chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 1.6 inch x 2.25 inch area of redness surrounding injection site on top of leg (RVL) that began at 9 pm on 04/08/2015. 4 cm area of redness on side of leg (RALT) that began at noon on 04/08/2015.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant), refers to an unspecified patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with one dose of an improperly stored (Merck) VARIVAX lot # K005179, expiry date 10-APR-2016 (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, different unspecified patients were vaccinated with about 19 doses" of improperly stored PROQUAD (Merck) lot # L002419, expiry date 23-JUL-2016, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a consumer referring to his wife, a female patient of unknown age. No relevant medical history or concurrent conditions were reported. On 10-OCT-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 mcg/ml (lot #, expiration date, dosage and route were not provided). The second and third doses were vaccinated on 07-NOV-2014 and 10-MAY-2015 respectively for the same indication (both lot#s, expiration dates dosages and routes were not provided). The reporter stated that in approximately 2015, the patient experienced an anti-HBs antibody negative, reported as "she was not immunized for hepatitis B", which was considered as very unusual by the physician. The outcome of the anti-HBs antibody negative was unknown at the time of this report. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Dry skin, Erythema, Skin exfoliation
Clinical narrative: Information has been received from a female consumer of unknown age referring to herself. The patient's pertinent medical history and drug allergies were not reported. On an unknown date of 2014 (reported as last year) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, strength and route unknown). On an unknown date of 2015 (reported as this year) the patient experienced a thumbnail sized flaky red spot with a pimple. The spot of the red pimple was dry and flaky. The outcome of the event was unknown. Causality was not provided. Additional information is not expected since there is no physician's contact information.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has ben received from a nurse referring to an 11 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 15-DEC-2015 the patient was vaccinated with an expired dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015; dose and route not reported). No adverse experience had been reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Anaphylactic reaction, Palpitations
Clinical narrative: Case number PHEH2015US019201, is an initial spontaneous report from a health care professional received on 24 Sep 2015. This report refers to a 54 years old male patient. The patient had a thyroid condition and was allergic to eggs/yolks. Concomitant medications which were over the counter included AMBIEN, ATIVAN, FLONASE and multivitamins. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly on an unknown date. On an unknown date after vaccination the patient experienced heart palpitations and anaphylaxis. as a result of the reaction the patient took BENADRYL and was stable at the time of this report. Final outcome of the events was unknown. Seriousness and causality of the events were not reported. Seriousness assessment of anaphylaxis was upgraded based on the NVS-IMS list.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via direct contact, Eye irritation
Clinical narrative: This spontaneous report has been received from a female pharmacist of unknown age, who was reporting on herself. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-DEC-2015, the pharmacist was splashed with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported) in both eyes before administration; she experienced inadvertent vaccine contact with eyes. On the same date, she experienced mild burning in both eyes. The patient did not seek medical attention. The outcome of burning in both eyes was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to a 49 year old male patient. The patients' pertinent medical history and drug allergies were not reported. On 26-JUN-2015 the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 mcg/ml (lot#, dose, strength and route unknown). On 09-DEC-2015 the patient was vaccinated with the second dose of RECOMBIVAX HB 10/1.0 mcg/ml (lot # L026598 with expiration date of 26-JUN-2017, 1.0 ml, intramuscular). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 13-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US017681, is an initial spontaneous report received from a pharmacist on 07 Sep 2015. This report refers to a 12 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: not reported) intramuscularly on 05 Sep 2015. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Sex: U
Vaccine: FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US018120 is an initial spontaneous report received from a nurse on 15 Sep 2015. This report refers to a patient whose age was not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly on 14 Sep 2015. It was reported that the vaccine administered was expired and it was given to the patient in error by another member of the nursing staff. No adverse events were reported following the medication error.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 02-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US018176, is an initial spontaneous report from a pharmacist received on 15 Sep 2015. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173906) intramuscularly on 14 Sep 2015. No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose and route were not reported, lot # L039659, expiration date 15-MAR-2017). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US018401 is a spontaneous report initially received from a nurse on 15 Sep 2015. This report refers to a 51 year old male patient. Past medical history and concomitant medications were not reported. The patient's vaccination history included seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2015 which was tolerated well. The patient was vaccinated with initial dose of FLUCELVAX (batch number: 006011A) at a dose of 0.5 ml intramuscularly in the left deltoid on 11 Sep 2015 which was of season 2013/2014 and the vaccine was outdated. The reporter enquired how to proceed with this year's flu vaccine. No adverse event occurred following the maladministration (expired vaccine used). Follow up information received from a nurse on 28 Oct 2015: Updated patient demographics (initial, date of birth, age, gender, height and weight), suspect vaccine was coded from influenza unknown to FLUCELVAX, dose, route, site, vaccination date and batch number of suspect vaccine and vaccination history.