chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# M028553 and expiry date 07-JUN-2018) (lot# M017290 and expiry date 07-APR-2018) (lot#M023380 and expiry date 11-MAY-2018) (lot# M009767 and expiry date 23-FEB-2018) (lot# M019643 and expiry date 20-APR-2018) (lot# M024677 and expiry date 01-MAY-2018) (lot# M027347 and expiry date 01-JUN-2018) and (lot# M032493 and expiry date 06-JUL-2018) subcutaneously (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Numbness/paresthesias whole body, headache that started right after injection was given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot#L035510, expiration date: 13-MAY-2017); lot# L023866, expiration date: 24-MAR-2017; lot# L013193, expiration date: 20-JAN-2017 and lot# L010844, 16-NOV-2016) (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ, orally, lot# M007311, expiration date 30-NOV-2017 (dose was not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J013394, expiration date: 25-AUG-2016; lot # L019298, expiration date: 22-JUN-2017) (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with M-M-R-II (Lot# M008588, expiry date: 16-FEB-2018, Lot# L041457, expiry date: 22-OCT-2017) (route: subcutaneous) following a temperature excursion of 51F for 24 hours. No adverse effects were reported in any patients. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 15 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # M027886, 03-JUN-2018 and (wistar ra 27-3) M-M-R II M002419 12-JAN-2018. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (lot # M011663, expiration date 08-SEP-2017; lot # M018637, expiration date: 11-OCT-2017) (dose and route were not provided). The temperature excursion was of 11F in a time frame of 30 minutes. Data logger was reported as Yes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUX, TDAP, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date (reported as recent date), the patient was vaccinated with doses of ZOSTAVAX (dosing details , lot# and expiration date not reported), ADACEL (dosing details not reported) and unknown form of influenza virus vaccine (unspecified) (dosing details not reported). On an unknown date, the patient developed body aches (pain). The patient sought medical attention (unspecified). The outcome of the event was unknown. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 15 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016 the patient was vaccinated with improperly stored doses of VARIVAX lot # M027886 03-JUN-2018 and M-M-R II M002419 12-JAN-2018. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# L042846, expiration date 15-SEP-2017 and lot# M033334, expiration date 11-AUG-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies was provided. On an unknown date, the patient was vaccinated with M-M-R II injection, intramuscularly (dose, lot#, expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with improperly stored doses of PROQUAD lot # M032497 22-JAN-2018. No adverse effects were reported. Additional information has been requested.
Age: 5.0
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 5 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016 the patient was vaccinated with improperly stored PROQUAD lot # M032497 22-Jan-2018. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated injection site was hot to touch, red and swollen. Pt went to walk in clinic. Pt states she has a small  lump at injection site.
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Information was received on 28-OCT-2016 from a pharmacist regarding a 66 year old female consumer. Medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016 the female patient received an injection of PNEUMOVAX 23 (lot # M020521, expiration 17-NOV-2017) in her left arm. The pharmacist reported that the patient reported to her that she developed a warm red raised rash on the back of her arm behind the injection site approximately one day after receiving the PNEUMOVAX 23 injection. The patient went to an urgent care center and was given a prescription for an unnamed antibiotic, which she filled on 27-OCT-2016. The patient reported to the pharmacist that she missed a couple days of work due to the reaction. The outcome of warm red rash on the back of her arm behind the injection site was unknown. The pharmacist did not rate the causal relationship between warm red rash on the back of her arm behind the injection site and PNEUMOVAX 23. No additional information was available. No further information is expected.
Age: 1.42
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 27-OCT-2016, the patient was vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX lot # M027347, 01-JUN-2018 and (wistar ra 27-3) M-M-R II M032153 22-APR-2017. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via Pfizer (2016467917) 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, the patient was vaccinate with a dose of PNEUMOVAX 23, (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced rash. The reporter consulted if the patient gets a bad rash with PNEUMOVAX 23, is there a possibility that the patient will experience the same when he/she gets the dose of PREVNAR 13 a year after. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. The reporter consulted if the patient gets a bad rash with PNEUMOVAX 23, is there a possibility that the patient will experience the same when he/she gets the dose of PREVNAR a year after. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a 29-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not provided. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016164682.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Crying, Underdose, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of crying in a 2-month-old female patient who received ROTARIX (batch number A41CB568A, expiry date 17th October 2017). On 10th November 2016, the patient received ROTARIX (oral). On 10th November 2016, less than a day after receiving ROTARIX, the patient experienced crying, vomiting and underdose. On an unknown date, the outcome of the crying, vomiting and underdose were unknown. It was unknown if the reporter considered the crying and vomiting to be related to ROTARIX. Additional details were provided as follows: The GlaxoSmithKline had not been previously contacted about any adverse event for this patient. This case was not associated with product complaint. After the ROTARIX vaccine was administered the patient received other intramuscular injections, began to cry and threw up the ROTARIX, which led to underdose.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # M027347, 01-JUN-2018. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with GARDASIL (lot # M011117, expiry date 07-DEC-2017, dose, dose number, vaccination site, route unspecified). The vaccines were exposed to a temperature of 33 Fahrenheit (F) for 1 hour and 57 F for 1 hour. No previous temperature excursions were reported. Product quality complaint (PQC) was not involved. No adverse effects were reported. Digital data logger was not involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information is not expected because the reporter refused to contact further.
