chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Muscular weakness, Myalgia, Neck pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 67 year-old female patient of other race received the first single dose of PREVNAR 13 via an unspecified route of administration on 09May2017 at 4 pm in left arm for immunisation. Medical history included allergy from an unknown date and unknown if ongoing. The patient was concomitantly taking some other unspecified medications. No family medical relevant history was present. No other vaccines were administered the same day or within four weeks prior. The patient experienced injection hurt real bad on 09May2017. The evening of the next day, on 10May2017, she noticed pain in her left arm, generalized to the shoulder area. She rubbed her arm in ASPERCREME, and then iced it because the cream didn't do any good. Because she was still having pain and weakness in her left arm up to the shoulder area, she started taking ADVIL, that evening as well. On 11May2017, she went to work and was still icing her left arm and taking 2 ibuprofen per day. She also started feeling very sleepy, had muscle aches and pains, and fatigue. That continued for 11May2017 and 12May2017. On 13May2017, she started having headaches behind her right eye. She described them as funny kind of headaches but not migraines. On 14May20017 she was tired and lethargic, and just laid around and slept all day. She went to work the next day even though she was still tired and lethargic, and her co-workers told her that she needed to go to the doctor. She stated that she also noticed, on that day, that her arm was very red and irritated. On 15May2017 or 16May2017 she went to the doctor due to the events. The doctor measured the area on her left arm that was red and irritated, and it was about 3 inches. It was also really itchy. The doctor prescribed a 4 day dose of prednisone. The redness and itching resolved a couple of days after she finished prednisone on an unspecified day in May2017. She had also stopped the trolamine salicylate by this time because it wasn't working. She was still having headaches behind her right eye, but since last week, the headaches were getting better. They were still there, but they were intermittent. She also still had the weakness in her left side up in the should area. It was bad the first week, but it has improved. She could feel the pain going up the left side of her neck if she raised her left arm. On 26May2017 she felt like the whole thing was coming on her again. She clarified that she felt like she did the day that she went to the doctor. It lasted into the evening, about 4-5 hours. She has never had that feeling before in her life, so she recognized it immediately. The patient recovered from redness and itching on an unspecified day in May2017, she was recovering from weakness in her left arm up to the shoulder area and headache, she was not recovered from pain in her left arm, generalized to the shoulder area and pain going up the left side of her neck if she raised her left arm, outcome of the other events was unknown.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Skin irritation, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 67 year-old female patient of other race received the first single dose of PREVNAR 13 via an unspecified route of administration on 09May2017 at 4 pm in left arm for immunisation. Medical history included allergy from an unknown date and unknown if ongoing. The patient was concomitantly taking some other unspecified medications. No family medical relevant history was present. No other vaccines were administered the same day or within four weeks prior. The patient experienced injection hurt real bad on 09May2017. The evening of the next day, on 10May2017, she noticed pain in her left arm, generalized to the shoulder area. She rubbed her arm in ASPERCREME, and then iced it because the cream didn't do any good. Because she was still having pain and weakness in her left arm up to the shoulder area, she started taking ADVIL, that evening as well. On 11May2017, she went to work and was still icing her left arm and taking 2 ibuprofen per day. She also started feeling very sleepy, had muscle aches and pains, and fatigue. That continued for 11May2017 and 12May2017. On 13May2017, she started having headaches behind her right eye. She described them as funny kind of headaches but not migraines. On 14May20017 she was tired and lethargic, and just laid around and slept all day. She went to work the next day even though she was still tired and lethargic, and her co-workers told her that she needed to go to the doctor. She stated that she also noticed, on that day, that her arm was very red and irritated. On 15May2017 or 16May2017 she went to the doctor due to the events. The doctor measured the area on her left arm that was red and irritated, and it was about 3 inches. It was also really itchy. The doctor prescribed a 4 day dose of prednisone. The redness and itching resolved a couple of days after she finished prednisone on an unspecified day in May2017. She had also stopped the trolamine salicylate by this time because it wasn't working. She was still having headaches behind her right eye, but since last week, the headaches were getting better. They were still there, but they were intermittent. She also still had the weakness in her left side up in the should area. It was bad the first week, but it has improved. She could feel the pain going up the left side of her neck if she raised her left arm. On 26May2017 she felt like the whole thing was coming on her again. She clarified that she felt like she did the day that she went to the doctor. It lasted into the evening, about 4-5 hours. She has never had that feeling before in her life, so she recognized it immediately. The patient recovered from redness and itching on an unspecified day in May2017, she was recovering from weakness in her left arm up to the shoulder area and headache, she was not recovered