chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis, Renal transplant, Varicella
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient in her late 60's. Patient's medical history and drug reactions/allergies were not provided. In 2007 the patient was vaccinated with ZOSTAVAX. Route, dose and frequency were not provided. Patient's concomitant medications were not reported. In 2007, 2 months after vaccination with ZOSTAVAX, the patient underwent a kidney transplant. The patient experienced chickenpox and encephalitis 2 months after the kidney transplant. The patient sought unspecified medical attention. No further information provided. The outcome of kidney transplant, encephalitis and chickenpox was unknown. Causality was not provided by the reported. Upon internal review the events kidney transplant and encephalitis were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 25-MAR-2014, the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous (lot number H045787, expiry date 24-FEB-2014). On 25-MAR-2014, the patient received an expired dose of PROQUAD. The outcome of patient received an expired dose of PROQUAD was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's medical history and other drug allergic reactions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose number, dose unit, lot number and expired date unknown) for shingles prevention by an unspecified healthcare provider. No concomitant medications were reported. On an unspecified date the patient had injection site reaction, injection site was itchy and red. The outcome of injection site reaction, injection site was itchy and red was unknown. No further information provided. 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 nurse. Nurse reported that an unspecified number of patients have received Dose 2 of GARDASIL late. Nurse did not have specified dates of when Dose 1 and Dose 2 were administered but she knew some patients have returned to the office late to receive Dose 2. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Booster dose missed, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unkonwn age. "About 10 years ago" (In approximately 2004), the patient started to receive Hepatitis A (manufacturer unknown). The pharmacist reported he believed that the patient received VAQTA (dose, route and lot number were not reported) as the first dose of Hepatitis A vaccine (but it could have been another company's Hepatitis A vaccine, and pharmacist reported that this patient never received a booster dose. No adverse effects reported. No PQC was filed. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 28-MAR-2014 the patient was vaccinated with an expired MMR II (expiry date 07-MAR-2014, lot number unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therapy with MMR II was unknown. The outcome of events was unknown. The relatedness of the events to the therapy with MMR II was unknown. No product quality issue was reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram head normal, Condition aggravated, Convulsion, Electrocardiogram normal
Clinical narrative: Influenza virus vaccine. Seizure. 40 y.o. f presents to ED via EMS 10/19 with witnessed seizure x 2. (received flu vaccine 5PM 10/18, went to bed, seized 00:30 heard by daughter and again in ED 04:00 10/19). PMH: hx normal pressure hydrocephalus, s/p ventriculostomy, 2 brain surgeries after which she developed seizure disorder, currently maintained on NEURONTIN and "as needed" KLONOPIN, last seizure 6 months ago, has had several breakthrough seizures over time. Neuro consult. Prior to coming in, she had a flu vaccine so the exact precipitating cause is unknown, it is possible it could be the flu vaccine, but she has had flu vaccine in past without problems. ATIVAN and fosphenytoin given, admit to hospital, meds adjusted, neuro consult. Discharged 10/20/13. ADDENDUM: occurred prior to admit and was reason for admit. VAERS report. Per neuro: potential triggering or irritating factors could include flu vaccine and intermittent use of clonazepam."
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lethargy, Local swelling, Pain, Ultrasound Doppler
Clinical narrative: Pt. d/c 3/3/14 had PNEUMOVAX on day of discharge. Returned to hospital the following day with very swollen RUE and lethargy. She was given one dose vancomycin. Admitted and treated with several doses of TORADOL for pain. Started on several days of Amoxicillin which will finish as outpatient. Patient was afebrile, clinically improved and stable at d/c.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal, X-ray limb normal
Clinical narrative: Pt. d/c 3/3/14 had PNEUMOVAX on day of discharge. Returned to hospital the following day with very swollen RUE and lethargy. She was given one dose vancomycin. Admitted and treated with several doses of TORADOL for pain. Started on several days of Amoxicillin which will finish as outpatient. Patient was afebrile, clinically improved and stable at d/c.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Anger, Anxiety, Autism, Depression, Insomnia
Clinical narrative: Initial report was received on 20 March 2014 from a consumer who is also the patient's parent. A child had received the following vaccines: Dose 1, 2, and 3 of PENTACEL, lot numbers C3193AA, C3434AA and C3434AA respectively on 03 July 2009, 28 August 2009 and 19 October 2009 respectively; TRIPEDIA, lot number U397AA on 05 October 2011 and DAPTACEL, lot number C4050AA on 25 November 2013, and an unspecified amount of time later developed Autism. According to the patient's mother, "My kids came down with ADHD and Autism after receiving vaccinations. They now have to see a psychiatrist and are on lots of medications. My kids father and I do not have these disorders so it's not something that is genetic". She also reported "that her three children and her boyfriend's two children all have experienced issues after receiving their normal childhood vaccine. Her 9 year-old son has Asperger's and has attempted suicide, her 13 year-old daughter has ADHD and has attempted suicide and boyfriend's has two sons age 11 who have autism. All of the children have anger management issues, learning disabilities, high levels of anxiety, depression and experience insomnia. No further information was reported. Outcomes were not reported. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Learning disability
Clinical narrative: Initial report was received on 20 March 2014 from a consumer who is also the patient's parent. A child had received the following vaccines: Dose 1, 2, and 3 of PENTACEL, lot numbers C3193AA, C3434AA and C3434AA respectively on 03 July 2009, 28 August 2009 and 19 October 2009 respectively; TRIPEDIA, lot number U397AA on 05 October 2011 and DAPTACEL, lot number C4050AA on 25 November 2013, and an unspecified amount of time later developed Autism. According to the patient's mother, "My kids came down with ADHD and Autism after receiving vaccinations. They now have to see a psychiatrist and are on lots of medications. My kids father and I do not have these disorders so it's not something that is genetic". She also reported "that her three children and her boyfriend's two children all have experienced issues after receiving their normal childhood vaccine. Her 9 year-old son has Asperger's and has attempted suicide, her 13 year-old daughter has ADHD and has attempted suicide and boyfriend's has two sons age 11 who have autism. All of the children have anger management issues, learning disabilities, high levels of anxiety, depression and experience insomnia. No further information was reported. Outcomes were not reported. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB increased, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Pt presented with chest pain worse with inspiration, fuond to have positive cardiac markers. Evaluated and thought likely myopericarditis.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Myoglobin blood increased, Myopericarditis, Painful respiration, Troponin increased
Clinical narrative: Pt presented with chest pain worse with inspiration, fuond to have positive cardiac markers. Evaluated and thought likely myopericarditis.
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Headache and fever/sweating that lasted from 10:00 PM on April 1st to 10:00 AM on April 2nd.
Age: 0.41
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: After I got home and tried to get patient out of her car seat she started to cry cause I moved her. She didn't stop crying for at least an hour. Then I had to lay her on my bed and not move or try to move her or she would start screaming all over again. The crying went on, off and on, for hours. Also she would wake up to interact with anyone. Her leg was red, swollen, hard and was only hot around the area that she got the shot. She had a fever that I couldn't get to go away with Tylenol. I tried to pick her up to try to give her a bath to try to ease some pain and lower her temp. But she wouldn't let me touch her with out belting out in pain. She decreased how often she was nursing and I couldn't get near her very easily without her screaming in pain. This went on for 24 hrs then I could hold her certain ways without her being in screaming pain. She would still cry while I held her but if I could get her where her leg wasn't touching anything she would be ok. After 2 days she started to get back to a normal eating schedule. We still had to hold her a certain way for at least 4-5 days. I called her and they told me this was normal and not to worry, numerous times.