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, (dose was not reported, lot # L020859, expiration date 19-JAN-2017). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an adolescent female patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. In approximately 2011 (reported as approximately 4 years ago), when the patient was 16 years old, she was vaccinated with the first dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On 10-DEC-2015, the patient was in the office and would be administered a dose of GARDASIL 9 (lot #, expiration date, exact dose and route of administration were not reported), as the second dose in the series. No adverse effects were reported. No PQC (product quality complaint) was involved. The outcome of interchange of vaccines was unknown. The relatedness between this event and suspect therapies was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US019081, is an initial spontaneous report received from a nurse on 24 Sep 2015. This report refers to a 19 year old female patient. Past medical history and concomitant medication was not reported. Vaccination history was reported as unknown. The patient was vaccinated with FLUCELVAX (batch number: 173252) subcutaneously into the lower left arm at a dose of 0.5 ml at 2:00 PM on 23 Sep 2015. No adverse event was reported. The case was reported as non-serious. A follow-up report received from the nurse on 02 Nov 2015: Updated patient demographics, dose, vaccination time, vaccination site and other clinically relevant information in the narrative.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, frequency, route of administration and indication were not reported, lot number# J016187, expiration date: 21-OCT-2016, K002746, expiration date: 09-DEC-2016, K011077 expiration date: 30-MAR-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUC3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2015US019222 is an initial spontaneous report from a health care professional on 29 Sep 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date. It was reported that accidentally the patient again received one more dose of FLUCELVAX (batch number: not reported) on the date before reporting. No adverse event reported following this medication error (inappropriate schedule of vaccine administered).
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US019290, is an initial spontaneous report received from a pharmacist on 28 Sep 2015. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly 23 Sep 2015. No adverse event was reported. No further information was provided.
Age: 17.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020966 is an initial spontaneous report from a nurse received on 15 Oct 2015. This report refers to a 17-year-old patient of an unknown gender, who was inadvertently vaccinated with FLUCELVAX (batch number: 17087A) at a dose of 0.5 ml intramuscularly on an unknown date. No adverse event reported following this medication error.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020983, is an initial spontaneous report from a pharmacist received on 15 Oct 2015. This report refers to a 16 months old female patient. Medical history and concomitant medications were not reported. The pediatric patient was vaccinated with FLUCELVAX (batch number: 173991) 0.5 ml intramuscular in error. The case was assessed as non-serious. No adverse event was reported following this medication error.
Age: 0.83
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020987, is an initial spontaneous report from a pharmacist received on 15 Oct 2015. This report refers to a 10-months old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 09 Oct 2015. No adverse event reported following this medication error (inappropriate age at vaccine administration).
Age: 1.4
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020988 is an initial spontaneous report from a pharmacist received on 15 Oct 2015. This report refers to a 16-months-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number:173991) at a dose of 0.5 ml intramuscularly on 09 Oct 2015. No adverse event reported following this medication error.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency, route of administration and indication were not reported, lot number# L018499 expiration date: 25-FEB-2017, L022259 expiration date: 06-APR-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US019298, is an initial spontaneous report received from a pharmacist on 28 Sep 2015. This report refers to a 10 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly 23 Sep 2015. No adverse event was reported. No further information was provided.
Age: 16.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020466, is an initial spontaneous report received from a pharmacist on 09 Oct 2015. This report refers to a 16 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscular on 09 Oct 2015. No adverse event was reported following the maladministration (inappropriate age at vaccine administered). No further information was provided.
Age: 16.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020653 is an initial spontaneous report received from a pharmacist on 08 Oct 2015. This report refers to a 16 year old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 173991, expiry date: 31 May 2016) on 09 Oct 2015. No adverse events were reported following the maladministration.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US019749, is an initial spontaneous report received from a healthcare professional on 02 Oct 2015. This report refers to a 14 year old pregnant female patient. Medical history and concomitant medication was not reported. Nurse reported that she administered FLUCELVAX (batch number: 173988) intramuscular to this pregnant patient on 01 Oct 2015. No adverse event was reported. No further information was provided.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021097, is an initial spontaneous report received from a healthcare professional  on 19 Oct 2015. This report refers to an 11 years old male patient. Medical history and concomitant medication were reported as unknown. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 16 Oct 2015. It was reported that the patient was under the age of 18 years and received the vaccine inadvertently. No adverse event was reported following this medication error.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021006, is an initial spontaneous report from a nurse received on 13 Oct 2015. This report refers to a 16-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unknown date. The patient did not experience any side effects or reactions due to the vaccine.
