chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Excessive eye blinking, Muscle twitching, Pyrexia, Seizure, Vomiting
Clinical narrative: Seen 6/3/19 for vaccine update only no illness, no fever Seen 6/7/19 for fever up to 102 on 6/6/19, 2 episodes non bilious, non bloody, emesis 6/6/19 * Seen 6/15/19 - mom states had 3 minute seizure on 6/14/19 with temp 101 full body twitching, eyes blinking,  repeat temp 100.5  followed by emesis x 2 - hx of febrile seizure at 9 mo old - w stare -> seen in ED
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: low grade fever vomiting body aches
Age: 2.08
Sex: F
Vaccine: HEPA
Symptoms: Gait inability
Clinical narrative: Not walking 10 hours after vaccine and for next 24 hours. She is well today
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left deltoid 8 cm x 6 cm  Tx: Cephalexin 500mg TID x 7 days
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT CALLED THIS MORNING REPORTING SEVERE PAIN IN RIGHT ARM THAT HAS CAUSED LIMITED MOBILITY IN THE ARM. PATIENT SAID PAIN STARTED UPON RECEIVING VACCINATION AND HAS CONTINUE THROUGHT THE WEEKEND TIL TODAY 7/2/19. PATIENT HAS CALLED HIS ORTHOPEDIC DOCTOR AND AWAITING REPLY.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Gait disturbance, Myalgia, Pyrexia
Clinical narrative: Patient complains of severe joint/muscle in all over body but especially hip. He said it was helped by ice pack and tylenol. I lasted 5 days and then resolved. He stated it was so bad on Friday, 6/28, that he had trouble walking. He also experienced fever, chills and all over body shaking.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Patient complains of severe joint/muscle in all over body but especially hip. He said it was helped by ice pack and tylenol. I lasted 5 days and then resolved. He stated it was so bad on Friday, 6/28, that he had trouble walking. He also experienced fever, chills and all over body shaking.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash and hives, itching on arms legs stomach back hands feet; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  This spontaneous report was received from a health professional referring to a 11 years old male patient. Concurrent condition included allergy, allergy to nuts, allergy to plants and grass allergy. Concomitant therapy included hydrochloride (ZYRTEC) for allergies nasal congestion.  On 21-FEB-2018 at 16:00 pm, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # N017686, expiration date: 02-FEB-2020  dose 1, strength and frequency were unknwon, intramuscular in the right arm) for prophylaxis and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (lot# 7Y29Z, dose 1, intramuscular in the left arm, strength, frequency and expiration date were unknown) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA)( lot# U5835AA, dose 1, intramuscular in the left arm, strength, frequency and expiration date were unknown).  On 22-FEB-2018 at 6:30 am, the patient experienced rash and hives, itching on arms legs stomach back hands feet. The patient was seen at a facility was given prednisone 20mg 1 tab twice a day for 5 days, was also given fluticasone propionate (FLONASE) for nasal congestion. The patient returned to the medical clinic on 23-FEB-2018 for continued rash, his mom stated it was worse, solumedrol 60mg once shot was given this day. The patient was to continue prednisone 20mg 1 tab twice a day for "tomorrow" and hold "this afternoon" dose since injection was given "today". The outcome of rash was reported as not recovered. The causality assessment was not provided by the reporter.      Follow up information has been received from a healthcare professional on 26-JUN-2019. The patient's information has been updated. It was reported "the patient here for WCC". The outcome of the event rash was reported as recovered on an unknown date.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV
Symptoms: Pyrexia, Rash, Roseola
Clinical narrative: Fever of 104° followed by trunk rash Was informed over the phone she had Roseola based on symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever over 104° followed by a trunk rash Treated same as previous reaction
Age: 0.5
Sex: M
Vaccine: DTAPIPV, RV1
Symptoms: Barium enema, Constipation, Enema administration, Intussusception, Vomiting projectile
Clinical narrative: Projectile Vomiting, no bowel movements. Saw P.A. Sent to emergency room where he received an xray, then transferred to Hospital. He was given a barium enema to reverse intussusception.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, RV1
Symptoms: X-ray
Clinical narrative: Projectile Vomiting, no bowel movements. Saw P.A. Sent to emergency room where he received an xray, then transferred to Hospital. He was given a barium enema to reverse intussusception.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Diplopia, Dizziness, Full blood count, Haematochezia, Metabolic function test
Clinical narrative: Rash on left forearm (petechiae approx. 1cm x 2.5cm), lightheadedness, double vision when reading, blood in one stool last night.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Petechiae, Rash, Urine analysis normal
Clinical narrative: Rash on left forearm (petechiae approx. 1cm x 2.5cm), lightheadedness, double vision when reading, blood in one stool last night.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Headache, Injection site pain, Injection site swelling
Clinical narrative: Localized pain/swelling at injection site, fever 103 degrees, severe headache, joint/body aches, generalized weakness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Localized pain/swelling at injection site, fever 103 degrees, severe headache, joint/body aches, generalized weakness
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Myalgia, Pyrexia
Clinical narrative: Chills, shivers, muscle pain, severe back pain, felt like I had fever although I did not take my temperature
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue  Muscle pain  Fever?
