chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a  78 y.o. female with a history of HTN, DMII, anxiety and depression presenting with worsening shortness of breath over the past 1 week. Pt went to PCP on 9/13 and was ordered curb-side rapid COVID test, and was notified the following day that it was positive. Pt underwent Regeneron infusion on 9/15. When symptoms worsened pt came to ED for further evaluation and treatment.   Patient was admitted to the COVID-19 cool floor.  Patient was placed on AV APS for acute hypoxic respiratory failure.  It appears her mask was dislodged, oxygen saturations to dropped patient went into PEA cardiac arrest.  ROSC obtained patient was transferred to the ICU where she was coded again.  Once again, ROSC regained.  Patient was placed on an epinephrine followed by norepinephrine and vasopressin.  hydrocortisone followed by hydrocortisone every 8 hr.  Family was at bedside they were notified of patient's poor prognosis.  They asked patient remains a full code.   Once again patient coded, asystole.  ACLS protocols were started, family was updated in a asked patient"s status to DNR patient expired soon after. time of death240hr
I contracted COVID-19 on 06/20/2022 with symptoms of fever, congestion, loss of smell, loss of taste, fatigue, chest pain, chest tightness, chills, and sore throat. I was prescribed prednisone, benzonatate, and received an IV infusion of bamlanivimab on 06/25/2022 at home. I was ill for 10 to 12 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
Red, swollen, itching. Tx: Keflex po 250mg cap, CQ F/O #40 Benadryl - po 14 mg 1 cap, po every 4-6 hour prn.
Asthenia; Nausea; Vomiting; A spontaneous report was received from a Pharmaceutical Company concerning a 90 Years-old male patient who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced nausea, vomiting, generalized weakness with a fatal outcome.  The patient's medical history is aortic aneurysm, aortic stenosis, coronary artery disease, hypertension, cardiac heart failure,  atrial fibrillation, HLD, ischemic heart failure, pacemaker, ventricular fibrillation, peripheral vascular shunt, palpitations, hypotension, and small bowel obstruction. No concomitant medications were provided.  On 06 FEB 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.  On 11 FEB 2021, the patient experienced the events, nausea, vomiting, generalized weakness. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 12 FEB  2021. The cause of death was unknown.  Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
pt did not learn to say by-by, dada & mama until age 4;neurologist dx pt as having expressive language delay;pt has been in speech school training since age 3;pt shows sign of autism;
immediate pain, achiness everywhere, severe joint pain, change in voice, pleurisy, distant heart sounds, tachycardia, fever requiring multiple outpatient rheumatology and primary care visits, essentially necessitating hospitalization. Work up shows new + ANA, low complements, + histone,  consistent with drug-induced lupus
Patient, female , brought into pharmacy to receive Fluzone Quad, one immunization, cosigned by Mom and was given immunization by myself.    Used appropriate needle and vaccine,  and patient seemed fine for a minute, was walking out of booth toward mom and her sister.   Mom said " do you want a new bandaid?"  and I offered to change the bandaid and when starting to put new on on skin , the patient passed out in the booth.   The mom immediately rushed to the patient (daughter) and held her head and brought her back by talking to her and moving her head.   A  fire fighter in line at the pharmacy rushed over also, and a nurse who knew the mom.   All three assisted the patient ,and within  a few minutes she had her color back and could respond in about five minutes.   Mom stayed on top of her daughter.   The mom said "she has low blood sugar, and never has seizures, and has had flu vaccines in the past , with no problems.   The EMR came to check her out, but mom took her home.
Skin rash; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 06Apr2021 at 15:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included type ii diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Apr2021, the patient experienced skin rash and itchy from 2 days after the shot for about 10 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event itchy and included treatment with unspecified anti-itchy skin medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events skin rash and itchy was resolved on 18Apr2021, after the duration of 10 days.  No follow-up attempts are needed. No further information is expected.
Vaccine was administered when patient was 16 years old (authorized for 18 and older). No known adverse events.
pt recvd vax & 24 hrs later exp an itch & rash on arm & neck; treatment DPH;
patient returned to pharmacy 30 minutes post immunization and reported itching and a faint rash. We gave her a dose of benadryl as per patient requested after reviewing injection site reactions. I followed up with her 5 hours post vaccination and she has not had any more itching or hives.
This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 28-SEP-2017 the patient was vaccinated with improperly stored doses of GARDASIL 9 from lot N017697 expiry date 21-JAN-2020 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1710USA000490: US-009507513-1711USA004679: US-009507513-1711USA004680: US-009507513-1711USA004676: US-009507513-1711USA004677.
19 year old female presented to vaccination site on 04/20/2021 for Booster vaccine; scribe noted patient had received Moderna (COVID-19 vaccine) initial dose on 4/23/2021 upon entering vaccine information for booster after inoculator had administered Pfizer BioNTech vaccine to Left Deltoid. Patient reports she did not have her vaccine card with her and did not recall which vaccine she had received as initial dose. Patient was evaluated by P.A. at site, and remained in observation to monitor for any adverse effects; none noted. Patient was provided with VAERS.org  website, and RN Supervisor contact information for any future concerns.
It was a little drop dripped out during administration of Moderna booster covid vaccine at 1:10 pm on 1/10/2022. Patient was concerned that he might not get the full dose. Per protocol, we gave patient another dose of 0.25 ml Moderna booster covid vaccine at 2:38 PM on 1/10/2022.
Severe reactions including hospitalization; This case was reported by a pharmacist via sales rep and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID 19 VACCINE.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given Shingrix a few weeks after Covid vaccine and had severe reactions including hospitalization. The reporter agrees to follow up from GlaxoSmithKline. This case has been linked to the case US2022AMR033535 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR033535:Same reporter. Patient 1 of 2.
swollen, sore arm. Hot and reddened within 24 hours with 3 inch diameter of redness.  Headache and lethargic for 28 hours.  Lethargy better after 68 hours, yet arm still painful, swollen and red.
Patient received both shots and then a few minutes later she fell backwards. A nurse in the waiting room felt she suffered 2 (5 minute) seizures. After she fell she was awake and coherent . An ambulance was called and transported her to emergency room.
Patient flushed, tachycardia, elevated BP, headache, nausea, vomiting, chest pain
temperature of 99.6; severe shivering; Muscle ache; Back ache; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix, the patient experienced fever, shivering, muscle pain, back pain and headache. On an unknown date, the outcome of the fever, shivering, muscle pain, back pain and headache were recovered/resolved.   It was unknown if the reporter considered the fever, shivering, muscle pain, back pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 69 years or 70 years. About 10 hours after vaccination, the patient experienced a temperature of 99.6 degree F and severe shivering, muscle and back aches, and headache which were lasting for about 6 to 8 hours. The patient wanted to know, how common was this reaction? The patient was wondering if 2nd dose would be the same. If so, she need to time the second dose for a time when she had nothing to attend to.      Lab Comments: On an unknown date, the patient's body temperature was recorded as 99.6 degree F.
Severe pain & stiffness about 3-4 hours after the vaccine, unable to raise arm away from body, pain from injection site up to middle of the right side of my neck, pain in neck muscle when swallowing. Next day, still painful and stiff, developed bright red welt looking spot on inside and outside of bicep that was tender and hot to the touch.
Patient had syncopal episode with left-sided headache and left-sided heaviness on 5/3/2021.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. No Medical History information was reported.On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided. PAT_MRN_ID: 01767194 The vials were frozen, sipped in refrigerated temperature and then refrozen for storage once arrive at facility. On 06-Oct-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.
Arm started to swell where she got the shot; Tingling in her fingertips; Swelling in her fingertips; Pain in her fingertips; Gets sick every time she eats; Arm started to hurt where she got the shot; Feels nauseated when she eats ,gets nauseous every time she eats; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started to swell where she got the shot), PARAESTHESIA (Tingling in her fingertips), PERIPHERAL SWELLING (Swelling in her fingertips), PAIN IN EXTREMITY (Pain in her fingertips) and ILLNESS (Gets sick every time she eats) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm started to swell where she got the shot), PARAESTHESIA (Tingling in her fingertips), PERIPHERAL SWELLING (Swelling in her fingertips), PAIN IN EXTREMITY (Pain in her fingertips), ILLNESS (Gets sick every time she eats), MYALGIA (Arm started to hurt where she got the shot) and NAUSEA (Feels nauseated when she eats ,gets nauseous every time she eats). At the time of the report, PERIPHERAL SWELLING (Arm started to swell where she got the shot), PARAESTHESIA (Tingling in her fingertips), PERIPHERAL SWELLING (Swelling in her fingertips), PAIN IN EXTREMITY (Pain in her fingertips), ILLNESS (Gets sick every time she eats), MYALGIA (Arm started to hurt where she got the shot) and NAUSEA (Feels nauseated when she eats ,gets nauseous every time she eats) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitants medications was reported.   No treatments medications was reported.  Patient 2nd dose is scheduled on 4Sep2021.She has been hesitant to get her 2nd dose. noted
swelling & redness, swelling started primarily in the deltoid region & has spread distally down past the elbow @ this time;arm has been erythematous w/mild itching;
Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurts. Legs especially hurt.
