chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning pain in her thigh; weakness; tiredness; back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) 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: BURNING SENSATION (non-serious) with onset Apr2021, outcome "unknown", described as "burning pain in her thigh"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tiredness"; BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "back pain".  Additional information: Verbatim and Event Description: Caller (Withheld) is reporting adverse events after getting the first dose on Saturday 03APRIL2021, she's experiencing burning pain in her thigh, weakness, tiredness, and back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had DPT/OPV/HIBTITER running 102 temp on 3rd day had sz w/104 temp; Seen in ER w/o any source of infection; No signs of Meningitis; Pt seen in Peds office on 4th day w/103.6 temp.
Patient had itching at the site on 10/7/16. Patient had received flu shots in the past. Patient received the quadrivalent FLUZONE, came to health center on 10/11 with local macular papular rash. Patient given antihistamine and steroid cream. Patient given referrals to allergist for follow up.
Around ~3 days after the vaccination, the spot where the Band-Aid was was reddened and raised in the exact shape of the Band-Aid (no history of being allergic to adhesive of band aids).  Next day there was a non raised 'blotch' of dark red/pink area on the right side of my lower neck.  Next day I had a full body rash/hives that I can best describe it as morbilliform (measles-like) from the neck down all the way to my feet.  It never affected my face.  The rash stayed itchy throughout the day and night.  I required Benadryl multiple times a day with minimal effect.  After ~3 weeks it subsided slowly.  No outpatient treatment sought.  Picture evidence gathered.
On 1/25/21 when patient came for second dose of COVID19 vaccine, patient complained the arm she received the 12/28/20 COVID19 vaccine in continues to be sore.  Soreness started 12/29/20 and was very sore through 12/30/20.  Despite 28 days since first vaccine dose, patient indicates she still has arm soreness, although less than the initial two days following the first dose.
TINGLING/NUMBNESS IN FEET-COLLAPSED @HOME. TESTED IN ER FOR STROKE, HYDROCEPHALITS, ETC.  ALL TESTS NEGATIVE. HOSPITALIZED, CONTINUED AND CONTINUES TO WORSEN. INCOMPLETE DX @ THIS TIME.
The pt developed clinical hypogonadism in 10/99. Treated with testosterone replacement.
On 4/16/2021 patient reported left leg pain began on 4/12/2021. Pharmacist recommended the patient seek medical attention at the nearest emergency room.
After the vaccine came home took 45 min nap felt fine. I had my annual physical in June 2021 all of my bloodwork came back completely crazy. I was advised to retake my bloodwork. My kidneys showed to be in Stage 3 renal failure, white blood count high, platelets extremely low, iron level, calcium level sky high, thyroid numbers was very low not working barely even there. I haven't ever experienced any of this before the vaccine. I have referred to hematologist, oncologist to follow-up and around 40 different blood works done. I got my mammogram done in August 2021 my lymph nodes on left side are enlarged. The doctors can't find anything in my bloodwork; considering doing a bone marrow biopsy. I had no Kidney problems before vaccine and no history in my family. Since the vaccine I changed my diet lost 38lbs and seen a dietician still hasn't helped my anxiety and depression has worsened.
This is a spontaneous report from a contactable physician via Pfizer sales representative. An 80-year-old patient of an unspecified race/ethnicity and gender received PREVNAR 13 (Lot # R49358, Exp. date 30Apr2018), via an unspecified route of administration at single dose in the arm on 14Mar2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced golf ball size lump at injection site, pain and swelling on entire arm, fever, chills, headache. The outcome of the events was unknown.
body ache; chills; headache; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: not reported, expiration date: not reported) via an unspecified route of administration on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient had mild reaction, chills, body ache and headache she wanted to know if she could take Dayquil/Nightquil. Outcome of the events was unknown.   Follow-up attempts are completed. No further information was expected.
Woke up middle of night itching all over, hives.  Did not seek medical attention.  Lasted roughly 1 day.
Tongue swells on and off since April. Multiple painful spots. Resolve onto white circles within 24 hours. Ent referral could not dx Not allergy as can be triggered without food. Bizarre and annoying immune response.
Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizziness; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 07:30am, at the hospital, (at the age of 80-years-old) as single dose for Covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin (about 21 years old, Inflammation and redness, system gets flush), sulfonamide derivatives. The patient previously took aspirin (e.c.), keflex, sulfur, cellcept and experienced hypersensitivity to all. Concomitant medication included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient had inflammation on face, red as a beet, (dermatitis) (non-serious) on an unspecified date with outcome of unknown , malaise (non-serious) on an unspecified date with outcome of unknown, had arm hurt, left arm (pain in extremity) (non-serious) on an unspecified date with outcome of unknown , headache (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , dizziness (non-serious) on an unspecified date with outcome of unknown. The clinical course was as follows, at about 4pm the patient went outside, he "felt flushed, but didn't look in the mirror a friend told me to put sunblock on. I looked at my face and saw my face beet red. I just laid down, my arm felt bad, like a Charlie horse, like someone smacked me in the arm." Caller states his symptoms are, "basically inflammation through the body, then headache, weakness, dizziness, malaise, one good thing, no fever or nausea. Some uneasiness, vacillation, physical weakness. The patient don't drink alcohol, drink water and took Tylenol after the vaccine.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two weeks following receiving second Moderna vaccine, I began having bilateral hand and wrist pain. I have a history of osteopenia, and osteoarthritis in my hands and thumbs. My right hand became very swollen.  My physician placed me on Prednisone treatment, which resolved the swelling. The pain continued however. My physician ordered labwork for RA factor, which showed a slight increase above WNL value. I was referred then to hand surgeon. Under his care, I had bilateral hand x-rays (no significant results), and prescription for Celebrex 200mg/day.  The pain remained unabated. The hand surgeon then injected cortisone into both thumb joints. The pain remained unabated. After nearly three months of doctors' assessments, I was sent for an MRI of the  right wrist. I was informed immediately that I needed to set up an appointment with a rheumatologist.  While my RA factors had been only slightly elevated with earlier labwork, the RA specific testing (CCP) ordered by the rheumatologist, showed results >250 (WNL value is <20).   I am currently being treated with Prednisone 20mg/day, Methotrexate 20mg/week, and Folic Acid 1mg/day.  The pain level is now manageable, but range of motion in my wrists is very limited.
H1N1 vaccine at 1012 AM IM (3 plus PC) child said he was nauseated and vomited. BP 118/68 P. 82 RR 20 - lungs clear - BS (F. stick) 111. T 98.1. This was given at school  in clinic. Mother called an d said another child was sick last week. She asked that child go to ER at clinic. Child went home later that day. No sore throat at 10:40 Am lasting problem.
Day after first shot, experienced  some arm pain, elevated temperature, chills, very tired.  Of concern, blood pressure spiked to 149/78 (usually 120/70) and stayed elevated all day.  I contacted my cardiologist  late in the afternoon and he advised me to come in if the blood pressure did not return to normal the next day.  The next day, all symtoms disappeared and I felt normal.  When I received my second shot yesterday the doctor giving the injection said the blood pressure spike after the first shot was unusual and asked me to submit a VAERS  report.  My symptoms after the second shot  were a much more significant loss of mobility in the arm, which has returned to near normal.   but no blood pressure issue
1:00P arm began to hurt, 3:30P became very tired, began shivering, shaking felt very cold. Remained cold until 7P went to bed 9pm - woke 6A next day with no arm discomfort and feeling fine.
EXTREMELY SICK; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced extremely sick. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Antibodies increase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211032028.
pt recv vax 10FEB98 & presented to office on 5MAR98 w/? herpetic lesions;?herpetic lesions clustered on rt knee, 1 on buttock, 1 on central sternum, 1 lt hip, 1 lt flank;
Red, raised all over body rash. Throat felt a little tight. Some wheezing. Over the course of 6 hours, 150 mg of BENADRYL taking to relieve symptoms. Prednisone 60 mg for 2 days, 40 mg 2 days, 20 mg for 3 days.
Day after vaccine I have joint pain and fatigue and as the days progressed the symptoms I I had experienced with covid from march 2021 was more pronounced such as nose burning, headaches, taste changing, increased sneezing.  I woke up multiple times within the night of Nov 29th with my body feeling hot however no fever and in the morning I was extremely exhausted, did not feel like my normal self and hot body continued but no fever.  November 30 is when tachycardia began with heart rate of 120s-130s stationary, shortness of breath, high blood pressure of 189/100 however during hospital ED visit I did experience higher reads, burning chest pain, fatigue to which caused for testing to discover I had pericardial effusion and resulted in a 4 day hospital stay and sent home for outpatient care that I am currently under as the fluid is still around my heart.  Also was discovered to have low hemoglobin and required 2 bags of iron
Reported by caregiver.  Patient had pain on injection in the arm which continues.  He is able to raise and lower the arm.  He does not have pain to the touch, but has a constant thumping/pain.
inappropriate administration of MENACTRA with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old male patient who had an inappropriate administration of menactra with no reported adverse event, while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines  included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  On 21-Jun-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE( lot U7191AA and expiration date: 18-Jan-2023) at a dose of 0.5ml via intramuscular route in the right anterior thigh as prophylactic vaccination.  On 21-JUN-2022, the patient had an inappropriate administration of menactra with no reported adverse event (product administered to patient of inappropriate age)(latency: same day).   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event .   At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pharmacy accidentally administered dose of expired vaccine to patient on 7/20/22. Vaccine expired 2/8/22. Error was discovered when checking stock for an upcoming appointment. Manufacturer was contacted and they advised that the expired dose should be considered invalid.  I explained this to the patient and she has scheduled an appointment to repeat the dose. Patient did not report any adverse events.
