chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; This is a spontaneous report received from a contactable other hcp. A 48-years-old female patient received first dose of  (Solution for injection), via an unspecified route of administration, administered in Arm Left on 26 Jan 2021 18:30 as single dose for Covid-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Concomitant medications included Hydrochlorothiazide and Betahistine. It was reported that patient was not pregnant at the time event. On 26 Jan 2021, the patient experienced red hives starting at neck and chest and radiating to arms and face, lightheaded and swollen tongue. The events were non-serious. Patient received Benadryl as treatment for events. It was reported that patient was not taken any vaccine in four weeks nor had Covid and tested the same post to vaccination. Outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
Flu like symptoms; very hot to touch; Vaccination site itchy; Headache; Injection site was very red; Injection site rash; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Injection site was very red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included INSULIN GLARGINE (LANTUS), METOPROLOL TARTRATE, AMLODIPINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash) had resolved.            Patient reported that the side effects healed after couple of days.  Treatment medications was not provided by the reporter   This case was linked to MOD-2021-030690 (Patient Link).
pt recv vax & 10 mins p/vax pt exp dizziness, shaking, nausea, tightness in the chest when breathing, tachypnea & chills; tx w/Visteril;
pt exp gen patches of hives over torso, neck, legs, lt deltoid erythema, large as described by PMD office;
its 3.5 inch red circle around injection; I got itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I got itchy arm) and INJECTION SITE ERYTHEMA (its 3.5 inch red circle around injection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN, AMLODIPINE, LEVOTHYROXINE, FOLIC ACID, ZINC, MAGNESIUM, POTASSIUM and VITAMIN B COMPLEX for an unknown indication, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL F), APPLE CIDER VINEGAR, ASCORBIC ACID, DOCOSAHEXAENOIC ACID, VITAMIN E NOS, XANTOFYL, ZEAXANTHIN, ZINC (OCUVITE MAX), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LOSARTAN, TAMSULOSIN, TERAZOSIN, ALLOPURINOL, TRAZODONE and HYDROCODONE.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (I got itchy arm). On 14-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (its 3.5 inch red circle around injection). At the time of the report, PRURITUS (I got itchy arm) and INJECTION SITE ERYTHEMA (its 3.5 inch red circle around injection) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
This spontaneous case, initially received on 15-Oct-2018, reported by a non-healthcare professional concerns a 63-year-old adult male patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 12-Oct-2018, at 3 PM, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location, batch number and expiry date: not reported]. It was reported that the patient was okay on the weekend. On 15-Oct-2018, in the morning, 3 days after vaccination, the patient developed a reaction to the vaccine and felt dizzy, so he went back to bed. Later, on the same day, the patient experienced dry heaving when he went to work. It was reported that the patient also experienced a headache and dizziness, but no fever. The dizziness at the time of the call had subsided. The patient did not receive any treatment associated with the event. At the time of this report, the patient had recovered from the event dizziness. The outcome of the event dry heaving and headache was not reported. The reporter assessed this case as non-serious.
Weird feeling came over me. Check Blood pressure it was good. Went to an appt with mother was told temp at 102.4 this was 2 1/2 hours after shot. Also had vision loss by 25% for 2 days. Weird feeling stayed with me for as ling as eyes were acting up.
Patient developed rapid onset of dyspnea, light headedness and tachycardia. Was taken to the ED where she was treated with an antihistamine and IV fluids.  Symptoms resolved.  6 days after the vaccine, was having shortness of breath and left arm pain (not the arm where injection was received) and was diagnosed with a pulmonary embolism.
Patient developed fever (101-103.5) after receiving immunizations. Also developed redness around injection site.
ABOUT 30 MINUTS AFTER VACCINE, PATIENT REPORTS STRANGE TASTE IN HER MOUTH.  STATES FOOD NOW TASTES "FUNNY"-DOESN'T TASTE THE WAY IT USED TO.  SYMPTOMS ONGOING.  DID NOT SEEK MEDICAL ATTENTION.
Severe joint pain all joints except shoulders, 3 severe headaches within 1 week. Deep lower back pain (excrutiating). Continued for nearly 2 months
pt recv vax & following vax pt exp a rise in sugar levels;pt vaccinated w/2 more doses of vax & exp consistent rise in blood sugar following each dose;SEP96 lab eval was negative for anti-HBs;
Patient under age of 18 received Moderna vaccine, which is not approved for patients >18 years old. Pt reports no adverse medical effects from vaccine.
