chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: DTAP
Symptoms: Hiccups, Increased appetite, Poor quality sleep, Pyrexia, Skin warm
Clinical narrative: Temperature on weekend, Mom reports infant felt warm on Friday afternoon/evening; Saturday/Sunday temperature up to 101; constant nursing and not sleeping well; had one time episode of "hiccup" breathing. Fever down Sunday am; returned in afternoon. No fever today (Monday).
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Patient woke up feeling run down and exhausted that progressed throughout the day. Also felt nauseous, dizzy and woozy. Dissipated the next day. No treatment.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: On 1/3/2020 patient reported to pharmacy for second dose of Shingrix.  During consultation prior to administration when asked on reaction to first vaccine, he reported no issue except an ongoing reduced range of motion in the left arm.  He reported no pain but an inability to extend arm past 90 degrees when moving above head.  Comparison to other arm was roughly  30-45 degrees less in upwards range of motion.   He reports this has been ongoing since administration of first vaccine.  No complaint at this time however, patient stated he has an appointment with physician 1/6/2020 and will ask physician to evaluate range of motion and for injury prior to second dose administration.
Age: 1.17
Sex: M
Vaccine: UNK
Symptoms: Eczema, Pyrexia
Clinical narrative: Developed fever to 102F for 2 days , following Prevnar Vaccine. Within 2 weeks developed now-in set moderate eczema
Age: 18.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Vaccine (VARIVAX) was repeated on 15-NOV-2019 (third dose).; No adverse effects reported; Patient was vaccinated with Varivax reconstituted with expired sterile diluent; This spontaneous report was received from a nurse and refers to an 18-year-old patient of unknown gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications, and drug reactions or allergies was provided.  On 07-OCT-2019, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form for prophylaxis (lot number R034396, has been verified to be a valid, expiration date reported and validated as 27-NOV-2020) (concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  On 08-OCT-2019 (reported as on the next day), it was realized that an expired sterile diluent ( lot number R022280 has been verified to be a valid, expiration date reported and validated as 06-OCT-2019) was used for the reconstitution of the varicella virus vaccine live (oka/merck)(VARIVAX) vaccine used to vaccinate the patient the prior day (expired product administered). No adverse effects were reported.  Follow-up information was received from the registered nurse on 27-DEC-2019. The patient's exact date of birth and gender were provided.  On 07-OCT-2019, at 2:30pm, the male patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously on the left arm and he also received meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) via intramuscular on the left deltoid (concomitant therapy), both as immunization.   The patient did not require any treatment for the reported events.   It was also reported that the vaccination was repeated on 15-NOV-2019 (inappropriate schedule of product administration) and that there was not any temperature excursion as a result of reading the Digital Data-logger.
Sex: F
Vaccine: MMR
Symptoms: Eczema
Clinical narrative: After got vaccination, the patient developed incurable eczema; This spontaneous report has been received from a consumer referring to her daughter, a female of unknown age. Information about the patient's past drug and medical history, as well as her concomitant therapies and allergies were not reported.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (concentration, dosage, anatomical location, administration route, lot number, and expiration date were not reported) for prophylaxis. Subsequently, the patient developed incurable eczema. The outcome of the event was unknown. Therefore, the patient was not recovered from the event at the reporting time.   It was unknown if the patient sought medical attention, or if she performed any laboratories or studies.  The causality assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the occurred event was not reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2001USA000651:
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to a 12 year-old child, no AE; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1959 and expiry date: 30-Jun-2020) via intramuscular route in the right deltoid, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that Flublok Quadrivalent was administered to a 12 year-old child.