chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult patient who received ENGERIX B. Co-suspect products included ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B and ENGERIX B, the patient experienced therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder and therapy non-responder were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B and ENGERIX B. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were received as follows: The age at vaccination was not reported. The reporting pharmacist stated that she had an adult patient who had undergone two full series of ENGERIX-B, but after having titers drawn after each series (after an unknown period of time following completing each series), the patient did not achieve minimum titer levels to achieve immunity, which led the patient to be a therapy non responder. The patient's physician prescribed a 40 mcg dose for a third series for the patient, despite the patient not being a dialysis patient, but the 40 mcg dose was not administered by the time of reporting. The reporting pharmacist did not feel comfortable sharing patient information, and did not have access to lot numbers and expiration dates.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased
Clinical narrative: Mother reports pt started with temp evening 8/7 - she gave Ibuprofen temp cont throughout NOC she cont with ibuprofen. On 8/8 temp spiked and cont to climb after ibuprofen also gave TYLENOL take increased to 104 degrees before coming down. Pt seen Dr at clinic and he informed mother temp R/T vaccine
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Quality of life decreased, Rhinorrhoea, Sneezing
Clinical narrative: Pt states that since he received flu shot on 9/26/16 he has uncontrollable sneezing and runny nose and had decreased his quality of life.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: DTaP was ordered by Dr. on 8-1-17. Patient was given PENTACEL. Error found 8-4-17. Called Guardian - and she reports no symptoms. Sanofi was notified and left message with County Health Dept.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Cold sweat, Decreased appetite, Eating disorder, Haemoglobin decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaginal bleeding in a 48-year-old female patient who received BOOSTRIX. Concurrent medical conditions included fibroids (caused bleeding in the past, but they had been inactive for a long time). On 27th July 2017, the patient received BOOSTRIX (intramuscular). In July 2017, 12 hrs after receiving BOOSTRIX, the patient experienced vaginal bleeding. On 27th July 2017, the patient experienced vomiting, abdominal pain and cold sweat. On an unknown date, the patient experienced hemoglobin decreased and decreased appetite. The patient was treated with ibuprofen. On an unknown date, the outcome of the vaginal bleeding and hemoglobin decreased were not recovered/not resolved and the outcome of the vomiting and cold sweat were recovered/resolved and the outcome of the abdominal pain and decreased appetite were recovering/resolving. The reporter considered the vaginal bleeding, vomiting, abdominal pain, cold sweat, hemoglobin decreased and decreased appetite to be related to BOOSTRIX. Additional details were reported as follows: The patient's concomitant medication included Multivitamin. On 27th July 2017 at 14:00, the patient received BOOSTRIX on the left arm. Four hours after the vaccination, the patient had sudden onset of vomiting, a sharp pain in her abdomen and cold sweats. The patient had to take 2 ibuprofen because the pain was so bad. A few hours later, the abdominal pain had settled into a dull ache but she began experiencing vaginal bleeding. Less than a week after the vaccination, over the weekend the patient could barely eat and had no appetite and had low haemoglobin. At the time of reporting she could eat, but her appetite was still down. On 2nd August 2017, the bleeding had continued and was worse, which was described as haemorrhaging. The patient visited her OB/GYN on the day of reporting and would have visited day before reporting, if she could have got an appointment. The patient was not hospitalized, but if the haemorrhaging continued she was afraid if she would have to have a transfusion. The patient already told that her haemoglobin had dropped. The patient stated that the bleeding was worse than any of her previous fibroid surgeries and this might have caused by BOOSTRIX, because she was fine when she walked into her physician's office to receive the vaccine. While the patient did not provide her own address, but she had given permission to contact her physician with the required information.