chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First noticed a sore back of the mouth, my throat itself did not hurt when swallowing, just the way back of mouth. Then I noticed a rash on the trunk of my body. Below shoulder blades, above panty line. Most red spots on front of body, sporadically spaced. Not itchy. Some spots on back side. Two areas where the spots were more grouped like half inch by 1.5 inch both on left side of body under armpit and top of breast. Otherwise spaced all over like on belly area. Day of shot I was anxious and was a very little dizzy with chest flipping after shot, but could breath fine. I think I noticed the sore throat next the next evening. And maybe the rash the next day after that - not really sure of the timeline. Today is 1 week and 3 days after shot. I still have the rash. The sore throat is much better. Chest still flip flops but not very often - still could be anxiousness.
This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 11:45 (Batch/Lot Number: EL3247) at the age of 45-year-old, as single dose for COVID-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number EL3247) on 20Jan2021. Medical history included food allergy from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norelgestromin (XULANE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity.  The patient experienced within 6 hours of vaccination my tongue started to hurt (sides and underside) and a few sores developed on right side of my tongue (glossodynia) (non-serious) on 10Feb2021 17:30 with outcome of recovering, my tongue are scalloped in appearance (tongue disorder) (non-serious) on 10Feb2021 17:30 with outcome of recovering , glands in my neck are also sore/inflamed (lymphadenopathy) (non-serious) on 10Feb2021 17:30 with outcome of recovering.
Woke up on day 8 with red, swollen, itchy rash at injection site. Approximately 3? in diameter. There was no allergic reaction on days 1-7.
This spontaneous report as received from a nurse refers to a 5 months 22 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as L038503 with expiry date: 18-DEC-2017, intramuscularly. Administered doses of vaccines experienced the temperature excursion of 32.97 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 25 year old female patient with allergies to penicillin and sulfa drugs-unspecified reaction and no pertinent medical history. On 22-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage, route not reported) and experienced no type of reaction, then had a 2nd dose of GARDASIL (lot # J015378, expiration date: 09-APR-2016, dosage and route unknown) administered on 24-JUL-2014 and began to experience "rash, fever, chills, nausea, and joint pain" on an unspecified date after the 2nd administration. Concomitant therapies included NUVARING. Nurse reported that the patient went to an unspecified emergency department on an unspecified date for treatment due to the symptoms but did not know if the patient was admitted to the hospital. No lab diagnostics studies was performed. Nurse reported that the patient was treated with MOTRIN (unspecified dose and frequency) for fever and ZOFRAN (unspecified dose and frequency) for nausea. Nurse reported that the patient stated on the reporting day, 01-AUG-2014, that she was recovering from the symptoms. Additional information has been requested.
Patient was sitting and state she felt she was going to passout. Patient became very pale in the face, took blood pressure and it was 80/55.
Per parents, soon after vaccine administration, patient had blisters (3) around injection site and approximately 3-4cm2 area of redness for several days.
Medication error - reached the patient no harm, additional monitoring to preclude harm.  A nurse (RN) diluted new vial of vaccine at 10:41 am. In the midst of adding diluent to vaccine vial, a patient arrived at our vaccine station. After drawing up and administering the 0.3 ml vaccine the RN looked at the vial again and noted that it was almost empty. She became concerned because she had just mixed a new vial and the amount of fluid remaining was not at the expected level. We immediately stopped and reported this to an employee who contacted pharmacy. We notified the patient that there was a discrepancy and had him wait for > 30 minutes to watch for any reaction. (APRN) called him at 1:30p to check on him and apprise him of the possibility of receiving higher than recommended concentration of vaccine. He stated he felt fine and felt no unusual symptoms.
The vaccine given was the wrong vaccine. Patient was to receive PCV13 and was given HPV.