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received second dose of Imovax series on 10Dec2019 instead of 07Dec2019 as scheduled; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demography who received RABIES (HDC) VACCINE [IMOVAX RABIES] and it was reported that the patient received the second dose of Imovax series on 10-Dec-2019 instead of 07-Dec-2019 as scheduled (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 10-Dec-2019, the patient received the second dose of suspect RABIES (HDC) VACCINE (lot number not reported) via unknown route at an unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was not reported if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: 2- doses of Fluzone High-Dose during the same season, No AE; accidentally administered the Fluzone High-Dose in error not the pneumonia vaccine, no AE; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 67 year old female patient who received two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] during the same season due to the consumer was to receive a pneumonia vaccine but was given a dose of Fluzone High-Dose instead.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 01-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ301AA and expiry date 24-Jun-2020) via intramuscular route in the left deltoid. On 10-Dec-2019 she also received an extra dose of the same vaccine  with an unknown batch number via intramuscular route at an unknown administration site.  It was a case of actual medication error due to extra dose administered and wrong vaccine administered. The patient received 2 doses of Fluzone High-Dose during the same season due to the consumer was to receive a pneumonia vaccine but was given a dose of Fluzone High-Dose instead. The nurse reported that the CMA accidentally grabbed the HD not the pneumonia vaccine.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 28 years patient was given Fluzone HD in error/ no AE; 6 month pregnant patient inadvertently was given the Fluzone High-Dose in error/no AE; 28 years patient was given Fluzone HD/ no AE; Initial information received on 20-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 28 years old female patient who received 0.5 ml of dose INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ242AA expiry date 04-MAY-2020 via intramuscular route in the left deltoid on 20-Dec-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported 6 month pregnant patient inadvertently was given the Fluzone High-Dose in error/no AE occurred at 6 Months of pregnancyThe reported 28 years patient was given Fluzone HD/ no AE occurred at 6 Months of pregnancyThe reported 28 years patient was given Fluzone HD/ no AE occurred at 6 Months of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No past pregnancy was reported.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that vaccine was given to a 28 years old patient.  It was also a case of vaccine exposure during pregnancy. Fluzone High Dose was inadvertently given to a 6 month pregnant patient.  At the time of reporting, it was not reported if patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received Quadracel subcutaneously that was intended in the left vastus lateralis (intramuscular)/No AE; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 year old male patient who received received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] subcutaneously which was intended in the left vastus lateralis (intramuscular) (incorrect route of product administration).  Medical history, past medical treatment, vaccination and family history were not provided.  The patient received concomitant therapy with MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD]  On 16-Dec-2019, the patient received a dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5635AA, expiration date: 18-JUN-2021] via subcutaneous route in unknown administration site.  It was a case of actual medication error due to incorrect route of product administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: during administration of vaccine patient only received the diluent and not the ACTHIB powder/No AE; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 12 months old female patient who received only diluent and not the ACTHIB powder (product preparation issue), while administration of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccines included PROQUAD, PREVNAR 13 and HEPATITIS A.   On 26-Dec-2019, the patient received only diluent and not the ACTHIB powder of suspect HIB (PRP/T) vaccine [diluent lot: U6376AA, diluent expiration date: 08-Feb-2024, powder lot UJ099AA, powder expiration date: Jun-2020] via unknown route at an unknown administration site.  It was a case of actual medication error due to product preparation issue.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of vaccine Ipol was administered to the patient, no AE; Initial information received on 30-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old male patient who vaccinated with an expired dose of vaccine IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Dec-2019, the patient received a expired 0.5 ml dose of suspect IPV (VERO) (lot number: N1K931M and expiry date: 18-Nov-2019) via intramuscular route in the left deltoid.  It was actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Balance disorder, Dizziness, Nausea, Pain
Clinical narrative: Pain  through out entire body on most of the day after injections. On the second day, felt dizzy and fainted two times rested most of the remainder of the day. On the third day was dizzy and unstable and nauseated and threw up and feeling weak most of the day.  No treatment as of yet just resting.
