chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US011442 is an initial spontaneous report received from a nurse on 21 may 2013 with a follow up information received on 11 Jun 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. Her concomitant vaccinations included VARIVAX (batch number: H016760) on to left arm and ADACEL (batch number: CA365AA) on to right arm; both vaccine at a dose of 0.5 ml administered on 21 May 2013. She was vaccinated only with 0.5 ml  MENVEO (batch number: M12028) intramuscularly on to right arm without being reconstituted with MenA powder component, on 21 May 2013. No adverse event was reported following this drug administration error. It was reported that her mother was advised of the missing component and was offered to revaccinate in 2 months which she declined. No other information was available. Follow up information received on 11 Jun 2013: Reporter details, patient demographics (height and weight), site of vaccine administration, concomitant vaccine details updated.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown dates the patient was vaccinated with three doses of GARDASIL at month 0, 12th and 24th (dose, route, lot # not provided). No adverse effects were reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 31 year old female patient. No drug reaction or allergy was reported. The healthcare worker reported that the patient was seen by an unspecified physician on 16-JAN-2015 for a physical and during the physical, the patient reported to the physician that she was pregnant. The healthcare worker reported that the patient came back to the office on 30-JAN-2015, and on the same day patient received a dose of VARIVAX (Merck) (Lot# was reported as K00T186, expired on 28-MAY-2016), injection, 0.5 ml, subcutaneous (strength was unspecified). It was reported that at the reporting time patient had 2 months pregnancy (according to this, last menstrual period (LMP) was in DEC-2014). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US011443 in an initial spontaneous report received from pharmacist on 21 may 2013. This report refers to the patient of unspecified age and gender. Patient's medical history and concomitant medications were not reported. Patient was vaccinated with MENVEO (batch number: A 11082) intramuscularly on unspecified date. According to reporter, the patient received MenCWY liquid conjugate component only without reconstituted with MenA. Reporter noticed that they had one extra MenA vial in refrigerator and at the time of this report, they were investigating which patient received the partial dose of MENVEO. No adverse event was reported following this administration error.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse refers to an unknown number of patients of unknown age and gender. On unknown dates, 20 dose of improperly stored PROQUAD (Merck) (lot number, dose and frequency were unknown) were administered to the patients. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On 04-FEB-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J005067, expiration date: 17-JAN-2015, intramuscular injection (dose and dose number were not provided). Information about concomitant therapy was not provided. No known adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Allergy test negative, Dyspepsia, Eczema, Enzyme level test, Laboratory test normal
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to her 9 months old daughter. The female child was administered a first dose of COMVAX at the age of 3 months (estimated date: May 2006) and a second dose at the age of 6 months (estimated date: August 2006), (dose and route of administration was not reported). At the age of 3 months, 6 months and 9 months (estimated date: November 2006) she was also vaccinated with PREVNAR, IPV (unspecified) and DTP (reported as "DTP/AaP"). On an unknown date in 2006 (also reported as "twelve day after her daughter was administered these vaccines at 9 months old") the patient began to develop severe eczema, could not digest some unspecified foods and could not digest the protein from milk. On an unspecified date the patient sought a medical attention from an unspecified healthcare professional. The results of lab and diagnostic studies: "allergy testing, G tract analysis, enzymes, vitamin levels" performed on unspecified dates in 2006 revealed that she had no major allergies. Treatment for eczema was hydrocortisone and treatment for inability to digest some foods was a gluten free diet. The patient's outcome was recovered (dates unspecified). The patient continued to eat a gluten free diet. The relatedness between the events and COMVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring a patient of unknown age and gender. Information regarding concomitant therapy, concurrent conditions and medical history was not provided. On an unknown date, 18 months after receiving their first dose, the patient was vaccinated with the second dose of GARDASIL (dose, lot #, application site and route were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse refers to an unknown number of patients of unknown age and gender. On unknown dates, 30 dose of improperly stored VARIVAX (Merck) (lot number, dose and frequency were unknown) were administered to the patients. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013952, is an initial spontaneous report received from a nurse on 26 Jun 2013. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. Nurse mixed the Men A lyophilized conjugate of MENVEO (batch number: unknown), with a diluent and administered it on 25 Jan 2013. Liquid component Men CWY was not administered. No adverse event was reported following this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US015178, is an initial spontaneous report received from a pharmacist on 15 Jul 2013: This case refers to a 17 years old female patient. She was vaccinated with expired MENVEO (batch number: M10047 and expiry date: Dec 2012) intramuscularly on 12 Jul 2013. No adverse reaction was reported following this administration error.