chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 December 2013. The patient had received ACT HIB vaccine which was reconstituted might with sterile saline instead of 0.4 saline. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 11 September 2013. This is an invalid case as individual patient identifiers are missing. It was reported that sterile water was used to reconstitute Act-HIB vaccine and was administered to the patients. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 January 2014. Some patients (no information was provided regarding patients) had received a dose of Tetanus Toxoid Adsorbed on an unspecified date. It was reported that expired vaccine was administered. No adverse event was reported. List of documents held by sender: none.
Age: 0.1
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 September 2013. A 04-week-old patient had received a dose of ACTHIB on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 September 2013. This is an invalid case as individual patient identifiers are not reported. Some patient (No information was provided regarding the patient) had received expired dose of ACTHIB vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 13 September 2013. This is an invalid case as individual patient identifiers are not reported. The patient had received ACTHIB which was mixed with MMR diluent. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial case was received from a healthcare professional on 14 November 2013. A patient whose age, gender and medical history were not reported had received a dose of ACTHIB on an unspecified date (anatomical site, dose and batch number not reported). Patient had not reported concomitant medication. It was reported that patient had received vaccine which was incorrectly reconstituted. No adverse event was reported. At the time of event the outcome was unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 12 November 2013. This case is invalid as no information regarding patient was provided. It was reported that sterile water is used for reconstitution of ActHIB and administered. (No information regarding patient was provided). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: Initial information received from a healthcare professional on 15 July 2013. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid vaccine (manufacturer unknown, batch number, dose number, route and site of administration were not reported) on an unspecified date (unknown number of years ago). On an unspecified date, the patient presented rash. Complementary investigations and corrective treatments were not reported. At the time of this report, outcome of the event was not reported. Documents held by sender: none.
Age: 0.94
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to an 11 month old patient of unknown gender. On 01-APR-1999, the patient was vaccinated with the first dose of VARIVAX (Merck) injection, (strength, lot number, expiry date, dose and route were not reported), before 12 months of age. On 26-APR-1999, the patient received the second dose of VARIVAX (Merck) which was inappropriate schedule of VARIVAX (Merck) administered. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from the patient mother refers to her child of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, lot # were not reported). Concomitant therpay was not reported. The reporter reported that her child could not handle M-M-R II. The reporter did not go into detail about what could not handle. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study to detect and described any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX on 6th January 2015. The subject's last menstrual period was on 28th May 2014 and estimated date of delivery ws 4th March 2015. The subject received BOOSTRIX at week 32 of the pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. The subject had 3 previous full term pregnancies.
Age: 1.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 16-month old unk patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. 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.
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of drug dose administration too short in a 75-year-old male patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). Concomitant products included ENGERIX B adult. On 21st January 2015, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information received:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-FEB-2015 the patient was inadvertently vaccinated with a dose of M-M-R II instead of VARIVAX (Merck). No adverse effect reported. The reporter stated that this occurred due to a mistake with order entry into computer not product confusion. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 28-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX .5 ml on 23rd February 2014. The subject's last menstrual period was on 5th June 2014 and estimated date of delivery was 26th March 2015. The subject received BOOSTRIX during the second trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 04 November 2013. The patient had received ACT HIB that was reconstituted with sterile water and administered. The nurse reported that no clinical data on the use of other diluents than what was licensed with the vaccine. It was the opinion of our medical director that use of sterile water or 0.9% normal saline (NS) might lead to dissociation of the protein-polysaccharide conjugate. In the absence of clinical data showing that normal immunogenicity was retained using diluents, we cannot support this practice. Act HIB was an inactivated vaccine so can be repeated at earliest opportunity. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a neonate male who received ENGERIX B pediatric. Concomitant products included ENGERIX B pediatric. On an unknown date, the patient received the 2nd dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information received: Rph states infant received a second birth dose of ENGERIX-B. Rph did not have the lot number or expiration date of the vaccine.
