chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a  patient of unknown age and gender. A nurse reported that an unspecified number of unknown patients have been administered doses of PNEUMOVAX23 lot # K008409, expiration date 04-MAR-2016, intramuscular tha have underwent a temperature excursion. It was reported that PNEUMOVAX23 was stored at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. PNEUMOVAX23 lot # K008409 was given on 10-NOV-2014, 14-NOV-2014, 18-NOV-2014, 19-NOV-2014, 24-NOV-2014, 01-DEC-2014, 09-DEC-2014, 12-DEC-2014 and on 17-DEC-2014. No adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
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. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of RECOMBIVAX HB, which were improperly stored (incorrect product storage), were administered to unspecified number of patients, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. A nurse reported that an unspecified number of unknown patients have been administered doses of VAQTA lot # K009506, expiration date 22-SEP-2015, intramuscular that have underwent a temperature excursion. It was reported that VAQTA was stored at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. VAQTA lot # K009506 was given on 07-OCT-2015, 20-OCT-2014, 22-OCT-2014, 23-OCT-2014, 31-OCT-2014, 03-NOV-2014, 10-NOV-2014 and on 11-NOV-2014. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA
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. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of VAQTA, which were improperly stored (incorrect product stored), were administered to unspecified number of patients, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were note. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
Sex: U
Vaccine: HPV2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The reporter stated that the patient received 1 dose of CERVARIX on 23-OCT-2013, after which she received a complete 3-dose series of GARDASIL on unspecified dates, for a total of 4 doses of HPV vaccine. No adverse effect 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of GARDASIL, which were improperly stored (incorrect product stored), were administered to unspecified number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician. On an unknown date the 9 months and 23 days old patient of unknown gender was inadvertently vaccinated with a dose of ROTATEQ, route defaulted to oral (dose and lot number were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. Over a year ago, on an unknown date approximately in 2014, the patient was vaccinated with ZOSTAVAX dose 1 (strength, frequency, route, lot # were not reported). On an unknown date, patient was vaccinated with ZOSTAVAX. 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 licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-AUG-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H011417 and expiry date: 07-JUN-2014) 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 as received from a nurse refers to a patient of unknown age. A nurse reported that an unspecified number of unknown patients have been administered doses of GARDASIL lot # K009482, expiration date 06-MAR-2017, lot # K006117, expiration date 14-JAN-2017 and lot # K008621, expiration date 04-MAR-2017, intramuscular that have underwent a temperature excursion. It was reported that GARDASIL was reported at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. GARDASIL lot # K009482 was given on 03-DEC-2014, 04-DEC-2014, 05-DEC-2014, 16-DEC-2014, 18-DEC-2014, 19-DEC-2014, 23-DEC-2014, 31-DEC-2014 and on 12-JAN-2015. GARDASIL lot # K006117 was given on 03-OCT-2014, 07-OCT-2014, 17-OCT-2014, 31-OCT-2014, 01-NOV-2014, 03-NOV-2014, 10-NOV-2014, 14-NOV-2014 and on 18-NOV-2014. GARDASIL lot # K008621 was given on 14-OCT-2014, 22-OCT-2014 and on 29-OCT-2014. No adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. A nurse reported that on unknown date an unspecified number of patients have been administered doses of (Oka/Merck) VARIVAX (lot #, expiration date, dose and route were not reported). It was reported that (Oka/Merck) VARIVAX was stored at a 0 Celsius degree for 24 hours. No adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
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 05-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.
