chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age (not pregnant). On 14-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# not reported) intramuscularly. The patient stated injection hurt and burned at the time of administration (14-MAY-2013). No treatment was given and the patient did not seek medical attention. Therapy of ZOSTAVX continued. On 16-MAY-2013, the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old female patient. The patient had no medical history, no concomitant medication, and no drug allergy. On 20-NOV-2013, the patient was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly for vaccination. On 20-MAY-2013 the patient was vaccinated with an expired third dose of GARDASIL lot # 668261/1397AA, exp. date 09-APR-2013, 0.5 ml, intramuscular for vaccination. The patient experienced more burning than usual during the administration on 20-MAY-2013. The nurse reported that the "burning" quickly resolved and the patient "feels better now". Outcome of event was reported as recovered on 20-MAY-2013. No treatment was given. No lab test was done. The patient sought medical attention because the patient was at physician's office during administration. Additional information is not administration.
Age: 1.13
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Case received from a health care professional on 08-May-2013. Case is medically confirmed. A male patient received the first dose of VARIVAX (lot no. not reported) and concomitantly the first dose of PRIORIX (MFR GSK, lot no. not reported) in Jan-2013. At the beginning of May 2013, the patient developed Herpes zoster. The patient showed rash on the left arm and back, but no pain. The patient's family had moved (land of occurrence), which possibly led to stress. Also solar irradiation was reported as reason (living near the border). At the time of this report, the patient had not recovered.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pruritus, Rash generalised
Clinical narrative: Mother reported on 5/20/13 - 1 wk after vaccination her son would break out in a rash all over his body - trunk and extremities - itching - requiring BENADRYL. The rash would develop during PE, same time daily. After taking BENADRYL - 1 hour later itching would stop. 5/23/13 mother has not spoken to son today to see if itching occurring.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: This case was reported by a consumer and described the occurrence of sore throat in a 34-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to CECLOR and allergy to sulfa drugs. Concurrent medications included Birth control pill. On 12 May 2013 at 17:30 the subject received unspecified dose of BOOSTRIX (unknown, left arm). On 15 May 2013, 3 days after vaccination with BOOSTRIX, the subject experienced very sore throat and chest congestion. The subject reported she received a BOOSTRIX injection on 12 May 2013 and developed a very sore throat and chest congestion on 15 May 2013. At the time of report, no other information was provided. At the time of reporting the sore throat and chest congestion were unresolved.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Rash pruritic, Skin hypopigmentation
Clinical narrative: Diarrhea, followed by worsening pruritic rash over face and perioral hypopigmentation.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling at injection site.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Local swelling
Clinical narrative: High fever, shaking, dizzines, redness and swollen in area, difficulty breathing, paleness and weakness.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Pallor, Pyrexia, Tremor
Clinical narrative: High fever, shaking, dizzines, redness and swollen in area, difficulty breathing, paleness and weakness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discolouration, Joint swelling, Pain, Swelling
Clinical narrative: Pain, redness, swelling and later a red swollen line to my elbow.  I still have a red swollen area around my elbow that is painful to touch.  I have a brown area where the vaccine was injected.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Anxiety, Induration, Rash erythematous
Clinical narrative: Parent reports unsure of actual onset of rxn.  Brings child to this clinic. Both parents state that there is no apparent s/s of systematic infection. This nurse notes area of erythematous lesion c obvious induration.  Induration is measured at approximately 65*45mm oval shaped @ midline on child's RVL.  Child is anxious et guarded throughout exam but this rxn appears to be from anxiety r/t the previous vaccinations.  Pt does not show increased guarding as this RN palpates rxn site.  Discuss c father options r/t tx, including but not limited to warm or cool moist packs as well as APAP.  Also discuss s/s that should be reported to this RN or another qualified medical professional.  Parent asks appropriate questions et voices understanding.  Phone call also made to patients mother to explain situation as well as tx options, s/s requiring reporting, and possible causes for rxn.  Mother (who is an RN) also voices understanding. Both parents will call if c/o arise.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site swelling
Clinical narrative: Left leg swollen at site of injection. Mother took him to ER, said to use cold compresses, hydrocortisone cream on leg.
