chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Decreased activity, Rash, Speech disorder developmental, Swelling
Clinical narrative: Swelling, Rash that lasted several days. After the shots delayed speech, less playing as well.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: This case was reported by a other health professional and described the occurrence of influenza in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown. It was unknown if the reporter considered the influenza to be related to FLUARIX QUADRIVALENT. Additional information: three patients vaccinated with FLUARIX QIV that got the flu later in the season. MD did not have any further information at this time.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis, Haemoptysis, Productive cough
Clinical narrative: Bloody phlegm; coughing blood; nose bleeding
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: After a week of receiving vaccines, lt upper arm noted with bruising and tender to touch. 1/15/15 in clinic noted bruising to injection sites. Fresh large bruise noted to left inner arm and elbow area. Tender to touch. Instructed to apply ice pack to area. If symptoms worsen, report to private Dr or ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Nausea, vomiting, diarrhea day of vaccine. Softball size redness at injection site. Also hardness and swelling, pain, and heat at injection site, day of vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea day of vaccine. Softball size redness at injection site. Also hardness and swelling, pain, and heat at injection site, day of vaccine.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Palpitations
Clinical narrative: Palpatations, left upper arm redness, pain.
Age: 1.19
Sex: F
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Influenza virus test negative, Pyrexia
Clinical narrative: High fever to 104.7 rectal
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Area of arm redness, induration, pain (several cm) in area surrounding inj site.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Abdominal pain upper, Erythema nodosum, Headache, Nausea, Pyrexia
Clinical narrative: Developed: headache, nausea, stomachache and "fever" several hours after vaccination. (Temp not checked). Seen in ER on 11/17/14 to eval bumps on lower legs. COPA visit on 11/18/14: Painful lower leg bumps w/o itch. No cough, slight runny nose, no vomit/diarrhea, afebrile. No sore throat. Dx with erythema Nodosum (possibly due to Tdap). Rx: Ibuprofen every 6 hours.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Rash, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Developed: headache, nausea, stomachache and "fever" several hours after vaccination. (Temp not checked). Seen in ER on 11/17/14 to eval bumps on lower legs. COPA visit on 11/18/14: Painful lower leg bumps w/o itch. No cough, slight runny nose, no vomit/diarrhea, afebrile. No sore throat. Dx with erythema Nodosum (possibly due to Tdap). Rx: Ibuprofen every 6 hours.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Cough, Diarrhoea, Eye discharge, Influenza virus test negative, Pyrexia
Clinical narrative: 3 hrs after vaccine - vomiting, diarrhea, fever-102.6, dry heaves. Runny nose, cough, eye matting, vomiting, loose stools, fever 100 degrees continuing after 3 days.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Retching, Rhinorrhoea, Vomiting
Clinical narrative: 3 hrs after vaccine - vomiting, diarrhea, fever-102.6, dry heaves. Runny nose, cough, eye matting, vomiting, loose stools, fever 100 degrees continuing after 3 days.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Increased muscle weakness for 6 days.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Headache, Injection site reaction
Clinical narrative: Pt had injection site rxn following admin. trted with hot/cold compress tneu and APAP. About 2 wks later had dizziness and headache. She attributes this to the PREVNAR 13. Went to ER got DECADRON shot/BENADRYL... then later saw reg MD and told her to just cont BENADRYL saying its still occurring as of 12/19/14.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Fall
Clinical narrative: Pt was standing in x-ray dept waiting for sibling and suddenly leaned against doorway and slid to ground. Pt quickly awoke and sat in wheelchair by time nurse arrived. Cold ice pack placed behind neck. Pt sat in chair for approximately 15 min had some orange juice then left.
Age: 3.0
Sex: F
Vaccine: DTAP, FLUN4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right thigh - site of injection - 6" x 7.5" of erythema and induration, warm to touch - observe, cool compresses, ibuprofen.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Student was pregnant at time of vaccine administration. Denied being pregnant/possibility of getting pregnant over next couple months. Found to be pregnant on 11/14/15 after visiting doctor on 1/14/15. Pregnancy identified by Dr, ob/gyn. EDD in April 2015.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cyanosis, Lethargy, Nausea, Pallor
Clinical narrative: Infant several hours after vaccines were administered developed nausea, pallor, lethargy, circumoral cyanosis. No apnea was noted.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Musculoskeletal stiffness, Screaming
Clinical narrative: One hour after receiving vaccines, she started crying hard, screaming, and her body would be stiff every 2 minutes. This lasted 2 hours mom gave TYLENOL. No fever.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: 24 hrs after administration had T=102.6 and con't to spike fevers > 101.5 x 48 hrs. After temps subsided had myalgias x 24 hrs and gen. fatigue x 5-6 days. Last year spiked fevers to 101 24 hours after flu vaccine.
Age: 1.39
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: 2nd flu vaccine administered approx 8:20 am 1/15/15. Mom called approx 2:15 pm and reports rash to bil legs as reported by daycare. No respiratory issues. Was seen in office at 15:00 - given BENADRYL.
Sex: U
Vaccine: RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The physician reported that a patient on unknown dates was vaccinated with first dose ROTARIX and was vaccinated with second dose of ROTATEQ. The third dose of Rotavirus vaccine had not yet been administered. The pharmacy staff stated there was no adverse experience reported from the patient after administration of vaccines. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant regarding an unspecified number of patients (demographics not provided). On an unknown date, an unspecified amount of doses of ROTATEQ (route of administration not provided) that underwent temperature excursions were administered to an unspecified amount of patients. No adverse effect reported. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of breathing rate slowed in a 65-year-old female patient who received Flu Seasonal TIV Dresden. Co-suspect products fluticasone propionate, ADVAIR DISKUS inhalation powder (batch number AZP5555, expiry date January 2016) and (batch number 4ZP5555, expiry date January 2016) for asthma. Concurrent medical conditions included asthma. Concomitant products included PROAIR (nos) and lovastatin. On 14th October 2014 10:15, the patient received influenza vaccine unspecified (intramuscular). In 2001, the patient started ADVAIR DISKUS (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. On 14th October 2014, an unknown time after receiving Influenza vaccine unspecified and ADVAIR DISKUS, the patient experienced injection site pain, injection site induration, injection site swelling and injection site itching. On 16th October 2014, the patient experienced breathing rate slowed, tightness in chest and cough nonproductive. On 20th October 2014, the patient experienced night sweat. ADVAIR DISKUS was continued with no change. On 18th October 2014, the outcome of the injection site pain, injection site induration, injection site swelling and injection site itching were recovered/resoled. On 21st October 2014, the outcome of the night sweat was recovered/resolved. On unknown date, the outcome of the breathing rate slowed, tightness in chest and cough nonproductive were recovering/resolving. It was unknown if the reporter considered the breathing rate slowed, tightness in chest, cough nonproductive, night sweat, injection site pain, injection site induration, injection site swelling and injection site itching to be related to Influenza vaccine unspecified. It was unknown if the reporter considered the breathing rate slowed, tightness in chest, cough nonproductive and night sweat to be related to ADVAIR DISKUS. Additional information received on 22 October 2014: This patient underwent a physical last Tuesday and everything was normal. Two days later she began to experience a constant decline in her breathing and not feeling like she was breathing right. She almost went to the hospital ER on Monday night but took a couple extra doses of PROAIR and her breathing is improving. She also received a flu vaccination during this physical and experienced what seemed to be an injection sight reaction.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Night sweats, Respiration abnormal, Respiratory rate decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of breathing rate slowed in a 65-year-old female patient who received Flu Seasonal TIV Dresden. Co-suspect products fluticasone propionate, ADVAIR DISKUS inhalation powder (batch number AZP5555, expiry date January 2016) and (batch number 4ZP5555, expiry date January 2016) for asthma. Concurrent medical conditions included asthma. Concomitant products included PROAIR (nos) and lovastatin. On 14th October 2014 10:15, the patient received influenza vaccine unspecified (intramuscular). In 2001, the patient started ADVAIR DISKUS (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. On 14th October 2014, an unknown time after receiving Influenza vaccine unspecified and ADVAIR DISKUS, the patient