chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, No adverse event
Clinical narrative: Information as received on 16DEC2014 from a pharmacist regarding herself. The pharmacist (who was pregnant at the time- gestation unknown) reported that while preparing ZOSTAVAX on 15DEC2014 for administration to an unspecified patient, a drop of the vaccine fell onto her own hand. It was unspecified whether the unspecified patient received less than a full dose due to the pharmacist's exposure. No adverse effect was reported for the pharmacist's exposure or the unspecified patient. The pharmacist does not want to be contacted for follow-up. No further information was provided. No further information is expected. This is a corrected report. The term of "Exposure during pregnancy" was added to the case.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 15-JAN-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 12-FEB-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Macule, Papule, Pruritus, Urticaria
Clinical narrative: Desquamating generalized rash, face trunk, extremities consistent with pityriasis rosea, starting 4 days after the 3rd dose of GARDASIL.
Age: 12.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Pityriasis rosea, Rash generalised
Clinical narrative: Desquamating generalized rash, face trunk, extremities consistent with pityriasis rosea, starting 4 days after the 3rd dose of GARDASIL.
Age: 0.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, C-reactive protein normal, CSF culture negative, CSF test normal, Crying
Clinical narrative: 7pm tactile fever, 9:30pm arching head backwards, did not seem to engage eyes when spoken to, constant inconsolable cry.
Age: 0.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture urine negative, Decreased eye contact, Full blood count normal, Influenza virus test negative, Laboratory test normal
Clinical narrative: 7pm tactile fever, 9:30pm arching head backwards, did not seem to engage eyes when spoken to, constant inconsolable cry.
Age: 0.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Posture abnormal, Pyrexia, Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: 7pm tactile fever, 9:30pm arching head backwards, did not seem to engage eyes when spoken to, constant inconsolable cry.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Muscle pains started one day after shots -> progressed to arm weakness-> referred to neurology.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 3 days after vaccines, pt. developed urticaria on his trunk, upper and lower extremities. He was seen at a local ER, and was given prednisolone once daily for 5 days and BENADRYL every 6 hours.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 23-JUL-2013 and 25-AUG-2014 the patient was vaccinated with the first and second dose of GARDASIL, intramuscularly respectively (lot # and application site were not reported). Concomitant therapy was not reported. On 26-MAY-2015, the patient would receive the third dose. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL injection  (dose, route, frequency and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on an unknown date was an improperly stored vaccine administered to patient. But was unsure which ones, may have been M-M-R II, PEDVAXHIB or GARDASIL. No adverse effects reported at this time. No further details provided. There was no product quality complaint involved. The outcome of incorrect product storage and no adverse event was unknown. This case is linked to: 1505USA014703 and 1505USA004646 (same patient link). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Metal poisoning
Clinical narrative: This spontaneous report as received from a field employee via the physician refers to a 15 year old female patient. Concurrent condition, medical history and drug allergies were unspecified. Approximately in 2011, the patient received the first dose of GARDASIL, second dose in 2013 and in April 2015 and with the third dose of GARDASIL. The day after the third dose was given approximately in April 2015, the patient developed tail bone pain. The physician mentioned that the patient's mother was very upset about that and had done extensive research about the dangers of quadrivalent human papilloma (type 6, 11, 16, 18)vaccine online and the mother felt that the patient had aluminum toxicity. It was not confirmed by the physician that whether the patient has aluminum toxicity or not. No lab diagnostics studies were performed. No intervention to prevent serious criteria was reported. No treatment was given. Patient sought medical attention through a phone call. No product quality complaint involved. The outcome of event was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 62 years old female patient. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported). On an unknown date (after administration of ZOSTAVAX), the patient developed redness and warmth at the injection site. The patient sought medical attention (unknown type) and did not require a medical treatment. There was no lab diagnostics and studies performed. On an unknown date, the patient recovered from the adverse events. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 50 year old female patient. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported) to prevent shingles. On an unknown date (reported as approximately one year 1 later), the patient developed shingles. On an unspecified day, the shingles resolved. On an unknown date (reported as now), the patient experienced another case of shingles. The patient sought medical attention via contacting a pharmacist. The outcome of second case of shingles was not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, an immunization coordinator refers to an unspecified patients of unknown age and unknown gender. Since 30-MAR-2015, the unspecified patients were vaccinated with MMR II (lot # K007107 and expiry date: 16-MAY-2016), which was exposed to a temperature outside of the recommended range on 30-MAR-2015. No adverse effect was reported. No product quality complaint (PQC) was reported for MMR II. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Pt called and reported size width of silver dollar, redness. Informed to apply topical antibiotic or OTC cortisone 1% if itchy.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Skin warm
