. Rash is itchy but does not have blisters (yet) as of 4/8/14. No rash on torso or at injection site.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Case number PHEH2014US006809 is an initial spontaneous report from the consumer received on 02 Apr 2014. This report refers to a 18-year-old male patient. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date in Oct 2013. On 30 Mar 2014, he experienced flu symptoms. On 01 Apr 2014, lab test showed that swab was positive for influenza A. It was reported that there was a failure of flu vaccine. He was treated with TAMIFLU with improvement in 24 hours. The seriousness and causality of the events were not reported.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Angioedema, Crying, Injection site pain, Swelling face
Clinical narrative: Crying for 3 hours, right thigh is tender. Right facial swelling and angioedema with excellent response to 1ml of BENADRYL prior to visit. Persistent (3 1/2 hrs later) asymmetrical growth with crying (lower (R) lip not as noticeable).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cold sweat, Palpitations, Skin warm
Clinical narrative: Client BP went up, she had palpitations with warm clammy skin BP went from 136/80 to 170/98.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Pain in extremity
Clinical narrative: (L) arm pain s/p tetanus vaccine (Tdap) that triggered migraines.
Sex: U
Vaccine: MMR
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from an other health professional refers to unknown number of patients of unknown age. On an unkown date the patients was vaccinated with the first dose of M-M-R II (lot # not reported) (dose and route not reported). The reproter reported "they did not feel well after receiving their 1st dose of M-M-R II". The outcome of the event was unknown. Causality assessment was not provided. It was unknown if the patients sought medical attention. Additional information is not expected.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Pt. developed redness and mild swelling patch on left thigh - it was non-indurated and blanches on pressure. There is no evidence of infection. It is a little warm to touch. TX: warm compresses, BENADRYL PRN, skin care v close observation, signs of cellulitis to start antibiotics if needed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture positive, Varicella, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 60 year old female patient. The patient's current conditions included rheumatoid arthritis and the patient was on methotrexate, stopped 3 months before vaccination. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient got chickenpox on her face, the patient was seen in the office on December-2013, with vesicles on the face, vesicles were cultured and found to be varicella. At the time of the report the patient was recovered from varicella, the patient recovered on an unknown date. The patient went to the physician's office for medical attention and varicella was treated with Famciclovir at an unspecified date and the patient started on an unspecified biological medication for rheumatoid arthritis approximately in February 2014, 2 months after the patient was seen at the physician's office. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain, Surgery
Clinical narrative: Pt was admitted to hospital due to reaction/infection to the vaccine site.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Vaccination site infection
Clinical narrative: Pt was admitted to hospital due to reaction/infection to the vaccine site.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: DEATH, WITHIN 24 HOURS.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: DEATH, WITHIN 24 HOURS.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Asphyxia, Bed sharing, Death
Clinical narrative: DEATH, WITHIN 24 HOURS.
Age: 1.19
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever followed by a seizure.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Aggression, Anxiety, Convulsion, Dizziness, Dysarthria
Clinical narrative: This spontaneous report as received from a consumer refers to a 16 year old female patient with learning disabilities with maths and science and Drug allergies/reactions to amoxicillin (manufacturer unknown). Approximately in 2012 (reported as two years ago) the patient was vaccinated with 3 doses of GARDASIL. On 31-JAN-2014 the consumer reported that her daughter had changed. On 31-JAN-2014 the patient started to become dizzy, had convulsions and pseudo seizures. For these adverse reactions the patient had to go two hospital (3 times total) and had to stay there for a couple of days. Approximately in March 2014 (reported as couple weeks ago) the patient experienced mental change. The patient started to become "upset, lashing out at people, repeating herself, having high anxiety, wanting to speak constantly, verbally abusive, having suicidal thoughts, wants to slit her throat and stuck her fingers down her throat to make herself throw up". The patient also started to slur her speech asking her mother if she had a "stroke" and wanted to know if she had "cancer". The patient was admitted to the hospital and then was transferred to another hospital. The reporter stated that the patient was getting beat up by the other patients, but it might be (the patient) provoking them. The outcome was reported as not recovered/not resolved. The reporter believes that GARDASIL had caused the events in her daughter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Emotional distress, Logorrhoea, Mental status changes, Psychogenic seizure, Repetitive speech
