chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Injection site pain, Insomnia
Clinical narrative: It began (11pm on the day of injection) with sever pain in both injection site (Covid vaccine in left shoulder & Flu vaccine in right shoulder) that prevented my ability to sleep until 4:30 am.  In the morning  additional symptoms developed (continual pain in both shoulder, chest congestion, general body ache, mild headache, persistent smell of cigarette smoke (no one smokes) and low grade cough.   Symptoms present at time of reporting.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Parosmia, Respiratory tract congestion
Clinical narrative: It began (11pm on the day of injection) with sever pain in both injection site (Covid vaccine in left shoulder & Flu vaccine in right shoulder) that prevented my ability to sleep until 4:30 am.  In the morning  additional symptoms developed (continual pain in both shoulder, chest congestion, general body ache, mild headache, persistent smell of cigarette smoke (no one smokes) and low grade cough.   Symptoms present at time of reporting.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Presyncope
Clinical narrative: Very painful axillary lymphadenopathy (golf ball size) from 4hrs post vaccine requiring analgesics (Tylenol) with some relief. Continuing 48 hours post and slowly resolving. Presyncope episode 22 hours after vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea
Clinical narrative: Patient was a 10 year old Male that administered one dose of Pfizer Pediatric (0.2mL) at 1645 on 11/19/2021 at Vaccination Clinic. After roughly a few minutes, he began to exhibit signs that were seen to be a possible allergic reaction. He began to state that he was experiencing shortness of breath. Nurses assessed the patient and began initiating emergency care on the patient. At about 1654, 911 was called and Fire Department Paramedics arrived on scene at 1703. After careful assessment by both nurses and Paramedics, the patients was ruled out as not experiencing an allergic reaction. The patient was  thought to have been suffering from anxiety, with no severe complications. No medication was administered and patient was directed to stay in Observation Area longer for safety. Patient's condition began to improve and he went home with his father.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray, Chest discomfort, Electrocardiogram
Clinical narrative: Tightness on sternum as if ringing a towel. Heaviness on sternum as if someone was sitting on my chest. Irradiating feel on sternum as if I applied 10x the strength of icy hot for 7 days after Pfizer vaccine, dose 1.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased, Pain, Shoulder injury related to vaccine administration
Clinical narrative: , Patient 8 months post last COVID-19 vaccine.  Patient sustained vaccine injury (ongoing) to right shoulder (SIRVA) that may result in permanent disability. Patient unaware if vaccine injury reported to VARES.  Vaccine injury is SIRVA.  The injury is described as follows:  shoulder pain constant and described as a needle pain in his muscle all the time.  This pain increases with movement across the body and when he put it behind his back.   Patient reports some loss of functioning in his right arm.  Patient has seen several MDs with no improvement.   Pain constantly to 2-3 and increases to 6-7 upon movements described above.   MRI for further evaluation scheduled for 12/21.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Headache, Hyperhidrosis
Clinical narrative: Joint/Muscle pain, fever (48 hours), chills (started within an hour of receiving the vaccine, ongoing), nausea (comes and goes), swelling at injection site (immediate onset, ongoing), itching at injection site (immediate onset, ongoing), burning sensation at the injection site (immediate onset, stopped within 24 hours of receiving second dose), swollen painful lymph nodes (right armpit and base of neck on the right side, ongoing), palpitations (started at about 9:00PM 11/18/2021 and lasted about 12 hours), sweating (onset and length of duration same as palpitations), severe sudden headaches that come and go in waves (started at about 9-10PM 11/16/2021, ongoing), feeling of pressure on chest (onset and length of duration same as palpitations and sweating)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Joint/Muscle pain, fever (48 hours), chills (started within an hour of receiving the vaccine, ongoing), nausea (comes and goes), swelling at injection site (immediate onset, ongoing), itching at injection site (immediate onset, ongoing), burning sensation at the injection site (immediate onset, stopped within 24 hours of receiving second dose), swollen painful lymph nodes (right armpit and base of neck on the right side, ongoing), palpitations (started at about 9:00PM 11/18/2021 and lasted about 12 hours), sweating (onset and length of duration same as palpitations), severe sudden headaches that come and go in waves (started at about 9-10PM 11/16/2021, ongoing), feeling of pressure on chest (onset and length of duration same as palpitations and sweating)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations
Clinical narrative: Joint/Muscle pain, fever (48 hours), chills (started within an hour of receiving the vaccine, ongoing), nausea (comes and goes), swelling at injection site (immediate onset, ongoing), itching at injection site (immediate onset, ongoing), burning sensation at the injection site (immediate onset, stopped within 24 hours of receiving second dose), swollen painful lymph nodes (right armpit and base of neck on the right side, ongoing), palpitations (started at about 9:00PM 11/18/2021 and lasted about 12 hours), sweating (onset and length of duration same as palpitations), severe sudden headaches that come and go in waves (started at about 9-10PM 11/16/2021, ongoing), feeling of pressure on chest (onset and length of duration same as palpitations and sweating)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Skin hypertrophy, Urticaria
Clinical narrative: On 11/16/21, morning. I had itching in my upper legs (both) and scratched. Within a few minutes, I saw hives (small bubble rash) all around that area. Then I felt itching on other parts of the body - behind the ears, back of the neck, back of the hands, inside wrist, etc. Those itchy areas became read and thick. I tool antihistamine (Cetrizine) and a couple of hours later the bubbles disappeared but redness and scratchy sensation continued. Applied Cartizone anti-itch cream on the local spots. Continued the above treatment for 2 days and today (11/19), I had an appointment with my primary doctor. He asked me to continue the same treatment and added Calamine lotion. I never had any allergy before (food or drugs) and in the past 4 days did not eat anything new and never exposed to garden stuff. One of my friend had a similar reaction after Covid shot and has been getting these episodes once in a while.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st-Systemic itching  last 12 hours , sore arm, and fatigue for 3 days 2nd -systemic itching 24 hours, fever  and  fatigue, body aches x4 days, bloody nose., sore arm *3rd - sore arm but none of previous  symtoms. (Wrong vaccine?)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: By September, I have started getting fives a few hours in the evening daily. It?s itchy and it hurts sometimes. Nothing gets the itchiness to go away. Nothing helps to stop the itchiness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Muscular weakness
Clinical narrative: Fatigue; headache; muscle aches; weakness; fever, chills; nausea; vomiting; cough/runny nose.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Fatigue; headache; muscle aches; weakness; fever, chills; nausea; vomiting; cough/runny nose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint range of motion decreased, Mobility decreased, Pain, Skin discolouration
Clinical narrative: Swelling, extreme tenderness to tendons/ligaments (shoulder Joint ), significant decrease in ROM of the right shoulder (unable to abduct arm, move arm behind body, limited and painful to move are Forward and/or straighten arm at the elbow) , right pinky and ring finger numbness,  visible change in color (purple/blue) to both fingers and decrease in temperature to right hand overall especially pinky and ring finger (significantly cooler than the left hand).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling, extreme tenderness to tendons/ligaments (shoulder Joint ), significant decrease in ROM of the right shoulder (unable to abduct arm, move arm behind body, limited and painful to move are Forward and/or straighten arm at the elbow) , right pinky and ring finger numbness,  visible change in color (purple/blue) to both fingers and decrease in temperature to right hand overall especially pinky and ring finger (significantly cooler than the left hand).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Sore arm and lot of muscle soreness and weakness throughout my body! Also extreme tiredness.  This is different than what I  experienced after my 2nd shot.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain lower, Cold sweat, Headache, Myalgia, Nausea
Clinical narrative: Throbbing Headache: 3rd dose, started on day 2 muscle aches 2nd dose: started 4 hours later lasted 5 days Muscle aches 3rd dose/booster: started 12 hours later cold sweats 2nd dose: started 4 hours later lasted 4 days Cold sweats 3rd dose/booster: started 24 hours later sharp lower abdominal pain: 3rd dose started 10 hours later nausea, sore arm: 2nd and 3rd dose lasted 20 hours
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Throbbing Headache: 3rd dose, started on day 2 muscle aches 2nd dose: started 4 hours later lasted 5 days Muscle aches 3rd dose/booster: started 12 hours later cold sweats 2nd dose: started 4 hours later lasted 4 days Cold sweats 3rd dose/booster: started 24 hours later sharp lower abdominal pain: 3rd dose started 10 hours later nausea, sore arm: 2nd and 3rd dose lasted 20 hours