Med error. Patient received infant/toddler dose of Moderna instead of the adult concentration dose.
TOOK GARDASIL VACCINE FEB 2007 WHEN I WAS 25. I WAS A VIRGIN AND HAD NO PRIOR ABNORMAL PAPS OR HEALTH PROBLEMS. MY LEG DEVELOPED A HUNDRED PINPOINT WARTS JUNE/JULY 2007 AND WENT TO DERMATOLOGIST. TOOK 1 1/2 YEARS TO GO AWAY. MY FIRST ABNORMAL PAP SMEAR  WAS THAT FALL, SEPT 2007. BIOPSY SHOWED MILD DYSPLASIA. WENT AWAY AFTER 6 MONTHS BUT MILD DYSPLASIA CAME BACK IN SEPT. 2009. NEED SURGERY NOW TO REMOVE PRECANCER CELLS IN CERVIX. ALSO DEVELOPED MONO, STREP THROAT SEVERAL TIMES, URINARY TRACT INFECTIONS, AND FIRST YEAST INFECTION SINCE TAKING VACCINE SHORTLY AFTER. NEVER FELT THE SAME SINCE.
stated that p/vax pt suddenly limp in moms arms; father thought pt was sleeping; pt was in & out of consciousness x 10 mins; mom states did not seek medical help
New onset hematochezia  & diarrhea began 1wk after vaccine #1. Underwent colonoscopy w/ GI MD on 3/19/21, now diagnosed w/ ulcerative colitis. Post procedure had to undergo 1 month of enemas, two months of steroids, now life long mesalamine therapy.  Will need ongoing stool samples & colonoscopies indefinitely
UPON ARRIVAL TO THE OBSERVATION AREA PT BEGAN TO FEEL DIZZINESS, DIAPHORETIC, HEART RACING AND NAUSEA
Approx 1 week after first vaccine patient noticed a lump/lesion on left side of neck. It was tender and itchy. One week after that (approx 2 weeks after vaccine) broke out in rash from head to toe. Required dermatology appointment and subsequent skin biopsy with a 21-day course of steroids. Skin biopsy results done on 9/15/2021 showed reactive lymphoid infiltrate including to a drug eruption.
Mild headache, slight nausea, fatigue, sore shoulder near injection site. All symptoms lasted less than 24 hours.
Swollen red, itchy lump - Now gone  Now having severe injection site/arm pain for last 3 weeks. I work in the health care field so I was able to get my vaccine early. I do not have any redness or lumps now. It is slightly warm to touch, but when pressed it seems to sink in some. It is a dull ache which keeps me sleeping on my back. It has not gotten any better. I will reach out to my primary soon.
This spontaneous report was received from a registered nurse via company representative concerning a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitants therapies. On an unknown date, the patient was vaccinated with both VARIVAX and PROQUAD, (dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
The vaccine was given during a time frame where the Local Health Department found there was a refrigerator excursion.
left breast tenderness/tenderness in her breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol was high" (unspecified if ongoing), notes: Verbatim: Cholesterol was high.; "She is pre-diabetic" (unspecified if ongoing), notes: Verbatim: She is pre-diabetic. The patient's concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious) with onset 2021, outcome "unknown", described as "left breast tenderness/tenderness in her breast". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she got the first dose, waited the recommended 7 weeks and got the second dose on 01Dec2021. Patient was experienced tenderness in her breast after the first dose. Stated that the week after the second dose she had chest pain. Patient went to her doctor and got an EKG. Stated that her blood pressure was normal but she still has chest pain. Patient has a doctor's appointment at 1:30 and does not know if she needed to go on a beta blocker. Patient cannot get a cardiologist appointment because everyone is backed up for a month. Patient was upset that she went to the vaccine place and they give you documents and they should have this noted on first page and it was on the third page. Patient thought that pain would go away and it has not. It has been three weeks. The other women only had breast tenderness and she has heart constrictions and cannot sleep at night. Tenderness with the first dose was in her left breast on the side. Stated that she now has chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878670 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878669 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878634 Same reporter/ drug/ event for different patients.
Pulmonary Embolism on right (HCC) - Multi Blood Clods on the right lung
The pt was hospitalized for thrombocytopenia, platelets were 14,000 on admission. Was re-hospitalized for platelets below 50,000. Per F/U 6/21/01: The mother had taken the pt to the doctor on 8/8/00, after noticing that the pt had a bruise on his chest that was increasing in size. She did not know how the bruise began. She stated that she had put him to sleep on 8/7/00 and when he woke up, she noticed the bruise. The pt has a history of bruising easily beginning at 6 months of age. The mother states that the pt is very active, plays hard and gets bruised easily. In the past month, she has also noticed that the pt has had epistaxis X 2 and in the past few days, he had a small amount of bleeding from his gums. The pt is twin number 1 of a pair and his sister has not had any similar problems. The pt has never seen a specialist regarding his bruises. He had no hematemesis, no hematuria and no blood in his stools. The mother also states that the pt has had 18 ear infections in the past year. He was not treated with PE tubes for these infections. His twin also had recurrent ear infections but not as many. Prior to admission, the pt had no fever, nausea or vomiting and no rhinorrhea or cough. On exam: The pt had a erythematous, papular rash present over perianal area surrounding buttocks. Skin with multiple bruises in different stages of healing and petechiae on the chest and face. Per mother, he was having more difficulty walking than usual. After IV IP, the pt responded to IV IG and after approx. 20 hours, platelets came on up. The pt should follow-up in Hematology Clinic and also be seen immediately and have is platelets checked, if he has further brusising and bleeding.
Information has been received from a physician concerning a 22 year old female with no medical history and no concurrent conditions, who on 11-JAN-2008 was vaccinated with a second dose of Gardasil (Lot# 659653/1448U).  Concomitant therapy included prenatal vitamins (unspecified).  Subsequently, the patient was pregnant.  The estimated conception date was 12-DEC-2007, the patient's last menstrual period was 28-NOV-2007, and the estimated delivery date was 03-SEP-2008.  On 11-JAN-2008 an ultrasound was performed and showed one gestational sac, and was positive for yolksac fetal pole.  On 31-JAN-2008 and 01-FEB-2008 repeat ultrasounds were performed and showed a single intrauterine pregnancy, crown-rump length (CRL) was approximately 7.9 weeks, there was no fetal heart tones with embryonic demise.  The patient did not have any previous pregnancies and no full-term deliveries.  On 08-FEB-2008 the patient experienced a spontaneous abortion nine weeks and one day from her last menstrual period.  The products of conception were examined and were normal appearing. The fetus was not normal due to chromosomes 69XXY.  At the time of the report, the outcome of the patient was unknown.  Upon internal review spontaneous intrauterine embryonic demise was considered to be an other important medical event.  Additional information has been requested.
Felt paralyzed, left foot paralyzed. Second day. Third day woke up with rashes all over. Has graves? disease and overactive thyroid.
swollen red hard and paiful area above the nipple. This happened after the first shot and went away after a couple of day, though thqt one was on my other nipple.
My shoulder is in a lot of pain I can't lift it and, it feels like some is torn in my shoulder and a little pain in my arm but in my shoulder bad when I lift it there is a lot of pain.
IN THE MORNING OF 7/25/19, PT'S SON CAME TO TELL ME THAT HIS MOM HAVE "BAD CHILLS" ALL NIGHT AND SEVER PAIN AT SITE OF INJECTION, I TOLD SON TO TELL PT TO TAKE TYLENO, AND DO COLD COMPRESSES.  THE SON ASK ME  SHOULD PT NEED HER SECOND DOSE, I TOLD HIM I WILL DO RESEARCH AND CALL THEM BACK
This spontaneous report as received from a 80 year old male physician with high cholesterol and latex allergy reporting on himself. The patient was retired as a physician. The physician reported that "about 15 years ago" he volunteered to be in a clinical study with ZOSTAVAX at the end of the study he found out that he received the placebo so he stated that after the study was completed, he was eligible to receive ZOSTAVAX. The physician stated that he received a dose of ZOSTAVAX after the study was completed. On an unspecified day approximately in 2000 (reported as "about 15 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose, route and frequency not reported). Concomitant therapies included pravastatin sodium, LUMIGAN, aspirin, multivitamins (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate and CoQ10. In approximately 19-DEC-2014 (reported as "about two weeks ago"), the physician was diagnosed with shingles on the left side of his scalp by his dermatologist. The physician stated that he developed itching and pain on the left side of his scalp "a couple of days prior" to being seen by his dermatologist. He was prescribed "probetathal propionate" topical solution for the itching on his scalp on an unspecified date as well as he applied desonide cream an unspecified amount of times to his scalp for the itching as well since an unspecified date. On approximately 23-DEC-2014 (reported as "about ten days ago"), the physician had a biopsy of the shingles on his scalp and was awaiting the results. At the time of the report, the patient was reported as recovering from shingles. No further information was provided. Additional information has been requested.