Age: 1.27
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received PEDIARIX (batch number L9L2K, expiry date 5th June 2016). Previously administered products included dtap vaccine (dose 1), dtap vaccine (dose 2), dtap vaccine (dose 3 ), ipv vaccine (dose 1), ipv vaccine (dose 2), ipv vaccine (dose 3), hepatitis b (dose 1), hepatitis b (dose 2) and Hepatitis B (dose 3). On 11th November 2014, the patient received a dose of PEDIARIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administration was unknown. Additional information received: On 11/11/14 a new medical assistant to the practice gave 3 patients a dose of PEDIARIX when they were all only due to receive DTaP. All 3 doses of PEDIARIX were from lot# L9L2K (expiration date 6/5/16). They were not due for the other components in the vaccine. The first patient's initials are ND. Their previous doses of DTaP were given on 10/7/13 and 2/10/14. Their previous doses of IPV were given on 10/7/13 and 2/10/14. Their previous doses of hepatitis B were given on 8/6/13. 10/7/13 and 2/10/14. This case is one of the 3 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: HPV2
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received CERVARIX (batch number unknown, expiry date 21st September 2014). In November 2014, the patient received CERVARIX. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Pharmacist calling on behalf of a vaccination clinic with minimal information at the time of the call. Last week (exact date unknown) a patient received an injection of an expired CERVARIX vaccine (Sept 21 2014).
Age: 74.0
Sex: M
Vaccine: DTAP
Symptoms: Underdose, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 74-year-old male patient who received INFANRIX (batch number 2J534, expiry date 13th September 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered, wrong vaccine administered and underdose. On an unknown date, the outcome of the wrong vaccine administered, wrong vaccine administered and underdose were unknown. Additional information received: 74 years old male patient received a dose of INFANRIX instead of the intended BOOSTRIX.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccine underdose in a 19-year-old female patient who received HAVRIX 720 Junior (batch number M7L59, expiry date 26th December 2016). On an unknown date, the patient received HAVRIX 720 Junior. On an unknown date, an unknown time after receiving HAVRIX 720 Junior, the patient experienced vaccine underdose and wrong vaccine administered. On an unknown date, the outcome of the vaccine underdose and wrong vaccine administered were unknown.
Sex: U
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX. Co-suspect products included HAVRIX and ENGERIX B. On an unknown date, the patient received KINRIX at an unknown dose, HAVRIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, HAVRIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Unstable KINRIX, HAVRIX and ENGERIX were administered. HCP does not have additional patient info for AE.
Sex: F
Vaccine: DTP
Symptoms: Hypotension
Clinical narrative: This case was reported by a physician and described the occurrence of low blood pressure in a female patient who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTP vaccine, the patient experienced low blood pressure. On an unknown date, the outcome of the low blood pressure was unknown. It was unknown if the reporter considered the low blood pressure to be related to DTP vaccine. Additional information received: Pharmacist reported that a patient developed a severe reaction such as her blood pressure "bottoming out" after receiving a DTP vaccine and was sent to an emergency room. No further information was provided.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received HAVRIX 1440 adult. On 21st November 2014, the patient received HAVRIX 1440 adult 1 ml. On an unknown date, an unknown time after receiving HAVRIX 1440 adult, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and accidental overdose were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and accidental overdose to be related to HAVRIX 1440 adult. Additional information received: Adult dose of HAVRIX given to a 2 year old boy by mistake. No further details readily available.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU3, FLU4, HEP, HEPA, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was treated by a other health professional and described the occurrence of incorrect storage of drug in a patient who received INFANRIX. Co-suspect products included PEDIARIX, KINRIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLUARIX QUADRIVAENT. On an unknown date, the patient received INFANRIX at an unknown dose, PEDIARIX at an unknown dose, KINRIX at an unknown dose, HAVRIX at an unknown dose, ENGERIX B at an unknown dose, BOOSTRIX at an unknown dose, FLUARIX at an unknown dose and FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, PEDIARIX, KINRIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLUARIX QUADRIVALENT, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Vaccines stored at too cold of temperature were administered to multiple unknown patients. INF, PDX, KIN, HVR, ENG-B, BST, FLX, FLX QIV all exposed on multiple occasions since 10/1/14 to colder temperatures to 31 deg F. They were reading manual thermometers mornings and evenings. Now they have these 31 deg F recordings since they put in place continuous monitoring and VFC is requiring them to contact us. They have given over the past month these exposed vaccines to various children in this clinic. Nurses were under impression if temp got below 32, as long as it got back up it was ok. Long-standing practice according to this administrator. They will have to back track to see patients were given the vaccine now.