chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In May 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
hives on left cheek area, neck ,face, upper chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on left cheek area, neck ,face, upper chest) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives on left cheek area, neck ,face, upper chest). On 27-Apr-2021, URTICARIA (hives on left cheek area, neck ,face, upper chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Treatment information was not provided
Had blood work done that was all negative had a EKG and echocardiogram that were negative. Also sleep study that was shown no signs of sleep. Continue to struggle with exhaustion & fatigue. This may be some better now due to adding some supplements  to help sleep. But I'm hoping to follow up with a neurologist to rule out other issues due to twitching in right hand & feet at night.
Shooting @ throbbing pain L arm + hand. Info given by son. Pt does not speak English.
my left arm tingles several times a day.  started after the shot,  happens every day, and it still does it.
Administration of Kinrix to 9 month old instead of Pediarix; Administration of Kinrix to 9 month old instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 06-June-2022 Reporter's comment: The health care professional reported the administration of Kinrix to 9 month old patient instead of Pediarix. The reporter consented to follow-up. Additional supportive information: The patient received dose of Kinrix instead of Pediarix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Left deltoid pain, difficulty lifting left arm, started 5/2/16. Fever 101 degrees F, chills and headache - started 5/3/16.
some sort of anaphylactic reaction; Eyes were full of blood; throat swelled up; bilateral conjunctivitis; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via Agency (Reference number- US-SANOFI-00457182) and transmitted to Sanofi on 02-Feb-2021.  This case involves a female patient (unspecified age) who had some sort of anaphylactic reaction (anaphylactic reaction), eyes were full of blood (ocular hyperaemia), throat swelled up (pharyngeal swelling) and bilateral conjunctivitis (conjunctivitis), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  In February 2016, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] ( lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2016, the patient developed a serious some sort of anaphylactic reaction (anaphylactic reaction) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On an unknown date in 2016, the patient developed a non-serious eyes were full of blood (ocular hyperaemia), throat swelled up (pharyngeal swelling) and bilateral conjunctivitis (conjunctivitis) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  Information on lot number was requested for this case.; Sender's Comments: This case concerns female patient (unspecified age) who had anaphylactic reaction, ocular hyperaemia, pharyngeal swelling and conjunctivitis, after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Moderna COVID-19 Vaccine EUA Started with Fever, Chills, overall not feeling well, light headed, dizziness & weakness. Then progressed to SEVERE WORST Headache I have ever had, pain was so bad that I was unable to sleep or function the entire night & into the following day. Body aches all over with terrible pain & limited use of my L upper arm. Fever/chills would come & go. Had diarrhea, nausea, no appetite. Lasted approx 36 hrs. I still continue to have the worst Headaches off & on 3 months later, which are "migraine" like in nature. I have NEVER had frequent Headaches prior to this injection nor this "type" of Headache.
Within 24 hours of receiving the Shingrix vaccine the patient noticed that approximately 3 inches below the vaccine site a red and hot band had formed across the width of her arm. She presented to the pharmacy to day to show me. Her arm was still red and hot, but the area had decreased to only the front  portion of her arm. She had not taken any anti-inflammatory medications to help with the symptoms
I had a concussion March, I was outside of my house carrying a plant, blacked out, fell and lacerated my skull on a column, I was unconscious for less than thirty minutes. I was then admitted to the ER. I was then diagnosed with a concussion and got multiple tests and everything came back within normal range. April 29, 2022 towards the end of the week after my vaccine I started to notice a fluctuation in my blood pressure, I called my cardiologist and he prescribed medication. The blood pressure continued to fluctuate and did not seem to help much in regards to the Rx. I then got a changed prescription, and it still has not been helping. If this continues to fluctuate, I will be reaching out to my physician to see next steps. I am unsure of this being caused by the vaccines that I have received.
Intussusception, reduced by Laparoscopic surgery. Symptoms: crying episodes of every 10 minutes.
Red area around site 3 inches x 4 inches in size. Afebrile. Site warm to touch.
Arm and shoulder pain to left arm started yesterday shortly after vaccine. When i woke up this morning it was very painful and i had a limited range of motion to that arm. Both symptoms have improved slightly over the course of today. Also the vaccine was injected higher than the recommended two fingers below the acromian process in my arm.
Pt was given seasonal flu vaccine on 10/4/22. He was then given a second dose on 10/11/22. No adverse effects were reported at the time of this report.
Broke out in shingles on left neck, chest area.  Symptoms started 72 hours after injection.  Low grade fever, body aches, malaise
Tested positive for COVID19 and received both Moderna doses.; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 and received both Moderna doses.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 and received both Moderna doses.). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 and received both Moderna doses.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive: positive (Positive) positive antibody test.         No treatment medication provided by reporter. No concomitant medication provided by reporter. Suspect product batch number is unknown.   Action taken with mRNA-1273 (Moderna Covid-19 vaccine) was not applicable.   Reportedly, the patient was tested positive for COVID 19 after both doses of the vaccine, however, there were no any reported signs or symptoms of COVID-19 disease. The exact dates of the first and the second vaccination were not reported. The company causality for the event SARS-CoV-2 test positive is not applicable having in mind that the mRNA-1273 does not contain a virus capable of causing infection.; Sender's Comments: Reportedly, the patient was tested positve for COVID 19 after both doses of the vaccine, however, there were no any reported signs or symptoms of COVID-19 disease. The exact dates of the first and the second vaccination were not reported. The company causality for the event SARS-CoV-2 test positive is not applicable having in mind that the mRNA-1273 does not contain a virus capable of causing infection.
Information has been received from a pharmacist concerning a 33 yr old female who in 2001 was vaccinated with two doses of varicella virus vaccine live. In 2005 the pt presented with negative antibody titers. The pharmacist stated that there may have been some question as to whether the proper dosing schedule was used in 2001. Unspecified medical attention was sought. At the time of the report the pt had not recovered. There was no product quality complaint involved. Additional information has been requested.
A pharmacist reported that a 2 to 4 month old infant received Prevnar and subsequently developed a fever of 102 degrees F. The infant was treated symptomatically. This is 1 of 5 pt from this facility who developed an adverse experience following receipt of Prevnar.
PAIN AND SWELLING AT AND AROUND INJECTION SITE, CANNOT MOVE ARM.
Fever of 103.5 not controlled by acetaminophen, vomiting, loose stools, crying, inability to rest well.
Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 011F21A, 031A21A and 011M21A) for COVID-19 prophylaxis.     Allergies to medications, food, and other products was reported as unknown. Acute illnesses at the time of vaccination and up to one month before was reported as unknown. It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Diabetes and Blood pressure high.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 9:26 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 9:26 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Vaccines expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.  The event did not cause the patient to seek medical care. There was not any other potential causes and  it was unknown if the patient experienced a similar event in the past.  No treatment medications were provided.
ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/9/2022 METABOLIC ENCEPHALOPATHY  HYPOXIA 12/8/2021 METABOLIC ENCEPHALOPATHY  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/9/2022 CANCER METASTATIC TO UNSPECIFIED LUNG  HYPOXIA 12/8/2021 CANCER METASTATIC TO UNSPECIFIED LUNG         ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/9/2022 SUPPLEMENTAL OXYGEN DEPENDENCE         HYPOXIA 12/8/2021 SUPPLEMENTAL OXYGEN DEPENDENCE
Pt found unresponsive at home and brought to ED - unable to resuscitate; pronounced dead.  5/9/08 Autopsy report states COD as changes c/w viral pneumonia, bilateral & manner of death as natural. Autopsy report states patient arrested while at home & transported to ER.
Shortness of Breath, Headache, Dizziness, Chills in upper body and feet, Pain on left side of head, coughing one day, heart pounding.
dizziness; arm immobility/ inability to use arm; weakness in limbs; lack of appetite/ unable to eat or drink; lethargy; fever; nausea; fatigue; chills; soreness at injection site/ tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MOBILITY DECREASED (arm immobility/ inability to use arm), MUSCULAR WEAKNESS (weakness in limbs), DECREASED APPETITE (lack of appetite/ unable to eat or drink) and LETHARGY (lethargy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 09-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 2:00 AM, the patient experienced DIZZINESS (dizziness), MOBILITY DECREASED (arm immobility/ inability to use arm), MUSCULAR WEAKNESS (weakness in limbs), DECREASED APPETITE (lack of appetite/ unable to eat or drink), LETHARGY (lethargy), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (soreness at injection site/ tenderness at injection site). 10-Mar-2021 at 2:00 AM, the patient experienced PYREXIA (fever). At the time of the report, DIZZINESS (dizziness), MOBILITY DECREASED (arm immobility/ inability to use arm), MUSCULAR WEAKNESS (weakness in limbs), DECREASED APPETITE (lack of appetite/ unable to eat or drink), LETHARGY (lethargy), PYREXIA (fever), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (soreness at injection site/ tenderness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100 to 101 degree f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pediatric Pfizer, undiluted, was given to the patient instead of the regular Pfizer dose.
Pain at injection site immediately with vaccine administration- progressing to severe pain radiating down arm to wrist. Diffuse limb pain persists with intermittent focal pain and exacerbation at wrist/forearm often localized to site of old healed fracture. Continues with current pain x >4 weeks. Dizziness and lightheadness started within 10 minutes of injection and lasted 15-20 minutes from onset of symptom, no syncope. Paresthesia and sensory pain, exquisite pain to light touch, pallor, numbness and tingling in hand and fingers started within 12 hours of injection and continues with intermittent exacerbation x > 4 weeks. Weakness intermittent starting within 12 hours of injection.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 42 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 7/16/99, 8/9/99, and 6/18/00 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "short term memory loss, panic attacks, rashes, fatigue, flu-like symptoms, arthralgias, myalgias, chronic depression, insomnia, headache, numbness, dizziness, and confusion." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an infectious disease specialist and received anti-inflammatory and other medications without relief of symptoms. On 15Sept04 the attorney alleged that the pt, now 43 years old, experienced arthralgia, myalgias, insomnia, numbness, dizziness, short term memory loss, and confusion. Time to onset, treatment, amd outcome were not reported. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: no further information. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, he experienced flu like symptoms and not feeling any better, he did not know what type of Covid test taken. He, stated vaccine did not work for him. On 06-NOV-2021, He was started feeling bad and sick on Saturday and not much better since. On 08-NOV-2021, he made coffee in morning and could not taste it. He stated his wife bought a couple of home test Covid kits she tested negative while he was positive, then he made appointment at pharmacy and got positive results. On same day, he experienced suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint: 90000201208.; Sender's Comments: V0: 20211119231-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
11/14/2019 I received a flu shot at Pharmacy in my right arm/shoulder. The pain of the needle going into my arm was much more painful than any other shot I have received. I noticed the band-aid was placed very high up on my shoulder. Immediately I had trouble moving my arm and by that evening symptoms had progressed to extreme pain and I needed assistance dressing. The pain continued to worsen the following days and I lost mobility of any upward or outward motions due to intense pain.   (continued on continuation page)