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Vaginal haemorrhage, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaginal bleeding in a 48-year-old female patient who received BOOSTRIX. Concurrent medical conditions included fibroids (caused bleeding in the past, but they had been inactive for a long time). On 27th July 2017, the patient received BOOSTRIX (intramuscular). In July 2017, 12 hrs after receiving BOOSTRIX, the patient experienced vaginal bleeding. On 27th July 2017, the patient experienced vomiting, abdominal pain and cold sweat. On an unknown date, the patient experienced hemoglobin decreased and decreased appetite. The patient was treated with ibuprofen. On an unknown date, the outcome of the vaginal bleeding and hemoglobin decreased were not recovered/not resolved and the outcome of the vomiting and cold sweat were recovered/resolved and the outcome of the abdominal pain and decreased appetite were recovering/resolving. The reporter considered the vaginal bleeding, vomiting, abdominal pain, cold sweat, hemoglobin decreased and decreased appetite to be related to BOOSTRIX. Additional details were reported as follows: The patient's concomitant medication included Multivitamin. On 27th July 2017 at 14:00, the patient received BOOSTRIX on the left arm. Four hours after the vaccination, the patient had sudden onset of vomiting, a sharp pain in her abdomen and cold sweats. The patient had to take 2 ibuprofen because the pain was so bad. A few hours later, the abdominal pain had settled into a dull ache but she began experiencing vaginal bleeding. Less than a week after the vaccination, over the weekend the patient could barely eat and had no appetite and had low haemoglobin. At the time of reporting she could eat, but her appetite was still down. On 2nd August 2017, the bleeding had continued and was worse, which was described as haemorrhaging. The patient visited her OB/GYN on the day of reporting and would have visited day before reporting, if she could have got an appointment. The patient was not hospitalized, but if the haemorrhaging continued she was afraid if she would have to have a transfusion. The patient already told that her haemoglobin had dropped. The patient stated that the bleeding was worse than any of her previous fibroid surgeries and this might have caused by BOOSTRIX, because she was fine when she walked into her physician's office to receive the vaccine. While the patient did not provide her own address, but she had given permission to contact her physician with the required information.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 41-year-old female patient who received BOOSTRIX (batch number 594SR, expiry date 8th July 2019). On 24th July 2017, the patient received BOOSTRIX. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: The patient received a dose of BOOSTRIX on left arm and experienced pain in the same arm. It was unknown, how soon the event developed relative to receiving the injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Left mid arm with 5 cm firm erythematous slightly raised warm area of skin. No vesicles or skin breakdown. Feels a little itchy, not painful. Recommend ice. Continue to observe, expect will begin to improve after tomorrow.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Ear pain, Injection site reaction, Nasal congestion, Otitis media, Pyrexia
Clinical narrative: Pt started developing fever (104 degree F) 1 day after vaccine administration. Pt also developed papular rash on extremities 5 days after vaccine administration. Pt presented to doctor's office on 8/1/17 with multiple papules on upper and lower extremities and nasal congestion.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Pt started developing fever (104 degree F) 1 day after vaccine administration. Pt also developed papular rash on extremities 5 days after vaccine administration. Pt presented to doctor's office on 8/1/17 with multiple papules on upper and lower extremities and nasal congestion.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Patient has nerve pain in lower left arm and left shoulder.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pain
Clinical narrative: Rash, pain in area of injection 1 day after injection. Achy, no fever.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Approximately 6 hours post injection patient developed fever and muscle aches - for next five days fever, nausea, malaise, loss of appetite and all over body muscle pain.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Anxiety, Obsessive-compulsive disorder
Clinical narrative: Mom states that child was never anxious or have OCD symptoms until two weeks after getting GARDASIL. Since that time has seen our psychologist. Also developed abdominal pain 1 month after vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Patient claimed she had the reaction on 7/1/17, redness, swollen, warm, bumps - she took 2 BENADRYL and used icepacks then it's gone on 7/5/17 (pt. consulted MD, not hospitalized).