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. Concurrent condition included allergy to preservatives (unspecified). No medical history and concomitant medication were reported. On unspecified day in 2009 (reported as 6 years ago), the patient was vaccinated with pneumococcal vaccine (23-valent) (manufacturer unknown) (dose, route. lot number and expiration date were not reported). On unspecified day in 2009 (reported as 6 years ago), the patient had an allergic reaction to the pneumococcal vaccine (23-valent) (manufacturer unknown). At the time of vaccination the patient was informed by her physician that the pneumococcal vaccine, (23-valent) (manufacturer unknown) was packed in preservatives. The outcome of an allergic reaction was not reported. The relatedness between the event and pneumococcal vaccine, (23-valent) (manufacturer unknown) was not provided. No product quality complaint was filled. Additional information is not expected as the patient did not complete the report and decline to provide the contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practitioner Nurse refers to a patient (age and gender not reported) who on 27-JAN-2015, was vaccinated with an expired ZOSTAVAX (Lot No. J013451, exp. 24-JAN-2015), 0.65 ml, subcutaneous in the left arm. No adverse effect has been reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown date. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information: A 4 month old patient received KINRIX instead of INFANRIX. Doctor did not know the patient's DOB, initials nor vaccine lot number or expiration date.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, route, lot # were not reported) dose 1. Concomitant therapy was not reported. On an unknown date, the patient experienced severe rash after administration of the first dose of M-M-R II. Patient sought medical attention by an office visit. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of severe rash was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse and described the occurrence of extra dose administered in a 6-year-old male patient who received KINRIX (batch number KJ924, expiry date 22nd October 2015). Concomitant products included KINRIX. On 14th October 2014, the patient received the 2nd dose of KINRIX. On 14th October 2014, an unknown time after receiving KINRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: A 6 years old child was immunized with 2 doses of KINRIX as catch-up vaccination in the primary series of DTAP>
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of drug dose administration interval to long in a male patient who received ENERIX B. Previously administered products included ENGERIX-B. In November 2014, the patient received the 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information: The 2nd dose of ENGERIX-B was late (administered today?). The 1st dose was administered in June 2014.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This case was reported by a nurse and described the occurrence of vaccine underdose in a 19-year-old female patient who received HAVRIX (batch number 4GY72, expiry date unknown). Previously administered products included HAVRIX. On 25 November 2014, the patient received the 2nd dose of HAVRIX .5 ml. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. It was unknown if the reporter considered the vaccine underdose to be related to HAVRIX. Additional information: 0.5ml of HAVRIX given to a patient who had just turned 19 year old, as the second dose in series.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a 24 year old female patient. Patient's pertinent medical history and drug reactions were unspecified. On 11-DEC-2014 the patient was vaccinated with dose 1 of GARDASIL series. Concomitant medications were reported as prenatal vitamins. On an unknown date, the patient experienced exposure during pregnancy as she became pregnant shortly after administration of GARDASIL. On an unknown date, patient sought medical attention and visited physician's office. On an unknown date urine human chorionic gonadotropin (HCG) and serum HCG tests were performed. The LMP and EDD were not known. Outcome of the adverse event was reported as unknown. No product quality complaint (PQC) was involved. The causality was unspecified. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of Hepatitis B vaccine (manufacturer unknown) (dose, dose number, lot/batch# and expiration dates were not reported). On an unknown date(s)(reported as years later), when the titers were drawn for Hepatitis B on these patients, the titers were low. The outcome of the event was unknown. The relatedness between the event and Hepatitis B vaccine (recombinant) (manufacturer unknown) was not reported. This is one of the several reports from the same reporter. Additional information is not expected as the physician did not wish to be contacted.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received INFANRIX (batch number AT57M, expiry date 19th June 2016). On 10th September 2014, the patient received the 1st dose of INFANRIX. On an unknown date, the dose was an unknown dose. On 10th September 2014, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. INFANRIX was continued with no change. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: On 10 September 2014, HCP gave a dose of INFANRIX to a 7 year old patient as the 1st dose in the DTaP series.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, RV1, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. Co-suspect products included BOOSTRIX, PEDIARIX, KINRIX, INFANRIX, ROTARIX and ENGERIX B. On an unknown date, the patient received HAVRIX at an unknown dose, BOOSTRIX at an unknown dose, PEDIARIX at an unknown dose, KINRIX at an unknown dose, INFANRIX at an unknown dose, ROTARIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, BOOSTRIX, PEDIARIX, KINRIX, INFANRIX, ROTARIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Several of GSK vaccines were exposed to temperatures below 32F and some patients were administered these vaccines. No details available.
