chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID vaccinated patient who admitted through ED testing positive for COVID.  Patient died of COVID complications on 12/08/202.  Provider discharge note below:  "70 YO male patient with a past medical history of chronic kidney disease, hypertension, coronary artery disease, COPD on 2.5 L who presented to the ED 12/5/21 for evaluation of diarrhea with recent COVID exposure. He was hypotensive with CXR showing cardiomegaly with bilateral pulmonary edema. Labs significant for Cr 10.8, EGFR 4, K 6.0, CO2 12, AG 27, AST 289, ALT 122, lactate 4.6-- >1.2, procalcitonin 2.32. Found to be COVID positive. Nephrology consulted and he was started on emergent dialysis. He was admitted for further management of acute renal failure superimposed on stage 4 chronic kidney disease and acute respiratory insufficiency in the setting of HAGMA and COVID 19.   He had significant metabolic acidosis and was placed on bicarbonate therapy.  CT chest showed pulmonary emboli and he was started on heparin drip. He developed worsening respiratory status despite bipap therapy. In discussion with CCU, family elected transition to comfort care with hospice support.    He was admitted to hospice 12/7 and started on continuous fentanyl drip for dyspnea. He passed at 0427 on 12/8. "
Had moderna booster following J&J vaccine back in March. Starting 7 hours after booster developed pain/tenderness in lymph nodes under arm on left side (same side as shot). By 12-15 hours there has been big swelling in this area. Pain and swelling still present 44 hours after injection.
Developed 101° temperature approximately 10 hours after vaccination, which lasted approximately 12 hours. Temperature went down to 100° and lasted approximately 12 more hours. Temperature went down to 99° and lasted approximately 6 more hours before returning to normal. Also, red and swollen at injection sight.
Jansen COVID-19 Vaccine EUA A coworker mentioned his wife had received the dose and had some chills the next day.
ON 12-31-22 CLIENT WOKE AT 5:15 AM, PLANNING TO TRAVEL.  HE HAD GOTTEN DRESSED AND MADE BREAKFAST AND TOOK AM MEDS.  STATED" ALL AT ONCE RIGHT ARM WENT NUMB, THEN RIGHT LEG FELT LIKE IT HAD A 10 POUND WEIGHT ON IT AND IT WENT NUMB.  TOLD HIS WIFE, SHE THEN DROVE HIM TO HOSPITAL.  WHEN ARRIVED AT ER, BLOOD PRESSURE WAS 200+/100+ (DID NOT KNOW VALUES) A CT-SCAN WAS COMPLETED AND LAB WORK. THEN WAS TRANSFERRED TO ALTERNATE HOSPITAL ER VIA GROUND AMBULANCE. HAD ANOTHER CT-SCAN WITH LABS.  WAS ADMITTED AND RELEASED ON JANUARY 2, 2023.  HE WAS TOLD THAT SOME PLAQUE HAD BROKEN LOOSE AND CAUSED A STROKE.  STATED HAD A COUSIN THAT ALSO HAD A STROKE AFTER RECEIVING HER BIVALENT BOOSTER.
Headache, Myalgia, After 1st dose arm sore x 2 days, HA first day. After 2nd dose - sore & red arn that decreased over 5 days, HA mornings of day 4 & 5. Narrative:
no adverse event; Improperly stored vaccine was administered to patients; This spontaneous report was received from an other health care professional referring to 13-month-old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 23-FEB-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) (intramuscularly in right thigh, lot #W006412, expiration date 23-FEB-2024, exact dose and dose number were not provided) for prophylaxis.  On 20-JAN-2023, the suspect vaccine experienced a temperature excursion from -14 to -10 degrees Celsius for 1 hour (product storage error). There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). It was indicated that medication error could occur during storage in clinical practice. Adverse event had been reported previously to manufacturer. The patient was vaccinated at private doctor's office/hospital. Temperature excursion occurred as a result of a reading from a Data Logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007723: US-009507513-2304USA007731: US-009507513-2304USA007733: US-009507513-2304USA007842:
include cough, sore throat, congestion, runny nose. starting on 10/19/21
administered vaccine that was in the fridge for longer than what manufa. recommended. Called pfizer and they said revaccinate patient.