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PNEUMOVAX 23 injection - arm is very sore with a red bump. Told to take TYLENOL and ice arm - confirmed w/Doctor.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Lip swelling, Pruritus
Clinical narrative: Patient called after 3 days of receiving vaccine that he got itching on his bottom of feet and he started to get his lip swollen. Patient started taking BENADRYL and it helped him. He got better and had no severe reaction.
Age: 87.0
Sex: U
Vaccine: FLUA3, PPV
Symptoms: Dizziness
Clinical narrative: Pt was dizzy at the counter and was about to fall.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Rash
Clinical narrative: Patient had a fever day after shot was given. Also developed a rash on her knees and axilla. Went to MD on 8/9/2017 for evaluation.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain from shoulder to elbow in arm first day (the second day swollen spot above elbow from PNEUMOVAX 23 arm only (left arm).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, pain and swelling at injection site as well as low grade fever. No medications prescribed, recommended ice on injection site and TYLENOL or ibuprofen for pain and fever.
Age: 5.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Decreased appetite, Diarrhoea, Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Patient presented with R Shoulder blanchable erythema from the R Shoulder down to R Axilla circumferentially. Area was hot to the touch. Subjective fever per MOC.  +Diarrhea and poor appetite as well reported by mother of child.
Age: 5.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pyrexia
Clinical narrative: Patient presented with R Shoulder blanchable erythema from the R Shoulder down to R Axilla circumferentially. Area was hot to the touch. Subjective fever per MOC.  +Diarrhea and poor appetite as well reported by mother of child.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, Injection site pruritus, Injection site urticaria
Clinical narrative: PATIENT MISTAKENLY RECEIVED A FOURTH DOSE OF GARDASIL. DOSAGES GIVEN OF GARDASIL 9 ON 6/1/16, 8/9/16, AND 12/16/16 SHOWED NO ADVERSE EFFECTS. DOSAGE GIVEN ON 8/8/17 CAUSED LARGE WHEAL AT SITE WITH SIGNIFICANT ITCHING AND URTICARIA. APPLIED TOPICAL STEROID TO SITE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Arthralgia, Crying, Pain in extremity, Pyrexia, Screaming
Clinical narrative: About 13 hours after vaccines we're given son woke up screaming crying of high fever and complained of knee and hand pain.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a other health professional refers to an 81 year old female patient. The patient's medical history included herpes zoster. On an unknown date in 2016, the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent. In June 2017, the patient experienced herpes zoster and pain. The outcome of herpes zoster and pain is unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1707USA009909.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX for prophylaxis reconstituted with properly stored sterile diluent. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA004467.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 2013, the patient was vaccinated with ZOSTAVAX for prophylaxis. In July 2017, the patient experienced herpes zoster. The outcome of herpes zoster is unknown. Causality assessment was not provided. This is one of two reports from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1707USA009067.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD lot # N001489, expiration date 12-JUL-2018 for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). The vaccines and sterile diluent(STERILE DILUENT) were excursed under -9°C to 8°C for about 15 minutes. Digital data logger involved. No adverse events reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004400:
Sex: U
Vaccine: PNC13, PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 2 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-JUL-2017, the patient received one dose of PNEUMOVAX 23 (lot # M039060, expiration date 22-MAY-2018; dose and route were unknown) (drug administered to patient of inappropriate age) for prophylaxis as well as one dose of PREVNAR 13 (lot # and expiration date were unknown). No adverse reactions were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash generalised, Scab