Age: 19.0
Sex: M
Vaccine: YF
Symptoms: Back pain, Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt called at 2:00 PM to report nausea, vomiting and chills.  This RN spoke to him at 3:30 when he added low back pain and fever, he did not have the exact temp.  He had spoken to his primary physician who instructed him to go to the ER.  He was on his way at 3:30.
Age: 1.18
Sex: M
Vaccine: DPP
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash. Breathing problems.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash visible at site of vaccine injection over triceps muscle. Pt given course of antibiotic treatment (cephalexin) and prednisone by primary care provider.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Left leg swollen to double the size. Hard all the way up and down both sides of thigh. Red and warm to touch.
Age: 1.6
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose, persistent high fever 103+.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Body temperature increased, Computerised tomogram head normal, Gait disturbance, Lumbar puncture normal, Nuclear magnetic resonance imaging brain
Clinical narrative: Pt received vaccines 5-15-13. Pt with temp of 101.9 at home on 5-19-13 and was "walking like he was dizzy". Pt was seen at facility on 5-19-13. Pt was given morphine and VALIUM at facility to obtain CT scan of head. CT scan normal. Pt was transferred to hospital on 5-19-13 and was discharged 5-21-13. MRI at hospital showed questionable subtle signal abnormality within the subarachnoid space of bilateral occipital lobes on flair imaging, raising possibility of meningitis.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: White blood cell count decreased
Clinical narrative: Pt received vaccines 5-15-13. Pt with temp of 101.9 at home on 5-19-13 and was "walking like he was dizzy". Pt was seen at facility on 5-19-13. Pt was given morphine and VALIUM at facility to obtain CT scan of head. CT scan normal. Pt was transferred to hospital on 5-19-13 and was discharged 5-21-13. MRI at hospital showed questionable subtle signal abnormality within the subarachnoid space of bilateral occipital lobes on flair imaging, raising possibility of meningitis.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 15 month old female patient with no pertinent medical history and no drug reactions or allergies, who on 03-NOV-2006, was vaccinated subcutaneously with a dose of M-M-R II (dose and lot number not reported). It was reported that 10 days after the vaccination, on 13-NOV-2006. the patient developed fever of 106. No lab diagnostics studies were performed. The patient was possibly taken to the hospital to emergency room and was released without a hospitalization. Unspecified treatment was given for the experience. The patient recovered on an unspecified date. The relatedness for fever and M-M-R II as unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date in August 2012, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an unknown age and gender, patient with no pertinent medical history reported. The medical assistant reported that on 21-AUG-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant therapies included an Hepatitis A vaccine (manufacturer unknown) administered on 21-AUG-2012 (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date in August 2012, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 14 years old, female patient with no pertinent medical history reported. On 16-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit) for a total of 13 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 11-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 26-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. This is an amended report the adverse event codification was updated. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: TYP
Symptoms: Flatulence, Nausea
Clinical narrative: Mild nausea and gas after 1st and 2nd dose. Symptoms disappeared after 10 months.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 23-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left ar, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: 12.5 cm ax 11.5 cm area of erythema on (R) thigh at site of injections, slightly warm, started KEFLEX to cover for cellulitis, complete resolution by 5/20/13.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect dose administered, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old female patient with strong gag reflex, occasional spitter. On 20-MAY-2013 the patient received an incomplete dose of ROTATEQ (lot # not reported) (dose and route not reported), because she vomited during the administration of the first dose. When a second dose was administered, she vomited again. There was no concomitant medications. The patient was in the medical office when adverse event occurred. The patient recovered from vomiting on 20-MAY-2013. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Received vaccine on 5/15/13. Circular red rash developed at injection site and expanded to size of half-dollar. Swollen and itchy (not painful). No better/no worse as of Saturday 5/18.