chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Ultrasound scan
Clinical narrative: Extreme soreness at injection site, couldn't move arm, bulging out swelling, redness, burning, itching, fever, headache.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Full blood count, Irritability, Lumbar puncture, Metabolic function test
Clinical narrative: Irritability, possible seizure < 6 hours after vaccine. Hospitalization and neurology eval ongoing.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called about 10 days after receiving vaccine. Said her arm hurts when she bends it as crossing arms in front of herself. She says feels pulling. Hard to get dressed.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Breast oedema, Contusion, Oedema peripheral, Pain, Rash
Clinical narrative: Pain, swelling, bruising, edema arms and breast on left side of body only, rash.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Pain, swelling, bruising, edema arms and breast on left side of body only, rash.
Sex: U
Vaccine: RVX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unspecified date in March and April 2014 doses of ROTATEQ were exposed to a supported temperature excursion. On an unknown date the doses of ROTATEQ oral, (strength, dose, frequency, lot and expiration date were not reported) were administered to an unspecified number of patients on an unspecified dates. No adverse events had been reported. The reporter indicated that there was no follow up information for this case. No additional information was available. Additional information is not expected, because the reporter did not wish to receive any additional correspondence for this case.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: This spontaneous report as received from a physician of unknown age via company representative refers to himself. Pertinent medical history was unspecified by reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous, dose, lot number and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date after 2 years of being vaccinated, the patient developed mild case of shingles. The physician explained that when he woke up in the morning on an unknown date was not feeling well and his wife noticed spots on his forehead. No other symptoms were reported. Treatment was given for the event and the details were unspecified by physician. The physician reported that he recovered with no trouble. The causality was unknown. No additional adverse event information was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Rash
Clinical narrative: This spontaneous report as received from a physician of unknown age via company representative refers to himself. Pertinent medical history was unspecified by reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous, dose, lot number and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date after 2 years of being vaccinated, the patient developed mild case of shingles. The physician explained that when he woke up in the morning on an unknown date was not feeling well and his wife noticed spots on his forehead. No other symptoms were reported. Treatment was given for the event and the details were unspecified by physician. The physician reported that he recovered with no trouble. The causality was unknown. No additional adverse event information was reported. 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 an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ, 2 ml, orally. No concomitant medications were reported. On an unknown date the patients were administered improperly stored ROTATEQ. No adverse events were reported. Outcome of administering the improperly stored ROTATEQ, was unknown. There was no product quality complaint involved. This is one of the two cases 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 nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Oka/Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccination administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 01-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 03-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern refers to a patient of unknown age and gender. No pertinent medical history was reported. On 21-NOV-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot # J007786 and expiration date was 25-SEP-2014) (strength, dose and route were not reported) which was expired on 25-SEP-2014. Also reported the dose was supported. Concomitant therapy was not reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received (Merck) VARIVAX (doses, routes of administration, lot # and expiration dates were not reported) stored at 8F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 03-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 06-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB (lot number, expiration date, dose, route were not reported) that underwent post supported temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients were vaccinated with a dose of VAQTA (lot number, expiration date, dose, route were not reported) that underwent post supported temperature excursion. 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 registered nurse refers to unspecified number of patients of unknown age and gender. On 08-OCT-2014, unspecified number of patients were vaccinated with a dose of GARDASIL (lot # K001631, expiration date:06-NOV-2016), 0.5 ml, intramuscular that underwent post supported temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning to a 15 years old female patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Local swelling, Rash macular, Swelling
Clinical narrative: Nov 16 - Nose/face blotching redness swelling, pox. Nov 17 - Swelling in neck (mild). Nov 12- Quarter sized bruise at injection site (just below deltiod). All sx still present now at 11.20.14 9 pm.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Laboratory test abnormal