experienced injection site pain, injection site induration, injection site swelling and injection site itching. On 16th October 2014, the patient experienced breathing rate slowed, tightness in chest and cough nonproductive. On 20th October 2014, the patient experienced night sweat. ADVAIR DISKUS was continued with no change. On 18th October 2014, the outcome of the injection site pain, injection site induration, injection site swelling and injection site itching were recovered/resoled. On 21st October 2014, the outcome of the night sweat was recovered/resolved. On unknown date, the outcome of the breathing rate slowed, tightness in chest and cough nonproductive were recovering/resolving. It was unknown if the reporter considered the breathing rate slowed, tightness in chest, cough nonproductive, night sweat, injection site pain, injection site induration, injection site swelling and injection site itching to be related to Influenza vaccine unspecified. It was unknown if the reporter considered the breathing rate slowed, tightness in chest, cough nonproductive and night sweat to be related to ADVAIR DISKUS. Additional information received on 22 October 2014: This patient underwent a physical last Tuesday and everything was normal. Two days later she began to experience a constant decline in her breathing and not feeling like she was breathing right. She almost went to the hospital ER on Monday night but took a couple extra doses of PROAIR and her breathing is improving. She also received a flu vaccination during this physical and experienced what seemed to be an injection sight reaction.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with doses of oral, ROTATEQ (dose, route of administration, anatomical location, lot# and exp.date were not reported) that underwent a temperature excursion. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In 2014 (exact date unspecified, reported as between 26-NOV-2014 through 01-DEC-2014) those patients received an improperly stored oral, ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse symptoms reported. The temperature excursion for all vaccines was found to be supported with in-house stability data. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age and unknown ethnicity with routine vaccination. On 29-SEP-2014 the patient was vaccinated with ROTATEQ, (lot # was not provided), oral for routine vaccination. On 29-SEP-2014, 1 day after onset of therapy the patient experienced after an unspecified infant patient received a dose of ROTATEQ, he vomited and we are not sure he received the full dose and after an unspecified infant received  a dose of ROTATEQ, he vomited. When asked the patient's present status the nurse stated "he was back in the office today (date unknown) got another dose of ROTATEQ and was fine.  The outcome of after an unspecified infant patient received a dose of ROTATEQ, he vomited and we are not sure he received the full dose and after an unspecified infant patient received a dose ROTATEQ, he vomited is unknown. Action taken with the therapy drug was unknown. The reporter considered after unspecified infant patient received a dose of ROTATEQ, he vomited and we are not sure he received the full dose and after an unspecified infant patient received a dose of ROTATEQ, he vomited to be not related to ROTATEQ. Additional information is not expected.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received on 09-DEC-2014, from a female consumer (age not reported) reporting on herself. The female patient reported "I had a reaction to a pneumonia shot." No dates provided. The manufacturer was not further specified. The patient could not provided the specific name of the product she received so PNEUMOVAX23 could not be ruled out in this case.  Treatment and outcome of the event was not reported. No further adverse event information was provided.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Arthropathy, Blood pressure increased, Condition aggravated, Erythema, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received on 09-DEC-2014, from a female consumer (age not reported) reporting on herself. The female patient reported "I had a reaction to a pneumonia shot." No dates provided. The manufacturer was not further specified. The patient could not provided the specific name of the product she received so PNEUMOVAX23 could not be ruled out in this case.  Treatment and outcome of the event was not reported. No further adverse event information was provided.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: This spontaneous report was received on 09-DEC-2014, from a female consumer (age not reported) reporting on herself. The female patient reported "I had a reaction to a pneumonia shot." No dates provided. The manufacturer was not further specified. The patient could not provided the specific name of the product she received so PNEUMOVAX23 could not be ruled out in this case.  Treatment and outcome of the event was not reported. No further adverse event information was provided.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received on 09-DEC-2014, from a female consumer (age not reported) reporting on herself. The female patient reported "I had a reaction to a pneumonia shot." No dates provided. The manufacturer was not further specified. The patient could not provided the specific name of the product she received so PNEUMOVAX23 could not be ruled out in this case.  Treatment and outcome of the event was not reported. No further adverse event information was provided.
