chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 04-FEB-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reported excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall support range of -58 F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. A nurse reported that an unspecified number of unknown patients have been administered doses of RECOMBIVAX HB lot # J007946, expiration date 24-MAR-2016 and lot # J14855, expiration date 16-APR-2016, intramuscular that have underwent a temperature excursion. It was reported that RECOMBIVAX HB was stored at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. RECOMBIVAX HB lot # J007946 was given on 08-OCT-2014, 10-OCT-2014, 21-OCt-2014, 24-OCT-2014, 30-OCT-2014, 10-NOV-2014 and on 21-NOV-2014. RECOMBIVAX HB lot # J014855 was given on 11-DEC-2014, 12-DEC-2014, 30-DEC-2014 and on 20-JAN-2015. Additional information has been requested. This is one of several reports from the same reporter.
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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 17-JUN-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H0108796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 Since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same source. 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 registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent condition or medically history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB (lot number, Expiry date, route and dose were not reported), that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.
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. No concurrent condition or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, Expiry date, route and dose were not reported) that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.
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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-OCT-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J0002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 29-JAN-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the 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 as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J000141 and expiry date: 04-JUL-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015 reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that product were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014402 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports 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 was received from a medical assistant concerning a patient of unknown age and gender. Information about medical history or concurrent conditions was not provided. On 05-AUG-2014 the patient was vaccinated with an incorrect stored dose GARDASIL 0.5 ml, intramuscularly injection (frequency, lot number and expiration date were not provided), which had underwent a temperature excursion. Concomitant medications were not reported. No adverse effect was reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis
Clinical narrative: This spontaneous report as received from an approximately 30 year old female patient regarding herself. On an unknown date in August 2014 the patient was vaccinated with PNEUMOVAX 23 (lot number and expiry date unknown) (dosing regimen and frequency unknown) at her place of employment. No concomitant medications were reported. On an unknown date approximately in 2014 (also reported as two weeks later) the patient experienced bronchitis. The patient stated that since she was vaccinated she has bronchitis four times. No lab diagnostic studies were performed. The patient did not seek professional medical attention. The patient self treated the bronchitis with Z-Pak. The outcome of bronchitis was reported as not recovered. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of the event bronchitis was not recovered. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information about medical history or concurrent conditions was not provided. On 22-DEC-2014 the patient was vaccinated with an incorrect stored dose of GARDASIL 0.5 ml, intramuscular injection (frequency, lot number and expiration date were not provided), which had underwent a temperature excursion. Concomitant medications were not reported. No adverse effect was reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 20-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the 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 as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-SEP-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # K009471 and expiry date: 03-JAN-2016) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the 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 as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-NOV-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the 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
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 improperly stored VARIVAX (Merck) (dose, route of administration and indication were not reported). No adverse effects were 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-MAR-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports 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 was received from a medical assistant concerning a patient of unknown age and gender. Information about medical history or concurrent conditions was not provided. On 17-JUL-2014 the patient was vaccinated with an incorrect stored dose of GARDASIL 0.5 ml, intramuscular injection (frequency, lot number and expiration date were not provided), which had underwent a temperature excursion. Concomitant medications were not reported. No adverse effect was reported and there was no product quality complaint involved. 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 licensed practical nurse refers to a patient of unknown age and gender. The patient pertinent medical history was not reported. On 18-FEB-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient was administered the first dose of GARDASIL (intramuscularly 0.5 ml) on 05-OCT-2013, the second dose of GARDASIL (intramuscularly 0.5 ml) on 08-FEB-2014, and the third dose of GARDASIL (intramuscularly 0.5 ml) on 17-APR-2014. No adverse effects reported. 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 23-JUN-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The medical history of the patient included chicken pox. On 29-JAN-2015 the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication instead of ZOSTAVAX. No concomitant medications were reported. No adverse events were reported. The action taken with (Oka/Merck) VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with (Oka/Merck) VARIVAX was unknown. No product quality issue was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Viral titre decreased
Clinical narrative: This spontaneous report as received from certified medical assistant and refers to a female adult patient of unknown age. The patient had the MMR II (dose, strength not reported), series on unspecified dates as a child (dates not provided). On an unknown date the patient had titers drawn which showed "less than normal" titers for mumps. The outcome of "less than normal" titers for mumps was reported as not recovered/not resolved. The relatedness between event and MMR II was not reported. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient described redness at injection site and swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, and redness around inj site (left arm) 7 cm x 6 cm (diameter).
