chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 04-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 24-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 19-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 12-JAN-2015 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 20-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K004394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 01-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 25-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 03-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 13-NOV-2014 the patient was vaccinated with the third dose of ROTATE4Q (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 18-NOV-2014 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 25-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomjitant medications reported. No adverse efect reported. There was no product quality complaint (PQC) involved. The outocme was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Age: 0.2
Sex: M
Vaccine: FLU4
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 2-month-old male patient who received FLUARIX QUADRIVALENT (batch number 75XC, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, 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: A 2 month old patient received FLUARIX QIV instead of PEDIARIX.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 05-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date, unspecified number of patients were vaccinated with doses of Oral, ROTATEQ (dose and lot# was unknown) which were improperly stored. The outcome of the events was unknown. This is one of several reports received form the same reporter. Additional information is not expected as reporter is not willing to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 12-JAN-2015 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a doses of GARDASIL, VAQTA, RECOMBIVAX HB and ROTATEQ (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 26-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 02-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 28-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 13-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Asthma, Cryptococcosis, Death, Dysphonia
Clinical narrative: Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Encephalopathy, Euthyroid sick syndrome, Headache, Hydrocephalus, Hyperkalaemia
Clinical narrative: Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Mechanical ventilation, Meningitis, Palpitations, Pleural effusion, Proteinuria
Clinical narrative: Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Renal failure, Sepsis, Shock, Swelling
Clinical narrative: Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Toxoplasmosis
Clinical narrative: Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscular weakness, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm and shoulder pain, limited range of motion arm weakness - received shot 12-12-14 still having pain 1-28-15. Can't sleep on that side cause of pain. Went to doctor 1-26-15, doctor prescribed methylprednisone.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: Pain all over, burning sensation all over. Unable to move without great effort. Could not lay on her back because of pain. The worse is the burning in "the nerves". Headache, very tired, nausea, pain on stomach, vomiting. Severe pain on legs, arms, back. When she got to MD gave her prednisone and hydrocodone. Client came on 1-23-15. C/O pain and burning sensation. No relief with medication. Called for help. They were not able to help.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Vomiting
Clinical narrative: Pain all over, burning sensation all over. Unable to move without great effort. Could not lay on her back because of pain. The worse is the burning in "the nerves". Headache, very tired, nausea, pain on stomach, vomiting. Severe pain on legs, arms, back. When she got to MD gave her prednisone and hydrocodone. Client came on 1-23-15. C/O pain and burning sensation. No relief with medication. Called for help. They were not able to help.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain in left shoulder at administration type. Diclofenac 75 mg BID x 30 days. Orthopedic consultation - pain continues.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye discharge, Ocular hyperaemia, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt claims that she had fever, chills, chest congestion and red eyes - with yellow discharge same after the vaccination administered.
Age: 1.13
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, swollen area of right thigh after recent vaccine. Dx: cellulitis of (R) thigh. TX: BACTRIM oral 10 days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site joint pain, Paraesthesia
Clinical narrative: Left shoulder pain in joint. Decreased ROM, numbness, tingling in left arm, pain 8/10, painful through to reporting on Tuesday, symptoms decreasing now (over weekend total arm rest, ice and anti-inflammatories).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 03-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Age: 13.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4
Symptoms: Activities of daily living impaired, Crying, Headache
Clinical narrative: Patient received vaccines 1.26.15 approx 8:15 AM. At noon that day pt's mother was notified by school patient crying due to headache. Treated with TYLENOL without significant relief. Headache continued next 3 days without significant relief. Missed school of Wednesday. Headache resolved by Friday. Mother states pt had never had a severe headache ever before.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse concerning an unspecified number of patients of unknown age and gender. Medical history and current condition of the patient were not reported. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ oral (lot#, expiry date, dose unspecified). Concomitant therapy was not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Alopecia, Skin disorder, Visual impairment
Clinical narrative: Scalp and facial dots. Hair fell out, eyebrows fell out. Vision problems.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Alopecia, Rash, Skin disorder, Visual impairment
Clinical narrative: Scalp and facial dots. Hair fell out, eyebrows fell out. Vision problems.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Injection site erythema
Clinical narrative: Patient complained of being dizzy after given vaccine on 1-19-15-continued with dizziness on and off x 4d. Also headaches on and off. Also injection site (R) arm red.
Age: 0.24
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left leg with profuse swelling and redness approx 1-2 hrs. after vaccines given. Seen in our clinic at 1513 and swelling much less. Still with some redness and hot to touch. Pt very fussy since vaccines. Cries when leg is touched.
Age: 0.24
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Left leg with profuse swelling and redness approx 1-2 hrs. after vaccines given. Seen in our clinic at 1513 and swelling much less. Still with some redness and hot to touch. Pt very fussy since vaccines. Cries when leg is touched.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV
Symptoms: Erythema, Injection site movement impairment, Pyrexia, Skin warm
Clinical narrative: Red dots next to vaccine site. Hot to the touch and fever developed, pt unable to straighten left leg.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Increasing warmth and redness at injection site. Given 1/31/15.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash, itching and swelling to injection site (3 days after administration). Treatment: diphenhydramine HCL at home for 3 days.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope twice within 5-10 minutes of vaccination. Responded to lying down, juice, snacks.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 16 week old patient of unknown gender. On 28-JAN-2015, the patient was vaccinated with the first dose of ROTATEQ 2 ml, (strength, lot number and expiry date were not reported) orally (inappropriate schedule of vaccine administered). The nurse stated that patient data was not presently available to answer all questions. No adverse effects reported. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Measles, Rash, Viral skin infection
Clinical narrative: Pt started developing rash on Sunday 2/1/15. Was seen at hospital and was Dx with skin viral infection. Mother stated rash got worse and brought him to clinic on 2/3/15 where he was Dx w/ measles.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 11-year-old male patient who received FLULAVAL Quadrivalent (batch number XZ3SP, expiry date 30th June 2015). On 11th November 2014, the patient received FLULAVAL Quadrivalent (intramuscular). In November 2014, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL Quadrivalent was continued with no change. In November 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL Quadrivalent. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL Quadrivalent. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse concerning an unspecified patient of unknown age and gender. Medical history and current condition of the patient were not reported. On 07-JAN-2015 the patient was vaccinated with a dose of improperly stored M-M-R II (lot# reported as J000200, expiry date: 09-JAN-2015) (dose, route unspecified). Concomitant therapy was not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported) instead of a dose of the prescribed dose of ZOSTAVAX. No adverse effects were reported. There was no concomitant medication provided. Additional information is not expected, because no follow up available.
Age: 0.19
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received HAVRIX (batch number 59D74, expiry date 9th December 2014) and (batch number 59D74, expiry date 5th February 2016). On 9th December 2014, the patient received the 1st dose of HAVRIX. On an unknown date, the dose was an unknown dose. On 9th December 2014, an unknown time after receiving HAVRIX, 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: HCP called to report that they gave an adult dose of HAVRIX to a 2 month old patient. They meant to give the patient PEDIARIX. They said the nurse chose the wrong product by accident. As of now, no adverse events have been reported by the patient/parent.
Sex: U
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a consumer refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (dose, route of administration and lot # were not reported). On an unknown date the patient experienced unspecified adverse reaction. The outcome of the event was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no pertinent medical history or drug reactions/allergies. On 26-JAN-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX vial (lot # K012924, expiration date reported as 29-NOV-2015), once, subcutaneously. No co-suspect therapies were reported. There were no concomitant medications. The pharmacist reproted that on 28-JAN-2015, the patient called in to the pharmacy stating that she developed a "red, itchy rash or patch" at the injection site that was "red and warm to the touch" (approximately in January 2015). No treatment was given for the adverse events and no lab diagnostics studies were performed. At the time of the report, the patient had not recovered from the events injection site rash, injection site pruritis, injection site erythema and injection site warmth. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site bleeding in a unk patient who received ENGERIX B. On an unknown date, the patient received the 2nd dose of ENGERIX B (unknown). On an unknown date, Immediately after receiving ENGERIX B, the patient experienced injection site bleeding. On an unknown date, the outcome of the injection site bleeding was unknown. It was unknown if the reporter considered the injections the bleeding to be relate to ENGERIX B. Additional details provided as follow: It was reported that the blood came out while administering ENGERIX B.