Age: 74.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Syncope, Vomiting
Clinical narrative: Pain  through out entire body on most of the day after injections. On the second day, felt dizzy and fainted two times rested most of the remainder of the day. On the third day was dizzy and unstable and nauseated and threw up and feeling weak most of the day.  No treatment as of yet just resting.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Crying, Ear infection, Pyrexia, Vomiting
Clinical narrative: 10:55 15 month old male status post intramuscular DTaP by, MA. Patient reacted with vomiting andcrying. No seiza activity, no hives/ no respiratory distress noted. Vital Signs obtained. and patient ear temp Elevated from 99.9 to 102.9 Parents declined antipyretic  rectal suppository as following clinic standing orders for fever. Dr informed of patient's vomiting and at bedside for Physician evaluation. Dr advised for child to have nasal/ pharyngeal swab for Influenza test. Parents declined. 11:11 Dr reports he suspected an ear infection as well, and an adverse reaction to DTaP vaccine. Parents were advised by doctor to take child to emergency department for further eval. Patient had stopped vomiting and was only awake and crying at this time. Parents left the clinic with child. At 4:19pm same day, Dr contacted mother of child by phone to follow up. Report in patient's chart read:"Patient's symptoms (fever and vomit) had resolved and parents never took child to Emergency Department to avoid child being exposed to other sick children. "
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Headache, Mobility decreased, Musculoskeletal pain
Clinical narrative: Shot administered in Left deltoid Terrible shoulder, elbow, back & arm pains Headaches Nerve pains Took notes as symptoms varied and increased/decreased with attempts to treat
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain in extremity, Spinal X-ray abnormal, Spondylitis
Clinical narrative: Shot administered in Left deltoid Terrible shoulder, elbow, back & arm pains Headaches Nerve pains Took notes as symptoms varied and increased/decreased with attempts to treat
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: C-reactive protein normal, Full blood count normal, Metabolic function test, Musculoskeletal pain, Periarthritis
Clinical narrative: Sore shoulder than progressed into a frozen shoulder. Suspect exacerbation of latent impingement syndrome. Exercises started, no resolution yet.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Red blood cell sedimentation rate increased, Rotator cuff syndrome, Tendonitis, X-ray limb abnormal
Clinical narrative: Sore shoulder than progressed into a frozen shoulder. Suspect exacerbation of latent impingement syndrome. Exercises started, no resolution yet.
Age: 17.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient c/o pain in Right arm since receiving flu shot on 10/10/2019. Normal range of motion, but has pain with movement. Will be seeing primary care on 1/7/2020.  No warmth or edema noted at injection site.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Administered Menveo on L arm then administered Hep A in R arm. After the Hep A was given, patient started to feel dizzy and then fainted. She did not fall off exam table, I was able to catch her. She gained consciousness within seconds. The provider came into the room and examined her. BP was taken and patient was kept for an additional 30-45 mins in office for monitoring.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Rash erythematous, Rash pruritic, Skin lesion
Clinical narrative: approximately 24 hours (1/4/20) after vaccine patient developed large red, raised rash  starting on legs that over the next 24-36 hours spread to trunk, upper extremities and face. Rash was red, raised, and itchy. Rash had begun to resolve on 3rd day and on day of presentation (1/6/20) had only few scattered raised red targetoid lesions on face and hands.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Injection site mass
Clinical narrative: Per provider, 0.25cm lump on right thigh. no other adverse events.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Eye swelling, Fatigue, Feeling cold
Clinical narrative: Patient received Shingrix vaccine the evening of 12/27/2019. Patient was fine for the first 24 hours. Then injection site got extremely red and painful, patient put ice on the injection site for 30 minutes then had severe shivering and was breathing "very hard." Patient then went to bed for 1 hour, woke up feeling "very cold," went back to bed and then started sweating for the rest of the night. Patient's body was "extremely sensitive from head to toe, just by touch." Patient got diarrhea, eyes became swollen "which made him even more tired." As of 01/01/2020, the patient is feeling better, arm is still sore and eyes are "still a bit puffy" but are improving.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Hyperhidrosis, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Patient received Shingrix vaccine the evening of 12/27/2019. Patient was fine for the first 24 hours. Then injection site got extremely red and painful, patient put ice on the injection site for 30 minutes then had severe shivering and was breathing "very hard." Patient then went to bed for 1 hour, woke up feeling "very cold," went back to bed and then started sweating for the rest of the night. Patient's body was "extremely sensitive from head to toe, just by touch." Patient got diarrhea, eyes became swollen "which made him even more tired." As of 01/01/2020, the patient is feeling better, arm is still sore and eyes are "still a bit puffy" but are improving.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Periorbital swelling, Respiration abnormal
Clinical narrative: Patient received Shingrix vaccine the evening of 12/27/2019. Patient was fine for the first 24 hours. Then injection site got extremely red and painful, patient put ice on the injection site for 30 minutes then had severe shivering and was breathing "very hard." Patient then went to bed for 1 hour, woke up feeling "very cold," went back to bed and then started sweating for the rest of the night. Patient's body was "extremely sensitive from head to toe, just by touch." Patient got diarrhea, eyes became swollen "which made him even more tired." As of 01/01/2020, the patient is feeling better, arm is still sore and eyes are "still a bit puffy" but are improving.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Patient received vaccination 9/27/2019 and continued to have extreme soreness at the site of vaccination. Patient complains of not being able to lift arm , and states she has been going to physical therapy to regain motion in arm and to help with pain that she is still experiencing months later.
