chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age (gender unspecified). The healthcare worker reported the patient was vaccinated with GARDASIL INJ 120 Y on 13-JAN-2010, 30-JUN-2010, 20-JUL-2011, 30-JUL-2012 and 04-OCT-2012. No adverse symptoms reported. No information about patient's medical history, concomitant medication or drug allergy. Causality was not provided. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 10:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 27-Oct-2021 at 10:07 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 70.90 for dose administered on 27-Oct-2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 35 degrees Fahrenheit at 09 AM to 10 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 04-Nov-2021. Product moved to clinic on 27-Oct-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Patient accidentally was given a Moderna booster when they should have been given a Pediatric Pfizer.  No adverse signs and symptoms during observation.  Family is aware.  Doctor medical director of County Public Health notified.
other people were sick for a day or two after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (other people were sick for a day or two after the vaccine) in a patient of an unknown age and gender 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, the patient experienced ILLNESS (other people were sick for a day or two after the vaccine). At the time of the report, ILLNESS (other people were sick for a day or two after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.   This case was linked to MOD21-062316, MOD21-062432, MOD21-062450, MOD21-062662 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-062316:Same reporter, different patient MOD21-062432:Same reporter, different patient MOD21-062450:Same reporter, different patient MOD21-062662:Same reporter, different patient
I drank 16 ounces of water 1 hour prior to getting vaccinated. However, within 20 minutes of receiving the 1st. dose, my throat felt dry and there was a slight burning sensation at my throat. Also, th; I drank 16 ounces of water 1 hour prior to getting vaccinated. However, within 20 minutes of receiving the 1st. dose, my throat felt dry and there was a slight burning sensation at my throat. Also, th; the right side of my tongue and the back of my tongue near my throat became slightly swollen to where there's some discomfort; The right side of my tongue and the back of my tongue near my throat became slightly swollen to where there's some discomfort; This is a spontaneous report from a contactable consumer (Patient).   A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0178 and expiry date was not reported), via an unspecified route of administration into left arm on 01Jun2021 at 14:00 (at the age of 48-year-old) on left arm as Dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included: known allergies (Allergic to Aspirin through my teen years; mild gluten sensitivity), Asthma, and Allergies (Seasonal, Dust mites, Animal dander (horses, cats and some dogs)). The patient did not receive any other vaccines in four weeks of first dose. Concomitant medications within two weeks of first dose were Vitamins and OTC Pain medications. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was neither tested positive for covid prior vaccination nor post vaccination. The patient stated that she drank 16 ounces of water 1 hour prior to getting vaccinated. However, within 20 minutes of receiving the 1st dose on 01Jun2021 at 14:00, her throat felt dry and there was a slight burning sensation at her throat. Also, the right side of her tongue and the back of her tongue near throat became slightly swollen to where there's some discomfort, but she was only monitoring these effects since she can still breathe and function normally. The patient did not receive any treatment for reported adverse events. Outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 24-JUL-2014 the patient was vaccinated with ZOSTAVAX (also reported as ZOSTAVAX vial 19400 PFU) (lot # K000328, Exp date: 06-MAR-2015, strength, dose, frequency and route unspecified). In July 2014 the patient experienced injection site reaction. The patient sought medical attention via contacting pharmacist. The outcome of injection site reaction was unknown. This is one of several reports received from the same source. Additional information has been requested.
fever; she couldn't walk good; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201, expiry date: Jun2021), in left arm, shoulder area, on 09Mar2021 at 13:30 (at the age of 64-years-old) at single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS), cervical myelopathy, and arthritis that was bone on bone in her right hip. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Family medical history relevant to AEs was reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications included ongoing duloxetine hydrochloride (CYMBALTA), ongoing baclofen, ongoing calcium, ongoing multivitamins (vitamins NOS), ongoing tamsulosin hydrochloride (FLOMAX), ongoing ergocalciferol (VITAMIN D), vitamin D3, diclofenac sodium (VOLTAREN). No additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks). The patient reported fever post vaccination. She was told by a nurse to not take MOTRIN but TYLENOL 24 hours after receiving the vaccine. The patient got the vaccine on 09Mar2021 and was told she could not take her MOTRIN. She had multiple sclerosis, cervical myelopathy, and arthritis that was bone on bone in her right hip. She told not to take pain relievers for 24 hours after the shot as it would cause something to happen with the vaccine. Patient explained that when someone had all these different things, it was hard to be told that they could not take medications. After the vaccine, she could not walk good and had a fever. The fever and the other events started on 10Mar2021, about 3am. She could not walk well at 3am in the morning when she got up. When a person had multiple sclerosis, whenever anything happened it took out their legs. It was also noted that she had muscle aches after the shot on 10Mar2021 at 3 am, all of that too. This was getting better. The patient was told she could take TYLENOL and relayed she did take a couple TYLENOL for the fever. The events did not require a visit to emergency room or to physician office. Relevant tests were reported as no. No treatment was administered for muscle ache and walking difficulty. The patient was recovering from the events.
Within 7-10 days of receiving the Moderna COVID Booster, I began to feel itchy.  After a couple days of the itchy feeling, I began to notice red marks/rash associated with the itching.  Soon, I was red often and itchy--mainly in the groin, armpits, neck/face and torso.  Itchiness later found to be dermatographia.
pt recvd vax; devel redness, swelling, tenderness at inject site;lasted 2 days;
Nausea; Pt c/o nausea 15 mins after receiving vaccine. She denied chest pain, SOB, difficulty breathing, or other complaints. Past med hx as reported by patient is carotid artery disease. Pt assessed and evaluated by NP and paramedic. Pt had mild anxiety, BP - 157/80.
Patient, are we tracking adverse reaction to the Covid 19, vaccine.  Reason being, I developed flu-like system the day after receiving my first dose on 2/17/2021 and my lymph node under my left arm was swollen after the vaccine for 2 days and painful. In order to  rest properly, I had to  sleep with a pillow under left my arm.   The second  dose, was done on 3-1-21.  I developed flu-like symptoms, became lethargic, had to leave work, had an temperature of 103.2 on Tuesday night continued into Wed evening 3-2-21 . Thursday morning 3-4am,my LEFT ear was very painful, to the point I had to be seen at urgent care on Thursday. I was dx with strep and LEFT ear inf
No adverse event; booster dose in October 2021/ I'm immunocompromised, too; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (booster dose in October 2021/ I'm immunocompromised, too).    No concomitant medications were reported. Age of the patient, DOB and age group were mentioned as unknown. It was reported that on Sep-2022, patient received Moderna Bivalent booster dose also. No treatment medications were reported.
The claimant was given Hepatitis B #1 at 4:00. The claimant left the clinic at approx 4:20. She informed me the next day that after she was home for about 15 minutes she developed swelling on her face and neck as well as hives on her chest. She informed me that she took Benadryl and the hives went away, but the swelling stayed the same. The claimant denied any difficulty swallowing or breathing. I  instructed the claimant to go to an urgent care facility to be evaluated. She was prescribed Prednisone and Hydroxyzine HCL. The claimant did have difficulty swallowing on 1/18/20 and went to the emergency room where she was given IV Medrol and discharged.
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 an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of administration not provided). On an unknown date after receiving the ZOSTAVAX, the patient broke out in a painful rash on his right side, encompassing the right side of his head, face and scalp. Since his initial outbreak, the patient has suffered several additional attacks of shingles, as well as vision, hearing and balance issues. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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. The outcome of the events was considered to be not recovered. Causality assessment was related. Shingles, vision issues, hearing issues, and balance issues were considered to be disabled. Additional information has been requested.
VACCINE GIVEN NEXT DAY AFTER TEMPERATURE EXCURSION FROM 46.2-46.7F; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine given next day after temperature excursion from 46.2-46.7f. On MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine given next day after temperature excursion from 46.2-46.7f and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210530429.
irregular heartbeats; joints hurting real bad; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (a 20 year history of irregular heartbeats), Open heart surgery (7 to 8 years ago) and Cardiac ablation (7 to 8 years ago).   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Mar-2021, the patient experienced ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPRIN) for Joint pain, at an unspecified dose and frequency. On 08-Mar-2021, ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats) had resolved.            No Concomitant Medications were  provided by Reporter.   Reporter did not allow further contact
Vaccination site pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-073354, MOD-2021-073354 (Patient Link).   Reporter did not allow further contact
local reaction of redness, hardness & pain; no fever, no muscle aches; 14FEB92 f/u no addtl event info; only minimal pt info returned; no prev allergic reaction; in good hlth;
Patient's spouse called to report patient was having reactions to vaccine: vomiting, dizziness, headache, vertigo, she went to urgent care and was treated for vertigo. She was pale due to vomiting.
Initially my right eye and tongue swelled.  Fortunately, I did not go into full anaphylaxis.  At 10:00 that night I had incredibly severe chest pain.  This insane chest pain persisted for 32 hours.  My heart still does not feel "normal" or "precovid vaccine".  Along with the chest pain, around 1:00 a.m. I began shaking uncontrollably and could not get warm.  The shaking and cold persisted for 12 hours.
About 15-20 minutes after receiving vaccine, pt. began to feel nauseous, nearly passed out and had unusual swallowing sensation. Parents reports she turned pale or blue.. EMS was called and advised administration of epinephrine which parents did. Family subsequently took pt. to ED where she was given benadryl, famotidine, and decadron. She was discharged home after being observed several hours. She was diagnosed with anaphylaxis.
13 hrs after shot: woke up with fever 101, migraine, sore face, sore throat, upper extremety myalgias. Sx lasted 20hrs, treated with nyquil severe (acetaminophen) every 6 hrs + ice pack  Residual sore throat, temps in 99F following day
This spontaneous report was received from a health care professional and refers to a currently 91 year old patient of unknown gender. No information regarding patient's medical history, current conditions and drug reactions or allergies were provided. On an unspecified date in 2013, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, dose number, administration route, lot number and expiration date were not provided) for prophylaxis. And in this occasion the patient experienced some allergy signs such as pain on the injection site, and itching. (Hypersensitivity), (pruritus) and (injection site pain). The outcome of the events was unknown and the events were considered to be related to PNEUMOVAX 23. Sender's Comments: US-PFIZERINC-US19012730.
Pt's wife wanted it reported on VAERS that pt experienced decrease appetite, malaise, chills, low-grade fever four days after receiving his vaccine. He also had a quarter-sized welt at the injection site. I informed her that those were not uncommon reaction, but she wanted it reported none the less.
Screaming, extreme crying, entire body stiffening for over 3 hours. Didn't appear to be seizure-like, but body was very stiff and would not relax. Gave Tylenol to try and ease pain if there was any. Did not help. Would not nurse or be comforted in any way.
feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get up from bed; Fever (101°F); Atrial fibrillation; Pericarditis; A spontaneous report was received from a non-healthcare professional concerning a 67-year-old, female patient who developed a fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation.    The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Pentasa, metformin, insulin, Zoloft and atorvastatin.  The patient received their first of two planned doses of mRNA-1273 (lot number 028L20A) on 20 Jan 2021 in the right arm for prophylaxis of COVID-19 infection.  The patient developed a fever on 25 Jan 2021, and it got up to 101 degrees Fahrenheit on 26 Jan 2021.  On 26 Jan 2021 she felt must worse, couldn't take food, and couldn't get up from bed. On 27 Jan 2021, she was taken to the emergency room where her oxygen saturation was low, but the fever was gone.  She was placed on oxygen, and blood work had elevated troponin. The patient was diagnosed with pericarditis and she was kept overnight. On 28 Jan 2021 she had atrial fibrillation and the medical team couldn't convert her chemically.  She was stabilized on 30 Jan 2021 and she was feeling much better.   Treatments of these events included oxygen and ibuprofen.    The events, fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation were considered Recovering.; Reporter's Comments: This case concerns a 67 year old female who experienced serious unexpected events of feeling abnormal, decreased appetite, bedridden, elevated troponin, pericarditis, and atrial fibrillation, and a serious expected event of fever. The events began 6 days after first dose of mRNA-1273. Treatment with ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Case number PHEH2012US009446 is an initial spontaneous report received from a pharmacist on 03 May 2012. This report refers to a 17-years-old female patient. Her medical history, past drugs, current conditions and concomitant medications was unspecified. She received only the MenCWY-135 liquid component of MENVEO (batch number: 090701) intramuscularly on to unspecified site without reconstituting the Men A lyophilized conjugate vaccine component on 07 Jan 2012. No adverse event was reported following this drug administration error.
My armpit is swollen(right side), and there is a lump on my neck (right side)