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date, the patient may has been vaccinated with ZOSTAVAX (dose, anatomical location, lot # and expiration date were not reported) by intramuscular route. On an unknown date, the patient experienced soreness at the site of ZOSTAVAX administration. The outcome of the event was unknown. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Viral titre decreased
Clinical narrative: This spontaneous report as received from a female physician refers to herself. In January 2014 (exact date unspecified, reported as about one year ago) was vaccinated with the first and the second (series of 2 doses) RECOMBIVAX HB injection (5/0.5 mcg/ml, intramuscular, 0.5 ml each). On an unknown date, the patient had no detectable titer after receiving two pediatric doses. The patient stated that no adverse effect was reported. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Underdose
Clinical narrative: This case was reported by a pharmacist and described the occurrence of vaccine underdose in a 11-year-old male patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016). Previously experienced adverse reactions included nonspecific reaction (The patient had reactions to other vaccines, not identified, in the past). In 2014, the patient received the 1st dose of BOOSTRIX (unknown) .1 ml. On an unknown date, an unknown time after receiving BOOSTRIX the patient experienced vaccine underdose and off label use. On an unknown date, the outcome of the vaccine underdose and off label use were unknown. Additional information was provided. The office only gave him 0.1mL of the dose to see how the patient responds (no AE events from the administration reported by RPh). The 0.1mL dose was administered at 9:15AM this AM and wants to give the remainder today. The administration is not at the pharmacy by at a clinic (allergist). No adverse event was reported.
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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J004159 and expiry date: 08-APR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.97
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antibody negative, No adverse event, Seroconversion test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old female patient. On 16-JUN-1997, 08-AUG-1997 and 26-MAR-1998, the patient was vaccinated with the first, second and third dose of RECOMBIVAX HB respectively (0.5 ml, intramuscular, left arm), (lot # and expiration dates were not provided). Other suspect therapies included the first and second dose of VARIVAX (Merck) (dose, route, lot #, expiration date and dates of vaccinations were not provided). On 07-JAN-2015, the test for Hepatitis B surface antibody was negative. Therefore, a fourth dose of RECOMBIVAX HB was administered on the same date. In addition the nurse also reported that the test for VARIVAX (Merck) failed to seroconvert so another dose of VARIVAX (Merck) 0.5 ml, (subcutaneous, left arm), was given on that same date. No adverse effects reported. At the time of the report the outcome of Hepatitis B surface antibody negative and seroconversion test negative was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 13-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-JAN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client received varicella vaccine 1/6/2014 at 1400. On 1/8/2014 in a.m. client noticed site of immunization swollen, warm and reddened.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 17-JUL-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
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 a dose of M-M-R II (dose, lot number and expiration date were not reported). On an unknown date, 26 days after receiving the first dose, the patient was vaccinated with the second dose of M-M-R II. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 07-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-OCT-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014402 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-APR-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007594 and expiry date: 27-JUN-2015) which was improperly stored. Primary reproter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-JUL-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reproter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reproter. 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 30-SEP-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-NOV-2013, the patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J00681 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-JUN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reproted) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J01402 and expiry date: 13-NOV-2015 which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No average effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Right arm pain and redness.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Burning sensation, Erythema, Pruritus, Urticaria
Clinical narrative: Starte 3 hrs post injection burning, redness, progression to all over hives, itching-Tx with BENADRYL 3 days, prednisone 3 day, PROVENTIL inhaler.
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. No concurrent condition or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of VAQTA (lot number, Expiry date, dose and route were not reported) that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.