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Lethargy, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient. On 13-MAY-2013 the patient was vaccinated with the first dose of GARDASIL lot # H021346, exp. 01-OCT-2015, intramuscular. The physician administered the GARDASIL shot to the male patient, then had the male patient wait 10 minutes prior to leaving the office area to go complete blood work in another area of the facility. Upon completing the routine blood work, which was scheduled during this doctor's appointment, this male patient experienced lightheadedness and feeling of being dizzy. The laboratory staff then escorted the male patient back to the office area where the office nurse was informed of the patient's condition. The office nurse had the male patient lie down in the room and vital signs were taken, of which blood pressure reading of 128/109 was obtained. The office nurse continued to monitor the patient's condition which was not improving much. The patient was very lethargic and had to be shaken 3 times to be aroused along with having to have his father assist him to the bathroom "because of being out of it." After a period of 1 hour, the physician felt as though the patient was stable enough to be sent home. The physician followed up on 15-MAY-2013 with the patient who was still experiencing lightheadedness and being dizzy, "I just don't feel like myself." The patient was not recovered from the event at reporting time. Therapy with GARDASIL was reported as continued. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age (currently 19 years old) gender not reported). The reporter stated the patient received series of GARDASIL (lot # not reported) (dose not reported, intramuscular route): the first dose was received on 12-JUL-2007, the second dose received on 11-MAR-2009 and the third dose received on 02-MAR-2011. Concomitant therapy was not reported. The reporter stated not all doses were administered in the same office, yet the doses were administered within the same practice. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Rash, Tongue disorder
Clinical narrative: Pt was given ZOSTAVAX SC at 10 am 5/23/13. After vaccine pt stated burning at injection site. Rechecked pt after a few min, stated it was a little itchy. Observed pt for 15 min looked at injection site. No welt, swelling, and redness. Eval anaphylaxis. S/sx no problems w/ breathing, swelling, face or tongue. I explained to pt s/sx of anaphylaxis and what to watch for at site of injection. She said she felt fine and I told her she was free to go. Call with any problems throughout the day. Pt called me at 11:15 am stating she didn't know if she was having a reaction, but had a rash developing that you could see under magnification and the her tongue had 2 little bumps at the end of it. I asked if her breathing was ok - she needed to go to ER or primary MD office to be evaluated. She said she was fine to drive, didn't need to call 911. I called dr office to let them know I gave her the ZOSTAVAX vaccine, she had a rash starting and was coming in to be evaluated. I followed proper procedures and protocol. Pt was evaluated by dr - she came back to pharmacy with OTC meds and MD sent prednisone tapes for ADR to vaccine at 1:27 pm. I spoke with pt and told her I would check on her in a few days.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an unknown age, female patient with no pertinent medical history reported. On 23-NOV-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 20-FEB-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not see medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 0.61
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Received rotavirus #3, PREVNAR 13, IPV #3, Dtap #3, Hib #3 on 5/17/13 at clinic. Hives started morning of 5/23/13.
Age: 38.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Chills, Injection site pain, Musculoskeletal pain, Neck pain, Rash
Clinical narrative: Patient received Hepatitis A and B vaccine on 5/6/2013 had received a prior Hepatitis B as first dose years ago. Pt noted a rash below the vaccination that resolved had chills no fever. Since that c/o bilateral shoulder L>R and neck pain. No injury to area no admitted straining. Patient attributes pain directly to injection.
Age: 28.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TYP
Symptoms: Blood pressure decreased, Dizziness, Loss of consciousness
Clinical narrative: Patient became dizzy and passed out within a minute of receiving last (4th) vaccine. He passed out for 5 secs. His blood pressure dropped to 85/52 HR 43. He had sustain HR around 40 and had to be sent to ER via ambulance.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Convulsion, Musculoskeletal stiffness, Pallor, Postictal state
Clinical narrative: After leaving office, mother noticed patient stiffening and turning grey. She returned to office. Patient examined by dr. Observed for 1 hour. Dx - post vaccine seizure with post ictal phase. Sent home/fluids and rest. Dr called at 20:40, no further episodes doing fine, per mom.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Pyrexia, Tympanometry abnormal
Clinical narrative: Febrile illness 103-104 degrees x 24 hours.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypopnoea, Somnolence
Clinical narrative: Patient felt drowsy after the episode with few seconds of shallow breathing. Lasting for about 2-3 minutes.
