chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About three months after receiving my second dose, I began experiencing severe abdominal pressure and pain and a quickly climbing fever. I went to the ER, in (Privacy) because we were traveling. They diagnosed me with pancreatitis and a severe UTI. I was treated with IV antibiotics and steroids. I had an allergic reaction to the Cipro while I was there and was given Benadryl. It took about two weeks to recover from that. I could barely eat anything for about one to two weeks after.
Erythema, swelling at injection site greater than palm of pt's hand followed by headache and fever of 102 degrees Fahrenheit. No tx done at this time.
Pain in chest sharp + burning. Knot in throat, flush in face  0855 - called to see pt for Cp after immunization, 0900 - 120/82 - 84 - 99% CP continued mid chest radiating up to throat, sharp, 0915 - 105/68 - 80 - 99% CP  continued, flushed, itching, hives, Rolaids x 2, 0920 - insurance called per clinic - called EMS, 0925 - 107/74 - 99% - 88 - 22, - clearing throat - hives to (B) UE's, throat, jaw line, 0930 - 112/74 - 98% - 83 -20, Tums x 3, 0937 EMS arrived
No additional AE; consumer reporting improperly stored vaccine administration; This spontaneous report was received from a nurse and refers to patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. Concomitant therapy included sterile diluent (manufacturer unknown).   On 21-OCT-2020, the patient was vaccinated with the first dose of improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type rHa, lot# T015600 is a valid lot number, expiration date 02-NOV-2021 (strength, route and site of administration were not provided) for prophylaxis. The temperature was 10 Fahrenheit (F) degrees for 2 hours. There were no previous temperature excursion. The digit data logger was involved. No additional adverse event was reported. The outcome was unknown.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA009775: US-009507513-2010USA009997: US-009507513-2010USA010221:
- No side effect reported - patient is 53 y/o, received H1N1 FLUMIST intended for 5 - 49 y/o, healthy male adult - No Adverse effect, pt feels fine.
24 hours after the injection I had a sore arm, developed slight body aches and headache.  Since the injection I had been getting headaches almost daily, mostly on my right side of my head.  On Dec. 5, 2021 I noticed I was getting a sore eyebrow.  Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest.  My eyebrow also started to swell and was slightly pink.  When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis.  After a couple days my eye was not getting any better and started to itch severely.  Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could.  On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day.  I saw a doctor on Dec. 11 & was diagnosed with shingles.  They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
Received their booster doses as 0.5ml instead of 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received their booster doses as 0.5ml instead of 0.25 ml) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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) (unknown route) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received their booster doses as 0.5ml instead of 0.25 ml). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Received their booster doses as 0.5ml instead of 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Nurse reported, three patients received their booster doses as 0.5 ml instead of 0.25 ml on 02-Nov-2021.
Inflammation popping up different areas of my body every day. No pain associated with it. My extensive research that the photos posted of those how had it reflects 99% sure it's MULTI SYSTEM INFLAMMATORY SYNDROME..SEVERAL CAT SCANS, EXTENSIVE BLOOD WORK AND URINE TEST.  Was told by ER doctor he had no clues what it could be.
On school bus ride home pt. felt some nausea, legs tingling and numb. No vomit or diarrhea. At time of ER visit, Pt. felt well. neg, physical exam. Probable Vasovagal reaction.
Redness and swelling on the arm but approximately 2 inches from injection site, headache, fever and chills
Janssen COVID-19 Vaccine EUA Awful headache, fever over 102, slow, weak, muscle aches, injection site hurts a lot.
Started as a scratchy/sore throat.  Took a test on 5/19 and it was negative.  I tested positive for 5/20.  Called my Dr same day and did a rapid and pcr test and gave me Paxlovid.