Age: 23.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: Injection site pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102. 0 (reported via patient). Left arm pain/shoulder pain. Mild nausea (intermittent).
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old male patient who received INFANRIX (batch number AT57M, expiry date 19th June 2016). On an unknown date, the patient received INFANRIX (injection) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administration and inappropriate age at vaccine administration were unknown. Additional information: The patient inadvertently received INFANRIX instead of BOOSTRIX. No adverse event 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 09-SEP-2014, the patient was vaccinated with VARIVAX (Merck) (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 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 30-OCT-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (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 (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: 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 14-OCT-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J014235 and expiry date: 07-MAY-2015) 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 age 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.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Two tone reddened area upper right arm. Lighter red area 75mm x 70mm with dark red area 35mm x 30mm. Slight itching, denia burning.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: By night the site of the immunization was sore and swollen. It is hard to move arm. Has not taken any medication.
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 27-SEP-2013, the patient was vaccinated with PROQUAD (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, 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. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Vaccinated with ZOSTAVAX in 2013. Diagnosed with shingles last week.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: Received the PNEUMOVAX 23 23/0.5 inj Marc vaccine on 1/14/15. Had the following side effects: fever, chills, rash, muscle aches, fatigue, tenderness, headache, joint pain, and warmth, redness, swelling at injection site for four days. Unable to lift arm (injection site) above head for 24 hours after injection.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Joint warmth, Myalgia, Pyrexia
Clinical narrative: Received the PNEUMOVAX 23 23/0.5 inj Marc vaccine on 1/14/15. Had the following side effects: fever, chills, rash, muscle aches, fatigue, tenderness, headache, joint pain, and warmth, redness, swelling at injection site for four days. Unable to lift arm (injection site) above head for 24 hours after injection.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Tenderness
Clinical narrative: Received the PNEUMOVAX 23 23/0.5 inj Marc vaccine on 1/14/15. Had the following side effects: fever, chills, rash, muscle aches, fatigue, tenderness, headache, joint pain, and warmth, redness, swelling at injection site for four days. Unable to lift arm (injection site) above head for 24 hours after injection.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: Rash, tingling (pins and needles) about a week after shot. Treatment possible acyclovir tabs and Caspsaicin cm.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site urticaria
Clinical narrative: 4 days after MENACTRA vaccine noticed one hive at site of shot. lasted 3 days. BENADRYL given on Sun and Mon. No other symptoms. No fever. No rash.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning 5 patients of unknown age and gender. Relevant medical history was not reported for any of the patients. The pharmacist stated the 5 patients had expired product administered, as they were inadvertently administered ZOSTAVAX, lot number J012660, with expiry date of 10-JAN-2015 (dose and route were not provided), between the dates of 11-JAN-2015 through 28-JAN-2015. Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. Nurse reporting that a patient did not receive the GARDASIL (0.5 ml, intramuscularly) series at the correct intervals. Dose 1 was administered sometime in April 2012, Dose 2 was administered sometime in July 2014 and Dose 3 was administered on 04-AUG-2014. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown gender and age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with the first doses (one dose) of VARIVAX (Merck) (dose, lot/batch#, expiration dates were not reported). It was reported that since 1996, when VARIVAX (Merck) was approved and only one dose was indicated, about 25 percent of vaccinated patients ended up with the wild type of chicken pox (dates unspecified). The outcome of the event was unknown. The relatedness between the event and VARIVAX (Merck) was not reported. This is one of the several reports from the same reporter. Additional information is not expected as the physician did not wish to be contacted.
