chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Middle insomnia, Pyrexia, Speech disorder
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 6 month old female patient. It was reported that the patient had none medical history or concomitant medication or drug reaction. On 16-MAY-2016, the patient was vaccinated with ROTATEQ Orally (lot number and expiration date were not reported); PENTACEL lot # C5075AA and PREVNAR 13 (lot number and expiration date were not reported). The reporter stated that this last two vaccines were given separate in separate sights (lot number, expiration date, dosage and route of administration were not specified for all vaccines). ON 27-MAY-2016 (also reported as 27-JUN-2016), the reporter stated that the patient was less responsive to sound and also had a minor fever of 99.6, furthermore it was reported that the patient was acting strangely, as well as the next morning, it was reported that the patient was not interacting and talking. Nevertheless, the reporter referred on that same day in the afternoon the patient was doing much better. It was also reported that the patient sought medical attention by taking the patient for an exam, though the clinician's exam was normal, the patient was arrange to get hearing test. However, the mother decided not to take the patient to hearing specialist, since the baby was only 6 month. At the time of the report, the outcome of less responsive to sound, minor fever and abnormal behavior was recovered. Additionally, it was reported that no treatment was given for the adverse events, that no laboratory diagnostics were performed, that no intervention to prevent serious criteria was necessary, that the adverse events was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The relatedness between the adverse event and ROTATEQ was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from a 60 year old female patient, refers on herself. The patient had allergy to penicillin and she was breast cancer survivor. None concomitant medications she was given. On01-JUN-2016, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). On the same day, the patient experienced "raised red rash, little "breakout bumps" on her back for an unspecified reason". An unspecified treatment was given. Non lab diagnostics was performed. At the time of report the patient was not recovered from the event. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Constipation, Headache, Influenza, Myalgia
Clinical narrative: This spontaneous report as received from a 60 year old female patient, refers on herself. The patient had allergy to penicillin and she was breast cancer survivor. None concomitant medications she was given. On01-JUN-2016, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). On the same day, the patient experienced "raised red rash, little "breakout bumps" on her back for an unspecified reason". An unspecified treatment was given. Non lab diagnostics was performed. At the time of report the patient was not recovered from the event. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neck pain, Pruritus, Pyrexia, Viral test
Clinical narrative: This spontaneous report as received from a 60 year old female patient, refers on herself. The patient had allergy to penicillin and she was breast cancer survivor. None concomitant medications she was given. On01-JUN-2016, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). On the same day, the patient experienced "raised red rash, little "breakout bumps" on her back for an unspecified reason". An unspecified treatment was given. Non lab diagnostics was performed. At the time of report the patient was not recovered from the event. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a 60 year old female patient, refers on herself. The patient had allergy to penicillin and she was breast cancer survivor. None concomitant medications she was given. On01-JUN-2016, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). On the same day, the patient experienced "raised red rash, little "breakout bumps" on her back for an unspecified reason". An unspecified treatment was given. Non lab diagnostics was performed. At the time of report the patient was not recovered from the event. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal pain upper, Chills, Dyskinesia, Headache, Nausea
Clinical narrative: Intense pain and then fainting with some jolting, lost bladder control.  Chills, headache, nausea, intense stomach pain the next night.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Pain, Syncope, Urinary incontinence
