chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site swelling
Clinical narrative: 6 month vaccines were administered 10 day ago. Child developed a small bump in left thigh area where vaccines were given. (No fever, no pain, no rash). Mother was advised to massage area, warm compresses - will most likely resolve with time. Not visible only palpable.
Age: 39.0
Sex: F
Vaccine: MMR, TYP
Symptoms: Eye pain, Headache, Nausea, Pain, Rash
Clinical narrative: Nausea, Headache, Eye pain, body aches, rash.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Severe pain at injection site; limited range of motion due to pain.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Nausea, Pain, Swelling
Clinical narrative: Swelling nausea fatigue pain. Turned into sweats.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler abnormal, Vaccination site swelling, White blood cell count increased
Clinical narrative: Pt developed swelling at site of vaccine injection on right arm and swelling on left arm found to have a left brachial vein DVT.
Age: 27.0
Sex: F
Vaccine: FLUC4, HEP, PPV
Symptoms: Erythema, Hypersensitivity, Infection, Local swelling
Clinical narrative: PATIENT CALLED OUR STORE TO REPORT HE WENT TO THE EMERGENCY ROOM REGARDING HIS LEFT ARM, WHICH HAD A RED, SWOLLEN SPOT FOLLOWING THE ADMINISTRATION OF 3 VACCINES ON THE 17TH. HE REPORTED THAT STAFF WAS UNDECIDED IF HE HAD AN INFECTION OR AN ALLERGIC REACTION.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: 102F fever  for 24 hours and sever soreness at injection site. Cannot move that shoulder for two days.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: The arm after the ZOSTAVAX. Swelling (about the size of a small cutie) redness, tenderness but not painful. Not hard to the touch. No red streaks going down the arm.
Age: 1.67
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia, Irritability
Clinical narrative: Irritability, injection site tenderness, decreased sleep, fever, injection site redness, and injection site swelling (increasing per day).
Age: 1.67
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Irritability, injection site tenderness, decreased sleep, fever, injection site redness, and injection site swelling (increasing per day).
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site bruising, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Started with chills Thursday evening, then body aches all over.  Friday morning, extreme body aches.  Fever developed that evening, spiked at 101.7 early on Saturday morning before breaking.  Large red, swollen, feverish circle (about the size of a tennis ball) developed Saturday morning just at and below injection site.  Fever and body aches were gone on Saturday, but skin reaction spread further down arm on Sunday and Monday before going away.  Went to Urgent Care on Sunday to have arm checked for infection, but there was none.  No treatment for any side effects other than ibuprofen.  After skin reaction cleared, there was still slight discoloration on arm, looked like bruising under skin.  Seems to be mostly gone now.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Started with chills Thursday evening, then body aches all over.  Friday morning, extreme body aches.  Fever developed that evening, spiked at 101.7 early on Saturday morning before breaking.  Large red, swollen, feverish circle (about the size of a tennis ball) developed Saturday morning just at and below injection site.  Fever and body aches were gone on Saturday, but skin reaction spread further down arm on Sunday and Monday before going away.  Went to Urgent Care on Sunday to have arm checked for infection, but there was none.  No treatment for any side effects other than ibuprofen.  After skin reaction cleared, there was still slight discoloration on arm, looked like bruising under skin.  Seems to be mostly gone now.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Swelling
Clinical narrative: Swelling red unable to move my arm.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Rash
Clinical narrative: Pain (L) shoulder radiating to forearm. Joint pain. Rash along forearm.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Pain (L) shoulder radiating to forearm. Joint pain. Rash along forearm.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Chills, Cough, Headache, Influenza
Clinical narrative: Initial unsolicited report received from a consumer via other company (Novartis, Manufacturer report number: PUS2016US133198) on 07 February 2017. This case involves a 76-year-old female patient who was vaccinated with a dose of FLUZONE HD and a dose of Pneumonia Vaccine (batch number, expiration date, dose, site and route of administration were not reported) on 01 October 2015. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed symptoms of headache, fever, aching all over, had horrific cough, could not stop coughing, had chills, flu symptoms exaggerated and was sick for a month. It was reported that patient can't remember if she had pneumonia or not. Lab data included chest x rays. Corrective treatment was not reported. Outcome of event cough was recovered (lasted about 6-8 weeks) and outcome of other event was not reported. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer via other company (Novartis, Manufacturer report number: PUS2016US133198) on 07 February 2017. This case involves a 76-year-old female patient who was vaccinated with a dose of FLUZONE HD and a dose of Pneumonia Vaccine (batch number, expiration date, dose, site and route of administration were not reported) on 01 October 2015. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed symptoms of headache, fever, aching all over, had horrific cough, could not stop coughing, had chills, flu symptoms exaggerated and was sick for a month. It was reported that patient can't remember if she had pneumonia or not. Lab data included chest x rays. Corrective treatment was not reported. Outcome of event cough was recovered (lasted about 6-8 weeks) and outcome of other event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: HEPA, PNC13, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concomitant medications were reported. On an unknown date, the patient was vaccinated with two doses of VAQTA (which had a lot # of M036458 with an expiration date of 02-MAR-2018; however, the dose, anatomical location, and route of administration were unknown). Despite this, no adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Pruritus, Tenderness
Clinical narrative: Localized swelling (30 x 40 cm), tenderness, redness, itchiness, pain.
Sex: M
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: This spontaneous report was received from a consumer who refers to himself a 70 year old male patient with a medical history of herpes type 2 virus (since 1975). In 2013, the patient was vaccinated with ZOSTAVAX, "one shot" (dose and lot number not reported) intramuscular (considered incorrect route of drug administration) for prophylaxis at the recommendation of his physician due to his age. On the same date in 2013, within a couple of minutes of each other, the patient was also vaccinated with (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED), (manufacturer, dose, frequency, route and lot number not provided) for prophylaxis. The patient reported within 36 hours after he was vaccinated with ZOSTAVAX, he developed one "major" herpes attack. The patient did not receive treatment for his "major" herpes attack but sought medical attention by visiting his physician. The patient had his blood count performed during his annual physical. Since being vaccinated with ZOSTAVAX, the patient has not had a herpes type 2 attack and feels like he has been miraculously cured of his herpes attacks which have plagued him for nearly 40 years. In addition, the patient thought the ZOSTAVAX somehow suppressed or possibly caused his herpes type 2 virus in his body to go into some kind of remission. The outcome of "major" herpes attack was reported as recovered/resolved. The reporter considered therapeutic response unexpected to be related to ZOSTAVAX and the relationship between "major" herpes attack and ZOSTAVAX was not provided. Additional information has been requested.
Sex: M
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Blood count, Condition aggravated, Herpes virus infection
Clinical narrative: This spontaneous report was received from a consumer who refers to himself a 70 year old male patient with a medical history of herpes type 2 virus (since 1975). In 2013, the patient was vaccinated with ZOSTAVAX, "one shot" (dose and lot number not reported) intramuscular (considered incorrect route of drug administration) for prophylaxis at the recommendation of his physician due to his age. On the same date in 2013, within a couple of minutes of each other, the patient was also vaccinated with (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED), (manufacturer, dose, frequency, route and lot number not provided) for prophylaxis. The patient reported within 36 hours after he was vaccinated with ZOSTAVAX, he developed one "major" herpes attack. The patient did not receive treatment for his "major" herpes attack but sought medical attention by visiting his physician. The patient had his blood count performed during his annual physical. Since being vaccinated with ZOSTAVAX, the patient has not had a herpes type 2 attack and feels like he has been miraculously cured of his herpes attacks which have plagued him for nearly 40 years. In addition, the patient thought the ZOSTAVAX somehow suppressed or possibly caused his herpes type 2 virus in his body to go into some kind of remission. The outcome of "major" herpes attack was reported as recovered/resolved. The reporter considered therapeutic response unexpected to be related to ZOSTAVAX and the relationship between "major" herpes attack and ZOSTAVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Injection site nodule, Rash
Clinical narrative: This spontaneous report was received from a nurse, who was also the patient's mother, via a company representative concerning to her daughter a 18 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In July 2016 (reported as "about 6 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV); the reporter indicated that there was not adverse experiences reported at that time. In September 2016 (reported as 2 months later), the patient was vaccinated with the second dose of GARDASIL 9 in an arm (dose, route, lot number and expiration date were not reported) for prevention of HPV and with an unspecified dose of influenza virus vaccine inactivated (unspecified), which was administered in the other arm (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced a huge knot on the arm  where the HGARDASIL 9 was administered and a bad rash on her upper body (arms and torso). It was reported that the patient sought medical attention on an unknown date, however it was unknown whether treatment was given for the adverse events or laboratory diagnostics studies were performed. Then, on an unknown date, after 2 weeks, the patient recovered from both events. It was reported that the patient was reviewing the situation with her physician and trying to decide if she would get a third dose of GARDASIL 9. A product quality complaint was not involved. The causal relationship between the events and GARDASIL 9 and influenza virus vaccine inactivated (unspecified) was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Nodule, Rash