Age: 49.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: MD ordered Tdap. Mistakenly given Dtap. No adverse reactions noted after administration. Immunization coordinator, MD made aware of event. Followed appropriate procedure for error.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Rash erythematous
Clinical narrative: Within 5 minutes burning at site of injection. Mild redness about 1" in diameter. Given 25mg diphenhydramine 25mg. Within 5 minutes burning subsided. Rash pink 1" in length 1/2" width.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Eating disorder, Fluid intake reduced, Irritability, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 15 month old male patient with no pertinent medical history and no drug reactions or allergies. On 16-APR-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # H017243, expiration date 17-SEP-2014) SQ. There was no concomitant medication. The medical assistant reported that on 20-APR-2013, the patient experienced a fever of 101.5 F throughout the night, had a rash on the stomach, arm, face, legs and back, rash was worse in the diaper area, hands and feet. The patient had a rash, redness, and soreness at the injection site. The patient was treated with TYLENOL and MOTRIN. There were no lab diagnosis/studies performed. At the time of the report, the patient had recovered. The medical assistant requested a lot check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 15 month old male patient with no pertinent medical history and no drug reactions or allergies. On 16-APR-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # H017243, expiration date 17-SEP-2014) SQ. There was no concomitant medication. The medical assistant reported that on 20-APR-2013, the patient experienced a fever of 101.5 F throughout the night, had a rash on the stomach, arm, face, legs and back, rash was worse in the diaper area, hands and feet. The patient had a rash, redness, and soreness at the injection site. The patient was treated with TYLENOL and MOTRIN. There were no lab diagnosis/studies performed. At the time of the report, the patient had recovered. The medical assistant requested a lot check. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Vaccine on Monday. Thursday pt presents to physician's office with fever, chills, possible cellulitis, and severe vaginal herpetic infection.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Genital herpes, Pyrexia
Clinical narrative: Vaccine on Monday. Thursday pt presents to physician's office with fever, chills, possible cellulitis, and severe vaginal herpetic infection.
Age: 1.37
Sex: M
Vaccine: HEP
Symptoms: Insomnia, Irritability, Pain, Pyrexia, Vomiting
Clinical narrative: Initially irritability and soreness, then vomiting and high fever.  High fever and vomiting continue.  Difficulty sleeping.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 14-SEP-2013, the patient was vaccinated with dose 1 of RECOMBIVAX HB, (lot number, expiry date and route was not reporter) On 04-FEB-2013, the patient was vaccinated with dose 2 of RECOMBIVAX HB, (lot number, expiry date and route was not reported) which was late. Concomitant medications were not reported. No symptoms were reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 13 years old male patient. In 2011 the patient was vaccinated with first dose of GARDASIL (dose, route, injection site, lot# and indication not provided). On 17-MAY-2013 (reported as now) the patient was vaccinated with the second dose of GARDASIL (dose, route, injection site, lot# and indication not provided). The reporter stated that the patient was late for his second dose of GARDASIL. No adverse effects reported. The outcome of events was unknown. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 12 month old patient. Physician assistant reported that patient was given a dose of VARIVAX (merck) (strength, formulation, lot#, dose/frequency, route and duration were unspecified) in one arm and a dose of PROQUAD (merck) (strength, formulation, lot#, dose/frequency, route and duration were unspecified) in the other arm during one office visit (date unspecified). No adverse effect reported. Outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Multi-organ failure