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a male patient who received ENGERIX B adult (batch number FB3A3, expiry date 28th January 2016. Concomitant products included TWINRIX. On an unknown date, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced wrong vaccine administered and drug dose administration interval too long. On an unknown date, the outcome of the wrong vaccine administered and drug dose administration interval too long were unknown. Additional information: TWINRIX was started on 0, 1 and 6 month schedule. The patient received TWINRIX at dose 1 but was inadvertently given ENGERIX-B for dose 2. The patient was also late on the schedule. He received the ENGERIX-B dose 2 months after dose 1 of TWINRIX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, raised-sign of swelling to the size of a lemon.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender who on 26-AUG-2013 and on 15-OCT-2014 was vaccinated with a doses of GARDASIL (dose, lot #, expiration date and route were not reported) respectively. No known adverse effects. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients medical history was not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (therapy type, dose, route, lot# and expiration date were not reported), exposed to 50.5 F for 77 hours and 44 minutes. Concomitant medication was not reported. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients medical history was not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose, route, lot# and expiration date were not reported), exposed to 50.5 for 77 hours and 44 minutes. Concomitant medication was not reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis
Clinical narrative: This spontaneous report has been received from a healthcare provider via a field representative concerning a 56 year old female patient. The patient's medical history and drug reactions/allergies were not specified. On 19-DEC-2014 the patient was vaccinated with PNEUMOVAX23 lot # K009105, expiration date 21-JAN-2016, (dose, frequency and route was not provided). Then the patient was seen at an urgent care center on 21-DEC-2014, and was diagnosed with bronchitis. On 05-JAN-2015, the patient was seen in the office and was prescribed unspecified antibiotics and was scheduled for a chest x-ray which was not performed at the time of reporting. The outcome of bronchitis was reported as not recovered/not resolved. The causality of PNEUMOVAX23 to the event of bronchitis was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: This spontaneous report as received from a 56 years old female patient refers to herself. Patient's concurrent condition included fibromyalgia, anxiety and other unspecified medical issues. She was allergic to LYRICA and penicillin. On 06-JAN-2015 the patient was vaccinated with ZOSTAVAX 0.65 ml, injection in the right arm (route, lot # not reported). Concomitant therapies included acetaminophen, NORCO, OXYCONTIN, PRELONE, diazepam (manufacturer unknown), 37.5 (units not provided) EFFEXOR, PROTONIX and 1 mg estrogen (unspecified). On 06-JAN-2015 within 30 minutes after receiving the vaccine the patient felt "dopey and foggy headed". Then later on the same day she experienced itching all over her body and the injection area became swollen, painful and hot as well. The patient sought medical attention and spoke with the physician. As a medical treatment she took hydroxyzine and iced the injection site. There were no lab diagnostic studies performed. The adverse events lasted "6-7 days" and by the time of the report were improving (recovering). Relatedness between the events and ZOSTAVAX was not specified. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 68 year old female patient with no drug reactions/allergies. No information on patient's medical history or concomitant therapy was provided. On 13-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 (route, dose and frequency not reported, lot # not reported as K018528). On 14-JAN-2015 (also reported as today) the patient called the office to report extreme tenderness, redness and swelling about the size of a half dollar at the injection site. There was no lab diagnostic studies performed. The nurse reported that advised the patient to administer cold compresses to the site and ibuprofen as needed to treat the symptoms. Patient's present status was reported as not recovered. The patient sought medical attention and called to physician office. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Axillary pain, Oedema peripheral, Skin irritation