Sex: U
Vaccine: CHOL
Symptoms: Faeces discoloured, Faeces soft
Clinical narrative: GREEN STOOLS; This spontaneous case (PVX2019-897) was received from a nurse on 16-Apr-2019. It describes a female consumer who had green stools, after the administration of Vaxchora (lot no: 7000012 and expiry date: Jun 2019) for an unknown indication.   Case report: The consumer took the first dose of Vaxchora on 09-Apr-2019 and after 3 to 4 days, she had green stools. She stated that it was partly a dark organic green, and there were also parts of brighter green towards the ends of the stool. Stools were softer than her normal bowel movements. She did not have diarrhea, cramping, chills, fever or headache. There were no changes in her diet. On 22-Apr-2019, an additional information was received with the outcome of event.  The consumer's past medical condition included mitral valve prolapse and mild seasonal allergies. She did not have any history of gastrointestinal illness.  The consumer's past medication included Hepatitis A and B vaccine which was taken a week before (Apr 2019), Measles, mumps, and rubella (MMR) vaccine on 05-Apr-2019, and tetanus vaccine on 29-Mar-2019.  Action taken with Vaxchora was unknown.  The consumer had recovered from the event green stools.; Sender's Comments: Company's Comment : In this case a female consumer passed green stools following administration of first dose of Vaxchora. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vaxchora is assessed as possible . Also, there is concomitant intake of multiple vaccines which could have contributed to the event.
Age: 15.0
Sex: M
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GAVE VAXCHORA TO A 15-YEAR-OLD; A spontaneous case was received from a nurse on 24-Apr-2019 for two consumers.   Based on the information obtained from the nurse, two individual case safety reports PVX201904-000319 (PVX2019-985; 15-year-old male) and PVX201904-000320 (PVX2019-986, 16-year-old male) were created and cross-linked in the database.  It describes a 15-year-old adolescent male consumer whose nurse "gave Vaxchora to a 15-year-old". The consumer was receiving oral Vaxchora for cholera prophylaxis.  Case report: A 15-year-old male consumer had Vaxchora on 19-Apr-2019.  Action taken with Vaxchora with was not applicable.  The clinical outcome of the event "gave Vaxchora to a 15-year-old" was unknown.; Sender's Comments: Company's Comment: The causality of the event "gave Vaxchora to a 15-year-old" was considered as not applicable.
Age: 16.0
Sex: M
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GAVE VAXCHORA TO A 16-YEAR-OLD; A spontaneous case was received from a nurse on 24-Apr-2019 for two consumers.   Based on the information obtained from the nurse, two individual case safety reports PVX201904-000319 (PVX2019-985; 15-year-old male) and PVX201904-000320 (PVX2019-986, 16-year-old male) were created and cross-linked in the database.  It describes a 16-year-old adolescent male consumer whose nurse "gave Vaxchora to a 16-year-old". The consumer was receiving oral Vaxchora for cholera prophylaxis.  Case report: A 16-year-old male consumer had Vaxchora on 19-Apr-2019.  Action taken with Vaxchora with was not applicable.  The clinical outcome of the event "gave Vaxchora to a 16-year-old" was unknown.; Sender's Comments: Company's Comment: The causality of the event "gave Vaxchora to a 16-year-old" was considered as not applicable.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported; patient was mistakenly administered one dose of VARIVAX; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 11-JUN-2019, the patient was mistakenly administered one dose of varicella virus vaccine live (oka/merck) (VARIVAX) by subcutaneous route, lot # R027995, expiry date on 01-OCT-2020, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old patient (pt) of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 10-JAN-2008, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for long term prevention of shingles and zoster-related conditions.               On an unknown date, the pt was treated for herpes zoster as a result of zoster vaccine live (ZOSTAVAX) use. At the time of the report, the pt's outcome was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects noted at this time; patient, 5 days old, inadvertently received a dose of ROTATEQ that was selected instead of another unspecified vaccine; patient, 5 days old, inadvertently received a dose of ROTATEQ that was selected instead of another unspecified vaccine; This spontaneous report was received from a medical assistant referring to a 5 day old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 20-JUN-2019, the patient inadvertently received a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route, lot # R026541, expiry date on 11-JUL-2020, for prophylaxis; that was selected instead of another unspecified vaccine. No treatment was needed to be given. Patient was presently with parents in office and no adverse effects were noted.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Arnold-Chiari malformation, Hypoaesthesia, Muscle tightness, Nuclear magnetic resonance imaging abnormal, Skin tightness
Clinical narrative: left sided numbness//tightness in the face and jaw/ numbness on the other side of her face; left sided numbness//tightness in the face and jaw; Chiari Malformation; This spontaneous report was received from a physician and refers to a 23-year-old female patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapy included drospirenone, ethinyl estradiol (YAZ). On 04-JUN-2019, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, intramuscularly (injection site was not reported), lot # 1602281, expiration date: 21-JUL-2021, for HPV prevention. On 04-JUN-2019, hours after administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient experienced left sided numbness or tightness in the face and jaw. On an unspecified date in June 2019, the patient visited an unspecified emergency room, however, was not admitted to the hospital. On an unspecified date in June 2019, while in the emergency room, the patient underwent Magnetic resonance imaging (MRI), which showed Chiari Malformation. It was unknown, if Chiari Malformation was present before or after administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date, the patient developed numbness on the other side of her face. The patient did not receive any treatment. The outcome of the events was not reported. The relatedness between the events and the suspect product was not provided.  Upon internal review, the event of Chiari Malformation was considered to be medically significant.