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US013521, is a combined initial and follow-up spontaneous report received from a nurse on 19 Jun 2013 and from nurse manager on 21 Jun 2013. This report refers to a 19-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X11082 and expiry date: 01 Jun 2014), intramuscular without being reconstituted with Men A component on 05 Jun 2013. After that again he was vaccinated with complete dose of MENVEO on an unspecified date. No adverse reaction was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US014330, is an initial spontaneous report received from a healthcare professional (office manager) on 01 Jul 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. She inadvertently received only Men A lyophilized conjugate component of MENVEO (batch number: A12006) reconstituted with another sterile diluent intramuscularly on 28 Jun 2013 instead of Men C, W, Y component of MENVEO. No adverse reaction was reported following this administration error.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013447 is an initial spontaneous report received from a nurse on 19 Jun 2013, and with a follow up report received from nurse on 09 Jul 2013. This report refers to a 13-year-old male patient. His past medical history and concomitant medication were not reported. He received only Men A lyophilized component of MENVEO (batch number: M12024, expired date: Dec 2014) reconstituted with a sterile diluent (not with Men CYW-135) intramuscularly into left deltoid on 17 Jun 2013 at 11 AM. No adverse event was reported following medication error. Nurse reported that he will be revaccinated. No further information was provided. Follow up report received from nurse on 09 Jul 2013. Updated site of vaccination and patient demographics.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 5 years old male patient with multiple food allergies: peanut, tree nut, avocado, wheat. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified, PNEUMOVAX could not be ruled out) (dose, lot number, expiration date were not reported). On an unknown date, the patient experienced unspecified reaction. The patient recovered from the reaction on an unspecified date. Relatedness between the event and vaccination with PNEUMOVAX 23 was not provided. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified amount of patients of unknown age and gender. The nurse reported that an unspecified amount of doses of GARDASIL (lot#, dose and route not reported) that underwent a temperature excursion was administered to the unspecified amount of patients on an unknown dates. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's medical history and current conditions were not provided. On 23-JAN-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number and expiration date were not reported), 0.5 ml, intramuscular. No concomitant medications were reported. No adverse events were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's medical history and current conditions were not provided. On 27-JAN-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number and expiration date were not reported), 0.5 ml, intramuscular. No concomitant medications were reported. No adverse events were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Arthralgia, Decreased appetite, Dizziness, Headache, Musculoskeletal pain
Clinical narrative: 1/23/15- Shot 1/24/15- Painful rash on arm-large. Lasted to 2/1/15- Still itches, shoulder pain. Racing heart first two days, dizziness, loss of appetite and headache. Still have joint, muscle pain.
Sex: U
Vaccine: PNC13
Symptoms: Myalgia, Palpitations, Pruritus, Rash
Clinical narrative: 1/23/15- Shot 1/24/15- Painful rash on arm-large. Lasted to 2/1/15- Still itches, shoulder pain. Racing heart first two days, dizziness, loss of appetite and headache. Still have joint, muscle pain.
Age: 1.28
Sex: M
Vaccine: DTAP, HEP
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Hives all over body and itching w/ swelling. ER prescribed prednisone and BENADRYL.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt came in 2 day before 2/5/15 which would have been 2/3/15. Left bicep with mild erythema color and edema.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with none pertinent medical history, drug reactions or allergies. In January 2015 (exact date unspecified) the patient completed a five day dose of acyclovir at an unspecified dose. On 03-FEB-2015 the patient was vaccinated with a first dose of ZOSTAVAX (0.65 ml, subcutaneous, lot# reported as: K018175 with expiry date: 10-JAN-2016). Concomitant therapies included trazodone hydrochloride, hydrochlorothiazide, triamterene and escitalopram. On 05-FEB-2015 the patient experienced a large, swollen, red area with blisters at the injection site. The patient was instructed by the pharmacist to take BENADRYL and an ibuprofen and to apply a cool compress to the injection site. None lab diagnostics studies were performed. The patient sought medical attention via calling the pharmacist.  The outcome of a large, swollen, red area with blisters at the injection site was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: High fever, chills, body ache.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gave Hep A too early.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Induration, Mobility decreased, Urticaria
Clinical narrative: Patient reports hard welt w/ warm feeling. Can "barely move hand". Took place about 1 day after receiving vaccine. Patient also reports unusual heavy diarrhea.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt. states arm was sore for approx 10 days after Pneumo shot. Went away and now she can't move arm again.
