chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patient of unknown demographics. The concurrent condition, medial history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L041204, Expiry: 20-OCT-2017). The vaccines were stored at 19 F for 160 hours. There were no previous temperature excursions. No adverse events were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Left arm is swollen with red rash 6" X 4".
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 25-APR-2016, the patient was inadvertently administered with GARDASIL (dosing details were not reported) lot # J006850, expiry: 25-APR-2016 intramuscularly. It was confirmed by the primary reporter which dose in the series of three was administered. No adverse effects reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an 18 month old male patient. The patient's pertinent medical history and drug reaction or allergies were not reported. On 24-MAR-2016 at 11:12 a.m., the patient was inadvertently vaccinated with the first dose of GARDASIL (lot # L040459 with expiry date 06-APR-2017), intramuscularly in the right thigh. Concomitant vaccines included the fourth dose of PEDIARIX (lot # 924JA) and the first dose of hepatitis A virus vaccine inactivated; both administered intramuscularly in the left thighs on 24-MAR-2016 at 11:12 a.m. There was no illness at the time of vaccination. No relevant diagnostic tests and laboratory data were performed. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Local reaction, Pyrexia
Clinical narrative: This spontaneous report was received via a company representative from a currently 32 year old female patient who is also a medical intern regarding herself. Concurrent conditions included asthma. The patient's drug reactions/allergies and concomitant medication were unspecified. On an unspecified date between the months of August 2014 and October 2014, the patient was vaccinated with one dose of PNEUMOVAX 23 (route, lot number and expiration date unknown). On an unspecified date after the administration of PNEUMOVAX 23, the patient experienced a painful, local injection site reaction as well as a fever and sought medical attention at an unspecified emergency room. On the same day she was diagnosed with cellulitis at the injection site and was sent home with an unspecified antibiotic. On an unspecified date, the patient had fully recovered from the adverse events. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2016, the patient vaccinated with an improperly stored dose of ROTATEQ, lot # L027076, expiration date 25-MAY-2017 (dose was not reported) and PEDVAXHIB lot # L035880, expiration date 11-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low - 28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213 expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # L027076, expiration date 25-MAY-2017 (dose was not reported) and PEDVAXHIB lot # L035880, expiration date 11-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low - 28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K016966, expiry date 10-MAY-2017 (dose, route of administration and administration site were not specified). Administered doses of GARDASIL underwent temperature excursion at 10 Celsius degrees for 30 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a vendor and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 09-MAY-2016, the patient was vaccinated with an expired dose of VAQTA injection, expiry date January 2016 (dose, route of administration, lot # and administration site were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. The reporter stated that a healthcare professional from the physician's office at which this occurred would call to follow up and provide contact details of an appropriate healthcare professional to whom follow-up correspondence might be sent. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 13-MAY-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot# K008409, expiration date 04-MAR-2016; anatomical location was not reported) 0.5 ml, frequency reported as once, intramuscularly. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 30-MAR-2016, the patient received improperly stored VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 01-MAR-2016, the patient received improperly stored VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 14-MAR-2016, the patient received improperly stored VARIVAX (Merck) lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient' concurrent conditions, medical histories and concomitant medications were not reported. On 23-FEB-2016, the patient received improperly store VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient' concurrent conditions, medical histories and concomitant medications were not reported. On 22-FEB-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degree Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 08-MAR-2016, the patient received improperly stored VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided).  There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician via a company representative referring to an unspecified number of patients of unknown age and gender.  Concurrent conditions and medical history of the patients were not reported. On unknown dates, the physician administered PNEUMOVAX23 (lot#, expiration date, dose and route unspecified) every five years to the an unspecified number of unspecified patients. It was not specified how many doses the unspecified number of unspecified patients had received. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown dates in 2016 (dates ranging from 26-FEB-2016 to 04-MAY-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, administration site, lot # and expiry date were not specified). Administered doses of RECOMBIVAX HB underwent temperature excursion at minimum 29 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. There was previous temperature excursion on 25-FEB-2016, with temperature at minimum 30 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown dates in 2016 (dates ranging from 26-FEB-2016 to 04-MAY-2016), the patients were vaccinated with improperly stored doses of VAQTA injection (dose, route of administration site, lot # and expiry date were not specified). Administered doses of VAQTA underwent temperature excursion at excursion on 25-FEB-2016, with temperature at minimum 30 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown dates in 2016 (dates ranging from 26-FEB-2016 to 04-MAY-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, administration site, lot # and expiry date were not specified). Administered doses of GARDASIL 9 underwent temperature excursion of minimum 29 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. There was previous temperature excursion on 25-FEB-2016, with temperature of minimum 30 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 05-MAY-2016, the patient was inadvertently administered an expired dose of PNEUMOVAX23 (lot # K018528 and expiration date 14-APR-2016, dose and route of administration were not reported. Concomitant therapy was not reported. No adverse effects were noted. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 25-APR-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 02-APR-2016 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot# K009107, expiration date 21-JAN-2016) (dose and route unspecified). Other suspect and concomitant therapies were not reported. The reporter stated the PNEUMOVAX23 did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 11-APR-2016 the patient was vaccinated with a dose of RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hyperaemia, Induration, Injection site pain, Limb discomfort
Clinical narrative: Pain at injection site within approximately 6 -8 hr of injection, then by following day developed erythema and induration along medial aspect of arm along with discomfort. Symptoms have gradually improved and today has only minimal hyperemia along medial aspect of arm.
