chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 128 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's medical history and concomitant therapies was provided. On 19-OCT-2016, the patient was inadvertently administered an expired dose of M-M-R II, expiration date: 15-OCT-2016 (lot#, dose and route of administration were not reported) which was expired. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 12 month old patient of unknown gender. No information on their pertinent medical history, drug allergies and reactions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported). On the same unknown date, the patient was also vaccinated with a dose of PROQUAD (dose, route of administration, lot# and expiration date were not reported_. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A), referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored VARIVAX (lot # M002061, expiration date 12-JAN-2018; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. It was unknown, whether the patient had any concomitant therapies, pertinent medical history or known drug reactions or allergies. On unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M003659, expiration date: 20-SEP-2017, (dose and route of administration were not provided). No information whether any adverse event occurred was provided. Administered doses of vaccines experienced a temperature excursion of 25 degrees Fahrenheit for 7 days. There were no previous temperature excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 45 year old patient of unknown gender. The patient had previous administration of PREVNAR 13. On 03-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # M033086 and expiration date 05-MAY-2018) 0.5 ml, unknown route. No concomitant medication were reported. On 03-OCT-2016 (reported as within 24 hours of receiving PNEUMOVAX 23) the patient experienced warmth, redness and swelling below the injection site. The patient sought medical attention by calling the pharmacy on unspecified dates. The pharmacist reported that the patient was advised a treatment of pain killers and call their physician if symptoms get worse. The outcome of the events reported as unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. This case is cross linked with the MARRS# (same reporter link) 1610USA005734. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date between 01-SEP-2016 and 09-OCT-2016, the patient received improperly stored VARIVAX injection (lot #L037560, expiration date 29-SEP-2017; dose and route were unknown). No adverse effects were reported. The vaccine was stored under temperature 18.03 Fahrenheit degree for 16 hours. There was no prior temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a healthcare professional regarding temperature stability issue of (Wistar RA 27-3) M-M-R II. Information on administration of the vaccine or about the patients was not reported. No adverse event was reported. This is one of the two reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date between 01-SEP-2016 and 09-OCT-2016, the patient received improperly stored VARIVAX injection (lot # L037560, expiration date 29-SEP-2017; dose and route were unknown). No adverse effects were reported. The vaccine was stored under temperature 18.03 Fahrenheit degree for 16 hours. There was no prior temperature excursion. Digital data logger was involved. This is one of several reports received from 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 certified medical assistant (C.M.A), referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with PROQUAD (lot # M011663, expiration date 08-SEP-2017; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received a dose of improperly stored RECOMBIVAX HB injection (lot # M001578, expiration date 21-NOV-2018; dose unknown), intramuscularly. No adverse effects were reported. The vaccines were stored under temperature 35 Fahrenheit degree for 1 hours. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Lymphadenopathy, Pain
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a 26 years old non-pregnant female patient. Pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. On 05-OCT-2016, the patient received a dose of GARDASIL 9 via intramuscular injection in the right gluteal (lot# M024261 with expiry date: 30-JUL-2018) (dosing details not reported). On 09-OCT-2016, the patient noticed soreness, redness and inflamed lymph node. Patient came to the office on 12-OCT-2016 and was prescribed KEFLEX 500 mg bid for 7 days. No lab diagnostic studies were performed. On 19-OCT-2016, the patient came back to the office and was recovered. Causality of the events was not reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 10-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of (wistar ra 27-3) M-M-R II lot # M016234, expiry date 31-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 14-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II (lot # M016234, expiry date 31-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # M004885 and expiry date 23-OCT-2017). No adverse events were reported. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 12-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II (lot # L047134, expiry date 24-NOV-2017, dose, dose number, vaccination  site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reaction and concomitant medications were unspecified. On 10-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II lot # M016234, expiry date 31-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L043703, expiration date 03-NOV-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding multiple patient of unknown demographics. Information on pertinent  medical history, drug reactions/allergies and concomitant medications were not reported. The pharmacist reported that multiple unspecified patients received improperly stored PNEUMOVAX 23 lot# K006681 with unspecified expiry date (dosing details not reported). No adverse events were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-AUG-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 78 year old patient of unknown gender. The patient had previous administration of PREVNAR 13. On 03-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # M033086 and expiration date 05-MAY-2018) 0.5 ml, unknown route (reported as indication for vaccination). No concomitant medication were reported. On 03-OCT-2016(reported as within 24 hours of receiving PNEUMOVAX 23 the patient experienced warmth, redness and swelling below the injection site. The patient sought medical attention by calling the pharmacy on unspecified dates. The outcome of the events was reported as unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. This case is cross linked with MARS# 1610USA012553 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 14-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II lot # M015931, expiry date 30-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. product quality complaint (PQC) was not involved. This is 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 was received from a healthcare professional regarding temperature stability issue of VARIVAX. Information on administration of the vaccine or about the patients was not reported. No adverse event was reports. This is one of the two reports. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report as received from physician refers to a currently 20 years old female patient. No medical history, concurrent condition and concomitant medications were reported. On 13-DEC-1995, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (strength, dosing details, anatomical location were unknown). Subsequently, she received her second and third doses of hepatitis b vaccine (recombinant)(manufacturer unknown) on 12-JAN-1996 and 16-JUL-1996 respectively. On 16-JAN-1997 (also reported as on 16-JAN-1992), the patient was vaccinated with VARIVAX. On 17-APR-1997 and 21-JAN-2000, she received first and second doses of MMR. The patient received four doses of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxo(DTP) and poliovirus vaccine inactivated (unspecified)(DPV/IPV) on 16-FEB-1996, 18-APR-1996, 04-JUN-1996 and 24-JUN-1996 and 07-APR-1997. The patient received four doses of Hib conj vaccine (unspecified carrier)(HIB) on 16-FEB-1996, 18-APR-1996, 04-JUN-1996 and 07-APR-1997. On 04-JUN-1996, the patient received measles virus vaccine live (unspecified) vaccine. On an unknown date the patient experienced lack of seroconversion and the patient was transferred into the reporting physician's office. The outcome of lack of seroconversion was not known. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 01-AUG-2016, the patient was vaccinated with a dose of temperature excursion M-M-R II (dose, route, lot number and expiration date were unknown), which experienced temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. There was no information about the patient's pertinent medical history, drug reaction or allergies reported. On 21-JUL-2016, the patient received the first dose of GARDASIL (dose, site and route of administration, expiry date and lot# were not reported). The second dose of GARDASIL was administered on 21-SEP-2016 (dose, site and route of administration, expiry date and lot# were not reported). On 13-OCT-2016, the patient was vaccinated with the third dose of GARDASIL lot # M014929, expiry date 27-MAY-2017 (dose, site and route of administration were not reported) earlier than the recommended schedule. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with first dose of RECOMBIVAX HB (dose 1 ml, lot #, expiry date, vaccination site, route not provided). On an unknown date in July 2016, the patient was vaccinated with second dose of RECOMBIVAX HB (dose 1 ml, lot # expiry date, vaccination site, route not provided). It was reported that, on 20-OCT-2016, the patient was vaccinated with third dose of RECOMBIVAX HB (dose 1 ml, lot # expiry date, vaccination site, route not provided) (Inappropriate schedule of vaccine administered). No adverse effects were reported. Product quality complaint was not involved. No further information was available. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition, medical history and concomitant medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, M005733, 01-OCT-2017, M006111 18-NOV-2017, M016238 07-DEC-2017. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K010522, expiration date 25-FEB-2016, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K0105422, expiration date 25-FEB-2016, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 22-JUN-2016, the patient was vaccinated with a dose of M-M-R II (dose, route, lot number and expiration date were unknown), which experienced temperature excursion. The patient wanted to check a titer for M-M-R II. This is one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On 26-JUN-2016, the patient received dose of improperly stored VAQTA with lot# M011116 and expiration date 17-MAY-2017, via intramuscular route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On 23-JUN-2016, the patients received dose of improperly stored VAQTA with lot # M011116 and expiration date 17-MAY-2017, via intramuscular route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unspecified date in September 2016 (reported as 1 month ago), the patient was inadvertently administered with an improperly stored doses of M-M-R II (lot # L007216, expiration date 03-MAR-2017, albumin status rHA) and VARIVAX (lot # M000996, expiration date 07-JAN-2018), (strength and dose were not provided for both vaccines), subcutaneously. There were not concomitant medications reported. No adverse effects reported. Additional information is not expected since the reported denied the consent to contact her.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about the concurrent condition, historical medication and concomitant medication. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB, lot # M014923/ expiration date- 17-FEB-2019, lot # M001814/expiration date- 15-OCT-2018, lot no. M027882/expiration date- 14-APR-2019. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On 13-JUN-2016, the patient received dose of improperly stored VAQTA with lot# M011116 and expiration date 17-MAY-2017, via intramuscular route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # M000761 with expiry date 18-JAN-2018, # lot M025865 with expiry date 24-MAY-2018, dose, strength, vaccination site, route unspecified). The vaccines were exposed to a temperature of 8.8 Fahrenheit (F) for 50 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On 13-JUN-2016, the patient received doses of improperly stored RECOMBIVAX HB with lot# L033343 and expiration date 13-SEP-2017; via intramuscularly route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-OCT-2016, the patient was inadvertently vaccinated with an expired dose of (wistar ra 27-3) M-M-R II (lot # K018965, expiration date: 15-OCT-2016, dose and injection site were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2016, the patient was vaccinated with an expired dose of PEDVAXHIB 0.5 ml, once, intramuscularly, lot # J015437 with an expiration date 09-OCT-2016 (anatomical location was not reported). No adverse effects were reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse (who was also an office manager) refers to a 55 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-SEP-2016, the patient was vaccinated intramuscularly with 1 ml dose of RECOMBIVAX HB (lot # M011838, expiry date 09-AUG-2018). Concomitant medications were not reported. On 28-SEP-2016, the patient had pain in the right arm during movement and she called the office to report that. No treatment was given. The outcome of the event was unknown. The relatedness between the event and RECOMBIVAX HB was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a registered nurse (who was also an office manager) refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2015 (reported as "a year ago"), the patient was vaccinated with unknown dose of GARDASIL (route, lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date in 2015, the patient complained of pain after administration of GARDASIL. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician refers to three female (also reported as male) patients of unknown age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 lot # M000386, expiration date 17-AUG-2017 (dose, route of administration were not reported. On unknown dates, within 24 hours after PNEUMOVAX 23 administration, the patients experienced severe swelling and redness in their arms, neck stiffness and muscle pain in their shoulders. On unknown dates, the patients came back to physician's office and were treated. The physician reported that it took 5-7 days for all the symptoms to go away. The patients did not need to go to the hospital or seek further treatment. The outcome of the adverse events was reported as recovered (on unknown dates). The relatedness between the adverse events and the PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant regarding multiple unspecified patient with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that an unspecified number of unspecified patients received improperly stored M-M-R II  lot# L012482/Expiry date: 10-APR-2017, L023386/Expiry date: 25-JUN-2017 and L033589/Expiry date:02-SEP-2017 on unspecified dates in 2016 (dosing details not reported). Temperature/time frame: 21-SEP-2016: 16.3F for 2 hours and 23-SEP-2016: 6.1F for 2 hours 15 minutes. The call was due to data logger. Prior excursions on 15-SEP-2016: 13.5F for 4 hours and on 16-SEP-2016: 63.1F for 4 hours. No product quality complaint (PQC) was involved. This is one of the three same reporter linked case. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 17-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II (lot # M015931, expiry date 30-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that an unspecified number of unspecified patients received improperly stored VARIVAX lot# L039093 with expiry date: 06-OCT-2017 on an unspecified date in 2016. Temperature/time frame: 21-SEP-2016: 16.3F for 2 hours and 23-SEP-2016: 6.1F for 2 hours 15 minutes. The call was due to the data logger. Prior excursions on 15-SEP-2016: 13.5F for 4 hours and on 16-SEP-2016: 63.1F for 4 hours. No product quality complaint (PQC) was involved. This is one of three same reporter linked case. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 12-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II lot # M016234, expiry date 31-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that an unspecified number of unspecified patients received improperly stored PROQUAD lot# M004891/expiry date: 25-JUL-2017 and M022399/expiry date: 01-NOV-2017 on unspecified dates in 2016 (dosing details not reported). Temperature/time frame: 21-SEP-2016: 16.3F for 2 hours and 23-SEP-2016: 6.1F for 2 hours 15 minutes. The call was due to a data logger. Prior excursions on 15-SEP-2016: 13.5F for 4 hours and on 16-SEP-2016: 63.1F for 4 hours. No product quality complaint (PQC) was involved. This is one of the three same reporter linked case. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a 19 years old non pregnant female patient regarding herself. Pertinent medical history was reported as hypothyroidism. Drug reactions/allergies were reported as none. The patient reported that she had received M-M-R II on 12-DEC-1997 and 16-JUN-2001 (dosing details not reported). On 14-AUG-2000, the patient received VARIVAX (dosing details were not provided). Concomitant medications were not reported. In September 2016, the patient was informed the titer level for measles, mumps and rubella and varicella titers were low. No treatment was given for the events. The patient sought medical attention by talking to the physician. On an unknown date, the patient underwent unspecified blood work with results unknown. Outcome and causality of the event was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route, frequency, lot # and expiry date not reported) (inappropriate age at vaccine administration). No adverse symptoms were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 17-year-old female patient who received BEXSERO (batch number 151301D, expiry date 31st December 2016). Co-suspect products included MENVEO (batch number U5390AA, expiry date 12th September 2017). On 18th October 2016, the patient received BEXSERO and MENVEO. On 18th October 2016, 5 hrs after receiving BEXSERO and MENVEO and less that a day after receiving MENVEO, the patient experienced swelling arm, vaccine administered at inappropriate site and labeled drug-drug interaction medication error. On an unknown date, the outcome of the swelling arm was not recovered/resolved and the outcome of the vaccine administered at inappropriate site and labeled drug-drug interaction medication error were unknown. It was unknown if the reporter considered the swelling arm to be related to BEXSERO and MENVEO. Additional details were provided as follows: The case was previously reported to Doctor. The age at vaccination was not reported. The patient received unknown dose of BEXSERO on right deltoid and experienced swollen right arm.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent and concomitant medications was provided. On 05-JUL-2016, the patient received dose of improperly stored RECOMBIVAX HB with lot# L033343 and expiration date 13-SEP-2017, via intramuscular route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-APR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 240 hours, with the highest recorded temperature of 1 degrees Fahrenheit (1 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.