chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On an unknown date the unspecified patients were vaccinated with an unknown number of doses of GARDASIL (lot number not reported) and RECOMBIVAX HB (lot number not reported) that were improperly stored, 31.0 degrees F. for possibly 24 hours and from 31.5-35 degrees F. for 58 days, No adverse effect reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her sister in law of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number not provided). On an unknown date the patient developed shingles. The outcome of shingles was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. In October 2012, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml. The pharmacist reported that he might had given a patient a ZOSTAVAX shot that had some bubbles in it. No adverse experienced were reported. The outcome of the event was unknown. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner (NP) refers to a patient of unknown age. On an unspecified date in February 2008 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided) and on 04-MAR-2013 was in the office to receive second dose. No adverse symptoms were reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphagia, Erythema, Swelling, Urticaria
Clinical narrative: Pt in office 330PM at 730PM went to give a bath to child was hives head to toe. Gave CLARITIN 1 tsp. Hives dissipated then rash turned to big welts very raised red. No resp/swallowing difficulty went to be in am all gone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to herself, a 50 year old female patient. On 08-FEB-2012 the patient was vaccinated with ZOSTAVAX (lot number not provided) dose 1, 0.65 ml, subcutaneous. On 09-FEB-2012 the patient experienced blisters and redness around the injection site which were 1/2 inch to 1 inch in size and later the area became hard and spread to the back of her arm. She was treated with a warm and cold compress and VALTREX. The events resolved in about a week. The relatedness was not provided. Additional information is not expected.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Crying, Diarrhoea, Diet refusal, Irritability, Pyrexia
Clinical narrative: Continued excessive diarrhea requiring bathing and clothing changes up to 8 times in 24 hours, continued high-pitched screaming for up to 3 hours, inability to be consoled, refused nursing, fever, irritability.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Screaming
Clinical narrative: Continued excessive diarrhea requiring bathing and clothing changes up to 8 times in 24 hours, continued high-pitched screaming for up to 3 hours, inability to be consoled, refused nursing, fever, irritability.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Chills, Eosinophil percentage decreased, Injection site erythema, Injection site pain
Clinical narrative: Pt had PNUPS vaccine on 2/27/13. On 3/2/13, he developed redness, tenderness and warmth at the vaccine site. He contacted his PCP who prescribed KEFLEX 500 mg QID. He went to the ER for evaluation on the evening of 3/2/13.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site swelling, Lymphocyte percentage decreased, Neutrophil percentage increased, Pyrexia, White blood cell count increased
Clinical narrative: Pt had PNUPS vaccine on 2/27/13. On 3/2/13, he developed redness, tenderness and warmth at the vaccine site. He contacted his PCP who prescribed KEFLEX 500 mg QID. He went to the ER for evaluation on the evening of 3/2/13.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Pt had PNUPS vaccine on 2/27/13. On 3/2/13, he developed redness, tenderness and warmth at the vaccine site. He contacted his PCP who prescribed KEFLEX 500 mg QID. He went to the ER for evaluation on the evening of 3/2/13.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Full blood count abnormal, Injection site induration, Injection site swelling, White blood cell count increased
Clinical narrative: Pt had PNUPS vaccine on 2/27/13. On 3/2/13, he developed redness, tenderness and warmth at the vaccine site. He contacted his PCP who prescribed KEFLEX 500 mg QID. He went to the ER for evaluation on the evening of 3/2/13.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood follicle stimulating hormone increased, Dizziness, Headache, Hot flush
Clinical narrative: Adverse symptoms included, but not limited to, severe head aches, dizziness, neausea, vertigo & hot flashes. 23 year old patient had blood drawn approximately a week and half after first Gardasil injection and it was discovered that patient's FSH level was a 72, far above normal range indicating Premature Ovarian Failure or Premature Menopause. In addition patients menstrual cycle ceased after first Gardasil injection.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Premature menopause, Vertigo