Age: 0.2
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old patient of unknown gender. Medical history and concurrent conditions were not reported. On 02-FEB-2015, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneous (lot number and expiration date were not provided) and a dose of VARIVAX (Merck) (route, lot number and expiration date were not reported). No concomitant medication was reported neither was any adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that, on 28-JAN-2015, an unspecified physician's office administered an expired dose of ZOSTAVAX (lot # J006828; expiration date 14-SEP-2014) to the patient, (dose and route not provided). No symptoms were reported. Additional information is not expected because the reporter did not provide consent to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 08-JAN-2015, doses of VARIVAX (Merck) which were exposed to a supported temperature excursion, had been administered to an unspecified number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified) on unspecified dates. No adverse effects were reported. No concomitant therapies were reported. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
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 6-month-od female patient who received KINRIX (batch number PY3DZ, expiry date unknown) and (batch number PY3DZ, expiry date 31st May 2016). On 16th December 2014, the patient received KINRIX. On an unknown date, the dose was an unknown dose. On 16th December 2014, 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: Medical assistant reports that a KINRIX vaccine was accidentally administered to a 6 month old patient. No AEs reported as a result of the administration.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a child unk patient who received HAVRIX pediatric (batch number M7L59, expiry date 16th December 20160. On an unknown date, the patient received HAVRIX pediatric. On an unknown date, an unknown time after receiving HAVRIX 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: Medical assistant reports a pediatric patient received their booster dose of HAVRIX 2 weeks early.
Age: 57.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of wrong vaccine administered in a 57-year-old male patient who received INFANRIX (batch number HM4FY, expiry date 6th December 2016). Concurrent medical conditions included leukemia. In November 2014, the patient received INFANRIX .5 ml. On an unknown date, an unknown time after receiving INFANRIX, 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 received: 57 years old male being admitted to hospital for treatment of leukemia, has received multiple vaccinations to protect him while in treatment in the hospital. Instead of BOOSTRIX, INFANRIX was given (0.5 mL) to this man about a month ago with no reaction.
Age: 0.2
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 2-month-old male patient who received KINRIX (batch number KJ92, expiry date 22nd October 2015). On an unknown date, the patient received KINRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. 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: Office Manager reports that 2 month old child inadvertently received KINRIX vaccination. No other AE's were voiced. Caller was transferred to Medical Information Scientist as requested.
Sex: U
Vaccine: DTAP, HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received ENGERIX B (batch number 3B93H, expiry date 26th September 2015), (batch number AHBVC148BB, expiry date 8th September 2014) and (batch number FB3A3, expiry date 28th January 2016). Co-suspect products included HAVRIX (batch number N434L, expiry date 19th February 2016), (batch number 793JR, expiry date 15th February 2016) and (batch number PC527, expiry date 8th June 2015) and INFANRIX (batch number AC14B153AA, expiry date 18th September 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received HAVRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving ENGERIX B, HAVRIX and INFANRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Public Health Nurse called on behalf of office to find out the stability of INFANRIX, ENGERIX-B and HAVRIX after being exposed to temperatures above recommended storage range (up to10.2C) intermittently for 232 hours. Vaccine doses have been given to patients. HCP did not have information about these patients available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On 30-JAN-2015 unspecified number of patients were vaccinated with doses of GARDASIL (dose, route of administration, anatomical location and lot# was unknown) which were improperly stored (Incorrect product storage). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reporter is not willing to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to a child of unknown age and gender. On 29-JAN-2015 the subject was vaccinated with a dose of VAQTA (lot# unspecified), injection, strength was reported as 25/0.5 (unit unspecified) (dose, frequency and route were unspecified). The reporter reported that the subject was inadvertently administered an adult dose instead of a pediatric dose. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 30-JAN-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, frequency and route were not reported) (lot # K014834 and expiry date: 15-DEC-2014). No adverse effect was reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 30-JAN-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, frequency and route were not reported) (lot # J013453 and expiry date: 24-JAN-2015). No adverse effect was reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 16 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (strength, dose and lot# were unknown). (Drug administered to patient of inappropriate age). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date, unspecified number of patients were vaccinated with doses of VAQTA (dose, route of administration, anatomical location and lot# was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reported is not willing to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients with unknown ages and genders. On unknown dates the patients were vaccinated with improperly stored VAQTA (route, lot# and dose were unknown). No symptoms reported. It was not specified if the patients sought for medical attention. This is one of several reports received from the same reporter. Additional information is not expected as the medical assistant did not want to be contacted.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 82 year old male patient. The patient's pertinent medical history was none and drug allergies were unspecified. Approximately in 2009 (reported as about 6 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were unspecified). Concomitant medications were unspecified. On 21-JAN-2015 (reported as 6 years later), the patient had a rash which was diagnosed as zoster on his right arm. The patient sought medical attention and the treatment received was unspecified. The outcome of zoster was reported as not recovered/not resolved. The causality of zoster was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse concerning an unspecified number of patients of unknown age and gender. Medical history and current condition of the patients were not reported. On an unknown date the patients were vaccinated with a dose of improperly stored VAQTA (lot#, expiry date, dose unspecified). Concomitant therapy was not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU3, FLU3, HEP, HEPA, TDAP
Symptoms: Incorrect route of drug administration, Wrong technique in drug usage process
Clinical narrative: This case was reported by a nurse and described the occurrence of intramuscular formulation administered by other route in a patient who received INFANRIX. Co-suspect products included KINRIX, PEDIARIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLULVAL. On an unknown date, the patient received INFANRIX at an unknown dose, KINRIX at an unknown dose, PEDIARIX at an unknown dose, HAVRIX at an unknown dose, ENGERIX at an unknown dose, BOOSTRIX at an unknown dose, FLUARIX at an unknown dose and FLULAVAL at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, KINRIX, PEDIARIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLULAVAL, the patient experienced intramuscular formulation administered by other route and wrong injection technique. On an unknown date, the outcome of the intramuscular formulation administered by other route and wrong injection technique were unknown. Additional information received: INFANRIX, KINRIX, PEDIARIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX, FLULAVAL may have been injected SC vs IM, or using insufficient length of needles in several pediatric patients. No patient details available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients with unknown ages and genders. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (route, lot# and dose were unknown). No symptoms reported. It was not specified if the patients sought for medical attention. This is one of several reports received from the same reporter. Additional information is not expected as the medical assistant did not want to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JAN-2015 the patient was inadvertently vaccinated with RECOMBIVAX HB, intramuscularly, dose: 1 ml, lot # H013865 which expired on 13-JAN-2015. No adverse effects were reported for the patient. Additional information is not expected because the reporter did not give a consent for the follow up.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. On an unknown dates (reported as at age-appropriate times), the patient received two doses of VARIVAX (Merck) (dose, route, anatomical location, lot # and expiration date were not reported). On an unknown date (reported as one month after), the patient experienced varicella-like rash. The reporting nurse did not think that varicella-like rash was confirmed by medical examination. The outcome of varicella-like rash was unknown. The relatedness between the event and the vaccination with VARIVAX (Merck) was not provided. This is the one of the several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date, unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose, route of administration, anatomical location and lot# was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reporter is not willing to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 02-FEB-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # H011183, expiration date 31-JAN-2015) (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. Concomitant therapies were not reported. The outcome of the events was unknown. Additional information has been requested.