chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse, refers to a 65 year old female patient. No information on the patient's pertinent medical history and drug reactions or allergies was provided. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N014946, expiry date: 01-FEB-2019, intramuscularly for prophylaxis (strength and dose number were not reported). Concomitant therapies included influenza virus vaccine (unspecified). On 24-OCT-2017 (reported as: "8 hours later"), the patient experienced: fever, chills, sleeplessness, hives, rash and sore arm at injection site. Nurse reported that all symptoms resolved on approximately 25-OCT-2017, by the next morning without any treatment. Arm soreness persisted for 3 to 4 days and resolved without treatment on approximately 28-OCT-2017. The patient did not seek medical attention. No lab diagnostics were performed. The causality assessment between the events and PNEUMOVAX 23 was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Chills, Injection site pain, Insomnia, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse, refers to a 65 year old female patient. No information on the patient's pertinent medical history and drug reactions or allergies was provided. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N014946, expiry date: 01-FEB-2019, intramuscularly for prophylaxis (strength and dose number were not reported). Concomitant therapies included influenza virus vaccine (unspecified). On 24-OCT-2017 (reported as: "8 hours later"), the patient experienced: fever, chills, sleeplessness, hives, rash and sore arm at injection site. Nurse reported that all symptoms resolved on approximately 25-OCT-2017, by the next morning without any treatment. Arm soreness persisted for 3 to 4 days and resolved without treatment on approximately 28-OCT-2017. The patient did not seek medical attention. No lab diagnostics were performed. The causality assessment between the events and PNEUMOVAX 23 was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse, refers to a 65 year old female patient. No information on the patient's pertinent medical history and drug reactions or allergies was provided. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N014946, expiry date: 01-FEB-2019, intramuscularly for prophylaxis (strength and dose number were not reported). Concomitant therapies included influenza virus vaccine (unspecified). On 24-OCT-2017 (reported as: "8 hours later"), the patient experienced: fever, chills, sleeplessness, hives, rash and sore arm at injection site. Nurse reported that all symptoms resolved on approximately 25-OCT-2017, by the next morning without any treatment. Arm soreness persisted for 3 to 4 days and resolved without treatment on approximately 28-OCT-2017. The patient did not seek medical attention. No lab diagnostics were performed. The causality assessment between the events and PNEUMOVAX 23 was not reported.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Streptococcus test positive
Clinical narrative: i expected my arm to hurt for a couple of days afterwards since that's completely normal. But it didn't end there. Instead, it kept going. It's been two weeks and the pain hasn't gone away and it's spread down my arm.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives, mainly around the torso appeared a few hours after the shot. Hives were gone by morning but reappeared each night and began to increase in intensity and duration after a week. Doctor consultation one week after the shot. Received prescription for Methylprednisolone 4 mg. Seems to be helping.
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Swollen, warm to the tough. indurated.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 01-OCT-2015, the patient was vaccinated with GARDASIL 9, injection, intramuscularly (dose, lot #, expiration date were not reported) for prophylaxis. On 25-OCT-2016, the patient received next dose of GARDASIL injection, intramuscularly (dose, lot #, expiration date were not reported). No known adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 24-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, injection (lot # N021170 with expiration date on 27-OCT-2018; dose and route of administration were not reported) for prophylaxis. Sterile diluent which was used to reconstitute vaccine and was properly stored. The vaccine experienced a temperature excursion of 15 to 46 degrees Fahrenheit for 1 hour. Previous temperature excursion also from 15 to 46 degrees Fahrenheit, lasted for 4 hour 30 minutes. The temperature excursion was detected by a digital data logger. No adverse reaction was reported.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male patient of unknown age. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9, injection, intramuscularly (dose, lot # and expiry date were not reported) for prevention of Human Papillomavirus (HPV). On the same date, while still in the physician's office, the patient experienced dizziness and vomiting immediately after receiving GARDASIL. The patient recovered from these symptoms before leaving the office. The reporter did not assess the relatedness between the events and GARDASIL. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA001248.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On unknown date in 2016, the patient was vaccinated with dose of GARDASIL 9 (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. On an unknown date (six to eight weeks after receiving the final dose of the GARDASIL 9), the patient experienced joint pain in the hips and knees. The primary reporter stated that the patient grew 4 inches in the past year, 2016. The outcome of body height increased and joint pain in the hips and knees was unknown. The relatedness between the events and GARDASIL 9 was not defined by reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was reported. On 12-AUG-2017, the patient was vaccinated at Pharmacy with ZOSTAVAX 19400 plaque-forming unit (PFU), 1 dose, subcutaneously in the left arm (lot # and expiration date were not provided) for prophylaxis (reported also as : "to prevent shingles"). Other suspect therapies included sterile diluent (Merck). On 23-OCT-2017, the patient sought medical attention and called the pharmacy to report that from 12-AUG-2017 (reported also as:"since the vaccine"), she has had "pain at the injection site that shoots down the arm". The pharmacist reports also that, the patient stated that, "the pain persists, but it comes and goes". No rash and no bump at the injection site was reported. No lab tests were done. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date in approximately 2012 (reported as about 4 to 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot number and expiration date were not provided). On 24-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient who is in his 70's with gout. Concomitant therapies included allopurinol. The patient's pertinent medical history was not reported and historical drug included PREVENAR 13 which was receipt in approximately August 2016. The patient did not have drug reaction or allergies. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, injection (dose and route of administration were not reported) (lot # N013521 with expiration date on 23-JAN-2019). On the same date, the patient was also administered a "high dose flu shot" - influenza virus vaccine inactivated (unspecified) (INFLUENZA VIRUS VACCINE INACTIVATED (UNSPECIFIED)) (dose, route of administration, lot number and expiration date were not reported).  On 25-OCT-2017, the patient began to complain of redness, warmth and pain at the site of the PNEUMOVAX 23 injection and the injection site was raised. The reporter noted that the patient had been taking ibuprofen to manage the pain. No laboratory diagnostic studies were performed. The outcome of the events was not recovered, also reported as "ongoing". The causality between the events and the suspect therapies were not reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Gingival swelling, Pain in jaw, Swelling face, X-ray normal
Clinical narrative: This spontaneous report as received from an office manager refers to a 51-year-old female patient with no pertinent medical history and no drug reactions or allergies. On approximately 12-OCT-2017 (reported as two weeks ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) for shingles prevention. Concomitant therapies included sterile diluent (STERILE DILUENT), multivitamins (unspecified), iron (unspecified) and calcium (unspecified). On approximately 22-OCT-2017 (reported as 10 days after receiving ZOSTAVAX), the patient experienced jaw pain, jaw swelling and swelling of the gums. The patient sought medical attention (reported as "dentist and doctor"). On an unknown date, the patient had a jaw X-ray (results were normal) and "blood work" done (results unknown). An unspecified treatment was given for the events. The outcome of pain in jaw, jaw swelling and swelling of the gums was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications was reported. On 26-OCT-2017, the patient was vaccinated with two separate pediatric doses of VAQTA for prophylaxis (strength, lot # and expiration date were not reported). No adverse effects reported. This is one of 2 reports received from the same reporter. Sender's Comments: US-009507513-1711USA009694.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On approximately 18-OCT-2017 (reported as "around"), the patients were vaccinated with improperly stored doses of ROTATEQ with lot # M044399, expiration date 25-JUN-2018 (route, dose, dose number, frequency and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The medical assistant reported that administered doses of vaccines experienced the temperature excursion of 32°F to 35°F (35F) degrees Fahrenheit for 24 hours and the nurse reported a temperature excursion of 35°F degrees Fahrenheit for 24 hours. On the other hand, a previous temperature excursion of 35°F degrees Fahrenheit for 36 hours was also reported. There was no data logger involved.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse and refers to a 8 year old male patient.  The patient had not medical history, concurrent conditions nor concomitant therapies to be reported. The patient had not illness at the time of vaccination. On 27-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX second dose, lot # N017397, expiration date (07-JUN-2019)  (dose and anatomical location were not reported), for prophylaxis. The sterile diluent(DILUENT MRK) used for reconstitution of VARIVAX was properly stored.  No adverse effects were reported.  The vaccine was exposed to a temperature excursion of  6°F - 14°F for 1 hour 40 minutes and previous temperature excursion  was 6°F - 14°F for 3 hours 41 minutes; which were call because of a data logger. No adverse effects were reported.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 10 weeks old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 07-JUN-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. On 09-AUG-2017, the patient received another dose of improperly stored PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00235 with the expiration date of 26-OCT-2019) for prophylaxis. The administered doses of PEDVAXHIB underwent multiple temperature excursion between 34 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 6 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 09-JUN-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 34 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012766.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who referred 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 01-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # M013156, expiration date on 15-OCT-2017 (dose and route of administration were not reported), for prophylaxis. The medical assistant stated that PNEUMOVAX 23 did not experience any temperature excursions prior to administration. No adverse symptoms were reported.