chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Gene mutation identification test positive
Clinical narrative: This literature marketed report has been received from the authors of a published literature article title, regarding a 2 year old male patient with recurrent respiratory infections since age 6 months, hypogammaglobulinemia and atypical heterozygous Artemis mutations associated with an unrelated gene mutation (heterozygous transmembrane activator and CAML interactor (TACI) (Chromosome 17) and a heterozygous variant mutation on DNA Cross-Link Repair 1C (DCLRE1C) (Chromosome 10)). It was reported that the patient was immunodeficient. It was also stated that the patient's mother and father with an isolated TACI and Artemis mutations respectively were both asymptomatic. The patient had low serum immunoglobulin G (IgG) and normal lymphocyte subsets. On an unknown date, the patient was vaccinated with a dose of (manufacturer unknown) PPV23, injection, (dose, route of administration and injection site were not reported) and PCV13, (formulation, dose, route of administration and injection site were not reported). There were no concomitant medications reported. On an unspecified date, the patient developed failed antibody responses to PPV23 and PCV13 respectively. Genetics performed on an unspecified date revealed a variant mutation of the DCLRE1C gene of unknown significant: c.251C>G (p.S84C) and a heterozygous missense  mutation of TNFRSF13B (TACI) gene associated with common variable immunodeficiency (CVID) type 2: c.310T>C (p.C104R). The outcome of failed antibody responses to pneumococcal polysaccharide and conjugate vaccines was unknown at the time of the report. The authors considered the event to be related to PPV23 (manufacturer unknown). This is one of two reports received from the same literature article (cross referenced with MARRS# 1603USA001572). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and concerns an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with VAQTA (Lot# L023232, expiry: 25-FEB-2017) (route, dose and strength were not reported) that was improperly stored at 46.7 Fahrenheit for 14 hours and 40 minutes. No adverse effects were reported. There was no prior temperature excursions noted. This is one of the two cases from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPH, IPV, RVX
Symptoms: Blood test normal, Body temperature increased, Febrile convulsion, Lethargy, Urine analysis normal
Clinical narrative: Febrile seizure with temperature 102.5. Also acts very lethargic for the first 5 days after immunizations.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Formication, Pruritus generalised
Clinical narrative: Feeling of bugs crawling all over body. Itching all over body & in groin area.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to ten patients of unknown age and gender. The patients' medical history and drug reactions/allergies were not reported. On 10-MAR-2016 doses of VARIVAX (Merck) (lot# L043619, expiration date 02-NOV-2017) were improperly stored to -2.2C for 8.25 hours. Then on unspecified dates since 10-MAR-2016 the patients each received a dose of the improperly stored VARIVAX (Merck) (dose and route unknown) (incorrect product storage). There were no known adverse effects. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 2 year old female patient. The patient's medical history and drug allergies were none. Concomitant therapies included THERAFLU which was given on 06-MAR-2016. On 09-MAR-2016, the patient was vaccinated, into her left thigh, with PEDVAXHIB (Lot# L030870, expiry: 10-JUN-2016) (dosing details not provided). In the evening of 09-MAR-2016, the patient broke out into hive like rash which began at the injection site. The patient sought medical attention and visited the office on 10-MAR-2016 and the hive like rash had spread across patient's entire body. The patient was diagnosed as having an allergic reaction to the PEDVAXHIB. The patient was treated with BENADRYL and prednisone. No lab tests were performed. The outcome of the urticaria was reported as not recovered/not resolved. The relatedness between the event urticaria and PEDVAXHIB was reported as related. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored VARIVAX (Merck) (lot # reported as L043624, expiry date 03-NOV-2017 and lot # reported as L040419, expiry date 14-OCT-2017) (dose, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was noted as 11 Fahrenheit for 40 minutes. Also, previous temperature excursion was reported as multiple defrost cycles. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Merck) injection (dose and route not specified) lot # L027287, expiry date: 21-JUL-2017. No adverse effects were reported. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician via field representative, refers to multiple unspecified patients (which included friends as well as individuals that were going to nursing school) of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. On unknown dates, these patients were vaccinated with the complete three-dose series of RECOMBIVAX HB and subsequently received a booster dose as well, (inappropriate schedule of drug administration). On unknown dates, titers were drawn from these unspecified patients and they did not have antibody titers for hepatitis B (hepatitis B antibody negative). Outcome of the event, hepatitis B antibody negative was unknown. Reporting physician did not assessed the causality of the event with respect to therapy with RECOMBIVAX HB. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Abnormal faeces, Flatulence
Clinical narrative: ROTATEQ given at 2 mo on 1/18/16. Parents report that child has abdominal pain, (+) gas, large odorous stools for approximately 48 hours later.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain, Cough, Wheezing
Clinical narrative: 5 min. after FLUMIST. C/O abdominal pain, followed by harsh cough, wheezing. Treatment albuterol neb 2x, PRELONE 15/5ml, 5ml.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itching developed on Rt upper arm where KINRIX and FLUZONE given.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test, CD4 lymphocytes, Flow cytometry, Impaired work ability, Joint range of motion decreased
Clinical narrative: This literature study report was received from the authors of the published abstract and refers to 22-year-old female subject. As part of a small pre-clinical study of stage-specific antibody responses to pneumococcal vaccination, the authors enrolled a 22-year-old female with a history of asthma. At recruitment she denied previous vaccination. On unspecified day she received PNEUMOVAX 23 and within seven days developed a large local reaction lasting seven days; she was unable to work for three days due to limited range of motion and pain. After the event, medical records from a hospitalization for severe asthma three months prior to study entry were obtained and, upon review, she had received PNEUMOVAX 23. Blood was collected on day 0 (prior to vaccination), and on day 7 and day 35 post vaccination. Flow cytometry was performed on PBMC, and IgG anti-pneumococcal capsule antibody levels and opsonophagocytosis titers were measured with serum. At day 7, the subject failed to produce a robust plasma blast response. IgM + CD27 + memory B cells, the ratio of ASC to PC, and the numbers of CD4 and CDS T cells were unchanged. At day 35, IgG anti-capsule antibody levels and pneumococcal opsonophagocytosis titers were unchanged. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pain
Clinical narrative: This literature study report was received from the authors of the published abstract and refers to 22-year-old female subject. As part of a small pre-clinical study of stage-specific antibody responses to pneumococcal vaccination, the authors enrolled a 22-year-old female with a history of asthma. At recruitment she denied previous vaccination. On unspecified day she received PNEUMOVAX 23 and within seven days developed a large local reaction lasting seven days; she was unable to work for three days due to limited range of motion and pain. After the event, medical records from a hospitalization for severe asthma three months prior to study entry were obtained and, upon review, she had received PNEUMOVAX 23. Blood was collected on day 0 (prior to vaccination), and on day 7 and day 35 post vaccination. Flow cytometry was performed on PBMC, and IgG anti-pneumococcal capsule antibody levels and opsonophagocytosis titers were measured with serum. At day 7, the subject failed to produce a robust plasma blast response. IgM + CD27 + memory B cells, the ratio of ASC to PC, and the numbers of CD4 and CDS T cells were unchanged. At day 35, IgG anti-capsule antibody levels and pneumococcal opsonophagocytosis titers were unchanged. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# L033138, expiration date 31-AUG-2017, dose, anatomical location and route of administration were not reported). There was no previous excursion reported, time frame was 13 days and 20.5 hours with temperature 0.5 Celsius degree. No adverse events were reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 78 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 09-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 lot # L018503, expiry date 16-MAR-2017 (dose, route and site of administration were not reported). The patient did not take any concomitant medications. On 10-MAR-2016, she experienced generalized weakness and could not lift her arm. There were no lab diagnostics studies performed. The outcome of the events was unknown. The patient sought medical attention via calling the physician's office. The relatedness between the events and suspect therapy was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.73
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient administered PROQUAD vaccine (MMRV) instead of MMR. Also rec'd varicella that day. No s/s or tx noted/given.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Overnight vomiting several hours after taking oral Typhoid better by AM and went to school. Father has similar episode several days prior.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Rash at site of injection and spreading further on the arm. Itching and redness as well. No blisters. No other symptoms.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Constipation, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day of vaccination redness, swelling, pain, warmth left thigh. Discontinued rolling and refused to bear weight on legs. Seems fatigued and has had some change in stool pattern (constipation). Recently has started rolling again. Sits well.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site warmth, Mobility decreased, Weight bearing difficulty
Clinical narrative: Day of vaccination redness, swelling, pain, warmth left thigh. Discontinued rolling and refused to bear weight on legs. Seems fatigued and has had some change in stool pattern (constipation). Recently has started rolling again. Sits well.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Constipation, Injection site erythema, Injection site swelling, Malaise, Mobility decreased
Clinical narrative: Day of vaccination redness, swelling, pain, warmth left thigh. Discontinued rolling and refused to bear weight on legs. Seems fatigued and has had some change in stool pattern (constipation). Recently has started rolling again. Sits well.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Neurological examination, Weight bearing difficulty
Clinical narrative: Day of vaccination redness, swelling, pain, warmth left thigh. Discontinued rolling and refused to bear weight on legs. Seems fatigued and has had some change in stool pattern (constipation). Recently has started rolling again. Sits well.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Red patch (R) lateral thigh. Painful and itchy. A minimally elevated red flat patch with induration 8-9 cm in diameter.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Dysuria, Gait disturbance, Injection site movement impairment, Urinary incontinence
Clinical narrative: Limping, not walking on left leg since receiving 2 vaccines in LVL. 3 days no fever, seen in clinic for dysuria and urinary incontinence x 2 days.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: (L) deltoid pain beginning on 03/04/2016 the day after getting a TDAP.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, warmth, swollen and tenderness.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Ear pain, Malaise, Nuclear magnetic resonance imaging
Clinical narrative: Became sick, fever, swollen face and next and bad ear pain then arm pain which finally diagnosed as brachial neuritis.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Radiculitis brachial, Scan, Swelling face
Clinical narrative: Became sick, fever, swollen face and next and bad ear pain then arm pain which finally diagnosed as brachial neuritis.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Pt had 2 febrile seizures since vaccines administered.
Age: 0.2
Sex: M
Vaccine: 6VAX-F, PNC10, RV1
Symptoms: Crying, Decreased appetite, Pain, Screaming
Clinical narrative: Uncontrollable screaming, crying shortly after vaccination was given. This carried on for 8 hours. Patient would not eat or nurse for almost 8 hours because he was screaming and clearing in pain. At the time he was eating every 2 hours. We gave him infant Tylenol (proper dosage for his size and age) after the screaming and crying would not stop 5 hours after vaccinations. My son was never colicky or a cryer. I believe it was encephalitis brought on by the Dtap vaccine.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: Pt here for unscheduled nurse visit for c/o rash/burning of RUE at site of  Pneumovax injection 3/8/16. Afebrile at 98.5. RUE with diffuse redness/warmth of upper portion of arm, and slightly edematous. States pain only when touched at 5/10, chief complaint is "burning".  Provider examined patient: Patient reports redness erupted at injection site the day of injection and progressed to shoulder pad distribution.  No pain just redness and warmth. Patient also reports another rash in BL axillae which has had previously. EXAM: SKIN: 10cm area of erythema, swelling, and warmth on R upper arm surrounding the Pneumovax injection site; pinpoint erythematous congruent papular eruptions BL  axillae. LUNGS: CTA. HEART: RRR. A/P: 1) Localized allergic reaction - trial of medrol dose pack; area of erythema was demarcated with a pen and patient was advised to call back if the redness spread beyond this line; patient also advised to go to ER if symptoms worsen; Pneumovax  placed in allergy list.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt here for unscheduled nurse visit for c/o rash/burning of RUE at site of  Pneumovax injection 3/8/16. Afebrile at 98.5. RUE with diffuse redness/warmth of upper portion of arm, and slightly edematous. States pain only when touched at 5/10, chief complaint is "burning".  Provider examined patient: Patient reports redness erupted at injection site the day of injection and progressed to shoulder pad distribution.  No pain just redness and warmth. Patient also reports another rash in BL axillae which has had previously. EXAM: SKIN: 10cm area of erythema, swelling, and warmth on R upper arm surrounding the Pneumovax injection site; pinpoint erythematous congruent papular eruptions BL  axillae. LUNGS: CTA. HEART: RRR. A/P: 1) Localized allergic reaction - trial of medrol dose pack; area of erythema was demarcated with a pen and patient was advised to call back if the redness spread beyond this line; patient also advised to go to ER if symptoms worsen; Pneumovax  placed in allergy list.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autism spectrum disorder, Motor dysfunction, Social avoidant behaviour
Clinical narrative: Loss of milestones. Went from cooing, smiling, rolling to complete cessation of all sounds. Also stopped rolling and stopped interacting. After 2 weeks, slowly began to vocalize and regain motor skills. Did not seek medical attention.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 injection, lot # L016429, expiration date 09-AUG-2017 (strength, dose, route and site of administration were not reported), which were exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours (cumulative time to the date of reporting). No adverse effect was reported. There were no previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Antibody test negative, Appendicectomy, Biopsy site unspecified abnormal, Crohn's disease
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 11 year old male patient. The patient's concurrent conditions and medical history were not provided. The patient did not have drug reactions or allergies. On 02-DEC-2005, the patient was vaccinated with a first dose of VARIVAX (Merck), and 13-AUG-2015 he was vaccinated with the second dose of VARIVAX (Merck) (strength, dose, route, anatomical location, lot number and expiration date were not provided). The patient did not take any concomitant medications. The nurse reported that since an unspecified date, (over the past several years), the patient was complaining of abdominal pain, subsequently, on 02-DEC-2015, the patient was hospitalized for 48 hours, where an appendectomy, requiring intubation was performed. During the procedure, a biopsy was performed which showed a chronic inflammation with occasional granuloma; due to this finding, the patient was diagnosed with Crohn's Disease (the patient would began an unspecified immunosuppressive therapy agent in the near future). It was also reported, that due to negative titers, the patient was administered a third dose of VARIVAX (Merck) on 22-DEC-2015. The nurse considered the event of appendectomy to be serious event, as it required intubation during surgery. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Endotracheal intubation, Granuloma, Inflammation
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 11 year old male patient. The patient's concurrent conditions and medical history were not provided. The patient did not have drug reactions or allergies. On 02-DEC-2005, the patient was vaccinated with a first dose of VARIVAX (Merck), and 13-AUG-2015 he was vaccinated with the second dose of VARIVAX (Merck) (strength, dose, route, anatomical location, lot number and expiration date were not provided). The patient did not take any concomitant medications. The nurse reported that since an unspecified date, (over the past several years), the patient was complaining of abdominal pain, subsequently, on 02-DEC-2015, the patient was hospitalized for 48 hours, where an appendectomy, requiring intubation was performed. During the procedure, a biopsy was performed which showed a chronic inflammation with occasional granuloma; due to this finding, the patient was diagnosed with Crohn's Disease (the patient would began an unspecified immunosuppressive therapy agent in the near future). It was also reported, that due to negative titers, the patient was administered a third dose of VARIVAX (Merck) on 22-DEC-2015. The nurse considered the event of appendectomy to be serious event, as it required intubation during surgery. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old female patient. The patient had no pertinent medical history, drug allergy/reactions or concomitant medications. On 04-MAR-2016, the patient was vaccinated with one dose of ZOSTAVAX (lot # L029482 and expiry date 06-NOV-2016) (dosing details unspecified) subcutaneously for shingles. Approximately on an unknown date in March 2016, the patient experienced "redness and swelling at the ZOSTAVAX injections tie that was the size of a fist and the site was also itchy as well". She sought medical attention. on 06-MAR-2016, the patient presented to the pharmacist and the pharmacist recommended the patient to take BENADRYL for the redness, swelling and itchiness, but the pharmacist does not know if the patient had indeed taken any BENADRYL. No lab diagnostic studies were performed. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPVX, UNK