Age: 56.0
Sex: M
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hepatitis A instead of an adult dose.  Patient had no reactions and  was told what had happened by phone within 30 minutes of noticing the error and was given an appointment to come back for the correct vaccine.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pain, Vomiting
Clinical narrative: The left arm shoulder slightly inflammed/swollen compared to right shoulder and slight redness at initial check.  Patient complained of vomiting day after flu shot. Not able to have full range of motion due to pain. Able to lift arm and rotate but it is painful to do so. Pain has lasted for 4 weeks. Patient said it got a little better but still painful. Has tried Tylenol and "Zyflammed OTC", as well as heat/cool pads. The alternating heat/cool has helped.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm soreness radiating to rest of arm. Limited range of motion
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Arm soreness radiating to rest of arm. Limited range of motion
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oedema peripheral, Rash, Urticaria
Clinical narrative: RASH, HIVE, BLISTERS ON SKIN; EDEMA OF LOWER EXTREMITIES . OCCURRING AFTER VACCINE AND STILL PRESENTLY EXPERIENCING
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: rash to left arm
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Shoulder injury related to vaccine administration
Clinical narrative: Patient had reports pain upon lifting arm, tingling and numbness
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states left arm became swollen, red, edematous and painful after the injection and did not sleep for 2 days
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives on face, torso, hands, and arms
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Dizziness, Fall, Loss of consciousness, Nausea
Clinical narrative: Shingrix #1-received December 30, 2019. Following morning at appx. 7:00am felt nauseous and then dizzy enroute to bathroom. Increased dizziness,difficulty seeing and then lost consciousness. Fell striking undersink cabinet door which shattered inside. When I regained consciousness,my husband helped me into bed. Applied ice pack to back of neck. Thursday January 2, 2020 got eye exam to check for detached retinas  at Clinic.  On  Saturday evening January 4, 2020,my husband noticed swelling and bruising  on  left forehead. Evaluated at Hospital ER. Emergency Room staff ordered x-rays of my neck.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Spinal X-ray, Swelling face, Visual impairment
Clinical narrative: Shingrix #1-received December 30, 2019. Following morning at appx. 7:00am felt nauseous and then dizzy enroute to bathroom. Increased dizziness,difficulty seeing and then lost consciousness. Fell striking undersink cabinet door which shattered inside. When I regained consciousness,my husband helped me into bed. Applied ice pack to back of neck. Thursday January 2, 2020 got eye exam to check for detached retinas  at Clinic.  On  Saturday evening January 4, 2020,my husband noticed swelling and bruising  on  left forehead. Evaluated at Hospital ER. Emergency Room staff ordered x-rays of my neck.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Admit to emergency department for hives . Treating orally with steroids
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Cutaneous lupus erythematosus
Clinical narrative: Patient was diagnosed with cutaneous lupus 10 weeks post vaccine.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Pruritus, Rash erythematous, Rhinorrhoea
Clinical narrative: On 11/17/2019 Started coughing,  runny nose and itching, and red rashes on face, back, and legs.
Age: 69.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Dysphagia, Fatigue, Pain
Clinical narrative: fatigue, upset stomach, diahhrea, body aches in bed for 3 days.  Then on the 11th, attempted to eat steak and got Dysphagia for the first time to the point I almost went to ER as couldn't swallow for 5 hours!
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Contusion, Erythema, Hyperhidrosis
Clinical narrative: Night of shot felt feverish (clammy and alternating sweats and chills) no fever. Very painful around shot area. Swelling increased for five days even with icing the area and ibuprofen.  Bruising started on day three and spread until day five.  On day five (peak of reaction) the swollen/red area was five inches tall and 3 1/2 inches across in the area between elbow and shoulder.  Did not know how to measure how elevated the swelling was, but guesstimate is about 100 mL worth of liquid in the area.  Starting on day five the bruising and swelling started migrating down the arm towards the wrist and also started moving to the inside of the arm.  But second week knots (sort of like bath beads) started forming and moving down the fore arm.  Took about 3 1/2 weeks for the knots/beads to go away completely.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nodule, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Night of shot felt feverish (clammy and alternating sweats and chills) no fever. Very painful around shot area. Swelling increased for five days even with icing the area and ibuprofen.  Bruising started on day three and spread until day five.  On day five (peak of reaction) the swollen/red area was five inches tall and 3 1/2 inches across in the area between elbow and shoulder.  Did not know how to measure how elevated the swelling was, but guesstimate is about 100 mL worth of liquid in the area.  Starting on day five the bruising and swelling started migrating down the arm towards the wrist and also started moving to the inside of the arm.  But second week knots (sort of like bath beads) started forming and moving down the fore arm.  Took about 3 1/2 weeks for the knots/beads to go away completely.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Rash vesicular
Clinical narrative: Customer developed painful red blister on upper right (unilateral) torso which looks like shingles, after few days of getting the shingrix shot
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Cough, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: Fatigue, generalized aches and bone pain, malaise, cough, severe sore throat.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Fatigue, generalized aches and bone pain, malaise, cough, severe sore throat.
Age: 76.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Confusional state, Dizziness
Clinical narrative: No initial reaction, but patient reports that later that day she developed some dizziness (no falls or loss of consciousness), weakness, and confusion. Weakness and confusion resolved completely by the time she reported these symptoms on 1/6/20 (seen in clinic for a scheduled appointment for other reasons); she continues to feel intermittent dizziness but gradually improving. Please note that she has a history of vertigo in the past so unclear whether these symptoms are truly related to vaccination or if this could be a coincidence.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Dr office called us to report that patient developed shingles 2-3 weeks after receiving vaccine
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Nausea, Pain, Vomiting
Clinical narrative: Fatigue, body ache,, severe nausea and vomiting two days after receiving flu vaccine
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose was given too early.  First dose was administered on 11/13/19 and the second dose was administered on 1/6/2020 (54 days later).
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Exposure during pregnancy, Food allergy, Intensive care, Oral allergy syndrome
Clinical narrative: I did not notice it until trying to eat a food after delivering my child but I had suddenly developed afood allergy called oral allergy syndrom. After s subsequent pregnancy and flu shot I then developed anaphylaxis from the oral allergy syndrome.  After a 3rd shot and another pregnancy I developed a allergy to almonds and was in the icu.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Influenza like illness, Injection site pain, Lip swelling, Pain
Clinical narrative: on 12/17/19 I Obtained 2nd dose (shot) of Recombinant Zoster SHINGRIX at 0830 am at Dr. First dose there was only achy feel and sort arm where shot was administered. Began feeling "flu-like" at 5pm. At 8pm I felt flu like, feverish, achy, stomach ache and minor swollen lips ( not visible but felt it ) . I took 2 Benedryl and went to sleep .  At 0030 am on 12/18/19 I felt worse and had a solid (not dots) rash on Neck, Inside Elbows, inside forearm, Torso, armpits, thighs. At 0700am I felt worse and rash continued and slightly itchy but not enough to scratch. Took 2 tablets of Benedryl To date 12/19 the rash continues but flu like symptoms have subsided. On 12/19 I did notify my physician Dr I do get similar reactions to NSIADS, Zinc, Penecillin