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 22 year old female patient. the patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent (MERCK). On 02-NOV-2017, the 22 year old patient was vaccinated with a dose ZOSTAVAX 19400 PFU, subcutaneously, lot # N020852 with expiration date: 31-JUL-2018 (anatomical location was not reported) for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and 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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N012618 with an expiration date 21-APR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 11 days and 9 hours. Data logger was not involved. There were no previous excursions. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA009893: US-009507513-1711USA009892.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 07-NOV-2017, the patient was vaccinated with an expired dose of M-M-R II (albumin status was not provided) lot # L043704 with an expiration date 04-NOV-2017 for prophylaxis (route of administration was not reported) which was reconstituted with sterile diluent (strength, dose, frequency, lot# and expiration date were not reported). There was no side effects reported.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 2 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N014945, expiry date 31-AUG-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Age: 0.42
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 5 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N014945, expiry date 31-AUG-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 19 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 13 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.92
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 23 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 15-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 17 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 15-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Age: 1.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 21 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 16-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 3 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 18-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation irregular
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 25 year old female patient, who was non-pregnant and had human papillomavirus infection since an unspecified date. The patient's concomitant therapy, drug and allergy history were not provided. On 04-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot number L040054, expiration date 26-DEC-2017, for prophylaxis (strength, dose and frequency were not reported). On 05-NOV-2017, the patient had her menstrual cycle, which was two weeks earlier than she expected. It was also reported that she had always had "very regular" menstrual periods, so she felt that getting her menstrual period earlier than expected was abnormal for her. Treatment was not given and lab diagnostics or studies were not performed. The outcome of menstruation irregular was reported as not resolved. The causality assessment between the event and GARDASIL 9 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to an adult patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with PROQUAD (dose, route, lot # and expiration date were not reported) for prophylaxis by an unknown "technician" in the office (Drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose and route of administration was not reported) lot # M047519, expiration date: 04-AUG-2018 for prophylaxis. The vaccines was stored in between 47 and 77 (67) Fahrenheit degrees for 12 hours. There was no previous temperature excursions. The Digital Data Logger was involved. No adverse effects were reported.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This spontaneous report was received from a nurse via poison and drug center refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-NOV-2017 at 15:23, the patient was vaccinated with RECOMBIVAX HB (strength, dose and frequency were not reported) lot # N006321 with expiry date 08-NOV-2017 for prophylaxis. On 12-NOV-2017, an exposure panel was done on the baby and the hepatitis B surface antigen screen came back positive and the hepatitis neutralization was confirmed. They are not sure if the test came positive because the baby just got the RECOMBIVAX HB injection. They are going to test the mother and baby but they are concerned about the possibility of giving RECOMBIVAX HB to the baby. It was unknown if the baby will receive any further RECOMBIVAX HB injections. The outcome of Hepatitis B surface antigen positive and Neutralizing antibodies was unknown. The reporter did not provide the causality assessment between the events and RECOMBIVAX HB.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 18-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently administered a dose of PROQUAD subcutaneously (dose, route of administration, lot# and expiration date were not provided) for prophylaxis.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's friend regarding a pregnant female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient became pregnant. On an unknown date, the pregnant patient (gestation unspecified) was vaccinated with VARIVAX for prophylaxis (dose, route and lot# were not reported (exposure during pregnancy). The LMP (Last Menstrual Period) and EDD (Estimated date of delivery) was not known.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Product expiration date issue
Clinical narrative: This spontaneous report was received from a pharmacist refers to an adult patient of unknown age and gender. the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in approximately 2017, the patient was vaccinated with an expired dose of ZOSTAVAX expiration date 18-JUL-2017 (dose, route, anatomical location and lot# were not reported) for prophylaxis. The expiration date was misinterpreted due to "expiration dating convention" which was "2017JULY18".