After the needle entered his arm, there was fluid that ran to the back of his arm to the elbow; This spontaneous case was reported by a patient family member or friend and describes the occurrence of UNDERDOSE (After the needle entered his arm, there was fluid that ran to the back of his arm to the elbow) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced UNDERDOSE (After the needle entered his arm, there was fluid that ran to the back of his arm to the elbow). On 04-Mar-2021, UNDERDOSE (After the needle entered his arm, there was fluid that ran to the back of his arm to the elbow) had resolved.            This report refers to a case of vaccine underdose for mRNA-1273, lot #031M20A, with no associated AEs.; Sender's Comments: This report refers to a case of vaccine underdose for mRNA-1273, lot #031M20A, with no associated AEs.
PT  C/O  DIZZINESS, FATIGUE, AND A PROGRESSIVE TENSION HEADACHE THAT SHE EXPERIENCED  AT THE ONSET OF HER COVID INFECTION. PT DENIES CHEST PAIN OR PRESSURE, SOB, AND PARESTHESIAS. DENIES CHANGES IN VISION. VS @ 1:25 PM BP 140/80 HR 81 SpO2 97% PT DOES NOT APPEAR TO BE IN ACUTE DISTRESS. PT'S HEADACHE IMPROVED 100%.  HER FATIGUE AND LIGHTHEADEDNESS IS PERSISTENT AFTER 10 MIN OF CONTINUED OBSERVATION. DAUGHTER OF PT STATES, THEY WISH TO CONTINUE HER RECOVERY AT HOME. PT D/C FROM OBSERVATION IN STABLE CONDITION.
A few hours after I received my first vaccination, after going to bed, I woke up with deep heart pain. It lasted for about 5 minutes. The next day I was sitting down on the couch and the deep heart pain started again. I took Advil for it and that seemed to help. Each day, for the next 7 days following the night I received the vaccination, I would get the same heart pain randomly and periodically. It wouldn't matter if I was sitting down, laying down or standing up and moving around, it just came on suddenly.  I realized that Advil would ease the pain, so I would take two Advil when the pain started. I had no other symptoms, as in shortness of breath or rapid heart beat, just the deep heart pain. Finally, around the seventh day after getting the vaccine I noticed that the intermittent heart pain was gone.
patient who is 12 days past the recommended time to get the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient who is 12 days past the recommended time to get the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient who is 12 days past the recommended time to get the 2nd dose). On 11-May-2021, PRODUCT DOSE OMISSION ISSUE (patient who is 12 days past the recommended time to get the 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.
This case was reported by a physician and described the occurrence of fever in a male subject in his thirties who was vaccinated with Twinrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The reporting physician denied that the subject had experienced any adverse events following previous vaccinations. On an unspecified date prior to 24 July 2006, the subject received the 1st dose of Twinrix. One day after vaccination with Twinrix, the subject experienced fever of 104 degrees F, myalgia, fatigue and injection site tenderness. At the time of reporting the outcome of the events were unknown.
SPITTING BLOOD FOR PAST 4 MONTHS; BLURRY VISION; DIZZINESS; STOMACH INFLAMMATION; LONGER MENSTRUAL CYCLE; BURNING SENSATION THAT FLOWS AROUND HER HEAD; FEELS LIKE IT IS POPPING ON HER BRAIN; STOMACH ISSUES; TINGLING OF FACE; NUMBNESS OF FACE; COLD SENSATION THAT FLOWS AROUND HER HEAD; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: intrauterine contraceptive device, and concurrent conditions included: nonsmoker, non-alcoholic, and menstrual irregularity, and other pre-existing medical conditions included: The patient does not have any allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced spitting blood for past 4 months. On 12-APR-2021, the patient experienced blurry vision. On 12-APR-2021, the patient experienced dizziness. On 12-APR-2021, the patient experienced stomach inflammation. On 12-APR-2021, the patient experienced longer menstrual cycle. On 12-APR-2021, the patient experienced burning sensation that flows around her head. On 12-APR-2021, the patient experienced feels like it is popping on her brain. On 12-APR-2021, the patient experienced stomach issues. On 12-APR-2021, the patient experienced tingling of face. On 12-APR-2021, the patient experienced numbness of face. On 12-APR-2021, the patient experienced cold sensation that flows around her head. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spitting blood for past 4 months, blurry vision, dizziness, stomach inflammation, numbness of face, tingling of face, longer menstrual cycle, cold sensation that flows around her head, burning sensation that flows around her head, and stomach issues, and the outcome of feels like it is popping on her brain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Patient received the first stick where the hub of the needle was split and the vaccine ran down his arm.  Upon deciding that he had not received any of the vaccine, I administered a second dose bc the hub was split all the way down.   I administered it and left him to go wash my hands.  After about a minute, we heard a loud sound.  When I got to him, he was getting up and was pale. His face was white, hands clammy and sweating.  He did not remember falling.  I took his bp which was 99/65.  My tech went and got him some water.  He started drinking and then vomited.  He said he immediately felt better.  his girlfriend went and got him some juice.  He sat there for about 15 more minutes.  He sated that he felt fine, but he had not had anything to eat or drink that morning.  (also a beer the night before).  He got up and walked out without any help and was going to get him something to eat.  He was hungry.
disseminated papular eruption; Intensely itchy; lesions; This case was reported by a physician via call center representative and described the occurrence of papular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included skin lesion (developed hundreds of lesions initially) and dermatitis allergic. Previously administered products included older immunization with an associated reaction of skin lesion.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced papular rash, pruritus and skin lesion. On an unknown date, the outcome of the papular rash and pruritus were recovering/resolving and the outcome of the skin lesion was unknown.   It was unknown if the reporter considered the papular rash, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the older immunization a few years ago. She had hundreds of lesions initially and diagnosed with dermal hypersensitivity dermatitis on biopsy.  The patient experienced disseminated papular eruption which began 3 days after receiving the Shingrix injection. It was intensely itchy.  The events were better but not clear after treating with 40 mg of prednisone. The patient again started to develop new lesions, 1 month after the initial injection. No patient information or vaccine batch number or expiry date was available. The reporter did not consent to follow-up.      Lab Comments: on an unknown date, biopsy was performed
105 fever for a week. Approximately 5 chicken pox blisters. ER visits on 5/23/2013, 5/26/2013, and early AM on 5/28/2013. Last ER visit had us transferred to another and admitted until release in the late afternoon on 5/30/2013. Patients father, who has already had the chicken pox as a child, contracted a single chicken pox blister the day after the vaccination. Patients mother, who also had the chicken pox as a child, contracted shingles in early June.
This is a spontaneous report from a contactable nurse via a Company representative. This nurse reported for herself. A 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date in 2016 at 0.5 ml, single for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced arm from her elbow up to her shoulder turned red and was swollen on an unspecified date in 2016 with outcome of recovered.  Also the reporter stated that did not think the vaccine was shaken vigorously prior to administration.
Patient was an 87 y/o female admitted for septic shock. She was started on and eventually maxed on 3 pressors. CT abd showed colonic obstruction with dilatation of large and small bowel. Patient was made DNR in the ED. Palliative care consulted on case. Family opted for comfort care.  Patient was asystole on monitor. No spontaneous breath/cardiac sounds ausculted. Patient did not withdraw to pain. Pupils fixed and dilated. She was pronounced and 1230 on 1/28/21
Pt. developed swelling in legs with purple discoloration under skin the day after flu shot given.  Pt. has seen doctor other than Dr., is on oral steroid - tentative diagnosis - allergic purpura.  3/19/08 Reviewed hospital medical records of 12/9-12/13/2007 admission. FINAL DX: Henoch-Scholein purpura, resolving. Records reveal patient experienced swelling & purplish discolortion of legs x several days.  PCP vs of 11/29 dx w/purpura & tx w/steroids.  Cleared lesions but they recurred in addition to discoloration & swelling of scrotum.  Tx w/IV steroids & transfused w/PRBC.  Improved & d/c to home on tapering steroids. .