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender with immunosuppression (unspecified medical condition) who several years ago on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The physician reported that he saw the patient who was given ZOSTAVAX and the patient eventually experienced multiple organ failure. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for multi organ failure and ZOSTAVAX was unknown. Upon internal review multi-organ failure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. Nurse noted that patient was administered the first dose in the VARIVAX (Merck) (strength, formulation, lot#, dose/frequency, route were unspecified) vaccination series on 22-MAR-2013. On 21-MAY-2013, the patient was inadvertently administered ZOSTAVAX (subcutaneous, strength, formulation, lot#, dose/frequency and duration were unspecified) instead of VARIVAX (Merck) for the second dose in the VARIVAX (Merck) vaccination series. No adverse effect reported. Patient present status was reported as other: no known adverse effect. Outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. In 2008 the patient was vaccinated with first dose of VARIVAX (merck) (dose, route and lot# not reported). In 2010 the patient was vaccinated with second dose of VARIVAX (merck) (dose, route and lot# not reported). It was reported that a recent varicella titer of the patient was low at 0.91, in approximately May 2013. The outcome of the patient was reported as not recovered. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient received her 12 month vaccines and within minutes developed hives on face and at site of administration of vaccines with more present left > right thigh. Afebrile; normal lung exam; given BENADRYL with improvement.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a female consumer via company representative who refers to her niece. On an unknown date the patient was vaccinated with GARDASIL (route, dose, number of doses, lot# not reported). As was reported that on an unknown date the patient died from complications while using GARDASIL. No more information were provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and Office Manager refers to a female patient of unknown age. The patient's medical history included had antibiotics therapy, prior to receiving ZOSTAVAX. On 11-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000447, in deltoid area (dose, route and expiration date were not reported). After vaccination, on an unknown date in 2013, the patient experienced reaction at the injection site (deltoid area), which was red, with swelling and heat. The outcome of events was reported as recovered/resolved. The relatedness between event and ZOSTAVAX was not reported. It is unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous information as received from an Office Manager refers to a female patient of unknown age. Medical history and concomitant medication were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not reported). On an unknown date the patient experienced mild reaction to ZOSTAVAX. The outcome of event is unknown. It was not reported if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 1.42
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site papule, Injection site scar
Clinical narrative: Redness and swelling to injection site (RLT). 2 or more fluid-filled papules at site after 7 days post injection. Papules resolved, pt's mother did not notice scabbing to area, but area remains discolored - scar-like appearance. Lump to area remained x 1 mo., but did resolve.
Age: 1.42
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Redness and swelling to injection site (RLT). 2 or more fluid-filled papules at site after 7 days post injection. Papules resolved, pt's mother did not notice scabbing to area, but area remains discolored - scar-like appearance. Lump to area remained x 1 mo., but did resolve.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and Office Manager refers to a female patient of unknown age. On 21-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000444, in deltoid area (dose and route was not reported). On an unknown date in 2013, after vaccination, the patient experienced reaction at the injection site (deltoid area), which was red, with swelling and heat. The patient was diagnosed with cellulitis and was treated with MEDROL patch. The outcome of events was reported as recovered. The relatedness between event and ZOSTAVAX was not reported. The Licensed Practical Nurse stated that pharmacy had quarantined the ZOSTAVAX vaccine with the Lot number J000444. This is one of several reports from the same source. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report received from a nurse (R.N.) refers to a 3 month old male patient. On 27-MAY-2013 the patient was vaccinated with a dose of PEDVAXHIB (lot # reported as 1531AA, exp. date 20-MAR-2013) (dose, route, injection site and indication not provided). On 17-MAY-2013, the patient administration of an expired dose of PEDVAXHIB. The outcome of the event was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Redness to arm; swelling to arm 6 cm redness below site of injection, warm painful to touch.
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: This is a spontaneous report by a contactable physician. A Pfizer Sales Representative reported on behalf of a physician for his female nurse who received PREVNAR 13 at 0.5ml single dose, intramuscular injection for immunization in Aug2012. Relevant medical history included unspecified condition. Relevant concomitant medications were unknown. Vaccine given on the same day and vaccines taken within the last four weeks were unknown. In Aug2012 the patient experienced severe unspecified reaction at the site of administration which she explained as inflammation and cellulitis. Therapeutic measures taken in response to the events included BACTRIM oral tablet and unspecified medication. Relevant lab data was unknown. At the time of the report she had recovered from all the above mentioned events on an unknown date.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report was received on 14 May 2013 from a non health care professional. A female patient (14-year-old at the time of the report) had received within the past three years at age 11 years DTaP (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount time later was confirmed to have pertussis (date of onset was not reported). No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2013-06013. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report was received on 14 May 2013 from a non health care professional. A male patient (12 years-old at the time of the report) had received within the past year at age 11 years DTaP (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later was confirmed to have pertussis (date of onset was not reported). No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2013-06012. Documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Troponin I normal
Clinical narrative: This study case was received from the investigator in a trial on 17 May 2013. A 32-year-old male subject whose past medical history included elevated cholesterol and eczema was found to have chest pain, unspecified 5 days after the subject had received the following vaccines on 20 November 2012: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and INFLUENZA, LIVE, INTRANASAL (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included on 25 November 2012: a normal Troponin I and an abnormal ECG. On 26 November 2012, the subject had a normal Echocardiogram. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Localized, indurated, erythema, swelling, 6 x 6 cm in size on (R) lateral upper arm.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 13 May 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject's medical history was not reported. The subject had received four doses of PENTACEL: dose one of PENTACEL, lot number C3305AA received on 23 June 2009; dose two of PENTACEL, lot number C3431AA, received on 01 September 2009; dose three of PENTACEL lot number C3497AA received on 22 October 2009; and dose four of PENTACEL, lot number C3670AA, received on 06 August 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 20 April 2013, approximately two years and eight months after the last dose. On 20 April 2013, the subject developed a cough and paroxysmal cough on same date, 20 April 2013, with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 08 May 2013. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 08 May 2013 for five days. The subject was not hospitalized. At the time of final contact on 09 May 2013, the subject's cough was still persisting. The duration of the cough was reported as 19 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 13 May 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject's medical history was not reported. The subject had received four doses of PENTACEL: dose one of PENTACEL, lot number C3305AA received on 23 June 2009; dose two of PENTACEL, lot number C3431AA, received on 01 September 2009; dose three of PENTACEL lot number C3497AA received on 22 October 2009; and dose four of PENTACEL, lot number C3670AA, received on 06 August 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 20 April 2013, approximately two years and eight months after the last dose. On 20 April 2013, the subject developed a cough and paroxysmal cough on same date, 20 April 2013, with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 08 May 2013. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 08 May 2013 for five days. The subject was not hospitalized. At the time of final contact on 09 May 2013, the subject's cough was still persisting. The duration of the cough was reported as 19 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Catatonia, Febrile convulsion, Heart rate increased, Laboratory test normal