Booster dose 19Aug2021; Booster dose 19Aug2021; This is a spontaneous report received from contactable reporter(s) (Physician) for a Pfizer sponsored program (004756). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 08:00 (Lot number: EW0196) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 02, Lot: EK4176 Expiry: Unknown), administration date: 04Jan2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose 01), administration date: Dec2020, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 19Aug2021 08:00, outcome "unknown" and all described as "Booster dose 19Aug2021".  Follow-up attempts are completed. No further information is expected.
Pyrexic episodes with systemic effects requiring hospitalization 48-72 hours post immunizations at 2 months and 4 months. 2/15/07 Received medical records from hospital which reveal patient experienced fever for 2-3 days prior to admit & admitted 1/10-1/12/07.  Patient experienced similar episode 11/06 when hospitalized for antibiotics s/p vax.  Attends daycare & several children at daycare were ill at time of this admit.  Exam revealed mild resp distress w/vitals WNL.  Had nasal congestion w/mucopurulent drainage.  Lungs w/scattered wheezes.  Tx w/nebs, steroids & IV antibiotics.  Improved & d/c to home on 1/12 to continue oral antibiotics, steroids & nebs. FINAL DX: Pneumonitis.
VAQTA was administered early, at 6 months of age. Mom was notified of invalid dose being administered and denied client having any signs or symptoms of concern.
Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for another 24 hours. Joint pain, headache and low grade fever for 48 hours.
therapy non-responder; Inappropriate schedule of vaccine; Inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose and Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced therapy non-responder, circumstance or information capable of leading to medication error and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the therapy non-responder, circumstance or information capable of leading to medication error and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient had negative titer results for nursing school after Engerix B (unspecified number of doses) and due to which she had orders for an accelerated dosing schedule for Engerix-B, which led to circumstance or information capable of leading to medication error and inappropriate schedule of vaccine administered. No additional information provided. The reporter consented to follow up.      Lab Comments: On an unknown date, the serology test was performed
left arm was hurting, where I got the shot; body aches; headaches; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headaches), MYALGIA (muscle pain) and VACCINATION SITE PAIN (left arm was hurting, where I got the shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (body aches), HEADACHE (headaches) and MYALGIA (muscle pain). On 17-Aug-2021, the patient experienced VACCINATION SITE PAIN (left arm was hurting, where I got the shot). At the time of the report, PAIN (body aches), HEADACHE (headaches), MYALGIA (muscle pain) and VACCINATION SITE PAIN (left arm was hurting, where I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  On 16-Aug-2021, the symptoms started a little, but it started again on 17-Aug-2021 after work.  No treatment information was provided by the reporter.
vaccine was administered to 2 patients from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 2 patients from an expired vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 2 patients from an expired vial). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 2 patients from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient received booster dose from an expired vial. No side effects were reported.  This is a case of Expired Product Administered concerning a female patient of unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a female patient of unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.
Moderna COVID-19 Vaccine EUA Swelling and redness at injection site, 8 days after first injection.
Elevated temperatures 99.8 every day since injection.  Extreme body aches and exhaustion.   I am only able to walk very slow because of the body pain. I have not been able to leave my house due to the excutating pain.  Extreme headaches,  level 7.  I do suffer from migraines,  my migraines are by my right occipital nerve.  The headaches I am currently having are an all over brain ache, pulsating pain. Advil and tylenol are providing no relief.   The CDC page said side effects only last a day or 2, I am now on day 5 of side effects and I am not seeing any relief.
needle hit her arm it was painful;; arm has become itchy; arm has become red; arm has become hot; she was very upset about a reaction that occurred while she was on the product.; Initial information received on 18-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer.  This case is linked to case 2022SA480609(CLUSTER).  This case involves a 71 years old female patient who experienced pain in arm during injecting  vaccine,arm has become itchy, arm has become red, arm has become hot and she was  upset about a reaction that occurred while she was on the product. after receiving  influenza quadrivalent recombinant vaccine [flublok].  The patient's past vaccination(s) included fluzone high-dose quadrivalent for immunization.  patient had history of Cancer (NOS).  The patient's past medical treatment and family history were not provided.  On 15-Nov-2022, the patient received a dose of 0.5 ml(milligram) influenza quadrivalent recombinant vaccine (with unknown formulation, strength, route, lot number and expiration) in the armNOS. for immunization.  On 15-Nov-2022 the patient developed needle hit her arm it was painful;(injection site pain)arm has become itchy (pruritus)  arm has become red (erythema)arm has become hot (feeling hot)she was very upset about a reaction that occurred while she was on the product(depressed mood) following (latency: same day)the administration of influenza quadrivalent recombinant vaccine.  It was also reported that she known that she would have a reaction like this to the product she would have continued using the Fluzone HD QIV and dealt with the arm swelling. She is frustrated and concerned as well about potentially not receiving enough antigen content. She states she read online from the CDC that the flu products all provide the same coverage, but feels she was misled. Apparently there was a remark from a 2020 article that the FLUZONE HD has four time she antigen of the FLUBLOK and FLUAD, and she doesn't understand why that was written. Because of this publication she feels like she was misled to receiving the wrong product due to the difference in antigen content and believes she may have to be revaccinated. Agent went over multiple vaccines per season standard as well as the antigen strain per dose for all three Sanofi flu products.  No lab data were reported.  Action taken: not applicable.  The patient was treated with paracetamol,  diclofenac and diphenhydramine hydrochloride for all treatments.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events; Sender's Comments:  01372459:
Pt recvd vax 15MAY91 & the following day exp arthralgia, myalgia, pharyngitis, & nausea for approx 16 hrs; @ time of report pt had recovered;
1240pm: Mother called nurse to the car. Pt was crying and feeling shaky. BP 92/58 HR 62 RR18 sats 99% T 98.4 Denies pain and SOB  Emt called to the car, patient evaluate. Pt calmer and denies shakiness after 10 mins. Parent refuses emt to transfer to the hospital.
Difficulty and painful breathing developed 24 hours after injection of 2nd dose; This is a spontaneous report from a non-contactable Other-HCP (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot unknown: True, lot unknown reason: Unable to locate or read the details), dose 2 via an unspecified route of administration, administered in Arm Left on 21Feb2021 15:00 PM (at the age of 35-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced difficulty and painful breathing developed 24 hours after injection of 2nd dose (non-serious) on 22Feb2021 16:00 PM. Adverse event: Difficulty and painful breathing developed 24 hours after injection of 2nd dose. Treatment was received for the adverse event was unknown. If COVID prior vaccination was unknown. If COVID tested post vaccination was provided as no. The outcome of event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient complained of irritation in her throat, slight sinus congestion, light headedness within 5 minutes of vaccine administration. No severe reaction occurred during the observation period. Patient reported all her adverse events was resolved before leaving the pharmacy. Patient was given a Benadryl 50mg to take in case allergic reaction comes back.
woozy feeling followed by 102+ fever, chills, muscle and bone aches, dizzy, headaches, chest pain/tightness, stomach aches, low appetite, weight loss, fatigue, low energy, nausea, hives & itches. Not fit to operate machinery for 4 days post injection. Car sick as passenger. Could not even after 5 days complete a day of work (12hrs). Was banned from work until I documented I see a clinic. Phone appointment secured a lab referral, and the directive to eat 3x day, rest when tired, hydrate. I felt I have lost a week in a blurr of pain and discomfort, fatigue and sleep. Second week was so weak and tired, showering was a challenge.
10/04/21 @ approximately 10:32 am two minutes or so after injection I started to feel like I was going to faint and I began to get sweaty on my forehead and chest. The pharmacist took my BP at 86/58 after 15 minutes my BP elevated to 93/65. 10/04/21 in pm I began to feel a headache and pressure in my Left ear. 10/05/21 developed soreness in Left arm at injection site approximately 5/10 level of discomfort. 10/06/21 developed pain and discomfort in my Left lateral lower abdominal area and Left lower back area. I developed constipation  10/07/21 symptoms resolved except Left abdominal wall pain
Administered TdaP, MCV-4, and H1N1 in RD.  IPV and varicella administered in LD.  Ten minutes after administration, pt developed a raised wheal-like area at the site of the IPV injection.  He was given oral Benadryl 25 mg and observed for 20 minutes.  There was no further reaction observed at that time.  The pt left with instructions to continue Benadryl q 4-6 hrs throughout the night and next day given by Dr.  Mother contacted by phone the next day, she stated that pt was doing better, the wheal was gone and there was only some redness at the site.  Pt had no pruritis or other reaction.
Pt received 4th dose DT and experienced a fever of 104, grand mal seizure lasting 20 minutes, taken to ER treated w/Valium. Following day given Amoxicillin for possible viral syndrome.  Child has hx of febrile seizure at 17 months of age.
Given a dose of the vaccine that had been left out of the refrigerator overnight; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given a dose of the vaccine that had been left out of the refrigerator overnight) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given a dose of the vaccine that had been left out of the refrigerator overnight). On 20-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Given a dose of the vaccine that had been left out of the refrigerator overnight) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided. The vial was initially stored in the refrigerator on 12DEC2021. The Date and time vial was first punctured at 10:20 AM on 19DEC2021. This patient stated that he had experienced no known symptoms.
Patient experienced redness(some rash) and itching around the injection site which is still there 4 days later but not getting any worse.
SHE WAS FEELING  DIZZY, LIGHT HEADEDNESS, CHEST FEELING TIGHT, SWEATING, NUMB FACE. LASTED ABOUT 5-10 MINUTES, THEN SHE WAS OK
medication was out-dated 9/8 and was administered on 9/16 - no adverse events reported 9/20, patient was offered to be re-vaccinated
Seizure with fever to 102. C. Counted < 5 min, generalized seizures.
Myalgia, Arthralgia, Fever, CoughWheeze, ErythemaMultiform, NauseaVomiting, extreme fatigue and weakness Narrative:
On 10/14/15 noticed itching at inj. site - saw red raised rash approx 2" x 3" at site. Over next 4 day increased to 3" x 4.5" was painful to pressure with pruritus. Then began to fade. Is still pink 10/21/15 - itchy 1" x 1" - fading. During inj. initially felt a lot of stinging - lasted 2 hr after.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Gastric reflux" (unspecified if ongoing). There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever started 1/2 after receiving vaccines 105 at 600pm despite Tylenol. 104.2 When seen office Motrin 50mg given 800pm and wet towel with fan. Temp 103.5
The Clinical Assistant, who prepared and administered the vaccination, did not reconstitute the medication by adding diluent prior to drawing it up into the syringe.  Volume in the syringe was correct, but dose was incorrect due to not being diluted.
Approximately 15 mins after administration of Tdap patient placed on  monitor for NST. Within minutes of reclining on NST chair pt became unresponsive after stating that she did not feel well, pulse noted to 140. Tonic movements of arms noted.  Oxygen mask, Pulse oximeter 100%, smelling salt given.  FHR initially 140 with accels to 160 then down to 90 - 100 X 2 mins during episode. EMS called. Episode lasted total @ 10 mins. Pt noted that she felt Chest pain and difficulty breathing immediately prior to episode and some residual chest after syncopal episode. BP 111/71   P 80    Prior to being transported by EMS to ED.