chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ankle fracture, Fall
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old male patient. There were no pertinent medical history or drug allergies/drug reactions. On 26-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose and route were not reported), lot # K016324, expiration date 24-DEC-2015. The patient's concomitant therapies were not reported. On 27-JUN-2015, the patient "tripped over a rug and went down a set of stairs and broke his ankle in three different places". the patient was taken to the hospital and was prescribed prednisone (manufacturer unknown) and an unspecified pain medication. At the time of the report, the outcome of tripped over a rug and went down a set of stairs and broke his ankle in three different places was reported as not recovered/not resolved. The relatedness between the events and therapy with ZOSTAVAX, was not reported. The reporter considered the event to be serious due to significant disability. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: So painful I physically could not move my arm - it was dead weight- had to have help or lift it with left arm. Pain during night prevented any sleep 2 days out I can raise hand to the elbow up chest high but still can't raise upper part of arm. Still throbbing and very sore if touched. I am having to lift my shot arm up to the computer and move it around with my left hand just to be able to type this. Going to a Dr 7/2 if not much improved.
Sex: U
Vaccine: FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Jun-2015) concerns a patient. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient experienced facial paralysis after receiving an unspecified flu vaccine. No additional information provided. The outcome was not reported.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching at the injection site three days after administration of Varicella immunization. Did not self-medicate or seek medical attention.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to an adult patient of unknown gender. The patient's medical history or concurrent condition were not provided. On an unknown date the adult patient was inadvertently administered a dose of pediatric RECOMBIVAX HB (injection, lot#, dose, route and therapy type were unspecified) (incorrect dose administered), then 10 days later was administered a 2nd dose of pediatric RECOMBIVAX HB (injection, lot#, dose, route were unspecified) (incorrect dose administered and inappropriate schedule of vaccine administered). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of doses of RECOMBIVAX HB, intramuscularly (lot# was not reported) which were each greater than the prescribed 0.5 ml. The nurse reported this occurred due to the fact that healthcare providers at her facility withdrew administered the entire contents of single-dose vials of all vaccines, and due to expected slight overfill of RECOMBIVAX HB single-dose vials. The doses that were ultimately administered to the patients could therefore range anywhere from 0.55 ml to 0.6 ml. No adverse effects were reported. No product quality complaint was identified since slight overfill of single-dose vials was expected. This is one of several cases from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Food allergy
Clinical narrative: Information has been received from a physician referring to a 4 and a half years old male patient. On an unknown date the patient was vaccinated with a first dose of M-M-R II (dose, frequency, lot# were not reported) with no problem and at the reporting time he was ready for his booster dose, but patient currently had mild egg allergy (patient could tolerate well-cooked egg). The physician wanted to make sure if patient would be able to tolerate M-M-R II booster dose. It was unknown at this time when patient developed egg allergy, either before or after the first dose of M-M-R II. No treatment was given for the event. The outcome of the event was reported as not recovered. Causality was not reported. The patient sought medical attention via office visit. Additional information has been requested.
Age: 0.13
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6-week-old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # 008874, dose, strength, route of administration and expiration date were not reported) which had temperature excursion. The lot source was public. No information on patient's concomitant medication was provided. There was no adverse event experienced. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 27-MAY-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.7
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 20 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 15-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received VAQTA (pediatric and adult) strength 25/0.5 (units not provided) (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received RECOMBIVAX PEDIATRIC and ADULT (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. 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 a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. No adverse events were reported. This is one of two reports from the same reporter. Additional information had been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a heath professional concerning a patient of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On 15-APR-2015, the patient was vaccinated with an improperly stored dose of M-M-R II, (lot #, strength, route of administration and dose were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received ROTATEQ (lot #, expiration date and dose were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the sane reporter. Additional information has been requested.
