chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 17 year old non pregnant female patient. The patient had no pertinent medical history and drug reactions or allergies and did not take any concomitant medication. On 17-AUG-2016, the patient was vaccinated with a first dose of GARDASIL 9 (formulation, route of administration, lot# and expiration date were not reported) as prevention of HPV. On an unspecified date in October 2016, the patient received a second dose of GARDASIL 9. On an unspecified date between September 2016 and October 2016 (reported as sometime after school started), the patient started loosing her hair. The patient's mother reported the patient's condition to a nurse practitioner, who did not know the cause of the hair loss. The reporter however thought it could possibly be caused by the GARDASIL 9. By December 2016, the patient's hair loss had gotten "increasingly worse". On an unknown date, the reporter took her daughter to see an unspecified dermatologist, who confirmed that 'her daughter had lost almost 50 percent of her hair". The patient was due for her final GARDASIL 9 injection (date not reported), but it would be consulted with the nurse practitioner if she should receive the injection. No treatment has been given to the patient. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. The relatedness between GARDASIL 9 and the event was considered as unknown. 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 pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 07-FEB-2017 at 08:12, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 03-FEB-2017 at 11:00, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 18-JAN-2017 at 14:22, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event, Product leakage, Product quality issue
Clinical narrative: This information has been received from a nurse prescriber concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on an unknown date, due to leakage during the administration, the patient did not receive a full dose of PNEUMOVAX 23 one shot once, with lot number M042599 and expiration date on 17-JUN-2018 (dose number and anatomical location were not provided), administered intramuscularly for prophylaxis. Product quality complained was involved. No adverse events effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 04-APR-2017 from a pharmacist who reported that a patient (age and gender not reported) was inadvertently administered a single dose of M-M-R II (lot# L009544, expiration 19-MAR-2017) subcutaneous with diluent on 03-APR-2017. Pharmacist reported that M-M-R II had expired on 19-MAR-2017. No adverse effects reported. No further information provided. Pharmacist did not want to be contacted. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified patient of unknown demographics. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA lot # M047658, expiration date 28-OCT-2017 for prophylaxis. The storage conditions were reported as follows: temperature 50° F, time frame 2 hours, with not previous temperature excursion. Data logger was involved. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013208.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions. On unknown dates, the patients were vaccinated with improperly store doses of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same source. Additional information has been requested; Sender's Comments: US-009507513-1704USA003212: Original Case : 1704USA003069 US-009507513-1704USA003210: Original Case : 1704USA003069 US-009507513-1704USA003211: Original Case : 1704USA003069
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions.  On unknown dates, the patients were vaccinated with improperly store doses of ROTATEQ orally (dose, lot number and expiration date were not reported) for prophylaxis. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1704USA003069: Original Case : 1704USA003069 US-009507513-1704USA003210: Original Case : 1704USA003069 US-009507513-1704USA003212: Original Case : 1704USA003069.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions. On unknown dates, the patients were vaccinated with improperly store doses of VARIVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same source. Additional information has been requested; Sender's Comments: US-009507513-1704USA003069: Original Case : 1704USA003069 US-009507513-1704USA003210: Original Case : 1704USA003069 US-009507513-1704USA003211: Original Case : 1704USA003069.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Three syncopal episodes while sitting in a chair over approximately 6 minutes.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Screaming, Vomiting
Clinical narrative: My daughter was screaming for 3.5-4 hours at a time. She would take a nap then wake up 15 minutes later and start the screaming process over and over again through about three days. While she was being nursed after the vaccination she started excessively vomiting for two minutes straight. Called doctors office and the nurse I spoke with told me it wasn't a true reaction because of no fever and I hung up on the woman and switched pediatrician's.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. No information regarding patient's concurrent conditions, medical history and concomitant therapies were reported. On 06-MAR-2017, the patient did urine pregnancy test which gave negative result. On 10-MAR-2017, the patient was vaccinated with a dose of VARIVAX 0.5ml subcutaneously, lot # M040139, expiration date: 28-SEP-2018. On 14-MAR-2017, the patient had a positive home urine pregnancy test. On 15-MAR-2017, the patient had a quantitative serum Human Chorionic Gonadotropin (hCG) test performed and it was positive. The last menstrual period (LMP) date and estimated due date (EDD) were unknown. The pregnancy outcome was pending. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were orally vaccinated with improperly stored doses of ROTATEQ lot # M032636 with an expiration date: 06-APR-2018, M035456 with an expiration date: 01-MAY-2018 and M032643 with an expiration date: 04-MAR-2018 (dose was not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not 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-009507513-1703USA014473: US-009507513-1703USA014472: US-009507513-1703USA014470: US-009507513-1703USA014469: US-009507513-1703USA007914:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 23-JAN-2017 at 09:24, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions. On unknown dates, the patients were vaccinated with improperly store doses of M-M-R II lot number L039551 (rHA), expiration date 07-OCT-2017; lot number M015931 (rHA), expiration date 30-MAR-2018 (dose and route were not reported) for prophylaxis. It was unknown the lot and expiration date of the properly stored sterile water diluent used to reconstitute the doses of M-M-R II. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003211:Original Case: 1704USA003069; US-009507513-1704USA003069:Original Case: 1704USA003069; US-009507513-1704USA003212:Original Case: 1704USA003069.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program [IBCC (Inbound Call Center for HCPs)].  A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single on unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced limitation of arm movement on an unspecified date with outcome of unknown.
Sex: F
Vaccine: FLUX
Symptoms: Blindness, Paralysis
Clinical narrative: Initial unsolicited case received from a consumer via social media on 29 Mar 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after receiving the flu vaccination the patient became permanently, 100 percent paralyzed and blind. The patient lab tests and corrective treatment was not reported. The outcome of the events were not reported. Upon internal review the company decided to consider the events as serious because of important medical events blind and paralyzed. List of documents held by sender: none.; Sender's Comments: This case involves a female patient who received an Influenza vaccine (manufacturer unknown) and was paralysed and became blind after the vaccination. This is a poorly documented case. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, time to onset, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Headache, Pharyngeal oedema, Tremor
Clinical narrative: Patient was taking the oral typhoid vaccine that was prescribed by our office and purchased at pharmacy. She took the first dose on 4/5/2017 and had a headache, then the next dose on 4/7/2019 another headache. The third dose on 4/9/2017 caused the feeling of swelling in her throat, stomach pain and headache with shaking present.  Patient then used her rescue inhaler thinking it was her allergies. Patient thought at first it was possibly something she ate, called her primary doctor and was advised not to take the last capsule.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Nausea, vomiting, and stomachache, joint pain, headache, tiredness, chills. Lasted over 24 hours. Pain was a 9 on a scale of 1-10, I was really sick!  I called physician and he prescribed benadryl, phenergine, and tylenol.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting, and stomachache, joint pain, headache, tiredness, chills. Lasted over 24 hours. Pain was a 9 on a scale of 1-10, I was really sick!  I called physician and he prescribed benadryl, phenergine, and tylenol.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: WOKE UP WITH RIGHT ARM PAIN, NUMBNESS IN RIGHT HAND AND PAIN IN ELBOW AND WRIST JOINTS.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: COULD NOT USE ARM WHERE VACCINATED. HIGH LEVEL OF PAIN. ICING AND ADVIL ON 4/8/2017 PROVIDED MINOR RELIEF. BY 4/10, USE OF ARM IMPROVED WITH MUCH LESS PAIN.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness unilateral
Clinical narrative: She reports that she developed persistent hearing loss in left ear about 2 weeks after vaccine administration.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (also reported as medical assistant) referring to an unspecified number of unspecified patients. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M026309, expiration date 11-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 53 degrees Fahrenheit for 2 hours. Data logger was involved. It was reported a previous temperature of excursion of 34 degrees Fahrenheit for 1 hour 15 minutes. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA003869:
Sex: M
Vaccine: MMR
Symptoms: Skin lesion
Clinical narrative: This spontaneous report was received from nurse prescriber and refers to a 4 year old male patient. The patient had none pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On 27-MAR-2015, the patient was vaccinated with a dose of M-M-R II (lot # reported as L021950, expiration date was not reported) and with a sterile diluent (lot # and expiration date were not reported) (dose and route were not reported for both medications) both administered for prophylaxis. On 25-APR-2016, the patient was vaccinated with a dose of VARIVAX (lot # L048467, and expiration date was not reported) and with a sterile diluent (lot # and expiration date were not reported) (dose and anatomical location were not reported for both medications) both administered subcutaneously for immunization. On an unknown date, after receiving both vaccines, the patient experienced lesions around eyes (face injury). Then, on an unknown date, the patient was seen at an urgent care by an unspecified eye doctor and he received an unspecified treatment. None laboratory diagnostic tests were performed. The outcome of face injury was unknown. The causality between face injury and both suspect therapies were not reported. Additional information has been requested.
Sex: F
Vaccine: RUB
Symptoms: Rubella antibody negative
Clinical narrative: cvxThis spontaneous report has been received from a physician referring to a currently 70 year old non-pregnant female patient. The patient's medical history and concurrent conditions were not reported. The patient had not any drug reactions or allergies. Concomitant therapies included CRESTOR, NEXIUM, CLARITIN-D, TANZEUM, TRADJENTA, Z-PAK, ONGLYZA, metformin and glyburide (+) metformin hydrochloride. On an unknown date, the patient was vaccinated with an unspecified rubella vaccine (manufacturer unknown) (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis.  She received an unspecified number of doses. On an unknown date, the patient visited the physician's office and a blood work was performed, then, it showed a low rubella titer. There was no further information or details provided. The outcome of the low rubella titers was unknown. The causal relationship between the low rubella titers and the rubella vaccine (manufacturer unknown) was not provided. Additional information has been requested.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 32-week-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were not reported. On an unknown date (reported as "four days after the patient past the age of 32 weeks"), the patient received a third dose of ROTATEQ orally (strength, dose, lot # and expiration date were not reported), for prophylaxis. No symptoms were reported. No product quality complaint (PQC) was reported. Additional information is not expected since the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 20-JAN-2017 at 09:04, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (also reported as medical assistant) referring to an unspecified number of unspecified patients. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ lot # M016238, expiration date 07-DEC-2017 (dose was not reported) orally for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 53 degrees Fahrenheit for 2 hours. Data logger was involved. It was reported a previous temperature of excursion of 34 degrees Fahrenheit for 1 hour 15 minutes. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012603.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Rash
Clinical narrative: Initial unsolicited report received from a consumer on 06-Jan-2017. This case was non-valid for unspecified adverse event was. This case is linked with: 2017SA004589, 2017SA004593 AND 2017SA004447. This case involves an 88-year-old female patient, who was vaccinated with INFLUENZA VACCINE (FLU VACCINE) (batch number, expiry date, route, dose not reported) on an unknown date. Patient's medical history and concomitant medication was not reported. On an unknown date, after the vaccination, the patient had reaction to a flu vaccine. Lab test and corrective treatment was not reported. Follow up report received from a consumer on 22 FEB 2017 and additional information received on 10 MAR 2017. Illness at the time of vaccination was none. On an unspecified date in OCT 2016 at 09:00 am the patient was vaccinated with INFLUENZA VACCINE (FLU VACCINE). On an unspecified date, following the vaccination the patient experienced muscle pain, rash, neck pain and shoulder pain. It was reported as exam by family doctor. On an unspecified date, at the age of 87 years old the patient received INFLUENZA VACCINE (FLU VACCINE). On an unspecified date (duration reported as 2 months), the patient was recovered from the events. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Laboratory test normal, Lumbar puncture normal, New daily persistent headache, Nuclear magnetic resonance imaging normal
Clinical narrative: 24/7 Headache. Finally diagnosed with New Daily Persistent Headache Months later.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Lethargy, swellin soreness of injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site rash, Pain, Pruritus
Clinical narrative: Patient woke with itching and burning on arm shot was given in, rash noted from elbow up. Patient went to Urgent Care with diagnosis of shingles and given a prescription for an anti-viral medication. Painful at sight of rash.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient woke with itching and burning on arm shot was given in, rash noted from elbow up. Patient went to Urgent Care with diagnosis of shingles and given a prescription for an anti-viral medication. Painful at sight of rash.
Age: 5.0
Sex: F
Vaccine: HEPA, IPV, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: MMRV was ordered for patient for routine vaccinations. ZOSTAVAX was administered.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Golf Ball sized area on deltoid. No redness, but warm to touch.
