chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days after my 2nd shot, I started ?spotting?. My period was not due for another 2 1/2 weeks. My cycle is extremely regular, every 28 days for over 10 years now. I have never spotted in between periods. I spotted off and on from 9/5-9/20 then my period started fully. It was originally due on 9/20. So I spotted for 2 1/2 weeks which I have never done before.  It is also heavier and more clotted than usual. I?m not sure yet if this will be a normal period from here out or not. I came across an article online about this happening to other women after their vaccine and it all made sense.  I felt like it was important to share this.
slept for most of 2 days, no energy, achy all day, balance was off, shot site was sore, was not able to lay on it or rub it
I started to feel a little spacey almost immediately after the injection, which increased over the afternoon at work (wasn't able to focus well mentally) and early evening; when I went to bed I became very dizzy when I turned my head and later in the night woke up with vertigo (visual spinning) and double vision, with some mild nausea. A little dizzy the rest of the night. All this morning I was spacey again, couldn't focus on my work, a little dizzy. Mild nausea and feel weak when I'm standing.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA054981 and 2023SA057733.   This case involves child patient of an unknown age and  gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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 guidelines. 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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Information has been received from a physician concerning a 17 year old female who on 05-SEP-2007 was vaccinated with a third dose of GARDASIL. On 05-SEP-2007, five minutes after the vaccination, the patient fainted. Medical attention was sought. The patient recovered 5 minutes after fainting and left office 15 minutes after recovery. No product quality complaint was involved. Additional information has been requested.
Child woke up during the night on 10-4-18 around 12;30 am having jerky movements in bed and was unconscious. Mom called 911 seizure lasted 3-4 minutes post ictal about 2 hrs. Temperature was up to 102.8 and diagnosed with febrile seizure and post-vaccine seizure.
Severe allergy symptoms from April to current date June 3rd 2021.  I have never had allergy symptoms since birth. A couple weeks after my first shot I got a constant runny nose and sneezing. The symptoms became amplified immediately after my second shot and have not gone away.  My doctor tested my blood for allergies and everything came back negative. Second course of action was to x-ray my sinuses and they came back as a ?normal study?. I am now taking Claritin daily to be able to function at work but I?m still stuffed up and my ears feel clogged causing me to not be able to hear very well.
woke up with bad hot flashes, cramping in legs and whole body, chest is heavy, sore throat
Patient started experiencing unusual  symptoms starting the morning of 2/11/17. Symptoms included extreme pounding headache sometimes relieved by APAP. She had muscle and joint  pain and nerve pain radiating throughout the body. Patient had on and off heavy breathing, chest tightness and intermittant increased heart rate. She also has a rash that stretches from the front to back side of her body concentrating mainly on the right side of the body where shot was given. Fever spiked to 102F on the 1st and 2nd day after the shot. Temp back to 99F on 2/13/17. Patient also felt drowsy and loss of appetite.  Fingers were somewhat swollen.
HEADACHE; TIRED; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 57 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, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 in left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced tired. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, tired, muscle aches and fever was not reported. This report was non-serious.
No adverse event; Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022; Temperature excursion occurred on 29-Nov-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis. No Medical History information was reported. On 02-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022). On 02-Dec-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022). Concomitant product use was not provided by the reporter. A total of 16 doses were administered, on 29-Nov-2022 (5), 30-Nov-2022 (4), 1-Dec-2022 (2), 2-Dec-2022 (2), 3-Dec-2022 (1), and 5-Dec-2022. It was unknown that the patient received any other vaccines on the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided. This case contains information for the 2nd of 2 patients who received vaccine on 02-Dec-2022. This case was linked to MODERNATX, INC.-MOD-2022-687688 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-687688:Same reporter
pt states that w/1st inject felt very tired, sick to stomach, fever 103, loose BM x 24 hrs sx onset 1 hrs p/inject;
This spontaneous report was received from a physician via a company representative regarding an unspecified amount of patients. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (oral by default, dose, lot number and expirations date were not provided). Concomitant medications were not provided. On an unknown date, the physician stated that she did not want to purchase a 3 dose vaccine of ROTATEQ. She said why she would do that when she can purchase a 2 dose vaccine (name and manufacturer were unspecified) and her patients will not get sick. The physician said whenever she administered the ROTATEQ vaccine the patients would get Rotavirus. The patients sought unspecified medical attention. At the time of the report, the patients outcome was unknown. Causality was not provided. Additional information is not expected since the reporter do not want to be contacted.
This spontaneous report as received from a physician refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history or concomitant therapies was provided. On an unknown date, the patient was vaccinated with one dose of ZOSTAVAX (dose, route of administration, lot number, expiration date were not reported) for prophylaxis, while she already had been vaccinated with ZOSTAVAX on an earlier, unspecified date. This was considered as an extra dose administered per the Prescribing Information. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected, as there was no consent to contact the reporting physician.
