chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.04
Sex: U
Vaccine: RV5, HEP, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 day old patient. The patient pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-JUL-2016, the patient received second dose RECOMBIVAX HB (lot # L039660 and expiration date 04-FEB-2018) 0.5 ml, intramuscular (Inappropriate schedule of vaccine administered). No adverse effects were reported. The patient also received the first dose of ROTATEQ on the same day (captured in MARRS# 1608USA002793). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 02-AUG-2016, the patient was inadvertently administered PNEUMOVAX 23 lot # L001311, which expired on 06-JUL-2016. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient "over 50 years old", regarding herself. The patient's medical history and concurrent conditions were not reported. On 11-FEB-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU injection, 19400 PFU subcutaneously (lot number, expiration date and anatomical location of administration were not reported. In approximately 2016, the patient experienced shingles (herpes zoster) and she was requesting a reimbursement. No product quality complaint was involved. The outcome of the herpes zoster and the causal relationship between the herpes zoster and the ZOSTAVAX were unknown. Additional information is not expected as the reporter did not wish further contact.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse, via a company representative, regarding a 12 years old female patient. The patient had no pertinent medical history and was unknown if the patient had previous drug allergies. On 26-JUL-2016, the patient was vaccinated with GARDASIL 9, injection, "one time" (strength, dose, lot number, expiration date, route and anatomical location of administration were not reported). The patient had no concomitant therapies. On 26-JUL-2016, 20 minutes after onset of therapy, the patient broke out in hives (urticarial), BENADRYL was provided and hives went away. The patient did not seek medical attention and no laboratory diagnostics were performed. No product quality complaint was involved. The outcome of urticarial was reported as recovered in approximately July 2016. The causal relationship between the urticarial and GARDASIL 9 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history and concurrent conditions were not provided. On an unknown date (reported as "a few years ago"), the patient was vaccinated with ZOSTAVAX injection (strength, dose, lot number, expiration date, route and anatomical location of administration were not reported), for prevention of shingles. On an unknown date, the patient developed "shingles on the right side of unspecified arm to her shoulder" (herpes zoster). The patient sought medical attention and went to the physician's office, but it was unknown if a treatment was given for the event. No product quality complaint was involved. The outcome of the herpes zoster and the causal relationship between the herpes zoster and ZOSTAVAX were unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, regarding a 14 years old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 27-JUL-2016, the patient was vaccinated with an adult dose of VAQTA injection (strength, dose, lot number, expiration date, route of anatomical location of administration were not reported. No adverse symptoms were reported and no product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Received vaccine 8/2/16. Parent noticed redness, swelling, bruising (L) upper arm today (8/4/16).
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information about the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number, expiration date, concentration, dose, route of administration and frequency were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected, as there was no permission to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On 28-JUL-2016, the patient was inadvertently administered M-M-R II (lot # K009956), which expired on 14-JUL-2016. No adverse effects reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Lateral left upper thigh swelling, warmth noticed at daycare, patient crying for 30 min, non tender today. At 1400, site is slightly edematous, 6cm x 9cm, diffuse, assynomical, location of PROQUAD vaccination. Ice was applied. Decreased swelling.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Mother states client received vaccine on 8/4 and was vomiting and running a fever all night. Mom also states client has numbness and tingling down her face. Nurse instructed mom to take child to see family dr or medical health place. Mom stated taking daughter to urgent care.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Headache, fatigue, nauseated, dizzy, fever, pale - after dose #2. Had severe arm pain for greater than 1 week after dose #1.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pallor, Pyrexia
Clinical narrative: Headache, fatigue, nauseated, dizzy, fever, pale - after dose #2. Had severe arm pain for greater than 1 week after dose #1.