Age: 1.11
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash papular
Clinical narrative: This spontaneous report was received from a physician refers to a 59 week old male patient. The patient was possibly allergic to nuts. On 19-JAN-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K010438, expiration date: 22-JUL-2016), 0.5 ml, subcutaneous. Concomitant medications were not reported. On 29-JAN-2015, the patient experienced rash papular as he developed a papular rash on his trunk and legs. The patient sought medical attention and his parents called the physician's office. The reporting physician reported that she will be seeing the patient in her office later on the same day regarding the rash. No treatment was given for the adverse event. No product quality complaint (PQC) was reported. Outcome of the event, rash papular was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a other health professional (healthcare worker) refers to a 74 year old female patient with hypertension, diabetes, hyperthyroidism, transient ischaemic attack and high cholesterol. On 26-JAN-2015 the patient was vaccinated with PNEUMOVAX 23, intramuscular (lot # K016294, expiration date: 28-APR-2016). Concomitant therapies included lisinopril (Manufacturer unknown), clopidogrel, levothyroxine sodium (Manufacturer unkonwn), simvastatin tablets, metoprolol, metformin, anagrelide hydrochloride and KEFLEX. On 27-JAN-2015, the patient experienced injection site rash, injection site erythema and injection site warmth since she developed a hot, red, sore, 3-4 inch rash at the site of PNEUMOVAX 23 injection. On an unknown date patient went to see the physician and was treated with penicillin. Outcome of the events was reported as recovering. Causality assessment was not provided. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to site immed. on MMR and Var.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Hypoaesthesia, Paraesthesia, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a licensed practical nurse practitioner refers to a 60 year old male patient with asthma and no known drug reactions or allergies. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # K012924 and expiry date on 29-NOV-2016, (route and dose were not provided). The patient has no any concomitant medications. It was reported that patient called to reporter's office on 12-JAN-2015 complaining of numbness in his face. The patient was sent to the emergency department of an unspecified hospital due to the symptoms. The patient was diagnosed with Bell's Palsy and was prescribed prednisone and acyclovir as treatment, then, patient was released from emergency room at the same date. Patient was seen in reporter's office on 29-JAN-2015 for follow up, and it was reported that his symptoms have improved substantially since starting treatment with prednisone and acyclovir but over the previous two days he began to experience tingling and heaviness on the right side of his face. At the time of the report, the patient was recovering from Bell's Palsy. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Rash
Clinical narrative: Severe rash, soreness from elbow to shoulder (L). Same as injection site. Treated with hydrocortisone cream 1% OTC.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified patients of unknown ages and genders who on unknown date in January 2015 (reported as since 21-JAN-2015) were vaccinated with a doses of M-M-R II, subcutaneous (dose, lot # and expiration date were not reported) which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Abdominal distension, Dyspnoea, Fatigue, Full blood count, Limb discomfort
Clinical narrative: States abdomen feels fuller than usual below solar plexus and feels like invading lung space. States feels like it is strenuous to climb steps when normally no problem. States feels like might be coming down with illness. States her limbs feel heavy. Easily fatigued, hard to breathe sometimes. Small pinpoint red spots on legs ? petechiae (normal platelet count).
Age: 46.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Malaise, Platelet count normal, Rash erythematous
Clinical narrative: States abdomen feels fuller than usual below solar plexus and feels like invading lung space. States feels like it is strenuous to climb steps when normally no problem. States feels like might be coming down with illness. States her limbs feel heavy. Easily fatigued, hard to breathe sometimes. Small pinpoint red spots on legs ? petechiae (normal platelet count).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified patients of unknown ages and genders who on unknown date in January 2015 (reported as since 21-JAN-2015) were vaccinated with a doses of RECOMBIVAX HB, intramuscular (dose, lot # and expiration date were not report4ed) which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 86.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 87.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: Patient notified of PEDIARIX given in error, was to receive PREVNAR 13 (pneumococcal).
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema to injection site (mild). Pt prescribed BENADRYL 12.5/5 and hydrort cream.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture negative, C-reactive protein normal, Culture urine negative, Full blood count normal, Language disorder
Clinical narrative: Patient had MMR #1, Varicella #1 and Hepatitis A #1 vaccines on 9/15/2011. He was seen on 9/23 and 9/24/2011 for fever for three days which father claimed persisted on and off for 8-9 days. Blood and urine cx were negative. Fever went up to 103.5 F. Since then noted by parents with delayed receptive and expressive speech. Today at 4 yo check up MMR declined because of lasting of high fever. His speech is now markedly improved.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient had MMR #1, Varicella #1 and Hepatitis A #1 vaccines on 9/15/2011. He was seen on 9/23 and 9/24/2011 for fever for three days which father claimed persisted on and off for 8-9 days. Blood and urine cx were negative. Fever went up to 103.5 F. Since then noted by parents with delayed receptive and expressive speech. Today at 4 yo check up MMR declined because of lasting of high fever. His speech is now markedly improved.
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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 20-JUN-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J002302 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014002 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck),  nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports 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 a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 11-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014402 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the 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 as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-DEC-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.