chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm developed some soreness on 6/18/18. On 6/19/18, I hurt all over, low grade fever 100.2 that increased to 101.8 (on TYLENOL) felt like I had the flu. Eyes buried, my tinnitus double or tripled, loss of appetite, chills, (L) arm hurt from just under (L) ear to my elbow. Body felt so cold I had to still tired. I've had sore arms before from vaccinations but never has one done.
itchy injection site; red injection site; swollen lymph nodes on neck; swollen lymph nodes under injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy injection site), LYMPHADENOPATHY (swollen lymph nodes on neck), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under injected arm) and VACCINATION SITE ERYTHEMA (red injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history reported.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on neck) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under injected arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy injection site) and VACCINATION SITE ERYTHEMA (red injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy injection site), LYMPHADENOPATHY (swollen lymph nodes on neck), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under injected arm) and VACCINATION SITE ERYTHEMA (red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment information not provided.
At 1:30 AM on September 2, 2021  the day after taking the flu shot, I awakened with an urgent need to go to urinate. When I did,  i saw bright red blood and black blood clots in my urine.. This went on during 20 minute intervals until 4:30 AM on the same morning of September 2, 2021 when it stop. The bloody   urination and clots has not occured since. I still have frequent urination and pressure pain from this episode.
9:25 am Returned to facility light headed, dry mouth and mouth tingling. Blood pressure 170/88 ,pulse70 ,pso2  99%.  Respirations even and unlabored.  Skin pink, warm and dry.   Sat a while reported mouth tingling better.  9:44 reported dizziness increased took her pepcid and atavert as she said her allergist suggested.  9:48 Client reported difficulty swallowing taken to the ER
Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Abdominal disorder (taking rifaximin antibiotic for abdominal issues). Concomitant products included RIFAXIMIN (XIFAXAN) for Abdominal discomfort.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) outcome was unknown.            Treatment details was not reported by the reporter. The patient was taking 500 mg of Rifaximin twice daily for 2 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2021: follow up : Dose detail of suspect vaccine updated and Event coding updated
pt recvd vax & devel fever of 103; inc t 105 after apap given;
Patient reported swelling of arm, redness, and pain for a week post vaccination and declined second vaccination.
Information has been received from a physician concerning a 7 and 1/2 year old male who in approximately 1999, at 12-months-old, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On December 19,2005, the patient presented to the office with a case of breakthrough chickenpox and a low grade fever. No further information was available. There was no product quality complaint. Additional information has been requested.
patient reports 2 weeks after receiving  2nd shot he starting having cramping in hands and feet.  Also started having whole body joint pain.
my blood sugar has been up; I was 197 before breakfast; my blood sugar has been up; I was 197 before breakfast; This is a spontaneous report from a contactable consumer reporting for self. A 65-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing insulin dependent diabetic, hypertension, and kidney disorder.  Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (LANTUS), acetylsalicylic acid (ASPIRIN), lisinopril to make his kidneys strong. The patient stated he had the first shot and he believe one of the side effects was it can cause your blood sugar to go up. So, he had to monitor his blood sugar more closely. He got the vaccine on Thursday (14Jan2021), since then his blood sugar had been up. He stated that he was taking his insulin aspart and insulin glargine. Like today (18Jan2021) he took 4 units of because he was 197 before breakfast. The outcome of event was unknown.    Information on Lot/batch number has been requested.
Within the first 48 hours body pain, fever, throwing up, swelling, headache. She did not go see a doctor.
This case was reported by a physician and described the occurrence of joint pain in an approximately 52 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  On unspecified dates "several years ago" the pt received an unspecified number of doses of Lymerix.  In approximately 1999, the pt began to experience joint pain and muscle pain and was referred to the reporting orthopedist.  As of 08/29/03, the events persisted.
CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 52 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, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle ache, and headache on 07-APR-2021. This report was non-serious.
pt brought to hosp with dyspnea; c/o light-headedness and wheezing; positive test for COVID; O2 supplementation; per death certificate, pt died in the hosp with causes of death being acute COVID 19 and acute Cardiac Arrest
Small intestines are shutting down. It's not working efficiently. It's called small intestinal bacterial overgrowth I've been on multiple rounds of antibiotics. A lot of fatigue. I've experienced headaches as well. I have to be on a special diet.