I was woken up at about 1:15AM with major night sweats  and vividly scary dreams of scary faces . I opened my eyes and I was still seeing the scary faces that were scaring me and causing me to yell and move around in bed while asleep. I girlfriend said I was yelling and moving around a lot prior to waking up. Once awake, I was still seeing the visions for about 2 minutes until I turned on the light and my eyes adjusted to the brightness. When I turned the light off and tried to go back to sleep, the faces appeared again. I was not able to go back to sleep and ended up getting out of bed and going out on the couch to watch TV to avoid being in the darkness and closing my eyes. I'm not one to dream very often and this was certainly and vividly scary night.
LOWER BACK PAIN, RIGHT SHOULDER MASS OPERATED, MEMORY LOSS, HEADACHES, JOINT PAIN, DRY MOUTH, HEARING LOSS, POOR VISION, BLURRY VISION, LIVER PROBLEMS (HIGH ENZYMES)CRAMPS, JUMPING IN BED AT NIGHT, DIFFICULTY SLEEPING.  05/21/2007 MR received from VA from 11/25/2005 to 1/30/2007.  Initial visit with c/o LBP and Migraine.  PE: WNL. Asessment LBP. PTSD screen (+). OV 12/07/05 with c/o LBP since June 2005, Headache since Nov. 2004, and epigastric pain x 2 years.  LPB 2' to "heavy equipment" and prolonged standing.  Has suffered from H/A since a bomb explosion. Primary care problem list:  Low Back pain, chronic allergic conjuctivitis, senile cataract, Person with feared complaint in whom no DX was made, Elevated LFTs.
Red eyes, cough, chest pain, loss of voice, throat irritation (burning sensation down throat and into lungs when inhaling).
Per client- redness, dry skin sore, hard as a knot developed at injection site 12/30.2010.   3/1/2011  purulent drainage came from injection site.  Client has and is under the care of a licensed independent practioner, this has required multiple visits from primary care provider, and is a financial burden.
Arthralgia of left arm/shoulder. Seen by PCP 5/15/17.
Itchy dry eyes that turned red on lids, lids started to swell slightly but by following day eyelids were very swollen. 3rd day eyelid swelling going down, but not fully recovered as of this report.
throbbing pain in right elbow and right hip; persistent numbness in right hand Narrative:  sometimes fingers are numb on right hand; still experiencing on/off but getting better (1/26/21)
Information has been received from a nurse concerning a 17 year old female who on 15-JAN-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot # 658563/1063U).  There was no concomitant medication.  On 15-JAN-2008 the patient experienced severe nausea after receiving the first dose of GARDASIL.  The patient sought unspecified medical attention in the office.  On 16-Jan-2008, the patient recovered from severe nausea.  No further information is available.  Additional information has been requested.
Patient contracted rubeola from MMR vaccine approximately 24 hours after administration she developed rash all over body.
Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.
got headache for a mont; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious social media case from a other health professional.  This case involves an unknown demographic patient who got headache for a month (headache), while the patient received INFLUENZA VACCINE.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got headache for a month (headache) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Large, red blotches and blisters consistent with second degree burns on both hands. Severe pain and itching going into 3rd week.
He did not feel good the next day; Woke up with sweats; fatigue; Swelling of lymph nodes in neck in opposite side of injection; scratchy throat; Pain; Bruising on left arm; He can still see a little discoloration in his arm; had no energy; he felt worse; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL3248), via intramuscularly, administered in left arm muscle on 15Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunization at School/Student Health Clinic. Patient's medical history included asthma (diagnosed many years ago as a child) and blood cholesterol. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) 60 units 100/50 two puffs daily, acid reducer and cholesterol medication, uses inhaler (unspecified) for Asthma. The patient previously took fluticasone propionate (FLOVENT). Patient had no vaccines administrated prior to covid 19 vaccine no additional Vaccines were administered on same day of the vaccine. On 16Jan2021, at 06:00 (reported as after the first few days) patient had had bruising on arm, not out of the ordinary. On 21Jan2021, at 06:00 patient started getting pain and swelling in lymph nodes in neck and a scratchy throat. That has been on for a while now. It was reported that last Friday, he felt worse and had fatigue at 10:00, did not feel well and in the middle of night, woke up with sweats on 30Jan2021 at 01:00. He did not feel good the next day. Now, he was back to swelling in lymph nodes and sore throat. There was a couple of days where he did not notice it at all and was supposed to get next vaccine on Wednesday and was not sure if he should or not. He provided his weight as 140ish. There was no prescriber. Patient still had a little discoloration in his arm, but it was not tender. Last Wednesday and Thursday, he felt good and could feel a little swelling in his lymph nodes, and on Friday, he felt more fatigued. Patient was always felt fatigued, but on Friday, he had no energy. The scratchy throat this morning was not as bad, but by this afternoon, it is least as sore or more of the same. He is still fatigued, but he can work. When he gets done with work, he was much more tired and fatigued and even during the day, he felt he was not quite right. The outcome events were not recovered for swollen lymph nodes, scratchy throat, fatigue, bruising on left arm and night sweats, and unknown for the rest of the events.  Follow-up attempts are completed. No further information is expected.