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: on 12/17/19 I Obtained 2nd dose (shot) of Recombinant Zoster SHINGRIX at 0830 am at Dr. First dose there was only achy feel and sort arm where shot was administered. Began feeling "flu-like" at 5pm. At 8pm I felt flu like, feverish, achy, stomach ache and minor swollen lips ( not visible but felt it ) . I took 2 Benedryl and went to sleep .  At 0030 am on 12/18/19 I felt worse and had a solid (not dots) rash on Neck, Inside Elbows, inside forearm, Torso, armpits, thighs. At 0700am I felt worse and rash continued and slightly itchy but not enough to scratch. Took 2 tablets of Benedryl To date 12/19 the rash continues but flu like symptoms have subsided. On 12/19 I did notify my physician Dr I do get similar reactions to NSIADS, Zinc, Penecillin
Sex: U
Vaccine: MNQ
Symptoms: Product label issue
Clinical narrative: Vials of Menveo vaccine came from the manufacturer with 2 different lot number on the vial.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Nasal congestion, Nasal obstruction, Oxygen saturation decreased, Respiratory rate increased
Clinical narrative: RN reported markedly increased periodic breathing with frequent desaturations for 2 hours after 6 hours after 6 hours of immunizations. NNP and MD reviewed the histogram which showed 19% of the time her oxygen saturations were below 80% during that time period. Differential includes: reaction to immunizations, nasal congestion/obstruction, discontinuation of caffeine a week ago. and sepsis concerns.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Night sweats
Clinical narrative: I went to my physician's office to receive my first Shingrix injection. The injection was given at approximately 2:00 pm. At approximately 8:00 pm that same evening, I began to get chills. By midnight, I was running a temperature of 103.6. I took Ibuprofen and Acetaminophen to lower my fever. Last night, I had a night sweat that soaked my entire bed, blankets and comforter. Today, almost two days later I feel awful. I did research the side effects and I was aware that some people get a low grade fever and chills. I had no problem with that. But to get a fever of 103.6, I feel is dangerous. If it had gone any higher, I would have had my spouse take me to the emergency room. I did have the shingles when I was in my early 20's. To be honest, I would have rather had another bout of shingles than the side effects of this drug. My physician's office advised me to come back somewhere in the vicinity of 4 months for the second dose. They can forget it. I would not recommended this medication and I will be advising friends and family to avoid receiving it. I'm on day 3 and feel like I was beat up. Although at the writing of this report I'm not running a fever, I feel beat down. I'm weak and have no appetite. I'm hoping this will subside soon. Again, I'm sorry I received this medication and will let everyone I know to avoid it.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I went to my physician's office to receive my first Shingrix injection. The injection was given at approximately 2:00 pm. At approximately 8:00 pm that same evening, I began to get chills. By midnight, I was running a temperature of 103.6. I took Ibuprofen and Acetaminophen to lower my fever. Last night, I had a night sweat that soaked my entire bed, blankets and comforter. Today, almost two days later I feel awful. I did research the side effects and I was aware that some people get a low grade fever and chills. I had no problem with that. But to get a fever of 103.6, I feel is dangerous. If it had gone any higher, I would have had my spouse take me to the emergency room. I did have the shingles when I was in my early 20's. To be honest, I would have rather had another bout of shingles than the side effects of this drug. My physician's office advised me to come back somewhere in the vicinity of 4 months for the second dose. They can forget it. I would not recommended this medication and I will be advising friends and family to avoid receiving it. I'm on day 3 and feel like I was beat up. Although at the writing of this report I'm not running a fever, I feel beat down. I'm weak and have no appetite. I'm hoping this will subside soon. Again, I'm sorry I received this medication and will let everyone I know to avoid it.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site swelling, Myalgia