Age: 0.14
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 7 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAX HIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 15-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Overdose
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of VAQTA, intramuscularly (lot# was not reported) which were each greater than the prescribed 0.5 ml. The nurse reported this occurred due to the fact that healthcare providers at her facility withdrew administered the entire contents of single-dose vials of all vaccines, and due to expected slight overfill of VAQTA single-dose vials. The doses that were ultimately administered to the patients could therefore range anywhere from 0.55 ml to 0.6 ml. No adverse effects were reported. No product quality complaint was identified since slight overfill of single-dose vials was expected. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of doses of GARDASIL, intramuscularly which were each greater than the prescribed 0.5 ml. The nurse reported this occurred due to the fact that healthcare providers at her facility withdrew administered the entire contents of single-dose vials of all vaccines, and due to expected slight overfill of GARDASIL single-dose vials. The doses that were ultimately administered to the patients could therefore range anywhere from 0.55 ml to 0.6 ml. No adverse effects were reported. No product quality complaint was identified since slight overfill of single-dose vials was expected. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to the 5 patients of unknown age and gender. On an unknown date the 5 patients were vaccinated with a doses of improperly stored, exposed to 9F for 7 hours of VARIVAX (Merck) 0.5 ml injection, subcutaneously (lot number and route were not reported). No adverse effects were reported. The outcome of the patients event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. Patients' concurrent and historical conditions were not reported. The reporter stated that unspecified patients received doses of improperly stored GARDASIL (dose, frequency, route, lot# and expiration date were unknown) on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. Patients' concurrent and historical condition were not reported. The reporter stated that unspecified patients received doses of improperly stored ROTATEQ (dose, frequency, lot# and expiration date were unknown) orally on unspecified dates. No adverse effect was 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: Information has been received from a health care worker concerning unknown number of patients of unknown demographics. On unspecified dates, the patients were inadvertently vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9) (dose, route, lot number and expiration date were unspecified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 04-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL (dose, route and site of administration were not reported, lot # K008931, expiration date 04-MAR-2017). No adverse symptoms were 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 has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 02-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL (dose, route and site of administration were not reported, lot # K008931, expiration date 04-MAR-2017). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-JUN-2015, the patient was vaccinated with improperly stored dose (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot number, dose and route were unkonwn). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5-month-old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 15-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB (lot # K008874, dose, strength, route of administration and expiration date were not reported) which had temperature excursion. The lot source was public. No information on patient's concomitant medication was provided. There was no adverse event experienced. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Mom reports that patient vomited at school and was unresponsive. EMS called they did not transport patient to hospital mom went to ED.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Very swollen/sore wrist/thumb joint.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Myalgia, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was warm to touch, swollen, redness noted and she had some muscle pain. Dr. recommended ICE for treatment.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot number, dose and route were unkonwn). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site swelling, Injection site warmth, Mobility decreased, Myalgia
Clinical narrative: Received the Tb shot in the left arm Friday morning, by Friday evening, area where the shot was received was swollen and hot to the touch.  Next day, arm was extremely sore and I was unable to lift it above my shoulder and had muscle aches all over my body, not severe and not needing medical attention.  Called a 24 hour nurse hotline and was told it was a normal reaction to the TB shot and if condition got worse or didn't improve within 5-7 days, to see my doctor.  Sunday, muscle aches were still happening but improving, arm swelling was going down and arm was no longer hot to the touch but still couldn't lift it above shoulder.  Monday, aches were more of a dull pain and arm was tender but mobility in it was returning. Tuesday, was a little tired but no aches and could lift arm above my shoulders but felt tightness in it, same for Wednesday.  Thursday, I could move and lift my arm without feeling any pain.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Skin tightness, Tenderness
Clinical narrative: Received the Tb shot in the left arm Friday morning, by Friday evening, area where the shot was received was swollen and hot to the touch.  Next day, arm was extremely sore and I was unable to lift it above my shoulder and had muscle aches all over my body, not severe and not needing medical attention.  Called a 24 hour nurse hotline and was told it was a normal reaction to the TB shot and if condition got worse or didn't improve within 5-7 days, to see my doctor.  Sunday, muscle aches were still happening but improving, arm swelling was going down and arm was no longer hot to the touch but still couldn't lift it above shoulder.  Monday, aches were more of a dull pain and arm was tender but mobility in it was returning. Tuesday, was a little tired but no aches and could lift arm above my shoulders but felt tightness in it, same for Wednesday.  Thursday, I could move and lift my arm without feeling any pain.
Age: 37.0
Sex: F
Vaccine: ANTH, JEV1, TYP
Symptoms: Abdominal pain upper, Chills, Disturbance in attention, Dysarthria, Feeling abnormal
Clinical narrative: Initially was light nausea and head spinning, then that amplified to worse nausea with tingling appendages. Then over the course of a couple hours, had migraine symptoms felt like I was going to vomit then my legs started going numb. Afterwards was slurred speech, all appendages including lips were tingling and numb. Horrible stomach ache, unable to focus on people talking and unable to respond clearly with a fever over 102 Fahrenheit with chills. After fever broke perfuse sweating eventually able to make more sense while speaking and head started to clear so I could understand more.
Age: 37.0
Sex: F
Vaccine: ANTH, JEV1, TYP
Symptoms: Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Migraine, Nausea
Clinical narrative: Initially was light nausea and head spinning, then that amplified to worse nausea with tingling appendages. Then over the course of a couple hours, had migraine symptoms felt like I was going to vomit then my legs started going numb. Afterwards was slurred speech, all appendages including lips were tingling and numb. Horrible stomach ache, unable to focus on people talking and unable to respond clearly with a fever over 102 Fahrenheit with chills. After fever broke perfuse sweating eventually able to make more sense while speaking and head started to clear so I could understand more.
Age: 37.0
Sex: F
Vaccine: ANTH, JEV1, TYP
Symptoms: Paraesthesia, Paraesthesia oral, Pyrexia, Vertigo
Clinical narrative: Initially was light nausea and head spinning, then that amplified to worse nausea with tingling appendages. Then over the course of a couple hours, had migraine symptoms felt like I was going to vomit then my legs started going numb. Afterwards was slurred speech, all appendages including lips were tingling and numb. Horrible stomach ache, unable to focus on people talking and unable to respond clearly with a fever over 102 Fahrenheit with chills. After fever broke perfuse sweating eventually able to make more sense while speaking and head started to clear so I could understand more.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: States arm has Red ring around vaccine site, swollen, hot to touch, and tender.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red ring around the site of injection, Hot to touch, swollen the size of baseball and tender to touch.