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 21 month old male patient. The patient had no pertinent medical history and drug reactions or allergies. Information regarding concomitant medication was unknown. On an unspecified date, the patient was vaccinated with VARIVAX (dose, route, anatomical location and lot# unknown) for disease prevention, which was reconstituted with sterile diluent (dose and lot# unknown). On 17-MAY-2017, the patient experienced rash and presented at physician office. On the same day, the patient began taking ZOVIRAX for treatment of the rash. Approximately on 19-MAY-2017 reported as two days after physician visit, the patient presented at physician office again with baby vesicles that were generalized on patient's skin. On 22-MAY-2017, the patient again presented at physician office "covered in a rash". On an unknown date in 2017, baby vesicles started to crust a few days later and patient recovered from "rash and baby vesicles" with no complications. Causality assessment was not provided by the reporter. There was no Product Quality Complaint (PQC) involved. The physician also reported that the patient's sibling, developed chickenpox "fourteen days after rash and baby vesicles" on patient recovered. The patient's sibling was 6 months old when chickenpox developed and sibling had never received VARIVAX. The patient's sibling began taking ZOVIRAX on an unspecified date, and chickenpox resolved without any issues. No further information provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; received dose of improperlly stored PROQUAD; This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age. On an unknown date the patients received doses of improperly stored PROQUAD (lot # N002915, expiration date: 24-JUL-2018 and N010114, rHA, expiration date: 24-SEP-2018) that were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # N016995, expiration date: 08-OCT-2019) for prophylaxis. No adverse effects were reported. The vaccines were stored under 13.5 Fahrenheit for 10 minutes. It was called because of a "data logger" and no previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002149:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX, lot# reported as N009779, expiration date 12-MAR-2017 for prophylaxis. Concomitant therapies included sterile diluent. The excursion under temperature 15 to 46 degree Fahrenheit for 5 hours. The previously excursion was 15 to 46 degree Fahrenheit for 6 hours. Digital data logger involved. No adverse events reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA004439.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-JUL-2017, the patient was vaccinated with 1 dose of improperly stored PROQUAD (route was not reported) (lot # M043306, expiration date 24-APR-2018) which was reconstituted with sterile diluent (manufacturer unknown) (lot# reported as M034582, expiration date: 27-APR-2019) (dose, units, frequency, route and indication were not reported) that was properly stored.  The administered dose of PROQUAD experienced a temperature excursion of -12 degree Celsius for 1 hour and 13 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 01-AUG-2017, the patient was inadvertently vaccinated with expired dose of GARDASIL 9 (dose and route of administration were not reported) lot # M014929 with expiration date: 27-MAY-2017. No adverse effects were reported. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to a 6 week old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 31-JUL-2017, the patient was vaccinated with a dose of pediatric VAQTA (lot # M039202, expiration date 11-MAR-2018, intramuscular; dose was unknown) for prophylaxis (incorrect dose administered and drug administered to patient of inappropriate age). No adverse effects were reported.
Age: 42.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 02-AUG-2017, the patient was vaccinated with one dose of improperly stored VARIVAX (lot # M033904, expiration date 20-JUL-2018, 0.5 ml, subcutaneous) for prophylaxis along with M-M-R II (lot # and expiration date were unknown) and hepatitis b virus vaccine (unspecified) (manufacturer unknown). The other two vaccines did not experience temperature excursion. No adverse effects were reported. The vaccine stored under -9 Celsius degree to 8 Celsius degree for 1 hour. Previous temperature excursion was -9 Celsius degree to 8 Celsius degree for 63 hours. Data logger was not involved.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition or medical history was unknown. On 31-JUL-2017 the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # M014929 with expiration date 27-MAY-2017, dose and route unknown) for prophylaxis.
Sex: U
Vaccine: VARZOS
Symptoms: Generalised oedema, Pruritus generalised, Secretion discharge
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of an unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date, the patient experienced pruritus generalised, secretion discharge (reported as fluid oozing "everywhere") and generalised oedema. The patient stated that the adverse event started at her ankles and then spread. The outcome of pruritus generalised, secretion discharge and generalised oedema was unknown. The causality assesment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age. On an unknown date the patients received doses of improperly stored VARIVAX (lot # M025871, expiration date: 24-MAY-2018 and M028553, expiration date: 07-JUN-2018) that were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # N016995, expiration date: 08-OCT-2019) for prophylaxis. No adverse effects were reported. The vaccines were stored under 13.5 Fahrenheit for 10 minutes. It was called because of a "data logger" and no previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA000172:
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a nurse prescriber referring to a 21 years old female patient. She had previously received birth control pills ethinyl estradiol norgestimate (ORTHO TRI-CYCLEN) until an unspecified date. The patient's concurrent condition and concomitant therapy were not reported. Nurse prescriber reported patient had an abnormal Pap smear, on an unspecified date in April 2017. Nurse prescriber reported patient informed the nurse prescriber, on 26-APR-2017, that patient had stopped the birth control pills, on an unspecified date. On 21-JUN-2017, the patient had a urine pregnancy test that was negative after two to three minutes and she was vaccinated with GARDASIL 9 (frequency, strength, lot# unknown), 0.5 ml, intramuscularly for prevention of human papillomavirus infection (HPV), however, urine pregnancy test result "turned pink", indicating a positive result (Vaccine exposure during pregnancy). Her last menstrual period (LMP) was 23-MAY-2017 and estimated date of delivery (EDD) would be 27-FEB-2018. The outcome of pregnancy was unknown. No adverse events were reported. The patient planned to terminate pregnancy and had not returned to the office. No treatment was given.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with ZOSTAVAX lot # N012092 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 16-JUL-2016, the patient was vaccinated with the first dose and on 18-AUG-2016, with the second dose of GARDASIL 9 for prophylaxis. On 18-AUG-2016, 1 month 3 days after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant referring to an unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with RECOMBIVAX HB Lot # N002913 with an expiration date on 23-FEB-2019 for prophylaxis, that had been improperly stored. No adverse effects were reported. The vaccines were stored at 48°F during 2 hours and 58 minutes and no previous temperature excursions were reported. The call was because of a data logger. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513- 1708USA004151:
Sex: U
Vaccine: PPV
Symptoms: Agitation, Pain
Clinical narrative: Information has been received from a pharmacist referring to several patients of unknown age and gender (pregnant: no). Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced soreness, pain and agitation after having been vaccinated. The outcome of the events was unknown. The causality assessment was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On unknown dates the multiple unspecified patients were vaccinated with a dose of improperly stored GARDASIL 9 (lot # M041212, exp date: 21-JUN-2019) for prophylaxis. The temperature was in 32 F degree to 35 F degree for 200 hours. There was no previous temperature excursion and no data logger involved. No adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-APR-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. On 01-APR-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004161: US-009507513-1708USA004162: US-009507513-1708USA004160:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age.  On SEP-2015 the patient was vaccinated with PROQUAD lot # M014301 for prophylaxis.  Other suspect therapies included VARIVAX. Concomitant therapies included sterile diluent (STERILE DILUENT). On SEP-2015 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD and VARIVAX.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Lot # N010247; expiration date 25-SEP-2018) for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was -14°C to -10°C for 257 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA011937: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M047662; expiration date 02-DEC-2018) for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was -14°C to -10°C for 257 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA003628: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA011937: US-009507513-1708USA003627: US-009507513-1708USA003630:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (Lot # M044347; expiration date 04-NOV-2018), (Lot # M047662; expiration date 02-DEC-2018), (Lot # N014366; expiration date 09-MAY-2019) for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was -14°C to -10°C for 257 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA011937: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Since 21-JUN-2017 the patients were vaccinated with improperly stored GARDASIL 9 (dose, lot #, expiration date and route were unknown) for prophylaxis. No adverse effects were reported. The coldest temperature was 32 Fahrenheit, time frame was unknown. There were multiple temperature excursions previously. The call was because of a data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004182: US-009507513-1708USA004183: US-009507513-1708USA004184:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot# M017983, expiration date 30-MAY-2018, lot# M028323 expiration date 26-SEP-2018, lot# M034780, lot# M041212, lot# M042853 (expiration dates were not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported.  