chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Decreased appetite, Dizziness, Echocardiogram normal, Fatigue, Heart rate increased
Clinical narrative: Fever, body aches and chills progressed to nasal congestion, sore throat, what spots on throat and tonsils, swollen/painful glands in neck, loss of voice, fatigue, dizziness, elevated heart rate, unusual tiredness/weakness, lack of appetite (lost 12 lbs), yellow skin and eyes, severe night sweats, forgetfulness, sensation of spinning, severe dry cough.
Age: 45.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Laryngoscopy normal, Lymph node pain, Lymphadenopathy, Lymphocyte count increased, Memory impairment
Clinical narrative: Fever, body aches and chills progressed to nasal congestion, sore throat, what spots on throat and tonsils, swollen/painful glands in neck, loss of voice, fatigue, dizziness, elevated heart rate, unusual tiredness/weakness, lack of appetite (lost 12 lbs), yellow skin and eyes, severe night sweats, forgetfulness, sensation of spinning, severe dry cough.
Age: 45.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Mononucleosis heterophile test negative, Nasal congestion, Night sweats, Ocular icterus, Oropharyngeal pain
Clinical narrative: Fever, body aches and chills progressed to nasal congestion, sore throat, what spots on throat and tonsils, swollen/painful glands in neck, loss of voice, fatigue, dizziness, elevated heart rate, unusual tiredness/weakness, lack of appetite (lost 12 lbs), yellow skin and eyes, severe night sweats, forgetfulness, sensation of spinning, severe dry cough.
Age: 45.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Pain, Pyrexia, Streptococcus test negative, Vertigo, Weight decreased
Clinical narrative: Fever, body aches and chills progressed to nasal congestion, sore throat, what spots on throat and tonsils, swollen/painful glands in neck, loss of voice, fatigue, dizziness, elevated heart rate, unusual tiredness/weakness, lack of appetite (lost 12 lbs), yellow skin and eyes, severe night sweats, forgetfulness, sensation of spinning, severe dry cough.
Age: 45.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Yellow skin
Clinical narrative: Fever, body aches and chills progressed to nasal congestion, sore throat, what spots on throat and tonsils, swollen/painful glands in neck, loss of voice, fatigue, dizziness, elevated heart rate, unusual tiredness/weakness, lack of appetite (lost 12 lbs), yellow skin and eyes, severe night sweats, forgetfulness, sensation of spinning, severe dry cough.
Age: 18.0
Sex: F
Vaccine: HEPATYP, HPV4, MEN
Symptoms: Loss of consciousness
Clinical narrative: Passed out cold for 10 minutes.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC10, VARCEL
Symptoms: Autism spectrum disorder, Decreased eye contact, Pyrexia, Regressive behaviour, Unresponsive to stimuli
Clinical narrative: He had a very high fever that night, I gave him tyllonel as his doctors office instructed. His fever lasted until the next day. We began noticing he was dating off out the corner of his eye, not making hardly any eye contact, not responding to his name, after a couple weeks we noticed he wasn't saying mama or dada or babbling at all anymore. We brought him back in and saw a nurse practioner, we told her our concerns about his last round of 9 doses of vaccines, and asked if it could be autism. She said "no, no, looking at him I can tell you right now he does not have asbergers. she said he looked fine and not to worry. I held onto her words and lived in a state of denial. My mother finally said listen hes 2 years old and not speaking or babbling, you need to get him evaluated. I did, at the Child Development Clinic on June 6, 2016 and they diagnosed him with autism spectrum disorder. We've had him speech therapy and occupational therapy ever since.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Immunology test, Injection site erythema, Local reaction
Clinical narrative: Immunity status testing; Local reaction to immunization, initial encounter Imz - Updated meningitis #2- had redness over site after injection. Patient was monitored 20 min and ice was applied to site. No systemic sx. Asked to call if any worsening sx and will call tomorrow to check in HPV x3, Tdap 2009, MENACTRA x1, Varicella x1 at age one. Had mild case at age 5. Needs immunity testing since only one vaccine given per guidelines. F/U in 1 year for next well check.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Tender, swollen lymph gland under left axilla.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 14 year old patient of unknown gender. Historical conditions, concurrent conditions and concomitant medications were not reported. On an unknown date, at the age of 12 years, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date not provided) for prophylaxis. On an unknown date, at the age of 14 years, the patient received the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date not provided) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from an an executive from the Department of Health Immunization Branch via a company representative refers to 14 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On unknown dates, the patients were vaccinated with two doses each of M-M-R II injection (albumin status, dose, route of administration, lot number and expiry date were not provided). On unknown dates, the patients experienced mumps. The outcome of the event was not reported. Relatedness between the event and M-M-R II was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative and refers to multiple unspecified patients of unknown age and gender. It was reported that the patients were non-pregnant. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of ZOSTAVAX injection, subcutaneously (dose, lot number and expiration date were not reported). A properly stored sterile diluent (STERILE DILUENT) (lot number and expiration date were not reported) was used to reconstitute ZOSTAVAX. On unknown dates, the patients experienced injection site soreness. The outcome of the event was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 13 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 in approximately 2015 (reported as two years ago), the patient was vaccinated with GARDASIL injection via intramuscular route (dose, lot number and expiration date were not reported). On an unknown date (reported as recently), the patient was vaccinated with GARDASIL 9 injection via intramuscular route, lot # reported as M002606 with expiration date 30-APR-2018 (dose was not reported). No side effects were reported. There was no product quality complaint involved. Lot M002606 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine. Additional information has been requested.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a healthcare worker who reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 or VAQTA (lot numbers, expiration dates, dosages, and routes of administration not provided) on multiple unspecified dates. No adverse effects reported. No further information provided. Temperature: Unknown Time frame: Unknown Previous temperature excursion: No Data logger involved: Yes. Follow-up information was received from the healthcare worker on 17-MAY-2017 who reported that multiple unspecified patients were vaccinated with improperly stored ROTATEQ (lot #M044395, expiration date 31-MAY-2018) and GARDASIL 9, (lot #M034780, expiration date 15-APR-2019 and lot #M041212, expiration date 21-JUN-2019) on multiple dates between 24-MAR-2017 and 15-MAY-2017 (24-MAR-2017, 27-MAR-2017, 28-MAR-2017, 29-MAR-2017, 04-APR-2017, 07-APR-2017, 10-APR-2017 to 11-MAY-2017, 13-MAY-2017 to 15-MAY-2017). VAQTA was not given. No adverse effects reported. Temperature excursions were reported as follows: Time frame in 47°F to 77°F (9°C to 25°C) from 5 min to 3 hrs 25 min for a total of 70 hrs 50 min. Follow-up information was received from a nurse on 18-MAY-2017 who reported that GARDASIL 9 (unspecified lot number) was actually exposed to 47°F to 77°F (9°C to 25°C) for a total of 256.5 hours, which is a longer time frame than what was previously reported. No further clarifying information was provided. No adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This prospective pregnancy report was received from a registered nurse referring to a 17 year old female patient. The patient's medical history, concurrent condition, drug and allergy history were not reported. The patient's last menstruation period was on 07-APR-2017. On 28-APR-2017, the patient was vaccinated with GARDASIL 9 lot # M0367059, expiration date 06-MAR-2019 (strength, dose, route of administration were not provided) for prophylaxis. The patient's concomitant medication was not reported. The reporter states that the patient had a positive pregnancy test on 15-MAY-2017 (first trimester of exposure), the estimated date of conception (EDC) was on 21-APR-2017, and the estimated date of delivery was on 12-JAN-2018. The pregnancy outcome was not reported. Adverse events were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 17-MAY-2017 from a nurse who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that an unspecified patient potentially received one or more doses of the three dose vaccination of GARDASIL 9 (lot, expiration, dose and site unknown) after 26 years of age. The nurse reported that she received all three doses of the three dose series at an unspecified physician's practice (vaccination dates not reported). No adverse effects reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a 52-year-old female patient who was referring to herself. The patient had no pertinent medical history and did not take any concomitant medications. The patient's concurrent conditions included allergy to morphine. On 14-MAY-2017, the patient was vaccinated with ZOSTAVAX, intravenously for shingles prevention. In May 2017 (reported as few hours after vaccination), the patient experienced redness, itchiness, warmth and swelling. The patient sought unspecified medical attention. There was no lab diagnostic studies performed and the patient did not received any treatment for an adverse events. At the time of the report, the events persisted. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017, reported as since 20-APR-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M006104 with expiration date 01-AUG-2017, lot# M022400 with expiration date 01-NOV-2017 and lot# reported as M043581 with expiration date 28-OCT-2018 (dose and route of administration were not reported). On 26-APR-2017, 02-MAY-2017, 03-MAY-2017 and 14-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot# M035690, expiration date 06-FEB-2018 (dose and route of administration were not reported). On 01-MAY-2017, 02-MAY-2017, 16-MAY-2017 and 17-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot# M038860, expiration date 13-MAR-2018. All vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). There was no adverse effect reported. From 20-APR-2017 to 18-MAY-2017, administered doses of vaccines experienced the temperature excursion between - 9 degrees Celsius and 8 degrees Celsius for about 315 hours and between -14 degrees Celsius and -10 degrees Celsius for about 376 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-00503517-1706USA001519.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Physician Assistant concerning a six month old baby (gender unknown).  On 15-MAY-2017 the patient was inadvertently vaccinated with GARDASIL 9, 1 DF, (dose, route and lot# unknown). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous report has been received from a male patient of unknown age, who was reporting on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-SEP-2010, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported). On 06-SEP-2010 (reported as 5 days after receiving the vaccine), the patient developed neuropathy. The patient also reported he has been treated by four different neurologists who have not been able to help him. No product quality complaint was involved. Therapy with ZOSTAVAX was not reintroduced. The outcome of the event was not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 24-APR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 24-MAY-2017, the patient was vaccinated with an expired dose of VARIVAX injection, lot # L013068 and expiration date on 14-APR-2017 (dose and route were not provided) for prophylaxis. Additionally it was reported that the sterile diluent (MRK) injection used to reconstitute the vaccine was not expired (lot, batch # and expiration date were not provided), and the patient did not experience any adverse event. Additional information has been requested.
Sex: U
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. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications were provided. On 26-MAY-2017, the patient was vaccinated with an expired dose of VARIVAX injection (lot # K016129, expiration date: 23-SEP-2016; dose and route of administration were not reported). The reporter stated that there were no previous temperature excursions regarding VARIVAX. No adverse symptoms were reported. No product quality complaint was involved. Additional information is not expected because there was no consent to further contact with the reporter.
Sex: U
Vaccine: HPVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative 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 medications was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 injection (exact dose; lot number, expiration date and route of administration were not reported). The reporter stated that the patient returned for the second dose in the vaccination schedule and on an unknown date in 2017, was vaccinated with an expired dose of GARDASIL injection (expiration date: February 2017; exact dose; lot number and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who was also the office manager and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 12-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015679: US-009507513-1705USA015680: US-009507513-1705USA015681: US-009507513-1705USA015683.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who was also the office manager and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 18-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015679: US-009507513-1705USA015680:  US-009507513-1705USA015681: US-009507513-1705USA015682:
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a physician via Pfizer (manufacturer control number: 2017211095), concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX 23 (allergy to vaccine). At the reporting time, the outcome of the event of allergy to vaccine was unknown. It was considered the event of allergy to vaccine to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions, drug and allergy history were not reported. The patient's concomitant medications were not reported. On 30-MAY-2017, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot # M018624 and expiration date on 28-MAY-2017 (dose and route were not provided) for prophylaxis, and no adverse effect was reported. There was no product quality complaint involved. 