Age: 12.0
Sex: F
Vaccine: HPV9, IPV
Symptoms: Dizziness
Clinical narrative: Once vaccine was administered by got dizzy and lightheaded.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stores doses of M-M-R II, lot numbers L015280, expiry date 30-APR-2017; L026553, expiry date 16-JUL-2017; L027432, expiry date 22-JUL-2017 and L032181, expiry date 25-AUG-2017; (doses and routes were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Drug administered to patient of inappropriate age, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received HAVRIX 1440 adult. On 25th April 2016, the patient received the 1st dose of HAVRIX 1440 adult 1 ml. In April 2016, less than a week after receiving HAVRIX 1440 adult, the patient experienced injection site pain. On 25th April 2016, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the injection site pain, inappropriate age at vaccine administration and accidental overdose were unknown. It was unknown if the reporter considered the injection site pain to be related to HAVRIX 1440 adult. Additional details were provided as follows: The patient accidentally received an adult HAVRIX vaccine at the age 16 year old, which led to inappropriate age at vaccine administration and accidental overdose. The patient had also experienced some pain at the injection site. The reporter did not know the actual date of birth, lot, expiration date at the time of reporting, as she was calling from home.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache (serious criteria other: as per reporter) and nausea. On an unknown date, the outcome of the headache and nausea were not recovered/not resolved. The reporter considered the headache and nausea to be related to BEXSERO. Additional details were provided as follows: The GSK sales rep did not have the patient's details, lot number or expiration dates. The patient experienced severe headache and nausea lasting longer than 7 days. The patient required Emergency Room/doctor visit.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and drug reactions/allergies was not provided. On unspecified dates in 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which has a lot # K010216 and expiration date 17-SEP-2016 (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The reporter stated that there was no previously temperature excursion. On 25 and 26-FEB-2016, the RECOMBIVAX HB were exposed to 9 Celsius (C) for 10 hours each day and a data logger was used to capture the excursion. No adverse effect was reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Herpes zoster
Clinical narrative: This spontaneous report as received from a licensed practical nurse refer to a 16 year old female patient. While she had concurrent condition of hirsutism, she had no drug reactions/allergies and her medical history was not reported. On 13-SEP-2000, the patient was vaccinated with the first dose of VARIVAX, subcutaneously (dose, lot #, expiration date and anatomical location were not reported). Subsequently, on 12-OCT-2011, she was vaccinated with the second dose of VARIVAX (which had a lot # reported as 0675AA but with no dose, anatomical location or expiration date reported), subcutaneously. On the same day, she was also concomitantly vaccinated with BOOSTRIX, MENACTRA, FLUZONE and H1N1. Following this, on unspecified dates after 12-OCT-2011, the patient had an outbreak of shingles three times. The patient sought medical attention by seeing a physician and was vaccinated with VALTREX, as treatment, following which she recovered on unknown dates. Subsequently, on 28-MAR-2016, a blood titre was performed showing that the patient was negative for varicella antibodies.  At the time of reporting, the outcome of being negative for varicella antibodies were unknown. No causal relationship between the events and the vaccination with VARIVAX was explicitly stated by the reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swollen at the site of injection.
Age: 66.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness and swollen at the site of injection.
Age: 47.0
Sex: F
Vaccine: HEP, TDAP, TYP
Symptoms: Contusion, Pain in extremity, Paraesthesia, Paraesthesia oral, Peripheral swelling
Clinical narrative: 4-28-2016 - Hep B, Tdap, Typhoid given. 4-29-16 Swelling and bruising, pain RT arm. 5-1-16 Left arm tingling, left hand tingling. 5-4-16 Left face and lips tingling. Advised contact PMD ASAP.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patient received a dose of improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017 and lot # L025737, expiration date 28-JUL-2017 dose and route were not provided) (incorrect product storage). It was exposed to temperature of 47.4F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-APR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (lot # I023386, expiration date 25-JUN-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse regarding multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored M-M-R II lot # L005290, expiration date 17-FEB-2017 and lot # L024264, expiration date 01-JUL-2017 dose and route were not provided. It was exposed to temperature of 50.3F for 1 hour and 20 minutes. Previously it was exposed to temperature of 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt presented to Urgent Care 5/5/16, c/o fever/chills and body aches since 5/4/16 PM. (L) deltoid noted redness, induration, pain and decreased ROM. Ceftriaxone 1 gm with Lidocaine IM XT, Cephalexin 500 mg QM x 10d.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Pt presented to Urgent Care 5/5/16, c/o fever/chills and body aches since 5/4/16 PM. (L) deltoid noted redness, induration, pain and decreased ROM. Ceftriaxone 1 gm with Lidocaine IM XT, Cephalexin 500 mg QM x 10d.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Eye pruritus, Laboratory test normal
Clinical narrative: Child with eye twitching after Hep A vaccine. Neurology did testing which was normal. No treatment was needed it was self resolved.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 11-APR-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 02-MAY-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 28-APR-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HEP, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a 9 week old female patient. Information about concurrent condition, medical history and concomitant therapy was not reported. The medical assistant reported the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # and dose not reported) and ROTATEQ (lot # and dose not reported) on 27-APR-2016 when 6 weeks old. Then on 12-MAY-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # and dose not reported) and ROTATEQ (lot # and dose not reported) when 9 weeks old. No adverse symptoms were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-APR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot#I023386, expiration date 25-JUN-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age. The patient's medical history, concomitant medication and concurrent condition were not reported. On 11-MAY-2016 the patient was inadvertently administered a dose of PROQUAD (Merck) lot # K020751, which expired on 30-APR-2016. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Rash, fever } 5 days, given hydroxyzine for itchiness.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Feeling hot, Headache
Clinical narrative: Pt experienced headache, dizziness, feeling hot, weakness without documented fever approximately 12 hrs after receiving the vaccine.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Sleep terror
Clinical narrative: No immediate AE. noted to have symptoms suggestive of night terrors. 1 week after administration which were notified of today.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Paraesthesia, Skin warm, Swelling
Clinical narrative: Redness, swelling, tingling, hot, cellulitis 1-3 days after injection Tx: Antibiotics, cool compresses, BENADRYL.
Age: 29.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Redness, warmth, painful injection site with swelling. Approximate area 15 cm X 9 cm as of 4/13/16. Injection received on 4/11/16. 4 mg methylprednisolone prescription and 800 mg BACTRIM prescription.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia
Clinical narrative: Vaccines at 4 mo well visit: PENTACEL, PCV, Rotavirus. One week later, mild diarrhea, green with flecks of blood. Resolved in a few days without sequelae.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Red spot (about 2 inches diameter) around injection site, no blister.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Peripheral swelling, Rash, Urticaria
Clinical narrative: Shingles light case; hives, blisters, rash all over both arms. Swelling of both arms. All of these lasting 5 days. Treatment: BENADRYL and calamine lotion.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, past drug history and concurrent conditions were not reported. On an unknown date in May 2016 (reported as either 05-MAY-2016 or 06-MAY-2016) the patient was vaccinated with first dose of RECOMBIVAX HB) (lot # L039660, expiry date 04-FEB-2018) dosing details and route unknown as injection. Concomitant medications were not reported. It was reported that the RECOMBIVAX HB had previously undergone a supported temperature. As of 06-MAY-2016, it was unknown if the patient continues to take RECOMBIVAX HB and the outcome of receiving a vaccine that had undergone a temperature excursion was unknown. This is one of the five reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding her medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with GARDASIL. Patient reported that recently on an unknown date, she was diagnosed with human papillomavirus (HPV). Thus, she inquired why Merck does not manufactures a vaccine to protect against all strains of HPV. Outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and gender. Their pertinent medical history, drug reactions/ allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (which had a lot # of L032760 and an expiration date of 24-FEB-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Apart