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Pyrexia, Tenderness
Clinical narrative: Information was received on 23-MAR-2017 from a nurse reporting from a physician's office via a company employee concerning an 80 year old female. No medical history or concomitant medications were reported. It was reported that the patient received "PCB13 one year ago". On 21-MAR-2017 the patient received a dose of PNEUMOVAX 23 (lot N003997, expires 20-OCT-2018) (dose and injection site not reported) within the last 2 weeks. The patient called back within 1 day of receiving the PNEUMOVAX 23 and complained of "arms that are red, painful to touch, feverish and diarrhea." The patient had called the physician office. Treatment was given for the adverse events (not specified). The outcome of the events is unknown. No other information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information was received on 28-MAR-2017 from an administrator regarding an approximately 25 year old female. Medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2017 the patient received a dose of ZOSTAVAX (lot # M013377 and expiration date 25-MAY-2017) in her right arm, instead of VARIVAX. The administrator did not know why the error happened.  Action taken in not applicable, outcome of events is unknown.  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 pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 03-FEB-2017 at 15:01, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 12-JAN-2017 at 13:32, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Rash, Vaccination failure
Clinical narrative: This spontaneous report was received from a currently 67 year old female patient of unknown age. The patient's concurrent conditions included high blood pressure. She reported that on an unspecified date in approximately 2004 (reported as when she was 55), she had her first shingles outbreak on her lower back, then on an unspecified date in approximately 2008 (reported as when she was 59) her shingles virus progressed to the point where "she felt like 1 thousand mosquitoes had stung all at once" and experienced extreme itching at which point she met with a physician who was against getting the ZOSTAVAX vaccine until he saw how bad her shingles were. On an unspecified date,  the patient was vaccinated with the first dose of ZOSTAVAX via subcutaneous, for prevention of herpes zoster (Strength, dose, lot # and expiration date were not reported). The patient's concomitant medications included an unspecified blood pressure medication. After getting the vaccination she experienced relief instantly. But she stated that after a couple of years on an unspecified date, started to get herpes zoster outbreaks (vaccination failure and herpes zoster) "here and there". She described the outbreaks as "small and pea sized bumps" with "no itch as all". She then started to get these outbreaks more and more but they were still small and pea sized bumps. On an unspecified date in approximately 2014 (reported as at the age of 65), the patient was vaccinated with the second dose of ZOSTAVAX via subcutaneous route, for prevention of shingles (Strength, dose, lot # and expiration date were not reported). The patient reported that it helped as much as the first time she "got the shot". At the time of this report she was still experiencing small outbreaks once to twice a year but referred at them as "barely nothing compared to what she had before getting ZOSTAVAX". No treatment was given for the events and no lab diagnostics studies were performed to the patient. The outcome of vaccination failure and herpes zoster was reported as not recovered. The reporter did not provide the causality between the events and ZOSTAVAX. Upon internal review, the event vaccination failure was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from  a register nurse (R.N) concerning to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant  therapies were not provided. On 31-MAR-2017, the patient was vaccinated with GARDASIL which had lot number L039066 and  expiration date on 19-MAR-2017, administrated intramuscularly for prophylaxis (dose, dosage number and anatomical location were not provided). The Patient was not expericiencing symptoms. There was no temperature excursion reporter. Product quality complaints were not involved. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 04-APR-2017 from a pharmacist regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported.  On 03-APR-2017 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # L017406 expiration 26-FEB-2017 unknown route for prophylaxis. No adverse effect reported. Additional information has been requested.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Aphasia, Balance disorder, Developmental delay, Emotional distress, Gait disturbance
Clinical narrative: High Fever for days, loss of speech, loss of ability to recognize things as before, difficulty walking and balancing, screaming fits for about 3 months, weight loss, repetitive movements with hands, hitting head on things, unconsolable. She still has not fully recovered her speech and still is not performing at age level since vaccination.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Head banging, Pyrexia, Screaming, Stereotypy, Weight decreased
Clinical narrative: High Fever for days, loss of speech, loss of ability to recognize things as before, difficulty walking and balancing, screaming fits for about 3 months, weight loss, repetitive movements with hands, hitting head on things, unconsolable. She still has not fully recovered her speech and still is not performing at age level since vaccination.