Clinical narrative: patient presented with approximately 3 inch long by 2 inch wide red area where vaccine was administered on back of right arm. Skin was warm to the touch. Patient did not complain of any other symptoms.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: 10 minutes following vaccine administration and during a venous blood draw, client became pale and fainted. Client was laid on exam bed-had been in sitting position.  She lost consciousness for 30 seconds. When client came to, resting BP was 110/58 and HR 56 @ 1330. Client alert and oriented.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Hot flush, Hyperhidrosis, Injection site erythema, Myalgia
Clinical narrative: HOT FLASHES, SWEATS, (I AM BEYOND MENOPAUSE) REDNESS AT INJECTION SITE THAT INCREASED. SEVERE MUSCLE SORENESS ALL OVER. SEVERE INTESTINAL DISTRESS AND NAUSEA, VOMITING.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: HOT FLASHES, SWEATS, (I AM BEYOND MENOPAUSE) REDNESS AT INJECTION SITE THAT INCREASED. SEVERE MUSCLE SORENESS ALL OVER. SEVERE INTESTINAL DISTRESS AND NAUSEA, VOMITING.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: On 5-13 - PREVNAR administered. 5-19 - pt showed up and showed arm 5" x 5" redness in area of shot and spreading. 5/21 - went to MD and got on BENADRYL 1 on 5/26 - all symptoms gone.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-neuronal antibody, Anti-neuronal antibody negative, Antibody test negative, Borrelia test negative, Computerised tomogram head normal
Clinical narrative: Guillain-Barre Syndrome-paralysis, pain.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture normal, Pain, Paralysis, Spinal X-ray normal
Clinical narrative: Guillain-Barre Syndrome-paralysis, pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5/25/15: Patient spoke of redness swelling pain at site of inject, advised. 5/26/15-swelling and pain increased a great deal in severity - patient also noted blistering - advised patient to seek medical follow up. Patient stated has "infection due to vaccine". Received antibiotics.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: 5/25/15: Patient spoke of redness swelling pain at site of inject, advised. 5/26/15-swelling and pain increased a great deal in severity - patient also noted blistering - advised patient to seek medical follow up. Patient stated has "infection due to vaccine". Received antibiotics.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: Patient fell asleep 2-3 minutes after vaccine administration.
Sex: F
Vaccine: FLU4
Symptoms: Atrial septal defect, Congenital anomaly, Foetal exposure during pregnancy, Heart rate irregular, Supraventricular extrasystoles
Clinical narrative: Initial solicited report received on 08 May 2015 from a consumer. This is a retrospective pregnancy registry case for Study QIVO8. A female infant born with congenital anomaly of patent foramen ovale i.e. days after (subject) received first intramuscular dose of FLUZONE QIV on 25 October 2014 in left arm (batch number: U173AA). The event appeared after visit was not reported. Ultrasound performed on mother of the subject on 34th weeks of gestation showed baby had irregular heartbeat with Premature atrial and Ventricular contractions (PACs and PVCs). Concomitant therapies were not reported. The lab data and corrective treatment were not reported. The outcome of the event of patent foramen ovale was unknown at the time of report. The investigator's causality assessment was not reported. Relationship to investigational product according to Company: associated. It was not reported if the serious adverse event led to the termination of the subject from the study. List of documents held by sender: none. This case was linked to case# 2015SA047942 (Pregnancy case).
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound foetal, Ventricular extrasystoles
Clinical narrative: Initial solicited report received on 08 May 2015 from a consumer. This is a retrospective pregnancy registry case for Study QIVO8. A female infant born with congenital anomaly of patent foramen ovale i.e. days after (subject) received first intramuscular dose of FLUZONE QIV on 25 October 2014 in left arm (batch number: U173AA). The event appeared after visit was not reported. Ultrasound performed on mother of the subject on 34th weeks of gestation showed baby had irregular heartbeat with Premature atrial and Ventricular contractions (PACs and PVCs). Concomitant therapies were not reported. The lab data and corrective treatment were not reported. The outcome of the event of patent foramen ovale was unknown at the time of report. The investigator's causality assessment was not reported. Relationship to investigational product according to Company: associated. It was not reported if the serious adverse event led to the termination of the subject from the study. List of documents held by sender: none. This case was linked to case# 2015SA047942 (Pregnancy case).