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. No information on his medical history and current condition was provided. On 17-NOV-2014, the patient was vaccinated with a dose (unspecified) of GARDASIL (route intramuscular, dose, lot number and expiration date were not reported). No concomitant medications were reported. On 20-NOV-2014, the patient experienced swelling, pain and irritation in the axillary area of his arm, after receiving GARDASIL. The patient sought medical attention and had an office visit with his physician on unspecified day. No information about lab diagnostics and studies performed. It was unspecified which dose of dosing series of GARDASIL the patient received so far and if the patient will receive any subsequent doses. The outcome of the swelling, pain and irritation in the axillary area of patient's arm was not reported. The relatedness between the events and GARDASIL was not provided. No product quality complaint was filled. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VAQTA (lo#, expiration date, dose and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 65 year old female patient via hall partners concerning herself, who enter a patient support program, title as H-5432, ZOSTAVAX patient segmentation message testing. The patient's concurrent condition included premature arthritis, high blood pressure and diabetes. The patient's medical history included heart valve (mitral valve) replacement. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, dose and lot # were unknown). Concomitant therapies included HUMIRA, COUMADIN, simvastatin (manufacturer unknown) and metformin. On an unknown date of November 2014 the patient experienced redness and soreness at injection site for 1 1/2 weeks. The outcome of events was reported as recovered/resolved with sequelae an unknown date of 2014 (reported as 1 1/2 weeks post injection). The reporter the events to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a male patient in his sixties. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (route, lot#, dose and frequency unknown). ADACEL was concomitantly given on the same day. A week later the patient developed "shingles". The patient sought medical attention via office contact. The outcome of shingles was unknown. The relationship of the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Asthma
Clinical narrative: This spontaneous report has been received from a nurse refers to a patient of unknown age and gender. On unknown date in 2003 the patient was vaccinated with the first dose of VARIVAX (Merck) (Lot number, dose and frequency were unknown). The patient was late for the second dose of VARIVAX (Merck). No adverse effects were caused by the first dose of VARIVAX (Merck). At the time of reporting, the patient was on prednisone which the reporter thought it was used for asthma. The outcome of asthma was not reported. The reporting nurse questioned if the second dose of VARIVAX (Merck) could be administered due to drug interaction with prednisone. Additional information is not expected because the reporter did not want to be contacted.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 18 year old female patient. No medical history or concurrent conditions reported. On 31-JUL-2013 the patient was vaccinated with the first dose of GARDASIL. (Route, lot# and expiration date were not provided). Concomitant therapy was not reported. On 21-OCT-2014 the patient was vaccinated with the second dose of GARDASIL (route, lot# and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 1 year old female patient. The health care worker reported that her 1 year old granddaughter may have been vaccinated with a dose of HPV vaccine (unspecified) and could not rule out GARDASIL administration. The health care worker reported that in APR-2014, the patient was seen at physician's office and it was documented on the patient's immunization record that the patient received one dose of HPV vaccine (unspecified) and that the physician's office was unsure if the patient received the dose. No adverse effects reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional reefers to a 2 year old female patient. On 05-OCT-2014, the patient was vaccinated with VAQTA (lot # K001792, expiry date: 22-OCT-2015) intramuscular in the left leg (reported as left vastus lateralis (VL)), that had been improperly stored. Number of previous doses administered was not reported. There had been no reported adverse events and no need for revaccination from the time of administration. The staff was still gathering information regarding the reported adverse event of incorrect product storage. No adverse reaction was reported. This is one of several reports received from the same source (MARRS # 1411USA008692, MARRS # 1501USA004614 and MARRS # 1501USA004615). Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 12 month old female patient. On 14-OCT-2014, the patient was vaccinated with a dose of VAQTA (lot # K008219, expiry date: not provided) dose 1, 0.5 ml, intramuscular in the left leg (reported as left vastus lateralis (VL), that had been improperly stored. Number of previous doses reported as 0. There had been no reported adverse events and no need for revaccination from the time of administration. The staff was still gathering information regarding the reported adverse event incorrect product storage. No adverse reaction was reported. This is one of several reports received from the same source (MARRS # 1411USA008692, MARRS # 1501USA004615 and MARRS # 1501USA004616). Additional information has been requested.