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Anxiety) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart murmur (Born with heart murmur) on 07-Nov-1994, Pneumonia (Developed  pneumonia at age 1.), Stomach function disorder (Developed stomach problems at age 25-26 (prescribed Dicyclomine)) and Lymph node dissection (Patient had surgery at age 11 for lymph node removal on the right side of the neck.). Concurrent medical conditions included Asthma (Developed asthma at age 1.) and Anxiety (Developed Anxiety at age 26-27 (prescribed Hydroxyzine)). Concomitant products included ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for Stomach function disorder.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced ANXIETY (Anxiety). The patient was treated with HYDROXYZINE ongoing since an unknown date for Anxiety, at a dose of 1 dosage form. In November 2021, ANXIETY (Anxiety) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered ANXIETY (Anxiety) to be possibly related.    Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Followup received on 15-NOV-2021 updated reporter information.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: DNA high risk/HPV 16, 18 were not detected; This spontaneous report was received from a nurse referring to her daughter, a currently 31-year-old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route, anatomical site, lot# and expiration date were not reported). On an unknown date, the patient get Human papilloma virus infection (she was determined to be "DNA high risk" and "HPV 16, 18 were not detected'). At the reporting time, the outcome of the event was unknown.  The causality assessment between the occurrence of the event and the suspect vaccine administration was not provided.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No other AE; she discovered she was pregnant when the second dose was administered; This spontaneous retrospective report was received from a 37-year-old pregnant female patient who reported on herself. There was no information about the patient's concomitant therapies or medical history provided. Her concurrent conditions included gestational diabetes.  On an unknown date in October or November 2020, the patient was administered the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in December 2020, the patient became pregnant with last menstrual period (LMP) date calculated as an unspecified date in 2020. On an unknown date in the first week of January 2021, the patient was administered the second dose of the suspect vaccine, in the top shoulder muscle as HPV prevention (exact dose, route of administration, lot # and expiration date were not reported). At the reporting time, the doctor told her she could not receive the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since she was pregnant. Estimated date of delivery (EDD) was 19-SEP-2021 (exposure during pregnancy). She gave birth on an an unknown date in 2021, the pregnancy outcome was live birth, fetal outcome was unknown. No adverse effects were reported.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events; Inappropriate schedule of vaccine administered; This spontaneous report has been received from a pharmacist, referring to a 17-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was not reported.  On an unknown date in 2015 (also reported as "at 11 years old"),  the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, formulation, lot number and expiration date were not reported) for prophylaxis.     On 11-SEP-2021, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, formulation, lot number and expiration date were not reported), this dose was out of the permitted vaccination's scheme timeframe (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant  and refers to a patient of unknown age and gender.    The subject' s concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 22-OCT-2021, the subject was vaccinated with improperly stored  0,5 milliliter of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # U006313 with expiration date 24-AUG-2021). The vaccine was stored in temperature between 6 to 14 Farenheit degrees for 1 hour and 3 minutes and in between 14 to 46 (20.8 F)Farenheit degrees for 20 hours and 32 minutes. There was no previous temperature excursions. There was no additional adverse events reported.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: denied further AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 04-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # KP24R, expiration date 24-OCT-2021 for prophylaxis (dose #, anatomical location and route of administration were not reported).   The vaccine was stored at the temperature that was reported as 50.5 degrees of Fahrenheit for 0 hours and 30 minutes. There was no previous temperature excursion reported.  The reporter denied further adverse events.   This is one of several reports received from the same reporter.  Lot Number KP24R is not valid for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and does not match any Company product; Sender's Comments:  US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007275: US-009507513-2110USA007316: US-009507513-2110USA006972: US-009507513-2110USA007269: US-009507513-2110USA007007:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: She denied further AE; administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 13-OCT-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (ml), lot # T013204, expiration date: 13-DEC-2021 (dose number and route of administration were not reported) for prophylaxis (product storage error).  The vaccine was stored improperly for the time frame of 30 minutes in the temperature of 50.5 Fahrenheit (F). There was no previous temperature excursion.  