Clinical narrative: This spontaneous report was received from a nurse, who was also the patient's mother, via a company representative concerning to her daughter a 18 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In July 2016 (reported as "about 6 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV); the reporter indicated that there was not adverse experiences reported at that time. In September 2016 (reported as 2 months later), the patient was vaccinated with the second dose of GARDASIL 9 in an arm (dose, route, lot number and expiration date were not reported) for prevention of HPV and with an unspecified dose of influenza virus vaccine inactivated (unspecified), which was administered in the other arm (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced a huge knot on the arm  where the HGARDASIL 9 was administered and a bad rash on her upper body (arms and torso). It was reported that the patient sought medical attention on an unknown date, however it was unknown whether treatment was given for the adverse events or laboratory diagnostics studies were performed. Then, on an unknown date, after 2 weeks, the patient recovered from both events. It was reported that the patient was reviewing the situation with her physician and trying to decide if she would get a third dose of GARDASIL 9. A product quality complaint was not involved. The causal relationship between the events and GARDASIL 9 and influenza virus vaccine inactivated (unspecified) was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified 25 year old male patient. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. In February 2016 (reported as "12 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). On 01-FEB-2017, the patient was vaccinated with the second dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an over 70-year old, female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown, date the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient experienced large swelling at the injection site. The outcome of large swelling at the injection site was unknown. The relatedness between the adverse event and PNEUMOVAX23 was not reported. Additional information is not expected, as there was no consent to contact the physician.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a nurse from a physician's office via a company representative refers to a male patient of unknown age. The patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported.    On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneouslly (dosage schedule, lot # and expiration date were not reported) for prevention of shingles (prophylaxis). On an unknown date, after receiving vaccination with ZOSTAVAX, the patient "broke out from head to toe in a rash" (rash generalised).  The outcome of rash generalised was reported as recovered.  The reporter did not assess causality between the rash generalised and the vaccination with ZOSTAVAX. There was no product quality (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-FEB-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M018436 and expiration date on 13-APR-2018 (Strength, dose, anatomical location and administration route were not provided) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursions of an unspecified temperature (reported as more than 14 Fahrenheit (F) and less than 46 F) with a time frame of 3 hours. It was reported that no previous temperature excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of ZOSTAVAX 19400 PFU, lot # M036297 and expiration date on 14-NOV-2017 (dose, anatomical location and administration route were not provided) for prophylaxis. No adverse effects were reported. The vaccine had an unspecified temperature excursion (reported as more than 14  Fahrenheit (F) and less than 46 F) with a time frame of 7 weeks. It was reported no previous temperature excursions and a digital data logger involved. No product quality complaint (PQC) was involved Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 with expiration date of 23-APR-2018 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008023: US-009507513-1702USA008024: US-009507513-1702USA008022.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood pressure fluctuation, Diarrhoea, Erythema, Peripheral swelling, Swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 33 year old female patient. The patient's medical history and concurrent conditions were not reported. On 04-FEB-2017, the patient was vaccinated with a dose of VARIVAX (intramuscularly; dose, lot # and expiration date were not reported) for prophylaxis. Concomitant therapies included cetirizine hydrochloride. On 08-FEB-2017, the patient experienced several adverse reactions: she had tenderness in the upper right arm that was red and swollen, her body was swelling, she also developed weight gain and diarrhea. On the same date, the patient complained about her blood pressure fluctuating. The patient sought medical attention and the physician prescribed her an unspecified medication and requested that she return in a week. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and VARIVAX was not provided. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness, Weight increased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 33 year old female patient. The patient's medical history and concurrent conditions were not reported. On 04-FEB-2017, the patient was vaccinated with a dose of VARIVAX (intramuscularly; dose, lot # and expiration date were not reported) for prophylaxis. Concomitant therapies included cetirizine hydrochloride. On 08-FEB-2017, the patient experienced several adverse reactions: she had tenderness in the upper right arm that was red and swollen, her body was swelling, she also developed weight gain and diarrhea. On the same date, the patient complained about her blood pressure fluctuating. The patient sought medical attention and the physician prescribed her an unspecified medication and requested that she return in a week. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and VARIVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician, referring to three unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot M007764 (strength, dose, administration route, anatomical location and expiration date were not reported) for prophylaxis. No adverse effects were reported in any patients. The vaccine had an unspecified temperature excursion (reported as greater than - 70 Fahrenheit (F) and below of 32 F) with a time frame of 40 hours. It was reported that no previous temperature excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004743:
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 unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. From 01-NOV-2016 through 01-JAN-2017, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, lot number M002254 with expiration date 15-NOV-2017 (dose was not reported) for prophylaxis. The ROTATEQ  was exposed to temperatures between 77 Fahrenheit and 86 Fahrenheit which was reported as the actual temperature exposure during 2 months. The vaccine was not exposed to previous temperature excursion. Data logger was filed. No adverse effects were 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 nurse and refers to a unspecified patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX23, lot number reported as M039060 with expiration date 22-MAY-2018, (dose, route and anatomical location were not reported) for prophylaxis. The PNEUMOVAX23 23 vials were exposed to temperatures between 8 Celsius and 25 Celsius during 5 hours and 35 minutes. The vaccine was not exposed to previous temperature excursion. Data logger was filed and no adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008075:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Extra dose administered, Oral administration complication, Vomiting projectile
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 months old female patient with pertinent medical history which was not reported at the time of the report and none drug reactions or allergies. The patient concomitant therapies were not reported. On 16-FEB-2017, the patient was vaccinated with the first dose of ROTATEQ, orally, (dose was not reported) for routine vaccination. On the same date after vaccination, the patient proceeded to projectile vomit. The patient was then administered a second dose of ROTATEQ and within 5 seconds the patient projectile vomited again. No treatment was given for the event and none laboratories diagnostics were performed. At the time of the report, the patient recovered from the projectile vomit on 16-FEB-2017. The relatedness between the event and therapy with ROTATEQ was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M014926 with expiration date of 17-FEB-2019 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008023: US-009507513-1702USA008024: US-009507513-1702USA002933:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L048209 with expiration date of 31-MAY-2018 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002933: US-009507513-1702USA008024: US-009507513-1702USA008022:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA, lot # M003025 with expiration date of 26-MAY-2017 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008023: US-009507513-1702USA002933: US-009507513-1702USA008022:
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 a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot number M031802, expiration date 09-NOV-2017, lot number M032636, expiration date 06-APR-2018, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was between 32 and 36 Fahrenheit degrees during 7 hours, and, below 32 Fahrenheit degrees (the lowest temperature was 29 Fahrenheit degrees), during a time frame of 6 hours. The vaccines did not experience any previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008038: US-009507513-1702USA008037: US-009507513-1702USA005634: US-009507513-1702USA008036:
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 a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA,  lot number M022924, expiration date 24-JAN-2018, lot number M033611, expiration date 02-MAR-2018, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was between 32 and 36 Fahrenheit degrees during 7 hours, and, below 32 Fahrenheit degrees (the lowest temperature was 29 Fahrenheit degrees), during a time frame of 6 hours. The vaccines did not experience any previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA008038: US-009507513-1702USA008037: US-009507513-1702USA008035: US-009507513-1702USA005634:
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 a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot number M023718, expiration date 09-AUG-2018, lot number M031574, expiration date 11-NOV-2018, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was between 32 and 36 Fahrenheit degrees during 7 hours, and, below 32 Fahrenheit degrees (the lowest temperature was 29 Fahrenheit degrees), during a time frame of 6 hours. The vaccines did not experience any previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008038: US-009507513-1702USA005634: US-009507513-1702USA008035: US-009507513-1702USA008036:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot number M031557, expiration date 07-APR-2019, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was between 32 and 36 Fahrenheit degrees during 7 hours, and, below 32 Fahrenheit degrees (the lowest temperature was 29 Fahrenheit degrees), during a time frame of 6 hours. The vaccines did not experience any previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005634: US-009507513-1702USA008037: US-009507513-1702USA008035: US-009507513-1702USA008036:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a unspecified patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number reported as M035385 with expiration date 08-APR-2018 or lot number M032642 with expiration date 04-MAR-2018, (dose was not reported) for prophylaxis. The ROTATEQ  was exposed to temperatures between 8 Celsius and 25 Celsius during 5 hours and 35 minutes. The vaccine was not exposed to previous temperature excursion. Data logger was filed. No adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007901:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician, referring to three unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ administered orally (strength, dose, administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported in any patients. The vaccine had an unspecified temperature excursion (reported as greater than - 70 Fahrenheit (F) and below of 32 F) with a time frame of 40 hours. It was reported that no previous temperature excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004743:
Age: 20.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood glucose normal, Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Patient experienced syncope and seizure for 5-7 seconds immediately after receiving injections of BOOSTRIX and HAVRIX vaccines. No trauma occured as a result of these events. EMT was called, blood sugar checked (91 mg/dL), she was taken to emergency room as a precaution. Release from emergency room with no complications within 2 hours.
Age: 61.0
Sex: U
Vaccine: PPV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 61 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions / allergies and concomitant medications were unknown. On 09-FEB-2017, the patient was vaccinated with a dose VARIVAX (Lot # M019641, expiration date 20-APR-2018, dose and strength were unknown for prophylaxis), instead of ZOSTAVAX. On the same day, PNEUMOVAX23 (Lot #M026317, expiration date 11-JAN-2018) was also administered. The nurse practitioner confirmed this event was a result of human error. No adverse effects were reported. No further  details were reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse, who worked in the office of a physician's assistant, via a company representative refers to a female patient of unknown age. Information regarding her pertinent medical history, drug reactions/ allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously, as a preventive measure against the herpes zoster virus (the dose, dosage number, anatomical location, lot # and expiration date were unknown). Subsequently, on an unspecified date, the patient developed an injection site reaction which was described in detail but, it was stated that the site was painful to touch. She sought medical attention and received a steroid injection as treatment. The outcome of the events, at the time of reporting, and the causal relationship between the events and the vaccine were unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. It was reported that, since 10-FEB-2017, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB with lot number L044707 and expiration date of 06-OCT-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored between 32 Fahrenheit degrees (°F) and 36°F (34.9°F) for 10 minutes. There was no previous temperature excursion and the temperature excursions were not detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008465:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-FEB-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB batch# K005424, expiration date 11-JUN-2016 (dose, route of administration were not reported) for prophylaxis. 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 as received from a medical assistant refers to unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. It was reported that, since 10-FEB-2017, the patients were vaccinated with an improperly stored dose of ROTATEQ with lot number M026315 and expiration date of 26-JAN-2018, orally (strength and dose were unknown) for prophylaxis, which was stored between 32 Fahrenheit degrees (°F) and 36°F (34.9°F) for 10 minutes. There was no previous temperature excursion and the temperature excursions were not detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007933:
Age: 1.25
Sex: F
Vaccine: HEP, MMR
Symptoms: Discomfort, Disorientation, Emotional distress, Hypersensitivity, Malaise
Clinical narrative: Symptoms general malise, discomfort starting at noon, not eating progressing to disorientation, non consolable until 6-7 AM next morning.  Tylenol administered 5cc with minimal help.  Minimal fever. Child hypersensitive to touch / consoling.