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a school nurse via a company representative regarding a 12 year old non pregnant female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 15-MAR-2016 (reported as the day before), the patient was vaccinated with a dose of GARDASIL or GARDASIL 9 (1 shot, via intramuscular route in an unspecified arm, dose and lot # were not reported) (it was not specified). On the same day, the patient received two others vaccines (unspecified). On an unspecified day in March 2016, the patient complained of pain down her arm. The affected arm was the one in which the vaccine was given. The patient was provided an ice pack and began to feel relief within minutes. The patient's outcome was recovering/resolving. The relatedness between the event and suspect therapy was not provided. Additional information is not expected as no contact details were provided.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Dermatitis atopic, Immediate post-injection reaction, Injection site erythema, Injection site oedema, Injection site urticaria
Clinical narrative: Pt here for unscheduled nurse visit for c/o redness of RUE. Pt received  Pneumovax on 3/14/16 and now with diffuse redness/warmth of upper portion of RUE. Slight edema noted. Afebrile at 98.7. No pain unless touched per pt report. Provider examined patient briefly: Patient reports that redness immediately erupted around Pneumovax injection  site. EXAM: VSS. SKIN: 8 sm wheal R UE at site of Pneumovax injection. A/P: atopic dermatitis; trial of prednisone and Benadryl; patient was advised to call immediately if no improvement or to go to ER if there is worsening.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Pt here for unscheduled nurse visit for c/o redness of RUE. Pt received  Pneumovax on 3/14/16 and now with diffuse redness/warmth of upper portion of RUE. Slight edema noted. Afebrile at 98.7. No pain unless touched per pt report. Provider examined patient briefly: Patient reports that redness immediately erupted around Pneumovax injection  site. EXAM: VSS. SKIN: 8 sm wheal R UE at site of Pneumovax injection. A/P: atopic dermatitis; trial of prednisone and Benadryl; patient was advised to call immediately if no improvement or to go to ER if there is worsening.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Client's Mom called in to health department to report fever of 102 and sore right arm. Mom denies any swelling or erythema. Mom describes child as having general malaise as well.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dermatitis atopic, Fatigue, Injection site bruising, Injection site erythema, Injection site haemorrhage
Clinical narrative: Patient seen in nurse clinic with c/o bruising and redness at injection site and feeling "drained and achy". VSS and WNL. Right shoulder bruise and redness noted. Provider examined patient. EXAM: SKIN: 2cm area of ecchymoses at the injection site with 3-4 cm area of erythema, induration and warmth distal to ecchymotic area. A/P: Atopic dermatitis at site of Pneumovax injection; prednisone 20mg twice x 5  days #10 RF0; diphenhydramine 25mng q6h prn #30 RF0 for fill at pharmacy, ER if symptoms worsen.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Pain
Clinical narrative: Patient seen in nurse clinic with c/o bruising and redness at injection site and feeling "drained and achy". VSS and WNL. Right shoulder bruise and redness noted. Provider examined patient. EXAM: SKIN: 2cm area of ecchymoses at the injection site with 3-4 cm area of erythema, induration and warmth distal to ecchymotic area. A/P: Atopic dermatitis at site of Pneumovax injection; prednisone 20mg twice x 5  days #10 RF0; diphenhydramine 25mng q6h prn #30 RF0 for fill at pharmacy, ER if symptoms worsen.
Age: 34.0
Sex: F
Vaccine: YF, YF
Symptoms: Arthralgia, Chest discomfort, Electrocardiogram ambulatory, Joint swelling, Palpitations
Clinical narrative: Developed symmetrical bilateral wrist tenderness and swollen hands progressing over the next 5 days to majority of her joints -- finally resolved with Ibuprofen.  On 3/16/16 she developed a racing heart rate and some chest discomfort -- went to Urgent Care and was advised she has PSVT and placed on a Holter monitor.  Currently as of today 3/18/16, continuing to have intermittent rapid heart rate.
Age: 34.0
Sex: F
Vaccine: YF, YF
Symptoms: Peripheral swelling, Supraventricular tachycardia
Clinical narrative: Developed symmetrical bilateral wrist tenderness and swollen hands progressing over the next 5 days to majority of her joints -- finally resolved with Ibuprofen.  On 3/16/16 she developed a racing heart rate and some chest discomfort -- went to Urgent Care and was advised she has PSVT and placed on a Holter monitor.  Currently as of today 3/18/16, continuing to have intermittent rapid heart rate.
Age: 34.0
Sex: F
Vaccine: YF, YF
Symptoms: Chest discomfort, Heart rate increased, Peripheral swelling, Tenderness
Clinical narrative: Developed symmetrical bilateral wrist tenderness and swollen hands progressing over the next 5 days to majority of her joints -- finally resolved with Ibuprofen.  On 3/16/16 she developed a racing heart rate and some chest discomfort -- went to Urgent Care and was advised she has PSVT and placed on a Holter monitor.  Currently as of today 3/18/16, continuing to have intermittent rapid heart rate.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Injection site swelling
Clinical narrative: SWELLING TO LEFT THIGH.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood culture negative, C-reactive protein normal, Cellulitis, Erythema, Full blood count normal
Clinical narrative: Pt received Tdap (R) arm, MCV (R) arm and HPV (L) arm on the 7th March 2016, around 1 PM - pt tolerated the vaccination well, was given under aseptic condition - pt left with mom. Mom called on 3-9-16 - stated had redness (R) arm couple of hrs after vaccination and on 3-9-16 developed fever 101 degrees F. Since office was closed pt was told to go to ER.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Pt received Tdap (R) arm, MCV (R) arm and HPV (L) arm on the 7th March 2016, around 1 PM - pt tolerated the vaccination well, was given under aseptic condition - pt left with mom. Mom called on 3-9-16 - stated had redness (R) arm couple of hrs after vaccination and on 3-9-16 developed fever 101 degrees F. Since office was closed pt was told to go to ER.
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, MMRV, TDAP
Symptoms: Underdose
Clinical narrative: 23 year old patient received VFC stock vaccine by error - patient receive pediatric dose of Hep A and Hep B.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, feverishness, fatigue, body aches.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 21.1 C, time frame: 16 hours) doses of VARIVAX (Merck) of lot/batch L042267, expiry date 27-OCT-2017 and lot/batch L036831, expiry date 24-SEP-2017 (dose, dose number, vaccination site and route of administration not provided) since 01-MAR-2016. There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports from same reporter link. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ oral liquid, lot # L013193, expiration date 20-JAN-2017, orally (strength and dose were not reported), which were exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours (cumulative time to the date of reporting). No adverse effect was reported. There were no previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-FEB-2016, the patient was vaccinated with improperly stored MMR II lot # K022284, expiry date 12-NOV-2016 (dose, route and site of administration were not reported). Temperature excursion was noted at 49.1 Fahrenheit for 13.5 hours. There was no previous temperature excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose (Oka/Merck) VARIVAX immunization series (lot # L002869, expiry date: 27-JAN-2017). The temperature excursion details were reported as follows: temperature 8 degree F, for a time frame of 10 hours. There were no other temperature excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, 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 medication were not reported. On 01-MAR-2016, the patient was vaccinated with dose of MMR II injection, lot # K022284, expiration date 12-NOV-2016 (strength, dose, route and site of administration were not reported), which was exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours (cumulative time to the date of reporting). No adverse effect was reported. There were no previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On 16-MAR-2016, the patient was inadvertently vaccinated with expired dose of VARIVAX (Merck) (dosing details, route not reported) lot # J009729, expiry date: 07-AUG-2015. No adverse effect reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Full blood count, Insomnia, Metabolic function test, Paraesthesia
Clinical narrative: Pt had feelings of needles on and off to both palms of hands and bottom of feet.  She states that its getting worse. Pt is having trouble sleeping.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 21.1 C, time frame: 16 hours) doses of PROQUAD of lot/batch # L046507 with expiry date 17-MAY-2017, lot/batch # L033696 with expiry date 28-FEB-2017, lot/batch # L050908 with expiry date 14-JUN-2017 and lot/batch # L009210 with expiry date 17-SEP-2016 (Dose, dose number, vaccination site and route of administration not provided) since 01-MAR-2016. There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports from same reporter link. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Cellulitis (L) arm - started to get red warm, on 3/7/16. Treated with KEFLEX, BENADRYL, warm compresses.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 2-month-old patient who received PEDIARIX. Co-suspect products included ROTARIX and PREVNAR. On an unknown date, the patient received PEDIARIX at an unknown dose, ROTARIX at an unknown dose and PREVNAR. On 12th March 2016, an unknown time after receiving PEDIARIX and ROTARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 12th March 2016. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to PEDIARIX and ROTARIX. Additional details were received as follows: The reporter stated that, after receiving previous vaccinations with PEDIARIX, ROTARIX and PREVENAR 13, the patient died.