The reporter denied further adverse event (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2110USA007269:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: She denied further AE; administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 14-OCT-2021, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 0.5 milliliter (ml), lot # KP24R, expiration date 24-OCT-2021 (dose number and route of administration were not reported) for prophylaxis (product storage error). The reporter confirmed the lot # and expiration date twice. Lot number KP24R is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). Lot number KP24R does not match any Company product as confirmed by Lot Verification team.  The vaccine was stored for the time frame of 30 minutes in the temperature of 50.5 Fahrenheit (F). There was no previous temperature excursion.  The reporter denied further adverse event (no adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; administered improperly stored; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 29-SEP-2021, the patient was vaccinated with incorrectly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, lot # T027115 with expiration date on 07-FEB-2021 (route of administration was not reported) for prophylaxis. No adverse event was reported. The vaccine experienced excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Vaccine expiration date recorded was 12-FEB-2015 when administred on 06-JUL-2016/did not know if product was expired then; She was not sure if someone at that time entered a invalid expiration date or if the product was expired then; This spontaneous report as received from a licensed practical nurse refers to a 15-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-JUN-2016, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot# L04862 (was verified to be invalid) (exact dose, route of administration, anatomical location were not reported) for prophylaxis. The nurse reportd that expiration date entered in the system on 07-JUN-2016 was 02-DEC-2015. She was not sure if someone entered an invalid date or if the product was expired then. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: No additional AE; incorrectly administered "too low" on the deltoid injection site; This spontaneous report was received from a certified medical assistant concerning a 33-year-old female patient. Information regarding the patient's concurrent conditions, medical history or concomitant medications was not reported.   On 29-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL administered intramuscularly for prophylaxis (lot # U007477, expiration date: 14-APR-2023) (dose number was not reported). It was reported that the vaccine was incorrectly administered "too low" on the deltoid injection site (Product administered at inappropriate site). No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; second dose of the vaccine was given 23 days after the first dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 15-OCT-2021, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T030710, expiration date 15-APR-2023, at a dose of 0.5 milliliter for prophylaxis. The vaccine was given 23 days after the first dose (inappropriate schedule of product administration). No additional adverse event reported.
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M abnormal, Cough, Genotype drug resistance test positive, Immunoglobulin therapy
Clinical narrative: This marketed literature report has been received from the authors of the published literature article as stated below, concerning a 22-year-old male patient with preB-cell acute lymphoblastic leukemia who underwent myeloablative allogeneic hematopoietic cell transplantation (HCT) from a HLA-identical unrelated donor using a peripheral blood allograft 4 years prior to presentation. His post-HCT course was complicated by acute graft-vs-host disease (GVHD) of the skin, eyes, gastrointestinal tract, and liver requiring intensified immunosuppression with tacrolimus, itacitinib, and prednisone. After clinical resolution of GVHD, all iatrogenic immunosuppression was discontinued on day +1335. Nine days post vaccination, he presented to the Hematology and Oncology Clinic with fevers up to 40°C (104°F), sore throat, nonproductive cough, and tender cervical lymphadenopathy. Twelve days post vaccination, he returned to the Hematology and Oncology Clinic after an asymptomatic, faint pink, maculopapular rash developed on his face and spread to his torso and upper extremities. He did not have conjunctivitis or coryza. He denied any recent measles exposures, sick contacts, or international travel. After consultation with Transplant Infectious Diseases, Clinical Epidemiology and Infection Prevention, and the Public Health, a diagnostic evaluation for vaccine-derived measles (Measles post vaccine) was performed. Serum measles immunoglobulin M antibody was positive and immunoglobulin G antibody was negative. Measles RNA was detected by polymerase chain reaction in urine and throat specimens. Viral genotyping by sequence analysis confirmed the strain to be genotype A (vaccine-derived) measles. He received a single dose of intravenous immunoglobulin (IVIG) 400 mg/kg. His symptoms resolved without sequelae. Despite his attendance at the Hematology and Oncology Clinic where other vulnerable individuals with solid tumor malignancies, hematologic malignancies, and HCT recipients were also present, no secondary cases occurred. The authors considered the event of vaccine-derived measles to be related to the suspect therapy. Upon internal review, the event of Measles post vaccine was considered medically significant.
