chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments:  US-009507513-1612USA003706.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: L043214, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments:  US-009507513-1612USA003706.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 19-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 19-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 20-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 23-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M020103, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The vaccines underwent a temperature excursion of -0.3 C for 22 hours. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Age: 4.0
Sex: U
Vaccine: MMR
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, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Age: 4.0
Sex: U
Vaccine: MMR
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, current conditions and concomitant medications were not reported. On 15-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Age: 4.0
Sex: U
Vaccine: MMR
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, current conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with M-M-R II (lot number: L036851), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Age: 4.0
Sex: U
Vaccine: MMR
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, current conditions and concomitant medications were not reported. On 15-SEP-2016, the patient was vaccinated with M-M-R II (lot number: L036851), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Age: 4.0
Sex: U
Vaccine: MMR
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, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Age: 4.0
Sex: U
Vaccine: MMR
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, current conditions and concomitant medications were not reported. On 22-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Age: 8.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 8 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with M-M-R II (lot number: L036851), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 6 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M004883, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 9 weeks old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 9 weeks old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a 9 weeks old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
Sex: U
Vaccine: MMR, UNK
Symptoms: Autism, Malaise
Clinical narrative: This spontaneous report was received from a nurse via social media and refers to a child of unknown age. No medical history, concurrent conditions, concomitant medications or past drugs were reported. Approximately in 1996 (reported as 20 years ago), the child received M-M-R II (vaccination details, lot #, expiry and dosing details not reported) for prophylaxis along with many other vaccines at one time. After receiving the vaccines, the child became very ill and developed autism. At the time of this report, the outcome and causality of events were unknown. No product quality complaint (PQC) involved. Upon internal review, autism was determined to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a 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 reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 for prophylaxis lot # M041394, expiration date 23-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.7 degrees Celsius for 6 hours. No adverse effects were reported. There was no previous excursion. The call was due data logger. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-DEC-2016, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX lot # L028279, expiration date 28-OCT-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker referring to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # L045956 with expiry: 17-NOV-2017 (dose, frequency and anatomical location not reported), for prophylaxis. The vaccine was exposed to a temperature of 10.4 degree Fahrenheit for 252 hours. No adverse effect reported. The vaccine had no previous temperature excursion. The call was because of data logger. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018; dose and route unknown) for prophylaxis, which was exposed to temperature excursion of 33.2 degrees Fahrenheit (F) for 12 hours and 43 minutes and 54.3 F for 1 hour and 23 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect had been reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004370: US-009507513-1612USA004371.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients.  Information about concurrent condition, concomitant medication and medical history was not provided.  The nurse reported that an unknown number of doses of GARDASIL-9, (Lot # M003659 Expiration date 20-SEP-2017) experienced a temperature excursion of -4F for 4 hours 31 minutes, and an unknown number of might have been administered to an unspecified number of patients. It was unknown if any patients experienced any side effects following administration of any of the vaccines. No other information was available. This report is one of the reports from same reporter. Additional information is not expected. because no consent to contact. Sender's Comments: US-009507513-1612USA004349: US-009507513-1612USA003524.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients.  Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of PEDVAXHIB, (Lot # M014925 Expiration date 16-FEB-2019) experienced a temperature excursion of -4F for 4 hours 31 minutes, and an unknown number of might have been administered to an unspecified number of patients. It was unknown if any patients experienced any side effects following administration of any of the vaccines. No other information was available. This report is one of the reports from same reporter. Additional information is not expected. because no consent to contact. Sender's Comments: US-009507513-1612USA003524: US-009507513-1612USA004348.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M014318, expiration date 30-SEP-2017, dose unknown) orally for prophylaxis, which was exposed to temperature excursion of was 33.2 degrees Fahrenheit(F) for 12 hours and 43 minutes and 54.3 F for 1 hour and 23 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect had been reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004258: US-009507513-1612USA004370.