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 05 September 2013. A patient received only diluent from the Act-Hib vaccine. No information was provided regarding the patient. List of documents held by the sender: None.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccine underdose in a 28-year-old female patient who received HAVRIX pediatric. On an unknown date, the patient received HAVRIX pediatric at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information received: HCP reports adult patient received a pediatric dose of HVR. HCP did not have lot number or expiration date of the vaccine.
Sex: U
Vaccine: TTOX
Symptoms: Pain
Clinical narrative: Initial report received from a healthcare professional on 05 June 2013. A female patient of unspecified demographics, whose illness at the time of vaccination and pre-existing medical conditions were unknown and concomitant medications were not reported, had received a dose of Tetanus vaccine from unknown manufacturer (Lot number was unknown, route and anatomical site of vaccination was not reported) many years ago on an unspecified date many years ago. On an unknown date, the patient complained of entire body aches after vaccination. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. List of documents held by the sender: None.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old patient of unknown gender. On 29-JAN-2015, the patient who was supposed to receive PREVENAR 13, was inadvertently vaccinated with a dose of PNEUMOVAX 23 (route intramuscular, dose, lot number and expiration date were not reported). There was no adverse effect reported. No product quality complaint was filled. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 06 November 2013. The patient had received ACTHIB. It was reported that diluent sprayed into the patient's eye. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to 13 unspecified patients of unknown demographics. Patients medical history and current condition was not reported. It was reported that since unknown date improperly stored VARIVAX (Merck) (Lot number and expiry date not provided) vaccines were administered to the patients. No adverse effects noted. Product quality complaint was not reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (licensed practical nurse) refers to a patient of unknown demographics. On 04-FEB-2015 the patient was vaccinated with VARIVAX (Merck) (lot # J001177, expiry date: 31-JAN-2015). The patient experienced expired product administered as he/she was mistakenly vaccinated with an expired dose of VARIVAX (Merck). No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event expired product administered was unknown. Reporter considered the event expired product administered to be not related to VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Initial report received from healthcare professional on 09 December 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received ACT-HIB (lot number and expiration date were unknown) (route, site and dose number not reported) on an unknown date. On an unknown date, patient was administered ACTHIB with sterile water used. It was the opinion of our Medical Director that use of sterile water or 0.9% NS might lead to dissociation of the protein-polysaccharide conjugate. In the absence of clinical data showing that normal immunogenicity was retained using these diluents, we cannot support this practice. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
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 BOOSTRIX. Co-suspect products included INFANRIX, KINRIX, PEDIARIX, ROTARIX, HAVRIX and ENGERIX B. On an unknown date, the patient received BOOSTRIX at an unknown dose, INFANRIX at an unknown dose, KINRIX at an unknown dose, PEDIARIX at an unknown dose, ROTARIX 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 BOOSTRIX, INFANRIX, KINRIX, PEDIARIX, ROTARIX, 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: This office spoke with a pharmacist at GSK approximately two weeks ago regarding the stability of their vaccines. They stated that they may have administered vaccines that were stored outside of recommended temperatures but could not be certain. There are several GSK vaccines potentially involved including BOOSTRIX, INFANRIX, KINRIX, PEDIARIX, ROTARIX and possible HAVRIX and ENGERIX B.
Age: 0.74
Sex: F
Vaccine: DTAPIPV
Symptoms: 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 9-month-old female patient who received KINRIX (batch number 23MJ7, expiry date 22nd October 2015). Previously administered products included PEDIARIX and PENTACEL. In September 2014, the patient received KINRIX. On an unknown date, an unknown 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.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a male patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to PEDIARIX. Additional information received: The consumer mentioned that her son, the patient, experienced a fever after being vaccinated with PEDIARIX.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a physician and described the occurrence f expired vaccine used in a 47-year-old male patient who received ENGERIX B (batch number K94NR, expiry date 8th June 2014). On 11th June 2014, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 06 August 2013. ACTHIB was mixed with sterile water and administered to a patient. No information was provided regarding the patient. There was 1 diluent left in the ACTHIB box. No adverse event was reported. List of documents held by sender: none.
Age: 1.1
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received KINRIX (batch number 3ZL2Y, expiry date 27th March 2016). On an unknown date, the patient received KINRIX. 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 received: Nurse gave 13 month old a KINRIX dose.
Age: 1.12
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Polymerase chain reaction, Rash vesicular, Varicella virus test positive
Clinical narrative: Zoster type rash started 1/26/15.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a patient who received ENGERIX B (batch number AHBVC148AB, expiry date 6th September 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Sex: M
Vaccine: 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 male patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug was unknown. Additional information: 3 patients vaccinated with vaccine that was stored at -2.56 C.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report received from a registered medical assistant refers to 52 year old male patient with no drug reactions or allergies who on 26-JAN-2015 was vaccinated with a dose of PNEUMOVAX 23 (lot # K008409, expiration date 04-MAR-2016), 0.5 ml, subcutaneous. On 28-JAN-2015 the patient experienced injection site pain, so the patient sought medical attention by office visit and was treated with unspecified antibiotic and unspecified pain medication. No laboratories diagnostic tests were performed. At the time of the report, the patient was recovering from injection site pain (reported as patient present status "doing well"). Additional information has been requested.
Sex: M
Vaccine: 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 malae patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: 3 patients vaccinated with vaccine that was stored at -2,56C.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 3 unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (route not reported) that were improperly stored. There were two lots involved (lot # K003420 exp date 06-MAR-2016) stability not supported and (lot # K007783 exp date 28-MAY-2016) which stability was supported. No adverse experiences were 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 pharmacist refers to unspecified number of patients of unknown demographics. On an unknown date these patients were vaccinated with GARDASIL (dose, frequency, therapy route, lot # and expiry date unspecified) which were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1502USA002011 and MARRS # 1502USA002298). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown demographics. On an unknown date these patients were vaccinated with doses of PEDVAXHIB (dose, frequency, therapy route, lot # and expiry date unspecified) which were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to PEDVAXHIB. This is one of several reports received from the same source (MARRS # 1502USA002011 and MARRS # 1502USA002297). Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 03-FEB-2015, the patient was vaccinated with a dose of M-M-R II (dose, lot number and expiry date were not provided) and a dose of VAQTA (dose, lot number and expiry date were not provided) that underwent a temperature excursion. The VAQTA dose was supported while the M-M-R II dose was not supported. No adverse experiences were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 39 year old non pregnant female patient. In 1975 the patient was vaccinated with a dose of M-M-R II (dose, route, lot # and expiration date were not provided). The reporter was unsure if it was "(M-M-R) or (M-M-R II)". In 2007 titers were drawn and was noted that the patient did not have immunity to the measles. The patient did not seek medical attention and no treatment was given for the event. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme 2 wks after first vaccine and 6 days ater 2nd.
Sex: U
Vaccine: HIBV
Symptoms: Exposure via direct contact, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 June 2013. A staff member inadvertently received an eye splash while drawing up ACTHIB. The reporter was unsure whether it occurred while drawing up diluent regarding the patient. No adverse event was reported. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: 10cm x 12cm oval-shaped erythematous patch, warm to touch at site of vaccine on (R) upper, lateral arm. Started on cephalexin 500mg tid x 10d.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Culture urine, Influenza virus test, Pyrexia, Streptococcus test, Urine analysis
Clinical narrative: Fever developed 1-26-15 in evening, present past two days max temp 102.8
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (healthcare worker) refers to unspecified number of unspecified patients. On unspecified dates since 28-OCT-2014 the patients received unspecified number of doses of RECOMBIVAX HB, intramuscular, which had been improperly stored. The patients experienced incorrect product storage as all of them received improperly stored RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event incorrect product storage was unknown. Reporter considered the event incorrect product storage to be not related to RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1502USA001980). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 June 2013. An expired dose of ACTHIB was administered to a patient. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a female patient of unknown age referring herself. On an unknown date in 2015 (a few weeks ago before reporting time) the patient was vaccinated with VARIVAX (Merck) (lot# was not reported). The patient took a pregnancy test and found that she became pregnant. The LMP and EDD was not known. The pregnancy outcome was outcome pending. The patient experienced vaccine exposure during pregnancy. The outcome of the vaccine exposure during pregnancy was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 19 June 2013. A patient was administered a dose of ACTHIB vaccine instead of hepatitis B vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 28 June 2013. A 12-month-old patient had received ACTHIB vaccine mixed with sterile water. No adverse event was reported. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Herpes zoster, Pain, Rash generalised