Clinical narrative: Adverse symptoms included, but not limited to, severe head aches, dizziness, neausea, vertigo & hot flashes. 23 year old patient had blood drawn approximately a week and half after first Gardasil injection and it was discovered that patient's FSH level was a 72, far above normal range indicating Premature Ovarian Failure or Premature Menopause. In addition patients menstrual cycle ceased after first Gardasil injection.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Balance disorder, Convulsion, Decreased appetite, Erythema
Clinical narrative: Redness, itchy, inflamed not eating, drinking, listless, nausea, weak, equilibrium off on 3rd day seizure, She continues to have these symptoms including redness, itchy, and all above symptoms.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Inflammation, Listless, Nausea, Pruritus
Clinical narrative: Redness, itchy, inflamed not eating, drinking, listless, nausea, weak, equilibrium off on 3rd day seizure, She continues to have these symptoms including redness, itchy, and all above symptoms.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Left deltoid injection site erythema, induration, and warmth with an annular ring appearance approximately 4 inches in diameter. Very pruritic. No systemic symptoms suggestive of infection.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age with pneumonia. Patient was hospitalized (believed to be hospitalized for pneumonia) prior to administration of the PNEUMOVAX23 and the Flu vaccine (Glaxo Smith Kline). On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number reported as H014653 and expiration 19-APR-2014) in the deltoid muscle. With in 5 minutes received Flu vaccine (Glaxo Smith Kline) (lot number AFLUA716BA expiration 30-JUN-2013) in the same deltoid muscle. On an unknown date the patient experienced the injection site reaction, and the injection site where the PNEUMOVAX23 and Flu vaccine (Glaxo Smith Kline) were administered was swollen, raised and red with a clear drainage (time frame development of injection site reaction was unspecified). The nurse reported that the infectious disease department in the hospital was involved. The patient was given a CT scan, on an unspecified date, of the affected arm due to the reaction. The patient was hospitalized for medical attention. The outcome was reported as not recovered. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site abscess sterile, Injection site cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age with pneumonia. Patient was hospitalized (believed to be hospitalized for pneumonia) prior to administration of the PNEUMOVAX23 and the Flu vaccine (Glaxo Smith Kline). On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number reported as H014653 and expiration 19-APR-2014) in the deltoid muscle. With in 5 minutes received Flu vaccine (Glaxo Smith Kline) (lot number AFLUA716BA expiration 30-JUN-2013) in the same deltoid muscle. On an unknown date the patient experienced the injection site reaction, and the injection site where the PNEUMOVAX23 and Flu vaccine (Glaxo Smith Kline) were administered was swollen, raised and red with a clear drainage (time frame development of injection site reaction was unspecified). The nurse reported that the infectious disease department in the hospital was involved. The patient was given a CT scan, on an unspecified date, of the affected arm due to the reaction. The patient was hospitalized for medical attention. The outcome was reported as not recovered. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Blood culture negative, Cellulitis, Computerised tomogram abnormal, Hepatitis B antibody negative, Hepatitis C antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age with pneumonia. Patient was hospitalized (believed to be hospitalized for pneumonia) prior to administration of the PNEUMOVAX23 and the Flu vaccine (Glaxo Smith Kline). On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number reported as H014653 and expiration 19-APR-2014) in the deltoid muscle. With in 5 minutes received Flu vaccine (Glaxo Smith Kline) (lot number AFLUA716BA expiration 30-JUN-2013) in the same deltoid muscle. On an unknown date the patient experienced the injection site reaction, and the injection site where the PNEUMOVAX23 and Flu vaccine (Glaxo Smith Kline) were administered was swollen, raised and red with a clear drainage (time frame development of injection site reaction was unspecified). The nurse reported that the infectious disease department in the hospital was involved. The patient was given a CT scan, on an unspecified date, of the affected arm due to the reaction. The patient was hospitalized for medical attention. The outcome was reported as not recovered. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age with pneumonia. Patient was hospitalized (believed to be hospitalized for pneumonia) prior to administration of the PNEUMOVAX23 and the Flu vaccine (Glaxo Smith Kline). On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number reported as H014653 and expiration 19-APR-2014) in the deltoid muscle. With in 5 minutes received Flu vaccine (Glaxo Smith Kline) (lot number AFLUA716BA expiration 30-JUN-2013) in the same deltoid muscle. On an unknown date the patient experienced the injection site reaction, and the injection site where the PNEUMOVAX23 and Flu vaccine (Glaxo Smith Kline) were administered was swollen, raised and red with a clear drainage (time frame development of injection site reaction was unspecified). The nurse reported that the infectious disease department in the hospital was involved. The patient was given a CT scan, on an unspecified date, of the affected arm due to the reaction. The patient was hospitalized for medical attention. The outcome was reported as not recovered. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Legionella test, Pyrexia, Soft tissue disorder, White blood cell count increased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age with pneumonia. Patient was hospitalized (believed to be hospitalized for pneumonia) prior to administration of the PNEUMOVAX23 and the Flu vaccine (Glaxo Smith Kline). On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number reported as H014653 and expiration 19-APR-2014) in the deltoid muscle. With in 5 minutes received Flu vaccine (Glaxo Smith Kline) (lot number AFLUA716BA expiration 30-JUN-2013) in the same deltoid muscle. On an unknown date the patient experienced the injection site reaction, and the injection site where the PNEUMOVAX23 and Flu vaccine (Glaxo Smith Kline) were administered was swollen, raised and red with a clear drainage (time frame development of injection site reaction was unspecified). The nurse reported that the infectious disease department in the hospital was involved. The patient was given a CT scan, on an unspecified date, of the affected arm due to the reaction. The patient was hospitalized for medical attention. The outcome was reported as not recovered. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 33-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), (non-gsk) PNEUMOVAX 23. Concurrent medical conditions included ankle surgery, back surgery, pneumonia and tobacco user. The subject was hospitalized on 25 February 2013 for pneumonia. On 26 February 2013 at 11:06 the subject received a dose of FLUARIX (1 unknown volume, unknown route, right deltoid), and on 26 February 2013 the subject received a dose of PNEUMOVAX 23 (unknown details, right deltoid) while in the hospital for pneumonia since 25 February 2013. On 26 February 2013, less than one day after vaccination with FLUARIX and PNEUMOVAX 23, the subject experienced injection site cellulitis, injection site redness, swelling injection site, and sterile abscess at injection site. The subject complained of injection site redness and injection site swelling on 26 February 2013. The reporter stated that "cellulitis and possibly abscess" adverse events onset on 26 February 2013 and the adverse events were local injection site reactions. On 27 February 2013, the subject was diagnosed with injection site cellulitis. At the time of reporting, the nurse stated that the subject "may have an abscess but this was not diagnosed." Per the nurse, the subject will get consults from surgery and infectious disease. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site abscess sterile, Injection site cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 33-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), (non-gsk) PNEUMOVAX 23. Concurrent medical conditions included ankle surgery, back surgery, pneumonia and tobacco user. The subject was hospitalized on 25 February 2013 for pneumonia. On 26 February 2013 at 11:06 the subject received a dose of FLUARIX (1 unknown volume, unknown route, right deltoid), and on 26 February 2013 the subject received a dose of PNEUMOVAX 23 (unknown details, right deltoid) while in the hospital for pneumonia since 25 February 2013. On 26 February 2013, less than one day after vaccination with FLUARIX and PNEUMOVAX 23, the subject experienced injection site cellulitis, injection site redness, swelling injection site, and sterile abscess at injection site. The subject complained of injection site redness and injection site swelling on 26 February 2013. The reporter stated that "cellulitis and possibly abscess" adverse events onset on 26 February 2013 and the adverse events were local injection site reactions. On 27 February 2013, the subject was diagnosed with injection site cellulitis. At the time of reporting, the nurse stated that the subject "may have an abscess but this was not diagnosed." Per the nurse, the subject will get consults from surgery and infectious disease. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Blood culture negative, Cellulitis, Computerised tomogram abnormal, Hepatitis B antibody negative, Hepatitis C antibody negative