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 referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of PNEUMOVAX 23 lot # M026317, expiration date 11-JAN-2018 (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. No adverse effects have been reported. The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 10 degrees Celsius for 4 hours and 17 minutes before administration to the patients. The previous temperature excursion was reported (time and temperature unknown). No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional and refers to a 1 year old male patient. The patient's concomitant therapies included M-M-R II, hepatitis A virus vaccine (unspecified) and PREVNAR 13. The patient had no known drug allergies (NKDA). On 03-APR-2017 15:15 hrs, the patient was vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018) dose 1, subcutaneously in the left thigh for prophylaxis. No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. This case is cross-referenced with 1704USA006422, 1706USA000221, 1706USA000261 and 1706USA001751 (Same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1704USA006422: US-009507513-1706USA000221: US-009507513-1706USA000261: US-009507513-1706USA001751.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional and refers to a 5 year old female patient. The patient's drug allergies included penicillin allergy. The patient's concomitant therapies included IPV, DTAP, VAQTA and M-M-R II. On 03-APR-2017 09:30 hrs, the patient was vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018) dose 2, subcutaneously in the left thigh for prophylaxis (incorrect product storage). No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. This case is cross-referenced with 1704USA006422, 1706USA000217, 1706USA000261 and 1706USA001751 (Same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1704USA006422: US-009507513-1706USA000217: US-009507513-1706USA000261: US-009507513-1706USA001751:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 01-JUN-2017, the patient inadvertently received an expired dose of GARDASIL (strength, dose, frequency were not provided) lot # M014929 with expiration date of 27-MAY-2017, intramuscularly for prophylaxis. No adverse adverse effects were reported. There was no product quality complaint (PQC) involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513 1705USA008347.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker 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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008347.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of PROQUAD (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that PROQUAD lot # K025760 (expiration date 08-JUN-2016), L005297 (expiration date 17-AUG-2016), L030591 (expiration date 10-FEB-2017) and L040413 (expiration date 13-APR-2017) underwent a temperature excursion in 2015. In October, November and December of 2015, the minimal/maximal temperature of the freezer was -2/6, -2/6 and -2/6 (units not provided) respectively. The lot number L046506 (expiration date 17-MAY-2017), M002053 (expiration date 11-JUL-2017), M006102 (expiration date 01-AUG-2017) and M011664 (expiration date 08-SEP-2017) underwent a temperature excursion in 2016. In January to March, May, July to October, and December of 2016, the minimal/maximal temperature of the freezer was -2/10, -7/15, -7/ 9, -4/8, -15/19, -6/7, -5/12, -5/10 and -10/10 (units not provided) respectively. There was no PROQUAD lot number reported in 2017 temperature excursions. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287: US-009507513-1706USA001288: US-009507513-1706USA001289: US-009507513-1706USA001287: US-009507513-1706USA001291: US-009507513-1706USA001292.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2017, the patient was vaccinated with an improperly stored GARDASIL 9 (lot: M041990: expiry date: 28-JUN-2019) (incorrect product storage). The vaccine was stored at 0C for 16 hours 10 minutes. The call was due to a data logger. No adverse effects were reported.  There was no prior temperature excursions. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#M041384, expiry date 07-JUL-2019) for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001645: US-009507513-1706USA001646: US-009507513-1706USA001647: US-009507513-1706USA001643: US-009507513-1706USA001644: US-009507513-1706USA001382.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (lot: M037770: expiry date: 01-JUN-2019). The vaccine was stored at 32F to 35F for 15 hours. No adverse effects were reported. There was no prior temperature excursions. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored VARIVAX (lot: M039318: expiry date: 20-SEP-2018) (incorrect product storage). The vaccine was stored at 15F for 4 hours and 30 minutes. Time frame was 45 minutes The call was due to a data logger. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001683:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, reported as since 20-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot# L035129 with expiration date 14-SEP-2017, lot# M033904 with expiration date 20-JUL-2018, lot# M000996 with expiration date 07-JAN-2018, lot# L035129 with expiration date 14-SEP-2017, lot# M025865 with expiration date 24-MAY-2018 and lot# M010484 with expiration date 01-MAR-2018 (dose and route of administration were not reported). On 25-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M025864, expiration date 24-APR-2018 (dose and route of administration were not reported). All vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). There was no adverse effect reported. From 20-APR-2017 to 18-MAY-2017, administered doses of vaccines experienced the temperature excursion between - 9 degrees Celsius and 8 degrees Celsius for about 315 hours and between -14 degrees Celsius and -10 degrees Celsius for about 376 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-00503517-1705USA009632.