Age: 0.6
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrences of wrong vaccine administered in a 6-month-old patient who received KINRIX. On an unkown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: The doctor reported that a 6 month patient received a dose of KINRIX by mistake. Doctor does not have the lot number or expiratory date of the vaccine given. Doctor does not have the patient DOB or initials.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage in a 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage was unknown. Additional information: CMA from clinic calling about 4 vaccines (This report is for KINRIX) that had a below temp excursion to 31 deg F last July of 2014 for KINRIX, HAVRIX, ENGERIX-B and RTX less 4 hours. Since then they have administered these vaccines to possibly multiple unknown patients of all ages. They do not have the lot numbers, expiration dates, or patient details at this time.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Nausea, Pallor, Pyrexia, Tinnitus
Clinical narrative: About  1 1/2 hrs after vaccine became nauseated, dizzy, ringing in ears. Co-worker told her she looks pale. Maybe slight fever. No vomiting.
Age: 1.63
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in  19-month-old female patient who received DTAP (batch number AC14B154B. expiry date unknown). On 14th August 2012, the patient received DTAP vaccine (intramuscular). On 14the August 2012, an unknown time after receiving DTAP vaccine, the patient experienced hives. On 18th August 2012, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to DTAP vaccine. Additional information: The onset of the hives occurred within several hours of administration. The nurse stated the patient was seen in the emergency, where it was thought the hives were a result of the band-aid. No information available regarding the batch or expiration date of the vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Pyrexia, Rash macular, Skin texture abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a 3-month-old female patient who received PEDIARIX. Concomitant products included Hib vaccine and rotavirus vaccine. On 2nd November 2014 12:00, the patient received the 1st dose of PEDIARIX. On 2nd November 2014 12:00, an unknown time after receiving PEDIARIX, the patient experienced injection site erythema. On 3rd November 2014, the patient experienced blotchy rash. On an unknown date, the patient experienced skin texture abnormal and fever. The patient was treated with TYLENOL. On 2nd November 2014, the outcome of the injection site erythema was recovered/resolved. On 5th November 2014, the outcome of the blotchy rash was recovered/resolved. On an unknown date, the outcome of the skin texture abnormal was not recovered/not resolved and the outcome of the event was recovered/resolved. It was unknown if the reporter considered the injection site erythema, blotchy rash,  skin texture abnormal and fever to be related to PEDIARIX. Additional information received: Mother reported daughter experienced an injection site reaction. Mother does not wish to be contacted. Information provided at time of report has been documented.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Pain
Clinical narrative: Redness, soreness, chills. Patient took BENADRYL. Pharmacy contacted MD 2/9/15.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-month-old patient who received KINRIX. On 2nd December 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. Additional information received: Physician reported that a patient that is younger than 4 years old was given a KINRIX vaccine. Patient did not have any symptoms.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received INFANRIX (batch number UNK, expiry date unknown). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIZ, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: INFANRIX was administered to a 7 year old patient.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 34-year-old male patient who received TWINRIX (batch number AHABB260A, expiry date 14th November 2014). On an unknown date, the patient received TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: the nurse practitioner reports a patient inadvertently vaccinated with an expired dose of TWINRIX.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of sweating in a 61-year-old male patient who received ENGERIX B adult (batch number 5G943, expiry date 31st October 2016). Concurrent medical conditions included unknown. Concomitant products included medication unknown (Unknown). On 24th October 2014, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On an unknown date, the dose was an unknown dose. On 25th October 2014, 1 days after receiving ENGERIX B adult, the patient experienced sweating and chills. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the sweating and chills were recovered/resolved and the outcome of the fever was unknown. The reporter considered the sweating, chills and fever to be possibly related to ENGERIX B adult. Additional information received: Nurse reports a patient who experienced swelling and chills after receiving an ENGERIX-B vaccination. The patient did not take his temperature, but he did feel like he was feverish during this time. The sweating and chills would last for about 30 min and would come and go during a two day period. By the third day the symptoms had resolved. It has not yet been determined if the patient will continue the series. The patient is currently 7 days late for his second dose of ENGERIX-B.