chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: PPV, TD
Symptoms: Pain in extremity, Vaccination complication, White blood cell count increased
Clinical narrative: Redness to thigh, pain to thigh, unable to bend knee - pain started after vaccine given, redness and pain worsened until patient presented to ED on 5/4/14, elevated CRP and WBC, clindamycin started, improved on 5/5 and discharged home, cellulitis versus vaccine reaction.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Started about one week after injection.  Has had imtermittent rash on arms, neck, posterior head, and groin that he describes as small bumps that are not vesicles or pustules.  Occurs about every other day or so lasting hours.  Pruritus.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Urticaria, Varicella
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient. The patient's medical history included eczema and chickenpox as a child at 6 or 7 years old (approximately in 1961). On 07-DEC-2013 the patient was vaccinated with ZOSTAVAX, (unknown dose and route of administration). It was reported that the patient developed chickenpox after being administered ZOSTAVAX. On 09-DEC-2013 the patient broke out in hives and went to the emergency room and was diagnosed with chickenpox. The patient visited doctor on 12-DEC-2013, 20-DEC-2013, and 27-DEC-2013. On those visits, the doctor reported that the patient was "still breaking out but getting better." On 02-JAN-2014, the doctor reported that the chickenpox had gotten worse, with more itching. The patient had a physical in March 2014, and the doctor reported that he had mild dermatitis on both arms. On 12-APR-2014 the doctor prescribed nystatin (manufacturer unspecified) for the mild dermatitis. It was also reported that prior to vaccination, the patient was last seen in June 2012. The outcome of broke out in hives on 09-DEC-2013 was reported as "still breaking out but getting better and the outcome of chickenpox had gotten worse on 02-JAN-2014 was reported as not recovered/not resolved. The outcome of mild dermatitis on both arms is unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse reported that the patient was vaccinated with a dose of MMR II and (Oka/Merck) VARIVAX (lot#, expiry and dosage unspecified) subcutaneously approximately in June 2010, in July 2013, and in April 2014. No known adverse effects reported. Additional information has been requested. Follow up information was received from nurse. Patient demographics were updated. Medical history included developmental delay and allergic rhinitis. On 07-APR-2014 at 5:51 PM, the patient was vaccinated with a dose of MMR II (lot number H018950, subcutaneous in left arm) (number of previous doses reported as 2) and (Oka/Merck) VARIVAX (lot number J006962, subcutaneous in right arm) (number of previous doses reported as 2). On 07-APR-2014 at 5:51 PM, the patient received other vaccines DAPTACEL (manufactured by Sanofi) (lot number C4457AA) in left arm intramuscularly. Number of previous doses were reported as 5. The patient also received IPOL (manufactured by Sanofi Pasteur) (lot number J1727) intramuscularly in right arm on 07-APR-2014 at 5:51 PM. Number of previous doses were reported as 4. The patient was vaccinated at private doctors office or hospital and vaccine was purchased with public funds. Concomitant medications were reported as none.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a consumer via FDA (Agency number: 2014-2020) refers to a female patient of unknown age who is the consumer's daughter. On an unknown date the patient was vaccinated with GARDASIL (manufacturer unknown) (dose, route, indication and lot # not reported). On an unknown date the patient experienced adverse reaction. The consumer requested a copy of a VAERS report that was file don the patient behalf after she had an adverse reaction to the HPV vaccine. The outcome of adverse reaction was unknown. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 40 year old male patient with no drug reactions or allergies. The patient's concurrent conditions included: diabetes, hyperlipidemia, hemodialysis. The patient's medical history included brain injury. On 06-JAN-2014 the patient was vaccinated with the first dose of RECOMBIVAX HB (strength: 40mcg/ml, dose:40mcg, administered intramuscular in the left deltoid). One month later, in February 2014, a blood draw was negative for the hepatitis B surface antigen. Patient had blood draws taken since October 2013. On an unspecified date in 2014, the patient received the second dose of dialysis formulation of RECOMBIVAX HB (strength: 40mcg/ml, dose:40mcg, administered intramuscular in the left deltoid, lot# J009218, expiration date 22-MAY-2016). Two days post vaccination (2014), the patient had a venous blood draw and was inadvertently tested for a hepatitis B surface antigen. The result was positive for hepatitis B. The pharmacist stated that had created an issue for the facility because they needed to know if the patient was infectious, and whether the hemodialysis patient therapy should have continued. Pharmacist questioned if the hepatitis b vaccine dialysis formulation RECOMBIVAX HB could cause a false positive result. The outcome of the reported event was unknown. The relatedness between the reported event and therapy with RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Anti-erythrocyte antibody positive, Blood group O, Exposure during pregnancy, Rhesus antibodies negative
