chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Small hive-like rash on both hands. Very slight rash on abd. No rash noted around inj. site.
Itchiness; Rash on foot and rash spread to her legs; Rash on her foot very red; Swelling of legs; Vulval rash; Tachycardia; Nausea; Fever; Tiredness; Lymph nodes of her armpit became swollen; Pain on her bones(big bones like her hips); Chills; Feeling cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Pain on her bones(big bones like her hips)), PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red) and PERIPHERAL SWELLING (Swelling of legs) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 037a21b) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced BONE PAIN (Pain on her bones(big bones like her hips)), FEELING COLD (Feeling cold) and CHILLS (Chills). On 23-Apr-2021, the patient experienced PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red), PERIPHERAL SWELLING (Swelling of legs), VULVOVAGINAL RASH (Vulval rash), TACHYCARDIA (Tachycardia), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness) and LYMPHADENOPATHY (Lymph nodes of her armpit became swollen). On 28-Apr-2021, BONE PAIN (Pain on her bones(big bones like her hips)), PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red), PERIPHERAL SWELLING (Swelling of legs), VULVOVAGINAL RASH (Vulval rash), FEELING COLD (Feeling cold), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness) and CHILLS (Chills) had resolved. At the time of the report, TACHYCARDIA (Tachycardia) and LYMPHADENOPATHY (Lymph nodes of her armpit became swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood pressure measurement: (High) High blood pressure.         Concomitant product use was not provided by the reporter. Treatment details included a self prescribed medication Benadryl cream & 2 Benadryl pills 25mg.Patient  called ER and went to hospital where she was given a cocktail:intravenous serum hexadrol 0.6mg benadryl advil 0.5mg pepsid 20mg 2ml Toradol, To be taken when she got back home:steroids prednisone 20mg twice a day and naproxen.  Action taken with mRNA-1273 in response to events were not applicable.
On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ASTHENIA (Loss of energy), SOMNOLENCE (feeling sleepy), PYREXIA (fever), CHILLS (chills) and MYALGIA (soreness; aches). On 07-Mar-2021, ASTHENIA (Loss of energy), SOMNOLENCE (feeling sleepy), PYREXIA (fever), CHILLS (chills) and MYALGIA (soreness; aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not reported.
After receiving the vaccine inflammation increased in my body. My legs started heating up. It has been continuously there. Never in the past have I experienced this except like 2 times maybe if I was dehydrated, but the heating up in my feet, legs, and hands I have never experienced before. I have gone to the doctor. I am not sure if it is vaccine related. This has affected my lifestyle after taking this vaccine. My inflammation is still continuing. It's only in my legs and lower body.
06/08/2022 He started with a slight sore throat that evening. The next morning, he woke up perspiring heavily and had a fever. On 6/9/2022 he tested positive for COVID, home test. The doctor was contacted. He ordered PAXLOVID that day. His fever continued that day, and he was very tired. By 6/10/2022 his fever was gone. And by 6/12/2022 his sore throat was gone. He is back to normal today.
pt recvd vax & approx 1wk later exp dark urine; 12JUL93 19 days p/recvd vax exp jaundice & elevated liver function tests; exp no fever & no abdo pain; began exp fatigue & was hospitalized 26JUL93; dx severe hepatitis;
Day after vaccine patient had pain in arm after four days went to doctor because pain turned in to a severe rash. Md treated patient with minocycline 100mg  twice a day for 7 days, swelling has gone down rash is minimal at this time.
feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6201 NDC, Exp: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "positive for Covid after one dose vaccine"; BNT162b2 (DOSE 1, SINGLE, Lot: EN6201 NDC, Exp: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for Covid-19 immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them"; BNT162b2 (DOSE 2, SINGLE, Lot: EN9581 NDC, Exp: Unknown), administration date: 08Mar2021, when the patient was 76-year-old, for Covid-19 immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise.  Additional Information: It was reported that the other 2 boosters made her feel sick, but that did not last long. Report was not related to a study or programme. Takes something else for the heart. No Other Conditions, Investigations. Covid-19 vaccine was a Pfizer product. Treatment included just Tylenol. No prior vaccinations within 4 weeks. No family medical history relevant to AE, No emergency room visit and no physician office visit. There was a product complaint to report. Clarified that caller previously tested positive for Covid. Had it really bad, a long time there, she was really sick. Didn't want it again. Actually had Covid before, twice. The firs time, was down for 6 weeks, probably. Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down. Tested again positive and it was not as bad as the first time, because she had the shot. Clarified further that caller had not had any Covid vaccines prior to first time testing positive for Covid. When she was positive for Covid the second time, she had received just one dose of the Covid vaccine, prior.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210413 same patient, different vaccine dose/AE;US-PFIZER INC-202201209676 same reporter/patient/vaccine, different dose/AE;
6AUG98 mom reported pt had blister like lesions on lower abd & legs & that pt had these for 2-3 days;mom advised to bring child to office;dx chickenpox;
This consumer report (initial receipt 29-Aug-2012) concerns a female patient. On 28-Aug-2012 the patient received a flu shot (manufacturer and batch no. not specified). On 28-Aug-2012 the patient experienced severe pain at the injection site and developed a fever. Her temperature went up to 104.2 F. She also experienced chills overnight. The outcome for the events was recovering.
