chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.04
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-03-20.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Vaccination complication
Clinical narrative: Adv eff bact vac NEC/NOS on 2014-04-01.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-04-11.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Toxicity to various agents
Clinical narrative: Poisoning-BCG vaccine on 2014-04-14.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-04-18.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempts to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chills, Hypoaesthesia, Immediate post-injection reaction, Muscle spasms
Clinical narrative: This spontaneous report as received from a 21 year old female consumer refers to herself. The patient reported that on 19-JUN-2014 she went to her OBGYN for the second injection of GARDASIL (lot#, dose, route not reported). Concomitant therapy was not reported. The patient started having an adverse reaction as soon as she received the injection with her arm starting to go through spasms. After leaving the physician's office, the patients started experiencing nausea, and severe pain in her arm, shoulder, neck and back and she also started having chills while driving her car. The side of her face became numb and her legs were weak. The patient was currently going to Urgent Care for an evaluation. At time of the report, outcome of the events was reported as not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 21 year old female consumer refers to herself. The patient reported that on 19-JUN-2014 she went to her OBGYN for the second injection of GARDASIL (lot#, dose, route not reported). Concomitant therapy was not reported. The patient started having an adverse reaction as soon as she received the injection with her arm starting to go through spasms. After leaving the physician's office, the patients started experiencing nausea, and severe pain in her arm, shoulder, neck and back and she also started having chills while driving her car. The side of her face became numb and her legs were weak. The patient was currently going to Urgent Care for an evaluation. At time of the report, outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients (no patient information known). On an unknown date, the unspecified number of patients were vaccinated with ZOSTAVAX, 19400 PFU (plaque forming units) (dose, route of administration, lot # and expiration date were not provided), that was improperly stored outside the prescribing information. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further adverse event was information available. A follow-up (after previously unsuccessful telephone call) was received form the pharmacist who reported that 2 doses of ZOSTAVAX, 19400 PFU (plaque forming units) (lot# J011829, expiration date 26-DEC-2014) (dose and route of administration were not provided) were administered (specific dates were unavailable at this time) to 2 unknown patients. No specific information on the patients was available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to 4 patients of unknown age and gender. On an unknown date the 4 patients received improperly stored ROTATEQ (lot#, strength, doe, frequency unspecified). Temperature excursions for the vaccine were supported with in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to a patient of unknown age and gender. On an unknown date the patient received improperly stored RECOMBIVAX HB (lot#, strength, dose, frequency, route unspecified). Temperature excursions for the vaccine were supported with in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Started with a lot of arm pain that radiated down same arm (R). Started the same evening after receiving immunization. Pain gradually subsided and after 6 wks - resolved.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age with autism. On 07-APR-2013 the patient was vaccinated with the first 0.5ml dose of VAQTA intramuscular for work purposes (strength and lot# unknown). On 07-SEP-2013, the patient was vaccinated with the second 0.5ml dose of VAQTA intramuscular for work purposes (strength and lot# unknown). Nurse stated patient received vaccination at unspecified pediatrician's office. Nurse stated she has no patient details and no vaccine lot information. No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Hypersensitivity, Incorrect drug dosage form administered, Rash, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US012139, is an initial spontaneous report received from a nurse on 16 Jun 2014. This report refers to a 13 year old male patient. Past medical history and concomitant medications were not reported. He received only MENVEO, (batch number: A12129), reconstituted with a sterile water instead of MENCYW-135 intramuscularly on 12 Jun 2014. He developed a rash and difficulty  breathing shortly after vaccine administration, but he was also administered other medications around the same time as MENVEO, that may have caused the allergic reaction. Corticosteroids were administered to the patient and allergic reaction is not present to the date (resolved). The seriousness and causality of the events were not reported.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Irritability, Opisthotonus, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arching back in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVENAR. Concurrent medications included Ranitidine and ZANTAC. On 11 June 2014, the subject received unspecified dose of PEDIARIX (unknown route and injection site), unspecified dose of PREVENAR (unknown route and injection site). In June 2014, less than one week after vaccination with PEDIARIX and PREVENAR, the subject experienced arching back, irritability and fever (40 Deg. C). On 12 June 2014 in the morning, the subject was brought back into the doctor's office and from there was taken by ambulance to the emergency room. The reporter thought the subject was not admitted to the hospital but she did not see any further information in the chart to indicate that. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. After these events, pertussis vaccination was added as a possible allergy to subject's chart.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, RECOMBIVAX HB underwent a temperature excursion and was administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a male adult patient older than 20 years of age. Concomitant medication and pertinent medical history were not provided. On 24-JUN-2013, the patient was vaccinated outside of prescribing information with the first 0.5ml dose of RECOMBIVAX HB (injection, 5/0.5mcg/ml, route unknown). And the second dose was administered on 28-APR-2014. No adverse effects noted by patient. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-04-24.
Age: 50.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient developed varicella infection approximately 18 days post first vaccine administration.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dermatitis, Rash
Clinical narrative: Drug dermatitis NOS on 2014-04-29, clinician comment: Pt also received amoxicillin at the same visit so may be amox reaction. Rash occurred on day 9 of antibox and 9 days after getting MMR vaccine.
Age: 3.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Adverse drug reaction, Local reaction
Clinical narrative: Adv eff med/biol sub NOS on 2014-05-09, clinician comment: local reaction.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-05-14.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-04-18.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Allergy to vaccine, Injection site reaction, Rash pruritic, Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-04-18.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-04-18, tetanus toxoids allergy on 2014-05-13, clinician comment: pruritic rash at site of injection.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Allergy to vaccine, Injection site reaction, Rash pruritic, Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2014-04-18, tetanus toxoids allergy on 2014-05-13, clinician comment: pruritic rash at site of injection.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site itchy, swollen red hard and hot when touched.  Area was getting larger and larger.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash on left upper extremetiy with moderate swelling, ill-defined borders.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient received IPV and MMR on his Rt thigh. swollen tender right inguinal node, painful to touch with erythema 2 by 3 cm.  Injection site is not visible (no redness or swelling).  Treating with an oral anbx.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Large hives covering entire torso, shoulders, back, stomach, groin, neck, face, and smaller amount down legs.  Hives approx. size of a dime - nickel.  Extremely itchy and fast spreading.
Age: 7.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: WHEEZING, HIVES, WELTS ALL OVER BODY.
Age: 1.11
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash papular, Rash vesicular
Clinical narrative: Per Maternal Grandmother large flat patches to face, armpits and trunk started AM on 6/13/14 was taken to PCP, sent home with Claritin.  On 6/23/14 Fine papular rash to chest, face and back, went back to PCP where they were told it looks like varicella.
Age: 51.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Crying, Emotional distress, Fatigue, Sensation of heaviness
Clinical narrative: Very tired, became very emotional (weepy), had a long cry after got upset about something, rested, then limbs felt very heavy.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: PAIN, SWELLING AT INJECTION SITE, AND DIFFICULTY RAISING LEFT ARM. NO IMMEDIATE TREATMENT PER PATIENT.  WILL BEGIN USING IBUPROFEN, APPLY ICE PACKS PER INSTRUCTION.
Age: 45.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Local reaction, Rash
Clinical narrative: He apparently had a severe local reaction to his Prevnar vaccine at our last appointment and developed a rash on his back that improved with topical steroids. He also was extremely fatigued for 5 days but is now feeling back to his baseline. I think his symptoms were all due to Prevnar and he will continue to monitor and let us know if he starts feeling different to his baseline.
Age: 18.0
Sex: M
Vaccine: HPV2
Symptoms: Blood glucose normal, Confusional state, Dizziness, Eye movement disorder, Hyporesponsive to stimuli
Clinical narrative: Right after vaccine was administered pt stated he felt dizzy. MA had pt lay down and then he started twitching, contracting his forearms and his eyes rolled back into his head. At that time mother in the room got upset and multiple doctors including myself went into the room. He had a second episode both lasting only about 5-10 sec. He was in a slight post-ictal state- somewhat confused/not responding at baseline. EMS was called and by the time they arrived he was closer but not quite at baseline.
Age: 18.0
Sex: M
Vaccine: HPV2
Symptoms: Immediate post-injection reaction, Joint contracture, Muscle twitching, Postictal state
Clinical narrative: Right after vaccine was administered pt stated he felt dizzy. MA had pt lay down and then he started twitching, contracting his forearms and his eyes rolled back into his head. At that time mother in the room got upset and multiple doctors including myself went into the room. He had a second episode both lasting only about 5-10 sec. He was in a slight post-ictal state- somewhat confused/not responding at baseline. EMS was called and by the time they arrived he was closer but not quite at baseline.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patient experienced underwent a temperature excursion and no adverse effect reported. The outcome of underwent a temperature excursion and no adverse effect reported is unknown. The reporter considered underwent a temperature excursion and no adverse effect reported to be not related to GARDASIL. {Additional information has been requested./ Additional information is not expected.}
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 18 year old female patient. Medical history and concurrent conditions were not reported. In 2014, the patient was vaccinated with the second dose of GARDASIL (lot number, expiration date, strength and route were not reported). Co-suspect and concomitant therapies were not reported. Pharmacist reported that in 2014, patient was in pharmacy to received second dose of GARDASIL. Patient had received first dose of GARDASIL in 2012 (reported as about two years ago). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner and a healthcare worker refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The healthcare worker reported that on unknown dates, unspecified amount of patients were vaccinated with PNEUMOVAX 23 (lot number, dose, route and frequency were not provided) which were improperly stored. The PNEUMOVAX 23 was exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. The nurse practitioner reported that she was unsure if the PNEUMOVAX 23 had undergone excursions since 01-JAN-2014. She reported that "some" might have undergone multiple excursions and "others" might have undergone no excursions but she was not exactly sure of which ones. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner and a healthcare worker refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The healthcare worker reported that on unknown dates, unspecified amount of patients were vaccinated with RECOMBIVAX HB (lot number, dose, route and frequency were not provided) which were improperly stored. The RECOMBIVAX HB was exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. The nurse practitioner reported that she was unsure if the RECOMBIVAX HB had undergone excursions since 01-JAN-2014. She reported that "some" might have undergone multiple excursions and "others" might have undergone no excursions but she was not exactly sure of which ones. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner and a healthcare worker and a nurse practitioner refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided.The healthcare worker reported that on unknown dates, unspecified amount of patients were vaccinated with PEDVAXHIB (lot number, dose, route and frequency were not provided) which were improperly stored. The PEDVAXHIB was exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. The nurse practitioner reported that she was unsure if the PEDVAXHIB had undergone excursions since 01-JAN-2014. She reported that "some" might have undergone multiple excursions and "others" might have undergone no excursions but she was not exactly sure of which ones. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, VARIVAX (Merck) underwent a temperature excursion and was administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, PROQUAD underwent a temperature excursion and was administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. on 25-JUN-2012 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported) and on 18-JUN-2014 the patient was vaccinated with another dose of ZOSTAVAX (dose, route, lot number not reported). No adverse symptoms reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse to a 13 year old female patient. On 20-JUN-2014 the patient was vaccinated with a fourth dose of RECOMBIVAX HB (5/0.5 mcrg/ml, 0.5ml, intramuscular) in place of VAQTA. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local expanding redness noted 1 d after vaccination w/ DTaP and IPV immunizations. 9 cm well demarcated redness and 7 cm induration at mid (R) thigh.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Oedema peripheral, Pain
Clinical narrative: Received vaccine on 6-23-14. C/O pain all week. Mom noticed on Friday that area where shot was given was full of fluid. Mom call pediatrician. Denied redness, warmth, or temperature. They were out of town and sent to ER. No treatment required at this time. 6-30-14 area of fluid is resolving and denies any pain.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a unspecified patient. The patient's medical history and current condition are not reported. On an unknown date the patient was vaccinated with 2nd dose of GARDASIL (Lot # and expiry date not reported) of dose 0.5 ml via intramuscular route 1 year after the first dose of GARDASIL and received the third dose of GARDASIL about 60 days after the second dose of GARDASIL. No adverse effects are reported. Product quality complaint is not reported. The outcome of event is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified patient of unknown age and gender. On an unknown date, the product was improperly stored at -2 C for 2 hours. On 25-JUL-2014, the patients were vaccinated with VARIVAX (dose, route and lot were not reported). No adverse effects reported. This is one report of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified patients of unknown age and gender. On an unknown date, the product was improperly stored at -2 c for 2 hours. On 25-JUN-2014, the patients were vaccinated with ZOSTAVAX (dose, route and lot were not reported). No adverse effects reported. This is one report of two reports from the same source. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Glossodynia, Pyrexia, Rash, Sinusitis
Clinical narrative: Immuz 6/4/14, 6/5/13 fever 103 deg, 6/6/14 rash on legs-saw MD told sinus infection but no nasal symptoms, ordered med but mom didn't get. Sat 6/7- tongue ache and swollen- gave BENADRYL every 4 hours and went down. No appetite x 3-4 days-Rash now fading.
Age: 1.26
Sex: M
Vaccine: HEPA
Symptoms: Swollen tongue
Clinical narrative: Immuz 6/4/14, 6/5/13 fever 103 deg, 6/6/14 rash on legs-saw MD told sinus infection but no nasal symptoms, ordered med but mom didn't get. Sat 6/7- tongue ache and swollen- gave BENADRYL every 4 hours and went down. No appetite x 3-4 days-Rash now fading.
Age: 0.49
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Injection site swelling
Clinical narrative: 5/27/14 1600 Pt mother called - left message for return call. Nurse called back. Pt had 4 mth old vaccines around 10:00am and has been crying ever since. Mother c/o leg slight swollen. Mother states she has given infant MOTRIN, batch and placed ice pack on leg. Counseled parent per policy. Infant quiet on phone P/T feeding. Advised parent since concerns take to PCP/ER. 5-28-14 0800 TC to pt # left message for return call. 5-29-14 1000 TC to pt # left message - TC x3 no answer.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swollen (R) arm. Swollen at site of KINRIX. Went to PMD.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Blepharospasm, Electroencephalogram normal, Hypoaesthesia
Clinical narrative: Numbness (L) arm 6:30. Eye twitching 10:30PM. 11PM went to ER.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blood test, Chills, Nausea, Pyrexia, Rash
Clinical narrative: Nausea at 9PM. Nausea, chills, low grade fever around 100. Vomiting, face swollen, rash on face and neck went to ER 10:30A.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Swelling face, Vomiting
Clinical narrative: Nausea at 9PM. Nausea, chills, low grade fever around 100. Vomiting, face swollen, rash on face and neck went to ER 10:30A.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm, Swelling
Clinical narrative: 05/03/2014 Moderate other Pt had severe swelling, redness with heat. Had fever for 4-5 days. Arm stayed extremely sore.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Blistery rash on left forearm that is painful. Pt was diagnosed with shingles at ER and was started on an antiviral.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner and a healthcare worker refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The healthcare worker reported that on unknown dates, unspecified amount of patients were vaccinated with GARDASIL (lot number, dose, route and frequency were not provided) which were improperly stored. The GARDASIL were exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. The nurse practitioner reported that she was unsure if the GARDASIL had undergone excursions since 01-JAN-2014. She reported that "some" might have undergone multiple excursions and "others" might have undergone no excursions but she was not exactly sure of which ones. No adverse effect reported. On an unknown date an unspecified amount of patients were vaccinated with GARDASIL which were improperly stored. No adverse effect reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.66
Sex: M
Vaccine: DTAP, HIBV, MMRV, PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None known
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer refers to a friend, patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, strength, route were not reported, lot number and expiration date). Co-suspect and concomitant therapies were not reported. On an unknown date the patient developed shingles after receiving dose of ZOSTAVAX. At the time of the report the outcome was unknown. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Laboratory test, Panic attack, Presyncope, Tachycardia
Clinical narrative: Tachycardia, marked edema, (L) deltoid. Presyncope x3 necessitating both an urgent care and ED evals. Episode has triggered "panic attacks".
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Hyperhidrosis, Presyncope
Clinical narrative: Pt became weak, dizzy and diaphoretic after receiving injections - near syncopal episode. B/P decreased 86/50. Observed pt for 1/2 hr, gave her crackers and soda. She had not eaten much all day.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Swelling, redness around inj site, hot to touch, hurt to walk. Prescribed diphenhydramine 12.5mg/5mL = 7.5mL PO TID, PRN x5 days.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Arthropod bite, Rash, Rash pruritic
Clinical narrative: Mother reports child developed a rash that appeared like mosquito bites to face, arms, chest, and back, on 6-26-14. Around 7:00pm rash was very itchy. On 6-27-14 child was seen again at the office and rash greatly improved. Medication given was BENADRYL and started with prednisolone.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Noticed swelling, itchiness, redness as of 6/27/14 at night. Improved within weekend. Measured in office 35x45 mm.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: SOB, throat tightness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Rash, Rash pruritic
Clinical narrative: Patient received ZOSTAVAX at 6:04pm on Friday 6-27-14. Since that time she has experienced a rash of about 6 inch in length. She states that a hard nodule is present at injection site. On occasion rash is itchy. I suggested using ice packs and BENADRYL/CLARITIN. If symptoms persist follow up with her physician.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: 06/30/14 Pt was seen at the walk-in clinic today, reported red, itchy rash the next evening of the vaccination - bilateral rib area below both breasts, bilateral armpits, underarms, bilateral thigh and groin. Continues to worsen and spread.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site extravasation, Injection site haemorrhage, Injection site pain
Clinical narrative: This spontaneous report was received from a physician and a healthcare student, who is also the patient's mother, concerning a 17 year old female patient, with no pertinent medical history or drug reaction/allergies. On 16-JUN-2014, the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, frequency, strength and route were jot reported). Concomitant therapy includes an unspecified birth control pills. Healthcare student reported that patient received GARDASIL injection and experienced pain, bleeding and a significant quantity of the GARDASIL ran done the patient's arm, on 17-JUN-2014. Healthcare student was concerned that patient did not received full dose of GARDASIL. Bleeding stopped and pain resolved after use of ice pack at the injection site. The physician stated that the date on which the patient received her first dose of GARDASIL was 16-JUN-2014. The physician does not believe that "more than a drop" of the dose leaked out of the patient's injection site. At the time of the report the outcome was unknown. The patient seek medical attention at the physician's office. Patient received an ice pack to injection site as treatment. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: Redness, swelling at vaccine site. Fever.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of unspecified patients. On unspecified dates in 2014 the patients were vaccinated with doses LIQUID PEDVAXHIB (lot #, expiration date, dose and route unspecified) which were exposed to a previous temperature excursion on 20-MAY-2014. The nurse was not aware of any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a other health professional refers to a 37 year old female patient. On an unknown date the patient received two doses of M-M-R II (lot#, expiration date, dose, route, indication not reported) when the patient was a child. On an unknown date the physician had her titers checked and it was found that her titers were negative for MMR. The physician then decide to administer one dose of M-M-R II to the patient. In May 2014 ("one month ago") the patient was vaccinated with third dose of M-M-R II (lot#, expiration date, dose, route, indication not reported). The patient's titers had not been checked after it was administered. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of unspecified patients. On unspecified dates in 2014 the patients were vaccinated with doses of GARDASIL (lot #, expiration date, dose and route unspecified) which were exposed to a previous temperature excursion on 20-MAY-2014. The nurse was not aware of any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received form a nurse refers to an unspecified number of unspecified patients. On unspecified dates in 2014 the patients were vaccinated with doses of RECOMBIVAX HB (lot #, expiration date, dose and route unspecified) which were exposed to a previous temperature excursion on 20-MAY-2014. The nurse was not aware of any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient given GARDASIL too soon between 2nd injection and 3rd injection. No reactions. Patient mother notified.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Abscess, Abscess drainage, Injection site nodule
Clinical narrative: Pt entered clinic 5/13/14 stating she developed a small bump near vaccine site that developed about a week after receiving vaccine. Area assessed by dr. No fevers or redness noted. Just tender pt had stated due to history and not being sure it was a reaction. Pt referred to PCP and to return in a week for a check. A week after pt returned stating she was seen in ED for an abscessed cyst and it was drained.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Lymph node pain, Malaise, Pain in extremity
Clinical narrative: Large bulge in arm/swelling. Redness/itchiness/soreness in arm. Soreness in lymph nodes (under armpit). Drowsy/under the weather feeling.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Peripheral swelling, Pruritus, Somnolence
Clinical narrative: Large bulge in arm/swelling. Redness/itchiness/soreness in arm. Soreness in lymph nodes (under armpit). Drowsy/under the weather feeling.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (L) deltoid. KEFLEX 500mg TID x10d. BENADRYL 25mg.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Arthralgia, Cheilitis, Facial pain, Fall, Laceration
Clinical narrative: Pt received hepatitis A and HPV vaccine at office visit. Pt walked out to car and passed out and fell on face. Pt had lacerations to 3 fingers on (R) hand 1 finger on left hand near (R) eye, lip swelling and reddened, painful to touch area on (R) cheek and (R) knee. All happened within 10 minutes of receiving vaccines. Both vaccines were last dose in series.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Lip swelling, Loss of consciousness
Clinical narrative: Pt received hepatitis A and HPV vaccine at office visit. Pt walked out to car and passed out and fell on face. Pt had lacerations to 3 fingers on (R) hand 1 finger on left hand near (R) eye, lip swelling and reddened, painful to touch area on (R) cheek and (R) knee. All happened within 10 minutes of receiving vaccines. Both vaccines were last dose in series.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness unilateral, Cough, Lacrimation increased, Loss of consciousness, Malaise
Clinical narrative: Case number PHHY2013US014938 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 476167) website on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211593) on 26 Jun 2014: This report refers to an 11-year-old polymedicated male patient. He was vaccinated with FLUVIRIN (batch number: 1206001 and expiry date: 30 Jun 2013) intramuscularly on 03 Oct 2012. On 06 Oct 2012, the patient became sick with runny nose, sore throat and cough. After about 1 week of vaccination, his right eye started watering. He went to the ophthalmologist a week later and she advised him that he was having optic neuritis. He lost partial vision in his right eye due to this and was admitted into hospital for 6 days. He was having watery eye with 10 to 15 minutes black outs numerous times a day. Outcome of the events were reported as condition unchanged as of 04 Dec 2012. Seriousness was reported as hospitalization. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211593) on 26 Jun 2014: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Optic neuritis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Case number PHHY2013US014938 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 476167) website on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 211593) on 26 Jun 2014: This report refers to an 11-year-old polymedicated male patient. He was vaccinated with FLUVIRIN (batch number: 1206001 and expiry date: 30 Jun 2013) intramuscularly on 03 Oct 2012. On 06 Oct 2012, the patient became sick with runny nose, sore throat and cough. After about 1 week of vaccination, his right eye started watering. He went to the ophthalmologist a week later and she advised him that he was having optic neuritis. He lost partial vision in his right eye due to this and was admitted into hospital for 6 days. He was having watery eye with 10 to 15 minutes black outs numerous times a day. Outcome of the events were reported as condition unchanged as of 04 Dec 2012. Seriousness was reported as hospitalization. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 211593) on 26 Jun 2014: Updated batch review report.
Age: 28.0
Sex: M
Vaccine: FLUC3
Symptoms: Heart rate increased, Oxygen saturation decreased, Paraesthesia, Pruritus, Throat tightness
Clinical narrative: Case number PHHY2014US012763 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 514797) website on 03 Feb 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 279323) on 23 Jun 2014. This case refers to a 28 year old male patient. He had no known drug allergies and his concomitant medications were not reported. On 26 Nov 2013, the patient was vaccinated with FLUCELVAX (batch number: 005021A) intramuscularly in the right arm. Three minutes after the vaccination, he developed itching and tingling sensation followed by tightening of throat after a minute. Vital signs were as follows; pulse rate was 105 beats per minute, oxygen saturation was 95% which was decreased to 91% on room air and blood pressure was 152/82. The patient developed hives on upper extremities and his trunk. He was treated with EPIPEN at a dose of 0.3 mg using an auto injector and high flow oxygen through non re-breather mask. His oxygen saturation improved to 100% but pulse rate remained at 110 beats per minute. The patient was transported to a hospital. The outcome of the events was not reported. The causality and seriousness of the events were not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 005021A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 279323) on 23 Jun 2014: Updated batch review report.
Age: 28.0
Sex: M
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US012763 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 514797) website on 03 Feb 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 279323) on 23 Jun 2014. This case refers to a 28 year old male patient. He had no known drug allergies and his concomitant medications were not reported. On 26 Nov 2013, the patient was vaccinated with FLUCELVAX (batch number: 005021A) intramuscularly in the right arm. Three minutes after the vaccination, he developed itching and tingling sensation followed by tightening of throat after a minute. Vital signs were as follows; pulse rate was 105 beats per minute, oxygen saturation was 95% which was decreased to 91% on room air and blood pressure was 152/82. The patient developed hives on upper extremities and his trunk. He was treated with EPIPEN at a dose of 0.3 mg using an auto injector and high flow oxygen through non re-breather mask. His oxygen saturation improved to 100% but pulse rate remained at 110 beats per minute. The patient was transported to a hospital. The outcome of the events was not reported. The causality and seriousness of the events were not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 005021A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 279323) on 23 Jun 2014: Updated batch review report.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ, TDAP, VARCEL, HPV2, MNQ, TDAP, VARCEL
Symptoms: Blood test, Complex regional pain syndrome, Fibromyalgia, Hypoaesthesia, Local swelling
Clinical narrative: Case number PHHY2014US051453 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 522136) on 24 Apr 2014 with a follow up report received from VAERS on 28 May 2014 with a follow up report received from the Quality Assurance department (QA reference number: 303056) on 02 Jun 2014 and a follow up report from the QA department received on 19 Jun 2014. This report refers to a 13-years-old female patient. Her medical history included asthma, tonsillectomy, Helicobacter pylori infection, allergic rhinitis and lactose intolerance. Her concomitant medications were not reported. She was vaccinated with MENVEO, (batch number: A11072), BOOSTRIX (other manufacturer, batch number: AC52B099CA), CERVARIX (other manufacturer, batch number: AHPVA169AB) and VARIVAX (other manufacturer, batch number: H016920) on 10 Jun 2013. On 11 Jun 2013, she had left arm pain from elbow all the way down to middle finger. It was reported that her arm was numb. She held it close to her body and used pain killers, ice and heat till 13 Jun 2013. She went to the physician and her hand and arm was swollen. It was reported that her hand was shaking and it hurt to move the fingers. She went to emergency room and had her blood work, magnetic resonance imaging (MRI) and X-ray done. She claimed that she had Reflex Sympathetic Dystrophy (RSD) and bad fibromyalgia. The event outcome was reported as condition unchanged. The event was reported non-serious, but was internally upgraded as medically significant by the agency. The causality was not reported. Based on the document review, it was stated that the MENVEO, batch number A11072 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from VAERS on 28 May 2014: Updated suspect vaccine trade names (MENVEO, BOOSTRIX, CERVARIX and VARIVAX) and vaccine batch numbers. Non significant follow up report was received from the Quality Assurance department on 02 Jun 2014: The QA reference number was updated. Follow up report from the QA department received on 19 Jun 2014: Updated batch review report.