chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II recombinant human albumin (rHA), lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-MAR-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 03-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-MAR-2017, the patient was vaccinated with an improperly stored doses of M-M-R II recombinant human albumin (rHA), lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported).  The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 01-DEC-2016, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 09-JAN-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 10-DEC-2017, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 30-JAN-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 10-DEC-2017, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 11-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 10-DEC-2017, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 17-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 10-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 30-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 12-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 09-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 30-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Age: 0.33
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 4 month old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 23-MAY-2017, the patient was inadvertently vaccinated with a dose of VAQTA 0.5 ml, intramuscularly, lot # M022924, expiration date 24-JAN-2018,  for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. Between 24-APR-2017 and 09-MAY-2017, the patients were vaccinated with improperly stored doses M-M-R II, lot numbers M011667, exp. 08-MAR-2018 and M032485 (rHA), exp. 06-JUL-2018 for prophylaxis. This report involved a digital data logger. No adverse events reported. Temperature and duration of excursion for the vaccine were as follows: -10.8°C for 6 hrs. 15 min -14.2°C for 45 min -12.5°C for 30 min -4.4°C for 11 hrs. 50 min 17.4F for 4 hrs. 35 min. This is one of three reports received from the same source. Additional information is not expected as scheduled follow up was received.; Sender's Comments:  US-009507513-1705USA007967: US-009507513-1705USA007838:
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to an 80 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 18-APR-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received.; Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013607: US-009507513-1705USA013608: US-009507513-1705USA013609: US-009507513-1705USA013610:
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 20-Mar-2017. This case involves a 66-year-old female patient who was vaccinated with a dose of ADACEL (batch number, expiry date dose form, frequency and site of administration not reported) via intramuscular route on 21-Feb-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as unknown. Illness at the time of vaccination was reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 21-Feb-2016, the same day following the vaccination the patient experienced numbness in lip and lower face. The patient was seen by a physician on an unspecified date. Relevant laboratory investigations were not reported. The patient received Steroid pack (unspecified) as corrective treatment. The patient had not recovered from the event. Follow-up report received from a pharmacist on 16-May-2017. Batch number of Adacel was reported as "45607AA" and expiry date was reported as 29-Mar-2019. List of documents held by the sender: None.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chills, Dysphagia, Fatigue, Headache, Increased upper airway secretion
Clinical narrative: This unsolicited case was received on 16-May-2017 from patient under reference number AE 17-0135. This case involves a 34-year-old male patient who was vaccinated with a dose of ACAM2000 (Batch number, expiry date, dose and dose in series were not reported) via percutaneous route in left arm and a dose of ANTHRAX VACCINE (Batch number, expiry date, dose, dose in series and route of administration were not reported) in right arm on 06-May-2017. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as seasonal allergies. Concomitant medications were not reported. On 14-May-2017, eight days following the vaccination, the patient had experienced headache, fever of greater than 100 F on and off, chills, fatigue, swollen left arm from the injection site to neck, swollen lymph nodes in the neck, had a buildup of mucous and some difficulty in swallowing. It was also reported that since receiving the vaccines, the patient had been experiencing increasing symptoms. Laboratory investigations were none. Corrective treatments were not reported. Patient was not recovered from the events. List of documents held by sender: none.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: This unsolicited case was received on 16-May-2017 from patient under reference number AE 17-0135. This case involves a 34-year-old male patient who was vaccinated with a dose of ACAM2000 (Batch number, expiry date, dose and dose in series were not reported) via percutaneous route in left arm and a dose of ANTHRAX VACCINE (Batch number, expiry date, dose, dose in series and route of administration were not reported) in right arm on 06-May-2017. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as seasonal allergies. Concomitant medications were not reported. On 14-May-2017, eight days following the vaccination, the patient had experienced headache, fever of greater than 100 F on and off, chills, fatigue, swollen left arm from the injection site to neck, swollen lymph nodes in the neck, had a buildup of mucous and some difficulty in swallowing. It was also reported that since receiving the vaccines, the patient had been experiencing increasing symptoms. Laboratory investigations were none. Corrective treatments were not reported. Patient was not recovered from the events. List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt received HPV vaccine around 5pm, got up right away after shot was given, pt walked to other side of the room and per RN pt was next to the door/ wall and passed out for maybe 5 seconds 5:05pm, pt came to and was helped up to a chair where she states she felt hot and sweaty, pt was A and O x 3. I gave pt a wet paper towel for her forehead and some M and M and water, I stayed with pt for 45 mins to monitor her. Pt states she felt much better after water and M and M, was able to get up and walk without issues. I reassured mom, pt was back to baseline and further care was not need at this time but if she wanted if any other worsening s/sx to call on call MD or go to ER.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 03-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1611USA011831:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 28-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA011831.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 01-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 3-year-old patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 16-MAR-2017, the patient was vaccinated with a dose of VARIVAX lot # M039318 (expiration date, dose, route of vaccination were not reported) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014463: US-009507513-1705USA013513: US-009507513-1704USA000004: US-009507513-1705USA013527:
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 20-month-old patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 13-MAR-2017, the patient was vaccinated with a dose of VARIVAX lot # M039318 (expiration date, dose, route of vaccination were not reported) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014463: US-009507513-1704USA000004: US-009507513-1705USA013512: US-009507513-1705USA013527:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported.  Since 01-MAR-2017, the patients were vaccinated with VARIVAX lot # M041079 (expiration date, dose, route and site of administration were not reported) for prophylaxis. Information regarding concomitant medication was not provided. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014463: US-009507513-1704USA000004: US-009507513-1705USA013512: US-009507513-1705USA013513:
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to an 62 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 23-APR-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received.; Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013608: US-009507513-1705USA013609: US-009507513-1705USA013610: US-009507513-1705USA013606:
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 60 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 02-MAY-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received.; Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013606: US-009507513-1705USA013607: US-009507513-1705USA013609: US-009507513-1705USA013610:
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 66 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 08-MAY-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received. Sender's Comments: US-009507513-1704USA006516: 1705USA013606: 1705USA013607: 1705USA013608: 1705USA013610:
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 68 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 08-MAY-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter.  Additional information is not expected as all the information has been received. Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013607: US-009507513-1705USA013606: US-009507513-1705USA013608: US-009507513-1705USA013609:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of hpv GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA000781: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA000781: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007711: US-009507513-1705USA007712.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA000781: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007712.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA000781: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source.  Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1611USA011831: