chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Headache, Hydrocephalus, Lumbar puncture, Nuclear magnetic resonance imaging, Ventriculo-peritoneal shunt
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency #665088) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient had no pertinent medical history at the time of vaccination and no concurrent illnesses were reported. On 08-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M020103, dose 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included vaccination with MENACTRA (dose number: 1, manufacturer: Sanofi Pasteur, vaccinated date: 08-SEP-2016, intramuscularly in the right arm, lot# U5392AA; dose and expiration date unknown) and HAVRIX (dose number: 1, manufacturer: GlaxoSmithKline, vaccinated date: 08-SEP-2016, intramuscularly in the left arm, lot# KT54C; dose and expiration date unknown) for prophylaxis. On 07-OCT-2016, the patient developed headache, blurred vision, loss of balance and was falling at school. It was also reported that the patient was feeling emotional with frustration tolerance decreased. On 11-OCT-2016, symptoms were continuing and she was taken to the emergency room. A CAT scan (Computerised tomogram) was done on the same day and she was admitted to the hospital. On 12-OCT-2016 an MRI (magnetic resonance imaging) was done. She was seen by a neurologist and diagnosed with fluid on brain and was treated with medication at that time. She was seen on 26-OCT-2016 and a spinal tap done to relieve pressure/fluid. She was having a shunt placed on 14-NOV-2016. The outcome of the events were unknown. Causality assessment was not provided. The Agency considered the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency #665088) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient had no pertinent medical history at the time of vaccination and no concurrent illnesses were reported. On 08-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M020103, dose 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included vaccination with MENACTRA (dose number: 1, manufacturer: Sanofi Pasteur, vaccinated date: 08-SEP-2016, intramuscularly in the right arm, lot# U5392AA; dose and expiration date unknown) and HAVRIX (dose number: 1, manufacturer: GlaxoSmithKline, vaccinated date: 08-SEP-2016, intramuscularly in the left arm, lot# KT54C; dose and expiration date unknown) for prophylaxis. On 07-OCT-2016, the patient developed headache, blurred vision, loss of balance and was falling at school. It was also reported that the patient was feeling emotional with frustration tolerance decreased. On 11-OCT-2016, symptoms were continuing and she was taken to the emergency room. A CAT scan (Computerised tomogram) was done on the same day and she was admitted to the hospital. On 12-OCT-2016 an MRI (magnetic resonance imaging) was done. She was seen by a neurologist and diagnosed with fluid on brain and was treated with medication at that time. She was seen on 26-OCT-2016 and a spinal tap done to relieve pressure/fluid. She was having a shunt placed on 14-NOV-2016. The outcome of the events were unknown. Causality assessment was not provided. The Agency considered the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Adverse reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 665294) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history (NKA on patient chart). Information on the patient's prior vaccinations and other medications were not reported. On 09-NOV-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # M023169 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ENGERIX-B, diphtheria toxoid, tetanus toxoid (VACCIN TD), IPOL, M-M-R II subcutaneous route in the left arm, lot # L035674, dose # 2 (dose, frequency and lot expiration date were not reported) for prophylaxis and VARIVAX subcutaneous route in the right arm, lot # M017292, dose # 2 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 09-NOV-2016, the patient had adverse reaction. The outcome of adverse reaction was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Asthenia, Blood test, Confusional state, Eye movement disorder, Feeling abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-666345) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's mom reported that the child has been evaluated several times due to continuous low grade fever and joint swelling over last two years. Information on the patient's prior vaccinations and other medications were not reported. On 09-NOV-2016 the patient was vaccinated with GARDASIL 9 lot # M018810 dose 1 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On the same day the patient was vaccinated with MENACTRA dose 1 (unspecified dose and frequency), intramuscularly in the right arm, BOOSTRIX dose 1 (unspecified dose and frequency), intramuscularly in the right arm and FLUZONE dose 8 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On 09-NOV-2016, the child reported that he couldn't hear or see or speak. The child's activities of daily living impaired. Child became pale, head fell back, eyes went into blank stare and rolled back. The child had abnormal posture, nervous system disorder, involuntary muscle contractions, lumbar puncture, gait disturbance and eye movement disorder. The child sat in chair for approximately 5 minutes with cold towels on his forehead, drank some water then with the help of assistance child was moved onto exam table and laid down. He laid for 5-7 min before color came back on face and lips, child began speaking more and reported he was feeling better. The child's mom reported that child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Laboratory test and blood test were performed. Next day (10-NOV-2016) child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 10-NOV-2016 -14-NOV-2016. Many tests were done including spinal tap. The patient's mom reported that, it was considered as neurological side effect due to the BOOSTRIX or GARDASIL 9. It was recommended that those vaccines should not be given again by neuro. The outcome of all the events was reported as recovered. Causality assessment was not provided. The case was considered to be serious as the events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Gait disturbance, Hypoacusis, Laboratory test, Loss of personal independence in daily activities, Lumbar puncture
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-666345) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's mom reported that the child has been evaluated several times due to continuous low grade fever and joint swelling over last two years. Information on the patient's prior vaccinations and other medications were not reported. On 09-NOV-2016 the patient was vaccinated with GARDASIL 9 lot # M018810 dose 1 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On the same day the patient was vaccinated with MENACTRA dose 1 (unspecified dose and frequency), intramuscularly in the right arm, BOOSTRIX dose 1 (unspecified dose and frequency), intramuscularly in the right arm and FLUZONE dose 8 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On 09-NOV-2016, the child reported that he couldn't hear or see or speak. The child's activities of daily living impaired. Child became pale, head fell back, eyes went into blank stare and rolled back. The child had abnormal posture, nervous system disorder, involuntary muscle contractions, lumbar puncture, gait disturbance and eye movement disorder. The child sat in chair for approximately 5 minutes with cold towels on his forehead, drank some water then with the help of assistance child was moved onto exam table and laid down. He laid for 5-7 min before color came back on face and lips, child began speaking more and reported he was feeling better. The child's mom reported that child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Laboratory test and blood test were performed. Next day (10-NOV-2016) child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 10-NOV-2016 -14-NOV-2016. Many tests were done including spinal tap. The patient's mom reported that, it was considered as neurological side effect due to the BOOSTRIX or GARDASIL 9. It was recommended that those vaccines should not be given again by neuro. The outcome of all the events was reported as recovered. Causality assessment was not provided. The case was considered to be serious as the events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Muscle contractions involuntary, Nervous system disorder, Pallor, Poor quality sleep, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-666345) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's mom reported that the child has been evaluated several times due to continuous low grade fever and joint swelling over last two years. Information on the patient's prior vaccinations and other medications were not reported. On 09-NOV-2016 the patient was vaccinated with GARDASIL 9 lot # M018810 dose 1 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On the same day the patient was vaccinated with MENACTRA dose 1 (unspecified dose and frequency), intramuscularly in the right arm, BOOSTRIX dose 1 (unspecified dose and frequency), intramuscularly in the right arm and FLUZONE dose 8 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On 09-NOV-2016, the child reported that he couldn't hear or see or speak. The child's activities of daily living impaired. Child became pale, head fell back, eyes went into blank stare and rolled back. The child had abnormal posture, nervous system disorder, involuntary muscle contractions, lumbar puncture, gait disturbance and eye movement disorder. The child sat in chair for approximately 5 minutes with cold towels on his forehead, drank some water then with the help of assistance child was moved onto exam table and laid down. He laid for 5-7 min before color came back on face and lips, child began speaking more and reported he was feeling better. The child's mom reported that child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Laboratory test and blood test were performed. Next day (10-NOV-2016) child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 10-NOV-2016 -14-NOV-2016. Many tests were done including spinal tap. The patient's mom reported that, it was considered as neurological side effect due to the BOOSTRIX or GARDASIL 9. It was recommended that those vaccines should not be given again by neuro. The outcome of all the events was reported as recovered. Causality assessment was not provided. The case was considered to be serious as the events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Speech disorder, Staring, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-666345) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's mom reported that the child has been evaluated several times due to continuous low grade fever and joint swelling over last two years. Information on the patient's prior vaccinations and other medications were not reported. On 09-NOV-2016 the patient was vaccinated with GARDASIL 9 lot # M018810 dose 1 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On the same day the patient was vaccinated with MENACTRA dose 1 (unspecified dose and frequency), intramuscularly in the right arm, BOOSTRIX dose 1 (unspecified dose and frequency), intramuscularly in the right arm and FLUZONE dose 8 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On 09-NOV-2016, the child reported that he couldn't hear or see or speak. The child's activities of daily living impaired. Child became pale, head fell back, eyes went into blank stare and rolled back. The child had abnormal posture, nervous system disorder, involuntary muscle contractions, lumbar puncture, gait disturbance and eye movement disorder. The child sat in chair for approximately 5 minutes with cold towels on his forehead, drank some water then with the help of assistance child was moved onto exam table and laid down. He laid for 5-7 min before color came back on face and lips, child began speaking more and reported he was feeling better. The child's mom reported that child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Laboratory test and blood test were performed. Next day (10-NOV-2016) child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 10-NOV-2016 -14-NOV-2016. Many tests were done including spinal tap. The patient's mom reported that, it was considered as neurological side effect due to the BOOSTRIX or GARDASIL 9. It was recommended that those vaccines should not be given again by neuro. The outcome of all the events was reported as recovered. Causality assessment was not provided. The case was considered to be serious as the events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency #668853) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder (ADD), tic disorder, asthma, possible celiac allergy to cat and dog dander and depression. No information regarding prior vaccinations and lab data was provided. Other medications included ADDERALL, PROZAC and Clonidine. On 28-NOV-2016, the patient was vaccinated with GARDASIL 9, lot # L038503, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced hives which then progressed to anaphylactic reaction. He was seen in emergency room, given epinephrine and steroids. The next day, symptoms recurred and he returned to emergency room and received epinephrine and steroids again. The outcome of anaphylactic reaction and urticaria was reported as recovered. Causality assessment was not provided. The Agency considered the events to be serious as life threatening. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin M increased, Exposure during pregnancy, Occupational exposure to product
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist who is also the female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The patient became pregnant on an unknown date. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The pharmacist, reported that she had administered an unspecified number of doses of VARIVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) to an unspecified number of patients for prophylaxis. The pharmacist stated that on an unknown date, she "recently" had a blood work performed which showed her immunoglobulin M (IgM) levels elevated. The pharmacist confirmed that she had never received a dose of VARIVAX and had not been topically exposed to VARIVAX. She wanted to make sure that her simply administering of the vaccines would not have caused an immunoglobulin M (IgM) elevation. At the reporting time the outcome of  immunoglobulin M (IgM) levels elevated was unknown. The reporter did not assess the causality between the immunoglobulin M (IgM) levels elevated and VARIVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a immunization official referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 21-APR-2017, the patient was vaccinated with an expired dose of M-M-R II and the albumin status was rHA; (strength, dose, route, frequency were not provided), the lot # was L012482 and expiration date of 10-APR-2017, for prophylaxis . The vaccine was reconstituted with sterile water diluent (unknown lot number and expiration date. However, the sterile water diluent was not reported to be expired when it was administered. No adverse effects were reported and no additional information was provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a male patient of unknown age (reported as "under the age of 15"). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUL-2015, the patient was vaccinated with the first dose of GARDASIL lot # K009482 with and expiration date on 06-MAR-2017, intramuscularly (strength and anatomical location were not reported) for prophylaxis.   After that, on 27-JUL-2016, the patient received a dose of GARDASIL 9 lot # L026602 with and expiration date on 19-OCT-2017, intramuscularly (strength and anatomical location were not reported) for prophylaxis. The reporting nurse stated that this was outside the prescribing recommendations. No adverse effects were reported.  No product quality complaint (PQC) was involved. 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 registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of ROTATEQ (dose, frequency and route were not reported) lot # reported as M042169 with expiration date of 22-JUN-2018, for prophylaxis. The temperature of the ROTATEQ was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA003158: US-009507513-1705USA003154: US-009507513-1705USA003150: US-009507513-1705USA003157:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of M-M-R II (dose, frequency and route were not reported) lot # reported as M045393 with expiration date of 14-NOV-2018 and lot # reported as M034387 with expiration date of 19-JUL-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the M-M-R II were properly stored. The temperature of the M-M-R II was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003154: US-009507513-1705USA003157: US-009507513-1705USA003158:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported.  On unspecified dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency and route were not reported) lot # reported as N003702 with expiration date of 08-NOV-2019, for prophylaxis. The temperature of the RECOMBIVAX HB was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003150: US-009507513-1705USA003157: US-009507513-1705USA003158:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of VAQTA (dose, frequency and route were not reported) lot # M047658 with expiration date of 28-OCT-2017, for prophylaxis. The temperature of the VAQTA was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003150: US-009507513-1705USA003154: US-009507513-1705USA003158:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route were not reported) lot # reported as N0003826 with expiration date of 14-OCT-2019, for prophylaxis. The temperature of the GARDASIL 9 was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003154: US-009507513-1705USA003157: US-009507513-1705USA003150:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring 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 since 13-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M041513, expiration date on 11-OCT-2018 (Strength, dose number, route and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature between 47°F (Fahrenheit degrees) to 77°F for 3 hours and 51 minutes and between 15°F to 46°F for 4 hours and 52 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. Additionally it was reported that the outcome was Supported for 3 months starting at the date of the excursion. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M035142, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M025864, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M035142, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 11 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot: M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot: M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot: M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved.  This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-MAR-2017, the patient was vaccinated with PROQUAD)(dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved.  This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Body temperature increased, Fatigue, Malaise, Posture abnormal
Clinical narrative: Initial unsolicited report received from a health care professional on 25-Apr-2017. This case involves 11-year-old male patient, who was vaccinated with a first dose of MENACTRA intramuscularly (Batch number: U5514AC, expiration date: 12-Mar-2018 and site of administration were not reported) and ADACEL intramuscularly (Batch number: C5212AA, expiration date: 05-Jun-2019, and site of administration were not reported) on 24-Apr-2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none and no known allergies were there. Patients Illness at time of vaccination was reported as afebrile possibly feeling a bit poor. Patient's concomitant medication was not reported. It was also reported that patient do not had any other vaccinations within 4 weeks of vaccinations. On 24-Apr-2017, same day following the vaccination, the patient was not feeling well as patient was weak and tired and had burning temperature of 102.4 degree F. It was reported that the patient sort of slumped over in his seat. Next morning temp was again over 102 degree F. Patient required emergency room (ER) / doctor visit. No other laboratory investigation was performed. Patient's corrective treatment was not reported. The patient did not recover from events. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Local reaction, Nausea
Clinical narrative: Initial unsolicited case received from a consumer (patient parent) on 24 Apr 2017. This case involves 14-year-old male patient who was vaccinated with first dose of MENACTRA (Batch number was unknown, expiry date and dose was not reported) via intramuscularly in left arm on 03 Apr 2017. The patient illness at the time of vaccination was not reported (reported as parent denied), the patient was allergic to peanuts, tree nuts, and it was also reported as the patient had hay fever. Concomitant medications were not reported. On 04 Apr 2017, one day following the vaccination, the patient developed a fever of (103-100.5) which has lasted 3 weeks, also experienced nausea, dizziness, and Local site reaction of redness and swelling. On 05 Apr 2017, the patient was evaluated by a physician. Other relevant lab tests were not reported. The patient took CEFTIN as a corrective treatment and which the patient did not tolerate. On an unknown date, the patient recovered from the events fever, Local site reaction of redness and swelling (reported as Local reaction resolved on its own), and the outcome of other events were unknown. List of documents held by sender: none.