chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016. (dose, route of administration and anatomical location not reported). The dose of PROQUAD (Merck) underwent temperature excursion. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports 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 was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-MAR-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot# L042846 and expiry date: 15-SEP-2017). The physician reported that it was unspecified which of the three dose series that this administration was. No adverse effects were reported. Temperature was reported as low of 33F to 35F for time frame of cumulative 48 hours. There was no previous excursion or no data logger. It was also reported that VAQTA was in the products tab and experienced a temperature excursion as well, but was not administered to a patient. MMR II was in the products tab and did not experience a temperature excursion, this was due to a general storage question. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports 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 as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-JAN-2016, the patient was vaccinated with an improperly stored (temperature: 58 degrees Fahrenheit (F), time frame: 1 hour and 30 minutes; no previous temperature excursion was reported) dose of MMR II lot # L007217, expiration date 03-MAR-2017 (albumin status, dose and route of administration were not specified). No adverse effect was reported. This is one of 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 was received from a registered nurse referring to a patient of currently 5 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache, Hypoaesthesia, Limb discomfort, Myopathy
Clinical narrative: This spontaneous report as received from a registered nurse via a field representative refers to a 15 year old non-pregnant female patient. There was no information about the patient's concomitant therapies provided. The patient did not have any pertinent medical history, known drug reactions or allergies. In 2009, the patient was vaccinated with a dose of GARDASIL 1 shot intramuscularly (lot # and expiration date were not reported). In 2010, the patient experienced numbness in her body, sore neck, myopathy, headaches, hip pain and limb discomfort. The patient sought medical attention and received unspecified infusions as a treatment for the adverse events. She had several unspecified neurological evaluations, but there was no result reported. The outcome of the events was reported as not recovered by the time of the report. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Neurological examination
Clinical narrative: This spontaneous report as received from a registered nurse via a field representative refers to a 15 year old non-pregnant female patient. There was no information about the patient's concomitant therapies provided. The patient did not have any pertinent medical history, known drug reactions or allergies. In 2009, the patient was vaccinated with a dose of GARDASIL 1 shot intramuscularly (lot # and expiration date were not reported). In 2010, the patient experienced numbness in her body, sore neck, myopathy, headaches, hip pain and limb discomfort. The patient sought medical attention and received unspecified infusions as a treatment for the adverse events. She had several unspecified neurological evaluations, but there was no result reported. The outcome of the events was reported as not recovered by the time of the report. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated concomitantly with ZOSTAVAX VIAL (19400 plaque-forming unit (PFU), dose, route of administration, lot# and expiration date were not reported) and PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patients experienced injection site reactions. The pharmacist noticed that more patients (unspecified number) experienced injection site reactions when ZOSTAVAX and PNEUMOVAX 23 were administered concomitantly than when ZOSTAVAX and PNEUMOVAX 23 were administered 4 weeks apart (captured in MARRS# 1604US005983). The outcome of injection site reactions was not reported. Causality assessment was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 15 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On 24-MAR-2016, the patient was vaccinated with third dose of GARDASIL 9, 1 shot intramuscularly. It was mentioned that they were sexually active. The doctor administered a pregnancy test, which came back positive after the vaccine had been administered. The stage of pregnancy was not stated, as it is believed to be in the very early stages. No treatment was provided. No product quality complaint was reported for GARDASIL 9. Outcome was unknown (also reported as not recovered). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This report was received from Pfizer Inc and was assigned a manufacturer report number (2016118776) for  PREVNAR 13. It was reported by a physician referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 17-AUG-2015, the patient was vaccinated with PREVNAR 13 and developed low grade fever that escalated to 104 degrees, extreme redness and swelling at the injection site. (1604USA006010). On 07-FEB-2016, the patient was vaccinated with PNEUMOVAX23 (anatomical location, dose number, lot number and expiration date were not reported). The patient's concomitant medications were not reported. On an unknown date, the patient experienced and unspecified reaction. At the time of the report, the outcome of the unspecified reaction was unknown and relationship between the event and vaccination with PNEUMOVAX23 was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 30-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB 10/0.1 microgram/ml, lot # K019502, expiry 04-FEB-2016, dose 2, 0.5 ml intramuscularly. No adverse effects were reported. It was reported that the vaccines were exposed to a temperature of 0 C for 3 weeks or 12C for 3 weeks during November 2015. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. This is 2 of the 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 30-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB 10/0.1 microgram/ml, lot # K019502, expiry 04-FEB-2016, dose 2, 0.5 ml intramuscularly. No adverse effects were reported. It was reported that the vaccines were exposed to a temperature of 0 C for 3 weeks or 12C for 3 weeks during November 2015. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. This is 1 of the 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report was received from a registered nurse via a company employee, referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (route, strength, dose, frequency and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced diarrhea. At the time of reporting, the outcome of diarrhea and the causality with the vaccine were unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 25-MAR-2016, the patient was vaccinated with improperly stored ROTATEQ lot # L008990, expiry date: 01-DEC-2016 (dosing details and route of administration were not reported). No adverse effect was reported. It was reported that the vaccines were exposed to a temperature of 1.4 C for a time frame of 2 hours 41 minutes. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 25- MAR-2016, the patient was vaccinated with improperly stored ROTATEQ lot # KL008990, expiry: 01-DEC-2016 and RECOMIVAX HB lot # L018501, expiry: 22-JUN-2017 (dosing details and rout of administration were not reported). No adverse effect was reported. It was reported that the vaccines were exposed to a temperature of 1.4 C for a time frame of 2 hours 41 minutes. No previous temperature excursion was reported. There were no product quality complaints (PQC involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concomitant conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 24-MAR-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L018501, expiry: 22-JUN-2017 (dosing details and route of administration were not reported). No adverse effect was reported. It was reported that the vaccines were exposed to a temperature of 1.4 C for a time frame of 2 hours 41 minutes. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a 68 year old female patient. The patient's concurrent conditions and medical history were not provided. On 25-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, route, anatomical location, lot number and expiration date were not provided). Other suspect therapies included REFLAFEN. On 26-MAR-2016, the patient experienced rash on her face. It was reported that the patient's rash did not appear to be a shingles related rash but just a "regular rash" on her face. There was no intervention to prevent serious criteria, the case did not involve cancer or overdose. There was no product quality complaint involved. The outcome of the adverse event was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was reported. On an unknown date, the patient was vaccinated orally with an improperly stored dose of oral ROTATEQ lot # L004453, expiry date 02-MAY-2017 (exact dose was not specified). The administered dose of oral ROTATEQ underwent temperature excursion at minimum 24 Fahrenheit degrees and maximum 48 Fahrenheit degrees for 24 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, injection site, lot# and expiration date were not provided). On an unknown dates, the patient had tenderness at the injection site for a few days. The patient did not receive any treatment for tenderness at the injection site. The pharmacist also stated that he 'normally hears this complaint after PREVENAR 13 injections and not generally after PNEUMOVAX 23 injections'. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-APR-2016, the patient was inadvertently vaccinated with an expired dose of MMR II lot # K003822 and expiration date: 14-MAR-2016 (dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in March 2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot # L020015 expiration date: 16-AUG-2017 (dose number, site and route of administration were not reported). There was no adverse effects reported. It was stated that the vaccine underwent a temperature excursion of 31 Fahrenheit for an unspecified time frame. In reference to previous excursion the reporting nurse stated that excursions showed minimum reached 31 Fahrenheit on several days starting March 2016 into April 2016. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in April 2016 (between 01-APR-2016 and 07-APR-2016) the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot # L020015 expiration date: 16-AUG-2017 (dose, site and route of administration were not reported). There was no adverse effects reported. It was stated that the vaccine underwent a temperature excursion of 31 Fahrenheit for an unspecified time frame. In reference to previous excursions the reporting nurse stated that excursions showed minimum reached 31 Fahrenheit on several days starting March 2016 into April 2016. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via Medical Representative refers to a patient of unknown age and gender. There were no medical history, drug reaction, allergies and concomitant medication reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route of administration were not reported). On an unknown date reported as "a year later", the patient was vaccinated with the second dose of ZOSTAVAX (lot#, expiration date, dose and route of administration were not reported). No adverse effect was reported. No product quality complaint was involved in this case. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 30 year old patient of unknown gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 09-MAR-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (which had a lot # of L041629 and an expiration date of 22-APR-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Additional information has been requested.
Age: 68.0
Sex: M
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 unknown age and gender. No medical history, drug reactions/allergies or concurrent conditions were reported. On 04-APR-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (which had a lot # of L035283 and an expiration date of 15-DEC-2016; dose, dosage number, anatomical location and route of administration were unknown). The temperature excursion for the vaccine was 53 F for a time frame of 20 hours. However, no adverse effects were reported. It was also reported that there had been no previous excursions and this excursion had been reported due to a data logger. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant  therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (refrigerated in temperature of 31.3 degrees Fahrenheit for 1 hour; previously temperature excursion was reported as 2 times; less than 34 degrees Fahrenheit for 20 minutes each time) doses of ROTATEQ (Lot # L013203 and expiration date: 28-JAN-2017, route of administration defaulted to oral (dose was not reported). No adverse effects were reported. This is one of 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 as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (frozen in a temperature of 8.8 degrees Fahrenheit for 20 minutes; no previous excursion was reported) doses of PROQUAD (Merck) Lot # L002421 and expiration date: 23-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. Between 22-MAR-2016 and 23-MAR-2016, the patients might be vaccinated (nurse stated: "I don't know which ones were administered" but might included oral ROTATEQ with improperly stored doses of ROTATEQ oral liquid, lot# L029615 with expiration date 15-MAY-2017, and lot# L038534 with expiration date 19-AUG-2017, orally (dose was not reported). No adverse effect were reported. This is one of several reports 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 as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. Between 22-MAR-2016 and 23-MAR-2016, the patients might be vaccinated (nurse stated: "I don't know which ones were administered" but might included MMR II with improperly stored doses of MMR II injection, lot# L026551 with expiration date 16-JUL-2017 and lot# L027431 with expiration date 22-JUL-2017 (dose and route of administration were not reported). No adverse effect were reported. This is one of several reports 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 as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. Between 22-MAR-2016 and 23-MAR-2016, the patients might be vaccinated (nurse stated: "I don't know which ones were administered" but might included VAQTA with improperly stored doses of VAQTA injection, lot# L043209 with expiration date 17-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports 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 as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# L043209 with expiration date 17-SEP-2017 (dose and route of administration were not reported). Temperature and time frame of excursion were reported as 49.8 Fahrenheit (F) and 33.4 F for an unspecified amount of time. The vaccine had also previous temperature excursion of 48.1 F for 1 hour and 15 minutes. No adverse effects were reported. This is one of several reports 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 as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (refrigerated in temperature of 31.3 degrees Fahrenheit for 1 hour; previously temperature excursion was reported as 2 times: less than 34 degrees Fahrenheit for 20 minutes each time) doses of PNEUMOVAX 23 single dose syringes Lot # L007720, expiration date: 08-JUL-2016 and Lot # L001311, expiration date: 06-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (refrigerated in temperature of 31.3 degree Fahrenheit for 1 hour; previously temperature excursion was reported as 2 times: less than 34 degrees Fahrenheit for 20 minutes each time) doses of RECOMBIVAX HB Lot # L038018 and expiration date: 13-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. The is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. Between 22-MAR-2016 and 23-MAR-2016, the patients might be vaccinated (nurse stated: "I don't know which ones were administered" but might GARDASIL 9) with improperly stored doses of GARDASIL 9 injection,  lot# L040164 with expiration date 20-FEB-2018 (dose and route of administration were not reported). Temperature and time frame of excursion were reported as 49.8 Fahrenheit (F) and 33.4 F for an unspecified amount of time. The vaccine had also previous temperature excursion of 48.1 F for 1 hour and 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: On 4-5-16 ZOSTAVAX (shingles) vaccine was administered to patient. On 4-8-16 patient reports redness and swelling at site of injection. I advised her to go ER today and patient diagnosed w/shingles and cellulitis. Antibiotics, anti-virals, and pain medications was prescribed to her as a result.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 5 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROAQUD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were not previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored doses of PEDVAXHIB lot # L012838, expiration date: 10-MAR-2018 and Lot # L030871, expiration date: 10-JUN-2018 (dose and route of administration were not reported). No adverse effects were reported. This is one of several 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 as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patient s received improperly stored doses of VARIVAX (Merck) Lot # L013068 and expiration date: 14-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in March 2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot # L020015 expiration date: 16-AUG-2017 (dose, site and route of administration were not reported). There was no adverse effects reported. It was stated that the vaccine underwent a temperature excursion of 31 Fahrenheit for an unspecified time frame. In reference to previous excursions the reporting nurse stated that excursions showed minimum reached 31 Fahrenheit on several days starting March 2016 in to April 2016. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refer to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# K040164 with expiration date 20-FEB-2018 (dose and route of administration were not reported). Temperature and time frame of excursion were reported as 49.8 Fahrenheit (F) and 33.4 F for an unspecified amount of time. The vaccine had also previous temperature excursion of 48.1 for 1 hour and 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-FEB-2016, the patient was inadvertently administered with a dose of PROQUAD (Merck) (lot and dosing details unknown) which was reconstituted with expired diluent (lot L005459, expiry 18-FEB-2016). No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 4 years ago and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The dose of PROQUAD (Merck) underwent temperature excursion: 14.47F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports 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 as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored doses of VAQTA Lot  # L015460, expiration date: 20-JUL-2017 and Lot # K010577, expiration date: 01-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (refrigerated in temperature of 31.3 degrees Fahrenheit for 1 hour; previously temperature excursion was reported as 2 times: less than 34 degrees Fahrenheit for 20 minutes each time) doses of GARDASIL (also reported as product unspecified) Lot # K010215 and expiration date: 05-MAY-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patient so unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were vaccinated with PEDVAXHIB lot # L035880, expiration date: 11-AUG-2018 (dose, route of administration and anatomical location were not reported) that was improperly stored. No adverse events were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7f for 2 hours and 15 minutes. There were o previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports 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 was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The dose of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports 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 was received from a registered nurse referring to a patient of currently 5 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports 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 was received from a registered nurse referring to a patient of currently 11 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports 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 was received from a registered nurse referring to a patient of currently 9 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.31
Sex: M
Vaccine: 6VAX-F, DTAP, HIBV, IPV, MENHIB, RV1
Symptoms: Erythema, Eye movement disorder, Immediate post-injection reaction
Clinical narrative: We brought our happy healthy 4 month old to his 4 month well baby checkup. And We decided to go along with our Doctors recommendation to Fully Vaccinate him. We did the full 7 shots in one visit! I saw after his administration of all of them his eyes Rolled into his head immediately and his whole body turned red. Something "left" my Son that Day sir!! And I'm mad about it! He had a clouded veil cast apon him after these Vaccines.. its heartbreaking. And My Son will NEVER BE THE SAME!!
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever 103 and febrile seizure.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Laboratory test normal, Pyrexia
Clinical narrative: Headache, fever.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pain
Clinical narrative: Severe pain at injection site lasting 3 days so far.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe pain at injection site lasting 3 days so far.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The reaction occurred all at the site of injection. It was swelling, hot, red, hard, and it hurt. As of now, the patient will be going to the doctor tomorrow if swelling has not gone down.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Patient stated she experienced fatigue and fever and just all over feeling of being ill the night the vaccine was given.  She noted going to bed early but when I asked about her fever she mentioned she did not actually check her temperature.  Her upper arm surrounding the vaccine is red and warm to the touch and somewhat painful.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient stated she experienced fatigue and fever and just all over feeling of being ill the night the vaccine was given.  She noted going to bed early but when I asked about her fever she mentioned she did not actually check her temperature.  Her upper arm surrounding the vaccine is red and warm to the touch and somewhat painful.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Patient states that she has had two cases of shingles since getting the vaccine, in a different dermatome and with more pain, than her breakouts previous to the vaccine. She believes she may have gotten a "bad batch" and would like it reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an advanced registered nurse practitioner referring to a 54 year old female patient. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dosage and route not reported). The patient had shingles outbreak on calves after ZOSTAVAX subsided in 2 weeks. On an unknown date, the patient was hospitalized due to the event. The outcome of shingles was unknown. The causality of the event with ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.64
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 7 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.