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tdap and PNEUMOVAX injected into left deltoid on 5/14/15. Developed pain, swelling, fever, headache. Redness, swelling and pain were in (L) upper arm. Seen in emergency room - given diagnosis of cellulitis and prescribed BACTRIM.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Tdap and PNEUMOVAX injected into left deltoid on 5/14/15. Developed pain, swelling, fever, headache. Redness, swelling and pain were in (L) upper arm. Seen in emergency room - given diagnosis of cellulitis and prescribed BACTRIM.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Decreased appetite, Fatigue, Pain
Clinical narrative: Pt. describes extreme fatigue and generalized body aches ot point of being bed-ridden x 2 days. No fever, nausea, diarrhea. Forced self up on 3rd day but fatigued and unable to do any activity. States able to eat and drink some but not usual amount.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chest X-ray normal, Chills, Cough, Dyspnoea
Clinical narrative: Onset chills, fever, cough, difficult breathing hives for 1 1/2 monts weakness. I tool Ibuprofen, cough medicine, BENADRYL.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Onset chills, fever, cough, difficult breathing hives for 1 1/2 monts weakness. I tool Ibuprofen, cough medicine, BENADRYL.
Age: 1.03
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling to vaccination site. (L) lower extremity, afebrile.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: ADAMTS13 activity decreased, Abdominal pain, Blood creatinine normal, Blood fibrinogen increased, Blood lactate dehydrogenase increased
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chromaturia, Confusional state, Coombs test negative, Cough, Diarrhoea
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dyspnoea, Fatigue, HIV test negative, Headache
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Impaired work ability, Increased tendency to bruise, Influenza like illness, Liver function test normal, Plasmapheresis
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased, Red blood cell schistocytes present, Thrombotic thrombocytopenic purpura
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: ADAMTS13 activity decreased, Abdominal pain, Anaphylactic reaction, Blood creatinine normal, Blood fibrinogen increased
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood lactate dehydrogenase increased, Chromaturia, Confusional state, Coombs direct test negative, Cough
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Dizziness, Fatigue, HIV test negative, Headache
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hepatitis viral test negative, Immediate post-injection reaction, Impaired work ability, Influenza like illness, Plasmapheresis
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased, Red blood cell schistocytes present, Smear site unspecified abnormal, Thrombotic thrombocytopenic purpura
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 14 May 2015. A 40-year-old female patient, whose medical history reported as hypertension, hyperlipidemia and type 2 diabetes, had received a dose of Influenza Vaccine (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date. Patient had received ZOCOR, Metformin, Lisinopril/HCTZ, PREVACID and TOPROL XL as a concomitant medication. On unspecified date, after vaccination patient had experienced cough and flu-like symptoms for one week. On an unspecified date during second week, after vaccination patient had experienced fatigue, headaches, dizziness, abdominal pain, confusion and dark urination which were rendering unable to complete tasks at work. Patient also experienced shortness of breath and increased bruising. Patient was diagnosed with acute TTP caused by autoantibody mediated (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) ADAMTS-13 deficiency. Patient was initially admitted to a hospital for diarrhea, lightheadedness on an unspecified date. Laboratory investigation includes, platelet count result found as 10000, lactate dehydrogenase (LDH) result was found as 800, fibrinogen result was 419, schistocytes on peripheral smear, Coombs test result was negative, Human immunodeficiency virus (HIV) result was negative, creatinine level was normal, ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13): result less that 3%, hepatitis panel: result negative, at the time of discharge patient platelet count above 200. The patient had received Prednisone, Corticosteroids and plasmapheresis as a corrective treatment. During her fourth treatment, the patient had an anaphylactic reaction. She was started on high dose of prednisone and two additional rounds of plasmapheresis with good response. The patient got discharged from hospital on an unspecified date. At the time of this report, patient was recovered from all events on an unspecified date. List of the document held by sender: none.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hemiparesis, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness, tingling weakness entire left side after vaccines in left arm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood iron normal, C-reactive protein normal, Full blood count normal, Madarosis, Metabolic function test normal
Clinical narrative: Loss of hair from eyebrows and eyelashes bilaterally.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test normal, Vitamin D decreased
Clinical narrative: Loss of hair from eyebrows and eyelashes bilaterally.