Had vaccine on February 13, 2003 with a major take, had an enlarged lymph node under left arm and minor fatigue that is still noted.  On Saturday April 5, 2003 started having severe pain in tail bone, but no memory of injury or fall.  On Sunday April 6, 2003 went to ER  and a xray of the coccyx was done and showed no fractures but showed inflammation which was treated with an injection and 2 prescriptions, Bextra and Percocet.  Off from work on Monday April 7, 2003.  On Wednesday went to Family Dr. for routine 6 month blood work (has taken 20-40 mg. Zocor for about 2 years, Levoxil, and INH for Positive skin test since January 2003.)  Lab results showed Alk. P. 211, SGPT 874, and SGOT 666.  Family Dr. and TB clinic Dr. recommended to stop all meds except Levoxil for Thyroid problems (had Thyroid removed in 2001). Thyroid levels at blood work was within the normal range and Cholesterol level was 274. Due to return to Family Dr. for repete blood work on Wednesday April 16, 2003.
had a PCR test and yesterday test came back positive; had a PCR test and yesterday test came back positive; This is a spontaneous case received from a female consumer. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: unknown) and second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: unknown), both via an unspecified route of administration on an unspecified date at a single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a pcr test and yesterday test came back positive. The patient underwent lab tests and procedures which included PCR test was positive on 13Apr2021.The outcome of the events was unknown.  Follow-up actions are closed.Further information cannot be obtained.
After receiving vaccines while checking out of office, he fainted. Came to very quickly, rested for 15 minutes, then mom took home. Small superficial abrasion left temple. Next day he began complaining of right sided lower back pain and feeling light-headed.  No other sx.  Sx subsiding as of 2/25/13.
EMPLOYEE BEGAN FEELING ATYPICAL. AFTER FALLING ASLEEP, SHE AWOKE SWEATING, FATIGUED AND WITH BODY ACHES. IN THE MORNING, SHE HAD A HEADACHE WITH MUSCLE ACHES BUT HAS IMPROVED
Fevers, chills, headache, myalgias, loss of taste and smell, nasal congestion. I tested positive for Covid-19 on 1/1/21. Again, I later found out that I was exposed to someone who tested positive on 12/24/20 and at the time did not have a mask on.
3 hours after vaccine administration, developed a raised, red, warm, urticarial, pruritic rash on the leg in which she got the shot.  She did not have a rash anywhere else and had no other symptoms.
Muscle aches and pain and weakness. Pt rested to recover. Took TYLENOL 500 mg 1 dose only. Per pt did strenuous long walk for 2 miles then got sick.
soreness @ inject site initially w/in 24 hrs devel numbness down rt arm to the thumb; some edema of thumb & wrist; fingers sore some weakness; unable to open a jar; some discoloration of the fingers for a few days; itchy rash on face;
Patient reported that three weeks after receiving first COVID vaccine, she experienced sever abdominal pain for 3-4 days. She said it would go away for a few days, then return. This happened 3 times over a three and a half week period.
SOME CHILLS; TIREDNESS; SLIGHT HEADACHE; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced some chills. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced slight headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, slight headache and some chills was not reported. This report was non-serious.
Pt received initial dose of vaccine on March 16, 2021. Pt received the second dose on April 15, 2021. Pt had CVA on  April 16, 2021 affecting right hand and lower arm with generalized weakness. Pt was fully cognizant at this time.  Pt developed pneumonia and was hospitalized in ICU on April 29,2021, requiring ventilation support. Pt died May 6, 2021.
PATIENT WAS IN OFFICE WITH SIBLINGS, PT, WAS LAST TO BE VACCINATED, DID NOT VERIFY PATIENT NAME BEFORE GIVING VACCINES, PT. RECEIVED IMMUNIZATIONS THAT BROTHER WAS SUPPOSED TO RECEIVE. PATIENT HAD ALREADY RECEIVED THESE IMMUNIZATIONS BEFORE. MOM STATED THIS WAS NOT THAT PATIENT AFTER PT. WAS GIVEN VACCINES. NOTIFIED MOM THAT HE DID RECEIVE THE DTAP-IPV AND MMRV AND THIS WAS NOT WHAT HE WAS DUE FOR. NOTIFIED PHYSICIAN ABOUT VACCINE ERROR. NOTIFIED MOM TO CALL IF ANY CONCERNS.
Hives on bilateral arms, neck, scalp, and torso, very itchy, started at injection site on right arm the day after injection then spread to other areas.  Treating with Prednisone taper, has just begun treatment