Information has been received from a Registered Nurse for the pregnancy registry for GARDASIL via a complete pregnancy questionnaire concerning a 20 year old female patient with obesity and a history of two previous pregnancies and one spontaneous abortion or miscarriage (date unspecified). On 19-APR-2011 the patient was vaccinated with the first dose of GARDASIL (route not provided) (lot#667866/1437Z). A home pregnancy test performed on an unspecified date, confirmed the patient was pregnant. On 25-MAY-2011 and ultrasound was performed which showed the patient was 7 weeks and 4 days pregnant. The patient's LMP was on 30-MAR-2011, and the estimated delivery date was on approximately 07-JAN-2012. Follow up information has been received from a health care worker via telephone call concerning the patient, who on 08-JAN-2012, delivered a baby girl at 40 weeks of gestation via C-section. The health care worker reported that C-section was performed due to no reassuring fetal heart tracing. The baby weighted 6 pounds, 2 ounces with an APGAR scoring of 9-9. There were no congenital anomalies and no complications experienced by either mother or baby post delivery. At the time of the report, the patient's outcome regarding C-section was unknown. Upon internal review C-section due to no reassuring fetal heart tracing was considered to be an other important medical event. Additional information is not expected.
p/vax pt cried high pitch as if frightened for 2 hrs on & off; seen @ hosp-no fever, won't take bottle; next day vomited-then OK;
Information has been received from a pharmacist concerning a patient who contracted shingles after close contact with individuals that had received ZOSTAVAX (Merck) (0.65ml, SC, one time shot). It was unknown if the patients sought medical attention. At the time of the reporting, the patients' statuses were unknown. This is one of several reports received from the same source. Additional information has been requested.
Felt exhausted, sciatic nerve in left buttocks flared up badly, felt a slight, brief chill like a fever for about 5 minutes, dizzy, felt out of it.
Unsure of vaccine manufacturer and lot data. High temperature (104) through the night. Soreness. Headache. Temperature partially responded to ibuprofen and cold shower.
Within the first 25 mins i got red and started itching. i took tylenol.  Went home my left arm was hurting couldn't left it all the way up. i took a benadryl.  I took a nap. Woke up about 11pm and my face felt numb like i went to the dentist it was my only left side of my face. i woke and went to  work. i felt really tired and my arm was hurting. my face was red and swollen on my left side. I went home early from work went to take another benadryl  and tylenol. i slept for 12 hours. Got up to go to work still felt the same. i went home and called my medical hotline and told me to go to the er. i went to er. They did blood work and an CT scan. They were going to have come back to get an MRI on my head on friday. I went to go have MRI done Friday about 7pm. My shoulder and neck felt stiff on my left side. My arm still feels heavy, like it falling asleep. My face is numb and tingly still. i am waiting on all my results. i still feel the same.
Dizziness; Fever of 103F; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (Fever of 103F), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported.).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever of 103F), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 04-Feb-2021, DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (Fever of 103F), CHILLS (Chills) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature increased: 103 (Inconclusive) 103F.         No concomitant medications reported. Treatment included Held ice on her head.
Mom called-mosquito bite size area where received vaccine, no fever, no other issues. No drainage, no bigger, not painful. 2 days later had lump there.
60 year old female history of SLE came here after getting Flu shot vaccine with ascending numbness in both lower extremities.
Headache, fever, chills, fatigue around 18 hours after shot. Additionally, I woke up the morning after to pain in my toe, which spread to my foot and groin lymph nodes. I eventually went to the ER and was told my toe was infected. I had previously had a small cut on my toe and the doctor believes that the inflammatory response my body initiated from the vaccine exacerbated this infection.