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a consumer of unknown age refering to herself. The patient's current conditions includes being allergic to feathers and also stated that during the 1970's, she received an unspecified "flu" vaccine and had an unspecified reaction to the vaccine due to the allergy mentioned before. On an unspecified date, reported as few years ago, the patient was vaccinated with ZOSTAVAX for prophylaxis (route, anatomical location, lot number and expiration date were not reported). In 2016, the patient was hospitalized 3 times for pneumonia. At the reporting time, the outcome of pneumonia is unknown. The reporter did not assess the relatedness between ZOSTAVAX and the adverse events. pon internal review, pneumonia was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 20 year old female patient. The patient's medical history included fainting after unknown vaccines in the past. No information regarding the patient's concurrent conditions and concomitant therapies was provided. The patient had no allergies. On an unknown date in January 2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 09-NOV-2017, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly, lot # N010497 with expiration date on 15-JAN-2020 (dose was not provided) for prophylaxis. On 09-NOV-2017, the patient fainted for about one minute while sitting in a chair after the vaccination. When the patient woke up, she was nauseous for less than 20 minutes. No treatment was given for adverse events. No lab tests were performed. The outcome of fainting was reported as recovered/resolved. The outcome of nausea was not reported unknown.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report has been received from a pharmacist, and refers to a 62 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date  in November 2016, reported as "one year ago" the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported). On an unspecified date, reported as recently, the patient had blood work for an unknown hospitalization (adverse event) that showed no immune response to pneumonia strains (Serology negative). There was not treatment given for the adverse event and the patient did not seek medical attention. There was not product quality complaint. At the time of reporting, the outcome of the events and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unspecified date in September 2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (strength, dose, frequency, dose number and administration route were not reported) lot number M010440, expiration date 09-DEC-2018, for prophylaxis. On an unspecified date in 2017, the vaccines were exposure to a temperature excursion; the data logger registered a temperature range between 47 Fahrenheit (F) and 77 F (54.6 F) for 2 hours. The previous temperature excursion registered was 47 F to 77 F (54.1 F) for 1 hour. No adverse effects were reported. Sender's Comments: US-009507513-1711USA009697: US-009507513-1711USA009695: US-009507513-1711USA009696.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 54 year-old male patient. The patient's medical history, concurrent conditions, drug and allergy history were not provided. On 17-NOV-2017, the patient was vaccinated with a dose of M-M-R II (recombinant human albumin (rHA)) subcutaneously (strength, dose, frequency and dose number were not reported), lot number N008366, expiration date 13-MAR-2019, for prophylaxis; instead of the prescribed ZOSTAVAX. Concomitant therapies included an sterile diluent (lot number and expiration date were not provided). No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse prescriber referring to a 18 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 19-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 by intramuscular route, (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that on 21-JUL-2017, the patient was given the second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unspecified day in September 2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency, dose number and administration route were not reported) lot number M032495, expiration date 06-JUL-2018, for prophylaxis. Concomitant therapies included a properly stored sterile diluent used for reconstitution (lot number and expiration date were not provided). On an unspecified date in 2017, the vaccine was exposure to a temperature excursion; the data logger registered a temperature range between 6 Fahrenheit (F) and 14 F (13.1 F) for 2 hours. The previous temperature excursion registered was 6 F to 14 F (9 F)  for 1 hour. No adverse effects were reported. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA009695: US-009507513-1711USA009696: US-009507513-1711USA008021:
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This non-valid spontaneous report was received from a pharmacist via a company representative and refers to two non-pregnant patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. In approximately September 2017, reported as "within the last month", the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). The patients were administered PNEUMOVAX 23 with the same lot number. In approximately September 2017, both patients experienced swelling, which lasted two to three days. The pharmacist reported that the patients followed up with him for the swelling and he recommended that they "ice" the swollen area. The pharmacist received no follow up after this. The outcome of the event of swelling was reported as recovered/resolved (in approximately September 2017). The relatedness between the event of swelling and PNEUMOVAX 23 was not assessed by the reporter. Follow-up information was received on 17-NOV-2017 from the pharmacist. On 24-JUL-2017, the elderly female patient who was over 65 years old was vaccinated with PNEUMOVAX 23 (lot # N010106, expiration date: 15-NOV-2018). The patient had recovered from the event of swelling within a week. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA001540.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and 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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N012618 with an expiration date 21-APR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 11 days and 9 hours. Data logger was not involved. There were no previous excursions. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA002375: US-009507513-1711USA009893.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. An 81-year-old female patient received, on 11Nov2017, at the age of 80 years, PREVNAR 13 (Lot. T08483, Expiration date: Sep2018, NDC number: 00005197102, UPC number: N300051971022) at single dose, for immunization. Relevant medical history included blood pressure and cholesterol. Concomitant medications included oral valsartan, tablet, 80 mg, once daily, from an unspecified date and ongoing, for blood pressure abnormal and oral lovastatin tablet, 40 mg, once daily, from an unspecified date and ongoing, for blood cholesterol abnormal. On 18Nov2017, the patient's arm was very red, swollen and warm to touch. Clinical outcome of the events was unknown at time of this report.
Sex: F
Vaccine: FLU3
Symptoms: Mental status changes, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 12-Oct-2017. This case is linked to cases 2017SA199339, 2017SA199365, 2017SA199373, 2017SA199379 and 2017SA199397 (same reporter). This case involves a female patient (age at time of the reaction was not reported) who was vaccinated with a dose of FLUZONE HIGH-DOSE (Batch number: UI845AB, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history includes recurrent falls. Concomitant medications were not reported. On an unknown date, after the vaccination, the patient experienced fever of 104 degree Fahrenheit and mental status change. The patient refused to go to hospital. Other laboratory investigations and corrective treatment were not reported. The outcome of both the events was not reported. Documents held by sender: none
Sex: F
Vaccine: TD
Symptoms: Mobility decreased, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 10-Oct-2017. This case is linked with case 2017SA199729 (same reported and same vaccine). This case involves a female patient (onset age not reported) who was vaccinated with a 0.5 ml single intramuscular dose of TENIVAC (batch number, expiry date and site of administration were not reported) on 27-Sep-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, two weeks following the vaccination, the patient experienced difficulty raising her arm up over her head due to the pain. The patient's laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Drug administered at inappropriate site, Erythema, Fatigue, Migraine
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) on 26-Oct-2017. This case involves 11-year-old female patient who was vaccinated with 0.5 ml dose of ADACEL (frequency once, batch number, expiration date, dose and site of administration was not reported)via intramuscular route on 25 Aug 2017. It was reported that, the patient did not receive any other vaccines. The patient had a medical history revealed that; the patient was allergic to peanuts and seasonal allergies. Concomitant medications was not reported. On an unspecified date, following the vaccination, the patient experienced red, swollen, arm, was unable to move arm for about 1 week, and then has experienced "migraine headaches", muscle pain, fatigue and inability to move jaw along with coughing fits. Stated she believed the vaccine was administered "too high up on the arm. Lab data and corrective treatment were not reported. The patient was not recovered from the events (continued to today 26 Oct 2017). List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Myalgia, Peripheral swelling, Trismus
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) on 26-Oct-2017. This case involves 11-year-old female patient who was vaccinated with 0.5 ml dose of ADACEL (frequency once, batch number, expiration date, dose and site of administration was not reported)via intramuscular route on 25 Aug 2017. It was reported that, the patient did not receive any other vaccines. The patient had a medical history revealed that; the patient was allergic to peanuts and seasonal allergies. Concomitant medications was not reported. On an unspecified date, following the vaccination, the patient experienced red, swollen, arm, was unable to move arm for about 1 week, and then has experienced "migraine headaches", muscle pain, fatigue and inability to move jaw along with coughing fits. Stated she believed the vaccine was administered "too high up on the arm. Lab data and corrective treatment were not reported. The patient was not recovered from the events (continued to today 26 Oct 2017). List of documents held by sender: none.