chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The client was vaccinated on 7/28/2022 with an expired Moderna vaccine. The vaccine was thawed and accidentally used 1 day following the marked B.U.D. date of 7/27/2022.  Pt tolerated vaccination well on 7/27/2022. The vaccine administration error was not realized until after vaccination clinic ended and RN returned thawed/non-punctured Moderna vaccine to Pharmacy. Safety event completed in Pharmacy, team leadership aware. Additional safety checks and protocols put into place to mitigate future risk of administration errors in both the Pharmacy as well as on our Mobile vaccination team.
Could not sleep; Dry throat; Cough; Arm pain like never experience in life, could not lean on it/the pain was so exurban; Chills; Fever; Extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban) and CHILLS (Chills) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had any allergies to medications, food and other products. The patient did not had any medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. The patient did not had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in January 2022. Concomitant products included TRAMADOL for Pain.    On 20-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Extreme fatigue). In July 2022, INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Extreme fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive - Yes.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was reported that the pain was so exurban it was like patient was having covid all over again. The patient was angry and thinking of suing because patient lost 5 day of quality of life that patient would never get back. The patient would never get vaccinated. The patient went to hospital for observation. The patient did not experienced a similar event in the past. It was reported that the symptoms were stabilizing. No treatment information was reported.
Within 3 hours the patient began feeling feverish and was shaking. For the following 48 hours the patient felt unwell and didn't go out. Her arm had a 4 inch diameter rash and was swollen. This was still visible 72 hours later. She reported aching joints, no appetite and a severe headache for the first 48 hours.
Information has been received from a registered nurse concerning a 15 month old patient who on 02/28/2005 was vaccinated subcutaneously in the left arm with a 0.5ml dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 02/28/2005, immediately after vaccination, the patient broke out in hives at the injection site.  The patient was treated with oral diphenhydramine hydrochloride.  Subsequently, on an unspecified date, the patient recovered from hives at the injection site.  The nurse requested lot number check.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the research center and was released.  There was no product quality complaint involved.  Additional information has been requested.
Headache, fever, SOB, chills, dizziness.  Took Tylenol for Headache and fever.  Time off work for 2 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 13:30 as dose 1, single (Lot number: EN6208), on 07Apr2021 at 13:30 as dose 2, single (Lot number: EW0151), in left arm and on 07Oct2021 at 15:15 as dose 3 (booster), single (Lot number: EW0187) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Sleep apnea (treated with CPAP)" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing); "IB" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 30May2022; TRUVADA; MIRTAZAPINE; ALVESCO; CETRIZINE; FLUTICASONE, start date: 31May2022. Past drug history included: Metformin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical significance: Patient received PF-07321332, ritonavir (PAXLOVID), from 31May2022 to 04Jun2022 for covid-19 treatment.  No follow-up attempts are possible. No further information is expected.
nosebleed; noticed a spot on her arm, not quite a rash, but like a circle; This is a spontaneous report from a Pfizer sponsored program. A contactable 31-years-old female other HCP reported for herself.  A 31-years-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 19May 28May2021 at 14:13:37  as a 2nd dose single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on unknown date as a 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient (yesterday as reported) started experiencing nose bleeds and noticed a spot on her arm, not quite a rash, but like a circle.  She asked if, nose bleeds been reported.  and What should she do about it. Patient stated she had been having it since yesterday and today (dates unspecified). She was sent home from work and is going to an Urgent Care clinic. The outcome of the events were unknown.  Information on the lot/ batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
EMS called to pt's house after he experienced SOB and stated he felt like he was going to fall (per pt's family); cardio-pulmonary arrest; pt still asystole when brought to ED; pt died in the ED; pt had a positive COVID test earlier in the month, on 9/1/21
Developed fairly severe left arm pain from injection site persisting. Dr apt 12/17/15 for severe pain L shoulder/bursitis started on Prednisone dose pack.