Sex: U
Vaccine: HEPA, HPV4, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: unspecified number of patients were vaccinated with improperly stored vaccines; No adverse symptoms; This spontaneous report has been received from a business professional referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patients were vaccinated with hepatitis a vaccine, inactivated(VAQTA); rotavirus vaccine, live, oral, pentavalent(ROTATEQ), quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL); and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.     The vaccines were exposed to a temperature below 36°F (2°C) (30°F) during a time frame of 67 hours. No previous temperature excursions. No adverse effects.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient received an expired dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.         On 29-APR-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (expired product administered) lot # N012619 and expiration date 21-APR-2019, subcutaneous for prophylaxis (dosage schedule, anatomical location were not reported). No adverse effects were reported in the patient.     The outcome of expired product administered and no adverse event were unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 07-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000998: US-009507513-1907USA000999: US-009507513-1907USA001000: US-009507513-1907USA001001: US-009507513-1907USA001002: US-009507513-1907USA001003: US-009507513-1907USA001004: US-009507513-1907USA001005: US-009507513-1907USA001006: US-009507513-1907USA001007: US-009507513-1907USA001008: US-009507513-1907USA001009: US-009507513-1907USA001010: US-009507513-1907USA001011: US-009507513-1907USA001012: US-009507513-1907USA001013: US-009507513-1907USA001014: US-009507513-1907USA001015: US-009507513-1907USA001016: US-009507513-1907USA001017: US-009507513-1907USA001018: US-009507513-1907USA001019: US-009507513-1907USA001020: US-009507513-1907USA001021: US-009507513-1907USA001022: US-009507513-1907USA001023: US-009507513-1907USA001024: US-009507513-1907USA001025: US-009507513-1907USA001026: US-009507513-1907USA001027: US-009507513-1907USA001028: US-009507513-1907USA001029: US-009507513-1907USA001030: US-009507513-1907USA001031: US-009507513-1907USA001032: US-009507513-1907USA001033: US-009507513-1907USA001034: US-009507513-1907USA001035: US-009507513-1907USA001036: US-009507513-1907USA001037: US-009507513-1907USA001038: US-009507513-1907USA001039: US-009507513-1907USA001040: US-009507513-1907USA001041: US-009507513-1907USA001042: US-009507513-1907USA001043: US-009507513-1907USA001044: US-009507513-1907USA001045: US-009507513-1907USA001046: US-009507513-1907USA001047: US-009507513-1907USA001048: US-009507513-1907USA001049: US-009507513-1907USA001050: US-009507513-1907USA001051: US-009507513-1907USA001052: US-009507513-1907USA001053: US-009507513-1907USA001054: US-009507513-1907USA001055: US-009507513-1907USA001056: US-009507513-1907USA001057: US-009507513-1907USA001058: US-009507513-1907USA000862:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Dizziness, Labyrinthitis, Tinnitus, Vertigo
Clinical narrative: hearing loss; Bouts of extreme dizziness/ was diagnosed with vertigo; labyrinthitis; vesicular neuritis; Tinnitus; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.       On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)"), the patient suffered bouts of extreme dizziness. She presented to the emergency room and was diagnosed with vertigo, labyrinthitis, vesicular neuritis, hearing loss and tinnitus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct an proximate result of the Company´s conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   All the event were considered to be disabling, and upon internal review, the event of deafness was considered to be as medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Vestibular neuronitis
Clinical narrative: hearing loss; Bouts of extreme dizziness/ was diagnosed with vertigo; labyrinthitis; vesicular neuritis; Tinnitus; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.       On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)"), the patient suffered bouts of extreme dizziness. She presented to the emergency room and was diagnosed with vertigo, labyrinthitis, vesicular neuritis, hearing loss and tinnitus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct an proximate result of the Company´s conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   All the event were considered to be disabling, and upon internal review, the event of deafness was considered to be as medically significant.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 27-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 15-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 17-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 20-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 03-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 04-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.