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a 18 month old male patient. On 22-OCT-2014, the patient was vaccinated with VAQTA (lot # K008219, expiry date: not provided) dose 2, intramuscular in the left leg (reported as left vastus lateralis (VL)), that had been improperly stored. Number of previous doses reported as 1. There had been no reported adverse events and no need for revaccination from the time of administration. The staff was still gathering information regarding the reported adverse event of incorrect product storage. No adverse reaction was reported. This is one of several reports received from the same source (MARRS # 1411USA008692, MARRS # 1501USA004614 and MARRS # 1501USA004616). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant regarding an unspecified number of patients (demographics not provided). On an unknown date, an unspecified amount of doses of PEDVAXHIB (route of administration not provided) that underwent temperature excursions were administered to an unspecified amount of patients. No adverse effect reported. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant regarding an unspecified number of patients (demographics not provided). On an unknown date, an unspecified amount of doses of GARDASIL (route of administration not provided) that underwent temperature excursions were administered to an unspecified amount of patients. No adverse effect reported. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information was received from a medical assistant regarding an unspecified number of patients (demographics not provided). On an unknown date, an unspecified amount of doses of VARIVAX (Merck) (route of administration not provided) were administered to an unspecified amount of patients. No adverse effect reported. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician, (physician received a call from a pharmacy) refers to a patient of unknown age and gender. No pertinent medical history or current conditions reported. On an unknown date the patient was vaccinated with an expired dose of GARDASIL. (That was patient's second dose). (Route, lot# and expiration date were not provided). Concomitant therapy was not provided. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a male patient of unknown age, who on 07-OCT-2014, was vaccinated with a dose of M-M-R II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, route of administration were not provided, lot # J011548 with expiration date: 19-DEC-2015). No adverse symptoms reported. The ZOSTAVAX did not have previous temperature excursions. ZOSTAVAX was supported with post expiry data. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a female patient of unknown age, who on 08-OCT-2014, was vaccinated with a dose of MMR II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-JAN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # J013345, expiration date: 11-JAN-2015), dose and route not were reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. In August 2013 the patient was vaccinated with the first dose of GARDASIL (injection, route of administration, lot number and expiry date were not reported). In approximately in January 2015 the patient wanted to be vaccinated with the second dose of GARDASIL. No adverse symptom was reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a male patient of unkonwn age, who on 09-OCT-2014, was vaccinated with a dose of M-M-R II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dyspnoea, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 68 year old female patient with COPD and emphysema who on 04-DEC-2014 was vaccinated with ZOSTAVAX. Concomitant therapies included COUMADIN. The patient reported, "the day after I received ZOSTAVAX on 05-DEC-2014, the area around the injection site was pink and warm to touch. The area has since gotten larger, my arm is pink down to the elbow and there is a knot underneath. My blood pressure has gone up about 4 points and my breathing has become labored." The patient called her physician's office. The patient was treated with BENADRYL and other unspecified medication (dosages/frequencies/manufacturers unknown). The outcome of area around injection site pink and warm to touch, injection site area has gotten larger, my breathing became labored, my blood pressure has gone up about 4 points were reported as recovering/resolving. No further AE information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients. The pharmacist reported on unspecified dates, an unspecified number of patients were vaccinated with ZOSTAVAX and PNEUMOVAX 23 less than four weeks apart. The