Graves' disease; lymphedema; she had a breakthrough covid case in September 2021; she had a breakthrough covid case in September 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Sep2021, outcome "unknown", COVID-19 (medically significant) with onset Sep2021, outcome "recovered" and all described as "she had a breakthrough covid case in September 2021"; BASEDOW'S DISEASE (hospitalization, medically significant) with onset Sep2021, outcome "unknown", described as "Graves' disease"; LYMPHOEDEMA (hospitalization) with onset Sep2021, outcome "unknown", described as "lymphedema". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) positive. Additional information: Not sure which vaccine she had. Most of this information was gleaned from Prevention magazine. Will put 27Nov as awareness date since that is when first learned of hospitalization, though most other details learned 28Nov.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Symptoms arose night of 4/1/21, including rapid onset heart palpitations, headaches, muscle spasms, insomnia, GI symptoms (food intolerances, previously none existed), numbness/tingling in extremities. All symptoms have persisted over the past 6 months.   First went to see GP  who had no idea what could be going on, sent me to endocrinologist checked for thyroid/sex hormone levels which were normal. Had 5 additional panels ordered by separate neuro-endocrinologist/GP/endocrinologist turn up nothing.  Returned   for medical treatment and saw GP  who suspected the vaccine/relation to COVID. Ordered ECG and echocardiogram both of which turned up normal. Multiple panels of blood work performed, only panel from 07/02/21 indicated slightly elevated TPO antibodies (48 IU/mL) and ANA (1:80), along with showing reactivated EBV (EBV IGG VCA >750 U/mL, EBV Early AG 61.4 U/mL, EBV Nuclear AG IGG 264 U/mL).  Symptoms persisted, was prescribed SSRI lexapro, but discontinued after 2 weeks due to worsening of symptoms. In late August went to urgent care twice and emergency room for pain in the chest, back, heart palpitations, radiating pain down arms and chin. ECG was performed twice which was normal, with additional blood work at urgent care. Referred to another endocrinologist which performed blood work on thyroid, sex hormones, thyroid antibodies, and 24 hr urine sample. TPO levels increased to 398 U/mL. Went to see gastroenterologist for GI symptoms, along with ENT for a symptom which arose over time, difficulty swallowing.  Overall seeing more than 13 health providers have provided no answers, and therapies have proved ineffectual. The only improvements have been observed with the passing of 6 months. During this time I have been unable to continue working and have had to stay home entirely.  In all I have the following available upon request: - 11 panels of blood work (ordered by GPs, endocrinologists, rheumatologists) - 24 hour urine test - CT scan of abdomen - Echocardiogram/ECG
Anaphylaxis 2 hours after vaccine. Extreme swelling/tightening of throat, difficulty breathing, talking, dizziness and feeling faint, spots in vision, choking, coughing,  chest tightness.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 24-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA000180:
RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE ON 02/26/21. WENT TO ER ON 02/27/21  COMPLAINING OF HEMATEMESIS AND BLOCK COLORED STOOL. ANTICOAGULATED ON ASPIRIN AND PLAVIX. DIAGNOSED WITH UPPER GI BLEED AND ADMITTED TO HOSPITAL ON 02/27/21.
patient was nausous, severe fatigue to the point she couldn't stay awake and had vertigo
Right after the shot I felt short of breath and light headed. I went home and took ibuprofen and used the Breo inhaler. I felt that way the rest of the night and it continued on for the next few days. I continued taking my normal medicines and on day three I felt 90% okay.
Very sore arm, headaches, flu like symptoms throughout body. Fever, sore muscles throughout.
Admitted 3/18 - 3/21/14 for Rotavirus (+) gastroenteritis. Symptoms began on 3/15/14.
Vaccines given 5/6/03. On 5/7/03, patient presented to office with complaints of temp 101.4, yellow vomiting and lethargy (per great grandmother). On exam, the patient was lethargic, pale, skin cool, diaphoretic. BP 88/48, Pulse 210. The patient had a very brief apneic episode but aroused with stimulation. IV access in office with LR initiated in office. Patient transferred via EMS to medical center. Discharge summary states lethergy. msv
Fever of 103, chills, cough, lower lobe pneumonia on erythromycin;
pt stated minor   redness/ hives reaction  and puffy eyes  when she got home but subsided with benadryl .  woke up at 130 am on 4/8  with fever of 104 f .   fever broke and  pt sweated profusely-- had headache and run down feeling  most of  4/8.  fever is down but still feeling tired
PATIENT WAS GIVEN AN ADULT DOSE OF PFIZER INSTEAD OF PEDIATRIC DOSE FOR THE 2ND DOSE IN SERIES.
Sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got vaccinated with Shingles vaccine 3 years ago and experienced sore. After the 2nd dose the patient was ok, hardly any side effects. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104223:same reporter
PT PASSED OUT. HAD HX OF PASSING OUT AT SCHOOL WHILE IN CLASS. PARAMEDIC CAME, HYDRATION OFFERED. SX RESOLVED, NO TRANSPORT.
May have gotten a dose 2 hours and 5 minutes outside of the 6 hour limit of use of an open Moderna vial of vaccine.
started w/achy joints, swollen gland especially behind lt ear;rash started on face down neck, chest, arms-fever, sore throat;rash spread, itchy, eyes swollen;saw MD;
Pt c/o chest tightness in middle are of chest Pt assessed: VS: 150/80 98HR 94% Rested for 10 min.  After 10 min, VS: 142/80 O2Sat 95%, Denies chest tightness, pressure, heart palpitations.
Patient suffered loss of vision in his right eye on 4/15/21.  Evaluation by neurology and ophthalmology consultants have diagnosed him with nonarteritic ischemic optic neuropathy
Initial report from the health care professional received on 01 Dec 2009: This patient had received FLUVIRIN on 29 Nov 2009. The batch number was 102042P1A. On the morning of 01 Dec 2009, the patient had dizziness, chills and shortness of breath. At the time of the report, the events were ongoing. No further information received at the time of the report.