Clinical narrative: Information was received from an investigator concerning a 15 month old female, who entered a study. On 11-APR-2012, consent was obtained and the subject was randomized to be vaccinated with DTaP-HepB-Hib-IPV, PREVNAR 13 and rotavirus vaccine live at 2, 4, and 6 months of age. On 11-APR-2011 (as reported by the site), 08-JUN-2012 and 27-AUG-2012, the subject was vaccinated IM with the first, second and third 0.5 ml dose, respectively, of DTap-HepB-Hib-IPV (injection site not reported). Other study vaccines include the first, second and third IM 0.5 ml dose, respectively, of PREVNAR 13 (injection site not reported) and first, second and third PO 2 ml dose, respectively, of rotavirus vaccine live. On 08-MAY-2013 the subject was vaccined with toddler dose in study series with the fourth 0.5ml IM dose of PREVNAR 13 (injection site not reported) and the first 0.5ml IM dose of PENTACEL (injection site not reported) to complete the childhood immunization series. There was no secondary suspect therapy. Previous therapy history included Hep B on 06-FEB-2012. On 08-MAY-2013, subject experienced febrile seizure (intensity severe) and was hospitalized. On 08-MAY-2013, subject was seen for well child check, was in good health and no fever. Subject was given 15 month vaccines at 12:15. At 16:50, subject's mother contacted the office and reported they had taken the subject to the ER due to the subject had a seizure. Per parent; after leaving the office, subject was acting normal-talking, laughing, eating, "etc". At about 15:30, subject had a seizure, described as a catatonic state, subject would not repond to parents and seemed a "little stiff" and had a rapid heartbeat. Subject was brought immediately to the local ER. Temperature taken in the ER was 103 (unit of measurement not reported). On 09-MAY-2013, subject was seen in office for re-check following ER visit: physical exam was normal along with labs that were checked (not further specified). On 08-MAY-2013, subject recovered from febrile seizure. There was no action taken with study vaccine therapy. The reporting investigator considered febrile seizure as not related to the first, second and third dose of DTaP-HepB-Hib-IPV, PREVNAR 13, rotavirus vaccine live but related to the fourth dose of PREVNAR 13 and the first dose of PENTACEL. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Information was received from an investigator concerning a 15 month old female, who entered a study. On 11-APR-2012, consent was obtained and the subject was randomized to be vaccinated with DTaP-HepB-Hib-IPV, PREVNAR 13 and rotavirus vaccine live at 2, 4, and 6 months of age. On 11-APR-2011 (as reported by the site), 08-JUN-2012 and 27-AUG-2012, the subject was vaccinated IM with the first, second and third 0.5 ml dose, respectively, of DTap-HepB-Hib-IPV (injection site not reported). Other study vaccines include the first, second and third IM 0.5 ml dose, respectively, of PREVNAR 13 (injection site not reported) and first, second and third PO 2 ml dose, respectively, of rotavirus vaccine live. On 08-MAY-2013 the subject was vaccined with toddler dose in study series with the fourth 0.5ml IM dose of PREVNAR 13 (injection site not reported) and the first 0.5ml IM dose of PENTACEL (injection site not reported) to complete the childhood immunization series. There was no secondary suspect therapy. Previous therapy history included Hep B on 06-FEB-2012. On 08-MAY-2013, subject experienced febrile seizure (intensity severe) and was hospitalized. On 08-MAY-2013, subject was seen for well child check, was in good health and no fever. Subject was given 15 month vaccines at 12:15. At 16:50, subject's mother contacted the office and reported they had taken the subject to the ER due to the subject had a seizure. Per parent; after leaving the office, subject was acting normal-talking, laughing, eating, "etc". At about 15:30, subject had a seizure, described as a catatonic state, subject would not repond to parents and seemed a "little stiff" and had a rapid heartbeat. Subject was brought immediately to the local ER. Temperature taken in the ER was 103 (unit of measurement not reported). On 09-MAY-2013, subject was seen in office for re-check following ER visit: physical exam was normal along with labs that were checked (not further specified). On 08-MAY-2013, subject recovered from febrile seizure. There was no action taken with study vaccine therapy. The reporting investigator considered febrile seizure as not related to the first, second and third dose of DTaP-HepB-Hib-IPV, PREVNAR 13, rotavirus vaccine live but related to the fourth dose of PREVNAR 13 and the first dose of PENTACEL. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Eye pain, Gastric hypermotility, Headache, Hyporesponsive to stimuli, Migraine
Clinical narrative: Laid down and woke with acute headache/migraine pain focal point behind left eye - extreme photosensitivity - pain led to increased gastric emptying and severe nausea and vomiting - unable to respond/vocalize at times during the pain. Subsided around 2AM 5/18/13 - most intense headache of my life 9/10 pain.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Photosensitivity reaction, Vomiting
Clinical narrative: Laid down and woke with acute headache/migraine pain focal point behind left eye - extreme photosensitivity - pain led to increased gastric emptying and severe nausea and vomiting - unable to respond/vocalize at times during the pain. Subsided around 2AM 5/18/13 - most intense headache of my life 9/10 pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swelling and painful.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash papular
Clinical narrative: Child started with sudden onset of fevers up to 102.6 degrees F on 5/18. In the morning, next day he was noticed with erythematous fine papular rash on trunk/lower face. Spread to upper limbs not to lower limbs yet on 5/20. Child had T about 102.6 F, retroauricular bilat soft adenopathies/rash papular erythematous on lower face, trunk, arms. Not on palms, soles/lower limbs. No toxic appearance eating well.