Age: 1.77
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Hives and redness appeared around the injection site 5 minutes following the vaccines. 1tsp of children's Benadryl was given and patient was observed at the office for half an hour and then observed an hour after the reaction occurred. After the hour was up, the hives and redness around the injection site started to disappear and patient seemed to be doing well.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Fatigue, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: On 05/21, child began to have runny nose. She then developed a fever on the 25th and 26th with temperatures ranging from 102.7-103.3. On 05/28/2015 child developed a rash that began on her cheeks and spread to the rest of her body. She also is experiencing extreme fatigue.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Contusion, Injection site pain, Pain
Clinical narrative: Case complained of pain at injection site the evening of immunization and had what resembled bruising on bilateral upper and lower legs and ankles the next morning. Severe pain reported. Saw MD at local clinic the day after the immunization.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PT HAS REDNESS AT SITE OF INJECTION (APPROXIMATELY 3 INCH DIAMETER) AND BUMP
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Approximately 20 Hives on both forearms. Took Allegra.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: INJECTION SITE HARD, HOT AND RED. (IT BEGAN 05/25/2015 AND GETTING WORSE TILL 05/27/2015. SHE PHONED TO PHARMACY 05/27/2015 EVENING)
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Pelvic pain
Clinical narrative: Heart palpitations, possible luteal phase defect, pelvic pain, possible PCOS.
Age: 0.52
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: 5/27/2015 7:30 & 8:00am 102 fever. Called facility at 8:00am. 9:00am 2.5mL of Infant Tylenol. 10:30am 100 fever. 1pm 100.8 fever, 2.5mL children's ibuprofen. 4pm 99.6 fever. 7pm 101.8 fever, 2.5 mL of infant Tylenol. 5/28/2015 Woke with no fever at 5:00am.
Age: 17.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Dizziness, Nausea, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging brain normal, Vertigo
Clinical narrative: Dizziness, nausea, trouble focusing vision.
Age: 17.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Vision blurred
Clinical narrative: Dizziness, nausea, trouble focusing vision.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Arm swollen tender and fever ..redness and hard around site
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age. No concurrent condition or medical history was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL. Concomitant medication was not reported. On an unknown date, the patient experienced seizure, a couple of minutes after receiving the vaccine. Approximately on an unknown date in May 2015 (reported as seen recently and now), the patient was seen at the medical office and was now experiencing vasovagal syncope. The outcome of vasovagal syncope and seizure was unknown. No product quality complaint was reported. Upon internal review, the event seizure was determined as medically significant. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to her friend of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dos and route of administration were not reported). On an unknown date, the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because the reporter did not want any follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 26-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB which was improperly stored (dose, route of administration, lot# and expiration date not reported). No adverse effect was reported. 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 certified medical assistant refers to multiple patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date the doses of VAQTA (lot # K007827 with expiry date: 09-DEC-2016 and lot#K012457 with expiry date: 04-JUN-2017) were administered post excursion to those multiple patients. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker via field representative referring to a patient of unknown age and gender. The patient was vaccinated with her first, second and third doses of GARDASIL (route, lot#, dose were unknown) on 12-AUG-2013, 18-SEP-2013 and 04-DEC-2013 (inappropriate schedule of drug administration), respectively. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Off label use
Clinical narrative: This spontaneous report as received from a healthcare professional as part of a marketing research program conducted by HRA, refers to an unspecified number of patient over the age of 19 (gender unknown) with no relevant medical history provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, lot number and route were not reported) to treat high-risk patients newly defined as asthmatics and smokers over the age of 19. The outcome of off label use was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant therapies was provided. On 29-JUL-2013, the patient was vaccinated with the first dose of GARDASIL. On 02-APR-2015 the patient was vaccinated with the second dose of GARDASIL; route and site of administration, lot# and expiration date were not reported for either of vaccination courses. There was no adverse event reported. Additional information has been requested.