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 33-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), (non-gsk) PNEUMOVAX 23. Concurrent medical conditions included ankle surgery, back surgery, pneumonia and tobacco user. The subject was hospitalized on 25 February 2013 for pneumonia. On 26 February 2013 at 11:06 the subject received a dose of FLUARIX (1 unknown volume, unknown route, right deltoid), and on 26 February 2013 the subject received a dose of PNEUMOVAX 23 (unknown details, right deltoid) while in the hospital for pneumonia since 25 February 2013. On 26 February 2013, less than one day after vaccination with FLUARIX and PNEUMOVAX 23, the subject experienced injection site cellulitis, injection site redness, swelling injection site, and sterile abscess at injection site. The subject complained of injection site redness and injection site swelling on 26 February 2013. The reporter stated that "cellulitis and possibly abscess" adverse events onset on 26 February 2013 and the adverse events were local injection site reactions. On 27 February 2013, the subject was diagnosed with injection site cellulitis. At the time of reporting, the nurse stated that the subject "may have an abscess but this was not diagnosed." Per the nurse, the subject will get consults from surgery and infectious disease. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 33-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), (non-gsk) PNEUMOVAX 23. Concurrent medical conditions included ankle surgery, back surgery, pneumonia and tobacco user. The subject was hospitalized on 25 February 2013 for pneumonia. On 26 February 2013 at 11:06 the subject received a dose of FLUARIX (1 unknown volume, unknown route, right deltoid), and on 26 February 2013 the subject received a dose of PNEUMOVAX 23 (unknown details, right deltoid) while in the hospital for pneumonia since 25 February 2013. On 26 February 2013, less than one day after vaccination with FLUARIX and PNEUMOVAX 23, the subject experienced injection site cellulitis, injection site redness, swelling injection site, and sterile abscess at injection site. The subject complained of injection site redness and injection site swelling on 26 February 2013. The reporter stated that "cellulitis and possibly abscess" adverse events onset on 26 February 2013 and the adverse events were local injection site reactions. On 27 February 2013, the subject was diagnosed with injection site cellulitis. At the time of reporting, the nurse stated that the subject "may have an abscess but this was not diagnosed." Per the nurse, the subject will get consults from surgery and infectious disease. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Legionella test, Pyrexia, Soft tissue disorder, White blood cell count increased
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 33-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), (non-gsk) PNEUMOVAX 23. Concurrent medical conditions included ankle surgery, back surgery, pneumonia and tobacco user. The subject was hospitalized on 25 February 2013 for pneumonia. On 26 February 2013 at 11:06 the subject received a dose of FLUARIX (1 unknown volume, unknown route, right deltoid), and on 26 February 2013 the subject received a dose of PNEUMOVAX 23 (unknown details, right deltoid) while in the hospital for pneumonia since 25 February 2013. On 26 February 2013, less than one day after vaccination with FLUARIX and PNEUMOVAX 23, the subject experienced injection site cellulitis, injection site redness, swelling injection site, and sterile abscess at injection site. The subject complained of injection site redness and injection site swelling on 26 February 2013. The reporter stated that "cellulitis and possibly abscess" adverse events onset on 26 February 2013 and the adverse events were local injection site reactions. On 27 February 2013, the subject was diagnosed with injection site cellulitis. At the time of reporting, the nurse stated that the subject "may have an abscess but this was not diagnosed." Per the nurse, the subject will get consults from surgery and infectious disease. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified.