Clinical narrative: Patient's OB/GYN notified patient that she has a clinically significant red blood cell antibody, anti-D, identified in the plasma.  The titer of this antibody is 64, above the critical cut-off for patients at risk for hemolytic disease of the fetus and newborn.  Patient with no history of transfusion.  Patient with no history of prior pregnancy.  The source of this antibody cannot be determined.  The only recent medical intervention was vaccination of Yellow Fever (Lot number UH672AA) for travel outside of the county.  Patient denies needle stick, IVDU, tattoo, or other known blood exposure.  This antibody has placed the patient and her developing fetus at risk for hemolytic disease of the fetus/newborn (HDFN).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. The patient's pertinent medical history was not reported. Approximately in 2009 (reported as 5 years ago) patient was vaccinated with first dose of GARDASIL. Approximately in 2014 (reported as recently) the patient was vaccinated with second dose of GARDASIL. No adverse effect reported. The outcome of second dose of GARDASIL was administered to a patient who had received the first dose of GARDASIL 5 years ago and no adverse effects was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Impaired work ability
Clinical narrative: Developed severe herpes zoster on right lower back.  Was ill for 8 days (missed 6 days of work). Did not receive any antivirals. (Pt. works at Health Dept and reported this in conversation, dates may not be correct.  He'll ask his physician to submit a full VAERS)
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Asthenia, Chills, Feeling abnormal, Feeling hot
Clinical narrative: Patient called stating yesterday she experienced "what felt like the flu".  States that she felt awful, stayed in bed all day, fever--felt like she was burning up then got the chills, sweat through all of her clothes and hair.  Today she's at work but she feels weak, unable to really think clearly.  I asked her what was her temperature, she didn't take it but knows how she feels when she has a fever.  Also, she recevied the Td back on 2/8/2000 and said she didn't have this same reaction to that vaccine.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Influenza like illness, Mental impairment, Pyrexia
Clinical narrative: Patient called stating yesterday she experienced "what felt like the flu".  States that she felt awful, stayed in bed all day, fever--felt like she was burning up then got the chills, sweat through all of her clothes and hair.  Today she's at work but she feels weak, unable to really think clearly.  I asked her what was her temperature, she didn't take it but knows how she feels when she has a fever.  Also, she recevied the Td back on 2/8/2000 and said she didn't have this same reaction to that vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: On 10/23/2013 pt presented with soreness in LT Deltoid.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a 60 year old female patient. The patient's pertinent medical history included none. On 22-APR-2014 (Reported as 9 days ago) the patient was vaccinated with ZOSTAVAX (Dose/Frequency: 1 single shot, Therapy Route: Injection). Concomitant medications were not reported. Approximately on 24-APR-2014 (Reported as a couple days) a rash was began to form. The patient was diagnosed with shingles on 05-MAY-2014. The outcome of shingles was unknown. The causality was not reported. The patient sought medical attention by visiting the office of the reporting nurse practitioner. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 4 months old patient. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with first dose of ROTATEQ SUSPENSION 2 for vaccination at 4 months of age. No adverse effects were reported. The healthcare worker reported that the patient received the first dose of ROTATEQ at another unspecified facility, date unspecified. The outcome of vaccinated with first dose of ROTATEQ for vaccination at 4 months of age and no adverse effect was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a recently 69 year old female healthcare worker via a company representative refers to herself. The reporter stated that she received ZOSTAVAX (lot# unspecified) dose, frequency and location unspecified on an unspecified date in 2008 and had a "reaction on her left side" at that time (estimated in 2008). The reporter stated that on an unspecified date in 2012 she was diagnosed with shingles. At the time of the report, the outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to three unspecified patients of unknown age. On 28-APR-2014, three unspecified patients were vaccinated with ZOSTAVAX, expiry date 10-APR-2014, 0.65 ml (milliliter), subcutaneously. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. No further information was provided. This report is linked to 1405USA001640 by the same reporter link. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Foaming at mouth, Grand mal convulsion