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a desk assistant via company representative, refers to a female patient of unknown age. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On an unknown date, the patient was mistakenly vaccinated with a fourth dose of GARDASIL (strength, dose, route of administration, lot number and expiration date were unknown). The reporter specified there was an overdose. There were no concomitant therapies reported. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning to an 11 years old female patient. The patient's pertinent medical history and concurred conditions were not reported. The R.N. reported that on 03-AUG-2016 the patient received an unspecified dose of LIQUID PEDVAXHIB (dose was not provided), per intramuscular route, lot # K000331, expiry date 23-OCT-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 68 year old female patient. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were unknown. On an unknown date, she was vaccinated with ZOSTAVAX. On an unknown date, she experienced injection site swelling and redness for 4 to 7 days. She recovered from the events on an unknown date. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JUL-2016, the patient was vaccinated with PEDVAXHIB injection, lot # L038502, expiration date 16-AUG-2018 (strength, dose, route and anatomical location of administration were not provided), along with a dose of PENTACEL; "which has Haemophilus influenza as a component". No adverse reactions were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information about the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL (lot number, expiration date, concentration, dose, route of administration and frequency were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hormone level abnormal, Premature menopause
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient who is currently 19 years old. The patient[s pertinent medical history included ADHD (attention deficit/hyperactivity disorder), dizziness and fainting unrelated to GARDASIL, injection and occurring on different unrelated dates. No previous drug reactions or allergies were reported. On 24-OCT-2007, the patient was vaccinated with first dose of GARDASIL, second dose 02-JAN-2008 and 3rd dose 15-SEP-2008 (dosing details were not reported) intramuscularly. On an unknown date patient's mother stated that her daughter the patient had been diagnosed with premature ovarian failure, and she believed is the result of her GARDASIL vaccination (premature ovarian failure). The patient has on an unspecified date seen a reproduction specialist and reported by the mother to have extremely high hormone levels (hormone level abnormal). The outcome of the events was not reported. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hormone level abnormal, Laboratory test abnormal, Premature menopause
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient who is currently 19 years old. The patient[s pertinent medical history included ADHD (attention deficit/hyperactivity disorder), dizziness and fainting unrelated to GARDASIL, injection and occurring on different unrelated dates. No previous drug reactions or allergies were reported. On 24-OCT-2007, the patient was vaccinated with first dose of GARDASIL, second dose 02-JAN-2008 and 3rd dose 15-SEP-2008 (dosing details were not reported) intramuscularly. On an unknown date patient's mother stated that her daughter the patient had been diagnosed with premature ovarian failure, and she believed is the result of her GARDASIL vaccination (premature ovarian failure). The patient has on an unspecified date seen a reproduction specialist and reported by the mother to have extremely high hormone levels (hormone level abnormal). The outcome of the events was not reported. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Vaccination site induration, Vaccination site swelling
Clinical narrative: Swollen, red, hard lump under skin near where vaccine was given.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Vaccine was administered very high in my right shoulder on 6/17/16. Extreme pained and stiffness of my shoulder joint ensued within 2 hours. Given a course of oral steroids and a muscle relaxer on 6/29/16. Pain and stiffness briefly improved, but returned after treatment. Seen by orthopedic physician 8/3/16 and treated with a steroid injection, scheduled for physical therapy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Incorrect route of drug administration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Head ache, nausea, injection site is swollen, hot, tender (FYI - I did note that the injection was given IM and not subq as per directions.)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Head ache, nausea, injection site is swollen, hot, tender (FYI - I did note that the injection was given IM and not subq as per directions.)
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Swollen, red, tender, fever on spot, swelling spreading, painful.