Age: 9.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021055, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to a 9 year old male patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml on 14 Oct 2015. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Sex: F
Vaccine: FLUC3
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: Case number PHEH2015US022884 is an initial spontaneous report received from a consumer on 03 Nov 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 03 Nov 2015. It was reported that she was breast feeding. No adverse events were reported following the vaccination.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2015US021674, is an initial spontaneous report from a health care professional received on 22 Oct 2015. This report refers to a 13-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX (batch number: 173989) intramuscularly on 22 Oct 2015. No adverse event was reported.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021092, is an initial spontaneous report received from a healthcare professional on 19 Oct 2015. This report refers to a 13 years old female patient. Medical history and concomitant medication were reported as unknown. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 16 Oct 2015. It was reported that the patient was under the age of 18 years and received the vaccine inadvertently. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US021015, is a combined initial and follow-up spontaneous report from a nurse received on 16 Oct 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173537, expiry date: Apr 2016 subcutaneously on 16 Oct 2015. No adverse event was reported following this medication error.
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021221, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 12 years old female patient. Medical history and concomitant medications were not reported. The patients was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 16.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020960, is an initial spontaneous report from a nurse received on 15 Oct 2015. This report refers to 16 years old patient of an unknown age. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 17087A) at a dose of 0.5 ml intramuscularly on an unknown date. The case was assessed as non-serious. No adverse event was reported.
Age: 10.0
Sex: F
Vaccine: FLUC3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US023393 is an initial spontaneous report received from a pharmacist on 09 Nov 2015. This report refers to a 10 year old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 173906) intramuscularly at a dose of 0.5 ml on 07 Nov 2015. No adverse events were reported following the maladministration.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019572, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 43 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020454, is an initial spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration.
Age: 18.0
Sex: M
Vaccine: FLUC3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020217 is an initial spontaneous report from a pharmacist received on 08 Oct 2015. This report refers to a 18-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 06 Oct 2015. On 08 Oct 2015, the patient was inadvertently vaccinated with FLUCELVAX (batch number: 173253) intramuscularly. No adverse event reported following this medication error (inappropriate schedule of vaccine administered).
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US022999, is an initial spontaneous report from a health care professional on 06 Nov 2015. This report refers to an 11-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient (under 18 years) was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly on 05 Nov 2015. No adverse event was reported.
Age: 81.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020238, is an initial spontaneous report from a pharmacist received on 09 Oct 2015. This report refers to an 81 years old male patient. Medical history and concomitant medications were not reported. On 02 Oct 2015 the patient was vaccinated with FLUCELVAX (batch number: 161211) that were expired on 01 May 2015. No adverse event was not reported.
Age: 81.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020451 is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to an 81 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration.
Sex: F
Vaccine: FLUC3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2015US019274, is an initial spontaneous report from a pharmacist received on 28 Apr 2015. This report refers to a pregnant female patient of an unknown age. Medical history and concomitant medications were not reported. Last menstrual period (LMP) was not reported. On an unknown date, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly. No adverse event was reported.
Age: 66.0
Sex: M
Vaccine: FLUC3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020344, is an initial spontaneous report from a pharmacist received on 09 Oct 2015. This report refers to a 66 years old male patient. Medical history and concomitant medications were not reported. The patient received two doses of FLUCELVAX (batch number: 174058) intramuscular on 30 Sep 2015. No adverse event was reported.
Age: 81.0
Sex: M
Vaccine: FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020445 is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to an 81 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration.
Age: 65.0
Sex: F
Vaccine: FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020449 is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to a 65 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration. The pharmacist stated that the patient was doing well and would be re-vaccinated. Following an internal review on 28 Oct 2015, it was found that the case PHEH2015US020230 was a duplicate PHEH2015US020449. Hence all the information from case PHEH20105US020230 was merged into PHEH2015US020449 and the case PHEH2015US020230 would be deactivated. Merged information included reporter's comment in the narrative (patient was doing well and would be re-vaccinated).
Age: 64.0
Sex: M
Vaccine: FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020453, is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015 with a follow up information received from the pharmacist on 09 Oct 2015. This report refers to a 64-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: 01 May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. The reporter stated that the patient was doing well and no adverse events were reported following the maladministration. The patient would be re-vaccinated. No further information was provided. Follow up information received from the pharmacist on 09 Oct 2015: Updated expiry date and reporter's comment.