Long periods of chills Fever of 102.7 Headache Arm pain Fatigue
Spotting started 4/28/21 continued until heavy, cramping, clotting period started 5/4/21 to date (today 5-9-21). Heaviness is starting to subside but still bleeding.
A few days after 2nd Pfizer vaccination, 82 year old woman was hospitalized due to a blood clot in spleen. Had no prior medical history.
Daughter had been hospitalized; A spontaneous report was received from a consumer concerning a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized.  The patient's medical history was not provided by reporter. Concomitant medications were not provided by reporter.  On an unknown date, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date following the vaccine administration, the patient was hospitalized. Treatment information was not provided by the reporter.   Action taken with mRNA-1273 in response to the event was not provided.    The outcome of the event, hospitalization was considered unknown.; Reporter's Comments: Very limited information regarding the event of hospitalization has been provided at this time.  Further information has been requested.
After 12 days my arm started turning red,/feverish, a little swollen and minimal pain. Today-Day 14- now pinkish/red, slight feverish/swollen, minimal pain
Day 1 (May 22, Sat) Almost No Symptom Day 2 (May 23, Sun) Mild muscle pain Day 3 (May 24, Mon) Severe chills, shaking, body aches - Symptoms start at midnight Day 4 (May 25, Tue) Mild Body ache, Severe Headache Day 5 (May 26, Wed) Mild headache, tiredness - Worked Day 6 (May 27, Thu) Severe dizziness, vertigo - Symptoms begin the night before
blood pressure was elevated; warm to touch at injection site; hard at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure was elevated), VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE INDURATION (hard at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HYPERTENSION (blood pressure was elevated), VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE INDURATION (hard at injection site). At the time of the report, HYPERTENSION (blood pressure was elevated), VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE INDURATION (hard at injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Blood pressure measurement: 152/81 mm/hg (Inconclusive) Elevated Blood pressure, 152/81 mm/Hg.     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 information provided
Information has been received from a physician, via a company representative, concerning a 21 year old female patient, who on 05-FEB-2007 was vaccinated IM, with the first dose of Gardasil, and on 02-APR-2007 with the second dose of Gardasil (Lot #654535/0136U). Concomitant therapy included an antibiotic containing sulfa (unspecified). On 05-APR-2007, three days later after the second dose was administered, the patient developed a red rash from her chin to her toes. The physician indicated he believed "the antibiotic containing sulfa" was "the cause of the rash." At the time of the report, it unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
fainted; Initial information received on 17-Mar-2023 regarding an unsolicited valid serious case received from a Non-Healthcare Professional.  This case involves a 16-year-old male patient who experienced fainted after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Mar-2023, the patient received total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, lot number and expiry date: not reported) via intramuscular route in unknown administration site for Vaccination.  On 16-Mar-2023 on the same day, the patient developed a serious event of fainted (syncope) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. This event was assessed as medically significant.  It was reported, patient had received vaccines after screening questions were answered. Went to check out escorted by his father to check out window. Assessed patient and he was moved to a room to be monitored. He was monitored for about 15 minutes. After monitoring it was recommended to father to take him to emergency room (ER).   It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (fainted).  At time of reporting, the outcome was Recovered / Resolved on 16-Mar-2023 for the event fainted.; Sender's Comments: Sanofi company comment dated 20-Mar-2023: This case involves a 16-year-old male patient who experienced fainted after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, medical treatment, family history, concomitant medications, medical history excluding other predisposing etiologies would be needed for complete assessment of the case.
I did not have an adverse reaction to the vaccine. On 04/21/2023, I had severe abdominal pain with vomiting. I went to the emergency room and was hospitalized for five days with a bowel obstruction. I am to avoid spicy foods for the next few weeks.
This spontaneous report as received from a health professional via field representative refers to a 12 year old male patient. No medical history, concurrent conditions and concomitant medication were reported. On 22-Sep-2015 the patient was vaccinated with the first dose of GARDASIL 9 lot # L014415 (dose, expiry date and route were not specified) with no adverse effect afterward. On 23-NOV-2015, the patient was administered with GARDASIL intramuscularly, 0.5 ml, lot # K016966, expiration date 10-MAY2015. Immediately after receiving GARDASIL, the patient "fainted" and "completely lost consciousness for 2 seconds". On the same day, he recovered completely and was discharged to home with no residual effects. No treatment was given and no laboratory tests were performed. The causality assessment was not provided. Additional information has been requested.
Patient is fully vaccinated. 50-year-old female presented to the hospital with a chief complaint of heart palpitation and anxiety. The patient sometimes wake up at night gasping for air. EKG showed no signs of ischemic cardiac event. Cardiac troponin negative.  CT chest, no acute abnormality.  Her 2D echocardiogram was normal.  CXR: No acute cardiopulmonary process. Medications: atorvastin, Vitamin D, B-12, Motrin and zoloft. Discharged home.