Sex: M
Vaccine: HPVX
Symptoms: Paralysis
Clinical narrative: This spontaneous report as received from a consumer through social media refers to a male patient of unknown age. There was no information on concomitant medication, concurrent condition and medical history. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis. Other suspect therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis. On an unknown date, the patient was paralyzed from the neck down. The outcome of paralysis was unknown. Causality assessment was not provided. Upon  internal review, paralysis was considered to be medically significant. This case has been linked with the MARRS case no. 1612USA003241 as E2B Linked Report. Additional information has been requested. Sender's Comments: US-009507513-1612USA003241.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-OCT-2016, the patient was vaccinated with the improperly stored (7.5F for 3 hours) dose of VARIVAX (lot # reported as M033904, expiration date 20-JUL-2018; dose and route of administration was not provided) for prophylaxis. The call was made because of the digital data logger. No previous excursion was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On 01-JUL-2016, 2 doses of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, subcutaneous, dose not reported) were inadvertently administered to patients for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169: US-009507513-1611USA010737.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-JUL-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On 22-JUL-2016, 2 doses of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, subcutaneous, dose not reported) were inadvertently administered to patients for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 02-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005164: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 09-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 11-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005168: US-009507513-1612USA005167: US-009507513-1612USA005169.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 08-NOV-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005169: US-009507513-1612USA005168.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 09-NOV-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005169.
Age: 17.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On 17-NOV-2016, 2 doses of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, subcutaneous, dose not reported) were inadvertently administered to patients for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168.
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Initial unsolicited report received from a non-health care professional (Sanofi employee) on 09 November 2016. This case involves a female patient (age reported as between five to years old) who was vaccinated with Fluzone Quadrivalent intramuscularly (dose, dose in series, batch number and expiry date and site of administration were not reported) on an unspecified date (reported as within last 5 days). The patient's medical history was unknown. Concomitant medications were not reported. On an unspecified date and duration following vaccination (reported as within last 5 days), the patient had a "bad headache". Laboratory data and corrective treatment were not reported. The outcome of the event was not recovered. List of documents held by sender: none. Follow-up information received from a non-health care professional (Sanofi employee) on 30 November 2016. The patient age was reported as between five to seven year old. It was reported that the patient received a Flu vaccine on an unspecified date.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Pyrexia, Rash erythematous
Clinical narrative: Initial unsolicited report received from a consumer (patient parent) on 28 Nov 2016. This case involves a 10 months old female patient who was vaccinated with a dose of FLUZONE (Batch number, expiry date and site of administration was not reported) administered intramuscularly on 07 Nov 2016. The patient illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown, and any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medication were not reported. On an unknown date 2 days after the vaccination the patient had fever 102.8 Fahrenheit and it was reported as four days later the patient had 3 complex febrile seizures and the patient was hospitalized on an unknown date, and it was reported as on an unknown date last week the patient started getting a red rash when eating cheerios which she never had before. The patient any other lab tests and corrective treatment was not reported. The outcome of the events were reported as not recovered. List of documents held by sender: none. Sender's Comments: Febrile convulsion is listed with INFLUENZA QUADRIVAL A-B VACCINE however red rash is not listed with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is compatible with the role of vaccine. Fever is the main cause of febrile convulsion. However details regarding relevant medical history, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Initial unsolicited report received from a nurse on 29 Nov 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number: UT5673NA, expiry date: 30 Jun 2017, dose, dose in series, were not reported) intramuscularly in left deltoid on 22 Nov 2016. Illness at the time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy. Concomitant medications were not reported. On 22 Nov 2016, immediately (since vaccination) following the vaccination, the patient had metallic taste. It was reported that, no other sx reported referred to PCP. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of drug administration
Clinical narrative: No.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood calcium increased, Injected limb mobility decreased, Injection site pain, Middle insomnia, Musculoskeletal pain
Clinical narrative: Constant stable musculoskeletal pain to right bicep with decreased mobility and nocturnal awakening with pain. Prednisone x5 days. Continues to have achy pain that is worse with use or pressure. Denies numbness, tingling, or weakness.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain
Clinical narrative: Constant stable musculoskeletal pain to right bicep with decreased mobility and nocturnal awakening with pain. Prednisone x5 days. Continues to have achy pain that is worse with use or pressure. Denies numbness, tingling, or weakness.
Age: 0.42
Sex: M
Vaccine: 6VAX-F, PPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever of 103.7 F with lethargy the eve of vaccinations and fever with lethargy 104.0 F post vaccination day 1.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: NO Known adverse event but patient was given Proquad vaccine instead of MMR. This resulted in an additional VARIVAX being given as he was also given a separate VARIVAX.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Diarrhoea, Mumps antibody test, Nausea, Neck pain
Clinical narrative: Fever, joint pain, neck pain, nausea, vomiting and diarrhea.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, joint pain, neck pain, nausea, vomiting and diarrhea.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Pruritus, Rash generalised, Retching
Clinical narrative: Throwing up, Dry heaves, aching at the spot of the shot. Chills, and Rash all over back and body and itching.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Throwing up, Dry heaves, aching at the spot of the shot. Chills, and Rash all over back and body and itching.
Sex: U
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: Information has been received from a physician via a company representative referring to unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, It was informed that multiple unspecified people reported to the physician about reading "somewhere" (unspecified) about premature ovarian failure occurring with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. It was unknown if there were patients involved. The outcome of the event and the causality were not reported. As on 28-NOV-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1609USA013051: Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (also reported as healthcare worker) 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 an improperly stored dose of GARDASIL 9 (lot# M003659, expiration date 20-SEP-2017; lot# M011117, expiration date 07-DEC-2017; dose and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under 49.1 Fahrenheit degrees for 40 minutes. On 30-NOV-2016, a call was placed to the registered nurse.  The healthcare provider was unable to answer the telephone call.  A detailed message was left requesting a return telephone call.  All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1610USA002044: MERCK 1610USA005665: Mfr number.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (rHA, lot # L023386, expiration date 25-JUN-2017; dose and route were unknown) for prophylaxis. The vaccine was exposed to 22.7 Celsius degree for 45 minutes. Temperatures were recorded with a data logger and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 27-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # L040961 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered untill 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1610USA004339: 1609USA013814-1609USA014830.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Entire shoulder area was red, warm to the touch, and very painful.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Induration, Injection site bruising, Injection site pain, Mass
Clinical narrative: Patient came in 12/9/16 with c/o numbness/tingling in arm where flu and PCV-13 shots were given on 11/16/16. She stated the shot hurt going in and that she had been having pain that would wake her up at night since having the shots. She also had a moderately hard lump on the inside of her elbow and a healing bruise at the injection site. I called RN and reported symptoms. Told patient to follow up with her doctor about the pain/numbness and to check golf ball size lump. RN.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Paraesthesia
Clinical narrative: Patient came in 12/9/16 with c/o numbness/tingling in arm where flu and PCV-13 shots were given on 11/16/16. She stated the shot hurt going in and that she had been having pain that would wake her up at night since having the shots. She also had a moderately hard lump on the inside of her elbow and a healing bruise at the injection site. I called RN and reported symptoms. Told patient to follow up with her doctor about the pain/numbness and to check golf ball size lump. RN.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site warmth, Loss of consciousness
Clinical narrative: Entire left shoulder area was red, warm to the touch and extremely Painful for 3 to 4 days after receiving the flu vaccine. The patient experienced weakness, paleness, and aching throughout her body for 2 to 3 days. She felt very weak and passed out the day after the immunization was administered.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pallor
Clinical narrative: Entire left shoulder area was red, warm to the touch and extremely Painful for 3 to 4 days after receiving the flu vaccine. The patient experienced weakness, paleness, and aching throughout her body for 2 to 3 days. She felt very weak and passed out the day after the immunization was administered.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Patient's mother scheduled an appointment for patient because he had a "hard, red, hot lump" on his right thigh where his influenza vaccine was administered.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Soreness, swelling, redness of more than 30MM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Polymyalgia rheumatica
Clinical narrative: Patient was diagnosed with Polymyalgia Rheumatica with symptoms appearing the weekend after the FLUZONE HIGH DOSE vaccine was administered. She was not sure if it had anything to do with the vaccine.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Pain, swelling, no fever, mildly pruritic, no hand pain/numbness/tingling.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: On 10/26/16 her Rt arm swelling and redness. She developed fever and body aches. The patient was admitted overnight and IV antibiotic therapy. Patient responded well to treatment and recovered 100%.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with a dose of improperly stored VARIVAX subcutaneous injection (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provide contact details to contact other registered nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009081: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA009085: US-009507513-1610USA009078: US-009507513-1610USA009082: MERCK 1610USA001984: Mfr number.