Clinical narrative: This spontaneous report as received from a consumer refers to a 16 year old female patient with learning disabilities with maths and science and Drug allergies/reactions to amoxicillin (manufacturer unknown). Approximately in 2012 (reported as two years ago) the patient was vaccinated with 3 doses of GARDASIL. On 31-JAN-2014 the consumer reported that her daughter had changed. On 31-JAN-2014 the patient started to become dizzy, had convulsions and pseudo seizures. For these adverse reactions the patient had to go two hospital (3 times total) and had to stay there for a couple of days. Approximately in March 2014 (reported as couple weeks ago) the patient experienced mental change. The patient started to become "upset, lashing out at people, repeating herself, having high anxiety, wanting to speak constantly, verbally abusive, having suicidal thoughts, wants to slit her throat and stuck her fingers down her throat to make herself throw up". The patient also started to slur her speech asking her mother if she had a "stroke" and wanted to know if she had "cancer". The patient was admitted to the hospital and then was transferred to another hospital. The reporter stated that the patient was getting beat up by the other patients, but it might be (the patient) provoking them. The outcome was reported as not recovered/not resolved. The reporter believes that GARDASIL had caused the events in her daughter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Self-induced vomiting, Suicidal ideation, Verbal abuse
Clinical narrative: This spontaneous report as received from a consumer refers to a 16 year old female patient with learning disabilities with maths and science and Drug allergies/reactions to amoxicillin (manufacturer unknown). Approximately in 2012 (reported as two years ago) the patient was vaccinated with 3 doses of GARDASIL. On 31-JAN-2014 the consumer reported that her daughter had changed. On 31-JAN-2014 the patient started to become dizzy, had convulsions and pseudo seizures. For these adverse reactions the patient had to go two hospital (3 times total) and had to stay there for a couple of days. Approximately in March 2014 (reported as couple weeks ago) the patient experienced mental change. The patient started to become "upset, lashing out at people, repeating herself, having high anxiety, wanting to speak constantly, verbally abusive, having suicidal thoughts, wants to slit her throat and stuck her fingers down her throat to make herself throw up". The patient also started to slur her speech asking her mother if she had a "stroke" and wanted to know if she had "cancer". The patient was admitted to the hospital and then was transferred to another hospital. The reporter stated that the patient was getting beat up by the other patients, but it might be (the patient) provoking them. The outcome was reported as not recovered/not resolved. The reporter believes that GARDASIL had caused the events in her daughter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Heart rate increased
Clinical narrative: Weakness, fast heartbeat, and dizziness.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 1.25
Sex: M
Vaccine: HIBV, IPV
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: Onset of fever, approx 101-102 F; Lethargy in the evening; Tired.
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. A few weeks ago, on a Friday (in 2014) the patient was vaccinated with PNEUMOVAX 23 (lot # not reported) and Tdap (lot# not reported) on the same visit but in separate arms (dose and route not reported). The patient called into the physician's office on Monday (24-MAR-2014) reporting he had an erythematous arm and local injection site swelling. The patient was seen at the physician's office on an unspecified date but "no treatment was given". The reaction resolved over time and the patient was fully recovered (in March 2014). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. No data about patient's demographics or medical history provided. On an unspecified date in August 2008 the patient was given the first dose of GARDASIL; dose, route and lot # not reported. The second dose was administered on an unknown date in December 2008, route and lot # not reported. On 26-MAR-2014 the patient was in the office to have the third dose of GARDASIL administered; dose, route and lot # not reported. There were no adverse effects to report. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On 24-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot # J013138; expiry date: 17-JAN-2015) one single shot via "injection". On an unspecified date in March 2014 the patient experienced injection site rashes and that were warm and spread across her arms after vaccination. The rash resolved itself on 28-MAR-2014 and the patient was completely recovered. The patient had not sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On 03-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J013138; expiry date: 17-JAN-2015) one single shot via "injection". On an unspecified date after vaccination the patient experienced injection site rashes and that were warm and spread across her arms. The patient was still not recovered the rash was still present. The patient had not sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 21 year old female patient. On 02-JAN-2014, the patient received first dose of GARDASIL (dose and frequency not reported). On 13-MAR-2014, the patient was vaccinated with her second dose of GARDASIL (dose and frequency not reported). On 25-MAR-2014, the patient reported to the practice that she was pregnant. The patient sought medical attention by consulting her physician. No adverse effect has been observed or reported. The nurse stated that the administration of the third dose of GARDASIL would be deferred until the patient would deliver her infant. The patient had her LMP (Last Menstrual Period) on 18-FEB-2014. An EDD (Estimated Date of Delivery) was 25-NOV-2014. The patient was exposed to GARDASIL during the first trimester of pregnancy. The pregnancy outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Apgar score, Foetal exposure during pregnancy, Intensive care, Neonatal aspiration, Premature baby
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 21 year old female patient. On 02-JAN-2014, the patient received first dose of GARDASIL (dose and frequency not reported). On 13-MAR-2014, the patient was vaccinated with her second dose of GARDASIL (dose and frequency not reported). On 25-MAR-2014, the patient reported to the practice that she was pregnant. The patient sought medical attention by consulting her physician. No adverse effect has been observed or reported. The nurse stated that the administration of the third dose of GARDASIL would be deferred until the patient would deliver her infant. The patient had her LMP (Last Menstrual Period) on 18-FEB-2014. An EDD (Estimated Date of Delivery) was 25-NOV-2014. The patient was exposed to GARDASIL during the first trimester of pregnancy. The pregnancy outcome was unknown. 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 registered nurse refers to unspecified patients of unknown ages and genders. The nurse reported that on unknown dates, unknown number of patients might have been vaccinated with doses of VARIVAX (Merck) (dose, lot #, expiration date and route of administration not reported) that had multiple excursions. No adverse effects were reported. Follow up information has been received from another registered nurse who reported an unspecified patient was in the office at the time of the report and was about to be administered (it was not reported whether the patient received the vaccine) a dose of VARIVAX (Merck) (dose not reported, lot # J005726 and expiration date 08-MAY-2015) which was stored outside of recommended temperature range as noted in prescribing information. Follow up information has been received from the registered nurse who stated that she was not in the office when the temperature excursion occurred. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 8 unspecified patients. On an unknown date the patients were vaccinated with PROQUAD (Merck) (lot # J015312, expiry date: 03-JUN-2015) (dose was not reported) which was stored improperly, exposed to 42F for 4 weeks. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown ages and genders. The nurse reported that on unknown dates, unknown number of patients might have been vaccinated with doses of PNEUMOVAX 23 (dose, lot number, expiration date and route of administration not reported) that had multiple excursions. No adverse effects were reported. Follow up information has been received from another registered nurse who stated that she did not had any additional information regarding PNEUMOVAX 23. She was not in the office when the temperature excursion occurred. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient C/O pain, tender to touch at injection site with redness around the area.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Sudden onset of rash in upper and lower body. No fever with the onset of rash.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chest X-ray normal, Cough, Fatigue, Malaise, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician and nurse via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # J000429. Other suspect therapies included AFLURIA (case number 1403USA014063) and PNEUMOVAX 23 (lot # J007059). No other concomitant medications were reported. On an unknown date following the administration of all the three vaccines the patient was coughing "so much her lungs hurt", reported feeling fatigued, "felt sick" and developed pain in her arm. Chest X-ray showed negative result. The patient sought medical attention by contacing the office. The outcome of coughing "so much her lungs hurt", reported feeling fatigued, "felt sick" and developed pain in her arm was not reported. Causality assessment was not provided. This case is linked to same patient link case # 1403USA014063 and same reporter link case # 1403USA014064. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pleuritic pain
Clinical narrative: This spontaneous report as received from a physician and nurse via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # J000429. Other suspect therapies included AFLURIA (case number 1403USA014063) and PNEUMOVAX 23 (lot # J007059). No other concomitant medications were reported. On an unknown date following the administration of all the three vaccines the patient was coughing "so much her lungs hurt", reported feeling fatigued, "felt sick" and developed pain in her arm. Chest X-ray showed negative result. The patient sought medical attention by contacing the office. The outcome of coughing "so much her lungs hurt", reported feeling fatigued, "felt sick" and developed pain in her arm was not reported. Causality assessment was not provided. This case is linked to same patient link case # 1403USA014063 and same reporter link case # 1403USA014064. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored ROTATEQ were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored RECOMBIVAX HB were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored VAQTA (dose, route and lot number not reported) were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored PNEUMOVAX23 (dose, route and lot number not reported) multidose vials were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports form the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored GARDASIL (dose, route and lot number not reported) multidose vials were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) (also reported as healthcare professional) refers to unspecified patients of unknown age. The healthcare reported that improperly stored M-M-R II (dose, route and lot number not reported) multidose vials were administered to an unspecified number of patients, demographics unspecified. No adverse effects were reported. It was unspecified if patients sought medical attention. This is one of several reports from the same reproter. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Crying, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Crying, itching, Rash all over body (pubic area and up stomach and back, face/forehead), fever of 101.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left arm hurt severely more than typical flu shot I've had in past.
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Induration, Pyrexia, Skin warm, Swelling
Clinical narrative: Fever, red raised area is hrad, warm and tender to touch, looks like a " bug bite".
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tenderness
Clinical narrative: Fever, red raised area is hrad, warm and tender to touch, looks like a " bug bite".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Per call from mom, left thigh red swollen, temp of 101 degrees. Advised cold compress - ibuprofen. Call 4/3 a.m. if no improvement. Mom called 4/3 a.m. - swelling increased - child acts OK but mom is concerned. Scheduled appt to see Dr - Dr examined, reassurance given.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No demographics or medical data of the patient were provided. On an unknown date the patient was vaccinated with GARDASIL dose number 1, dosage, route and site of administration, indication, lot# not reported. On an unspecified date, 18 hours after vaccination, the patient developed unspecified rash. The patient probably did seek medical attention. The outcome of rash is unknown. Relatedness between use of the GARDASIL and the reported adverse event was unknown. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 85 year old female patient. In 2006 the patient was vaccinated with ZOSTAVAX. Dose number, lot number, expiry date, route of administration and anatomical location of the vaccination were not reported. Concomitant therapies included a LIPITOR, metoprolol, XANAX and FLONASE. On 05-MAR-2014 the patient experienced shingles at which date the patient visited the office of the reporting medical assistant. The patient was treated with VALTREX and gabapentin for the event. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients had received improperly stored GARDASIL, PEDVAXHIB and ROTATEQ. No symptoms were reported. At time of report, the status of patient was unknown. Additional information has been requested.
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash papular
Clinical narrative: Small, papular, erythematous rash on upper and lower trunk.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Right arm pain since ZOSTAVAX 3/28/14, the redness, swelling x 1 day. Discussed warm/cold compresses. Keflex 500 mg 4 times daily x 7 days.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Beginning night of vaccination, developed induration erythema at site and fever 103.8 more than a day. 4 days later symptoms are improving.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. In March 2014 - reported as within the past 10 days - the patients were vaccinated with PNEUMOVAX 23. Indication for use, route of administration and anatomical location of the vaccination, dose number and dose were not reported. The administered vaccines were expired, the reporting pharmacist believed that the vaccines had been expired as of the end of February 2014, though he could not confirm the exact expiration date. No adverse events or outcome were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, warmth, tenderness on site of administration.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: ZOSTAVAX given instead of PROQUAD.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Injection site scab, Injection site swelling
Clinical narrative: Patient received influenza vaccine (AFLURIA) on 10/10/2013. Patient reported through the ED that at the time of the administration of the vaccine, the site of the injection became red and swollen with some urticaria. It eventually scabbed over and resolved on its own without incident. Patient stated that the scab and redness returned approximately 2 weeks prior to being seen in the ED. He decided to get it checked out this time and hence reported to the ED on January 6, 2014. There was a quarter sized scabbed area in the right deltoid with slight redness but no drainage. Patient was diagnosed with cellulitis and was given 10 day supply of SEPTRA DS. Infection resolved. Sulfamethoxazole/trimethoprim one tab BID.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Patient received influenza vaccine (AFLURIA) on 10/10/2013. Patient reported through the ED that at the time of the administration of the vaccine, the site of the injection became red and swollen with some urticaria. It eventually scabbed over and resolved on its own without incident. Patient stated that the scab and redness returned approximately 2 weeks prior to being seen in the ED. He decided to get it checked out this time and hence reported to the ED on January 6, 2014. There was a quarter sized scabbed area in the right deltoid with slight redness but no drainage. Patient was diagnosed with cellulitis and was given 10 day supply of SEPTRA DS. Infection resolved. Sulfamethoxazole/trimethoprim one tab BID.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Erythema, Mass, Pain, Pruritus
Clinical narrative: On 4-3-14 reported to Employee Health - dx with cellulitis. C/O 1 week after injection developed pain and lump formed. Saw primary care MD. Treated with antibiotics and still swelling. So referred to surgeon. Redness gone but still lump and itching. Seeing surgeon again on 4/15/14.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: On 4-3-14 reported to Employee Health - dx with cellulitis. C/O 1 week after injection developed pain and lump formed. Saw primary care MD. Treated with antibiotics and still swelling. So referred to surgeon. Redness gone but still lump and itching. Seeing surgeon again on 4/15/14.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: None, But patient was given expired vaccine (02/2014).
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Patient reported fever, redness and swelling of feet. Seen in ER by ER physicain and given dose of BENADRYL. Mother reports symptoms subsequently resolved and no other problems.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthenia, Eye movement disorder, Tremor, Visual impairment
Clinical narrative: 2-3 mins after blood drawn 1st vac. was administered (LA) MCV4, pt blinked/winced for pain. Pt claimed that she was feeling weak, nothing to eat that morning, then second vac. given (HepA-LA), pt's legs were shaking (impatient). 3rd vac. given (HPV-RA) pt claimed that she's seeing dark spots, leaned head against the wall (resting), noticed pt held hands up (breast level) and eyes were slightly rolled back. Physician was called and ordered 2L of O2, gave pt sweet (lollipop), mom gave pt a sandwich, lie down for observation. After 30 mins pt was discharged in no distress, vital signs were checked and were within normal limits.
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site swelling, Pyrexia, Rash generalised
Clinical narrative: Swelling at site of injection and full body rash and redness. Slight fever.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Malaise, Night sweats
Clinical narrative: Patient had some sweats last night without chills. Felt 'unwell' yesterday but better today. Erythema 17 x7 cm at site of injection.
Age: 54.0
Sex: M
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: None, patient was given expired vaccine (02/2014).
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Eye inflammation, Ophthalmic herpes zoster, Vision blurred
Clinical narrative: Information had been received from a letter (received on 04-APR-2014) written by a female who got a ZOSTAVAX vaccination at her local pharmacy (date not reported). Patient noted "Your scary commercials convinced me I should get your vaccination". Ten days later that patient reported she wound up in the emergency room on a Sunday morning with shingles in her left eye. She noted that before last Summer, she never had the shingles. Patient was treated and reported that she seemed to recover. Currently, patient noted as she sat at her computer she struggled to type a letter with vision only in one ye because the shingles had recurred and the inflammation in her left eye had blurred her vision to the extent that she could barely make out the largest E on the chart. Patient noted she had been treated with ophthalmic prednisolone, COMBIGAN solutions, valacyclovir and sterile lubricant eye drops. Patient's physician told her that after this occurrence was cured, she would need to go on long term low daily doses of valacyclovir. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, fever and red marks, the next morning the red marks are extending to pt's elbow, no fever, arm pain still persistent. Pt's mom brought her to ER.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Pain in extremity, Pyrexia, Rash, Rash erythematous
Clinical narrative: Arm pain, fever and red marks, the next morning the red marks are extending to pt's elbow, no fever, arm pain still persistent. Pt's mom brought her to ER.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea haemorrhagic, Intussusception, Irritability, Surgery, Vomiting
Clinical narrative: Vomiting, bloody diarrhea, fussy.