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 25-JUL-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J014235 and expiry date: 07-MAY-2015) 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.
Age: 15.0
Sex: F
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Blood test normal, Swelling, Tenderness, Thyroiditis
Clinical narrative: 1/13/15 pt. had tenderness and swelling along cervical and supraclavicular lymph node locations. 1/14/15 pediatrician diagnosed "thyroiditis" inflammatory. Blood work was all WNL. 1/28/15 Mother calls to report thyroiditis has resolved. No specific treatment.
Age: 15.0
Sex: F
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Blood test normal, Lymph node pain, Lymphadenopathy, Thyroiditis
Clinical narrative: 1/13/15 pt. had tenderness and swelling along cervical and supraclavicular lymph node locations. 1/14/15 pediatrician diagnosed "thyroiditis" inflammatory. Blood work was all WNL. 1/28/15 Mother calls to report thyroiditis has resolved. No specific treatment.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a child of unknown age and gender who on 13-JAN-2015, at 15:45, was vaccinated with a dose of MMR II (lot # K001231, expiration date 27-JAN-2016). Relevant medical and drug history was unknown. Relevant concomitant medication was unknown. On 13-JAN-2015, the refrigerator in the office went out of range and there was a temperature excursion of 2 hours and 45 minutes at a maximum temperature of 50.9 degrees Fahrenheit. The child was given the MMR II that experienced the temperature excursion at 15:45 on 13-JAN-2015 when the refrigerator temperature was 48 degrees Fahrenheit. The temperature excursion was supported. No adverse event were reported. It was unknown if there were any laboratory data. The outcome of getting the vaccine that experienced a temperature excursion was unknown. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Patient had temp of 104 on the 20th. Was given instructions to rotate TYLENOL and MOTRIN until fever comes down.
Age: 0.9
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site redness noted, rock hard, warm to the touch. That developed the evening after his D.V in AM. For injections on pt's (L) thigh only.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Varicella given (R) thigh rash (R) thigh started 1/27/15 now 2 x 3 cm erythema rash (R) thigh.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. The reporting pharmacist stated that an some improperly stored doses of ZOSTAVAX lot # K009810, expiration date: 10-OCT-2015 were administered (route of administration was unknown) to an unspecified number of patients on 01-JAN-2015 and 14-JAN-2015. No concomitant medication was reported, neither was any adverse event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccine underdose in a 21-year-old female patient who received HAVRIX (batch number 59N59, expiry date 5th September 2016). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX Junior, the patient experienced vaccine underdose and wrong vaccine administration. On an unknown date, the outcome of the vaccine underdose and wrong vaccine administered were unknown. Additional information received: Maladministration: Adult 21 years of age (Female) was given 720 EL.U instead of 1440 EL.U.