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nasal congestion, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling of throat gland in a 19-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 14 September 2014, the subject received 1st dose of BOOSTRIX (0.5 ml, intramuscular, left arm). On 14 September 2014, within hours of vaccination with BOOSTRIX, the subject experienced swelling of throat gland, stuffy nose and vomiting. At the time of reporting, the events were unresolved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous, Induration
Clinical narrative: Large bullous local response with intense local induration over 10 cm diameter.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Coordination abnormal, Immunodeficiency, Insomnia, Opisthotonus, Screaming
Clinical narrative: Pt 0 vaccines rec'd previously pt began decreased coordination, screaming, arching trunk x 1 month. Verbiage -> none. No sleep x 1 month. Coordination still decreased.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. Patient medical history and current condition was not reported. On 05-FEB-2015 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported) vaccination. On 05-FEB-2015, the patient experienced vomiting, aches, shakes, fever and nausea. The outcome of vomiting, fever, nausea, aches and shakes was reported as recovering/resolving. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Red swollen at site about 2 weeks after vaccine starting experiencing muscle and joint pain started in knee spread down leg. Then arms and hands.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Activities of daily living impaired, Chills, Dizziness, Dysstasia
Clinical narrative: Shaky hands, chills, dizzy, trouble standing and walking. Some fever, shot arm swollen (couldn't raise). Stomach upset (close to throwing up). Unable to drive. Unable to prepare meals. Took 1 full week to recover.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Impaired driving ability, Injected limb mobility decreased, Nausea, Peripheral swelling
Clinical narrative: Shaky hands, chills, dizzy, trouble standing and walking. Some fever, shot arm swollen (couldn't raise). Stomach upset (close to throwing up). Unable to drive. Unable to prepare meals. Took 1 full week to recover.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaky hands, chills, dizzy, trouble standing and walking. Some fever, shot arm swollen (couldn't raise). Stomach upset (close to throwing up). Unable to drive. Unable to prepare meals. Took 1 full week to recover.
Age: 27.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Upper extremity mass
Clinical narrative: Pt has a red, raised lump on the back of right arm that is warm to the touch.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Impaired driving ability, Insomnia, Musculoskeletal pain
Clinical narrative: Tetanus shot on 1/19/15-immediate stinging pain shoulder to fingertips-pain has been a solid constant 8 on scale of 1-10 (10 being natural child birth)-sharp intense pain w/certain movements-can't sleep for pain-difficult to dress, drive-pick items up.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pain in extremity
Clinical narrative: Tetanus shot on 1/19/15-immediate stinging pain shoulder to fingertips-pain has been a solid constant 8 on scale of 1-10 (10 being natural child birth)-sharp intense pain w/certain movements-can't sleep for pain-difficult to dress, drive-pick items up.
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of difficulty breathing in a female patient who received Tdap. On an unknown date, the patient received Tdap vaccine at an unknown dose. On an unknown date, an unknown time after receiving Tdap vaccine, the patient experienced difficulty breathing and swelling arm. On an unknown date, the outcome of the difficulty breathing and swelling arm were unknown. It was unknown if the reporter considered the difficulty breathing and swelling arm to be related to Tdap vaccine. Additional information: the pharmacist is reporting a patient experienced difficulty breathing and severe swelling of her arm after administration of Tdap. No further information was provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Age: 1.14
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Acne, Injection site reaction, Injection site scab, Injection site vesicles