During night shaking uncontrollably/thought I might have had a stroke when I was shaking. scared me to death; My hip hurt me so bad. Lasted 3 hours and then immediately went away.; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (During night shaking uncontrollably/thought I might have had a stroke when I was shaking.), FEAR OF DEATH (scared me to death) and ARTHRALGIA (My hip hurt me so bad. Lasted 3 hours and then immediately went away.) in an 84-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (During night shaking uncontrollably/thought I might have had a stroke when I was shaking.), FEAR OF DEATH (scared me to death) and ARTHRALGIA (My hip hurt me so bad. Lasted 3 hours and then immediately went away.). At the time of the report, TREMOR (During night shaking uncontrollably/thought I might have had a stroke when I was shaking.) and FEAR OF DEATH (scared me to death) outcome was unknown and ARTHRALGIA (My hip hurt me so bad. Lasted 3 hours and then immediately went away.) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
broke out from her ankle on up to her hip; her being sickly; leg started itching real bad, swelled up and had a rash; leg started itching real bad, swelled up and had a rash; leg started itching real bad, swelled up and had a rash; This is a spontaneous report from a contactable consumer. This 76-years-old consumer (Patient) reported for herself that she received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 15Apr2021 at single dose for cvid-19 immunization. Patient's medical history included She is allergic to latex and had X amount of surgeries (dates unspecified). Historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 VACCINE). Concomitant medications included diphenhydramine hydrochloride (BENADRYL) with unspecified dosage, indication. Consumer stated that she had the first dose of the Pfizer covid 19 vaccine and came home and did excellent. She got the second dose of the Pfizer covid 19 vaccine on 15Apr2021. She started breaking out the same day. She broke out from her ankle on up to her hip. She stated she is allergic to latex. She stated someone at the vaccination facility confirmed that she was ok to get the Pfizer covid 19 vaccine. Her primary doctor was informed of her allergies but wanted the patient to get the vaccine because of her being sickly and had 'x" amount or surgeries. A doctor insisted that she get the pneumonia shot and consumer stated she had a bad effect after getting the pneumonia shot. Consumer stated after the pneumonia shot her leg started itching real bad, swelled up and had a rash. She was given medication for the pneumonia reaction. Her leg had to be cleaned and wrapped. She came home from the second shot of the covid vaccine and the identical same thing happened. She is 2000 percent sure the reaction came from the vaccine. She has been taking Benadryl and has itch medicine and cleaning with alcohol. She stated she will have to go to the doctor. She asked about the payment for this. She also stated that she appreciated the agent's patience and listening to her. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Malaise, aching, fever, fine rash arms, hands, chest, shoulder, torso, headache "flu-like".
Swollen redness at the site of vaccination.  Hard and warm to touch and itchy.
24hr fever, hands & forearms, lips, face bluish, cold, eyes open, no LOC 8-10sec, trembling;
swelling in the joints of her fingers and knees; woke up red, itchy, and covered in hives; covered in hives; woke up red, itchy, and covered in hives; rash has been on different parts of her body, face and scalp.; chills; fever; weird dizziness; sore arm; in bed; constant rocking sensation like I'm on a boat; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ASTHENIA (in bed), SENSORY DISTURBANCE (constant rocking sensation like I'm on a boat), VERTIGO (vertigo) and JOINT SWELLING (swelling in the joints of her fingers and knees) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 033C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ASTHENIA (in bed), SENSORY DISTURBANCE (constant rocking sensation like I'm on a boat), VERTIGO (vertigo), DIZZINESS (weird dizziness), CHILLS (chills) and PYREXIA (fever). On 29-Dec-2021, the patient experienced JOINT SWELLING (swelling in the joints of her fingers and knees), PRURITUS (woke up red, itchy, and covered in hives), URTICARIA (covered in hives), ERYTHEMA (woke up red, itchy, and covered in hives) and RASH (rash has been on different parts of her body, face and scalp.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of half a Benadryl; HYDROXYZINE for Adverse event, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching, at an unspecified dose and frequency. On 18-Dec-2021, PAIN IN EXTREMITY (sore arm), ASTHENIA (in bed), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, SENSORY DISTURBANCE (constant rocking sensation like I'm on a boat), VERTIGO (vertigo), PRURITUS (woke up red, itchy, and covered in hives), URTICARIA (covered in hives), ERYTHEMA (woke up red, itchy, and covered in hives) and DIZZINESS (weird dizziness) had not resolved and JOINT SWELLING (swelling in the joints of her fingers and knees) and RASH (rash has been on different parts of her body, face and scalp.) outcome was unknown.            No medical history was provided by the reporter. Other treatment details include a couple of Antihistamines for her symptoms and  Oatmeal bath to help with itching.   This case was linked to MOD-2021-436416, MOD-2021-436428 (Patient Link).