Age: 22.0
Sex: M
Vaccine: HEPA, HPVX, JEVX, RAB
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 25-JUN-2015, the patient was vaccinated with improperly stored doses of VARIVAX (Merck) (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of improperly stored ROTATEQ (lot number, strength, dose and route were not reported). No adverse effects were reported. The outcome of the patients event was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12-month-old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008874, dose, strength, route of administration and expiration date were not reported) which had temperature excursion. The lot source was public. No information on patient's concomitant medication was provided. There was no adverse event experienced. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 26-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route not unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot number, dose and route were unknown). No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a patient who received ENERGIX B. Co-suspect products included TWINRIX. On an unknown date, the patient received ENGERIX B at an unknown dose and TWINRIX at unknown dose. On an unknown date, an unknown time after receiving ENGERIX B and TWINRIX, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. Additional information provided: 3 patients at this practice got either ENGERIX or TWINRIX per schedule. Titers were checked timely but did not have response to hep B. This case is one of the 3 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: HEP, HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a patient who received ENGERIX B. Co-suspect products included TWINRIX. On an unknown date, the patient received ENGERIX B at an unknown dose and TWINRIX at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B and TWINRIX, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. Additional information provided: 3 patients at this practice got either ENGERIX or TWINRIX per schedule. Titers were checked timely but did not have response to hep b. This case is one of the 3 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: HEP, HEPAB
Symptoms: No therapeutic response, Viral titre decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a patient who received ENGERIX B. Co-suspect products included TWINRIX. On an unknown date, the patient received ENGERIX B at an unknown dose and TWINRIX at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B and TWINRIX, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. Additional information provided: 3 patients at this practice got either ENGERIX or TWINRIX per schedule. Titers were checked timely but did not have response to hep b. This case is one of the 3 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 0.001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which 7,152 (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) during pregnancy on an unspecified date. 84 (1 percentage) neonate patients had develop major malformation as they were exposed to Tdap vaccine in utero. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Mechanical ventilation, Neonatal disorder
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 0.001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine exposure in utero, thus 27 (0.4 percentage) neonate patients experienced complications including ventilation required during first 24 hours. Patients were hospitalized on an unspecified date. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Intraventricular haemorrhage
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus one neonate patient had developed intraventricular hemorrhage grad 3-4. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Upon internal review, company assessed the event of intraventricular hemorrhage, grade 3-4 and vaccine exposure in utero as serious and important medical event. Documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Local swelling, Myalgia, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of localized muscle pain in a 44-year-old female patient who received BOOSTRIX (batch number B54KE, expiry date 2nd April 2017). This case was associated with a product complaint. Concurrent medical conditions included hypertension. On 5th June 2015, the patient received BOOSTRIX (subcutaneous) .5 ml. On 5th June 2015, less than a day after receiving BOOSTRIX, the patient experienced localized muscle pain, axillary pain and local swelling. On an unknown date, the outcome of the localized muscle pain, axillary pain, local swelling and product complaint were unknown. It was unknown if the reporter considered the localized muscle pain, axillary pain, local swelling and product complaint to be related to BOOSTRIX. Additional  information provided: The physician suspected a Quality Concern with this vaccine and their office has withheld the rest of this lot number. QA filed UV20150062. This case is one of the 2 cases reported by the same reporter for the same vaccine. Follow-up received on 19 June 2015: Some information was received as follow-up but for the other patient. Clarification has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of improperly stored of GARDASIL (lot number, strength, dose and route were not reported). No adverse effects were reported. The outcome of the patients event was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Very painful, stiffness of arm, took Tylenol extra strength to control severe pain. Reported back to Doctor.  Saw 2 doctors - recommended caution on taking extra strength explained in detail why a lower dosage is more favorable.  Advise to return or go to ER is condition worsen.  Advised it may be at least two weeks before arm return to normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Started with swelling and redness in arm and itchy arm.
Age: 43.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Fluid filled vesicle at injection site.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a 65 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 24-JUN-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 vial, strength reported as 25/0,5 (units not provided) (dose and route of administration not reported) (lot number K004930 and expiration date 06-MAR-2015). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 28-MAY-2015, the patient was vaccinated with improperly stored of (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 24-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old male patient with no pertinent medical history or drug allergies. On 29-JUN-2015, the patient was vaccinated with the first dose of GARDASIL (lot# reported as L010587, expiration date 03-NOV-2016, 0.5 ml/once) intramuscularly and a dose of MENACTRA. There was no other concomitant therapy. On 29-JUN-2015, approximately 5 minutes after receiving vaccination, the patient fainted in the office and he additionally experienced slight sweating. No lab diagnostics studies were performed. The patient recovered from the events within 30 minutes and went home with his mother. Additional information has been requested.
Age: 0.59
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 7 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 30-DEC-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008680, dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). The lot source was public. No information on patient's concomitant medication was provided. No adverse event was experienced. This is one of several reports received from the same reporter. Additional information has been requested.