Age: 1.51
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Lethargy, Pyrexia, Skin warm
Clinical narrative: Toddler began to feel warm to the touch in the afternoon of Monday the 14th, temperature was taken at apx 8 pm with a temporal scanner and read 104.  She was given 3.75 mL of childrens Tylenol, which broke the fever and allowed her to sleep. 3-4 times a day, everyday up to and including Thursday the 17th, her temperature spiked to 104 and remained elevated most of the rest of the time.  She was also lethargic and experienced loss of appetite, and was primarily breastfed during those 4 days. She was treated with Tylenol once to twice a day, to help her sleep, and was otherwise treated with sponging room temperature water on her face, neck and torso.  After speaking with advice nurse she was given doses of Tylenol every 4 hours starting Thursday at 5 pm, except while she slept overnight. At the same time the family left for a car trip and toddler was exposed to colder temperatures, which also seemed to help break the fever.  A few times friday she felt warm but her temperature was only slightly elevated.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Oropharyngeal pain, Throat tightness
Clinical narrative: Throat constriction, sore throat, difficulty swallowing.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Dyspnoea, Eye discharge, Fatigue
Clinical narrative: Swollen joints; mattery eyes; achy all over -flu like symptoms; tons of phlegm-bloody sputnum; headache; cough; loss of energy-tired; hard breathing. Went to doctor at local clinic got super drugs for cold prednisone and antibiotic-my lungs sounded good -so no xray-after I got home I got to thinking about the vaccine and maybe it caused my problems as it was not a lung issue- so I did not start the antibiotics or prednisone yet.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemoptysis, Headache, Increased upper airway secretion, Influenza like illness, Joint swelling
Clinical narrative: Swollen joints; mattery eyes; achy all over -flu like symptoms; tons of phlegm-bloody sputnum; headache; cough; loss of energy-tired; hard breathing. Went to doctor at local clinic got super drugs for cold prednisone and antibiotic-my lungs sounded good -so no xray-after I got home I got to thinking about the vaccine and maybe it caused my problems as it was not a lung issue- so I did not start the antibiotics or prednisone yet.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Swollen joints; mattery eyes; achy all over -flu like symptoms; tons of phlegm-bloody sputnum; headache; cough; loss of energy-tired; hard breathing. Went to doctor at local clinic got super drugs for cold prednisone and antibiotic-my lungs sounded good -so no xray-after I got home I got to thinking about the vaccine and maybe it caused my problems as it was not a lung issue- so I did not start the antibiotics or prednisone yet.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV1
Symptoms: Crying, Diarrhoea, Injection site nodule, Injection site pain, Screaming
Clinical narrative: Excessive high-pitched screaming, severe diarrhea requiring bathing and clothing changes up to 8 times in 24 hours, pea-sized knot at injection site that was painful to touch.
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Dermatitis, Rash generalised
Clinical narrative: Full body rash to include genitals.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In 2007/2008, the patient was vaccinated with the first dose of GARDASIL. The pharmacist stated that an unspecified patient wished to receive 2nd and 3rd dose of GARDASIL although she was unsure of her vaccine history. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to many, unspecified number of patients of unknown ages. On unknown dates the patients were intramuscularly vaccinated with the first, second and third dose of GARDASIL (every dose 0.5 ml). They took longer than a year to complete their GARDASIL series. No adverse effects reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult patient. On 27-FEB-2013 the patient was vaccinated with an expired dose of (oka/merck)VARIVAX. The (oka/merck) VARIVAX (lot number reported as 16832) expired on 09-DEC-2012. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician refers to a 24 year old female patient. Physician stated that patients have been coming in with incomplete GARDASIL series. On an unknown date in 2010(reported as 3 years ago), the patient was vaccinated with dose 1 GARDASIL(lot#, expiry not reported). No concomitant medications were reported. She did not receive the subsequent doses of GARDASIL. Physician inquired if the series could be restarted or give the patient the remaining 2 in the GARDASIL series. Physician wanted to know where to find guide lines for incomplete series. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Pruritus, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a 81 year old male patient regarding himself. On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date, the patient experienced shingles recently. The patient indicated he had red bumps and a rash on his stomach and back and he itches. The patient had blood work done every 3 months. Treatment rendered was Triamcinolone cream for hives rash. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a 81 year old male patient regarding himself. On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date, the patient experienced shingles recently. The patient indicated he had red bumps and a rash on his stomach and back and he itches. The patient had blood work done every 3 months. Treatment rendered was Triamcinolone cream for hives rash. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Dizziness, Fatigue