Arm soreness; This is a spontaneous report from a contactable consumer who reported for a patient. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EH9899) via an unspecified route of administration on 22Dec2020 at 06:45 (at an unspecified age) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to sulfa and nuts, from unspecified dates and unspecified if ongoing. Other medical history was reported as "none". Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was reported that it was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccination. On 22Dec2020 the patient experienced "arm soreness". It was reported that treatment was not received for the adverse event. The clinical outcome of the event "arm soreness" was recovered/resolved on an unspecified date.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Reports Hives (cheeks and neck); tightness in throat. Denies SOB, chest pain. BP: 133/98 HR: 80 Sp02: 100%  Refused transport to ER by the ambulance, refusal form signed Seen and cleared by EMS
Persistent pain in left deltoid (now 3 M post injection); numbness down extensor of forearm and back of hand since then. Decreased light touch dorsal/above left hand, light touch intact over forearm.
Pfizer-BioNTech COVID-19 Vaccine EUA Headache, body aches and extreme fatigue started on 12/20/2020. I had a doctor appointment on 12/22/20 for a routine visit and I told my doctor about these symptoms that had occurred and he stated that I needed to be tested for COVID since these were symptoms. He also ordered blood work and I had blood drawn. I had informed him at the beginning of the visit of my recent COVID vaccine last week.
Guillain-Barre Syndrome diagnosed on September 10, 2013 at Hospital (by Neurologist) - treated with IGA for four days, currently in recovery.
Felt cold; Vomiting; Felt freezing; Body aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt freezing), FEELING COLD (Felt cold), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FEELING COLD (Felt freezing), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Mar-2021, the patient experienced FEELING COLD (Felt cold) and VOMITING (Vomiting). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 25-Mar-2021 for Myalgia, Feeling cold and Headache, at a dose of UNK dosage form. At the time of the report, FEELING COLD (Felt freezing), FEELING COLD (Felt cold), MYALGIA (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.
Recieved flu shot 9/19 from hospital, which is her employer, on 9/19 claims to have had 3 incidents of weakness with falls. Legs gave out, one time hitting head. Not seen in ER. Spoke with Neurologist at hospital, did not think shot was related.
About 5pm in evening, started getting cold, shaking, white of eyes turned pink, there was matter in eyes, temperature was 100.2 ; laid down and it lasted 45 minutes.  Took a couple of Tylenol for the fever which reduced it. Eyes were still pink, throat was not sore but felt like if it was closing up. Sat down and drank some Gatorade/fluids. Next morning felt fine, eyes were just a little pink--they took one more day to clear up.   Called doctor the next day, and thought it was probably a virus not a vaccine reaction.   This is the first time the patient received the High Dose vaccine
Passed away from a Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 39 years old, on 11Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included wolff-parkinson-white syndrome from an unknown date to 15Mar2021. The patient was diagnosed with this later in life, but was told he probably had it his entire life it just hadn't caused any issues for him. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously got the flu vaccine for immunization every year with no issues. The patient passed away from a pulmonary embolism on 15Mar2021. The patient was not hospitalized prior to his death.  He died from the pulmonary embolism in his sleep. The reporter denied any medications, labs, testing, or treatments for her husband relevant to these events. The patient died on 15Mar2021. There was a private autopsy performed and they said that the Pfizer Covid Vaccine was one of the contributing factors to the patient's death. The autopsy said the vaccine was a contributing factor. The reporter stated she told them since they said it was the pulmonary embolism that killed him, then that's what it should say. The Medical Examiner was saying that the science for the vaccine is so new, they just don't have the data that they need.; Reported Cause(s) of Death: Pulmonary embolism
developed bilateral PE 1 week after her second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received COVID-19 Vaccine - Manufacturer Unknown (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: PULMONARY EMBOLISM (medically significant) with onset 2021, outcome "unknown", described as "developed bilateral PE 1 week after her second dose". The reporter stated that the query was about the COVID vaccine. The reporter had a patient who developed bilateral PE 1 week after her second dose about 9, 10 months ago and the patient want to get a booster dose and they were just wondering if we have information in that regard. The reporter did not specify which vaccine the patient received.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Allergic reaction; Gums and tongue itchy; Gums and tongue itchy; Uvula was swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), TONGUE PRURITUS (Gums and tongue itchy), GINGIVAL PRURITUS (Gums and tongue itchy) and ENLARGED UVULA (Uvula was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), TONGUE PRURITUS (Gums and tongue itchy), GINGIVAL PRURITUS (Gums and tongue itchy) and ENLARGED UVULA (Uvula was swollen). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), TONGUE PRURITUS (Gums and tongue itchy), GINGIVAL PRURITUS (Gums and tongue itchy) and ENLARGED UVULA (Uvula was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient was transported to emergency room on ambulance. In Emergency room, some medicine was given.