from pain in her left arm, generalized to the shoulder area and pain going up the left side of her neck if she raised her left arm, outcome of the other events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant reported on behalf of physician. A 65-year-old female patient received PREVNAR 13, (lot R94917, exp.date May2018, NDC number: 0005-1971-01) via intramuscular route in the right deltoid at 0.5ml single dose on 24May2017. Medical history included ongoing high cholesterol and heartburn. Concomitant medication included simvastatin at 10 mg, 1x/day ongoing, Biotin at 5000 ug, 1x/day ongoing, FIBER 625 mg ongoing, MULTIVITAMIN, COQ10 and vitamin D. Within a few hours of the vaccination, patient had swelling, redness, heat, and pain at the injection site. Within 24 hours, she had muscle weakness, aches, headache, vomiting, chills, and nausea. Patient had noted that the vomiting only lasted 4 hours but the other symptoms lasted three days. The outcome of the event vomiting was reported as recovered, the outcome of the other adverse events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Muscular weakness, Nausea, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable medical assistant reported on behalf of physician. A 65-year-old female patient received PREVNAR 13, (lot R94917, exp.date May2018, NDC number: 0005-1971-01) via intramuscular route in the right deltoid at 0.5ml single dose on 24May2017. Medical history included ongoing high cholesterol and heartburn. Concomitant medication included simvastatin at 10 mg, 1x/day ongoing, Biotin at 5000 ug, 1x/day ongoing, FIBER 625 mg ongoing, MULTIVITAMIN, COQ10 and vitamin D. Within a few hours of the vaccination, patient had swelling, redness, heat, and pain at the injection site. Within 24 hours, she had muscle weakness, aches, headache, vomiting, chills, and nausea. Patient had noted that the vomiting only lasted 4 hours but the other symptoms lasted three days. The outcome of the event vomiting was reported as recovered, the outcome of the other adverse events was unknown.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A female patient (Age: 75, Unit: Unknown) received PREVNAR 13 on 02Jun2017 at single dose for immunization. Medical history and concomitant medication were unknown. On unknown date the patient experienced fever chills and flu like symptoms. The outcome of the events were unknown. No follow up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Headache, Oxygen saturation decreased, Pain, Pyrexia
Clinical narrative: Slight fever began at 11:PM on 6/6/17. Body aches and fever increased to 102-103 throughout 6/6/2017. Aspirin and Tylenol were taken. headache, low blood oxygen saturation of 91 and heart rate of 130-145 treated with Xoponex through nebulizer brought O2 saturation back to 95. Fever reduced to 101 by 5:00 PM on 6/7/17. Body aches and back pain ended 6/8/17 at noon.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were administered improperly stored with PROQUAD (strength, dose, frequency and route were unknown; lot number and expiration were: L051098/17-JUN-2017, M006102/01-AUG-2017) for prophylaxis. No adverse effects reported. The temperature excursion was 6.8 degree Fahrenheit for 45 minutes. There was no previous temperature excursion. This report was for data logger. This is one of several reports received from the same reporter. All telephone call attempts to obtain follow-up information on 11-MAY-2017 have been unsuccessful.  Additional information has been requested. Sender's Comments: US-009507513-1608USA006030: MERCK 1608USA007923: Mfr number.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a neonate patient of unknown gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On an unknown date, between 20-APR-2017 and 11-MAY-2017, the neonate patient was vaccinated with VAQTA injection, lot # M039202, expiration date on 11-MAR-2018 (dose, route and site of vaccination were not reported). No adverse reactions were 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 medical assistant and refers to an unknown number of patients of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M033338, expiration date: 15-APR-2018 (dose was not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact.; Sender's Comments: US-009507513-1706USA003430: US-009507513-1706USA003431: US-009507513-1706USA003432: US-009507513-1706USA003433:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. The nurse reported that between 08-MAY-2017 and 24-MAY-2017, the patients were vaccinated with a single improperly stored dose of PNEUMOVAX23, intramuscularly (lot # N000508, expiration date 19-OCT-2017, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 49 Fahrenheit degrees, for 2 hours (supported). There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. This is one of 3 reports from the same reporter. Additional information is not expected, as there was no consent to follow up.; Sender's Comments: US-009507513-1706USA004263: US-009507513-1706USA004264:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender (reported as "multiple"; "about 1 in every 8"). No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated subcutaneously with ZOSTAVAX injection 19400 PFU (dose, lot number and expiration date were not reported) for indication reported as herpes zoster. On unknown dates, the patients experienced an "indurated erythematous" around the injection site of the ZOSTAVAX. The size of the "indurated erythematous" was about 4 inches in diameter. The patients were treated for "indurated erythematous" with diphenhydramine hydrochloride (BENADRYL). On an unknown date (reported as "in about a week"), the patients recovered from "indurated erythematous" (reported as "it was resolved"). The patients sought medical attention (saw the physician). No product quality complaint was involved. The relatedness between "indurated erythematous" and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates between 19-APR-2017 and 23-MAY-2017, the patients were vaccinated with improperly stored doses of    PNEUMOVAX23 lot # M038359 with expiration date 13-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 24 hours. A Digital Data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014464: US-009507513-1705USA014494: US-009507513-1705USA014495: US-009507513-1705USA014497:
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse refers to a 49 year old female patient. Patient had no pertinent medical history apart from allergy to tetracycline and Penicillin. On 09-SEP-2016, the patient was vaccinated with the first dose of VARIVAX (lot # K021484, expiry date: 03-NOV-2016) to prevent chickenpox. Dosing details and route of administration were not reported. The vaccine was reconstituted with sterile diluent (STERILE DILUENT). Concomitant therapies included simvastatin (ZOCOR). On approximately 23-SEP-2016, 2 weeks after administration of the vaccine, the patient experienced a red, bumpy skin rash around the injection site (injection site rash). It was reported that in December (unspecified date), the nurse noticed the rash when the patient appeared for the second administration of the vaccine. A serologic screen of antibody titers was performed which revealed 16.2 (units unspecified) (antibody test abnormal). At the time of this report, the second dose was not yet administered. The event of injection site rash was reported to have resolved on an unknown date. The outcome of antibody test abnormal was unknown. No causality assessment was provided by the reporter. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored PNEUMOVAX23 lot # M037533 and expiration date of 17-MAY-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes).  No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved.  This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001766: US-009507513-1705USA015824: US-009507513-1706USA001765:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Musculoskeletal pain, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a physician referring to a 61 year old male patient. The patient's concurrent conditions included intervertebral disc disease and iodine allergy. The patient did not have taken any known concomitant medication. On 08-FEB-2017, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The physician reported that the patient was seen at an unspecified primary care physician's office for knee pain and shoulder pain, "approximately 1 month after receiving the ZOSTAVAX. Then he saw an unspecified orthopedic surgeon on an unspecified date and was given a cortisone injection into his knee. Subsequently on 16-MAR-2017, the patient was seen at her office with hip pain and blood work for inflammation was ordered which results showed that the patient had elevated erythrocyte sedimentation rate (ESR) and a diagnosis of "polymyalgia" was given. Additionally a magnetic resonance imaging (MRI) was performed, the physician started the patient on therapy with prednisone 20 mg daily. It was reported that the patient now had complaint of severe numbness and tingling in his left arm. No further information was provided. There was no product quality complaint (PQC) involved. At the reporting time the outcome of the events was unknown. The reporter did not assess the causality between the events and ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report was received from a physician referring to a 61 year old male patient. The patient's concurrent conditions included intervertebral disc disease and iodine allergy. The patient did not have taken any known concomitant medication. On 08-FEB-2017, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The physician reported that the patient was seen at an unspecified primary care physician's office for knee pain and shoulder pain, "approximately 1 month after receiving the ZOSTAVAX. Then he saw an unspecified orthopedic surgeon on an unspecified date and was given a cortisone injection into his knee. Subsequently on 16-MAR-2017, the patient was seen at her office with hip pain and blood work for inflammation was ordered which results showed that the patient had elevated erythrocyte sedimentation rate (ESR) and a diagnosis of "polymyalgia" was given. Additionally a magnetic resonance imaging (MRI) was performed, the physician started the patient on therapy with prednisone 20 mg daily. It was reported that the patient now had complaint of severe numbness and tingling in his left arm. No further information was provided. There was no product quality complaint (PQC) involved. At the reporting time the outcome of the events was unknown. The reporter did not assess the causality between the events and ZOSTAVAX. 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 nurse practitioner and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M009378 with an expiration date 23-APR-2018, lot# L026602 with an expiration date 19-OCT-2017, and lot# M030380 with an expiration date 01-FEB-2019. There was no adverse effect reported. Administered doses of GARDASIL 9 experienced temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 4 days. There was no previous temperature excursion. A digital data logger was not involved. This is on of several reports received from the same reports. Additional information has been requested. Sender's Comments: US-009507513-1706USA004377: US-009507513-1706USA004379: US-009507513-1706USA004376: US-009507513-1706USA004378.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 05-JUN-2017,  the patient was vaccinated with an expired dose of M-M-R II lot # L020189 with expiration date of 03-JUN-2017(strength, dose, frequency, route of administration, were not provided) for prophylaxis. No adverse effects reported. No further details were available. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# M035487, expiration date: 23-FEB-2019 (dose and route of administration were not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact. Sender's Comments: US-009507513-1705USA009556: US-009507513-1706USA003430: US-009507513-1706USA003432: US-009507513-1706USA003433.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M037770, expiration date 01-JUN-2019 (dose and route of administration were not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact. Sender's Comments: US-009507513-1705USA009556: US-009507513-1706USA003430: US-009507513-1706USA003431: US-009507513-1706USA003432.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot# M035935, expiration date: 09-AUG-2018 (dose and route of administration were not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact.; Sender's Comments: US-009507513-1705USA009556: US-009507513-1706USA003430: US-009507513-1706USA003431: US-009507513-1706USA003432:
Age: 18.0
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 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-MAR-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion 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:
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-MAR-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion 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: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot number M047661 with expiration date 02-DEC-2018; lot number M045204 with expiration date 11-NOV-2018; lot number M036272 with expiration date 07-AUG-2018; and lot number reported as N002203 with expiration date 19-JAN-2019 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature of -14 Celsius (C) during 9 days, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004367:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, GARDASIL 9 doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004259: US-009507513-1706USA004260: US-009507513-1706USA004261: US-009507513-1706USA004262.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, VAQTA doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004260: US-009507513-1706USA004261: US-009507513-1706USA004262: US-009507513-1706USA003526:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, RECOMBIVAX HB doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004262: US-009507513-1706USA004261: US-009507513-1706USA004259: US-009507513-1706USA003526:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, GARDASIL doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004259: US-009507513-1706USA004260: US-009507513-1706USA004262: US-009507513-1706USA003526.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, PNEUMOVAX23 doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004259: US-009507513-1706USA004260: US-009507513-1706USA004261: US-009507513-1706USA003526:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. The nurse reported that between 08-MAY-2017 and 24-MAY-2017, the patients were vaccinated with a single improperly stored dose of RECOMBIVAX HB, intramuscularly (lot # M036156, expiration date 23-FEB-2019, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 49 Fahrenheit degrees, for 2 hours (supported). There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. This is one of 3 reports from the same reporter.; Sender's Comments: US-009507513-1706USA004264: US-0009507513-1705USA013741:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. The nurse reported that between 08-MAY-2017 and 24-MAY-2017, the patients were vaccinated with a single improperly stored dose of GARDASIL 9, intramuscularly (lot # M034195, expiration date 14-APR-2019, lot # M031557, expiration date 07-APR-2019, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 49 Fahrenheit degrees, for 2 hours (supported). There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. This is one of 3 reports from the same reporter. Additional information is not expected, as there was no consent to follow up. Sender's Comments: US-009507513-1705USA013741: US-009507513-1706USA004263.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot number M038228 with expiration date 06-MAR-2018; lot number M049123 with expiration date 13-JUN-2018; lot number reported as M048201 with expiration date 05-JUN-2020 and lot number reported as M044719 with expiration date 07-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature of -14 Celsius (C) during 9 days, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA003470.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant concerning a 16 month old patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 27-APR-2017, the patient was vaccinated with LIQUID PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments:  US-009507513-1704USA001797: US-009507513-1706USA004380: US-009507513-1706USA004381: US-009507513-1706USA004382: US-009507513-1706USA004383:
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant concerning a  5 month old patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 28-APR-2017, the patient was vaccinated with LIQUID PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed to a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments:  US-009507513-1704USA001797: US-009507513-1706USA004370: US-009507513-1706USA004381: US-009507513-1706USA004382: US-009507513-1706USA004383:
Age: 0.58
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant concerning a 7 month old patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 28-APR-2017, the patient was vaccinated with LIQUID PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed to a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments:  US-009507513-1704USA001797: US-009507513-1706USA004370: US-009507513-1706USA004380: US-009507513-1706USA004382: US-009507513-1706USA004383:
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant concerning a 16 month patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 28-APR-2017, the patient was vaccinated with PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed to a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received. Sender's Comments: US-009507513-1704USA001797: US-009507513-1706USA004370: US-009507513-1706USA004380: US-009507513-1706USA004381: US-009507513-1706USA004383.