2nd covid booster with moderna for first time, I am a diabetic type 2,Blood sugar levels have doubled since receiving the moderna vaccine and not responding to increased insulin.
Fever 101.9, Chills, Headache, Redness at injection area.  Extreme Soreness at and around injection area.  Fever off and on for 3 days.  Treatment with Tylenol
Face (cheeks) got very hot and red and a rash appeared.  By  Evening it had subsided and by the next morning pretty much gone.
pt recv vax & devel mild rash on neck & back of arms;rash description rash from face to toes that is extremely erythematous and papillar in areas w/some lichenification & scaling;
a 12-months old patient was given Menactra on accident instead Pneumococcal vaccine, No AE; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 12-months-old male patient who was given dose of 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number- U6586BA, expiry date- 20-Apr-2020) via intramuscular route in the left thigh on accident instead PNEUMOCOCCAL VACCINE for prophylactic vaccination on 08-Oct-2020 (wrong product administered).   Medical history, medical treatments and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE, HIB VACCINE and INFLUENZA VACCINE for prophylactic vaccination.  This was a case of an actual medication error due to wrong vaccine administered (latency same day).  At the time of reporting, patient had no adverse event.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Trihibit given 05/10/04 in lateral portion of left thigh. Onset of inflammatory reaction (induration, redness, warmth about 3 inches in diameter) at 48 hours post vaccine.  Non-tender, walking normally. Appears to be in no pain.
heart palpitations; Initial information received on 28-Feb-2023 regarding an unsolicited valid  serious case received  via consumer/Non-Health Care Professional.  This case involves a 61 years old female patient who was diagnosed with heart palpitations after receiving vaccine influenza vaccine and while being treated with teriflunomide [Aubagio].   The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On unknown date in Nov-2021, the patient started taking teriflunomide at a dose of 14 mg once daily (QD) via  oral (strength, formulation, batch number, expiry date: unknown) for Multiple sclerosis.  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (strength, dose, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On 06-Feb-2023 the patient diagnosed with a serious heart palpitations (palpitations) (unknown latency) following the first dose intake of teriflunomide and (unknown latency) following the administration influenza vaccine the patient was hospitalized for this event. It is unknown if there were lab data/results available.  Action taken with aubagio was unknown. Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.   The patient was hospitalized for heart palpitations.; Sender's Comments: Sanofi Company Comment dated 03-Mar-2023: This case involves a 61 years old female patient who was diagnosed with heart palpitations after receiving vaccine influenza vaccine and while treated with teriflunomide [Aubagio]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any family history and any relevant medical history of patient, any concurrent conditions precludes comprehensive case assessment.
HYPOTENSION 4/26/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT  were called vitals were alright. Once we were home vomiting subsided and he  slept hard.
Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022; Patient received the vaccine on 15-Apr-2022 but it had got expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 15-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 15-Apr-2022 but it had got expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 15-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Pharmacist was calling to verify an expiration date for lot number 026L21B. The pharmacist said that he thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. Caller stated 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022. Date the vial was initially stored in refrigerator was on 04-Apr-2022. The vial did not undergo any temperature excursions. No treatment medications were provided.
Pt presents at clinic 5/4/2007 with redness and warmth to right upper arm outer aspect, and c/o pain and tenderness since evening of 5/2/2007.  Was assessed to be cellulitis by provider and treated with Keflex 500mg, one capsule by mouth three times per day for 10 days.
Subsequently post vax, the vaccinee experienced aches in muscles which lasted a few days and then resolved.
I Began to have heart Palpitations within 2 days of Injection. Within 1 week my Face Broke out in a Red Rash with Blisters and my eyes swelled almost shut. Heart Palpitations got worse and For the First time in my adult Life I have been Put on medication for my heart.
pt had vax & was noted to be moaning, eyes rolling back & posturing movements of upper extremities; pt was helped to floor w/o injury  & was unconscious 5-10 sec; vomited x 2;