Age: 0.6
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrene of inappropriate age at vaccine administration in a female patient who received KINRIX (batch number 95ZT7, expiry date 10th October 2015). On an unknown date, the patient received KINRIX. On an unknwno date, an uknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: A 7 months old was administere with KINRIX as her 2nd DTAP and 2nd IPV.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose
Clinical narrative: This case was reported by a nurse and described the occurrence of accidental overdose in a 11-year-old male patient who received HAVRIX (batch number 4G7P2., expiry date 3rd October 2015). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information received: A 11 years old child was given an adult dose of HAVRIX by accident.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 8-week-old female patient who received PEDIARIX (batch number AC21B370AA, expiry date 16th August 2014). On 19th November 2014, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Nurse reports an expired vaccine was accidentally administered to a patient. No AEs reported as a result of the administration.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Mumps antibody test negative
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner refers to a 38 year old female patient without pertinent medical history and allergies. On an unknown date in 1983, the patient was vaccinated with one dose of M-M-R II, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported) when the patient was 7 years old. No concomitant therapy. The reporter stated that the patient was "about 12 weeks" pregnant (Maternal exposure before pregnancy). The patient became pregnant with and estimated last menstrual period (LMP) of 29-OCT-2014 and estimated date of delivery (EDD) of 05-AUG-2015. On 15-JAN-2015, the patient had a titer drawn an d the result of it was mumps antibody test negative described as the patient was negative for mumps. The reporter stated that the patient who is also a physician had a titer drawn because she was going to start a new job at a hospital. It was reported that the patient did not seek medical attention and treatment was not given for the event. The pregnancy outcome was outcome pending. Th outcome of mumps antibody test negative was unknown. The relatedness between mumps antibody test negative and therpay with M-M-R II was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: 1/29/15 1:30 pm. Pt received vacc in clinic 1/28 at 10:30 AM. Went to school after visit and had dinner that evening. (L) deltoid site swollen at both inj sites with redness 2" diameter. No swell/redness on (R) deltoid. 1/29 woke up 7 AM but school closed back to bed until 9 AM. Woke up c/o dizziness, stomach ache, one episode of emesis small amt of fluid. No fever, napping this PM. To continue with fluids and progress diet as tolerated. (L) arm swelling resolving. To urgent care if sxs worsen.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: 1/29/15 1:30 pm. Pt received vacc in clinic 1/28 at 10:30 AM. Went to school after visit and had dinner that evening. (L) deltoid site swollen at both inj sites with redness 2" diameter. No swell/redness on (R) deltoid. 1/29 woke up 7 AM but school closed back to bed until 9 AM. Woke up c/o dizziness, stomach ache, one episode of emesis small amt of fluid. No fever, napping this PM. To continue with fluids and progress diet as tolerated. (L) arm swelling resolving. To urgent care if sxs worsen.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report received from pharmacist refers to 75 year old female patient with no drug reactions or allergies and no pertinent medical history who on 01-DEC-2014 was vaccinated with a dose of ZOSTAVAX (lot # K010630, expiration date 30-OCT-2015) (dose and route were not reported). There was no concomitant therapy. On 28-DEC-2014 the patient developed a small rash on her face which patient believed it to be a small outbreak of shingles but the patient's physician had not confirmed that it was shingles. No treatment was given. No laboratories diagnostic tests were performed. The patient sought medical attention saw a physician. At the time of the report the outcome of rash was unknown. 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 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 unknown date, an unspecified number of patients were vaccinated with doses of GARDASIL, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported) which underwent a temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. No concurrent conditions or medical history were provided. The patient was vaccinated with three doses of M-M-R II injection (strength, dose, route of administration, lot# and expiry date unspecified for all) on unspecified dates. No concomitant medications were reported. On an unknown date, the patient had the titers drawn and it showed that she was not immune. It was also stated she was breastfeeding at the time of report. The outcome of the events was unknown. The relatedness between the events and M-M-R II was not reported. Additional information is not expected as there is no patient and physician's contact information and we could not do follow up with them.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness to (L) deltoid area, swollen, tender to touch
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about concurrent condtions and medical history were not providd. The healthcare worker reported that an unspecified amount of doses of GARDASIL that underwent a temperature exursion was administered to an unspecified amount of patients (0.5 ml, intramuscular, lot# not reported) on unspecified dates. No adverse effect reported. The outcome of the event was not 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 18-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 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: 59.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 59 year old patient of unknown gender. Patient's medical history, current condition and concomitant therapy were not provided. On 26-JAN-2015, the patient was vaccinated with a dose of expired PNEUMOVAX 23, lot # J005068, expiration date 18-JAN-2015, 0.5 ml, intramuscular in the right deltoid. No adverse effects were reported. Additional information has been requested.