Age: 2.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with VARIVAX lot # M027886, 03-JUN-2018 and M-M-R II M008588 16-FEB-2018. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant referring to a 61 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-NOV-2016, the patient was inadvertently given a dose of VARIVAX injection (lot # L019126, expiration date 27-MAY-2017; dose and route were unknown), instead of a dose ZOSTAVAX (wrong vaccine administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L018500, expiration date: 13-APR-2017) (dose and route of administration were not reported). No adverse effects were noted in any patients. Administered doses of vaccines experienced the temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was not consent to contact with the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L038503, expiration date: 18-DEC-2017) (dose and route of administration were not reported). No adverse effects were noted in any patients. Administered doses of vaccines experienced the temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact with the reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown date in 2016 (reported as "unspecified dates since 29-SEP-2016"), the patients were vaccinated with doses of improperly stored M-M-R II albumin status of rHA, lot # L040961, expiration date 19-NOV-2017 (dose and site of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 51.8 degrees Fahrenheit for 30 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 24-OCT-2016, the patient was vaccinated with expired RECOMBIVAX HB lot # K026666/expiration date- 22-OCT-2016. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L043214, expiry date: 30-AUG-2017) (incorrect product storage). The vaccine was stored at lowest temperature (reached was 1.1 degree C) for a cumulative time of 15 hour and 40 minutes. Previous temperature excursion and data logger were involved. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with GARDASIL 9 (lot #, expiry date, dose, dose number, vaccination site, route unspecified). The vaccines were exposed to a temperature of 33 Fahrenheit (F) for 1 hour and 57 F for 1 hour. No previous temperature excursions were reported. Product quality complaint (PQC) was not involved. No adverse effects were reported. Digital data logger was not involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information is not expected because the reporter refused to contact further.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with PNEUMOVAX 23 (lot # L024132, expiry date 21-JAN-2017, dose, dose number, vaccination site, route unspecified). The vaccines were exposed to a temperature of 33 Fahrenheit (F) for 1 hour and 57 F for 1 hour. No previous temperature excursions were reported. Product quality complaint (PQC) was not involved. No adverse effects were reported. Digital data logger was not involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information is not expected because the reporter refused to contact further.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M018810 and expiry date 28-MAY-2018) (lot# M028323 and expiration date 26-SEP-2018) (lot# M032650 and expiration date 31-MAR-2019) (lot# L036301 and expiration date 20-DEC-2017) intramuscularly (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from a phlebotomist referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-NOV-2016, the patient was vaccinated with VARIVAX (Lot: K016128, expiry date: 23-SEP-2016) (dose, route were not reported). The phlebotomist reported that the patient received an expired dose of VARIVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II, (lot# M004063 and expiry date 25-JAN-2018)(lot#M010426 and expiration date 01-MAR-2018)(lot#M032153 and expiration date22-APR-2017)(lot#M017346 and expiration date06-APR-2018) and (lot#M029229 and expiration date08-JUN-2018) subcutaneously(also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a office manager regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On an unspecified date, the patient was vaccinated with one dose of improperly stored VAQTA INJ 25/0.5 (lot# reported as ED72D and expiration date 07-SEP-2018) (1 dose, route of administration and anatomical location unknown). The detail of the storage was a temperature excursion to 29 Fahrenheit(F) for 1 hour 27 minutes, 31 Fahrenheit(F) for 2 hours, 30.2 Fahrenheit(F) for 1 hour 45minutes, 32 Fahrenheit(F) for 1 hour 52 minutes and 32 Fahrenheit(F) for 33 minutes. No adverse effect was reported. Additional information is not expected as the reporter denies consent to be contacted for further information.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot# L021637 and expiry date 05-NOV-2016) and (lot#L019836 and expiration date 24-MAR-2017) subcutaneously (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 15 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with VARIVAX lot # M027347, 01-JUN-2018 and M-M-R II M032153 22-APR-2017. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with improperly stored doses of PROQUAD lot # M032497, 02-JAN-2018. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# M022077 and expiry date 10-MAR-2019) (lot# L048848 and expiry date 09-AUG-2018) (lot# M020926 and expiry date 11-AUG-2018) (lot# M008551 and expiry date 02-JUN-2018) (lot# M011838 and expiry date 09-AUG-2018) (lot# M029233 and expiry date 09-AUG-2018) (lot# M032649 and expiration date 11-NOV-2018) and (lot# L030608 and expiration date 15-APR-2018) intramuscularly (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # M025194, expiration date 22-MAR-2019, dose and route not reported). It was reported that the vaccine was store at 47.69 F for 24 hours. The case was reported due to data logger issue. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M032497, 02-JAN-2018. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M007125 and expiry date 06-OCT-2017) (lot# M016919 and expiry date 17-FEB-2018) (lot#L046320 and expiry date 29-SEP-2017) (lot# M004726 and expiry date 19-OCT-2017) and (lot# M029252 and expiry date 14-MAR-2018) orally (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5ml (unspecified dose) with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M017334, 05-OCT-2017. No adverse effects were reported. This is one of the several cases received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Vaccine was administered to child on 8/30/16 as a second dose, previously vaccinated in error on 10/30/2008 with a first dose. Pt has a documented HX of chicken pox virus on 7/18/2007 by MD
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and genders. The patient's pertinent medical history or concurrent conditions were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB Intramuscular Injection (lot# M001578, expiration date 21-NOV-2018), (route, dose and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. It was reported that the therapy was not discontinued. There was no product quality complaint (PQC) involved. This was one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager (other health professional) refers to an unknown number of patients of unknown demographics. Pertinent medical histories, current condition, reactions and allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA dosage regimen were not reported (lot # M0278879 expiry date: 24-JAN-2018). Concomitant medications were not reported. On an unknown date, the patients received an unknown number of doses VAQTA following temperature excursions of 47.5F for 30 minutes and 65.4 F for 17 hours 45 minutes and 43.34F for 10 minutes (incorrect product storage). No adverse effects (no adverse event) were reported in any patients. No further information is available. No Product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not give us consent to contact physician. This is one of 3 reports received from same reporter. MARRS # 1611USA008585 and MARRS # 1611USA008534.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a other health professional refers to a 65 year old male patient. There was no information about concurrent condition, historical medication and concomitant medication. On an unspecified date in 2012 the patient was vaccinated with ZOSTAVAX. On an unknown date in October 2016 the patient was diagnosed with shingles. It was unknown by reporter that treatment was given for the reporter or not. Patient seek medical attention. The outcome of shingles was unknown. Causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager (other health professional) refers to an unknown number of patients of unknown demographics. Pertinent medical histories, current condition, reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 dosage regimen were not reported (lot # M023169 expiry date: 13-JUN-2018). Concomitant medications were not reported. On an unknown date, the patients received an unknown number of doses GARDASIL 9 following temperature excursions of 47.5F for 30 minutes and 65.4 for 17 hours 45 minutes and 43.34F for 10 minutes (incorrect product storage). No adverse effects were reported in any patients. No further information is available. No Product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not give us consent to contact physician. This is one of 3 reports received from same reporter. MARRS # 1611USA008585 and MARRS # 1611USA008584.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager (other health professional) refers to an unknown number of patients of unknown demographics. Pertinent medical histories, current condition, reactions and allergies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB dosage regimen were not reported (lot # M020926 expiry date: 11-AUG-2018). Concomitant medications were not reported. On an unknown date, the patients received an unknown number of doses of RECOMBIVAX HB following temperature excursions of 47.5F for 30 minutes and 65.4F for 17 hours 45 minutes and 43.34F for 10 minutes. No adverse effects were reported in any patients. No further information is available. No Product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not give us consent to contact physician. This is one of 3 reports received from same reporter. MARRS # 1611USA008584 and MARRS # 1611USA008534.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with their first two doses of GARDASIL or GARDASIL 9 "one year apart", (route of administration, lot # and expiration date were unknown). The nurse also reported that unspecified patients who receive either GARDASIL or GARDASIL 9, fainted after receiving the dose. At the time of reporting, the outcome of syncope was unknown. The causal relationship between the syncope and the vaccination with GARDASIL or GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-Nov-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II dose scheduled and route of administration not provided (lot # L024266, expiration date 01-JUL-2017). There were no concomitant medications reported. It was reported that temperature of excursion reported was 32.2 degrees Fahrenheit for 12 hours. There was a previous excursion on 18-OCT-2016 at 52 degrees Fahrenheit and on 23-OCT-2016 at 34 degrees Fahrenheit for 30 minutes according to the data logger. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse referring to a 7 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date (reported as "at age 1 year"), the patient was vaccinated with her first dose of VARIVAX, and subsequently, on an unknown date (reported as "at age 5 years"), she was vaccinated with her second dose of VARIVAX, (route of administration, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date (reported as "at 7 years old"), the patient developed a case of shingles. At the time of reporting, the patient had recovered from the Herpes zoster. The causality assessment between the Herpes zoster and VARIVAX was not provided. Additional information is not expected, no permission for further contact was provided.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination error
Clinical narrative: Vaccine was administered 10/30/2008. Child had a HX of chicken pox documented by MD on 07/18/2007. Vaccine did not need to be administered.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 lot # M016193 and expiry date: 24-JAN-2018 (dose and route were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5 ml (dose unspecified) with lot number K011188 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.