Age: 0.41
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Injection site warmth, Pain, Pyrexia, Screaming
Clinical narrative: After I got home and tried to get patient out of her car seat she started to cry cause I moved her. She didn't stop crying for at least an hour. Then I had to lay her on my bed and not move or try to move her or she would start screaming all over again. The crying went on, off and on, for hours. Also she would wake up to interact with anyone. Her leg was red, swollen, hard and was only hot around the area that she got the shot. She had a fever that I couldn't get to go away with Tylenol. I tried to pick her up to try to give her a bath to try to ease some pain and lower her temp. But she wouldn't let me touch her with out belting out in pain. She decreased how often she was nursing and I couldn't get near her very easily without her screaming in pain. This went on for 24 hrs then I could hold her certain ways without her being in screaming pain. She would still cry while I held her but if I could get her where her leg wasn't touching anything she would be ok. After 2 days she started to get back to a normal eating schedule. We still had to hold her a certain way for at least 4-5 days. I called her and they told me this was normal and not to worry, numerous times.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Human chorionic gonadotropin decreased, Human chorionic gonadotropin increased, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Information received on 21MAR2014 from an Investigator. A 28 year old female (gravida 1, para 0) experienced a spontaneous abortion. On an unspecified date in November 2013, the female received a second dose 2 of BIOTHRAX (Lot FAV324), 10 days prior to her last menstrual period (LMP), and 24 days prior to her estimated date of conception. It was noted that no other medications were administered on the same date as BIOTHRAX, but 10 days later on the first day of her last menstrual period, in December 2013, she received a primary dose of smallpox (Lot VV04-003A) and Yellow Fever (Lot UH347AA) vaccines. In January 2014, the subject was determined to be pregnant (48 days after vaccination with BIOTHRAX). Subsequently, she was contacted by the Investigator for possible enrollment in an ongoing pregnancy registry. Self referral was received in MAR2014 and it was determined that she was vaccinated prior to LMP and was therefore ineligible for the registry. At the same time the subject self-reported a spontaneous miscarriage which occurred in FEB2014 at estimated gestation age by LMP of 10+4 weeks, but an ultrasound at that time revealed the loss occurred at EGA 6+0 weeks based on pregnancy measurements. She was treated with PERCOCET for pain. Concomitant medications included TRINESSA and Prenatal vitamins. The Investigator/Reporter felt that the event was unlikely related to the administration of BIOTHRAX. No further information is expected.
Age: 32.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Abortion missed, Human chorionic gonadotropin, Maternal exposure before pregnancy, Ultrasound scan vagina abnormal, Uterine dilation and curettage
Clinical narrative: Information received on 21MAR2014 from an Investigator. A 32 year old female (gravida 1, para 0) experienced a missed abortion. On an unspecified date in December 2013, the female received a primary dose of BIOTHRAX (Lot FAV343), along with smallpox and typhoid vaccine, 4 days after last menstrual period and 10 days prior to estimated date of conception. She also received Influenza Split-preservative free vaccine on an unspecified date in November 2013. In JAN2014, the subject was determined to be pregnant (22 days after vaccination). Subsequently, she was contacted by the Investigator for possible enrollment in an ongoing pregnancy registry. Electronic medical records revealed that she had experienced a missed abortion at estimated gestational age (EGA) 11+1 weeks. An ultrasound at that time demonstrated crown rump length (CRL) of 0.65 cm, 0.48 cm with no cardiac activity and a collapsing gestational sac. She underwent a dilatation and curettage, and was treated with oxycodone hcl / acetaminophen, ibuprofen and methylergonovine maleate. By MAR2014, she had recovered. Relevant medical history - none. Concomitant medications - none. The Investigator/Reporter felt that the event could possibly be related to vaccine administration.
Age: 32.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Abortion missed, Foetal heart rate abnormal, Human chorionic gonadotropin increased, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Information received on 21MAR2014 from an Investigator. A 32 year old female (gravida 1, para 0) experienced a missed abortion. On an unspecified date in December 2013, the female received a primary dose of BIOTHRAX (Lot FAV343), along with smallpox and typhoid vaccine, 4 days after last menstrual period and 10 days prior to estimated date of conception. She also received Influenza Split-preservative free vaccine on an unspecified date in November 2013. In JAN2014, the subject was determined to be pregnant (22 days after vaccination). Subsequently, she was contacted by the Investigator for possible enrollment in an ongoing pregnancy registry. Electronic medical records revealed that she had experienced a missed abortion at estimated gestational age (EGA) 11+1 weeks. An ultrasound at that time demonstrated crown rump length (CRL) of 0.65 cm, 0.48 cm with no cardiac activity and a collapsing gestational sac. She underwent a dilatation and curettage, and was treated with oxycodone hcl / acetaminophen, ibuprofen and methylergonovine maleate. By MAR2014, she had recovered. Relevant medical history - none. Concomitant medications - none. The Investigator/Reporter felt that the event could possibly be related to vaccine administration.
Age: 32.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Ultrasound scan vagina, Uterine dilation and curettage
Clinical narrative: Information received on 21MAR2014 from an Investigator. A 32 year old female (gravida 1, para 0) experienced a missed abortion. On an unspecified date in December 2013, the female received a primary dose of BIOTHRAX (Lot FAV343), along with smallpox and typhoid vaccine, 4 days after last menstrual period and 10 days prior to estimated date of conception. She also received Influenza Split-preservative free vaccine on an unspecified date in November 2013. In JAN2014, the subject was determined to be pregnant (22 days after vaccination). Subsequently, she was contacted by the Investigator for possible enrollment in an ongoing pregnancy registry. Electronic medical records revealed that she had experienced a missed abortion at estimated gestational age (EGA) 11+1 weeks. An ultrasound at that time demonstrated crown rump length (CRL) of 0.65 cm, 0.48 cm with no cardiac activity and a collapsing gestational sac. She underwent a dilatation and curettage, and was treated with oxycodone hcl / acetaminophen, ibuprofen and methylergonovine maleate. By MAR2014, she had recovered. Relevant medical history - none. Concomitant medications - none. The Investigator/Reporter felt that the event could possibly be related to vaccine administration.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pruritus, Pruritus
Clinical narrative: This spontaneous report was received from a physician refers to a 62 year old male patient. The patient's medical history included shingles with post herpetic neuralgia. On an unknown date, the patient was vaccinated with ZOSTAVAX, (0.65 ml) subcutaneous. On an unknown date, within one hour after vaccination with ZOSTAVAX, the patient experienced pruritus and erythema at the injection site and also on trunk and right leg. On an unknown date, after 24 hours after vaccination with ZOSTAVAX, the patient experienced slight induration at the injection site; about 1 to 1.5 cm in diameter, there was one lesion on his trunk, multiple lesions on the inner aspect of his right thigh and one lesion on his left leg. The physician stated that these lesions were uniform and they are not papules. The physician stated that he believe that it looks like early shingles. The patient sought medical attention and visited the physician office. The physician also stated that he has already filed a report with VAERS. The physician offer of VZV packet. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: This spontaneous report was received from a physician refers to a 62 year old male patient. The patient's medical history included shingles with post herpetic neuralgia. On an unknown date, the patient was vaccinated with ZOSTAVAX, (0.65 ml) subcutaneous. On an unknown date, within one hour after vaccination with ZOSTAVAX, the patient experienced pruritus and erythema at the injection site and also on trunk and right leg. On an unknown date, after 24 hours after vaccination with ZOSTAVAX, the patient experienced slight induration at the injection site; about 1 to 1.5 cm in diameter, there was one lesion on his trunk, multiple lesions on the inner aspect of his right thigh and one lesion on his left leg. The physician stated that these lesions were uniform and they are not papules. The physician stated that he believe that it looks like early shingles. The patient sought medical attention and visited the physician office. The physician also stated that he has already filed a report with VAERS. The physician offer of VZV packet. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient (age and gender not reported). On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and lot number not reported), subcutaneous. After receiving PNEUMOVAX this unspecified patient developed edema (at an unspecified date) in the arm where this patient had PNEUMOVAX injected subcutaneously. Nurse reported that this patient was administered another dose of PNEUMOVAX at an unspecified date via the intramuscular route and no adverse reactions occurred. The outcome of event was unknown. This is one of the several reports received from the same source (linked mars # 1404USA000011). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. The pharmacist reported that after an unspecified patient was administered ZOSTAVAX they developed a "mild case" of shingles. The outcome of the shingles was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Rash, itchy (not painful). Lidocaine, Valacyclovir given to patient by MD. Confirmed case of shingles per MD.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac disorder, Death, Influenza, Influenza B virus test positive, Oropharyngeal pain
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of influenza B in a 10-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included automatic implantable cardioverter defibrillator pacer, congenital heart defect repaired by heart surgery. On 29 October 2013, the subject received a dose of FLUARIX (administration site and route unknown). On 23 March 2014, 5 months after vaccination with FLUARIX, the subject experienced sore throat. No test for flu was conducted and no antivirals were given. No swab testing for culture or sensitivity was done. At that time, he was stable from cardiac standpoint. On 25 March 2014, he was found unresponsive. A culture was took around pronouncement of the death which showed positive results for influenza B which was considered as a vaccination failure. The subject died on 25 March 2014 from cardiac complications and influenza B infection.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Unresponsive to stimuli, Vaccination failure
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of influenza B in a 10-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included automatic implantable cardioverter defibrillator pacer, congenital heart defect repaired by heart surgery. On 29 October 2013, the subject received a dose of FLUARIX (administration site and route unknown). On 23 March 2014, 5 months after vaccination with FLUARIX, the subject experienced sore throat. No test for flu was conducted and no antivirals were given. No swab testing for culture or sensitivity was done. At that time, he was stable from cardiac standpoint. On 25 March 2014, he was found unresponsive. A culture was took around pronouncement of the death which showed positive results for influenza B which was considered as a vaccination failure. The subject died on 25 March 2014 from cardiac complications and influenza B infection.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Muscle contractions involuntary, Muscle twitching, Neurological examination normal
Clinical narrative: This case was reported by a physician and described the occurrence of loss of feeling in arm in a 61-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject had no concomitant medication and no relevant medical history. Historic vaccination included influenza virus vaccine (manufacturer unspecified) given on an unspecified date without any reaction. On 6 November 2013 the subject received unspecified dose of FLULAVAL (unknown route, left arm). The lot number was reported as SKB7K04R from the reporter; however, based on a safety lot number review, the lot number was updated to 7KJ4R. In November 2013, 5 - 7 days after vaccination with FLULAVAL, the subject experienced loss of feeling in arm, upper arm and shoulder muscle twitching, tremor, numbness at the injection site, arm fasciculation and injection site tingling. The physician considered the events were clinically significant (or requiring intervention). Neurological tests were negative. At the time of reporting the events were worse.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Sensory loss, Tremor
Clinical narrative: This case was reported by a physician and described the occurrence of loss of feeling in arm in a 61-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject had no concomitant medication and no relevant medical history. Historic vaccination included influenza virus vaccine (manufacturer unspecified) given on an unspecified date without any reaction. On 6 November 2013 the subject received unspecified dose of FLULAVAL (unknown route, left arm). The lot number was reported as SKB7K04R from the reporter; however, based on a safety lot number review, the lot number was updated to 7KJ4R. In November 2013, 5 - 7 days after vaccination with FLULAVAL, the subject experienced loss of feeling in arm, upper arm and shoulder muscle twitching, tremor, numbness at the injection site, arm fasciculation and injection site tingling. The physician considered the events were clinically significant (or requiring intervention). Neurological tests were negative. At the time of reporting the events were worse.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Dysphonia, Headache, Throat irritation
Clinical narrative: Pt c/o "feeling allergies in throat", feeling hoarse, and headache.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles on single dermatome on chest.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Child was given an invalid dose of IPV.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Laboratory test normal, Pain, Pyrexia
Clinical narrative: Fever, headache, light-headed, feeling faint when trying to stand up.  Took Tylenol for fever and pain.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased activity, Influenza, Nausea
Clinical narrative: When we called, he stated he had "flu" symptoms (nausea and laid around a couple of days). Fine after that..
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Pain in extremity, Palpitations
Clinical narrative: Severe pain in both arms.  I had the shot split because of injection site issues in the past.  The next day I had a racing heart.  The next day the racing heart got worse.   It was painful..I also had a tightness in my chest that lasted several weeks.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a female consumer, age unknown, regarding a potential litigation case. The patient reported receiving a vaccination with ZOSTAVAX (specific date unknown). The patient reported now having "shingles in my eyes" (onset not provided). The patient was seeking compensation for the eye drops (unspecified) needed to help cure the shingles in her eyes "since this adverse event is because of ZOSTAVAX." Additional information is not expected at this time.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose, Blood pressure decreased, Dizziness, Fall
Clinical narrative: Dizziness.  Fall.  Blood Pressure Drop and stabilize within 15min.
Sex: U
Vaccine: HEP
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 of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route, lot and expiration date were not reported) that were exposed to 52 F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: TYP
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Cold-like symptoms = body aches.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count abnormal, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain left upper arm, radiating to shoulder, subjective fever, body aches, no chest pain, no wheezing.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, erythema both (R) and (L) deltoid muscle.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: She received vaccine on 2/22/14 and is still reporting a very sore arm with pain radiating in whole arm (as of 3/18/14).
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling hot, Immediate post-injection reaction, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills for at least 2 days, taking alternating Ibuprofen and TYLENOL - immediate felt hot after injection.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activated partial thromboplastin time, Arthralgia, Differential white blood cell count, Eyelid oedema, Full blood count
Clinical narrative: Malaise. Skin - fine pinpoint erythematous papular rash involving dorsal hands, wrists, dorsal feet, ankles, lower anterior legs. Petechial lesions on lower legs. Papules on abd and face. Swelling of eyelids - left upper with small papular lesion. Myalgias - arthralgia - left leg/knee.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Malaise, Myalgia, Papule, Petechiae, Rash generalised
Clinical narrative: Malaise. Skin - fine pinpoint erythematous papular rash involving dorsal hands, wrists, dorsal feet, ankles, lower anterior legs. Petechial lesions on lower legs. Papules on abd and face. Swelling of eyelids - left upper with small papular lesion. Myalgias - arthralgia - left leg/knee.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash papular, Urine analysis
Clinical narrative: Malaise. Skin - fine pinpoint erythematous papular rash involving dorsal hands, wrists, dorsal feet, ankles, lower anterior legs. Petechial lesions on lower legs. Papules on abd and face. Swelling of eyelids - left upper with small papular lesion. Myalgias - arthralgia - left leg/knee.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activated partial thromboplastin time normal, Arthralgia, Eosinophil count, Fatigue, Haemoglobin normal
Clinical narrative: Malaise. Skin - fine pinpoint erythematous papular rash involving dorsal hands, wrists, dorsal feet, ankles, lower anterior legs. Petechial lesions on lower legs. Papules on abd and face. Swelling of eyelids - left upper with small papular lesion. Myalgias - arthralgia - left leg/knee.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Monocyte count, Neutrophil count, Petechiae, Platelet count normal, Prothrombin time normal
Clinical narrative: Malaise. Skin - fine pinpoint erythematous papular rash involving dorsal hands, wrists, dorsal feet, ankles, lower anterior legs. Petechial lesions on lower legs. Papules on abd and face. Swelling of eyelids - left upper with small papular lesion. Myalgias - arthralgia - left leg/knee.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous, White blood cell count decreased
Clinical narrative: Malaise. Skin - fine pinpoint erythematous papular rash involving dorsal hands, wrists, dorsal feet, ankles, lower anterior legs. Petechial lesions on lower legs. Papules on abd and face. Swelling of eyelids - left upper with small papular lesion. Myalgias - arthralgia - left leg/knee.
Sex: U
Vaccine: HIBV
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 of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of PEDVAXHIB (dose, route, lot and expiration date were not reported) that were exposed to 52 F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
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 of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of MMR II (dose and route were not reported) lot number J002505 expiration date 20-FEB-2015 that were exposed to 52 F for 12 hours on February 2014. No adverse effect reported. It was also reported that MMR II was not supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site swelling
Clinical narrative: Local redness, swelling (R) deltoid no induration, normal range of motion.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Infection, Oedema peripheral
Clinical narrative: After injection pt states had swelling in bilat axilla area that evening. Took antihistamine chlortrimeton with decreased in sx. Seen in follow up 2 days later by MD who felt it was due to infection.
Sex: U
Vaccine: HPV4
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 of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of GARDASIL (dose, route, lot and expiration date were not reported) that were exposed to 52F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Localized reaction. Warm Rt. upper arm to touch. Aches and redness for 1 day.