pharmacist reported all doses ZOSTAVAX were administered subcutaneously and all doses of PNEUMOVAX 23 were administered intramuscularly. No adverse effect reported. No additional information provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a Registered Nurse concerning a female patient of unknown age. On 17-NOV-2014 the patient was vaccinated with MMR II, subcutaneous. It was later reported that the patient is pregnant, her last menstrual period was 14-OCT-2014 (estimated date of delivery 21-JUL-2015). The outcome of vaccinated with MMR II, during pregnancy is unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a female patient of unknown age, who on 21-OCT-2014, was vaccinated with a dose of MMR II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 20 year old male patient. Medical history and concomitant medications were not reported. The patient received his first dose of GARDASIL on 05-AUG-2013 and his second dose on 24-NOV-2014. No adverse experience was observed. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Skin lesion, Skin warm, Tenderness
Clinical narrative: Pt had arm to turn red, become warm, tender in 4 x 4 cm area 5-6h after injxn-then rash around reaction ->hips. 2 shots on shoulders-lesions are resolving now 2 days after.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: The following morning after his vaccine, the patient reports that his arm was swollen and painful. 2 days after, he presented to the pharmacy with a golf ball size knot on his deltoid and said it was painful to the touch.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist, reporting on her 23 year old son. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with dose of (Oka/Merck) VARIVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Pharmacist reported that her son, who was vaccinated with (Oka/Merck) VARIVAX on an unspecified date, experienced an episode of shingles "recently" on unspecified dates. At the time of the report the outcome of experienced an episode of shingles "recently" was unknown. Patient sought medical attention on an unknown date. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult (exact age was not reported) patient of unknown gender. On an unknown date between 28-DEC-2014 and 12-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) in error. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a male patient of unknown age, who on 28-OCT-2014, was vaccinated with a dose of M-M-R II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored one dose of PROQUAD (Merck) (injection, dose: 0.5ml, subcutaneous, lot number and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Noted with red rash to both hands, arms after eating lunch. Itching, mo applied cream to rash. No BENADRYL given 1/15/15. Rash noted to drying up. Small amt of rash noted to hands, arms clear. Instructed mom to give BENADRYL if itching continues and continue hydrocortisone cream as needed. Report to PMD or ER if symptoms re-occur.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In 2014 (exact date unspecified, reported as between 26-NOV-2014 through 01-DEC-2014) those patients received an improperly stored RECOMBIVAX HB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse symptoms reported. The temperature excursion for all vaccines was found to be supported with in-house stability data. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a patient of unknown age and gender, who on 02-DEC-2014, was vaccinated with a dose of MMR II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age, gender, ethnicity. Previous medical history were not reported. On 29-OCT-2013 the patient was vaccinated with GARDASIL dose 1, 1 DF, intramuscular (lot number was not provided). On 29-OCT-2013, 1 day after onset of therapy the patient experienced received first dose on 10/29/2013 and second dose on 02/11/2014 and the third dose being given on 12/03/2014 and no adverse event. The outcome of received first dose on 10/29/2013 and second dose on 02/11/2014 and the third dose being given on 12/03/2014 and no adverse event is unknown. Action taken with therapy drug was not reported. The reporter considered received first dose on 10/29/2013 and second dose on 02/11/2014 and the third dose being given on 12/03/2014 and no adverse event to be not related to GARDASIL. No further information were provided.
Age: 0.93
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received from an unspecified healthcare worker regarding a 2 year old male patient, who in April 2013, was vaccinated with VARIVAX (dosage and route of administration not provided). On 27-NOV-2014, the patient developed a rash and "shingles". The patient saw the doctor and was treated with hydroxyzine (manufacturer unknown). A varicella polymerase chain reaction (PCR) test was performed (results not provided). The outcome of the "shingles" and rash is unknown. Additional information has been requested.