Clinical narrative: Report regarding side effect after the administration of the second of two injections of Shingrix 50 Mcg/0.5 mil. As follows; Swelling at the injection site. Muscle pain. Felt tired. Headache, feverish, upset stomach and pain.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Report regarding side effect after the administration of the second of two injections of Shingrix 50 Mcg/0.5 mil. As follows; Swelling at the injection site. Muscle pain. Felt tired. Headache, feverish, upset stomach and pain.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was due for Menveo vaccine and was not given complete dose (only diluent). It was discovered when Imms coordinator was doing inventory that I was the only one that had given a vaccine from that batch of lot numbers. Parent was informed of error.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal X-ray, Asthenia, Central nervous system lesion, Chest X-ray, Communication disorder
Clinical narrative: Patient on clinical trial via a personalized vaccine WLT03233103, last vaccine given was 4/17/19 Cycle 10. Patient was admitted on 4/25/19 due to deterioration, increase of difficulty communicating, difficulty swallowing & sleepiness, increase weakness & confusion. update 13Dec2019 Patient was transferred to another long term care facility, family noted that he was deterioration of his physical state, was less communicative, having difficulty swallowing, and increase sleepiness. Patient came in for Dr. visit to evaluate on 4/15/19, Dr sent patient for Admission for infection work up, and Head CT. Patient was on clinic trail of MTA vaccine, began on 7/24/18 Vaccine 1, had vaccine on 4/17/19 and Poly-TCIC following day, also was given Bevacizumab #1 4/10/19. PI, does not attribute SAE to the Bevacizumab, the MTA vaccine or the Poly T.C.I.C. The patient died in the setting of the tumor on 11/17/2019 at home hospice. The last study visit was on 7/18/19 when the family and PI discussed hospice care. Prior to the patient's death he had an additional MRI Brain scan on 6 JUNE 2019 that showed similar dilation of the ventricles and increased DWI hypersensitivity of some of the lesions that likely corresponded to tumor. However, A pathology report showed no tumor growth-the patient had The PI has determined this is possibly related to the study treatment
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram head, Confusional state, Cytology, Death, Dysphagia
Clinical narrative: Patient on clinical trial via a personalized vaccine WLT03233103, last vaccine given was 4/17/19 Cycle 10. Patient was admitted on 4/25/19 due to deterioration, increase of difficulty communicating, difficulty swallowing & sleepiness, increase weakness & confusion. update 13Dec2019 Patient was transferred to another long term care facility, family noted that he was deterioration of his physical state, was less communicative, having difficulty swallowing, and increase sleepiness. Patient came in for Dr. visit to evaluate on 4/15/19, Dr sent patient for Admission for infection work up, and Head CT. Patient was on clinic trail of MTA vaccine, began on 7/24/18 Vaccine 1, had vaccine on 4/17/19 and Poly-TCIC following day, also was given Bevacizumab #1 4/10/19. PI, does not attribute SAE to the Bevacizumab, the MTA vaccine or the Poly T.C.I.C. The patient died in the setting of the tumor on 11/17/2019 at home hospice. The last study visit was on 7/18/19 when the family and PI discussed hospice care. Prior to the patient's death he had an additional MRI Brain scan on 6 JUNE 2019 that showed similar dilation of the ventricles and increased DWI hypersensitivity of some of the lesions that likely corresponded to tumor. However, A pathology report showed no tumor growth-the patient had The PI has determined this is possibly related to the study treatment
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: General physical health deterioration, Laboratory test, Magnetic resonance imaging brain abnormal, Neoplasm, Skin lesion
Clinical narrative: Patient on clinical trial via a personalized vaccine WLT03233103, last vaccine given was 4/17/19 Cycle 10. Patient was admitted on 4/25/19 due to deterioration, increase of difficulty communicating, difficulty swallowing & sleepiness, increase weakness & confusion. update 13Dec2019 Patient was transferred to another long term care facility, family noted that he was deterioration of his physical state, was less communicative, having difficulty swallowing, and increase sleepiness. Patient came in for Dr. visit to evaluate on 4/15/19, Dr sent patient for Admission for infection work up, and Head CT. Patient was on clinic trail of MTA vaccine, began on 7/24/18 Vaccine 1, had vaccine on 4/17/19 and Poly-TCIC following day, also was given Bevacizumab #1 4/10/19. PI, does not attribute SAE to the Bevacizumab, the MTA vaccine or the Poly T.C.I.C. The patient died in the setting of the tumor on 11/17/2019 at home hospice. The last study visit was on 7/18/19 when the family and PI discussed hospice care. Prior to the patient's death he had an additional MRI Brain scan on 6 JUNE 2019 that showed similar dilation of the ventricles and increased DWI hypersensitivity of some of the lesions that likely corresponded to tumor. However, A pathology report showed no tumor growth-the patient had The PI has determined this is possibly related to the study treatment
