chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered the 3rd dose of Pentacel 9 days too soon with no reported adverse event; Initial information received received on 02-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 months old female patient who was administered the 3rd dose of pentacel 9 days too soon with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2021, the patient received a first dose (dose-1) and on 10-Feb-2022 the patient received a second dose (dose-2) (dosage, form, route, administration site, strength: unknown); the patient received a third dose (3rd dose) 01-Mar-2022 of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (dose 0.5 ml to 2 ml via intramuscular route in left thigh); all with lot UJ474AAA and expiry date 09-Jul-2022 for prophylactic vaccination.  On 01-Mar-2022 the patient was administered the 3rd dose of pentacel 9 days too soon with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken was not applicable  Outcome was Unknown   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 the guidelines. 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.
Janssen covid-19 vaccine EUA shot @ 9:30 am left arm & left leg sore chills in-between 5-10:pm fever & severe body aches in-between 10:pm & 2:am ( couldn't even sit up to drink water ) finally got out of bed noon the next day
Pt developed left upper arm pain immediately after receiving the flu vaccine. Pain persisted with movement. Doctor prescribed Prednisone taper for a week. States pain  is better with prednisone. Will be finished with the prescription on 01/14/2002.
Information has been received from a pharmacist concerning a male who on approximately 09-OCT-2007 (reported as "about a month ago") was vaccinated with a 0.5 ML dose of Zostavax (Oka/Merck). The pharmacist reported that the patient was hospitalized with herpetic encephalitis. The patient's herpetic encephalitis persisted. The herpetic encephalitis was considered to be immediately life-threatening. There was no product quality complaint. In follow-up information received 09-NOV-2007, the pharmacist reported that she had limited information. She stated that a nurse came to the pharmacy and mentioned that they had a patient who was very sick and they were trying to figure out what was wrong with him. The nurse mentioned to the pharmacist that she reviewed the patient's history and the patient had been vaccinated with Zostavax (Oka/Merck) about a month ago. The pharmacist did not have any additional information since she did not review the chart and did not know who the treating physician was. In follow-up information received on 13-NOV-2007, the pharmacist reported that the pharmacy department had no further information. Herpetic encephalitis was considered to be an other important medical event. No further information is available.
Fever of 103F, palpitations, diarrhea, muscle pain, headache, anorexia, redness at the site of injection.
Patient falsified DOB when registering for vaccination, stating the minor's DOB was unspecified date. Guardian consented to the vaccination. Department of Health verified with statistical records that the patient's actual DOB is unspecified date which made the vaccine a contraindication.  No known adverse reactions noted.
Gave an adult dose HAVRIX to 18 year old patient. No adverse events reported.
This spontaneous report was received from a Licensed Practical Nurse referring to multiple unspecified patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of ZOSTAVAX reported lot # M003486 with expiration date of 27-MAR-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of -7 degrees C for a time of 411 minutes. No additional temperature excursion was reported. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Rash, fever acute URI and croup, went to Emergency Dept, was instructed to give Benadryl, children's Tylenol or Ibuprofen.
pt recv vax & father called @ 1840 w/pt w/fever & staring spells, ?stopped breathing x 5sec;taken to ER-looked great;peds ER MD feels pt had febrile tonic sz;t in ER 39.8;
Patient reports feeling dizzy at the end of the 30 minutes of observation. Indicates not eaten recently. BP 110/85, P72, R16, Sat 98, Dex 84. After ingesting 7oz of soda. Doctor was notified while patient is evaluated by emergency personnel. 4:30pm Dxt 116 at the time of being discharged he reports feeling good.
Patient received the Pfizer vaccine for the first and second dose but Moderna for the third. No events have occurred to date.
Moderna COVID-19 Vaccine. Received the vaccine at 8:30 AM 12/24. Morning of 12/25 I started to feel a slight sore throat and tender lymph nodes. By the early morning of 12/26 I was experiencing a moderate-severe headache, fatigue, swollen/red tonsils, swollen lymph nodes, congestion, sore throat, and trouble swallowing. Around 2:00 AM on 12/26 I took NSAIDS which only mildly helped. I went to an urgent care center at 9:30 AM on 12/26 where after my examination the CRNP ordered a strep test and COVID test. Strep test resulted positive, prescribed amoxicillin 875mg twice daily for 10 days, and prednisone 20mg twice daily for 2 days. As of now, 12/27, symptoms have significantly reduced. Awaiting COVID test results.
Symptoms = Serum sickness. Addison's disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn't think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.
still stiff; trigeminal neuralgia/bells palsy type thing/flared up; had a severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (still stiff), TRIGEMINAL NEURALGIA (trigeminal neuralgia/bells palsy type thing/flared up) and VACCINATION COMPLICATION (had a severe reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN (GABUTIN) for Nerve pain, BACLOFEN and LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (still stiff), TRIGEMINAL NEURALGIA (trigeminal neuralgia/bells palsy type thing/flared up) and VACCINATION COMPLICATION (had a severe reaction). At the time of the report, MUSCULOSKELETAL STIFFNESS (still stiff) had not resolved and TRIGEMINAL NEURALGIA (trigeminal neuralgia/bells palsy type thing/flared up) and VACCINATION COMPLICATION (had a severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a severe reaction from the first shot and ended up at the emergency room (ER) where they gave her two pain shots and a pain pill in the ER.  No medical history information was reported.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# M036459, expiration date: 18-JAN-2018 (dose and route of administartion were not reported). The vaccine was exposed to temperature below 32 degrees Fahrenheit (0 degrees Celsius), the lowest temperature was minus 40 degrees Fahrenheit for 1 cycle. The vaccine was exposed to incorrect temperature for 6 days 23 hours and 30 minutes.  Digital data logger was involved and there was no previous temperature excursion. No adverse effects were reported.  Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011637: US-009507513-1702USA002784: US-009507513-1702USA002782:
a rash appeared on parts of my body including torso, left foot, right wrist and thighs.; This is a spontaneous report from a contactable consumer. An 81-year-old female consumer (patient herself) reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in right arm on 05Feb2021 09:30AM (at the age of 81-year-old) at single dose for COVID-19 immunisation. The patient received first dose of BNT162b2 (Lot number unknown) on 15Jan2021 09:30 for COVID-19 immunisation. Relevant medical history included high cholesterol and high blood pressure. The patient had not COVID prior to vaccination. The patient was taking other medicines (unspecified) but concomitant medications were not reported. Four days after the second vaccination, on 09Feb2021 at 10:00PM a rash appeared on parts of her body including torso, left foot, right wrist and thighs. After seeking medical attention, she took the prescribed medication but had to go to ER on 12Feb2021 due the rash becoming discolored more of bluish-purple. The patient was treated with topical steroids then oral steroids. The event was not resolved. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mom reported that child's left arm (vaccination site) got swollen, hard and hot, child had temperature of 103.9F at 1:30pm; Tylenol was administered and 4 hours later temp was 101F and Mom gave child Tylenol again;  child had a bottle of milk since yesterday morning, refused to eat, and was restless; on 7/26/12 at 7:20am, arm swelling got worse and child's temp is 102F.
Pfizer BioNTech Covid 19 Vaccine EUA.  After about 45 minutes I experienced  lightheadedness/ dizziness then an intense ringing in my ears, which as of date is not as intense but still present constantly.
710AM pt recv vax;715AM stood up, syncope, awakened on floor, carpet , no head injury;722AM c/o dizziness, bP 84/60, BP 90/60;725AM given DPh, BP 90/78;830AM 90/78 standing, reports feeling better given a ride;
Information has been received from a nurse concerning a 41 year old patient (sex not reported) with unspecified pertinent medical history and drug reactions/allergies who on approximately 13-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F, 651374/0485F, or 651321/1036P). Concomitant therapy included influenza virus vaccine (unspecified) given at the same time. On approximately 13-NOV-2006, the patient experienced swelling, redness, rash on the lower arm and pain. The patient sought medical attention. The outcome was not reported. All vaccines from these lot numbers had been discarded. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of agency and was released by the regulatory agency. Additional information has been requested.
Pt developed high fever, sore red arm, chills - went to ER and Dx also with pneumonia - still with Sx.
Started getting an itchy rash around hairline and forehead. It spread to the back, both lower legs, both knees, shoulders, chest over the next several days, with intense itching. Was prescribed 7 days of steroids, antihistamine (Zyrtec), Pepcid. No relief or change with meds. Rash moved around to different areas of body and did not start to clear until 12/28/2015.
Acid Reflux; Diarrhea / Upset stomach; Nausea; Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore; Fatigued; Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach; Site of injection is hard; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach), DIARRHOEA (Diarrhea / Upset stomach), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), VACCINATION SITE INDURATION (Site of injection is hard) and FATIGUE (Fatigued) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach) and VACCINATION SITE INDURATION (Site of injection is hard). On 18-Mar-2021, the patient experienced FATIGUE (Fatigued). On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea / Upset stomach) and NAUSEA (Nausea). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach), DIARRHOEA (Diarrhea / Upset stomach), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), VACCINATION SITE INDURATION (Site of injection is hard), FATIGUE (Fatigued), VACCINATION SITE PAIN (Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore) and NAUSEA (Nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-081598 (E2B Linked Report).; Sender's Comments:  MOD-2021-081598:For second dose
Pulmonary embolism  and nonischemic cardiomyopathy.   Patient  completed 3 months of anticoagulation for a provoked PE because he had just had orthopedic surgery.     He is on ongoing medication therapy for nonischemic cardiomyopathy.  echocardiogram completed 10/2021 reveals an EF of 23%.
pt recvd vax 19SEP95 & ran low temp same evening given APAP;20SEP95 pt had no temp, appetite dec, activity level good;pt in bathtub w/father when stiffened, arched back & began thrashing limbs x 20-30sec, then cried shrill cry x 5min;to ER
pt presented to ED with SOB, cough, N/V/D x 3 days; PMH:  dementia, OSA on CPAP, chronic hypercapnic respiratory failure; intubated on 8/31; developed AKI and shock; transitioned to comfort care; extubation on 9/4; pt died shortly after extubation
patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Date of refrigeration was 07-May-2021.
Child complained of pain and difficulty moving arm. Mom reports moderate swelling, little redness, and area is not warm to touch. Symptoms occurred evening of the day vaccine was administered. 04/11/2002 swelling resolving and arm movement better.
a 18 month old female patient was inadvertently received a dose of Quadracel; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from an other health care professional.   This case involves a 18 months old female patient who was inadvertently received a 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5532AB, expiry date: 09-Oct-2020 via intramuscular route in the thigh NOS on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HAEMOPHILUS INFLUENZAE TYPE B) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was an actual medication error due to inappropriate age at vaccine administration.  It was not reported if the 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 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.  List of documents held by sender: none.
This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject ages between 40 and 49 yrs old who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. The pt was 47 yrs old at the time of this report. The pt received vaccination with Lymerix on 02Jun00, 06Jul00, and 16Jun01. At an unspecified time after vaccination with Lymerix, the pt experienced rheumatological symptoms including constant and intense joint pain and joint swelling in the shoulders, ankles, and hands. The attorney stated that the pt's knuckles have swollen to three times their normal size, and alleged that due to the severity of the symptoms the pt was placed on social security disability. Treatment included infliximab (Remicade). At the time of reporting the events were unresolved.
The client presented to the clinic with his mother for his first dose of vaccine. The client was vetted and a consent form was obtained.  It was identified after the client was vaccinated that the client did not meet the eligibility criteria.  Although education was provided in the daily briefing, the vaccinator still gave the vaccine even though the criteria was met. The client/mother was educated on Pfizer side effects and adverse reaction. The client/mother was informed that the client can not receive his second dose until he turns 16 years of age.  The client was observed with no side effects or adverse reaction noted.  Education was reinforced amongst the staff.
received an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th May 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The patient received an expired Bexsero vaccine. The reporter consented to follow-up.
Patient reported high fever on the night of receiving vaccine and the following day. Then 3 days after vaccination patient reported rash and hives all over body. Patient went to an urgent care and treatment from urgent care is not known.
Onset of dizziness/vertigo. At approximately 8 days after booster vaccination, dizziness persisted through the entire day. 13 days later, dizziness is still intermittently reoccurring.