This spontaneous report as received from a pharmacist via a company representative refers to a 76 year old patient of unknown gender. No concurrent conditions or medical history were provided. Patient was chicken pox naive (was never sick with chicken pox). On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) injection (dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. Eight weeks later (date unspecified), the patient received a second injection of VARIVAX (Merck). No adverse effects were noted. Additional information has been requested.
Really bad sore arm. Can't move arm all the way up without pain. Rash under the infection it is size of a baseball. Rash burns hurts an itching. It has been like this over 2 weeks now
Started having symptoms last week. I had really bad chills and was real tight in the chest; it proceeded to develop stuffiness and cough. I probably had a fever when I had the chills. I had body aches. I went in for a COVID test on October 28th positive result. No treatment yet. This afternoon I'm having a doctor's call and I've been offered to get the antibody treatment because my cough has been staying on. I had a flu shot on October 14th, 2021; injection in one of my arms. I had that at pharmacy.
lymph nodes on neck/collar bone swollen, tender and sore to touch.  Currently still swollen and tender
This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender. No concurrent conditions or medical history were provided. On 04-FEB-2016, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml injection, lot # K005415, 1 ml, intramuscularly (site of administration was unspecified), that had expired on 15-JAN-2016. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as there was no consent for further follow-up.
07/15/2014  Fever 101.8.  Tremors (twitches, tighten up, shake head) 07/19/2014 lacy, pinkish/red rash.
I had jaw pain, chest pressure, and left arm pain one evening. I had been heart pain as well so I called 911 and was taken to the hospital. There, I was put under several exams including cardiac enzyme testing, EKG, echocardiogram, and heart catheterization and was informed I suffered from spontaneous coronary heart dissection, or a heart attack. I spent two nights in coronary care unit. I was given heparin and aspirin as well as PLAVIX. I was prescribed CRESTOR during discharge until my follow-up appointment with my cardiologist. Currently, I'm doing better until my next appointment for better accuracy of diagnosis.
Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
On 3/13/01, pt given Tetanus Toxoid at another facility after scratching leg. Next day, she complained of flu-like symptoms, aches, body stiffness, fever of 102F. On 3/15/00, went back to original facility and was given Benadryl, Toradol and cortisone. Symptoms continued including pain, seizure, difficulty moving, SOB and swollen lips, tongue and face. Presented to our hospital complaining of above symptoms. Pt now claims she had the same reaction 7 years ago. Not given at out facility.  Diagnosed with allergic reaction, myopathy, rhabdomyalsis
Pins and Needles feeling down right arm and then numbness of hand. This  began immediately after injection and lasted for 24 hours. Could not use right hand to write it type.
Memory loss x4 days.  "Foggy" thinking for several days after that.  Extreme pruritis on body but long lasting on bilateral lower extremities.  Continues today.  Legs are scarred from scratching.  Itch feels "deep."  Have tried anti-itch sprays, benadryl, eczema lotions, oatmeal baths.  Limited success.
Body aches, headache, chills, shortness of breath, heart palpitations. Shortness of breath exacerbated by hot running water while washing dishes to the point I was unable to speak and had to take breaks to catch my breath. Heart palpitations were also significantly increased from hot water.
Patient received a influenza shot 10/18/04, Fluzone U1427AA, .05ml, IM. Patient nausea, low grade fever and chills and seen 10/25/04. She had sudden death 10/27/04. Medical Record received on 11/22/2004 states pt experienced viral syndrome, Baker's Cyst, and calf pain.
COVID- 19 Vaccine Patient used own Epi-pen after vaccine due to sensation of throat tightness and shortness of breath. Symptoms had resolved completely prior to presenting to emergency department. Patient treated with diphenhydramine 50 mg oral, dexamethasone 6 mg oral, and famotidine 40 mg oral. Discharged home with complete resolution of symptoms after two hours of observation.
received 3 quarters of 1 ml dose of Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B adult) (batch number 53967F, expiry date 6th December 2021) for prophylaxis.   On 23rd November 2021, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: The patient received 3 quarters of 1 ml dose of Engerix , which led to underdose. The pharmacist wanted to know is dose sufficient  does or the dose need to be repeated. The reporter consented to follow up.
Rash across my stomach that was very itchy; Stomach was bloated; Stomach was painful; Fatigue; Chills; Severe headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 31-Dec-2020, the patient experienced RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Severe headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   At the time of the report, RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Severe headache) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Fever of 103 x 4 days with continued elevated temp of 100 degrees x 6 weeks.  After initial 4 days of fever, rheumatoid arthritis began to flare. Multiple joints involved, needed to use cane.  Had been off biologics for two years.  Saw Rheumatologist in March.  Discussed vaccine and subsequent RA flare.  Placed on higher doses of prednisone with longer taper.  Returned in May to Rheumatologist.  I am now back on biologics and my RA status is no longer controlled.