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy, Measles, Morbillivirus test positive
Clinical narrative: This marketed literature report has been received from the authors of the published literature article as stated below, concerning a 22-year-old male patient with preB-cell acute lymphoblastic leukemia who underwent myeloablative allogeneic hematopoietic cell transplantation (HCT) from a HLA-identical unrelated donor using a peripheral blood allograft 4 years prior to presentation. His post-HCT course was complicated by acute graft-vs-host disease (GVHD) of the skin, eyes, gastrointestinal tract, and liver requiring intensified immunosuppression with tacrolimus, itacitinib, and prednisone. After clinical resolution of GVHD, all iatrogenic immunosuppression was discontinued on day +1335. Nine days post vaccination, he presented to the Hematology and Oncology Clinic with fevers up to 40°C (104°F), sore throat, nonproductive cough, and tender cervical lymphadenopathy. Twelve days post vaccination, he returned to the Hematology and Oncology Clinic after an asymptomatic, faint pink, maculopapular rash developed on his face and spread to his torso and upper extremities. He did not have conjunctivitis or coryza. He denied any recent measles exposures, sick contacts, or international travel. After consultation with Transplant Infectious Diseases, Clinical Epidemiology and Infection Prevention, and the Public Health, a diagnostic evaluation for vaccine-derived measles (Measles post vaccine) was performed. Serum measles immunoglobulin M antibody was positive and immunoglobulin G antibody was negative. Measles RNA was detected by polymerase chain reaction in urine and throat specimens. Viral genotyping by sequence analysis confirmed the strain to be genotype A (vaccine-derived) measles. He received a single dose of intravenous immunoglobulin (IVIG) 400 mg/kg. His symptoms resolved without sequelae. Despite his attendance at the Hematology and Oncology Clinic where other vulnerable individuals with solid tumor malignancies, hematologic malignancies, and HCT recipients were also present, no secondary cases occurred. The authors considered the event of vaccine-derived measles to be related to the suspect therapy. Upon internal review, the event of Measles post vaccine was considered medically significant.