Clinical narrative: Grand Mal seizure lasting approximately 5 minutes, foaming at the mouth, convulsions and unresponsive for 10 minutes.  Called 911, vitals checked out to be ok, went to emergency room, everything came back as normal, referred to a neurologist.  Went to neurologist had normal CT scan, EEG showed some abnormalities.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Grand Mal seizure lasting approximately 5 minutes, foaming at the mouth, convulsions and unresponsive for 10 minutes.  Called 911, vitals checked out to be ok, went to emergency room, everything came back as normal, referred to a neurologist.  Went to neurologist had normal CT scan, EEG showed some abnormalities.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Computerised tomogram, Fatigue, Full blood count, Headache
Clinical narrative: Initially had a headache off and on. A few days later on or about April 12 she started getting tired more easily. On April 19 she was extremely tired and had a persistent headache.  Finally, on April 21 she had an excruciating headache and elevated blood pressure in the morning.  By 2:30 p.m. the headache continued and she had become jaundiced as noted by a classmate on the way to catch the school bus home.  At approximately 5:30 p.m. the headache worsened and she lost the feeling in her left side and could not speak clearly or smile. I called her pediatrician, and spoke with the afterhours nurse who told me to get patient to the emergency room for a catscan.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Jaundice, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging, Sensory loss
Clinical narrative: Initially had a headache off and on. A few days later on or about April 12 she started getting tired more easily. On April 19 she was extremely tired and had a persistent headache.  Finally, on April 21 she had an excruciating headache and elevated blood pressure in the morning.  By 2:30 p.m. the headache continued and she had become jaundiced as noted by a classmate on the way to catch the school bus home.  At approximately 5:30 p.m. the headache worsened and she lost the feeling in her left side and could not speak clearly or smile. I called her pediatrician, and spoke with the afterhours nurse who told me to get patient to the emergency room for a catscan.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Speech disorder
Clinical narrative: Initially had a headache off and on. A few days later on or about April 12 she started getting tired more easily. On April 19 she was extremely tired and had a persistent headache.  Finally, on April 21 she had an excruciating headache and elevated blood pressure in the morning.  By 2:30 p.m. the headache continued and she had become jaundiced as noted by a classmate on the way to catch the school bus home.  At approximately 5:30 p.m. the headache worsened and she lost the feeling in her left side and could not speak clearly or smile. I called her pediatrician, and spoke with the afterhours nurse who told me to get patient to the emergency room for a catscan.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Lymphocyte count increased, Malaise, Metabolic function test, Mononucleosis heterophile test
Clinical narrative: This spontaneous report as received from a Nurse refers to a 16 year old female patient. The patient pertinent medical history included preemie and chronic rhinitis. On 02-APR-2014, the patient was vaccinated with first dose of GARDASIL lot # J011960 (one vial) intramuscular. Concomitant medication included NEXIUM. On 02-APR-2014, in the evening, the patient experienced a diffuse rash that began her arms which gradually spread to her whole body. It was reported that the rash was treated with BENADRYL and other unspecified histamine products on unspecified dates. On an unknown date in April 2014, the patient underwent laboratory studies was 62 absolute reactive lymphocytes. On an unknown date in April 2014 (also reported as 15 days or 2 weeks ago) the patient experienced general malaise. The outcome of the event 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: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report as received from a Nurse refers to a 16 year old female patient. The patient pertinent medical history included preemie and chronic rhinitis. On 02-APR-2014, the patient was vaccinated with first dose of GARDASIL lot # J011960 (one vial) intramuscular. Concomitant medication included NEXIUM. On 02-APR-2014, in the evening, the patient experienced a diffuse rash that began her arms which gradually spread to her whole body. It was reported that the rash was treated with BENADRYL and other unspecified histamine products on unspecified dates. On an unknown date in April 2014, the patient underwent laboratory studies was 62 absolute reactive lymphocytes. On an unknown date in April 2014 (also reported as 15 days or 2 weeks ago) the patient experienced general malaise. The outcome of the event 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: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report sa received from nurse refers to a patient of unknown age. On 25-APR-2014, the patient was vaccinated with ZOSTAVAX, expiry date 10-APR-2014, 0.65 ml (milliliter), subcutaneously. No concomitant medications were reported. No adverse effects were reported. No Product quality complaint was involved. The outcome of events was unknown. No further information was provided. This report is linked to 1405USA001930 by the same reporter link. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Prescription: "Inject 0.65 mLs into the skin ONCE for 1 dose." Pharmacist: Injected me TWICE, perhaps with the SAME needle. I did have a small cluster raised bumpy rash last night; but it has subsided this morning.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Grandma had said patient got her shot on Monday. She had a knot there. She stated she called on Wednesday and was told to take BENADRYL. She came in on Friday. Still had knot, arm was red and she was favoring her arm. Patient's arm was tender, warm and a little erythematous.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-APR-2014, the patient inadvertently administered PROQUAD (merck), subcutaneous after the labeled expiration date. The lot number was H019441 and expiration date was 25-APR-2014. No adverse effects reported by nurse. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Headache, Pain in extremity
Clinical narrative: Patient states after receiving immunizations on 3/28/14 in afternoon began having localized pain in right arm that has spread from head to down right leg with pain progressively getting worse. States took Ibuprofen with little relief of pain. Had allergy shots same day as immunizations.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Pallor
Clinical narrative: 3cm blanchable erythema (non tender, no warmth) on (R) deltoid.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 year old patient with no drug allergies/reactions. The patient's pertinent medical history was none. On 28-APR-2014 the patient was vaccinated with ZOSTAVAX (lot # J008436, expiry date: 11-OCT-2014, Dose: 0.65 milliliter (ml), subcutaneously. Concomitant therapies were reported as nothing really significant. On the first day patient was fine, (injection) site just a little warm. "Pharmacist stated that "in the last 2 days, the injection site was red, swollen and has blisters around it. The pharmacist reported that he was not aware of lab diagnostic studies performed. The outcome of injection site just a little warm and the injection site was red, swollen and has blisters around it was unknown. The causality was not reported. The patient sought medical attention (reported as contacted pharmacy). Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 year old patient with no drug allergies/reactions. The patient's pertinent medical history was none. On 28-APR-2014 the patient was vaccinated with ZOSTAVAX (lot # J008436, expiry date: 11-OCT-2014, Dose: 0.65 milliliter (ml), subcutaneously. Concomitant therapies were reported as nothing really significant. On the first day patient was fine, (injection) site just a little warm. "Pharmacist stated that "in the last 2 days, the injection site was red, swollen and has blisters around it. The pharmacist reported that he was not aware of lab diagnostic studies performed. The outcome of injection site just a little warm and the injection site was red, swollen and has blisters around it was unknown. The causality was not reported. The patient sought medical attention (reported as contacted pharmacy). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, VARCEL
Symptoms: Pruritus, Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Mom reported pt with fever starting 4-24-14 and started having spots. Pt to HU 4-28-14, fever lasted 1 d per mom with spots starting to spread. Pt with varicella-like rash with > 20 spots to back, chest, arms and legs, itching noted.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 24-APR-2014 the patient was inadvertently administered a dose of PNEUMOVAX 23 (lot # H014283) that had expired on 17-APR-2014. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from healthcare worker refers to a male patient of unknown age. The patient had no known pertinent medical history or drug reactions/allergies. On 21-MAR-2014, the patient was vaccinated with his first dose of GARDASIL injection, 0.5 ml, intramuscular (lot#, expiration date not reported). There was no concomitant medication. The healthcare worker reported that the patient received his first dose of GARDASIL and had a syncopal episode. She stated that the patient received the dose of GARDASIL, waited in the physician office for 30 minutes, and once the patient was at the car, the patient fainted. The healthcare worker also stated that the patient's family got him in the car and elevated his legs and the syncopal episode resolved "after a few seconds". She stated that the patient did not sustain any injuries due to his fall. No treatment was given for the adverse event. No lab diagnostics studies was performed. No intervention to prevent serious criteria. The outcome of the event was recovered on 21-MAR-2014. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) upper arm redness/swelling, sore.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Topical BENADRYL per mother. Informed patient to give antihistamine, MOTRIN, cold compresses on 10-17-14. Came into office 4-18-14 per Dr. Start ORAPRED solution 15 mg/5ml 5.5 ml 1 time a day for 3 days continue with BENADRYL and MOTRIN.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Rash generalised
