chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a pregnant female patient of an unknown age, reporting on herself. The patient did not have any pertinent medical history, concomitant medications, drug reactions or allergies. On 21-NOV-2016, the patient had her last menstrual period (reported as "last montly period"). Then on 22-NOV-2016, the patient was vaccinated with her second dose of VARIVAX (lot #, expiration date, strength and anatomical location were not reported) and other suspect therapy included a sterile diluent (manufacturer unknown) (lot #, expiration date, strength and dose were not reported); both administered subcutaneously, as prevention from varicella. On an unspecified date in April 2017 (reported as "at an unspecified time last week"), she had an ultrasound and her physician said that it showed that everything "looked good". At the reporting time, the patient was 21 weeks pregnant and it was stated that no treatment was given for the vaccine exposure during pregnancy. The outcome of the pregnancy was pending and the fetal outcome was unknown. The estimated due date (EDD) of the pregnancy would be on 28-AUG-2017. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a female patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 02-AUG-2013, 16-SEP-2014 and 10-AUG-2015, the patient was vaccinated with the first, second and third dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 24-FEB-2017 and 05-APR-2017, the patient was vaccinated with the first and second dose of GARDASIL 9 (dose, frequency and route were not reported) lot # M017983 with expiration date of 30-MAY-2018 and lot # M016193 with expiration date of 24-APR-2018, respectively, for prophylaxis. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: The patient received a dose of RECOMBIVAX HB on 03-APR-2017 and 18-APR-2017; This spontaneous report was received from a physician, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 03-APR-2017 and 18-APR-2017, the patient was intramuscularly vaccinated with the first and second doses of RECOMBIVAX HB injection (dose, frequency, 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, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates between 03-APR-2017 and 17-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX injection (dose, frequency and route were not reported) lot # M040139 with expiration date of 28-SEP-2018, for prophylaxis. The sterile diluent (manufacturer unknown) used to reconstitute the VARIVAX was not improperly stored. The temperature of the VARIVAX was between 6 °F and 14 °F for a time frame of 4 hours and 30 minutes, and between 15 °F and 46 °F for a time frame of 6 hours and 25 minutes. Also, a previous temperature excursion occurred between 6 °F and 14 °F for a time frame of 11 hours and 35 minutes. No adverse effects were reported. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date in November 2016, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration and anatomical location were not reported) for pneumonia (also reported as "therapy route: pneumonia") at an unspecified hospital. Then, on 17-APR-2017, the patient was vaccinated with PREVNAR 13. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unknown number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ (lot #, expiration date, strength and dose, were not reported), administered orally for prophylaxis. The storage temperature excursion was reported as 1.2 degrees Celsius (°C) for a time frame of 4 hours and 3 min. There was no previous temperature excursion. No adverse effects were reported in any patients. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008770: US-009507513-1705USA001817:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unknown number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL 9 (lot #, expiration date, strength, dose, route of administration and anatomical location were not reported), for prophylaxis. The storage temperature excursion was reported as 1.2 degrees Celsius (°C) for a time frame of 4 hours and 3 min. There was no previous temperature excursion. No adverse effects were reported in any patients. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008764: US-009507513-1705USA001817.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a registered nurse concerning multiple patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX with lot number M011665 and expiration date on 17-MAY-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent. The reporter stated that the diluent (lot number and expiration date were unknown) was stored properly. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 6 hours and 35 minutes. There was previous temperature excursion between -14 Centigrade degrees and -10 Centigrade degrees for 35 minutes and another excursion between -9 and 8 Centigrade degrees for 2 hours and 10 minutes. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008590:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6-month-old patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 20-APR-2017, the six month old patient was vaccinated with the first dose of ROTATEQ (orally; dose, lot# and expiration date were not provided), instead of "being administered their first dose of ROTATEQ between six and twelve weeks". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB for prophylaxis (dose, route, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001583: US-009507513-1705USA001584: US-009507513-1705USA001585:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning to multiple unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies, or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency and route were not reported) lot # L046506 with expiration date of 17-MAY-2017, for prophylaxis. The sterile diluents (manufacturer unknown) (lot # and expiration date were not reported) used to reconstitute the PROQUAD were properly stored. The temperature of the PROQUAD was between 6 °F and 14 °F for a time frame of 30 minutes. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA009837.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 20 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-JUL-2016 and on 13-APR-2017, the patient was vaccinated with a pediatric dose of VAQTA (lot # and expiration date were not reported) intramuscularly for prophylaxis.  There were no known adverse effects.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Injection site erythema, Injection site reaction, Injection site swelling, Peripheral coldness