Clinical narrative: Intense pain and then fainting with some jolting, lost bladder control.  Chills, headache, nausea, intense stomach pain the next night.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: Had been sore like normal shots. Wouldn't "work out" by moving arm. Now red, got, extremely sensitive, and causing fever and nausea.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Had been sore like normal shots. Wouldn't "work out" by moving arm. Now red, got, extremely sensitive, and causing fever and nausea.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Child felt fine during appointment.  Received vaccine of Menactra in left arm with little pain and Trumenba in the right arm with a lot of pain that has continued to worsen thru the day & into the night. His right arm has swollen slightly near injection sight. And right shoulder is sore.  Has pain moving his arm at all.  In addition, he has become increasingly ill feeling.  Developing a headache, nausea, & chills from 7:00 pm & it is continuing now at 1:30 am.  I have given him 3 tsp. of Childrens liquid Advil every 6 hours without much relief.  The pain has not let up, nor his other symptoms.  He has been drinking water & ice chips throughout the evening.  He feels so terrible right now after feeling fine going into his appointment to get these vaccines.  They were the only 2 he received today.  My son has not been sick in over a year! Until today. :(
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Nausea, Pain
Clinical narrative: Child felt fine during appointment.  Received vaccine of Menactra in left arm with little pain and Trumenba in the right arm with a lot of pain that has continued to worsen thru the day & into the night. His right arm has swollen slightly near injection sight. And right shoulder is sore.  Has pain moving his arm at all.  In addition, he has become increasingly ill feeling.  Developing a headache, nausea, & chills from 7:00 pm & it is continuing now at 1:30 am.  I have given him 3 tsp. of Childrens liquid Advil every 6 hours without much relief.  The pain has not let up, nor his other symptoms.  He has been drinking water & ice chips throughout the evening.  He feels so terrible right now after feeling fine going into his appointment to get these vaccines.  They were the only 2 he received today.  My son has not been sick in over a year! Until today. :(
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Erythema, Inflammation, Injection site erythema, Injection site induration
Clinical narrative: Severe pain/swelling/redness spreading around spot where shot was given. Swelling size of golf ball and hard to touch. Redness radiating down arm. Also started coughing morning of 7/6/2016.  Went back to doctor on morning of 7/9/2016. Diagnose was reaction to shot. Prescribed to take Tylenol or Aleve for pain, ice pack for swelling & Predisone 10 mg for inflammation. Take 5 pills @ once for next 3 days then 3 pills @ once for next 3 days.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Severe pain/swelling/redness spreading around spot where shot was given. Swelling size of golf ball and hard to touch. Redness radiating down arm. Also started coughing morning of 7/6/2016.  Went back to doctor on morning of 7/9/2016. Diagnose was reaction to shot. Prescribed to take Tylenol or Aleve for pain, ice pack for swelling & Predisone 10 mg for inflammation. Take 5 pills @ once for next 3 days then 3 pills @ once for next 3 days.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Dysgeusia, Headache
Clinical narrative: Patient is complaining of severe headaches (common side effect to vaccine) and also complaining of metallic taste in mouth (no new introductions of medications or new foods or no change in diet).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Hyperhidrosis, Visual impairment
Clinical narrative: Vision turned black, sweaty, clammy.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt had vaccine on 6/23 came back 7/9 complaining that arm still hurts a bit.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Allergy to vaccine, Local swelling, Muscular weakness, Pharyngeal oedema
Clinical narrative: PT. STATED ON 7/3/2016 HER LEGS GAVE OUT AND COULD NOT WALK 7/8- PT COMPLAINED OF SWOLLEN FACE, THROAT, AND NECK.  PT WAS TREATED AND RELEASED FROM THE ER ON BOTH DATES.  7-8-26 PT RECEIVED RX'S OF ALBUTEROL MDI, TESSALON, AND AZITHROMYCIN. PT MD STATED SHE WAS ALLERGIC TO SHINGLES VACCINE.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: PT. STATED ON 7/3/2016 HER LEGS GAVE OUT AND COULD NOT WALK 7/8- PT COMPLAINED OF SWOLLEN FACE, THROAT, AND NECK.  PT WAS TREATED AND RELEASED FROM THE ER ON BOTH DATES.  7-8-26 PT RECEIVED RX'S OF ALBUTEROL MDI, TESSALON, AND AZITHROMYCIN. PT MD STATED SHE WAS ALLERGIC TO SHINGLES VACCINE.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Circular rash at the area of administration as well as a few inches below.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: I am the husband and I am reporting this for my wife. We are not sure this is considered an adverse reaction. However, we want to report that my wife got a Shingles Vaccine (Zostavax) on June 25 and got a rash on her abdomen on July 5th. On July 9, it has been confirmed as a case of Shingles.
Age: 39.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pain, Pain of skin
Clinical narrative: Body aches, skin hurts (all over, not locally).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle twitching, Peripheral swelling
Clinical narrative: Pt had mild swelling and muscle twitching in RUE after receiving SQ Zostavax. Pt asked to sit for 10 minutes. After 10 minutes, swelling had seem to go down dramatically, but there were some muscle twitching still seen.