Clinical narrative: Patient called 36 hours after she received ZOSTAVAX injection to state that she had a raised, painful injection site reaction and a visual, non-erythematous total body rash, plus a 101 degree F fever. She used APAP to reduce fever and reported no further sx the following day. She did not seek medical treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: 12 x 8 cm red, indurated lesion of upper thigh; 6 x 3 cm secondary lesion of lower thigh.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Varicella post vaccine
Clinical narrative: Rash consistent with chicken pox over entire body starting 4/26/14, low grade fever.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Localized 5 x 5 cm erythematous (L) leg (MMR). Localized 3.5 x 3.5 cm erythematous rash (R) leg (Varicella).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Injection site - large red "egg" localized in right upper arm and very itchy appeared also hard on 5/1/14 - day after received vaccine. BENADRYL to treat started 5/2/2014.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Chapped lips, Lip swelling
Clinical narrative: 24 hours after receiving TWINRIX developed swollen lips/chapped lips.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Convulsion, Respiratory syncytial virus test, Urine analysis
Clinical narrative: Pt suffered two seizures within 3 days of the Dtap vaccine. Sz full body.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm is very sore and painful. Unable to lay on arm.
Age: 65.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Pt was here for 2nd dose of hep B. Hib given instead of hep B.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Developed shoulder pain after influenza injection in 28 Sept '13. Shot given high, with vaccinator standing over her. Has had pain for 7 months with certain movements in spite of P.T.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Developed shoulder pain after influenza injection in 28 Sept '13. Shot given high, with vaccinator standing over her. Has had pain for 7 months with certain movements in spite of P.T.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV2, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Rash consistent with a typical chicken pox outbreak in school at this time.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Gynaecomastia, Hypersomnia
Clinical narrative: This spontaneous report as received from the mother of a consumer refers to a 15 year old male patient. The patient did not have a pertinent medical history or drug reactions/allergies. On an unknown dates the patient was vaccinated with the complete series of GARDASIL (intramuscular injection). There were no concomitant medications. After receiving the complete series the patient began experiencing fatigue and was sleeping longer than usual. The patient's breasts were "about a C cup in size, which is too large for a boy". The outcome was reported as not recovered. No treatment for the events was given. No lab diagnostics were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed case of cellulitis post-vaccine.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information was received from a registered nurse regarding a 5 year old patient (gender unknown). On 26-MAR-2014, the patient was vaccinated with a (Oka/Merck) PROQUAD, lot # H015631, which expired on 23-FEB-2014 (dosage and route of administration not provided). No adverse effect reported. A second patient was also administered the expired vaccine (case #1404USA006598). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Varicella vaccine given 4/30 at approx 930 am. Noticed pain that same afternoon. Redness and swelling noted 5/1/14.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified patients may have received improperly stored ROTATEQ exposed to maximum 10C for multiple timeframes (on an unknown date). No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Rash c/w atypical chicken pox outbreak in school at this time.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with COMVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified patients may have received improperly stored COMVAX exposed to maximum 10C for multiple timeframes (on an unknown date). No adverse effects were reported. This is one of several reports from the same source. 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 physician refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VAQTA. dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified patients may have received improperly stored VAQTA exposed to maximum 10C for multiple time frames (on an unknown date). No adverse effects were reported. This is one of several reports from the same source. 