chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 year old female who on 14-JAN-2010 was vaccinated with a second dose of GARDASIL. About 20 minutes after receiving GARDASIL, when the patient was at home, she called the office back and reported that she was experiencing lots of dizziness and lots of nausea. The patient was advised to come into the office on 15-JAN-2010 or go to the hospital if she still felt dizzy and nauseous. As of 15-JAN-2010, the patient was still feeling dizziness and nausea and went back to the office. Follow up information was received from an administrator which reported that the physician did not remember who the patient was and did not have any further information. Follow up information was received from the physician which reported that the 16 year old female patient experienced dizziness and nausea after GARDASIL. The symptoms were not immediately started but the physician could not recall when the symptoms started in relation with when the vaccine was administered. No labs were performed. The patient's dizziness and nausea much improved shortly after ("over 24 hours"). No further information is available.
Soreness that was much worse than the first time, shivering, headache, neck pain, joint pain feeling like a sprain, pain to the touch no matter the position so I couldn't sleep. I didn't experience this on the first dose. Pain is less now so I'm sure I'll be better soon. Just wanted to report this.
Early the morning following the vaccination had acute headache that lasted through Sunday. I rarely get headaches. Also, general ache and flu-like symptoms accompanied. Monday morning, I had a episode of Transient Global Amnesia and went to the emergency room for a quick onset and intense loss of memory. This lasted for about 2-3 hours and subsided, returning to normal by late day.
large circular area 2 1/2 in w/3/4 in, red, warm & firm rt lateral upper thigh; swelling & redness has subsided only a bruise remaining;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 83-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC 2021, JAN 2022, and FEB 2022. Reporter said that they are filling out a temperature excursion assessment at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
A sore left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (A sore left arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B) for COVID-19 prophylaxis.     Concurrent medical conditions included Cirrhosis of liver and Hepatitis C.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (A sore left arm). At the time of the report, VACCINATION SITE PAIN (A sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received second dose of his primary series on 18-May-2021 (lot number 038C21A). Patient received in left deltoid.  The patient received first Moderna booster dose on 15-Aug-2022 (lot number 017B22A). Patient received vaccine in the left arm deltoid.   Treatment information was not provided.   This case was linked to MOD-2022-649967 (Patient Link).
Itchy spot at site of the injection 7 days after receiving vaccine. Area is painful and becoming slightly swollen, tender to the touch, hardened, and area is warm. Slight swelling on neck very close to the collarbone.
3 hours of uncontrollable, inconsolable crying. Afebrile. No local reaction.
3 hours after Vaccine...Began to ache and feel very tired 12 hours after Vaccine...ached at all joints , headache , very tired, no energy 24 hours after Vaccine...Began to vomit and experience diarrhea 36 hours after Vaccine...No energy or strength to stand, high fever, begin to talk non sensical, skin turning yellow 39 hours after Vaccine...Called 911
Mother t/c this A.M. regarding rash that appeared on this child approximately 48 hrs. after IZS (9/18/12) given. Mother stated it lasted about 3 days. Treated with antihistamine, resolved. No M.D. visit.
COVID- 19 Treatment; COVID- 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old patient received BNT162b2 (BNT162B2), on 02May2022 at 16:00 as dose 4 (booster), single (Lot number: Pk9893) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myocardial ischaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 04Jun2020, stop date: 07Jun2022; LISINOPRIL, start date: 04Jun2022, stop date: 22Jun2022; BUPROPION, start date: 30Jun2010, stop date: 22Jun2022; CARVIDOL, start date: 04Jun2020, stop date: 22Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 11 years 11 months 21 days after the suspect product(s) administration, outcome "recovering" and all described as "COVID- 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medical history: Ischemic heart disease.
Client presented in clinic on 4/3/09 @ 10:45 AM c/o swelling and redness of left arm. Client denies difficulty breathing and negative for rashes. Client advised to continue TYLENOL and warm and cold packs to arm. Enc to follow up with physician for any further symptoms and seek emergency TX if having difficulty breathing or Hive reaction.
MS relapse; This case was reported by a pharmacist and described the occurrence of multiple sclerosis relapse in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of multiple sclerosis relapse (for tolerance, refer case US2019AMR179704). Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced multiple sclerosis relapse (serious criteria GSK medically significant). The patient was treated with prednisolone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the multiple sclerosis relapse was unknown.   It was unknown if the reporter considered the multiple sclerosis relapse to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient recently received the Shingrix vaccinations and each time the patient got the vaccine and started in on an multiple sclerosis (MS) relapse the day after the vaccination. The relapses were curtailed by Prednisone. This left wondering the patient if other MS patients, or those with other autoimmune diseases, had been having similar adverse reactions to the Shingrix vaccine.
Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and feet bilat; primarily feet and primarily when he sat down. Also reported mild brief blotchiness to bilat lower forearms.  Narrative: Mildly anxious, mild reactions to which he was unsure if he should return to vaccination site or not. Denied dizziness, light-headedness, palpitations. Reported mild feeling of a 'rush' "kind of feeling, like, stimulated". VS: at 13:46: BP 14977. O2 99%, P 79, T 36.3. Reported he had been continuing doing his duties without difficulty but didn't know if he should be concerned. Noted blotchiness on forearms under different lighting when he went to restroom. Blotchiness mild to moderate and mostly resolved before he left. VS at 14:02: BP 136/69, O2 99%, P 80, T 36.7. Reported tingling mostly resolved if he stretches his legs out some. Reported anxiety over "the whole thing. It's just weird and I've been excited about the vaccine". Reviewed S/S to be aware of, when to seek medical attention and that he was feeling completely stable and comfortable before he left. Positively reactive to increased information and seeing improvement in blotchiness. Left at 14:08.
A small bump circular in shape is palpable at injections site.  Also a red circle formed around (bigger that the bump), and the area is hardened and painful.   The person could not raise the arm either.  It last approximately 5 to 7 days to improve symptoms.   But still painful for approximately 3 weeks (at the time for the 2nd dose).    The situation repeated with 2nd dose in the other arm (will report separately).
Information has been received from a nurse practitioner concerning a female with a family history of, "mother fainting when blood is drawn or has a shot" who was vaccinated with a first dose of Gardasil. Subsequently the patient fainted. Subsequently on the same day as the vaccination the patient recovered. Additional information has been requested.
muscle aches/aches; fatigue; mental fatigue "in a fog"; mental fatigue "in a fog"; 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 65 year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (12Mar2021), described as "muscle aches/aches"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (12Mar2021), described as "fatigue"; MENTAL FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset Mar2021, outcome "recovered" (12Mar2021) and all described as "mental fatigue "in a fog"".  Additional information: Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 08Mar2021. This was on a Monday, and reported that throughout the rest of the week until Friday (12Mar2021), he experienced muscle aches, fatigue (especially mental fatigue "in a fog"). He reported that he had mild list of things that could go wrong, like aches, and a lot of fatigue and mental fatigue. It passed. There was nothing serious enough to make him go to the hospital. He did not have fever, and just aches. It was mostly just the fatigue and mental fatigue.  He was in a fog for several days.  He didn't know if that was common or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a 52 year old female patient enrolled in a market research, reporting on herself. Patient's concurrent condition included diabetes mellitus. Information regarding her medical history and concomitant therapy was not provided. On 29-OCT-2015 the patient was administered with ZOSTAVAX (dosing details unspecified). On 30-OCT-2015, the patient experienced redness, swelling and pain at the vaccine injection site. Outcome of the events were reported as recovering. Reporter considered the events to be non-serious and related to ZOSTAVAX. Additional information is not expected. There was no consent for follow up.
pt recvd vax & glands under chin on right side were beginning to swell; pt felt warm to touch & was fussy; pt taken to MD & dx w/ reactionary mumps; pt vomited at night; pancreatis;
1st dose on 3/4/21 complained of left arm redness at the injection site raised area on 3/8/21, lasted 4 days.
Case number PHEH2012US020262, is an initial spontaneous report received from a health care professional on 08 Oct 2012. This report refers to a patient (unknown age and gender). The patient was vaccinated with only the Men CYW-135 liquid conjugate component of MENVEO (batch number: 11032) intramuscular, did not receive the MenA lyophilized conjugate on 08 Oct 2012. No adverse event was reported following this medication error.
Shot given left anterior thigh - redness and swelling started the next day covering the entire anterior thigh - redness and swelling resolved in 3 - 4 days. Pt. with temp. 100.5.
Varicella rash 6-7 days after vaccine w/VARIVAX. (observation).
This spontaneous report has been received from a nurse prescriber, and refers to a 19 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly for prophylaxis (dose, lot number and expiration date were not reported). On 06-DEC-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly for prophylaxis, lot # N018273, expiration date 17-JUN-2019  (dose and route of administration were not reported). There was not product quality complaint or adverse event involved.
I have been feeling tired since the vaccine and have had a chronic low-grade headache since as well.  Things have been okay until a couple of days ago.  I am a fanatic about skincare.  I developed a water blister-type rash on the right side of my chin ( not in my mouth).  The very next day, my neck started to hurt, and I noticed that my lymph node is swollen on the right side of my neck, just under my jaw.   The blisters have crusted over, but my chin and a bit of my cheek are swollen.
Patient tested positive for Covid on 01/04/2022 and was asymptomatic.  No other records were charted except that there were unspecified underlying health conditions.  Patient died.
Patient presented to emergency department on 10/2/2021 with cough, chest discomfort, and body aches. She had a COVID-19 exposure a week prior. Shew as found to be COVID-19 positive and was admitted for further management. She was treated with remdesivir, decadron, and supplemental oxygen. She was discharged home on 10/6/2021.