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Alopecia areata, Autoimmune disorder, Hyperthyroidism, Laboratory test
Clinical narrative: Autoimmune disorder. Hyperthyroidism. Alopecia areata.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a vaccine administrator referring to an unspecified number of multiple patients of unknown age and gender. The patients pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients received improperly stored ROTATEQ (lot # M014318, expiration date: 30-SEP-2017 and lot # M014544, expiration date: 27-NOV-2017), orally, dose unknown. Additional information is not expected since there is no consent to contact the physician.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. The patient was administered GARDASIL on 06-AUG-2015, 24-OCT-2015 and 22-DEC-2015. Concomitant therapy was not provided. No adverse effects reported. Additional information is not expected as we have no consent to contact the physician.
Age: 25.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a registered nurse referring to a 25 year old patient of unknown gender. The patient's concurrent or historical condition was not provided. On 25-MAY-2016 the patient accidentally received the first dose of RECOMBIVAX HB (dose, route, lot # and expired date unknown) as a pediatric dose. On 29-JUN-2016 the patient received a second dose of RECOMBIVAX HB (dose, route, lot # and expired date unknown) (product use issue) as an adult dose. No adverse effects reported. 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 a unspecified number of patients of  unknown age and gender. IN approximately 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route of administration were not reported, lot # L029631 with expiration date: 14-AUG-2017 and lot # L040458 with expiration date: 04-FEB-2018). No adverse effects were reported. Administered vaccine experienced the temperature excursion of 31.5 degrees Fahrenheit for 2 minutes on 10-MAY-2016. Data logger was involved. There was no previous temperature excursion. 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 was received from a healthcare worker and refers to a unspecified number of patients of unknown age and gender. In approximately 2016, the patients were orally vaccinated with improperly stored doses of ROTATEQ (dose and frequency were not reported , lot # L037574 with expiration date: 01-JUL-2016). No adverse effects were reported. Administered vaccine experienced the temperature excursion at 31.5 degrees Fahrenheit for 2 minutes on 10-MAY-2016. Data logger was involved. There was no previous temperature excursion. 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: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of M-M-R II injection, lot # reported as L037356 with expiration date 23-JUL-2017 (doses, routes of administration and therapy types were not reported). No adverse effects were reported. This is  one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. NO information regarding the patients' medical history, concurrent conditions or concomitant therapies were reported. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX injection (lot # reported as L037356 with expiration date 28-SEP-2017 and lot # reported as M007287 with expiration date 12-FEB-2018) (doses and routes of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: This spontaneous report has been received from a female patient (who was also a medical assistant) in her 30s reporting on herself, via company representative. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date in March 2014, the patient was vaccinated with a dose of GARDASIL injection (dose, lot # and expiry date were not reported). The patient stated that the dose of the vaccine was administered in her synovial bursa instead of deltoid muscle. There were no concomitant therapies reported. On an unknown date in 2014, the patient experienced shoulder pain. She had been in physical therapy for "quite some time" due to the event. The outcome of the event of shoulder pain was reported as not recovered. The relatedness between GARDASIL was not provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Peripheral swelling, Ultrasound scan
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a 17 year old male patient. In approximately June 2016 (reported as "within two weeks"), the patient was vaccinated with the first dose of a three dose series of GARDASIL (intramuscularly in the arm, dose was not reported, lot number was reported as L03510551417, expiration date unknown). In approximately June 2016, one week after the vaccination, the patient's arm swelled from the upper arm down to the wrist. He sought medical attention (reported as "taken to hospital") where he was given an ultrasound, which result was not provided. No treatment was given for the event. The swelling resolved on its own in approximately June 2016. Causality assessment was not reported. The physician could not identify a cause for the swelling, however patient's mother considered the event to be vaccine related. It is too soon to determine if the patient would continue with dose two and three of the GARDASIL series. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Chills, Hyperhidrosis, Vomiting
Clinical narrative: This spontaneous report as received from a patient's mother and refers to a 11 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JUN-2016, the patient was vaccinated with a first dose of GARDASIL 9 (strength, route of administration, lot # and expiration date were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (strength, dose and frequency, route of administration, lot # and expiration date were not reported) administered on the same day. On an unknown date in June 2016 (reported as several hours later) after getting the vaccination, the patient experienced vomiting that lasted about one hour, sweating and chills. There was not treatment given for the adverse events. There was no labs diagnostic performed. The reporter mentioned that her son had made a full recovery on 29-JUN-2016 (reported as of this morning). The patient's mother contacted her son's doctor. The relatedness between vaccination with GARDASIL 9 and meningococcal vaccine (unspecified) and the events was not reported. Additional information is not expected because the reporter refused to provide the physician's demographics.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative and referred to a patient of unknown age and sex. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23(lot #, expiration date, strength, dose and frequency were not reported). On an unspecified date, the patient experienced an unspecified adverse side effect involving PNEUMOVAX 23. The outcome of the adverse event was unknown at the time of the report. The relatedness between adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies was provided. On 07-May-2014, the patient was vaccinated with the first dose of GARDASIL lot # J011272, expiry date 21-APR-2016 (dose, route of administration and indication were nor reported). On 22-APR-2016, the patient received the second dose of GARDASIL 9 lot # L043213, expiry date 28-AUG-2017 (dose, route of administration and indication were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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. There was no information about the patient's concurrent conditions, concomitant therapies of medical history provided. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # L036822, expiration date: 24-DEC-2016 (dose was not reported. There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 30 days since 06-APR-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Lg. red localized red area around injection site Lt arm.