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 physician refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified patients may have received improperly stored GARDASIL exposed to maximum 10C for multiple timeframes (an on unknown date). No adverse effects were reported. 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 physician refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified patients may have received improperly stored PNEUMOVAX 23 exposed to maximum 10C for multiple time frames (on an unknown date). No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Began with rash maculopapular 4-15-14 arm, leg, torso and face (12-13 lesions) no vesicles.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 12 x 7 cm erythema right thigh with increased warm.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Local swelling, Malaise, Pyrexia, Rash pruritic
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old female patient with no drug reactions/allergies. On an unspecified date approximately in February-2014, reported as about two months ago the patient received the first dose of GARDASIL 1 single shot on the left arm (lot number and expiration date were not reported). Concomitant therapies included two other unspecified vaccines in right arm. On an unspecified date approximately in February-2014, after receiving her initial dose of GARDASIL the patient experienced bruising and swelling of the injected arm, and had an itchy rash from naval to face, a fever and malaise for approximately 4 days. This event was discovered when the patient went back for her second dose of first dose of GARDASIL at which time it was determined that she would not be continuing with the dosing regimen. Therapy with first dose of GARDASIL was discontinued at the time of the report and was reintroduced. The patient was recovered from the events at the time of the report. The patient did not sought for medical attention and did not received treatment for the events. No lab diagnostics were performed. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rash, Vaccination complication
Clinical narrative: 4/29/14 pt called DOH to report a reaction to MMR vaccine she received on 4/15/14. She is experiencing fever (102), rash and swollen glands in neck and feels achy. Pt advised to call MD which she did. Was told by MD probable reaction to MMR, take TYLENOL and if sx worsen to go to ER. 4/30/14 Spoke pt she is afebrile and rash is fading.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood test, Enema administration, Haematochezia, Intussusception, X-ray
Clinical narrative: This spontaneous report as received from a physician concerning a 3 month old male patient with no drug reactions/allergies and no pertinent medical history. On 27-FEB-2014 the patient was vaccinated with the first dose of ROTATEQ, oral (total dose was not reported). There was no concomitant medication. The physician reported that on 16-APR-2014, the patient developed intussusception and blood on his stools after receiving the first dose of either ROTATEQ or ROTARIX. The physician stated that she was not sure which product was administered to the patient and stated that she stocked both products in her office. The physician mentioned that the patient was sent to the emergency room from her office and was then hospitalized overnight  at a medical center. The patient was treated with IV fluids and air enema. On an unknown date, an x ray and an unspecified blood work were performed (no result were provided). At the time of the report, in 2014, the patient recovered from intussusception. The physician considered intussusception as life threatening. The causality between intussusception and ROTATEQ was not provided. Lot number A41FB396A is an invalid lot number for ROTATEQ. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Impetigo, Rash erythematous, Rash generalised, Varicella post vaccine
Clinical narrative: Pt broke out in red rash on right side of body with fluid filled vesicle. Rash on right arm, leg, abdomen and pubic area. Rx cephalexin, BACTROBAN. Dx impetigo, vaccine induced varicella.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: 5/1/14 approximately 12 hrs after vaccine felt feverish, achy, tired, slept after taking ibuprofen. Noticed redness and pain at injection site which persists today 5/5/14 at 9 am. Nausea no vomiting, diarrhea, headache. Still feels very tired and has redness at site o/w better but not resolved.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: 5/1/14 approximately 12 hrs after vaccine felt feverish, achy, tired, slept after taking ibuprofen. Noticed redness and pain at injection site which persists today 5/5/14 at 9 am. Nausea no vomiting, diarrhea, headache. Still feels very tired and has redness at site o/w better but not resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Child received 2 immunization injection Thurs., May 1st. Mother noticed a rash Saturday afternoon. The rash was raised above the skin and at first "looked like mosquito bites" per mother. Rash later that evening turned into welts "like hives". Oatmeal baths x2, BENADRYL po x2, steroid cream application. Sunday c/o some itching. No pain or fever. No problems breathing. Rash resolved by 5-5-14.