Sex: M
Vaccine: MMR
Symptoms: Oropharyngeal pain, Photosensitivity reaction, Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: This marketed literature report has been received from the authors of the published literature article as stated below, concerning a 22-year-old male patient with preB-cell acute lymphoblastic leukemia who underwent myeloablative allogeneic hematopoietic cell transplantation (HCT) from a HLA-identical unrelated donor using a peripheral blood allograft 4 years prior to presentation. His post-HCT course was complicated by acute graft-vs-host disease (GVHD) of the skin, eyes, gastrointestinal tract, and liver requiring intensified immunosuppression with tacrolimus, itacitinib, and prednisone. After clinical resolution of GVHD, all iatrogenic immunosuppression was discontinued on day +1335. Nine days post vaccination, he presented to the Hematology and Oncology Clinic with fevers up to 40°C (104°F), sore throat, nonproductive cough, and tender cervical lymphadenopathy. Twelve days post vaccination, he returned to the Hematology and Oncology Clinic after an asymptomatic, faint pink, maculopapular rash developed on his face and spread to his torso and upper extremities. He did not have conjunctivitis or coryza. He denied any recent measles exposures, sick contacts, or international travel. After consultation with Transplant Infectious Diseases, Clinical Epidemiology and Infection Prevention, and the Public Health, a diagnostic evaluation for vaccine-derived measles (Measles post vaccine) was performed. Serum measles immunoglobulin M antibody was positive and immunoglobulin G antibody was negative. Measles RNA was detected by polymerase chain reaction in urine and throat specimens. Viral genotyping by sequence analysis confirmed the strain to be genotype A (vaccine-derived) measles. He received a single dose of intravenous immunoglobulin (IVIG) 400 mg/kg. His symptoms resolved without sequelae. Despite his attendance at the Hematology and Oncology Clinic where other vulnerable individuals with solid tumor malignancies, hematologic malignancies, and HCT recipients were also present, no secondary cases occurred. The authors considered the event of vaccine-derived measles to be related to the suspect therapy. Upon internal review, the event of Measles post vaccine was considered medically significant.
Sex: M
Vaccine: MMR
Symptoms: Rash maculo-papular
Clinical narrative: This marketed literature report has been received from the authors of the published literature article as stated below, concerning a 22-year-old male patient with preB-cell acute lymphoblastic leukemia who underwent myeloablative allogeneic hematopoietic cell transplantation (HCT) from a HLA-identical unrelated donor using a peripheral blood allograft 4 years prior to presentation. His post-HCT course was complicated by acute graft-vs-host disease (GVHD) of the skin, eyes, gastrointestinal tract, and liver requiring intensified immunosuppression with tacrolimus, itacitinib, and prednisone. After clinical resolution of GVHD, all iatrogenic immunosuppression was discontinued on day +1335. Nine days post vaccination, he presented to the Hematology and Oncology Clinic with fevers up to 40°C (104°F), sore throat, nonproductive cough, and tender cervical lymphadenopathy. Twelve days post vaccination, he returned to the Hematology and Oncology Clinic after an asymptomatic, faint pink, maculopapular rash developed on his face and spread to his torso and upper extremities. He did not have conjunctivitis or coryza. He denied any recent measles exposures, sick contacts, or international travel. After consultation with Transplant Infectious Diseases, Clinical Epidemiology and Infection Prevention, and the Public Health, a diagnostic evaluation for vaccine-derived measles (Measles post vaccine) was performed. Serum measles immunoglobulin M antibody was positive and immunoglobulin G antibody was negative. Measles RNA was detected by polymerase chain reaction in urine and throat specimens. Viral genotyping by sequence analysis confirmed the strain to be genotype A (vaccine-derived) measles. He received a single dose of intravenous immunoglobulin (IVIG) 400 mg/kg. His symptoms resolved without sequelae. Despite his attendance at the Hematology and Oncology Clinic where other vulnerable individuals with solid tumor malignancies, hematologic malignancies, and HCT recipients were also present, no secondary cases occurred. The authors considered the event of vaccine-derived measles to be related to the suspect therapy. Upon internal review, the event of Measles post vaccine was considered medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Rash, Vertigo, Visual impairment
Clinical narrative: persistent skin rash; vertigo; balance issues; issues with her vision; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions and concomitant medications. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt suffered persistent skin rash (rash), vertigo, balance issues (balance disorder) and issues with her vision (visual impairment). As a result of these symptoms, the pt was seen and treated by medical providers and was still under care. As a direct and proximate result of the vaccination, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccination, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of rash, vertigo, balance disorder and visual impairment was not recovered. The reporter considered rash, vertigo, balance disorder and visual impairment to be related to zoster vaccine live (ZOSTAVAX). The reporter considered rash, vertigo, balance disorder and visual impairment to be disabling.