Clinical narrative: Information has been received from a 66 year old female patient with seasonal allergies concerning herself. On an unspecified date of January 2013 (reported as two years ago) the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot# and expiration date not provided). Concomitant therapies included tramadol hydrochloride and meloxicam. On approximately 29-DEC-2014 (reported as four weeks ago) the patient developed "a severe shingles reaction." The patient explained "I developed the shingles rash all over my body, I was in extreme pain, I felt very weak and was bedridden for days. I'm doing better now but I'm not fully recovered yet." The patient saw a physician several times for seeking medical attention. No lab diagnostics study was performed. "Antibiotics" (Product names and manufacturers were unspecified) was given for this event. At the time of reporting, the outcome of events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a nurse on 02 December 2013. The patient had received ACT HIB and was diluted with MMR diluent. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 20 June 2013. A 6-months-old had received third dose of ACTHIB, reconstituted with sterile water. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. Since 28-JAN-2015 improperly stored VARIVAX (Merck) (lot number, dose and frequency were unknown) was administered to unspecified patients. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional (healthcare worker) refers to unspecified number of unspecified patients. On unspecified dates since 28-OCT-2014 the patient received unspecified number of doses of GARDASIL, intramuscular, which had been improperly stored. The patients experienced incorrect product storage as all of them received improperly stored GARDASIL. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event incorrect product storage was unknown. Reporter considered the event incorrect product storage to be not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1502USA002229). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date, the patient completed the series of M-M-R II (route and lot # not reported). The nurse reported that on an unknown date, titers for measles were drawn to the patient and showed no evidence of immunity to measles (measles antibody negative). At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 15 May 2013. A patient received the powder portion of the ACTHIB reconstituted with sterile water (diluents for MMR) rather than the diluents that comes with the ACTHIB. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 July 2013. A 2-month-old patient (gender and date of birth was not reported) had received dose of ACTHIB and PENTACEL vaccine at same visit on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning 31 patients of unknown age and gender, who were vaccinated with a dose of M-M-R II (dose, dose number, lot number, expiration date and route were not reported), 6 doses of lot number K002528 (expiration date not provided) and lot numbers reported as 10 doses of K009894, 5 doses of K011313 and 10 doses of J016234, that underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 11 February 2013. It was reported that ACTHIB may have been reconstituted with Merck diluents instead of the diluents provided. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 26 February 2013. A patient (no other information was provided regarding the patient) had just received a 0.4% sodium chloride diluent of ACT-HIB vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 July 2013. A 06-month-old patient was administered both ACTHIB and PENTACEL. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 December 2013. This is an invalid case as individual patient identifiers are missing. It was reported that the patient (no information was provided regarding the patients) had received PENTACEL and ACTHIB at the same visit and did not need the forth IPV. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from medical assistant on 13 December 2013. An unknown age and gender had received ACT-HIB (no information was provided regarding the patient). Reporter stated that patient reconstituted with sterile water and administered. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: HIBV
Symptoms: Generalised erythema, Urticaria
Clinical narrative: Initial report received from healthcare professional on 12 August 2013. A 64-year-old female patient, whose concomitant medications were not reported, had received a dose of ACT-HIB (batch number, dose number, route and anatomical site of administration were not reported) on 09 August 2013. The patient was allergic to sulfa drugs and a history of lupus. On 10 August 2013, the patient experienced generalized red, raised rash like hives. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none. Follow-up information received from a healthcare professional  on 25 October 2013. On an unspecified date, the patient had recovered.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 24 July 2013. A patient was administered a dose of ACTHIB vaccine that was reconstituted with Merck diluent. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: PER, TTOX
Symptoms: Cough, Wheezing