from PROQUAD, reportedly, the temperature stability of VARIVAX (Merck); ROTATEQ; GARDASIL 9; M-M-R II; PNEUMOVAX pre-filled syringes and single dose vials; PEDVAXHIB; VAQTA; RECOMBIVAX; as well as PROQUAD with other lot numbers and expiration dates, were enquired upon. It was explicitly stated that none of these vaccines were administered. Additionally, no concomitant therapies were reported. The vaccines experienced a temperature excursion of -4 degrees C for a time frame of 6 hours. No previous temperature excursions had occurred and the aforementioned one was called out because of a data logger. Despite being vaccinated with doses of improperly stored PROQUAD, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from the physician via Market research Agency concerning a patient of unknown gender and race, which was the one out of 100 patients, aged between 11 to 22 years old (exact age not reported), who were enrolled in the program. The patient had no relevant medical history or concurrent conditions. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and lot # not reported). There was no concomitant medication. On an unknown date, the patient fainted after vaccination with GARDASIL 9. Then the patient woke up, stayed at pediatrician's office for 15-20 minutes and the blood pressure was checked before the leave (results not provided). No tests were carried out for diagnosis. The administration of the subsequent doses was not prevented and action taken with GARDASIL 9 was reported as continued. The outcome of the event was reported as recovering. The physician considered the event to be related to GARDASIL 9. Additional information is not expected because the physician was not willing to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored ROTATEQ lot #K022990, expiration date 26-JUN-2016 and lot # L001316, expiration date 10-NOV-2016 dose and route were not provided. It was exposed to temperature of 47.4F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in 2014 (also reported as about two years ago), the patient was vaccinated with the first dose of ZOSTAVAX (route, dose and lot # not reported). On 09-MAY-2016, the patient was administered a second dose of ZOSTAVAX (route and dose not reported, lot # L034724, expiry date: 09-DEC-2016). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored LIQUID PEDVAXHIB lot # L012838, expiration date 10-MAR-2018 and lot # L012835, expiration date 11-MAR-2018 dose and route were not provided (incorrect product storage). It was exposed to temperature of 47.7F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Road traffic accident, Seizure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of seizure in a 63-year-old female patient who received BOOSTRIX (batch number 2E9JG, expiry date 8th October 2017). On 3rd December 2015, the patient received BOOSTRIX. On 8th December 2015, 5 days after receiving BOOSTRIX, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). In December 2015, the patient experienced brain edema (serious criteria hospitalization and GSK medically significant) and cerebrospinal fluid protein increased (serious criteria hospitalization and GSK medically significant). The patient was treated with KEPPRA. On an unknown date, the outcome of the seizure, brain edema and cerebrospinal fluid protein increased were recovering/resolving. It was unknown if the reporter considered the seizure, brain edema and cerebrospinal fluid protein increased to be related to BOOSTRIX. Additional details were provided as follows: The patient had no past medical history of seizures. The patient experienced a seizure while driving which resulted in a car accident. The patient was taken to the emergency room and was admitted for an unknown period of time. The reporter additionally reported that the patient experienced edema of the brain, described as swelling of the temporal lobes diagnosed by nuclear magnetic resonance imaging (MRI) on 24th December 2015 and elevated protein in the patient's cerebrospinal fluid (45 mg). All other blood work was normal. On 3rd May 2016, the patient had a repeat MRI and the swelling was resolving. The reported batch number for BOOSTRIX (ZE9JG) does not exist and was updated to 2E9JG as per the sales database.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Brain oedema, CSF protein normal, Nuclear magnetic resonance imaging brain abnormal, Road traffic accident
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of seizure in a 63-year-old female patient who received BOOSTRIX (batch number 2E9JG, expiry date 8th October 2017). On 3rd December 2015, the patient received BOOSTRIX. On 8th December 2015, 5 days after receiving BOOSTRIX, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). In December 2015, the patient experienced brain edema (serious criteria hospitalization and GSK medically significant) and cerebrospinal fluid protein increased (serious criteria hospitalization and GSK medically significant). The patient was treated with KEPPRA. On an unknown date, the outcome of the seizure, brain edema and cerebrospinal fluid protein increased were recovering/resolving. It was unknown if the reporter considered the seizure, brain edema and cerebrospinal fluid protein increased to be related to BOOSTRIX. Additional details were provided as follows: The patient had no past medical history of seizures. The patient experienced a seizure while driving which resulted in a car accident. The patient was taken to the emergency room and was admitted for an unknown period of time. The reporter additionally reported that the patient experienced edema of the brain, described as swelling of the temporal lobes diagnosed by nuclear magnetic resonance imaging (MRI) on 24th December 2015 and elevated protein in the patient's cerebrospinal fluid (45 mg). All other blood work was normal. On 3rd May 2016, the patient had a repeat MRI and the swelling was resolving. The reported batch number for BOOSTRIX (ZE9JG) does not exist and was updated to 2E9JG as per the sales database.