This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004395: US-009507513-1708USA004394: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004408 : US-009507513-1708USA004409:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ lot # M042821, orally for prophylaxis. No adverse event reported. The vaccines were exposed to a temperature between 32-35 Fahrenheit degrees for a timeframe of 32 hours. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA004021:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with ROTATEQ orally (lot #: M038208 with expiration date: 04-MAY-2018, lot #: M043563 with expiration date: 09-JUN-2018) (dose, strength and frequency were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 33°F for 420 hours without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old patient. On 13-OCT-2014, at age 11 years, the patient received the first dose of GARDASIL. On  27-FEB-2015, the patient received the second dose of GARDASIL (lot K018149, expiry date 22-JUN-2016) and on 29-APR-2015, the patient received third dose of GARDASIL (lot L001442, expiry 04-NOV-2016) intramuscular for prophylaxis. On 29-APR-2015, 6 months 17 days after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 28-JUN-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects reported.; Sender's Comments:  US-009507513-1708USA002800:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-JUL-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects reported.; Sender's Comments:  US-009507513-1708USA002800:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with an incorrect storage RECOMBIVAX HB lot # M044032, expiration date  03-JUL-2019 for prophylaxis. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002800:Original Case : 1708USA002800
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUN-2017 the patient was vaccinated with M-M-R II lot # M010426, expiration date: 01-MAR-2018; lot # M032157, expiration date: 01-JUL-2018 and lot # M039913, expiration date: 26-SEP-2018, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced no adverse event. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002800: Original Case : 1708USA002800
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from other health professional refers to a patient of unknown age. On 24-JUL-2017 the patient was vaccinated with an incorrect storage GARDASIL 9 lot # N004798, expiration date: 31-OCT-2018 and lot # M037770, expiration date: 01-JUL-2019, for prophylaxis. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002800:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 10-JUL-2017 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number M037770  expiration date: 01-JUL-2019, lot number: N004798 expiration date: 31-OCT-2018) for prophylaxis (digital data logger). No adverse effects reported. ; Sender's Comments: US-009507513-1708USA002800:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 18-JUL-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects reported.; Sender's Comments:  US-009507513-1708USA002800:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 20-JUL-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). Concomitant therapies included sterile diluent (MRK). No adverse effects reported. Sender's Comments: US-009507513-1708USA002800.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot number M044032 expiration date: 03-JUL-2019) for prophylaxis (digital data logger). No adverse effects reported. Sender's Comments: US-009507513-1708USA002800.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant referring to an unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL 9 Lot #M042853 with an expiration date on 17-JUL-2019 for prophylaxis, that had been improperly stored. No adverse effects were reported. The vaccines were stored at 48°F during 2 hours and 58 minutes and no previous temperature excursions were reported. The call was because of a data logger. This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1708USA002974:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M042821, orally for prophylaxis. No adverse event reported. The vaccines were exposed to a temperature between 32-35 Fahrenheit degrees for a timeframe of 32 hours. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1708USA004021:u
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-APR-2017 the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On 01-APR-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004161: US-009507513-1708USA004162: US-009507513-1708USA003618:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-APR-2017 the patient was vaccinated with VAQTA for prophylaxis.  On 01-APR-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003618: US-009507513-1708USA004162: US-009507513-1708USA004160:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-APR-2017 the patient was vaccinated with ROTATEQ for prophylaxis. On 01-APR-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA004161: US-009507513-1708USA003618: US-009507513-1708USA004160:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored M-M-R II (lot M042846; expiry date: 21-OCT-2018) reconstituted with properly stored sterile diluent and VAQTA (lot N005274; expiry date: 03-APR-2018). The vaccines were exposed to temperature range of 9°C to 25°C for 16 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA004578.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M042853, expiration date 17-JUL-2019 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 32 degree fahrenheit to 35 degree fahrenheit for 480 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA004187: US-009507513-1708USA004188: US-009507513-1708USA004189: