chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She became violently ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She became violently ill) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ILLNESS (She became violently ill). In April 2021, ILLNESS (She became violently ill) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  The patient received the first dose of Moderna vaccine on 26Apr2021. She stated that 14 hours later, she became 'violently ill' for 3 days. The patient received the second dose of Moderna vaccine on 26May2021 and the same thing happened again. She became very sick.  Company Comment: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the first dose of the Moderna mRNA-1273 vaccine on 26Apr2021. The report stated that the patient became 'violently ill' 14 hours after vaccination. No further details were provided. Treatment information was also not provided. The event had resolved at the time of the report. The rechallenge was positive for the first dose since the event resolved after 3 days and the patient experienced 'the same thing' after administration of the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405737, MOD-2021-405713 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the first dose of the Moderna mRNA-1273 vaccine on 26Apr2021. The report stated that the patient became 'violently ill' 14 hours after vaccination. No further details were provided. Treatment information was also not provided. The event had resolved at the time of the report. The rechallenge was positive for the first dose since the event resolved after 3 days and the patient experienced 'the same thing' after administration of the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
No additional adverse events reported; an expired dose of MMR II was administered yesterday; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.   On 04-NOV-2021 (reported as yesterday), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S032036, expiration date 10-OCT-2021; strength and route were unknown) for prophylaxis (expired product administered). Caller reported that dose was properly stored up through the time of administration. No further information provided. No additional adverse events reported. No product quality complaints.
SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON  HER FACE; CHILLS; PAIN IN  RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.
Fever,  sore left underarm into chest area ( lymph nodes? ), headache, very tired ( napped all day today morning into evening ). Tylenol helped
Within 24h after vaccines administration patient started "twitching" all over and eyes were in a daze, fever 100.6, foggy this lasted about 20 secs. after that had couple of similar episodes but were much shorter. Patient was seen at ER hospital and admitted to hospital, spinal tap, CT scan and EEG were done and were all normal. No anticonvulsant given.
t101, chills, nausea, bone ache/pain, dehydration, somnolence;
I am 20 days late for my period. I took a pregnancy test about 7 days ago which came back negative. I?m not experiencing any extra stress or life changes that would throw off my period. I?m worried about having permanent fertility issues from the vaccine.
Client stated she felt faint and vomited. Noted client pale and skin diaphoretic
itchy injection site; injection site got swollen (the size of a quarter) throughout the night the swelling extended; injection site got hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended), VACCINATION SITE MASS (injection site got hard) and VACCINATION SITE PRURITUS (itchy injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended) and VACCINATION SITE MASS (injection site got hard). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy injection site). At the time of the report, VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended), VACCINATION SITE MASS (injection site got hard) and VACCINATION SITE PRURITUS (itchy injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included birth control.  No treatment information was provided.
Seizure, treated at ER. F/u with Dr., no treatment needed, self resolved, no fever.
Very sluggish,cold not  chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd day
This spontaneous report was received from a medical assistant and refers to unspecified amount of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. From 31-AUG-2017 until 21-SEP-2017, the patients were vaccinated with improperly storage doses of VARIVAX lot numbers N014369 with expiration date 09-MAY-2019 and N012487 with expiration date 20-APR-2019, for prophylaxis (strength, dosage schedule, route of administration and anatomical location were not reported). No adverse events were reported. The vaccine doses were exposed to a temperature of 15 degree Fahrenheit (°F) to 46 °F (22.5 °F) for 4 hours and 1 minute. There was a previous temperature excursion of -15 °F to 46 °F for 12 hours and 7 minutes. The data logger was involved. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA013232:
Patient was given shot and was walking out the door when four marks showed up on her skin.  They look a little like insect bites but they where not there before the shot.  We had the patient come back into the exam room and listened for wheezing.  As I sat and watched her 4 more hive broke out.  No redness around the inject site or hives, but two hives broke out on her side and then two more on her chest.  We set a timer and keep reassess her. No more hive broke out and 25 minutes after the shot her lung were clear and  no addition rash.  I gave 5mg of Claritin at about 10 minutes after the shot.
Severe rash, red eyes, enanthem within 2 days of administration. High fever. Diagnosed with Stevens Johnson syndrome by dermatology.
Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild headache; pain in my toes feeling like they were broken; chills; sweating.  Lasted from 3-7 pm although 4-7 I was in a sound sleep but aware of the symptoms I was feeling.  It was a very unusual feeling of unconscious then conscious delirium feeling.
One week subsequent to receiving Tetanus and Diphtheria Toxoids Adsorbed Purogenated pt developed an injection site reaction.
Starting around 10am, very tired and a headache and arm was sore from injection. Around 11:30am chills and loss of appetite. By 4pm in bed with severe headache, fever, chills, total exhaustion and muscle pain throughout my body. Woke up a little after 6pm and majority of the symptoms were gone. Went to bed that night around 11pm feeling tired and my ankle joints hurt. Woke up feeling much better on 4/25.
headache; sweats/hot flashes; sweats/hot flashes; ringing of ears that are still happening 4 days later; arm pain from shot but now seems ok; This is a spontaneous report from a contactable consumer. A 51-years-old female patient reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 14:00 (Batch/Lot Number: EN6203) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); omeprazole (PRILOSEC [OMEPRAZOLE]). The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 03Mar2021, the patient experienced headache, sweats/hot flashes, ringing of ears that were still happening 4 days later, arm pain from shot but now seems okay. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
SUSPECTED COVID-19; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20221222696, 20221222717 and 20221222695.
A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 34-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. 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.
Developed Chronic Spontaneous Urticaria 11 days after moderna booster. No past illnesses. First week developed hives and rashes all over with nonstop itchiness. Relieved by Benadryl pills. Hives would return with changes in temperature and when pills were not taken. Zyrtec is being taken everyday after the first week to help symptoms. 3 weeks after outbreak, dosage frequency has changed to every day and a half. Seems to be becoming more mild at present time with being able to go 48 hours without outbreak, but still feeling itchy, and then disappearing randomly throughout the day
At 9:00 PM patient told the mother he was not feeling well, c/o body aches, swollen lips, he was noted to have a fever and broke out in hives.  At some point, he began to vomit.  Dad is a physician assistant and administered Benadryl which helped some.  Speaking to the mother at 1:30 on 10/09/2019, he was much improved.
rt sided seizures onset 9MAY93; had rhinorrea onset 2MAY93 no fever;
A consumer reported that he/she read an internet concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # , dose and route not reported). On an unspecified date, the patient died of "clot blood" eight hours after vaccination. This is one of several reports from the same source. No further information is available.
Started with Rt. ear discomfort - like swimmers ear - for a few weeks prior to full bloom of BELL's PALSY - in Oct. went to E.R. and follow up with Dr office - on med. for 3 weeks still trouble with vision and mouth and singing voice, and sensitive to touch.
Pt states she experienced redness and severe itching on her arm x 2 weeks. It has now resolved.
Coughing; Coughing up phlegm/spitting up phlegm; Congestion; Like a sinus thing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH, PRODUCTIVE COUGH, NASAL CONGESTION, and SINUSITIS in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced COUGH, PRODUCTIVE COUGH, NASAL CONGESTION, and SINUSITIS. At the time of the report, COUGH, PRODUCTIVE COUGH, NASAL CONGESTION, and SINUSITIS had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication included blood pressure.   Most recent FOLLOW-UP information incorporated above On 27-Jun-2021: Follow-up information received on 27-JUN-2021. Updated outcome of the events (from unknown to recovered/resolved).
Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours of vaccination. The first evening my headache got significantly worse. I was  extremely thirsty, very tired, nauseous, vomiting, diarrhea, muscle pain, chills, fever, my left arm was very sore & swollen @ the injection site.  I slept for longer periods of time than normal, very disoriented & not clear on my thoughts & memory for days after.
Erythema and induration at injection site 11 1/2cm X 6 1/2cm.
Myalgia, Arthralgia, Fever, Fatigue  Narrative:  Employee contacted EOH to complain of Body Aches, Fever, Fatigue severe enough that they could not continue to work
PATIENT HAD RED BLOTCHES ON LEFT ARM RUNNING TOWARD SHOULD. LASTED FOR ABOUT 15 MINUTES BUT WENT AWAY AFTER THE PATIENT WAS GIVEN SOME BENADRYL.
Patient woke up at midnight the night after receiving the vaccine and he couldn't breathe and was gasping for air. He called 911 and tried using the oxygen he has at home but it didn't help. EMS took him to the hospital where he stayed for 4-5 days. Patient reports he even stayed in the ICU for 2 of those days. He was on steroids, antibiotics, and oxygen during his hospital stay. He reports multiple physicians recommended that he not receive the second COVID vaccine due to this reaction.
13FEB92 pt had MMR & 9 days later pt devel fever 99; then had sz & was taken to hosp; t103, dx fr MMR which resulted in sz;
6 days after receiving the shot in my left arm the area of the shot has become red, hard to the touch and hot to the touch.  It's painful and swollen.  Additionally, there are red blotches in small areas on the same arm.
Within 2 minutes of receiving shot, overwhelming deadening of sound, blackness in eyes, full body sweats, full body discomfort, very close to fainting for first 6-8 minutes. As those symptoms started to diffuse severe muscle cramping started in opposite arm of shot, moved thru body. Within 15 minutes the only symptoms left were the muscle cramps. Those continued for several days. Still lingering today, a week later.
he is bleeding a little; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). This male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was bleeding a little on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Gall Bladder attack starting at about 8pm. Normally attacks are gradual and start over a course of days, increasing in intensity. No symptoms of attack in morning, had vaccine, attack starting around 8pm. Attack was about a 7 out of 10, so not the worst. Also, lymph nodes started to swell under armpit day after, very painful. Stayed swollen for about 7 days.  She is also very very tired, even weeks after.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route, lot # and expiration date were not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Bright yellow (neon) urine, frequent urination Lower Back pain  Headache Body ache Chills Sweats Fatigue/exhaustion Diarrhea  Skin rash unexplained small random bruises on legs  All Lasted 3-4 days total
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42-year-old female patient received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1140349) at citrate free (1 in 1 week) and second regimen (Lot number: 1154832) at citrate free (1 in 1 week), all subcutaneous for hidradenitis. The patient's relevant medical history included: "Bladder issues" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Vaccination history included: BNT162b2 (Dose 1, Single, via Intramuscular route), administration date: 02Aug2021, when the patient was 42-year-old, for COVID-19 Immunization, reaction(s): "COVID pneumonia", "Lung scarring", "Bladder inflammation", "Inflammatory marker increased", "Joint pain"; BNT162b2 (Dose 2, Single, via Intramuscular route), administration date: 11Nov2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: FIBROMYALGIA (medically significant), outcome "recovering"; ARTHROPATHY (medically significant), outcome "unknown", described as "joint issues"; CROHN'S DISEASE (medically significant), outcome "recovering", described as "Crohn's aggravated". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of "fibromyalgia", "joint issues" and "crohn's aggravated" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical course: She had issues in the morning with her Crohn's, she had to go to the bathroom 3 times before she could start her day. She also had bladder issues but had those before Humira. It was unknown if patient was enrolled in a COVID--19 vaccine trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on known disease pathophysiology, the event of "fibromyalgia", "joint issues" and "crohn's aggravated  is assessed as not related to Suspected vaccine, and more likely due to medical history of the same. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Chills, fever of 102, body aches, headache, nausea, treated with alternating ibuprofen and acetaminophen, mostly resolved within 24 hours
dizziness, nausea and malaise for several weeks after first injection (May 2007); vomiting, diffuse joint pain, weakness, sleeping constantly after second injections (July 2007); bilateral petechial rash lasting for several months, fatigue, left sided tingling of arm and leg followed by face droop and drooling, headache lasting a few months, alopecia, and pain after her third injection (August 2007). Treated with pain medication, accupuncture, facet injections, radiofrequency rhizotomy procedures.  11/30/09 Medical records and discharge summary received for DOS 5/1-5/8 Final DX: Intractable headache and neck pain, nausea, vomiting, nausea  S/P Gardasil # 1 dizzy, nausea, weakness, malaise weakness. Improved. Gardasil #2 increased vomiting, weakness, diffuse joint pain.  Somnolence, fatigue.  Gardasil #3 w/meningitis vaccine, constant sleeping, anemia, bil petechial rash on legs, ANA eleveated, borderline low thyroid, L side tingling, facial droop w/headache for 10 min intermittently. Alopecia.  Pain clinic tx w/facet injections. 70% improved. Received additional  facet injection and  developed severe neck pain and headache. Nausea, vomiting. Could not get out of bed.  Steroids, fluids. Much improved. D/C to home w/pain meds.
Was seen on 10-28-20 For a WC, had a TDap vaccine. Came in on 10-30-20 Due to possible allergic reaction to vaccine. Mom stated red, swollen on (Lt) arm. And also itchy. Given Amox
Patient felt dizzy, tired, and nauseous. Patient also had a temperature of 100.1, and was given a PRN medication.
Pt recvd vax & devel flu-like sx, h/a, malaise, diarrhea, low grade fever & was tired; reporter indicated that pt had a complete recovery;
Preterm infant with severe apnea requiring resuscitation following administration of PEDIARIX vaccine.
pt recv vax & became cranky & was crying for several days;no other details are known as of the date of this report
Circle of red itchy skin approximately 3.5 inches in diameter appeared around injection site 8 days after vaccination. Sore muscle, skin is swollen and hot to the touch. No previous symptoms following vaccination. Discomfort reduced through ibuprofen and a topical antihistamine.
After the Second Pfizer Dose, an hour after my shot I had an allergic reaction. I had a rash and swelling.