Had a reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Had a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endocrine disorder (Unspecified neuroendocrine condition.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  Reporter states patient was rushed to the hospital due a reaction to the vaccine and was treated with ctreotide (unknown dose) for 24 hours and received 3 shots of epinephrine.  Very limited information regarding this event has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-100633, MOD-2021-104568 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. MOD-2021-100633:Reporter's First Dose MOD-2021-104568:Reporter's Second Dose
Severe headache, chills, fever and severe body wide muscle pain with lethargy. I am taking 2 500mg acetaminophen every 6 hours to help with the symptoms.
injection site in brick red and tennis ball in size; injection site in brick red and tennis ball in size; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE ERYTHEMA (injection site in brick red and tennis ball in size) and INJECTION SITE SWELLING (injection site in brick red and tennis ball in size) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site in brick red and tennis ball in size) and INJECTION SITE SWELLING (injection site in brick red and tennis ball in size). At the time of the report, INJECTION SITE ERYTHEMA (injection site in brick red and tennis ball in size) and INJECTION SITE SWELLING (injection site in brick red and tennis ball in size) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication included steroid cream for topical application no concomitant drugs included.
HAD A TEMP OF 100.2 STARTING ABOUT 3 PM ON 8-10-19.  WHOLE BODY ACHED  DID N'T THINK MUCH ABOUT IT.  8-11-19 STARTED RUNNING A FEVER OF AROUND 100 AGAIN AROUND 3 PM.   I HAVE HAD MANY VACCINES FOR FLU TO THE 1ST SHINGLES VACCINE AND HAVE NEVER HAD A REACTION LIKE THIS.
This medically confirmed literature case (initial receipt 20-May-2014) concerns a 76 year old male patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date after the flu vaccine, the patient presented with a one week history of generalised weakness and an unsteady gait. He had two episodes of non-bloody diarrhoea and decreased urine output. On physical examination, the patient was confused, lethargic and had dry mucous membranes. His temperature was 101.1 degrees F (Fahrenheit), heart rate was 102/minute, BP (blood pressure) was 112/66. A laboratory evaluation revealed Cr (creatinine) of 1.8mg/dL, BUN (blood urea nitrogen) of 50mg/dL, Hgb (hemoglobin) of 12.1 g/dl, hematocrit of 35.6%, platelet count of 35,000/uL, LDH (lactate dehydrogenase) of 590U/L and haptoglobin of <10mg/dL. C3 and C4 complement levels were both low at 58mg/dL and 12 mg/dL respectively. Schistocytes were seen on a peripheral smear. Urinalysis showed trace proteinuria and <1rbc/hpf (red blood cells per high power field). Plasma ADAMTS13 activity was normal and stools were negative for Shiga toxin-producing Escherichia coli. Despite therapeutic plasma exchange (TPE) for seven days, hemolysis continued, thrombocytopenia worsened and the patient developed multi-organ failure. Hemodialysis (HD) was initiated for uremia and volume overload on hospital stay day 10. The patient was commenced on eculizumab given that he had TPE-resistant Atypical Hemolytic Uremic Syndrome (aHUS). TPE was no longer performed. By four doses of eculizumab, his platelets normalised, LDH improved and he came off HD. His creatinine was stabilised at 1.1 mg/dl. Respiratory failure and hepatic injury also resolved. Genetic analysis did not demonstrate any factor H gene mutation in the patient. Outcome was unknown.