Age: 69.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Computerised tomogram, Confusional state, Dizziness, Dry mouth
Clinical narrative: Skin lesions, confusion, dry mouth, dizziness, abdominal pain, headache. Treated with Atarax, IV antibiotics.
Age: 69.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Laboratory test, Skin lesion
Clinical narrative: Skin lesions, confusion, dry mouth, dizziness, abdominal pain, headache. Treated with Atarax, IV antibiotics.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: Right eye twitching, right side of lip twitching. Lasting 30 seconds.
Age: 1.6
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse effects reported.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: Right Eye twitching, right side of lip twitching. Lasting 30 seconds.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Flank pain, Herpes zoster, Rash
Clinical narrative: SIGNIFICANT BACK AND SIDE PAINS. RASH ON BACK, AROUND RIB CAGE AND TO FRONT CHEST AREA DEVELOPED SHORTLY THEREAFTER. SOUGHT MEDICAL ATTENTION ON 5/2/2014 WHEN IT WAS REALIZED THIS WAS A CASE OF SHINGLES.  APPROXIMATELY ONE YEAR AFTER RECEIVING THE SHINGLES SHOT.  COINCIDENT WITH TIMING OF EXPERIENCE OF AN ACQUAINTANCE WHO DEVELOPED SHINGLES 1 YEAR AFTER THE SHOT.  CURRENTLY UNDER TREATMENT.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Smallpox
Clinical narrative: Pt had secondary smallpox lesion on rt forearm. No other locations.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram head normal, Cyanosis, Full blood count normal
Clinical narrative: Tonic Clonic Seizure, generalized, with cyanosis.  Fever of 104. Lasted appx. 2 minutes.  Went to hospital via ambulance and received CT scan, chest x-ray, CBC, blood culture, and Spinal Tap.  All test came back clear.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Grand mal convulsion, Lumbar puncture normal, Pyrexia
Clinical narrative: Tonic Clonic Seizure, generalized, with cyanosis.  Fever of 104. Lasted appx. 2 minutes.  Went to hospital via ambulance and received CT scan, chest x-ray, CBC, blood culture, and Spinal Tap.  All test came back clear.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Cyanosis, Grand mal convulsion
Clinical narrative: Tonic Clonic Seizure, generalized, with cyanosis.  Fever of 104. Lasted appx. 2 minutes.  Went to hospital via ambulance and received CT scan, chest x-ray, CBC, blood culture, and Spinal Tap.  All test came back clear.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Lumbar puncture normal, Pyrexia, Streptococcal infection, Streptococcus test positive
Clinical narrative: Tonic Clonic Seizure, generalized, with cyanosis.  Fever of 104. Lasted appx. 2 minutes.  Went to hospital via ambulance and received CT scan, chest x-ray, CBC, blood culture, and Spinal Tap.  All test came back clear.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Grand mal convulsion
Clinical narrative: Mild Tonic-Clonic Seizure.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Injection site scab, Myalgia, Pruritus, Rash erythematous
Clinical narrative: Patient reported being in good health while traveling. He was given his primary smallpox vaccine on 3/6/2003. No other vaccines given. Approximately 9 days later (3/15/2003) during his return trip home, he began to itch behind his left knee and noticed he had "large red dots" going up the back of bilateral legs, abdomen, back and lower arms. He described these dots as quarter/half dollar size flat, red raised lesions - "hives". He presented to medical and was sent to emergency room on 3/17/2003 and treated with ATARAX, ALLEGRA and ZANTAC. (These records unable to be located by medical record staff x3). On 3/18/2003 he presented to dermatology for follow up where providers documented "erythematous plaques on abdomen and lower back fading on comparison to yesterday's exam. Lesions were no longer painful to palpation compared to when active". He was diagnosed with urticaria and instructed to continue with ZANTAC, ALLEGRA and ATARAX. He was then flown home. He advised symptoms resolved 2-3 days after treatment initiated and they have not re-occurred since. He also reported a normal take to SPV site with scabbing (no site swelling, streaking, lymphadenopathy, headaches, chest pain or shortness of breath). He did admit to feeling very fatigued with diffuse muscle aches 1-2 weeks after vaccination that resolved with use of MOTRIN/TYLENOL (began use after onset rash). He denied new clothing, soaps, detergents, lotions, uniforms/mustang dry suits, chemical or foods. He reported no further reactions with subsequent vaccinations (IE: influenza, Td, AVA, typhoid, YV, and hep B), medications, foods, etc since.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised, Skin lesion, Skin plaque, Tenderness, Urticaria