Clinical narrative: Information has been received from an administrator referring to a 71 year old female patient. The patient's concurrent conditions included hyperlipidaemia, osteopenia and hypothyroidism. The patient had corticosteroids drug reaction. On 17-APR-2017, the patient was vaccinated with a second dose of PNEUMOVAX23 lot # M043987 and expiration date 30-JUN-2018 intramuscularly, on her left arm for prophylaxis. The date of administration of the first dose of PNEUMOVAX23 (route of administration, lot #, expiration date and anatomical location was unknown.) for prophylaxis. On 17-APR-2017, a few hours after administration of the second dose of PNEUMOVAX23, the patient developed redness, swelling, tightness, and warmth of the left upper arm, extending from the left elbow to the left shoulder. The patient's left hand felt cold, but there was no numbness. On 18-APR-2017, the patient developed a low-grade fever and she self-treated with TYLENOL. The patient sought medical attention (called office by phone). No laboratories were performed. On 24-APR-2017, the patient had recoverd from the events. Additionally, the reporter did not provided causal relationship between the events and vaccination with dose of PNEUMOVAX23. Additional information is not expected as no consent to contact Physician.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Skin tightness
Clinical narrative: Information has been received from an administrator referring to a 71 year old female patient. The patient's concurrent conditions included hyperlipidaemia, osteopenia and hypothyroidism. The patient had corticosteroids drug reaction. On 17-APR-2017, the patient was vaccinated with a second dose of PNEUMOVAX23 lot # M043987 and expiration date 30-JUN-2018 intramuscularly, on her left arm for prophylaxis. The date of administration of the first dose of PNEUMOVAX23 (route of administration, lot #, expiration date and anatomical location was unknown.) for prophylaxis. On 17-APR-2017, a few hours after administration of the second dose of PNEUMOVAX23, the patient developed redness, swelling, tightness, and warmth of the left upper arm, extending from the left elbow to the left shoulder. The patient's left hand felt cold, but there was no numbness. On 18-APR-2017, the patient developed a low-grade fever and she self-treated with TYLENOL. The patient sought medical attention (called office by phone). No laboratories were performed. On 24-APR-2017, the patient had recoverd from the events. Additionally, the reporter did not provided causal relationship between the events and vaccination with dose of PNEUMOVAX23. Additional information is not expected as no consent to contact Physician.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 25-APR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # M032153 and expiration date 22-APR-2017 (route of administration, dose and anatomical location were not provided) for prophylaxis in combination with sterile diluent. No adverse effects were reported.         Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 25 year old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On 11-APR-2017,  the patient was vaccinated with the first dose of M-M-R II (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. On 23-APR-2017, 13 days after onset of therapy, the patient developed a rash all over her body. The patient sought medical attention by contacting her pharmacist. It was reported that treatment was not given for the patient's event of rash. The outcome of rash was reported as not recovered/not resolved. The relatedness between the event of rash and  M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a register nurse via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that on an unknown date, the patient was inadvertently administered a dose of PREVNAR 13 (dose, route, lot number and expiration date were not reported) for prophylaxis, instead of an intended dose of PNEUMOVAX23 (dose, route, lot number and expiration date were not reported). The reason for the error was unknown. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates in April 2017 (reported as from 20-APR-2017 to 25-APR-2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot number M029251 with expiration date of 14-MAR-2018, lot number M042172 with expiration date of 08-JUN-2018, lot number reported as M034495 with expiration date of 31-MAY-2018 and lot number M039067 with expiration date of 18-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour 17 minutes at a temperature between 9 degrees Celsius and 25 degrees Celsius on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001801: US-009507513-1705USA001802:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fungal infection, Rash generalised
Clinical narrative: This spontaneous report has been received from a 64-year-old female consumer reporting on herself. The patient's historical conditions were not reported and her concurrent conditions included clotting disorders (unspecified) and autoimmune diseases (unspecified). The patient's concomitant therapies included warfarin sodium (COUMADIN), fosinopril sodium, alprazolam, atorvastatin, and carvedilol. She did not have any reactions/allergies. On 21-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and dose were not reported; route of administration was reported as injection and frequency as one injection) for the prevention of shingles which was reconstituted with a sterile water diluent (manufacturer unknown) (lot number and expiration date was not reported). On 18-MAR-2017, the patient experienced a body rash and a yeast infection. She then sought medical attention on an unspecified date and was treated with prednisone (manufacturer unknown) and hydroxyzine hydrochloride (manufacturer unknown), there were no laboratory diagnostic tests performed. At the time of this report, the patient had not recovered from her rash and fungal infection. The causality assessment between rash and fungal infection with ZOSTAVAX was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Facial paralysis, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patient received 3 doses of GARDASIL injection (doses, route of administration, lot# and expiration dates were not provided), which were not given accordingly to the schedule as per recommended in the prescribing information. The patient received the third dose of GARDASIL on an unknown date in 2013. On an unknown date, 10 days after receiving the third dose of the vaccine, the patient presented with unspecified Bell's palsy symptoms. The patient received an unspecified treatment for the event. The outcome of the event was not recovered. The causality between the adverse event and GARDASIL was not provided. Upon internal review, the event of Bell's palsy symptoms was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report was received from a consumer regarding her 6 month old male son. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 25-APR-2017 (reported as "yesterday"), the patient was vaccinated with a dose of ROTATEQ oral liquid (dose, lot number and expiration were not reported) administered orally for prophylaxis. According to the reporter, the patient spat at least half of it out. It was reported that the patient had previously received ROTATEQ and swallowed it without any issues. The outcome of the event infantile spitting up was not reported. The reporter did not provide a causality assessment between infantile spitting up and the suspect vaccine. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001581:
Sex: U
Vaccine: PPV
Symptoms: Febrile convulsion, Injection site cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a pharmacy technician refers to a patient of unknown age and gender. On 24-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 lot # M039060, expiration date 22-MAY-2018 for prophylaxis. On the same day, the patient experienced a 104 (units not reported) fever, febrile seizure, and cellulitis at the PNEUMOVAX23 injection site. On 25-APR-2017, the physician brought the patient back to the office and started the patient on a regimen of unspecified antibiotics. The outcome of events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Upon internal review, the event of febrile convulsion was considered to be medically significant. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored dose of VAQTA (lot# M038572, expiry date: 11-MAR-2018) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects 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-009507513-1704USA014865: US-009507513-1705USA001549: US-009507513-1705USA001551:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot# M037248, expiry date: 21-FEB-2019) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects 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-009507513-1705USA001550: US-009507513-1704USA014865: US-009507513-1705USA001549:
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: This spontaneous report was received from a nurse, via a company representative, regarding an unspecified number of infant patients (reported as "many babies") of unknown gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of ROTATEQ oral liquid (dose, lot number and expiration were not reported) administered orally for prophylaxis. According to the reporter, the patients spat the vaccine out and did not get the full dosage. It was reported that was a common problem and they cannot give more ROTATEQ as the patients only got what they could manage to swallow. The outcome of the event was not provided. The reporter did not provide a causality assessment between infantile spitting up and the suspect vaccine. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA015046:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 for prophylaxis (dose, route, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010803: US-009507513-1705USA001584: US-009507513-1705USA001585:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis (dose, route, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010803: US-009507513-1705USA001583: US-009507513-1705USA001585:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ per oral, for prophylaxis (dose, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010803: US-009507513-1705USA001583: US-009507513-1705USA001584:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates in April 2017 (reported as from 20-APR-2017 to 25-APR-2017), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number reported as M011840 with expiration date of 01-FEB-2018, lot number M023169 with expiration date of 13-JUN-2018, lot number M032650 with expiration date of 31-MAR-2019 and lot number M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour 17 minutes at a temperature between 9 degrees Celsius and 25 degrees Celsius on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. Additional information has been requested. Sender's Comments: US-009507513-1704USA014144: US-009507513-1705USA001802.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates in April 2017 (reported as from 20-APR-2017 to 25-APR-2017), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number L045117 with expiration date of 06-OCT-2018 and lot number M036156 with expiration date of 23-FEB-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour 17 minutes at a temperature between 9 degrees Celsius and 25 degrees Celsius on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014144: US-009507513-1705USA001801:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unknown number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored M-M-R II (lot #, expiration date, strength, dose, route of administration and anatomical location were not reported), for prophylaxis. The storage temperature excursion was reported as 1.2 degrees Celsius (°C) for a time frame of 4 hours and 3 min. There was no previous temperature excursion. No adverse effects were reported in any patients. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008764: US-009507513-1704USA008770:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAR-2017, the patient was vaccinated with the improperly stored dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse symptoms were reported. The vaccines were exposed to the light varying from 1 to 6 hours. The administrator confirmed that only 3 patients received the vaccines (captured in MARRS # 1705USA002115 and 1703USA005830) and the rest of the doses were discarded. his is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005830: US-009507513-1705USA002115:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAR-2017, the patient was vaccinated with the improperly stored dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse symptoms were reported. The vaccines were exposed to the light varying from 1 to 6 hours. The administrator confirmed that only 3 patients received the vaccines (captured in MARRS # 1705USA002114 and 1703USA005830) and the rest of the doses were discarded. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005830: US-009507513-1705USA002114:
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash generalised
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself. A 79-year-old female patient received the 1st dose of PREVNAR 13 via an unspecified route of administration at single dose into the left arm in Nov2016 for immunisation, she thought that the product was prescribed for flu prevention, received at the local pharmacy. A nurse administered the shot. She had other medical conditions years before, but did not provide them. No illness at the time of vaccination. She mentioned that she had other medical conditions years before, but did not provide them when asked. Concomitant medication included alprazolam oral 1 mg, 1x/day (each night) started probably about 10 years before and ongoing for sleep, and supplements. The patient previously took flu and experienced pain in extremity. She mentioned that her arm was sore after she received any type of flu shot. No history of previous immunization with the PREVENAR 13. No additional vaccines administered on same date of the suspect. The patient Shingles vaccine (uncertain) at left arm at least 4 weeks prior to the PREVNAR 13 shot. In Nov2016 she experienced sore arm after she received the product and she recovered completely the next day. In Dec2016 she experienced a rash all over her body 2 to 3 weeks after receiving the product and she still had it. Again, 2 to 3 weeks later she experienced a rash all over her body, referring to this time period as around the first or second week of Dec2016. She has been to dermatologists for rash and they seem to be treating the symptoms of rash and have not determined the cause. She was prescribed a product or products to help with the crazy itchiness from the rash. The product helped the itchiness, but the rash was still there. It worsened, but then it improved after she started receiving a pill that she did not recall the name of and it helped or made it better regarding the itchiness of the rash. The product she received had some type of chemo in it that took away the itching. Now the rash was right back. The rash used to be spotty originally, and now it was sores. She also referred to receiving some type of shot. She was prescribed many products for the rash. She routinely had received other flu shots in the past, but never experienced this event. Her arm was sore after she received any type of flu shot. Her doctor wanted her to receive the product again this year, but she was not going to receive another one. No tests performed. She was going to have an allergy test starting on 01May. No event required a visit to Emergency room, but the events rash all over her body and crazy itchiness from the rash required a visit to Physician office. A product complaint was filed.
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Confusional state, Disorientation, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age and ethnicity started to receive PREVNAR 13 via an unspecified route of administration at single dose on 07Apr2017 for immunization as a booster shot. The patient medical history and concomitant medications were not reported. On an unspecified date in 2017 the patient experienced severe headache and pain at injection site for 3 days, mental confusion, disorientation, myalgia, generalized weakness for approximately 10 days. The outcome of the events was  unknown. There was no quality issue associated with this event, no complaint.
Sex: M
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age and ethnicity started to receive PREVNAR 13 via an unspecified route of administration at single dose on 07Apr2017 for immunization as a booster shot. The patient medical history and concomitant medications were not reported. On an unspecified date in 2017 the patient experienced severe headache and pain at injection site for 3 days, mental confusion, disorientation, myalgia, generalized weakness for approximately 10 days. The outcome of the events was  unknown. There was no quality issue associated with this event, no complaint.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Type III immune complex mediated reaction
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a sales representative for two patients, this case is for the second patient. A female patient in her 80's of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5ml single dose in arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received PNEUMOVAX over one year before. The patient experienced arthus with redness of upper arm 3-4 days later on an unspecified date with outcome of unknown. Sender's Comments: The events arthus with redness cannot be excluded due to the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Linked Report(s): US-PFIZER INC-2017188145 same reporter drug event different patient.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram, Lethargy, Ultrasound scan, Vomiting
Clinical narrative: Lethargy, vomiting for 12hrs.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, General physical condition abnormal, Intussusception, Lethargy, Pallor
Clinical narrative: Vomiting, lethargy, pale started 8am morning of 2/28/17 in MD office. Child brought in because infant didn't "look right" air enema was performed and was successful to reduce intussusception.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: Vomiting, lethargy, pale started 8am morning of 2/28/17 in MD office. Child brought in because infant didn't "look right" air enema was performed and was successful to reduce intussusception.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left thigh redness, increased warmth and firmness, cellulitis cephalexin oral antibiotic.