Sex: U
Vaccine: 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 of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose ROTATEQ (dose, route, lot and expiration date were not reported) that were exposed to 52 F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Localized reaction: Pt reported lt deltoid area swelling and pain one day after receiving Tdap IM injection. Pt was evaluated by PCP. Mild swelling to lt deltoid area. Treatment ibuprofen and BACITRACIN.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Varicella immunization on 3/21/14. Left vastus lateralis. Cellulitis diagnosed 3/30/14 - left vastus lateralis.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram normal, Grand mal convulsion, White blood cell count increased
Clinical narrative: Tonic-clonic seizure about 36 hours after Hep A #1 vaccine administered.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised, Rash macular, Rash pruritic, Swelling face
Clinical narrative: Received RECOMBIVAX on 3-15-14. On 3-27-14 called office stating on 3-26-14 had swelling to face, blotchy itchy rash all over. Began taking BENADRYL P.O. 25mg.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 1.09
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Three hard bumps that seem to itch because daughter keeps scratching them.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, Irritability, Wrong drug administered
Clinical narrative: Child erroneously received Kinrix vaccine for his first DtaP and IPV vaccinations. No adverse outcome was noted besides mild fussiness and temp of 99.0 F felt to be consistent with immunization. Error was not discovered until 3 days after vaccine administered. I contacted ACIP and they advised that I should report event to VAERS but that these vaccines would count as part of child's DTaP & IPV series and would not have to be repeated. I have informed the mother of the error today and have taken steps within our clinic to avoid this error from happening again.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Dysuria, Pyrexia, Rash erythematous, Rash generalised, Vaccination complication
Clinical narrative: Mother reports that the child vomited twice within 10 minutes of receiving the vaccine.  Mother further states that the child had a fever of 102 that same night.  On 03/31/2014, mother states that her daughter developed small red bumps, about the size of a quarter on her left cheek.  On 04/01/2014, the red bumps spread over the entire body, including the genital area, causing the child to experience pain on urination.  Mother states she took her daughter to be evaluated by a pediatrician.  Mother further states that the pediatrician stated that the child was having a reaction to the MMR vaccine.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Mother reports that the child vomited twice within 10 minutes of receiving the vaccine.  Mother further states that the child had a fever of 102 that same night.  On 03/31/2014, mother states that her daughter developed small red bumps, about the size of a quarter on her left cheek.  On 04/01/2014, the red bumps spread over the entire body, including the genital area, causing the child to experience pain on urination.  Mother states she took her daughter to be evaluated by a pediatrician.  Mother further states that the pediatrician stated that the child was having a reaction to the MMR vaccine.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Fall, Nasal disorder, Pyrexia
Clinical narrative: Onset of fever and "fall" off chair 15 hrs after immunization of Hep A. Also nasal sx.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Hot flush, Hypoaesthesia, Muscular weakness, Musculoskeletal discomfort, Night sweats
Clinical narrative: Blurred vision. I have an absolutely perfect vision normally. For several days after vaccination I would try to focus really hard, but was unable to fully. Since 4 days ago my legs started getting numb at night and yesterday - during the day. Yesterday my left leg started going numb and giving way a little. Also got tingling sensation in fingers and weird feeling in muscles, as if they were "restless", for about an hour in the evening had to pay attention to typing, otherwise fingers would not type right (whereas usually I don't have to consciously think about it). Also rushes of hot blood to the legs and sweats at night.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia, Restlessness, Vision blurred
Clinical narrative: Blurred vision. I have an absolutely perfect vision normally. For several days after vaccination I would try to focus really hard, but was unable to fully. Since 4 days ago my legs started getting numb at night and yesterday - during the day. Yesterday my left leg started going numb and giving way a little. Also got tingling sensation in fingers and weird feeling in muscles, as if they were "restless", for about an hour in the evening had to pay attention to typing, otherwise fingers would not type right (whereas usually I don't have to consciously think about it). Also rushes of hot blood to the legs and sweats at night.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Atrial fibrillation, Back pain, Blood test, Dysaesthesia, Fall
Clinical narrative: Initially with back pain followed by dysesthesias, numbness, and paresis in a stocking glove distribution of both legs. Fell on few occasions because of lower extremity weakness.  Soon diagnosed with Guillain-Barre syndrome in addition to paroxysmal atrial fibrillation.  Treated with corticosteroids and antiarrhythmic medications.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging spinal, Paraparesis