Clinical narrative: Patient reported being in good health while traveling. He was given his primary smallpox vaccine on 3/6/2003. No other vaccines given. Approximately 9 days later (3/15/2003) during his return trip home, he began to itch behind his left knee and noticed he had "large red dots" going up the back of bilateral legs, abdomen, back and lower arms. He described these dots as quarter/half dollar size flat, red raised lesions - "hives". He presented to medical and was sent to emergency room on 3/17/2003 and treated with ATARAX, ALLEGRA and ZANTAC. (These records unable to be located by medical record staff x3). On 3/18/2003 he presented to dermatology for follow up where providers documented "erythematous plaques on abdomen and lower back fading on comparison to yesterday's exam. Lesions were no longer painful to palpation compared to when active". He was diagnosed with urticaria and instructed to continue with ZANTAC, ALLEGRA and ATARAX. He was then flown home. He advised symptoms resolved 2-3 days after treatment initiated and they have not re-occurred since. He also reported a normal take to SPV site with scabbing (no site swelling, streaking, lymphadenopathy, headaches, chest pain or shortness of breath). He did admit to feeling very fatigued with diffuse muscle aches 1-2 weeks after vaccination that resolved with use of MOTRIN/TYLENOL (began use after onset rash). He denied new clothing, soaps, detergents, lotions, uniforms/mustang dry suits, chemical or foods. He reported no further reactions with subsequent vaccinations (IE: influenza, Td, AVA, typhoid, YV, and hep B), medications, foods, etc since.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from the agency via the Freedom of Information Act concerning consumer who reported that her daughter received a dose of GARDASIL and had an adverse reaction. Reaction was not specified. No additional information was provided. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Hepatic enzyme increased, Hepatitis B antibody negative, Viral infection
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 17 year old female patient. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot, dose and route not reported) for childhood vaccination. Concomitant medication was not reported. On an unspecified date in February 2014, the patient came down with mild virus. On 28-FEB-2014, the patient was seen by the nurse. Blood tests were administered on the patient and it was found that he had elevated liver function enzymes and his Hepatitis B titers were not adequate (less than 3.10). The nurse stated that they will readminister RECOMBIVAX HB series. The nurse also stated that the patient was recovering, his "levels are coming down," and he felt some fatigue. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19,400 unit 1 standard package vial of 1 (lot number, dose and route were not reported). Co-suspect therapy was not reported. Concomitant therapy was not reported. On an unknown date, most of ZOSTAVAX injection came out of a patient's arm. The outcome of the events was unknown. 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 Nurse refers to a patients of unknown age and gender. On an unknown date, the patient was vaccinated with ROTATEQ (dose, duration and route were not reported). The nurse reported that an unknown number of doses of ROTATEQ, that were stored at 32 degrees F. for 30 hours have been administered. No adverse effect report. At the time of the report action taken was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (dose, duration and route were not reported). The nurse reported that an unknown number of doses of GARDASIL that were stored at 32 degrees F. for 30 hours have been administered. No adverse effect report. At the time of the report action taken was not reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician who reported that 90-100 patients were inadvertently administered 5 vaccines for prophylaxis from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with RECOMBIVAX HB had been improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.