Clinical narrative: Patient was given Hepatitis A 12/5/14. She develop pimple like rash at the injection site. The pimples or blisters have popped and scabbed over. Tx with hydrocortisone not helpful. Mom claimed the area is getting larger.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 09-JAN-2015 the patient was vaccinated with a dose of GARDASIL (lot# was unspecified, 0.5 ml, intramuscular) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 07-JAN-2015 the patient was vaccinated with a dose of GARDASIL (lot# was unspecified, 0.5 ml, intramuscular) which both underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The pharmacist reported the patient was administered the first dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were unknown) on 31-JUL-2013, the second dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were unknown) on 21-AUG-2014, and on 23-JAN-2015, to be administered the third dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were unknown) in the pharmacy. The patient experienced an inappropriate schedule of drug administration. No product quality complaint was involved. No adverse effects were reported. Additional information is not expected as the reporter did not want to be contacted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching within 15 minutes of injection after giving 2 capsules of diphenhydramine 25mg, she's not itching 4 hours later.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Since 01-JAN-2015, improperly stored PROQUAD (Merck) (lot#, expiration date, dose, frequency and route were unknown) were administered to multiple unspecified patients. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial overdose report received from a healthcare professional on 31 May 2013. It was reported that PENTACEL and IPOL both vaccines 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.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from health care professional on 15 May 2013. Only DTaP-IPV portion of PENTACEL was administered to a 4-month-old patient. No adverse event was reported. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial overdose report received from a healthcare professional on 20 May 2013. A 4-month-old patient received PENTACEL and IPOL vaccine in the same visit. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This case is linked to case number 2013-07182 (same reporter, same vaccine). Initial misuse report received from a healthcare professional on 07 June 2013. It was reported that a child was given only DTaP/IPV from PENTACEL. No adverse event was reported. Documents held by sender: none.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Dyspnoea, Irritability
Clinical narrative: Initial report received from a consumer (patient parent) on 19 June 2013. A 02-months-old female patient had received intramuscular dose of PENTACEL (lot number, dose number and site of vaccination was not reported), PREVNAR (Manufactured by Wyeth, lot number, dose number and site of vaccination was not reported), Hep B (lot number, dose number and site of vaccination was not reported) and administered rotovirus vaccine through oral route (lot number, dose number and site of vaccination was not reported) on 22 June 2013 at 9:30 am. The patient had medical history includes preemie born at 36 weeks with respiratory distress and concomitant medications was not reported. The patient had no illness at the time of vaccination. On 22 June 2013 after vaccination, the patient had experienced irritability and had intense crying spell for less than 3 hours, after the patient was calmed down, her breathing pattern was normal, but was gasping every now and then. For over a time the period between gasps became longer until it resolved. Corrective treatment was not reported and no laboratory tests were done. On 22 April 2013 at 17:00 hours, the patient had recovered from adverse events. Follow up information received from a healthcare professional on 29 July 2013: The patient received a dose of PENTACEL (lot number: C4340AA and expiry date: 14 April 2014), a dose of Hepatitis B vaccine (manufacturer unknown), (lot number: H020605 and expiry date: 13 March 2015), a dose of PREVNAR vaccine from other manufacturer (lot number: G75071 and expiry date: 30 November 2014) and a dose of "ROTATEQ" from other manufacturer (previously reported as Rotavirus vaccine) (lot number: J001615 and expiry date: 28 August 2014). 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 29 May 2013. It was reported that ACTHIB component from PENTACEL was reconstituted with sterile water and administered to a patient (no information was provided regarding the patient) without the DTAP/IPV component. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 May 2013. Only the DTAP-IPV portion from PENTACEL was administered to the patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 May 2013. A child received only DTaP/IPV component of PENTACEL and was not given the ActHIB component. No adverse event was reported. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015399, is an initial spontaneous report received from a nurse on 18 Jul 2013: This case refers to an 18 years old male patient. He received only Men C, Y, W-135 liquid conjugate of MENVEO vaccine (batch number: M12128), intramuscularly without being reconstituted with Men A component on 15 Jul 2013. No adverse reaction was reported following this administration error.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015500 is an initial spontaneous report received from a medical assistant on 18 Jul 2013. This report refers to a 14-year-old male patient. He received only Men CYW-135 liquid component of MENVEO (batch number: X11047) intramuscularly on 17 Jul 2013 (without being reconstituted with Men A). No adverse event was reported following medical error (inappropriate preparation of medication).