This spontaneous report was received from an approximately 50 year old licensed practical nurse with no pertinent medical history regarding herself. Current condition of the patient included penicillin allergy. On 30-JAN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose unspecified) outside of the left arm (exact route unspecified). Concomitant medications included trazodone hydrochloride (50 milligrams, at night) and vitamins (unspecified). Approximately on 30-JAN-2013 (less than 24 hours after vaccination), the patient experienced a rash at the site, erythema so bad that it looked like third degree burn, swelling streaking from the injection site of left arm down to the left elbow. Her arm was sore and she now had sore throat and swollen glands. She sought medical attention (went to doctor office) and she was prescribed with an antibiotic (unspecified) and prednisone. No laboratory diagnostic studies were performed. She stated that she was feeling little better but she had swelling to elbow and left arm was warm at the time of reporting. The relatedness for all the reported events was unknown for ZOSTAVAX. Additional information is not expected.
Foggy brain, cognition has decreased.  I have a lot of times I will stop a conversation mid stream due to my mind "going blank, " or the words just will not formulate.  This has been happening since the 1st  shot but has gotten worse and worse. After my 2nd shot it seems to have worsened alot and did not take as long to see symptoms.  Has gotten so bad it is causing me issues at work
Patient describes redness and itching at the injection site on 8/7 then the redness got brighter and swelling bigger to around 2 to 3 inches diameter by 8/9. Patient got concerned and went to see her Primary care Doctor on Friday and she was prescribed AUGMENTIN. She is taking medication since then and she is feeling better. The swelling is going down and she is feeling better.
9-10 days after patient developed diffuse erythematous papular rash. She was also taking amoxicilin for AOM.
1. Severe burning-like pain across right side of torso with no visible rash or skin changes that lasted for 3 weeks, accompanied by vertigo that also lasted the same time. Suggested treatment for shingles, but no rash or any other symptom, and neural pain went away gradually after 3-4 weeks.  2. Joint pain and frozen shoulder on the side of the injection lasting for over 6 months, to be treated with steroid injection and PT.  3. Abnormally heavy periods, no treatment.
Rectal bleeding; Colitis ulcerative aggravated; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) and COLITIS ULCERATIVE (Colitis ulcerative aggravated) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On 10-Feb-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) had not resolved and COLITIS ULCERATIVE (Colitis ulcerative aggravated) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product was reported.   The reporters causality for the events of Rectal bleeding and ulcerative colitis flare with Humira (Adalimumab) was reported as reasonably possible.  No treatment information was provided.  Company comment-This spontaneous case concerns an elderly female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Rectal haemorrhage  and Colitis ulcerative (reported as Colitis ulcerative aggravated) on an unknown date after receiving a dose(dose number not specified) of mRNA-1273 vaccine. Patient had received 1st and 2nd dose of mRNA-1273 vaccine on unknown dates. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Rectal haemorrhage was not resolved and Colitis ulcerative was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Rectal haemorrhage  and Colitis ulcerative (reported as Colitis ulcerative aggravated) on an unknown date after receiving a dose(dose number not specified) of mRNA-1273 vaccine. Patient had received 1st and 2nd dose of mRNA-1273 vaccine on unknown dates. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Rectal haemorrhage was not resolved and Colitis ulcerative was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
pt recv vax 12JUL95 & 20JUL96 pt exp a breakthrough chickenpox rash;rash was scabbed over by 26JUL96;
15 minutes after vaccination, I was severely tired and groggy which was to be expected. That lasted for a few hours then I felt more normal. Around 6.5 hours after vaccination, while standing in my kitchen, I rapidly became very dizzy and fainted, falling to the kitchen floor. My girlfriend was there and said I hit my head on the floor, and was passed out for about 5 seconds before regaining consciousness and slowly coming back to myself. I reminded dizzy for another 20-30 minutes and had to stay laying down, before I was able to come to my feet and feel not dizzy anymore. I had plenty of food and water, so this event felt directly related to the vaccine.
8th of January got shot. achy right arm and swollen for week. 24th took shower whole shot area was red with rash. could see mark where needle went in. felt tired and arm ached.