Age: 75.0
Sex: M
Vaccine: FLUC3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020455, is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to a 75-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX, (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported, lot number# L016427 with expiration date: 13-APR-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. The patients were vaccinated with incorrectly stored ROTATEQ (lot no. K016263, expiry date 26-JUN-2016) since 28-JUL-2015. Concomitant medications of the patients were unknown. No other adverse events were reported. The outcome of the incorrect product storage was unknown. No product quality complaint was reported. This is one of the 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 vocational nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 04-DEC-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # K026385, expiration date 15-DEC-2016 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021056, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to a 17 year old male patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml on 14 Oct 2015. The case was reported as non-serious. No adverse event was reported following the maladministration
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 11-DEC-2015, the patient was vaccinated with the second dose of VARIVAX injection, lot # K026385, expiration date 15-DEC-2016 (dose and route of administration were not provided) that was improperly stored. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US019297, is an initial spontaneous report received from a pharmacist on 28 Sep 2015. This report refers to a 12 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly 23 Sep 2015. No adverse event was reported. No further information was provided.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US019413, is an initial spontaneous report received from a pharmacist on 30 Sep 2015. This report refers to an 11 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: unknown) at a dose of 0.5 ml intramuscularly 29 Sep 2015. No adverse event was reported. No further information was provided.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US019416, is an initial spontaneous report received from a pharmacist on 30 Sep 2015. This report refers to a 16 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: unknown) at a dose of 0.5 ml intramuscularly 29 Sep 2015. No adverse event was reported. No further information was provided.
Sex: U
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US019417, is an initial spontaneous report from a pharmacist received on 30 Sep 2015. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX (batch number: 173252) subcutaneously on an unknown date. No adverse event was reported.
Age: 61.0
Sex: M
Vaccine: FLUC3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2015US019425, is an initial spontaneous report from a pharmacist received on 29 Sep 2015. This report refers to a 61 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174271) intramuscularly on 24 Sep 2015. Further the patient was administered a second dose of FLUCELVAX (batch number: 174271) on 28 Sep 2015. No adverse event was reported.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019552, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 57 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) at a dose of 0.5 ml intramuscularly on 23 Sep 2015. It was reported FLUCELVAX was at room temperature for 24 hours before administration. No adverse event was reported.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019559, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 55-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that the FLUCELVAX was stored at room temperature for 24 hours was administered to the patient. No adverse event was reported following the medication error.
Age: 27.0
Sex: U
Vaccine: FLUC3
Symptoms: Arthralgia
Clinical narrative: Case number PHEH2015US021287, is an initial spontaneous report from a nurse received on 18 Oct 2015. This report refers to a 27 years old patient of an unknown gender. Medical history included injured LT MCL (left medial collateral ligament). Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173991, expiry date: May 2016) on 14 Oct 2015. On the same day, two hours after vaccination the patient experienced pain in previously injured LT MCL (pain in joint involving lower leg). It was reported that the pain had increased in severity within 24 hours after the vaccination. Final outcome of the event was unknown. Seriousness and causality of the event was not reported.
Age: 33.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHEH2015US021282 is an initial spontaneous report received from a nurse on 19 Oct 2015. This report refers to a 33 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 28 Sep 2015. On an unknown date the patient experienced pain and redness at site for several days. She visited physician and was prescribed NSAID and Physical Therapy. Outcome of the events was reported as unknown. The events were reported as non-serious and causality of the events was not reported.
Age: 16.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US023400 is an initial spontaneous report received from a pharmacist on 09 Nov 2015. This report refers to a 16 year old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 173906) intramuscularly at a dose of 0.5 ml on 07 Nov 2015. The case was reported as non-serious. No adverse events were reported following the maladministration.
Age: 16.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US023399 is an initial spontaneous report received from a pharmacist on 09 Nov 2015. This report refers to a 16 year old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 173906) intramuscularly at a dose of 0.5 ml on 07 Nov 2015. No adverse events were reported following the maladministration.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a 71 year old female patient who was reporting on herself. The patient's medical history was not provided. Her concurrent conditions included high blood pressure. On 04-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (1 shot, subcutaneously; dose, lot # and expiration date were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and CRESTOR. On 05-DEC-2015, the patient experienced giant itchy hive on arm with redness and swelling. It was provided that the symptoms were localized at the site of ZOSTAVAX injection. The patient sought medical attention via a contact with an unspecified pharmacy. No treatment was given for the adverse events and none lab diagnostics studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 2 unspecified male patients, over the age of 15 years. On an unknown date the patients were vaccinated (on parents request) with doses of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot number and expiration dates unspecified). No adverse experience was reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021098, is an initial spontaneous report received from a health care professional on 19 Oct 2015. This report refers to a 5 year old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 16 Oct 2015. The case was reported as non-serious. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthma
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of asthmatic attack in a 19-year-old female patient who received BEXSERO (batch number 148901A, expiry date 30th September 2016). On 31st August 2015, the patient received BEXSERO .5 ml. In September 2015, several days after receiving BEXSERO, the patient experienced asthmatic attack. On an unknown date, the outcome of the asthmatic attack was recovered/resolved. It was unknown if the reporter considered the asthmatic attack to be related to BEXSERO. Additional details were received as follows: In September 2015, few days after receiving BEXSERO vaccine, the patient experienced asthma attack. The date when patient experienced asthma attack was not available.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (strength, dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. this is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored MMR II (strength, dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.