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Healthcare Professional had administered improperly stored VARlVAX to Patient; No additional adverse event; This spontaneous report was received from a nurse referring to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 05-OCT-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, frequency, were not provided) for prophylaxis; valid Lot No. U020244; has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 28-JUN-2023. And valid Lot No. U010395 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 01-APR-2023, and upon internal validation established as the same. The patient was also vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Albumin status was not provided) (strength, dose, route, frequency, lot number and expiration date were not provided) for prophylaxis, on an unspecified date.   The reporter stated that these vaccines doses were administered and the vaccines were improperly stored (incorrect product storage). They presented a temperature excursion with Temperature: 1.45°C on time frame 6 Hours (Temperature Excursion had occurred on 05-OCT-2021). It was reported that Previous temperature excursion occurred on 04-OCT-2021 at -10°C to 8°C (0.91 °C) for 6 Hours. Additional excursions had occurred after patient was administered the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on 08-OCT-2021 of -50°C to -15°C (-14.6°C) for 15 Hours; and on 13-OCT-2021 of 10°C to 8°C (0.54°C) for 13 Hours.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) by a pharmacist, for the long-term prevention of shingles and zoster related conditions (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided). Subsequently, the pt was treated by a physician for the following injuries resulting from vaccination: shingles (herpes zoster). The outcome of shingles was not provided and the causality assessment between shingles and zoster vaccine live (ZOSTAVAX) was reported as related.
Age: 81.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and refers to a currently 88-years-old patient of unknown gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route, lot # and expiration date was not provided) by a pharmacist (as prescribed by a healthcare professional) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles. At the reporting time, the outcome of shingles was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Nerve injury, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation via memo. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain her left knee and shoulder. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of all the events was considered as not recovered.   The reporters considered all the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered all the event to be disabling.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; a temperature excursion occurred/ROTATEQ was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported  The reporter indicated that on 11-OCT-2021, a temperature excursion occurred, the temperature was 9.7°C for a time frame of 1 hour, and there was not previous temperature excursion. Then, on 22-OCT-2021 the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # T003011 with expiration date 26-NOV-2021, 1 time dose, for prophylaxis (strength and route were not reported) , which experienced the temperature excursion (product storage error). No signs and symptoms were reported (No adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Chemotherapy, Neoplasm malignant
Clinical narrative: she has cancer; Covid illness; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and covid-19. The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the cancer was not recovered/not resolved and the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the cancer and covid-19 to be related to Shingrix.   Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine 2 years ago from reporting date and due to Covid illness she could not receive 2nd dose. The pharmacist would like to know how to proceed with this patient as the patient was probably receiving chemotherapy because she had cancer.  The reporter need time to check patient´s condition and personal details.  The reporter consented to follow-up. For tolerance of second dose refer linked case US2021AMR237320, reported by the same reporter. Note: The event cancer was conservatively captured as it was not clear if the patient got cancer before or after the Shingrix vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237320:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: initial dose, shingles within a week; This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. The action taken with Shingrix was unknown (Dechallenge was unknown). Rechallenge with Shingrix was unknown. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information reported are as follow: The reporter stated that the patient had experienced Shingles within a week after administration of first dose of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: mild headache next day; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2021, the patient received Shingles vaccine. In November 2021, 1 day after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The patient received her dose of Shingles vaccine, last week of reporting date. The patient got mild headache next day of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash, feels like sandpaper; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient received vaccine shot and developed rash.  The patient felt like sandpaper. This is one of the 3 cases, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237273:Same reporter US-GLAXOSMITHKLINE-US2021AMR237274:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: had a box of last year's flu vaccine that got administered to a couple of employees; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that they had a box of last year's flu vaccine (already expired) that got administered to a couple of employees, which led to expired vaccine used. Pharmacist would assume that they would need to be revaccinated with this year's formulation but was there a timeframe they must wait to get the current year's vaccine. They were supposed to be returned earlier in the year, but accidentally fell under the radar and were mixed in with this year's new flu, and then unintentionally administered to employees. No further information was reported. The reported consented to follow up.