Sex: F
Vaccine: HIBV
Symptoms: Deafness, Gene mutation identification test positive, Meningitis haemophilus
Clinical narrative: This case was reported in a literature article and described the occurrence of hemophilus influenza meningitis in a 12-month-old female patient who received HIBERIX. On an unknown date, the patient received HIBERIX at an unknown dose. On an unknown date, an unknown time after receiving HIBERIX, the patient experienced hemophilus influenza meningitis (serious criteria GSK medically significant) and hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hemophilus influenza meningitis was resolved with sequelae and the outcome of the hearing loss was not recovered/not resolved. It was unknown if the reporter considered the hemophilus influenza meningitis and hearing loss to be related to HIBERIX. Additional information was provided: This case was reported in a literature article and it described the occurrence of Haemophilus influenzae meningitis in a 12-month-old female child who had received unspecified Hib vaccines (manufacturers unknown). Approximately 7 years after this event, when the patient was 8 years old, her younger sister became unwell at 13 months of age, 3 weeks after being vaccinated, and died from disseminated vaccine-derived varicella infection. In the course of her illness, the patient's sister was diagnosed with severe combined immunodeficiency with a compound heterozygous missense mutations in recombination-activating gene 2. As a consequence of this, the rest of the family was tested and the patient and her father were found to have heterozygosity for the R73H mutation in the same gene. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates, the patient received an unknown number of unspecified Hib vaccine. Dosages unknown; administration routes and sites unspecified; batch numbers were not provided. On an unspecified date, an unknown period after the vaccination, the patient developed meningitis. The pathogen was identified as Haemophilus influenzae but its serotype was unknown. The authors commented that Haemophilus influenzae had been identified; but they did not provide any detail on the actual investigations performed. Treatment was unknown. Outcome was recovery with sequelae (hearing loss, severity unknown). The authors did not comment on any possible causal relationship between the vaccine and the event. The authors concluded that "although the varicella vaccine is contraindicated for most patients with known immunodeficiency, its efficacy and safety profile in immunocompetent children is excellent, and the benefits of the vaccine far outweigh the rare adverse events that can occur in children with undiagnosed immunodeficiency. Newborn screening for T-cell receptor excision circles can enable the early identification of T-cell developmental defects before live virus vaccines are administered. Unfortunately, such screening was not available for this patient at birth."