Age: 1.25
Sex: F
Vaccine: HEP, MMR
Symptoms: Pyrexia
Clinical narrative: Symptoms general malise, discomfort starting at noon, not eating progressing to disorientation, non consolable until 6-7 AM next morning.  Tylenol administered 5cc with minimal help.  Minimal fever. Child hypersensitive to touch / consoling.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (who was also a supervisor) refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 30-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 plaque-forming unit (PFU), lot # L027321 with expiration date 21-OCT-2016 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient under 15 years of age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 24-MAR-2016, the patient was vaccinated with the first dose of GARDASIL via intramuscular, as prophylaxis (Strength, dose, lot # and expiration date were not reported). On 07-JAN-2017, the patient was vaccinated with the second dose of GARDASIL 9. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, during the same office visit, the patient was vaccinated with PROQUAD and VARIVAX for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not informed). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 62 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with two doses of VARIVAX as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported).  On an unknown date, the patient tested negative for varicella titers (Varicella virus test negative). The outcome of varicella virus test negative was unknown. A product quality complaint was not involved. The causality between varicella virus test negative and VARIVAX was not provided. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 month old patient. The patient's concurrent conditions or medical history were not reported. Concomitant therapies included PREVNAR. On 07-FEB-2017, the patient inadvertently received a dose of PROQUAD subcutaneous injection (lot M029599, expiration date 12-OCT-2017) instead of PENTACEL. The nurse confirmed this event was not related to product confusion but was due to a human error. No further details were provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 08-FEB-2017, the patient was vaccinated with an expired dose of VARIVAX injection, 1 dose, lot # L002869 with expiry date 27-JAN-2017 (route of administration was not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The reporter stated that on unknown dates, the patient who is older than 26 years of age, was vaccinated with 3 doses of GARDASIL 9, intramuscularly (lot#, expiration date and indication were not reported). No adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 04-JAN-2017, 05-JAN-2017 and 12-JAN-2017, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23, lot number M040004 with expiration date 20-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. Also on 23-FEB-2017, improperly stored PNEUMOVAX 23 were reported. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours; Also on 04-JAN-2017, 12-JAN-2017, 13-JAN-2017, 17-JAN-2017 to 19-JAN-2017, from 24-JAN-2017 to 25-JAN-2017 and from 30-JAN-2017 to 31-JAN-2017, the vaccines were exposed to temperature of 33 Fahrenheit (F) (0.5 Celsius (C)) during 10 hours each day all of them in the first cycle. In addition on 05-JAN-2017, 06-JAN-2017, 09-JAN-2017, 21-JAN-2017, 23-JAN-2017, 27-JAN-2017 the vaccines were exposed to temperature of 34 Fahrenheit (F) (1.1 Celsius (C)) during 10 hours each day in the first cycle. Finally on 10-JAN-2017, 11-JAN-2017, 16-JAN-2017 and 26-JAN-2017, the vaccines were exposed to temperature of 35 Fahrenheit (1.6 Celsius (C)) during 10 hours each day in the first cycle. It was also reported that the vaccines were also exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 80 hours (dates unspecified). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007376: US-009507513-1702USA007377: US-009507513-1702USA002864.