This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of VAQTA injection (lot #K007827 with expiration date 09-DEC-2016, Lot# K008254 with expiration date 12-NOV-2015 and Lot# K005323 with expiration date 10-FEB-2017; dose and route were not provided). There was no concomitant medication reported. It was unknown if the patient sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
There is constant around the clock severe disabling pain in the right shoulder and arm.  Pain is burning and preventing sleep . Activities are limited because of pain. Unable to shower or move normally. Needs meds for pain every hour and a half.  There is nothing that really relieved this pain. Muscles of the shoulder and skin are extremely tender to touch. There is no rash over the skin, no trauma or injury to explain such constant pain. The pain started 4 hours after the booster and is present to date.
Next day Chills; extremely tender arm at injection site; hot sweats; achy body; nausea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received bnt162b2 (BNT162B2) solution for injection, (Batch/Lot number: unknown) dose 2 via unspecified route of administration in arm right, administration date 21Apr2021 12:00 at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, pregnant; "pregnant" (unspecified if ongoing), notes: Other medical history: Asthma, pregnant. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30May2021. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". Vaccination history included: Bnt162b2 (Dose number: 1) solution for injection, (Batch/Lot number: unknown) dose 1 via unspecified route of administration on an unspecified date, when the patient was 31 years old, for Covid-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "Next day Chills"; INJECTION SITE PAIN (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "extremely tender arm at injection site"; HYPERHIDROSIS (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "hot sweats"; PAIN (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "achy body"; NAUSEA (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "nausea"; DECREASED APPETITE (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "loss of appetite". Therapeutic measures were not taken as a result of chills, injection site pain, hyperhidrosis, nausea, decreased appetite.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Days 1-3 severe headache and weakness.  Starting Day 4 severe muscle weakness, muscle pain, muscle spasms, shortness of breath.   My symptoms seem to correspond to a diagnosis of Rhabdomyolysis and I am now undergoing regular IV infusions to help with my pain and weakness via a local Hematologist.   Symptoms Continue even today which is now 26 days post vaccine.  I still have difficultly walking any distance and have severe muscle pain
Pt vaccinated with Recombivax developed nausea, diarrhea progressing to tightness in throat & chest, "breathing was an effort" palpitations. Went to ER Given Benedryl; IV started; ABG's done & lab work. Followed w/ own MD - dx vaccine rxn.
Patient described having itching hives that looked irritated and caused discomfort after getting the influenza and shingles vaccines. She did not specify when the symptoms started. Recommended for patient to seek medical attention at the closest urgent care or hospital and gave her the address and office hours and offered to give recommendations for over the counter medications to treat the symptoms, however she refused and stated she preferred another to visit a physician.
PSEUDO-GOUT  DIAGNOSIS AFTER MY SECOND SHOT.    I WAS WALKING WELL AND EVEN RUNNING A LITTLE A FEW MONTHS AFTER MY KNEE SURGERY. AFTER MY FIRST SHOT MY KNEE STARTED TO BOTHER ME AFTER THE SECOND SHOT I COULD NOT WALK. I THOUGHT I WORKED IT TOO HARD BUT THEY FOUND CALCIUM PYROPHOSATE CRYSTALS IN THE FLUID AROUND MY KNEE.   I am not alone. The pro ball player caught it too.
I had a post in place I had surgery a couple of years ago and I had some permanent stitches. I noticed two cysts that were underneath my breast on the right side. They were painful as they got bigger. They were very large lumps. The doctor tried to drain the cysts which was 32CCs of fluid. I was OK for a few days and then something burst and a stitch came out. I returned to have some more stitches removed on 06/16/2021. The doctor said the stitches must have been permanent stiches from my previous surgery, but he was not sure where they came from. He had to explore to find the remaining stitches. The cysts were just fluid filled on Mammogram. I had a Breast Ultrasound in January of 2021 and there was no evidence of the cysts then. I also had a problem with a post for a dental implant. I have two implants on my right upper dental. I was getting a dental exam and there was a problem with my implant. My gums were very irritated around my implants. This was in the spring at the same time as the cysts were present. I don't know if my system was rejecting foreign bodies.
Received a dose on day 30 after the expiration time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose on day 30 after the expiration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 46-year-old male patient (race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the second injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
pt recvd flu vax & 6 days later was real ill from then until 5MAR t100-103.5 24 hrs day; went into hosp 15NOV93; ATB for 40 days; temp cont; hosp 16FEB-26; vasculitis from virus; 4MAY blood clot; no sx of cold or illness until took flu shot