tested positive for COVID on 23May; tested positive for COVID on 23May; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 30 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: "Birth control" (ongoing). Concomitant medication(s) included: JUNEL taken for contraception; FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "not recovered" and all described as "tested positive for COVID on 23May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (23May2022) Positive; (01Jun2022) Positive; SARS-CoV-2 test: (29May2022) Negative, notes: rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for COVID on 23May2022 and began paxlovid on 23May2022. She stopped after completing the full course of doses on 27May2022. Patient received antiviral treatment with paxlovid from 23May2022 to 27May2022 for COVID-19 event. On 29May2022, she tested negative on a rapid antigen test. On 01Jun2022 at 10:00 AM, patient symptoms have returned and tested positive with a rebound case. Patient did not received any treatment and not recovered after symptoms returned. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (23May2022) Positive; (01Jun2022) Positive; SARS-CoV-2 test: (29May2022) Negative, notes: rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Worsening of ocular myasthenia symptoms with ptosis after 4 years of being symptom free
Patient developed COVID symptoms on 3/29/2021. Diagnosed COVID + on 4/1/2021
MOTHER CALLED TO CANCEL NEXT APPT. WHICH WAS TO BE NOV. 17, 06, STATED THAT CHILD HAD A FEVER OF 104 FOR THREE DAYS AND THAN A RASH. IT TOOK A LONG TIME FOR HER TO FEEL BETTER. SHE WILL WAIT 2 MONTHS AND TRY SHOTS AGAIN.
MA administered the vaccine on 1/20/2023, but it had an expiration date of 1/11/2023. MA instructed to call and notify patient that dose must be repeated per CDC guidelines.
Redness and itching at injection site at time of injection. Twenty four hours later all signs of redness & itching disappeared. Day 2 Redness and itching returned,also had muscle aches . Redness & swelling was the size of a half dollar. Patient advised to apply cold pack and use benadryl and Tylenol for aches and pains. Day 3 symptoms seem to be subsiding. The patient only used cold pack and did not take any oral medications.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in September 2013 the patient was vaccinated with GARDASIL (lot # J0006850, expiry date: 31-MAR-2016). On an unknown date in August 2016, the patient received the next dose of GARDASIL 9 (also reported as "Unknown if GARDASIL HPV4 or GARDASIL 9") (Lot # M0003659, expiry date: 20-SEP-2017). No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient was given half dose of Moderna Bivalent Booster and was suppose to receive 0.5mcg. Wrong dose given.
Very tired and extremely sore arm, shoulder and neck starting at injection site.  This was dose #3 due to immunocompromised health.
Appx 20-30 min after injection, I started to have tingling of the right side of my face starting with my eyebrow, then moving to my cheek and then my chin. Sensations to sharp and dull were not altered. Tingling remains
Vaccines were administered on June 27, 2018 around 1:20pm. Patient developed a red, itchy rash on injection site on left anterolateral thigh where IPV vaccine was administered. 3 inches in diameter that remained for 8 days. Patient also had bruise and hard lump under the skin on right anterolateral thigh where DTaP vaccine was administered that has remained without diminishing currently. Patient woke up in middle of night/early morning on July 3, 2018 unable to keep her arms and legs still and was running a low grade fever. She slept until 10:45am on July 4, 2018. Temperature was 100.9 axillary. She continued to run fever through-out the day and night. At 17:05 on July 4, 2018, temperature was 104.4 axillary. She complained of a severe headache, Right arm and leg pain and was very lethargic. Lack of appetite since date of vaccinations.
Sore arm, loss of appetite, fatigue, extreme dizziness, drop in blood pressure
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a two-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 25-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
About 2 hrs p/immun pt had t104 on & off for 8-10 hrs; cried for longer that 3 hrs; Still fever on 23AUG91PM; Pt not taking formula; 26AUG91 Pt is fine fever stopped 24AUG91; no other problems; Pt taking fluids well;
9 days later, red rash, minor swelling, some soreness and itching at site in left deltoid
Approximately 24 hours after receiving an anthrax injection, the patient developed an itchy, red, raised area approximately the size of a 50 cent piece, at the injection site.
This spontaneous report as received from a Nurse refers to a 80 year old female patient. On 22-FEB-2014, the patient was vaccinated with PNEUMOVAX23 (Lot # J014401, expiration date 26-NOV-2014) (dose and route were not reported). Concomitant therapies included terbinafine (manufacturer unknown). On 24-FEB-2014, the patient experienced the injection site reaction. The site of injection presented with erythema, pain and tenderness. The patient did not received treatment for the adverse event. On an unspecified date, the patient sought medical attention. The outcome of the site of injection presented with pain and tenderness and the injection site presented with erythema was unknown. Additional information has been requested.
FEVER 102, BODY ACHES, CHILLS, ACHED FROM HEAD TO TOE LASTED 24 HOURS.