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M041212, expiry date 21-JUN-2019, lot# M034780, expiry date 15-APR-2019, lot# M032650, expiry date 31-MAR-2019, lot# M030380 expiry date 01-FEB-2019 for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M034387, expiry date 19-JUL-2018, lot # M029229 expiry date 06-AUG-2018  lot # M022408 expiry date 02-MAY-2018) for prophylaxis since 15-MAR-2017. The reporter did not have access to the lot# and expiration dates of the diluent that was used to reconstitute the M-M-R II. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger.  This is one of the several reports received from the same reporter. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M043424, expiry date 06-JUN-2018, lot # M026317 expiry date 11-JAN-2018) for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot# M039202, expiry date 11-MAR-2018) for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to 5 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients was vaccinated with an improperly stored PROQUAD (lot: M041084: expiry date: 04-APR-2018) (incorrect product storage). The vaccine was stored at 15F for 4 hours and 30 minutes. Time frame was 45 minutes The call was due to a data logger. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001419:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 28-FEB-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014153.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 07-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001722: US-009507513-1706USA001723: US-009507513-1706USA001721: US-009507513-1706USA001720: US-009507513-1706USA001724: US-009507513-1706USA001725: US-009507513-1706USA001726: US-009507513-1706USA001727: US-009507513-1706USA001728: US-009507513-1706USA001714: US-009507513-1706USA001719.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (lot: N005274: expiry date: 03-APR-2018) (incorrect product storage). The vaccine was stored at 32F to 35F for 15 hours. No adverse effects were reported.  There was no prior temperature excursions. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. The pharmacist reported for two patients. This is the first of two reports. A 87 year old female patient of an unspecified race/ethnicity received PREVNAR 13 at single dose, on an unknown date, for immunization. Medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced pain injection site and limited arm movement. The adverse events lasted about a day and then resolved on an unspecified date.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 66-year-old female patient of an unspecified race received PREVNAR 13 at single dose for immunization on unknown date via an unspecified route. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced pain in arm, the outcome of the event was unknown.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently given an additional Hep B vaccine. He was given a PEDIARIX combo vaccine that included a Hep B as well as an additional Hep B at todays visit. The parents were alerted while in the office.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: Mother noticed a rash on her daughter's back, and notice 3 spots at first and then increased in number over time. At time of visit mother could count 12 spots.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 10-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: Original Case: 1706USA001714 US-009507513-1706USA001721: Original Case : 1706USA001714 US-009507513-1706USA001722: Original Case : 1706USA001714 US-009507513-1706USA001723: Original Case : 1706USA001714 US-009507513-1706USA001719: Original Case : 1706USA001714 US-009507513-1706USA001714: Original Case : 1706USA001714 US-009507513-1706USA001725: Original Case : 1706USA001714 US-009507513-1706USA001726: Original Case : 1706USA001714 US-009507513-1706USA001727: Original Case : 1706USA001714 US-009507513-1706USA001728: Original Case : 1706USA001714 US-009507513-1706USA001729: Original Case : 1706USA001714.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 10-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: Original Case: 1706USA001714: US-009507513-1706USA001721: Original Case: 1706USA001714: US-009507513-1706USA001722: Original Case: 1706USA001714: US-009507513-1706USA001723: Original Case: 1706USA001714: US-009507513-1706USA001719: Original Case: 1706USA001714: US-009507513-1706USA001724: Original Case: 1706USA001714: US-009507513-1706USA001714: Original Case: 1706USA001714: US-009507513-1706USA001726: Original Case: 1706USA001714: US-009507513-1706USA001727: Original Case: 1706USA001714: US-009507513-1706USA001728: Original Case: 1706USA001714: US-009507513-1706USA001729: Original Case: 1706USA001714.