Moderna COVID-19 Vaccine EUA  Pudendal  nerve/testicular pain Aggravation of peripheral neuropathy Currently treating the testicular pain through physical therapy that was already doing for pelvic floor. But this a whole new problem. Moderate increase in otherwise existing peripheral neuropathy in feet legs and hands. Appointment with urologist next week. Testicular pain began about six to seven hours after shot and has remained for a week now.
Date and time adverse event started:  03/15/21 rash started at waist line and spread from there Recommendation: please apply a cold compress to the area where rash is presented, you could also take benadryl for the itching please take it at night prior to sleeping do not drive or use any heave machinery when taking this medication. Please contact your doctor for additional recommendations or for a check up since the rash diffused across your body, we want to make sure that if it is an allergic reaction it doesnt close your airway, if at any moment you do experience shortness of breath please go to the nearest emergency room.
Subsequent to receiving one dose of varicella virus vaccine live on 12/11/95, the pt presented to the physicians office on 2/19/99, with a mild outbreak of chickenpox. The pt had approximately 30 lesions in various stages (papules, vesicles and scabs) primarily on his face, neck, trunk and arms.
Pt states 24 hrs after shot she developed diarrhea and SOB (shortness of breath) and 2 days later passed out. Was admitted to hospital with low blood pressure and pt believes it was all due to flu shot.
Information has been received from a licensed practical nurse concerning a 19 year old female who on 28-NOV-2008 was vaccinated IM with a first pediatrical dose (0.5 mL) of VAQTA (lot # not reported) and on 22-JUN-2009 was vaccinated IM with a second pediatrical dose (0.5 mL) of VAQTA (lot # not reported).  No adverse effects were reported.  Additional information has been requested.
J&J vaccine given on 3/14. Pt states vaccine placement was too high and not given in the muscle. Pt states has permanent nerve damage as a result
Injection site pain began about 5 hours after getting vaccine and progressively worsened. Unable to lift arm above shoulder without significant pain at about 12 hours post injection. About 13-14 hours post vaccine, began having myalgias, chills. Took ibuprofen with some improvement of symptoms, but unable to sleep due to the combination of arm pain, chills and aches. Body aches and chills were gone by the morning but the arm pain lingered, less than the night before and improving each day, still there today, but much more tolerable.
Full right thigh is swollen from knee cap to hip, impaired mobility as a result of swelling, low grade fever.  No treatment given at time of report.
Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies who in June 2010, was vaccinated with a dose of VARIVAX (Merck) when she was around 2 weeks pregnant. Concomitant therapy included prenatal vitamin (unspecified) more than 200 doses. At the time of the report the patient was 17 weeks 3 days pregnant. No adverse reactions reported. No lab diagnostics studies were performed. Date of last menstrual period (LMP): 18-May-2010, estimate delivered date (EDD): 22-Feb-2011. Follow-up information has been received from an initial pregnancy questionnaire concerning a female patient without history of previous pregnancies, pre-term births or miscarriages and no live births who in June 2010, was vaccinated with a dose of VARIVAX (Merck). The physician stated that on 06-OCT-2010, a routine ultrasound was performed and the results were normal. On an unspecified date an ultrasound was performed and showed that hyperechoic amniotic fluid was noted at 40 weeks of gestation. On 25-FEB-2011 delivered a normal, healthy male baby weighing 7 pounds, 3 ounces at 40 weeks and 3 days of gestation. It was reported that the infant was normal, with no congenital anomalies and there were no other complications. The patient had a normal labor/delivery with no complications, no concurrent medical conditions, no diagnostic tests were performed during pregnancy and no infections or illness during pregnancy. It was unknown if the patient was tested for varicella antibodies before vaccination with VZV containing vaccine. There were no local reaction at vaccination site, varicella (chickenpox) symptoms post vaccination or herpes zoster (shingles) symptoms post vaccination. Additional information is not expected.
After receiving immunization on 5/14/02 IPV, DTaP, PCV. Mom states child started screaming and stiffening body next day ran high fever 102-103 deg F.
Patient reported extreme illness that started about 4 hours after administration. She reported high fevers, flu-like symptoms, diarrhea and nausea that kept her bed-ridden for about 2 weeks. She seems to have made a full recovery and consulted with her doctor who suggests to avoid any future booster doses if approved. She reported experiencing minimal side effects from the first two doses (primary series).