Clinical narrative: Patient was given MMR #2 for equivocal measles titer and was pregnant.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reddened swollen area to (L) lateral upper arm - 3 1/2 cm x 3 1/2 cm. (L) lateral mid thigh reddened and swollen - 10 cm x 13 cm.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Groin pain, Injection site swelling, Pyrexia
Clinical narrative: Severe swelling at injection site (football size); fever; severe pain radiating down to the groin; pain lasted 3-4 days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning to a 16 years old female patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal mass, Erythema, Local swelling, Upper extremity mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with drug reaction/allergy to sulfa. Other medical history was not reported. On 16-NOV-2014, the patient was vaccinated with ZOSTAVAX lot # K008880 expiry date 20-SEP-2015 (also reported as 09-SEP-2015), 0.65 ml, intramuscular (not sure if it was administered intramuscular) in the arm. Concomitant medication was not reported. In November 2014, after receiving ZOSTAVAX, the patient experienced red swollen lump on an unspecified part of her arm. Where the lump was located at, the reporter though ZOSTAVAX might have been administered intramuscularly, but was not sure. No treatment given for the events. No lab diagnostics performed. The patient went to the pharmacy on 21-NOV-2014 to show the pharmacist her symptoms. At the time of the report, action taken regarding therapy with ZOSTAVAX and the outcome of red swollen lump on arm were not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with LAMISIL allergy and hypercholesterolemia. On 23-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K009770, expiration date 09-OCT-2015, 0.65 ml, subcutaneous in the left arm for vaccination (dose number was unspecified). Concomitant therapies included simvastatin (manufacturer unknown). On 05-NOV-2014, the patient experienced rash of red bumps at the injection site on her left arm, the reported stated that the rash was painful and slightly itchy. The reporter also stated that it was unknown if it was shingles because the patient was not seen. The patient sought medical attention by calling the pharmacy. No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient who is currently 63 years old. The patient did not have pertinent medical history or drug reactions. On 03-SEP-2008 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). No concomitant therapies were reported. The pharmacist reproted that although the patient was administered the ZOSTAVAX but continued to have recurrent small patches of shingles on her back when she experienced "ongoing high stress periods." The onset date of the events was unspecified. Unspecified antiviral medications were given for the adverse event. No lab diagnostics studies were performed. The patient had sought for medical attention by seeing the pharmacist. The outcome of the events was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning to a 23 years old female patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot #K009811, expiration date: 19-JUN-2016) (route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age. On 17-NOV-2014, the patient was vaccinated with ZOSTAVAX vaccine (strength, dose, route of administration, anatomical location, lot # and expiration date not reported). No concomitant medication was reported. On an unknown date in November 2041, the patient developed full blown shingles. The outcome of the event was reported as not recovered/not resolved. The causality of the event was unknown. The patient sought medical attention. The pharmacist saw the patient on 21-NOV-2014. The patient was also seen by an unspecified physician. A product quality complaint (PQC) was not involved. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. Since 15-SEP-2014, unspecified number of patients have been administered improperly stored doses of PROQUAD (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse events were reported. No concomitant therapies were reported. The outcome of the events was unknown. 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 registered nurse refers to an unspecified number patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. Since 15-SEP-2014, unspecified number of patients have been administered improperly stored doses of (Merck) VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse events were reported. No concomitant therapies were reported. This outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date in 2012, the patient was vaccinated with first dose of GARDASIL (strength, dose, route of administration, anatomical location, lot # and expiration date not reported). No concomitant medication was reported. On an unknown date in 2013, the patient received the second dose of GARDASIL one year after the first dose. The physician was unsure of the dates that the first dose and second dose of GARDASIL were administered on but stated that the patient received her second dose of GARDASIL at least a year ago. No adverse effect was reported. The outcome of the events were unknown. A product quality complaint (PQC) was not involved. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 06-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reproter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-OCT-2014"), an unspecified number of patients received ZOSTAVAX (doses, routes of administration, lot # and expiration dates were not reported) stored for 8F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was inadvertently administered with PROQUAD (Merck) (dose, frequency, route of administration, lot # and expiry date not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was inadvertently administered with PROQUAD (Merck) (dose, frequency, route of administration, lot # and expiry date not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was inadvertently administered with (Merck) VARIVAX (dose, frequency, route of administration, lot # and expiry date not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with (Merck) VARIVAX. This is one of several reports received from the same source (MARRS # 1411USA011907). Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was inadvertently administered with (Merck) VARIVAX (dose, frequency, route of administration, lot # and expiry date not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with (Merck) VARIVAX. This is one of several reports received from the same source (MARRS # 1411USA011907). 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 06-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received GARDASIL (doses, routes of administration, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 08-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received RECOMBIVAX HB (doses, routes of administration, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Poor quality drug administered, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist stated that ZOSTAVAX looked clear in the syringe while the reconstituted product was being drawn up in the syringe. The reporter stated that it was administrated to the patient on unknown date, but did not reported if the patient endured any adverse reactions due to the vaccine's color in the syringe. The pharmacist inquired about the safety of this vaccine, which according to the prescribing information was supposed to look "semi-hazy to translucent" or "off-white to pale yellow liquid", 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 medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received PNEUMOVAX (doses, route of administration, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received VAQTA (doses, routes of administration, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dosing details unknown). No concomitant medications were reported. On an unknown date the patients were administered improperly stored GARDASIL. No adverse events were reported. Outcome of administering the improperly stored GARDASIL was unknown. There was no product quality complaint involved. This is one of the two cases 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 as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received PEDVAX HIB (doses, routes of administration, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with (Merck) VARIVAX (lot # J012816, expiry date 10-OCT-2015 and lot number K005180 with expiry date 10-APR-2016, dose 0.5 ml, subcutaneous). Concomitant medications were not reported. The reporter stated that (Merck) VARIVAX was administered to patients post temperature excursions. The reporter also stated that (Merck) VARIVAX was affected by prior excursions (no MARRS number available yet) and there also seemed to be additional excursions to (Merck) VARIVAX that have not been reported yet. There was no stability data provided. No adverse effects were reported. Outcome of administration of (Merck) VARIVAX post temperature excursions was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as pharmacy manager) via company representative refers to 19 patients of unknown demographics. The patients medical history and current conditions were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # not reported) dose 1. As the nineteen vials of ZOSTAVAX could not be reconstituted to the full, 0.65 ml dose amount, on an unspecified dates nineteen anonymous patients received incorrect doses of ZOSTAVAX between 0.5 ml and 0.6 ml. product quality complaint was filed. No adverse reactions were reported. Also reported that on an unspecified date an unspecified number of patients reported experiencing more pain when receiving any kind of unspecified reconstituted vaccine dose (vaccine, dosages, and manufacturers not specified) in which needle used during product reconstitution was also used for administering the injection. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on medical history and drug reactions or allergies. On 20-NOV-2014, the patient was vaccinated with second dose of RECOMBIVAX HB strength reported as 10 units reported as Y (unspecified units), product lot # H010965, dose, route not reported that expired on 01-JUN-2014. The RECOMBIVAX HB did not have any previous temperature excursions. The RECOMBIVAX HB was found to be supported with post expiry data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). No concomitant medication was reported. On an unknown date, the patient developed shingles. The patient received unspecified antiviral medication and gabapentin as a treatment of the adverse event (also reported as "(1) patient was given antiviral treatment only and the 2nd patient received the antiviral medication and gabapentin"). The patient sought medical attention, he visited the physician's office. The outcome of shingles was reported as recovering/resolving. The relatedness between the event and the ZOSTAVAX was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). No concomitant medication was reported. On an unknown date, the patient developed shingles. The patient received unspecified antiviral medication and gabapentin as a treatment of the adverse event (also reported as "(1) patient was given antiviral treatment only and the 2nd patient received the antiviral medication and gabapentin"). The patient sought medical attention, she visited the physician's office. The outcome of shingles was reported as recovering/resolving. The relatedness between the event and the ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old patient of unknown gender. It was reported that patient inadvertently received ZOSTAVAX dose and route not reported (lot # J005849; expiration date: 17-AUG-2014) in February 2014. The patient was supposed to received VARIVAX (Merck), but ZOSTAVAX was administered in error. The patient then received a first dose of VARIVAX (Merck) (dose, route and lot# were not reported) on 09-JUN-2014 and a second dose of VARIVAX (Merck) (dose, route and lot# were not reported) on 18-JUL-2014. Pharmacist stated that no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient had already received the first dose of GARDASIL (injection, 0.5 ml, lot# and route were not provided). But the patient was unable to receive the second "0.5ml dose" of GARDASIL during a scheduled appointment on an unspecified date because the vial was supplied empty (product quality complaint (PQC) filed). No adverse effect was reported. Additional information is not expected because no consent to contact physician.