Clinical narrative: Initially with back pain followed by dysesthesias, numbness, and paresis in a stocking glove distribution of both legs. Fell on few occasions because of lower extremity weakness.  Soon diagnosed with Guillain-Barre syndrome in addition to paroxysmal atrial fibrillation.  Treated with corticosteroids and antiarrhythmic medications.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Paresis
Clinical narrative: Initially with back pain followed by dysesthesias, numbness, and paresis in a stocking glove distribution of both legs. Fell on few occasions because of lower extremity weakness.  Soon diagnosed with Guillain-Barre syndrome in addition to paroxysmal atrial fibrillation.  Treated with corticosteroids and antiarrhythmic medications.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthenia, Bilirubin conjugated increased, Faeces pale, Fatigue
Clinical narrative: Day after received vaccine developed stomach ache, low grade fever.  Later that day developed rash.  Red not raised and not itchy on hands, inner aspects of both arms, back of knees and then body/trunk.  Some sore throat as well. Next day (3/20/14) developed some vomiting which continued to 3/21/14. 3/22/14 felt tired and weak.  Family flew to another state for family trip. When arrived later that night went directly to ER because she vomited a number of times on the flight and mom noticed she looked yellow.  Also mom thought stools looked light in color (mom is a nurse). At ER: thought dehydrated. Blood work: mildly elevated liver enzymes, direct Bili and GTT. ER thought she had a "hypersensitivity" reaction to vaccine.  Ultrasound of liver normal. He was given IV fluids and IV steroids. Also diagnosed with UTI. After leaving ER 3/23/14 developed skin peeling starting with hands, then face, arms, legs and trunk which continued for 1 week. By 3/31/14 liver labs normal but still peeling.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Glucose tolerance test abnormal, Hepatic enzyme increased, Hypersensitivity, Oropharyngeal pain, Pyrexia
Clinical narrative: Day after received vaccine developed stomach ache, low grade fever.  Later that day developed rash.  Red not raised and not itchy on hands, inner aspects of both arms, back of knees and then body/trunk.  Some sore throat as well. Next day (3/20/14) developed some vomiting which continued to 3/21/14. 3/22/14 felt tired and weak.  Family flew to another state for family trip. When arrived later that night went directly to ER because she vomited a number of times on the flight and mom noticed she looked yellow.  Also mom thought stools looked light in color (mom is a nurse). At ER: thought dehydrated. Blood work: mildly elevated liver enzymes, direct Bili and GTT. ER thought she had a "hypersensitivity" reaction to vaccine.  Ultrasound of liver normal. He was given IV fluids and IV steroids. Also diagnosed with UTI. After leaving ER 3/23/14 developed skin peeling starting with hands, then face, arms, legs and trunk which continued for 1 week. By 3/31/14 liver labs normal but still peeling.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash generalised, Skin exfoliation, Ultrasound liver normal, Urinary tract infection
Clinical narrative: Day after received vaccine developed stomach ache, low grade fever.  Later that day developed rash.  Red not raised and not itchy on hands, inner aspects of both arms, back of knees and then body/trunk.  Some sore throat as well. Next day (3/20/14) developed some vomiting which continued to 3/21/14. 3/22/14 felt tired and weak.  Family flew to another state for family trip. When arrived later that night went directly to ER because she vomited a number of times on the flight and mom noticed she looked yellow.  Also mom thought stools looked light in color (mom is a nurse). At ER: thought dehydrated. Blood work: mildly elevated liver enzymes, direct Bili and GTT. ER thought she had a "hypersensitivity" reaction to vaccine.  Ultrasound of liver normal. He was given IV fluids and IV steroids. Also diagnosed with UTI. After leaving ER 3/23/14 developed skin peeling starting with hands, then face, arms, legs and trunk which continued for 1 week. By 3/31/14 liver labs normal but still peeling.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting, Yellow skin
Clinical narrative: Day after received vaccine developed stomach ache, low grade fever.  Later that day developed rash.  Red not raised and not itchy on hands, inner aspects of both arms, back of knees and then body/trunk.  Some sore throat as well. Next day (3/20/14) developed some vomiting which continued to 3/21/14. 3/22/14 felt tired and weak.  Family flew to another state for family trip. When arrived later that night went directly to ER because she vomited a number of times on the flight and mom noticed she looked yellow.  Also mom thought stools looked light in color (mom is a nurse). At ER: thought dehydrated. Blood work: mildly elevated liver enzymes, direct Bili and GTT. ER thought she had a "hypersensitivity" reaction to vaccine.  Ultrasound of liver normal. He was given IV fluids and IV steroids. Also diagnosed with UTI. After leaving ER 3/23/14 developed skin peeling starting with hands, then face, arms, legs and trunk which continued for 1 week. By 3/31/14 liver labs normal but still peeling.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC10, RV1
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever and redness/swelling around injection site.