PATIENT WAS ADMINISTERED PROQUAD (MMRV) INSTEAD OF THE SEPERATE MMR AND VARICELLA.   NO TREATMENT INDICATED. PATIENT DOES NOT REQUIRE REIMMUNIZATION PER MANUFACTURER.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 02-OCT-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Vaccine administered by school RN at school.  Tdap and MCV4 IM in Right Deltoid on a Friday afternoon.  On Monday morning, student came to school health office and showed reaction on arm.  Student stated it occurred Friday night and there had been no change over the weekend (not worse or better.)  Denied fever.  Swollen reddened area around site of injection, ~5X5 area.  Spoke with mother and gave ibuprofen and iced twice during day.  Area around injection less swollen and less red and decreased in size.  At 2 pm on Monday, student returned and showed me a new area of redness and swelling on top of right shoulder.  Redness did not connect to original reaction site.  Two white raised areas in middle of reddened circle, ~3x3 in size.  Appeared allergic.  Also eyelids swollen and itchy.  Spoke with mom and gave Benadryl.  Mom took to urgent care that afternoon and was told by doctor that reaction was too long from immunization administration to be related.  Given antibiotic for phlebitis at injection site.  Allergic area on shoulder and eyes resolved after Benadryl administration and did not return.
I received the vaccine and within 20 minutes I started seeing dots and that lasted about two hours. I was also very dizzy and had terrible body aches right after the shot and that lasted about three hours. I took ibuprofen for those issues and it helped but it was still there. That all continued the rest of the day, after I went to bed and woke up the next morning and that's when I felt better.
Took shot on December 30th, 2020. January 3rd night I went to bed with bumps on the back of my head and itching pretty bad. I woke up sometime during the night and realized my top lip was swollen. When I got up the next morning my head was still itching and my top lip was still swollen.  Monday, January 4th, 2021, I began having? Dime sized? Rep spots come up on my body all over that itched pretty bad.  January 7th, my injection site turned really red and began to swell. I called my primary care physician and he immediately put me on some meds, both prescription and otc. The symptoms subsided January 9th. January 10th, I began to notice red spots began to appear again and itch. I continued the meds prescribed and thought it would go away, it did not and a few more appeared. Thursday, January 14, my left hand between my thumb and pointer finger began to hurt and turn red.  A few hours later the same thing began happening to my right hand. They both began to swell, itch, and turn hot. This lasted all Thursday night and part of Friday morning, and then the swelling, and itching, began moving into both wrist and forearms.  Both wrist and forearms turned red and were swollen mid way up the arm. The swelling subsided Saturday night, January 16th. The morning of Sunday, January 17th, my right foot became very tender and painful to walk.  I removed my sock and had a considerable red rash on the inside and bottom of my arch that was hot to the touch and itching.  A few hours later, a rash developed on the left side of my left foot, but not as painful or large. During this whole time, I have continued to have rashes and bumps appear all over my body, with them coming and going, usually lasting about 2 days.
HEART RATE HIGH; CHILLS; DIFFICULTY BREATHING/SHORTNESS OF BREATH; COUGHING; FEELING ANXIOUS; HEADACHE; FEELING UNWELL; INJECTION SITE SORE; INJECTION SITE WARMTH; FATIGUE; TIREDNESS; This spontaneous report received from a patient concerned a 54 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site warmth. On 08-APR-2021, the subject experienced injection site sore. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced feeling unwell. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced difficulty breathing/shortness of breath. On 12-APR-2021, the subject experienced coughing. On 12-APR-2021, the subject experienced feeling anxious. On 13-APR-2021, the subject experienced heart rate high. On 13-APR-2021, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) unknown, and Pulse rate (NR: not provided) 105. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of injection site sore, injection site warmth, fatigue, difficulty breathing/shortness of breath, coughing, heart rate high, tiredness, feeling unwell, chills and feeling anxious was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
COVID + on 12/1  when admitted and then discharged on 12/17. Readmitted on 12/20 for sepsis due to aspiration pneumonia. Bronshoxcopy done and admitted to Critical care. Had pink urine since starting eliquis during last admission for acute PE.  Converted to heoparin drip bu develiped gross hematuria , heparin stopped. Hematuria resolved on 12/27 and heparing restarted. Completed a full cours of antibiotics for pneumonia.Respiratory staus continued to decline. Decreasing BP and poorly controlled heart rate evaluated by cardiology. - metopralol and lasix given. CT thorax showed moderate bilateral effusions with atelectatic collapes of the lowe r and right middle lobe. Continued need fo hihg oxygenation. Patient requested comfort care 12/29.
Day after "Flu vaccine" generalized malaise 2 to 3 days later several generalized urticaria. Daily, difficult to control with antihistamines. Saw allergy sp. 2/4/2016. Work up negative. First episode. Has had flu shot in past.