Clinical narrative: This spontaneous report was received from a 75 year old male patient regarding himself. Patient had no drug reactions or allergies. On 04-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015780, expiry: 11-JUN-2014, route and dose not reported). No concomitant medications were reported. On 14-JAN-2013, the patient experienced some adverse experiences. The patient's baseline temperature was normally 97.6 degrees F. However, after receiving PNEUMOVAX23, his temperature moved up to 98.6 degrees F with frequent daily spikes to 99.2 degrees F. In addition, the patient has constant fatigue and feels very lightheaded. No treatment was received. Patient sought medical attention (unspecified). No laboratory diagnostic tests were performed. The patient also reported that in 2003 he had received the pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) before, but was not sure about the manufacturer or name of the product. The outcome of the events were reported as not recovered. The relatedness of the events with PNEUMOVAX23 was unknown. This is one of 2 reports received from the same source. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 23 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported). On an unknown date, the patient was rubeola IGG negative. The nurse stated that the first antibody titer showed equivocal results but the second antibody titer showed rubeola IGG negative. The outcome of second antibody titer showed rubeola IGG negative is unknown. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report was received from a 69 year old female patient regarding herself. On 27-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported and route was subcutaneous). On 28-FEB-2013, the patient developed oval hive at the injection site by about 2 inches by 1 1/2 inches. The patient that she felt that it was going away since her doctor advised her it was common. Treatment rendered for the event was CORTIZONE cream. The outcome of the event was reported as recovering. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age. On 14-NOV-2012, the patient was vaccinated with first dose of MMR II, (lot number, expiry date and  route was not reported). On 30-JAN-2013, the patient was vaccinated with second dose of MMR II, (lot number, expiry date and route was not reported). On 20-FEB-2013, the patient was vaccinated with third dose of MMR II, (lot number, expiry date and route was not reported). The nurse reported that she was trying to determine if the documentation of these vaccination is accurate. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: DTP, DTPHIB, HIBV, TD
Symptoms: Unevaluable event
Clinical narrative: Initial report was received from the scientific literature on 22 February 2013. Verbatim from the report: "Background: The delivery of the DPT vaccine has been plagued by concerns about a causal link to epilepsy and encephalopathy. The NVICP is a national effort within the Department of Health and Human Services to compensate children who develop neurologic problems within 72 hours of immunization. Objective: To describe clinical characteristics of children alleging seizure disorder as an injury due to vaccination. Methods: Retrospective record review of vaccine-alleged seizure disorder cases in children aged <2 years filing claim during 1995-2004. Results: NVICP retrieved 242 cases alleging seizure disorder as vaccine injury. Of 96 cases reviewed thus far, 71 were filed in 1995-6, 10 in 1997-2002. Half were male. Vaccines implicated (sometimes multiple) were DPT 75, MMR17, Hib and DT 2 each, DTaP and OPV one each. Less than half (42%) had a seizure within 72 hours of vaccination. There was a history of seizure before the alleged vaccine injury in 18%, abnormal neurological examination before the alleged vaccine injury in 13%. A definite diagnosis of pre-existing abnormality (tuberous sclerosis, epilepsy, congenital malformations, developmental delay) was given in 11%. Chronic myoclonic epilepsy developed in a quarter of the children. Conclusion: A significant number of children with alleged vaccine induced seizure disorders had pre-existing neurological or neurodevelopmental abnormalities. Among those developing chronic epilepsy, many had clinical features suggesting genetically determined epilepsy. Future studies of these children, including genotyping, may allow more specific therapy and prognostication and may have implications for public confidence in vaccination." Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 65 year old female patient. On an unknown date in NOV-2012, the patient was vaccinated with 0.65 ml of ZOSTAVAX (lot number and expiry date is not reported, route was subcutaneous). On an unknown date, the patient experienced pain and swelling at injection site. No treatment was provided. The outcome of pain and swelling at injection site was unknown. The patient sought medical attention (spoke with physician). Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Axillary pain, Brachial plexopathy, Feeling abnormal, Injection site papule, Pyrexia
Clinical narrative: Initial report was received from a consumer on 21 February 2013. A 4-year-old female patient received her third dose of an injection of DAPTACEL, lot number C4154AA, in the left deltoid on 19 February 2013 (route of administration not reported). Two days later, on 21 February 2013, the patient experienced the onset of adverse events. At night, the patient felt "punky" and had a fever of 101 degrees fahrenheit (38 degrees Celsius). The next day the fever dropped to 99 degrees fahrenheit (37 degrees Celsius). The patient had an ascending rash around her ankles and calves up the thigh, also on the wrist and hand, that was red, slightly raised, and not itchy. The patient had a clear papule at the injection site. The patient also had armpit pain and brachial plexus pain, only on the left side. There was concern "about vasculitis but not sure." The patient took TYLENOL at night for fever. The patient had positive ketones in the urine. The patient's outcome was not recovered. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Rash papular, Urine ketone body present
Clinical narrative: Initial report was received from a consumer on 21 February 2013. A 4-year-old female patient received her third dose of an injection of DAPTACEL, lot number C4154AA, in the left deltoid on 19 February 2013 (route of administration not reported). Two days later, on 21 February 2013, the patient experienced the onset of adverse events. At night, the patient felt "punky" and had a fever of 101 degrees fahrenheit (38 degrees Celsius). The next day the fever dropped to 99 degrees fahrenheit (37 degrees Celsius). The patient had an ascending rash around her ankles and calves up the thigh, also on the wrist and hand, that was red, slightly raised, and not itchy. The patient had a clear papule at the injection site. The patient also had armpit pain and brachial plexus pain, only on the left side. There was concern "about vasculitis but not sure." The patient took TYLENOL at night for fever. The patient had positive ketones in the urine. The patient's outcome was not recovered. Documents held by sender: None.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient (gender unspecified). On 03-MAR-2013 the patient was vaccinated with PROQUAD (Merck) and VARIVAX (Merck). Lot # and administration route was not provided. No adverse symptoms reports. it was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her sister's 5 month old female infant. On 01-MAR-2013 the patient was accidentally vaccinated with GARDASIL (lot number not provided) by an unspecified healthcare professional. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 26-FEB-2013, the patient received dose 1 MMR II (lot# and expiry not reported) 0.5 milliliter (ml), subcutaneously. On 05-MAR-2013, the patient was vaccinated subcutaneously with dose 2 of MMR II (lot# H012571, expiry: 29-JUN-2014). No adverse effects reported. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 04-MAR-2013 the patient received an expired dose of M-M-R II (Lot# 1644Z, expired on 24-NOV-2012), dose and route not reported. No adverse effect was reported. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: This spontaneous report as received from a 66 year old male patient with drug allergy to sulfa based medications refers to himself. The patient had no pertinent medical history. In October 2012 the patient was vaccinated with ZOSTAVAX (lot# reported as 8012576, exp September 2013) one time vaccine subdermal in the right arm. Other suspect therapies included influenza virus vaccine (lot# reported as 123023, exp May 2013) (manufacture: Narvartus). There was no concomitant medication. The patient was advised that he had itchiness starting on his back, but that the itchiness and blotches on his skin have settled into his forearm to his elbow (In October 2012) on his right arm, where the vaccine was administered. The patient had sought unspecified medical attention. No lab was given. Unspecified treatments was given for the events. No PQC involved. The outcome and action taken was not provided. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapies. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dizziness, Fatigue
Clinical narrative: This spontaneous report was received from a husband concerning his 67 year old wife (who is the patient). On 17-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date was not reported and route was injection). Concomitant medications were not reported. On 29-JAN-2013, the patient experienced some adverse experiences after she received PNEUMOVAX23. The husband stated that the patient's baseline temperature was normally 97.6 degrees Fahrenheit, however after receiving the medication, her temperature moved up to 98.6 degrees Fahrenheit. The patient had constant fatigue and felt very lightheaded. No laboratory tests were performed. At the time of this report the patient had not recovered from the reported events. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: The literature marketed report as received from a physician, author of the literature article, referred to 11 patients (age of 1-25 years old) who were diagnosed with blood malignancies (leukemias and lymphomas). Multiple studies indicated loss of immunity after chemotherapy and bone marrow transplant among pediatric cancer patients. Due to high probability of transfusions and reactivation of hepatitis B, some protocols recommend pre-screening of patients for hepatitis Bs antigen and antibody prior to the first dose of chemotherapy. We have noted that many cancer patients had negative prechemotherapy hepatitis Bs antibody even after standard immunization, while healthy controls mount a 90% response with detectable antibodies. This pilot study was developed to test the hypothesis that children with oncologic diagnoses have a prior defective immune response to standard immunization. All patients with a new malignant diagnosis from the institution over the last 2 years were included in this retrospective study. Physicians have found 44 cases from which they excluded 2 with infantile acute lymphoblastic leukemia diagnosed before one year old. All had received their full immunizations (lot#, dose/frequency and route were unspecified) prior to diagnosis.  From the included cases (age of 1-25 years old), 15/42 were found to have mounted an immune response to hepatitis B immunization, 16/42 were not reactive and 11/42 were not tested, resulting in an approximately 50% lack of immunity towards hepatitis B from the evaluated patients. When the diagnoses were analyzed, it was noted that there were 24 blood malignancies (leukemias and lymphomas) and 18 solid tumors (including brain tumors). For the blood malignancies: 11/24 had positive Hepatitis Bs antibodies, 11/24  had negative and 2/24 were not tested. For the solid tumors: 4/8 were reactive, 5/18 non-reactive and 9/18 were not tested. Even though half of solid tumors patients were not evaluated for immunity status, still the numbers show that a similar lack of immunity. This pilot study revealed that 50% of children with new cancer diagnosis have no immune response to standard hepatitis B immunization, compared with 10% of normal controls. Above data brings a different perspective on the current belief that chemotherapy results in loss of immunity suggesting a pre-existent deficiency in the immune response. A larger study would be developed shortly to confirm the pilot data and infer the significant implications of current findings. This was one of several reports that derived from the same literature link. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HPV4
Symptoms: Accidental exposure to product
Clinical narrative: This spontaneous report as received from a health care professional via field representative referred to a 4 month old patient. Patient was vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified) accidentally on an unknown date. No side effects indicated is unknown. The outcome was unknown. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. Respectively on 12-NOV-2012 and 28-FEB-2013 the patient was vaccinated with the first and second dose of VAQTA (15/0.5 U/ML) (dose, lot number not reported). No other co-suspect product were reported. No concomitant medications were reported. No adverse event reported. It was unspecified if the patient had sought medical attention. Action and causality of VAQTA was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Induration, Injection site erythema, Injection site swelling
Clinical narrative: C/O swelling and redness at injection sites Tdap. (L) arm induration 4 1/2 in long x 5 1/2 in wide. MENACTRA (R) arm induration 6 in long x 7 1/2 in wide pulse strong good cap refill.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a physician concerning a 67 year old male patient with penicillin allergy and Formoterol allergy. The physician declined to provide information regarding the pertinent medical history of the patient. On 21-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H013399 and 07-MAR-2014 respectively, dose unspecified), intramuscularly. The physician declined to provide information regarding the concomitant medications. Approximately on an unknown date in February 2013 (over a four-day period), the patient experienced painful, palm-sized, red rash at injection site. The patient sought medical attention (called the physician). No treatment was given. The physician declined to provide information regarding lab tests performed. Approximately on 28-FEB-2013 (within one weeks after administration of the PNEUMOVAX23, the patient recovered fully. The relatedness for painful, palm-sized, red rash at injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: This spontaneous report was received from the patient's mother refers to her 15 year old son with SINGULAIR allergy, ZYRTEC allergy and QVAR allergy. The patient's medical history included viral induced asthma. On an unknown date in 2012 (reported as last year), the patient was vaccinated intramuscularly with dose 1 and dose 2 of GARDASIL (lot# and dose not reported). No concomitant medications were reported. On an unknown date in 2012, the patient developed headachy and dizzy feeling after receiving each of his first 2 doses of GARDASIL. The reporter was unable to recall if the feeling also occurred with the patient's last dose as well. No treatment was received. No medical attention was sought. The outcome of headache and dizzy feeling was unknown. The relatedness for the events with GARDASIL was unknown. Additional information is not expected.