Age: 1.38
Sex: M
Vaccine: MMR
Symptoms: Culture urine negative, Pyrexia, Rash papular, Rash pruritic
Clinical narrative: Persistent Fever for 3 days with maximum temperature of 103.3 and papular pruritic rash to neck, chest, and upper abdomen. Non-erythematous rash. Onset of fever approx 36 hours after vaccine administration and onset of rash 48 hours after vaccine administration. Fever Responsive to NSAIDs but returned once medication wore off.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoacusis, Mydriasis, Nausea, Pallor, Seizure
Clinical narrative: Patient received MENACTRA IM injection to left deltoid and within a minute to two reported blurred vision, changes in hearing, nausea and appeared pale. Patient was sitting in exam table and was placed in supine position after reporting symptoms. Systolic blood pressure was reading 80 and patient started to have a seizure, pupils appeared dilated and patient was unresponsive. Medical assistant called EMS. Seizure lasted less than a minute and patient's BP was rechecked at 82/50 around 11:51 a.m. Patient was then awake and wanting to sit up because he was nauseated. Patient was still appearing pale. Paramedics arrived to clinic at 11:56 at which time patient was sitting up answering questions and found to be alert and oriented to person, place, time and recent events. Was able to identify his mother present in the room. Blood pressure was rechecked at that time at 92/60 and paramedics placed patient in stretcher. Patient was ambulatory and interacting with paramedics, his mother and myself.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Unresponsive to stimuli, Vision blurred
Clinical narrative: Patient received MENACTRA IM injection to left deltoid and within a minute to two reported blurred vision, changes in hearing, nausea and appeared pale. Patient was sitting in exam table and was placed in supine position after reporting symptoms. Systolic blood pressure was reading 80 and patient started to have a seizure, pupils appeared dilated and patient was unresponsive. Medical assistant called EMS. Seizure lasted less than a minute and patient's BP was rechecked at 82/50 around 11:51 a.m. Patient was then awake and wanting to sit up because he was nauseated. Patient was still appearing pale. Paramedics arrived to clinic at 11:56 at which time patient was sitting up answering questions and found to be alert and oriented to person, place, time and recent events. Was able to identify his mother present in the room. Blood pressure was rechecked at that time at 92/60 and paramedics placed patient in stretcher. Patient was ambulatory and interacting with paramedics, his mother and myself.
Age: 13.0
Sex: F
Vaccine: HEPA, HPVX
Symptoms: Abdominal pain upper, Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: Headache, swelling at injection point, body aches, stomach ache, fever of 101.8 controlled with Advil.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient states shoulder is sore near injection site.
Age: 17.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Deafness, Feeling abnormal, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Hearing loss, ringing in ears. Fever, headache, stiffness in the neck, dizziness, feels like he is in a fog.
Age: 17.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Tinnitus
Clinical narrative: Hearing loss, ringing in ears. Fever, headache, stiffness in the neck, dizziness, feels like he is in a fog.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure, Skin discolouration
Clinical narrative: High fever of 104, gave her a bath, and started having mild seizures in tub. Took her out of the tub, and she was turning a slight shade of purple/blue and was not responding to either myself or her father. Called 911 and she was rushed into the hospital by ambulance. Was given MOTRIN and fever had gone down to 98.0 rapidly. The doctors ruled out a bunch of ideas they had that could have induced fever. Thought it could have been UTI but could not get an urine sample via catheter. Never once was the word VACCINE brought up by doctor/nurse. MMR vaccine caused this reaction, and for that my daughters will never receive another.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Bacterial infection, Cellulitis, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Between 8:30-9:00 PM, patient started complaining that the site the vaccination was itching.  It looked red and slightly swollen around the injection at bedtime. The next morning patient complained that it was itchy again.  When I looked at it, the red swollen area was much larger-about the size of my palm, hot, and hard.  I called the nurse line at our pediatrician's office.  They said it is normal for the MMR/Varicella vaccine to itch, to ice it and give her Tylenol. The following day it did not look any better, so we scheduled an appointment for July 27th. We saw another doctor in the practice who said the swelling/redness was celluitis caused by external bacterial infection.  She prescribed Cephalexin for the infection. After completing the entire round of prescribed anti-biotics, the redness/swelling appears to be gone.  Patient has not complained of it bothering her since taking the anti-biotics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Between 8:30-9:00 PM, patient started complaining that the site the vaccination was itching.  It looked red and slightly swollen around the injection at bedtime. The next morning patient complained that it was itchy again.  When I looked at it, the red swollen area was much larger-about the size of my palm, hot, and hard.  I called the nurse line at our pediatrician's office.  They said it is normal for the MMR/Varicella vaccine to itch, to ice it and give her Tylenol. The following day it did not look any better, so we scheduled an appointment for July 27th. We saw another doctor in the practice who said the swelling/redness was celluitis caused by external bacterial infection.  She prescribed Cephalexin for the infection. After completing the entire round of prescribed anti-biotics, the redness/swelling appears to be gone.  Patient has not complained of it bothering her since taking the anti-biotics.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reaction were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of varicella vaccine live VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reactions were 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 medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of PNEUMOVAX 23 (Lot # reported as M018624, expiry date: 28-MAY-2017) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative, refers to multiple (over 40) unspecified patients of unknown age and gender. The concurrent conditions, drug reactions, allergies and medical history of the patients were not reported. On an unknown dates since 06-MAY-2016, the patients were vaccinated with a dose of improperly stored GARDASIL 9, (lot number was L044475 and expiration date of 12-MAY-2017, strength, route of administration and dose were not reported), which was stored on 05-MAY-2016 at -49 Fahrenheit degrees for 15.5 hours, from 06-MAY-2016 to 09-MAY-2016 at -48.7 Fahrenheit degrees for 63.5 hours and on 03-JUN-2016 at -46.9 Fahrenheit degrees for 63.5 hours. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two 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 was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, (lot # M000996, expiry date 07-JAN-2018. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with an improperly stored VARIVAX either from lot # M006729, expiry date 08-FEB-2018 or L03517, expiry date 14-SEP-2017, 0.5 ml, subcutaneous. No adverse effects were reported. Temperature at 7.2F for 20hours 30minutes. 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 multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored RECOMBIVAX HB strength 2.5/0.5 (unit unspecified) (lot #L018500, expiration date 13-APR-2017 and lot #J013394, expiration date 25-AUG-2016) (dose frequency: once) intramuscularly (dosing details and anatomical location were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports 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 medical assistant refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored doses of ROTATEQ (lot # 1028645, expiry date 25-MAY-2017 and lot #K010323, expiry date 10-MAY-2016) (strength, dosing details, anatomical location were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse affects were reported. No product quality complaint was involved. This is one of the several reports 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 was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (rHA, lot # m001150, expiration date 05-JUL-2017, route unknown). The vaccine had been stored under the temperature of 21.7 Fahrenheit. There was no previous temperature excursion and no date logger involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored GARDASIL (lot number/expiry date unknown) on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 Minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown date these unspecified patients were vaccinated with improperly stored GARDASIL 9 (lot # 104475 and expiry date 12-MAY-2017)(strength, dosing details, anatomical location were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No drug reactions or allergies were reported. On an unknown date the patient was vaccinated with M-M-R II (dosing details were not reported). On an unknown date the patient experienced rash and had to go to ER (emergency room). The patient sought medical attention. The outcome of the event rash was not reported. The reported did not provided the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD, either lot number M009745 with expiration date of 23-AUG-2017 or lot number L050908 with expiration date of 14-JUN-2017 (strength, route of administration, and dose were not reported), which was stored at -6.9 Celsius degrees for 2 hours (the temperature excursions were detected by a data logger). There was no previous temperature excursion. No concomitant therapies nor adverse effect were reported. This is one of two 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 registered nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, with lot number L050957 with expiration date of 17-DEC-2017 or lot number M006724 with expiration date of 08-FEB-2018 (strength, route of administration and dose were not reported), which was stored at -6.9 Celsius degrees for 2 hours (The temperature excursions were detected by a data logger). There was no previous temperature excursion. No concomitant therapies no adverse effect were reported. This is one of two cases 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 medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of VAQTA (Lot # M011116, expiry date: 17-JUN-2017/Lot # M009786, expiry date: 26-MAY-2017) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. 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 as received from a medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of RECOMBIVAX HB (lot # K021581, expiry date: 24-OCT-2016/Lot # M003658, expiry date: 02-JUN-2018) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. 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 medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of ROTATEQ (Lot # L038534, expiry date: 19-AUG-2017/Lot # reported as L042219, expiry date: 02-JUN-2017/Lot # M019706, expiry date: 24-OCT-2017/Lot # L033694, expiry date: 16-JUN-2017) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. 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 healthcare worker via a company representative, refers to multiple (over 40) unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown dates since 06-MAY-2016, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, lot number reported as L042214 and expiration date of 14-JUN-2017 (strength and dose were not reported), which was stored on 05-MAY-2016 at -49 Fahrenheit degrees for 15.5 hours, from 06-MAY-2016 to 09-MAY-2016 at -48.7 Fahrenheit degrees for 63.5 hours and on 03-JUN-2016 at -46.9 Fahrenheit degrees for 63.5 hours. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases 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 medical assistant refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored doses of M-M-R II (lot # L032182, expiry date 25-AUG-2017) (strength, dosing details, anatomical locations were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. the concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, either lot number L044526 with expiration date of 09-NOV-2017, lot number M004328 with expiration date of 26-JAN-2018 or lot number M009765 with expiration date of 23-FEB-2018 (strength, route of administration and dose were not reported). No concomitant therapies not adverse effect were reported. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD, either lot number L050910 with expiration date of 14-JUN-2017, lot number L030591 with expiration date of 10-FEB-2017 or lot number L041628 with expiration date of 20-APR-2017 (strength, route of administration and dose were not reported). No concomitant therapies nor adverse effect were reported. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored GARDASIL9 (lot number/expiry date unknown) on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 Minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Muscle twitching
Clinical narrative: The night after receiving vaccines (8 pm) he started twitching (10 sec) (extremities) after the 10 sec he had a few more jerks of arm/leg then he was fine. Slept through night. This A.M. had a few shoulder jerks, but not like night before. He's been happy. No vom, diarrhea.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia
Clinical narrative: The night after receiving vaccines (8 pm) he started twitching (10 sec) (extremities) after the 10 sec he had a few more jerks of arm/leg then he was fine. Slept through night. This A.M. had a few shoulder jerks, but not like night before. He's been happy. No vom, diarrhea.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Injection site reaction, Pain, Swelling
Clinical narrative: Patient had an injection site reaction. Patient reported pain with swelling and redness severe enough they were treated at the emergency room for the discomfort.
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 32 year old female patient. The patient's pertinent medical history included mitral valve regurgitation (prior to M-M-R). The patient's drug reactions or allergies were reported as none. On 15-JUL-2016 the patient was vaccinated with M-M-R II injection, 0.5 ml (lot # L041456, expiry date: 22-OCT-2017). On 22-JUL-2016, 7 to 10 days after the patient received M-M-R II the patient developed a large lump and pain at the injection site (injection site pain and injection site mass). The patient did not receive any treatment for the events. The outcome of the events injection site mass and injection site pain was not reported. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 05-JUL-2016, the patient was vaccinated with RECOMBIVAX HB lot # J010613. Expiration date-11-JUN-2016, (expired product administration). No adverse event was reported. No concomitant medication was involved. The outcome of event was unknown. No PQC (product quality complaint) was involved. 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 multiple patients of unknown demographics. The reporter stated that the patients received improperly stored ROTATEQ (lot number/expiry date unknown) on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 Minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. 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 as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored RECOMBIVAX HB (lot number/expiry date unknown) on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 Minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of GARDASIL (lot #M014929, expiry date: 27-MAY-2017) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. 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 nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored VAQTA (lot number/expiry date unknown) on unknown dates. No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 hours and 17 minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. 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 nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored PNEUMOVAX 23 (lot number/expiry date unknown)on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. 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 medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of M-M-R II (Lot # L032182, expiry date: 25-AUG-2017/ Lot # L026553, expiry date: 16-JUL-2017/ Lot # reported as L041456, expiry date: 22-OCT-2017) were administered to the patients on unspecified dates. No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.