Sex: U
Vaccine: VARCEL
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 age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates in 2017, reported as since 11-JAN-2017, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot number: M038226, expiration date: 07-SEP-2018 and lot number: M035688, expiration date: 10-AUG-2018; dose and route of administration were not provided). Other suspected therapy included sterile diluent (also reported as "diluent that was used to reconstitute the doses") (manufacturer unknown) (strength, dose, route of administration, lot number and expiration date were not provided). The nurse reported that there were multiple unspecified temperature excursions on unknown dates. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015097:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site haemorrhage, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 72 year old female patient with allergy to penicillin, valium and codeine. On 11-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml, intramuscular in the left upper extremity for routine vaccination (lot # M038359, expiration date 13-MAY-2018). Concomitant therapies included aspirin (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 12-APR-2017, the patient experienced pain at injection site. On 13-APR-2017, the patient experienced rash at injection site. On an unspecified date in April 2017, upon the physician assistant assessment, the patient's left upper extremity was ecchymotic with additional redness expanding to the left chest, swelling at the injection site, enlarged lymph nodes and fever. The physician assistant requested to perform unspecified blood work but the patient declined at the time of this report and requested to be performed later in a week period. The physician assistant prescribed antibiotic sulfamethoxazole (+) trimethoprim (BACTRIM) (unspecified strength, unspecified lot and unspecified expiration) to be started on 13-APR-2017. The outcome of all adverse events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 72 year old female patient with allergy to penicillin, valium and codeine. On 11-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml, intramuscular in the left upper extremity for routine vaccination (lot # M038359, expiration date 13-MAY-2018). Concomitant therapies included aspirin (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 12-APR-2017, the patient experienced pain at injection site. On 13-APR-2017, the patient experienced rash at injection site. On an unspecified date in April 2017, upon the physician assistant assessment, the patient's left upper extremity was ecchymotic with additional redness expanding to the left chest, swelling at the injection site, enlarged lymph nodes and fever. The physician assistant requested to perform unspecified blood work but the patient declined at the time of this report and requested to be performed later in a week period. The physician assistant prescribed antibiotic sulfamethoxazole (+) trimethoprim (BACTRIM) (unspecified strength, unspecified lot and unspecified expiration) to be started on 13-APR-2017. The outcome of all adverse events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Erythema of eyelid, Hot flush, Ocular hyperaemia
Clinical narrative: This spontaneous report was received from a male medical professional (credentials not specified) (age not reported) reporting on himself via a company representative. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 as prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after the administration of the second dose of the vaccine, the patient experienced redness in and around his eyes and hot flushed feeling around his eyes. The patient was treated with BENADRYL and it relieved the symptoms. On an unknown date, the patient recovered from the events. No further information was provided. The causal relationship between the events and GARDASIL 9 were not reported. Additional information is not expected since the healthcare professional's contact details was not provided.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning to multiple unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies, or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (dose, frequency and route were not reported) lot # L050561 with expiration date of 14-DEC-2017 and lot # M019841 with expiration date of 20-APR-2018, for prophylaxis. The sterile diluents (manufacturer unknown) (lot # and expiration date were not reported) used to reconstitute the VARIVAX were properly stored. The temperature of the VARIVAX was between 6 °F and 14 °F for a time frame of 30 minutes. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916:
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 age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates in 2017, reported as since 11-JAN-2017, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot number: M017337, expiry date: 05-OCT-2017; albumin status: recombinant human albumin (rHA); dose and route of administration were not provided). Other suspected therapy included sterile diluent (also reported as "diluent that was used to reconstitute the doses") injection (manufacturer unknown) (strength, dose, route of administartion, lot number and expiration date were not provided). The nurse reported that there were multiple unspecified temperature excursions on unspecified dates. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006353.