FEVER OF 101; FATIGUE; SEASONAL ALLERGIES; HAD NOT BEEN FEELING GREAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced seasonal allergies. On APR-2021, the subject experienced had not been feeling great. On APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101 unit not reported. Treatment medications included: naproxen sodium. On 27-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101, had not recovered from fatigue, and the outcome of seasonal allergies and had not been feeling great was not reported. This report was non-serious.
No additional AE/PQC; patient inadvertently received a dose of VARlVAX on 26-OCT-2021 with a labeled expiry of 25-JUN-2021; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 26-OCT-2021, the patient inadvertently received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) with a labeled expiry (strength, dose, frequency, route of administration, anatomical injection site were not provided; lot number S019583 has been verify to be a valid lot number for varicella virus vaccine live (Oka/Merck) with expiration date on 25-JUN-2021) for prophylaxis. There was no known temperature excursion. No additional adverse event.
exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; sore left eye; blood pressure very high and hard to control; shingles; This is a spontaneous report from a contactable consumer.   A 74-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 08Jan2021 13:30 at single dose for covid-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, neuropathy peripheral, asthma/allergies, headache, allergy to medications, food. Concomitant medications included azelastine, fluticasone propionate (FLONASE), metoprolol, gabapentin, levothyroxine sodium (LEVOTHYROXINE). The patient experienced shingles on 08Jan2021 (immediately after she got the shot), exhausted on 09Jan2021 03:30, slept most of day/night on 09Jan2021 03:30, pain in scalp, pimples, bumps on 09Jan2021 03:30, sore left eye on 09Jan2021 03:30, blood pressure very high and hard to control on 09Jan2021 03:30. Patient was treated with Valacyclovir, lisinipril, metropolis, aquafor. The outcome of shingles was unknown. The outcome of exhausted, slept most of day/night, pain in scalp, pimples, bumps, sore left eye, blood pressure very high and hard to control was not recovered.
Patient said he got his second Pfizer shot on 9-18, & on 9-19 he started to feel chest pressure, severe heart pain, palpitations and flutters. He went to see Dr on 10-4-21 because the symptoms continued 2-3 times a week. He called our pharmacy today to report the adverse reaction.
Uable to move due to fatigue; Aches all over; She woke up in the middle of the night with fever102.6; Head hurting; Joint pain that is really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 04-Feb-2021, the patient experienced PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting) and ARTHRALGIA (Joint pain that is really bad). On 05-Feb-2021, the patient experienced FATIGUE (Uable to move due to fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102.6 (High) body temperature 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
No fever - (L) thigh red, swollen and warm to touch. 10 cm x 9 cm.
48 hours after my vaccine I started to feel lightheaded upon standing up/ a head rush. Three weeks later I became really dizzy and the room was spinning, I went to the urgent care and everything came back clear. The doctors felt that I was dehydrated and just advised me to increase fluid and if it doesn't get better to come back in.
This patient experienced pain, erythema, swelling within 24hrs at the injection site, the induration remains. And then developed fever greater than 102 within 24hrs and myalgias severe.
It came on fairly hard. I had a headache and sinus congestion. Not too much coughing. A slight increase in temperate, I would say 99. I felt somewhat nauseated. I called the doctor right away and they prescribed the 5 day regimen of Paxlovid. I started this the same day my symptoms began. I increased my fluid intake. I started feeling better within 2 days. I was hopeful that I would be better by the next weekend. After 6 days, I started feeling bad again. I was still showing positive at this point. My reoccurring symptoms weren't as bad the second go around. I was just very tired. Paxlovid was not prescribed again, just nasal spray. I'm still testing positive as of today and isolating. I have a little sinus drainage and cough today.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
Chills, body aches, 101.9 fever, cough, bad headache, extreme fatigue, arm sore to touch , 36 hours later feeling better but still lethargic and cough remains, no fever 36 hours later but may return in PM hours