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product
Clinical narrative: Case number PHEH2013US015499 is a combined spontaneous report received from a nurse on 16 Jul 2013 and 18 Jul 2013, with a follow up received from the QA department (241596) on 20 Aug 2013. This report refers to an adult female patient (who is a nurse, doing her internship to become a nurse practitioner). This nurse while reconstituting MENVEO, (batch number: 12131), when putting needle in vaccine vial, no glass was shattered but the vaccine exploded and got all over the nurse hand (unspecified date). No other information was reported following medication error (accidental exposure while preparing drug for administration). Non significant follow up received from the QA department on 20 Aug 2013: Updated QA reference number.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015423, is an initial spontaneous report received from a medical assistant on 18 Jul 2013: This case refers to an 11 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X12025 and expiry date: Jan 2015), intramuscularly without being reconstituted with Men A component on 08 Jul 2013. No adverse reaction was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015420, is an initial spontaneous report received from a medical assistant on 18 Jul 2013: This case refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12025 and expiry date: Jan 2015), intramuscularly without being reconstituted with Men A component on 15 Jul 2013. No adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Laceration, Product container issue
Clinical narrative: Case number PHEH2013US015744 is an initial spontaneous report received from a physician on 19 Jul 2013. This report is also a quality complaint (QA reference number: 242310). This report refers to a patient whose identifiers were not reported. This patient's medical history and concomitant medications were not reported. After the dose was administered, a small crack was noticed in the vial of MENVEO (batch number: M12129, expiry date: 04 Feb 2019) on 18 Jul 2013. It was reported that the nurse was cut by the crack in the vial. No other vials in the box were cracked or damaged and there was no damage to the inner or outer packaging of the vial. There were no problems in withdrawing a full dose from that vial and there was no leakage from the vial and the nurse was not exposed to the vaccine. The outcome of the event injury was not reported. No other information was provided.
Age: 0.2
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2013US015634 is an initial spontaneous report received from a physician on 22 Jul 2013. This report refers to 2-months old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MenCYW-135 of MENVEO (batch number: X11071) intramuscularly in error instead of PREVENAR (other manufacturer, batch number: not reported) on 22 Jul 2013. No adverse event was reported following the inadvertent administration.
Age: 26.0
Sex: M
Vaccine: MNQ
Symptoms: Exposure via direct contact, No adverse event
Clinical narrative: Case number PHEH2013US015622 is an initial spontaneous report received from a pharmacist on 22 Jul 2013. This report refers to an adult male patient. While preparing MENVEO (batch number: A12009), a drop of the vaccine splashed in his eyes on 22 Jul 2013. No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US015821, is an initial spontaneous report received from nurse on 24 Jul 2013. This report refers to an 18 year old female patient. Her medical history and concomitant medication was not reported. Nurse reported that the patient had received MENACTRA (batch number: unknown, other manufacturer) in 2007 at age 12; MENVEO (batch number: unknown) in Aug 2012 at age 17 and again MENVEO (batch number: M11077) in Jul 2013 at age 18. No events were reported following this error. No further information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US015815 is an initial spontaneous report received from a nurse on 23 Jul 2013. This report refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number; A12123) intramuscularly on 22 Jul 2013. It was reported that he received MENVEO that had been at less than 2 degree C for a 48-hours period time with the lowest temperature reading of minus 14 degree C. No adverse event was reported following the medication error.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US015800 is an initial spontaneous report received from a pharmacist on 22 Jul 2013. This report refers to an 18-year-old male patient. He was vaccinated with an expired dose of MENVEO (batch number: A10047 and expiry date: Dec 2012) intramuscularly on 19 Jul 2013. Immediately the patient was vaccinated with the correct MENVEO (Batch number: A12009 and expiry date: Feb 2-14) on the same day. No adverse event was reported following the administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015789 is an initial spontaneous report received from a pharmacist on 22 Jul 2013: This report refers to a patient of unknown age and gender. This patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: unknown), intramuscularly, without being reconstituted with Men A component, on 22 Jul 2013. No adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US016004, is an initial spontaneous report received from a medical assistant on 25 Jul 2013: This case refers to a patient of unspecified age and gender. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: not reported), intramuscularly without being reconstituted with Men A component, three to four weeks ago on an unspecified date. No adverse reaction was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014931, is an initial spontaneous report received from a nurse on 10 Jul 2013. This report refers to an 18 years old adult female patient. Her medical history and concomitant medications was not reported. She received only with Men CYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11032) intramuscularly on 08 Jul 2013. She did not received Men A lyophilized conjugate vaccine component of MENVEO. No adverse event was reported following this administration error. No additional information was available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014921 is an initial spontaneous report received from a pharmacist on 10 Jul 2013: This report refers to an 18-year-old female patient. She was given only the MenCYW135 component of MENVEO (batch number: X11077) intramuscularly, without being constituted with MenA component, on 10 Jul 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014891 is an initial spontaneous report received from a nurse on 02 Jul 2013. This report refers to a 12-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that she was vaccinated only with the MenCYW-135 liquid component of MENVEO (batch number: X11064, expiry date: Dec 2013) on 20 Jun 2013 and did not receive MenA lyophilized conjugate. No adverse event was reported following the inadvertent administration.