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Somnolence
Clinical narrative: Patient on clinical trial via a personalized vaccine WLT03233103, last vaccine given was 4/17/19 Cycle 10. Patient was admitted on 4/25/19 due to deterioration, increase of difficulty communicating, difficulty swallowing & sleepiness, increase weakness & confusion. update 13Dec2019 Patient was transferred to another long term care facility, family noted that he was deterioration of his physical state, was less communicative, having difficulty swallowing, and increase sleepiness. Patient came in for Dr. visit to evaluate on 4/15/19, Dr sent patient for Admission for infection work up, and Head CT. Patient was on clinic trail of MTA vaccine, began on 7/24/18 Vaccine 1, had vaccine on 4/17/19 and Poly-TCIC following day, also was given Bevacizumab #1 4/10/19. PI, does not attribute SAE to the Bevacizumab, the MTA vaccine or the Poly T.C.I.C. The patient died in the setting of the tumor on 11/17/2019 at home hospice. The last study visit was on 7/18/19 when the family and PI discussed hospice care. Prior to the patient's death he had an additional MRI Brain scan on 6 JUNE 2019 that showed similar dilation of the ventricles and increased DWI hypersensitivity of some of the lesions that likely corresponded to tumor. However, A pathology report showed no tumor growth-the patient had The PI has determined this is possibly related to the study treatment
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus
Clinical narrative: Received: 11/5/19, had flu shots before, no allergies to eggs Symptoms (occurred after 30mins): redness, itchinessareas: stomach, side of stomach & 1 spot in the calf Remedies: she used poison oak Ivy remedy yesterday and it helped with itchiness isolated incident? Possible, pt stated she did pet a dog yesterday (but to her knowledge, no allergies is known to dogs before)My Recommendations: take benadryl & use HC 1%will follow up with her in 2 days to see if she gets better, will notate in system & reference in our adverse reaction database
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Electromyogram normal, Hypoaesthesia, Limb discomfort, Nerve injury, Pain
Clinical narrative: Patient reported arm discomfort, numbness and tingling the same day as vaccination occurred. Discomfort is ongoing and Pain Clinic provider indicated the following in -e-consult note: Therefore the symptoms are more likely c/w small cutaneous nerve damage from either needle/hydrostatic pressure damage during vaccination despite normal EMG as the symptoms match temporally and anatomically with injection time and site and small fiber damage is often not seen on EMG's. Rule of thumb for small fiber dmg is 90% better in 90 days and 99% better in a year. As long as the condition is slowly improving I would not recommend further modalities such as nerve blocks or even cutaneous infiltration and suggest continued watchful waiting and/ or symptomatic care with reassurance that this condition should slowly improve. If condition worsens, consider neuro econsult/consult and then can consider local infiltration/nerve blocks in addition to pharm and MH related pain control techniques. Please let me know if you have questions.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: Patient reported arm discomfort, numbness and tingling the same day as vaccination occurred. Discomfort is ongoing and Pain Clinic provider indicated the following in -e-consult note: Therefore the symptoms are more likely c/w small cutaneous nerve damage from either needle/hydrostatic pressure damage during vaccination despite normal EMG as the symptoms match temporally and anatomically with injection time and site and small fiber damage is often not seen on EMG's. Rule of thumb for small fiber dmg is 90% better in 90 days and 99% better in a year. As long as the condition is slowly improving I would not recommend further modalities such as nerve blocks or even cutaneous infiltration and suggest continued watchful waiting and/ or symptomatic care with reassurance that this condition should slowly improve. If condition worsens, consider neuro econsult/consult and then can consider local infiltration/nerve blocks in addition to pharm and MH related pain control techniques. Please let me know if you have questions.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site reaction, Rash
Clinical narrative: Skin rash & injection site reaction
Age: 32.0
Sex: M
Vaccine: PNC10
Symptoms: Anaphylactic reaction, Rash
Clinical narrative: Anaphylaxis & Skin Rash