Age: 0.58
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant concerning a 7 month old patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 28-APR-2017, the patient was vaccinated with LIQUID PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed to a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments:  US-009507513-1704USA001797: US-009507513-1706USA004370: US-009507513-1706USA004380: US-009507513-1706USA004381: US-009507513-1706USA004382:
Sex: F
Vaccine: DTAP
Symptoms: Central venous catheterisation, Muscle spasms, Thrombosis
Clinical narrative: Initial unsolicited report received from a consumer (patient himself) via other company (manufacturer report number: 2017TAR00369) on 30-May-2017. This case involves a female patients (age not reported), who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient previously received ENOXAPARIN SODIUM (Lovenox) for three months prior to starting WARFARIN SODIUM (Taro Warfarin) which started from an unspecified date of Oct 2016. Patient's medical history included diabetes, high blood pressure, kidney stones, GERD and cancer. The patient had a port placed in right shoulder and developed a clot post port insertion. Patient's concomitant medication included Irbesartan, glimepiride, sodium bicarbonate and omeprazole all from an unknown date. On an unspecified date, following the vaccination, the patient experienced muscle spasms. Patient's laboratory investigation and corrective treatments were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 5 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 17-FEB-2017, the patient was inadvertently vaccinated with second doses in immunization series for VARIVAX lot # M038225, expiration date 07-SEP-2018 (dose, route of administration and anatomical location were not reported) and PROQUAD lot # M037010, expiration date 21-FEB-2017, therapy type rHA (dose, route of administration and anatomical location were not reported). The doses were administered concomitantly, and were reconstituted with sterile diluent. No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Disorientation, Hallucination, Influenza virus test negative, Laboratory test normal, Malaise
Clinical narrative: This spontaneous report was received from a physician, concerning 12 year-old male patient. There were no concurrent conditions, medical history, drug reactions or allergies. His concomitant medications included CLARITIN. On 03-MAR-2017, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (dose and frequency were not reported) lot # M031557 with expiration date of 07-APR-2019, for Human papillomavirus (HPV). On an unspecified date in 2017, after vaccination, he experienced high fever, was disoriented and hallucinating. It was not specified when symptoms resolved and no medical treatment was given per physician. On 05-MAY-2017, the patient was intramuscularly vaccinated with the second dose of GARDASIL 9 (dose and frequency were not reported) lot # M041990 with expiration date of 28-SEP-2019, for Human papillomavirus (HPV). On 08-MAY-2017, the patient went to the clinic and he was treated for an unspecified practitioner; the patient had a "rapid strep test" that was negative and also a throat culture was taken. The patient's mother gave him an unspecified dose of over the counter ADVIL which did not bring down a fever of 104°F. On the same date, he was taken to the hospital emergency room (ER) and treated by an unspecified physician. His laboratories (unspecified) were normal, a flu test was negative and a diagnosis of acute nasopharyngitis was given. Additionally, the patient also had a positive streptococcus culture come back from the clinic and Z-PACK was prescribed (unspecified dose). In summary, the patient was sick for 3-5 days after second dose of GARDASIL 9. At the time of the report, the patient was recovering from fever of 104°F, acute nasopharyngitis and positive streptococcus culture. The causality between the adverse events and GARDASIL 9 was unknown. Additional information has been requested.