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history was reported. On 21-NOV-2014, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 10 VIALS of 1 (lot # J010654 and expiration date was 17-OCT-2014) dose 0.5 ml, intramuscular. Concomitant therapy was not reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Malaise, Pain
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 63 year old female patient with mild asthma, osteoarthritis and seasonal allergies. The patient had no known drug reactions or allergies. On 07-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # reported as K0009773 (route and expiration date were not provided). Concomitant therapies included PROTONIX, PROAIR, SYMBICORT and diclofenac. On 08-NOV-2014, the patient experienced headache and feeling unwell. The next day, on 09-NOV-2014, the patient noticed pain on the left trunk and rash and on 10-NOV-2014, the patient went to urgent care and she was diagnosed with shingles on that visit to urgent care. Also on 10-NOV-2014, the patient reported burning sensation around left trunk area to urgent care provider and patient was prescribed VALTREX and gabapentin from urgent care. On 11-NOV-2014, the patient called the physician's office to report an outbreak of shingles but did not come to see the physician until 12-NOV-2014. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 63 year old female patient with mild asthma, osteoarthritis and seasonal allergies. The patient had no known drug reactions or allergies. On 07-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # reported as K0009773 (route and expiration date were not provided). Concomitant therapies included PROTONIX, PROAIR, SYMBICORT and diclofenac. On 08-NOV-2014, the patient experienced headache and feeling unwell. The next day, on 09-NOV-2014, the patient noticed pain on the left trunk and rash and on 10-NOV-2014, the patient went to urgent care and she was diagnosed with shingles on that visit to urgent care. Also on 10-NOV-2014, the patient reported burning sensation around left trunk area to urgent care provider and patient was prescribed VALTREX and gabapentin from urgent care. On 11-NOV-2014, the patient called the physician's office to report an outbreak of shingles but did not come to see the physician until 12-NOV-2014. At the time of the report, the patient's status was unknown. 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 registered nurse refers to a patient of unknown age and gender. On 24-NOV-2014 the patient was vaccinated with a 0.5 ml dose of (Merck) VARIVAX, subcutaneous (lot# and dose# not reported) which was improperly stored. No adverse events were reported. The outcome of the event was not reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age, whose mother was a Hepatitis B carrier. On an unknown date, the patient was vaccinated with a series of RECOMBIVAX HB (dose, frequency and route of administration were not reported). No concomitants were reported. The titers came back negative. As treatment, a second series of RECOMBIVAX HB was again administered to the patient on unspecified dates and titers came back negative again. Unspecified lab diagnostics studies performed were performed. Action taken with respect to RECOMBIVAX HB was not applicable. The outcome of titers came back negative was unknown. Causality was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 11 year old female patient with no pertinent medical history. The patient received her second dose of GARDASIL (lot# and dose not reported, route reported as injection) in October 2014. On 19-NOV-2014 the patient came into the office for her third dose of GARDASIL and she was vaccinated with her third dose of GARDASIL (lot# and dose not reported, route reported as injection) which was outside of the prescribing information recommendation on the same day. The patient took no concomitant medication. No treatment was given for the event. The patient did not seek medical attention and no lab diagnostics studies were performed. The outcome of the event was not reported. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with doses of PROQUAD (Merck) (lot# not reported, 0.5 ml, subcutaneous), which were exposed to temperatures above 5 degrees F but below 19 degrees F for a total time of 9 hours above 5 degrees F. No adverse effect reported. The vaccines were not administered at the time of the 09-OCT-2014 call. Later it was reported that improperly stored vaccines administered was made known on 21-OCT-2014. This is one of several reports received from the same source. Follow up information has been received from the registered nurse on 29-OCT-2014. The registered nurse stated that she had no additional information to share with at this time. Follow up information has been received from the registered nurse on 04-NOV-2014. Nurse stated that clients were vaccinated with improperly stored PROQUAD (Merck) that had again been improperly stored. No adverse effect was reported. Additional information is not expected as the reporter did not want to be contacted about this report. The narrative has been updated.