Clinical narrative: Initial report received from a Consumer on 09 September 2013. A 66-year-old male patient whose demographic details including gender, date of birth and age at the time of event were not reported, had received a dose of Tetanus vaccine (Manufacturer unknown, lot number, dose number, route and anatomical location site of administration were not reported) and Whopping Cough vaccine (Pertussis vaccine) (Manufacturer unknown, lot number, dose number, route and anatomical site of administration were not reported) both on an unspecified date. The patient's medical history and concomitant medication were not reported. The patient's concurrent condition included smoker. On an unspecified date, the patient experienced wheezing and coughing. Laboratory details were not reported and received Sinus Medicine as corrective treatment. The outcome of the adverse events was not reported. Documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Initial report received from consumer on 05-Dec-2013. A female patient (age unknown) (medical history and concomitant medications were not reported) received Tetanus toxoid (lot number. expiration date, rout and site unknown) on an unknown date. Patient stated that after getting a tetanus toxoid her ankles swelled then her legs. Outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 October 2013. The cases were received on 21 March 2014. A patient had received a dose of Tetanus Toxoid on an unspecified date. It was reported that the patient received an expired dose of vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 02 May 2013. It was reported that a diluent was found left over in the box so a child may have received ACTHIB reconstituted with sterile water instead of ACTHIB Diluent. No more information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 16 April 2013. ACTHIB was inadvertently reconstituted with sterile water and administered to a patient (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 05 April 2013. The patient had used Merck diluent to reconstitute ACTHIB. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Overdose
Clinical narrative: Initial overdose report received from a healthcare professional on 10 May 2013. It was reported that ActHIB and PENTACEL both were administered on the same day (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV, IPV, DTAPIPVHIB, HIBV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 May 2013. PENTACEL, ActHIB and IPOL vaccines were administered to a patient on the same day. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV, IPV, DTAPIPVHIB, HIBV, IPV
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 May 2013. PENTACEL, ActHIB and IPOL vaccines were administered to a patient on the same day. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Initial misuse report received from a healthcare professional on 30 May 2013. It was reported that a patient received only the ActHIB diluent. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 17 May 2013. A medical assistant administered ACTHIB instead of a Hepatitis B vaccine to a patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 50.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 28 May 2013. A 50-year-old patient was administereed ActHIB instead of ADACEL. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case is linked to case number 2013-06987 (same reporter after ActHIB). Initial misuse report received from a healthcare professional on 21 May 2013. A nurse administered an expired ActHIB powder (batch number: UF566AA) with diluent (batch number: UH636AC) to a child. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a non-healthcare professional on 28 May 2013. It was reported that ACTHIB was mixed with sterile water and given as the third dose in the series. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 08 May 2013. ACTHIB was reconstituted with sterile water and administered (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 16 May 2013. It was reported that 1 diluent was left in the box, and sterile water was used to reconstitute ACTHIB and administered. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 29 May 2013. ACTHIB was reconstituted with Merck diluent and the dose was administered. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case is linked to case number 2013-06751 (same reporter after ACTHIB). Initial misuse report received from a healthcare professional on 21 May 2013. A nurse administered ACTHIB powder (batch number: UH767AA) with an expired diluent (batch number: UF640AB) to a child. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 14 June 2013. Administered 0.4 % saline diluent to a patient. No adverse event was reported. List of documents held by sender: none.
Age: 0.4
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 12 June 2013. A 05-month-old patient (No information was provided regarding the patient) had received ACTHIB reconstituted with Merck sterile water. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 05 June 2013. An expired dose of Tet Tox Ads were given. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 08 January 2014. A patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received ACTHIB on an unspecified date. The ACTHIB was reconstituted with sterile water instead of the diluent. The patient did not experienced any adverse event. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 14 January 2014. This is invalid case as the individual patient identifiers missing. Patient received ACTHIB which was reconstituted with sterile. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 02 January 2014. This is invalid case as the individual patient identifiers missing. Patient received ACTHIB which was reconstituted with sterile water. It a production reconstitution issue. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 February 2013. A patient (no other information was provided regarding the patient) had inadvertently administered the ACT-HIB diluent on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 15 February 2013. A patient (No information was provided regarding the patient) had received only the diluent from the ACT-HOB. No adverse event was reported. List of documents held by sender: none.