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Chills, Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Within 3 hrs of vaccine, patient had crampy abdominal pain and then diarrhea. She had chills and then had redness and swelling of her left upper arm. Seen by MD - recommended TYLENOL and ice.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Pain in extremity, Skin warm
Clinical narrative: Arm was sore and slightly red immediately after injection, but 6 days later redness had increased, arm was more sore and warm to touch - developing cellulitis and treated with cephalexin.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Urticaria
Clinical narrative: Patient developed hives on ext after vaccination, hives occurred with 24 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site urticaria
Clinical narrative: Large, red rash/raised welt at injection site on right thigh. Approx 2 inches in diameter. Tender and sore to touch. Onset time is time first observed. May have appeared hours earlier.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Woke up crying with fever and complaining of intense headache. He had a hard time moving because movement was painful. On 03/17/2016 his fever ranged from 101-104 degrees. The majority of the day it hovered around 102 with it reaching its peak the evening of 03/17/2016. He was unable to eat any food without vomiting until dinner last night. His continued symptoms were him being lethargic, having a fever, and his movement being painful. He still has a low fever today and has spent his day on the couch with a runny nose and complaining of a head ache.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: Woke up crying with fever and complaining of intense headache. He had a hard time moving because movement was painful. On 03/17/2016 his fever ranged from 101-104 degrees. The majority of the day it hovered around 102 with it reaching its peak the evening of 03/17/2016. He was unable to eat any food without vomiting until dinner last night. His continued symptoms were him being lethargic, having a fever, and his movement being painful. He still has a low fever today and has spent his day on the couch with a runny nose and complaining of a head ache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Large Rash.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Asthenia, Headache, Injection site cellulitis, Myalgia
Clinical narrative: Severe muscle aches, extreme weakness, headache, upset stomach, cellulitis at injection site.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site reaction, Injection site scab, Injection site swelling, Purulence
Clinical narrative: Patients mother noted slight swelling around injection site.  In center it was red, purulent, glossy.  Scabbed over a couple days later, once scabbed fell off; site was still red and purulent. No fevers noted.  Not hot to the touch, kid is not bothered by the injection site.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site pain, Nausea, Vomiting
Clinical narrative: Severe muscle pain at site of injection, nausea/vomiting, chills.
Age: 59.0
Sex: M
Vaccine: FLU4, HEP, MMR, TDAP, VARCEL
Symptoms: Injection site swelling, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Received Tdap and flu vaccine in Left arm on 2-16-16. 2 days later had swelling on arm and pain in arm when rotating arm backward from shoulder. Today at office visit requesting 2nd Td. Nurse palpated skin colored swelling approx. egg size midway upper left arm. Also pt has pain when moving arm backward. Symptoms reported as unchanged x 1 month. Nurse did not give 2nd Td. Spoke with Dr by phone and referred to see is established PCP.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Headache, Injection site reaction, Injection site warmth
Clinical narrative: Patient received Tdap vaccine 0.5ml IM in R deltoid at 1211 on 3/15/16 (GSK Lot # KJ4MS).  Pt woke up on 3/16/16 with headache and body aches, felt severe fever, dizzy, skin sore and warm at injection site and nauseous. Pt's husband called MD office to report but pt declined to come to office at that time.  MD prescribed ondansetron for nausea. Pt reported that her skin looked sun burnt at injection site.  Pt came to MD office on 3/18/16 and felt mostly better, but still felt hot, a little dizzy and nausea.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain of skin, Pyrexia, Sunburn
Clinical narrative: Patient received Tdap vaccine 0.5ml IM in R deltoid at 1211 on 3/15/16 (GSK Lot # KJ4MS).  Pt woke up on 3/16/16 with headache and body aches, felt severe fever, dizzy, skin sore and warm at injection site and nauseous. Pt's husband called MD office to report but pt declined to come to office at that time.  MD prescribed ondansetron for nausea. Pt reported that her skin looked sun burnt at injection site.  Pt came to MD office on 3/18/16 and felt mostly better, but still felt hot, a little dizzy and nausea.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Hypoaesthesia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: Complained of several intermittent episodes of right arm numbness and tingling down to her fingers; lateral 3 fingers. Progressed over time.  Was seen by Neurosurgeon and sent to Neurologist.  Had MRI scan head, neck and shoulder. Then EMG study that revealed a brachial neuritis pattern on right.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: Complained of several intermittent episodes of right arm numbness and tingling down to her fingers; lateral 3 fingers. Progressed over time.  Was seen by Neurosurgeon and sent to Neurologist.  Had MRI scan head, neck and shoulder. Then EMG study that revealed a brachial neuritis pattern on right.