Sex: U
Vaccine: VARZOS
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2014, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K000326, expiration date: 27-FEB-2015 (dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 40 days (reported as 40 days +) since 08-OCT-2014. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JAN-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K004930, expiration date: 06-MAR-2015 9dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 40 days (reported as 40 days +) since 08-OCT-2014. This is one of several reports received from the same reporter. Lot number K004930 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-NOV-2014, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K000326, expiration date: 24-FEB-2015 (dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 40 days (reported as 40 days +) since 08-OCT-2014. 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: This spontaneous report as received from a nurse, reported that on unspecified dates, an unspecified number of patients received an improperly stored dose of VARIVAX (dose and route not reported) (Lot # L048465, expiration date 02-DEC-/2017) or (Lot L048465, expiration date 02-DEC-/2017). No adverse effect reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 30-JUN-2016 the patient was vaccinated with expired M-M-R II (rHA, lot # K008625, expiration date 30-JUN-2016, dose and route were not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-JUN-2016, the patient was inadvertently vaccinated with a dose of ZOSTAVAX subcutaneous (which had a lot # L046899 and an expiration date of 23-JAN-2017; however, dose, dosage number and anatomical location were not reported), instead of a dose of VARIVAX. No other suspect or concomitants therapies were reported. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an 11 year old female patient. No information regarding the patient's medical history and concurrent conditions was reported. On 20-APR-2016 at 16:40, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the right arm (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 6 month old (at the time of the report the patient was 8 month old) female patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 02-MAY-2016 at 10:35, at the age of 6 month old, the patient was vaccinated with her first dose of ROTATEQ (lot# number reported as L033543, expiration date 30-MAY-2017, orally, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Lot number L033543 has been verified to be a valid lot number for ROTATEQ. Additional information is not expected as all required correspondence has been received.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding a female of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (in an unspecified shoulder, dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced feeling numbed from shoulder to elbow and side of the rib cage. It was unknown if the patient sought got the medical attention. The patient's outcome was unknown. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 9 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 16-APR-2016 at 09:59, the patient was vaccinated intramuscularly in the right arm with his first dose of GARDASIL 9 (lot # L044475 and expiration date 12-MAY-2017, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all required correspondence has been received.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old male patient. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous (which had a lot # L000455 and an expiration date of 06-JAN-2017; however, dose, dosage number and anatomical location were not reported). No concomitant medications were reported. No adverse event was reported. No product quality complaint was involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) concerning an unknown number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, VARIVAX (Lot # M006724; expiration date: 08-FEB-2018), was improperly exposed to -11.8 degrees C for 3 hours 32 minutes. Then, on an unknown date after this, an unknown number of patients received a subcutaneous dose of VARIVAX mentioned above (dose not reported). No known adverse effects. All of the date listed here was reconfirmed with the reporter. There was no PQC involved. Additional information is not expected as there is no consent to contact the reporter.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an 11 year old male patient. No information regarding the patient's medical history and concurrent conditions was reported. On 21-APR-2016 at 16:58, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the left arm, (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs, or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of the several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 16-NOV-2015, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route of administration and indication were not reported). The patient completed GARDASIL series on an unknown dates and on 22-JUN-2016, inadvertently received another dose of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot number L044475, expiration date: 12-MAY-2017). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L035882 with expiration date: 19-APR-2017 and lot # L048680 with expiration date: 10-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an 11 year old female patient. No information regarding the patient's medical history and concurrent conditions was reported. On 19-APR-2016 at 12:39, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the right arm (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-JUN-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported, lot # L040181 with expiration date: 18-AUG-2017). Concomitant therapy was not reported. No adverse effects were reported. Administered vaccine experienced the temperature excursion of 61.5 degrees Fahrenheit for 5 hours 30 minutes. Data logger was involved. Administered vaccine also experienced previous temperature excursion of 52.5 degrees Fahrenheit for 1 hour 15 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of unspecified patients. On unknown dates starting on or after 12-MAY-2016 the patients were vaccinated with PEDVAXHIB lot # L042259 (expiration date 18-AUG-2018), which was improperly stored at 31.4 F for 1000 minutes. There was no previous temperature excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.24
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 12 weeks old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-APR-2016 at 12:09, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Skin texture abnormal
Clinical narrative: This spontaneous report concerning a 52 years old female patient with drug hypersensitivity to FLAGYL and hot flush was received from the patient herself and a pharmacist. At the time of reporting, the patient had no pertinent medical history. On 27-JUN-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not provided), in her arm. Concomitant therapies included an unknown medication for hot flashes, ascorbic acid (reported as vitamin C), CLARITIN and vitamins (unspecified) (reported as multivitamin). On 28-JUN-2016, the patient noticed that she had a large, warm, red area which was approximately 2.5 inches by 2.5 inches on the back of her arm at the injection site. In addition, the patient stated that the area felt "bubbly or texture". Furthermore, it was reported that the patient received an unspecified treatment for the adverse events and that no laboratory diagnostic studies were performed. No product quality complain was involved. At the time of reporting, the outcome of the events of injection site warmth, injection site reaction and injection site erythema was not recovered. The causality between the events of injection site warmth, injection site reaction and injection site erythema and ZOSTAVAX was not assessed. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot# L013193 with expiration date 20-JAN-2017; lot# L028645 with expiration date 27-MAY-2017; lot# L023866 with expiration date 24-MAR-2017; lot# L035510 with expiration date 13-MAY-2017; dose was not reported; orally). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 9 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 27-APR-2016 at 17:06, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the right arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34 F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illnesses at time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all available information was obtained.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L042215, expiration date: 02-JUN-2017 (exact dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pain
Clinical narrative: Information has been received from a consumer refers to her 12 year old daughter. In the morning of 29-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 at a pediatric (dose, frequency and route were not reported). After being given the vaccine, the patient felt faint and her mother needed to carry her to lie down for about 10 minutes. It was unclear whether the event was due to GARDASIL 9 or the event of getting a vaccination and associated anxiety. Historically she had not felt faint with other vaccinations. The patient also felt pain in the injection site. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 12 year old female patient. No information regarding the patient's medical history and concurrent conditions was reported. On 22-APR-2016 at 12:15, the patient was vaccinated at the private doctor's office/hospital with the first dose GARDASIL 9 injection, lot # M004116, expiration date: 12-OCT-2017, intramuscularly in the right arm, (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report concerning a patient of unknown gender and age with pneumonia was received from a registered nurse. Medical history include therapy with (PREVNAR) for unknown indication. On 30-JUN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # K019386, expiration date: 09-JUN-2016 (strength, dose, route and frequency were not reported. No concomitant medications and adverse events were reported. No product quality complain was involved. 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 medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-MAY-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II, albumin status recombinant human albumin (rHA), lot # L027434, expiry date 22-JUL-2017 (dose, route and site of administration were not reported) which was also improperly stored. There were no adverse effects reported. Administered vaccines experienced following temperature excursions: on 14-MAY-2016 6 degrees Fahrenheit (F) for 1.5 hours and on 20-MAY-2016 5.9 degrees F for 5.5 hours. The freezer returned to proper range in between all excursions. Data logger was involved. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapy or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# K021581 with expiration date 24-OCT-2016; lot# K026531 with expiration date 15-APR-2017; lot# L042846 with expiration date 15-SEP-2017; lot# L003193 with expiration date 10-NOV-2016; lot# L010595 with expiration date 12-NOV-2016; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events 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
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # L043634/ expiration date- 03-NOV-2017. No concomitant medication was reported. On an unknown date patient experienced swelling and redness. The outcome of the swelling and redness was unknown. Causality was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.