chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed period for 2 months; Heavy period and cramps which was not the case before; Heavy period and cramps which was not the case before; This is a spontaneous report from a non-contactable reporter (consumer or other non hcp). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date an unknown date in Nov2021 (Lot number: unknown) at the age of 49 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset an unknown date in Nov2021, outcome "unknown", described as "Missed period for 2 months"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset an unknown date in Nov2021, outcome "unknown", described as "Heavy period and cramps which was not the case before"; DYSMENORRHOEA (non-serious) with onset an unknown date in Nov2021, outcome "unknown", described as "Heavy period and cramps which was not the case before". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding and dysmenorrhoea.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, took 1000mg Tylenol after 2 hours of chills, chills resolved within an hour. Chills started about 8am, I took Tylenol around 10am. Chills were gone by 11am. Sore arm for 48 hours after shot. Took 400mg ibuprofen as needed to relieve pain.
Received AVA, Fumist, & Typhoid vaccines on 10/14/2008; 1st LMP 10/1/2008; positive pregnancy test end of Oct 2008.
Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster).    Concomitant medications details were not reported by the reporter.  HCP states that they had a situation at the pharmacy where Moderna monovalent vaccine was administered to approximately 20 patients from 11-Jan-2023 to 21-Jan-2023, instead of the Moderna bivalent booster.  Treatment details were not reported by the reporter.  This report was considered for second patient out of 20 reported adult patients who received the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704234 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704234:Master case
On 3/15/2021 Moderna COVID19 Vaccine Vial Lot #014M20A was punctured at 10:45A, vaccine was given at 5;17P.  Vaccine expired at 4:45P (6 hours after punctured).  Reported to VAERS Report Moderna same evening, received response from Medical Affairs 3/18/2021.Representative gave instruction that repeat dose was not needed as viability of vaccine was demonstrated 12 hours after puncture time, however as there was no preservative there was increased likelihood of infection.  Patient was informed, patient denied signs of infection.  Patient was instructed to monitor for signs of infection at vaccine site.
Miscarriage diagnosed at 14 weeks 0 days. At the time of diagnosis, fetus was measuring 13 weeks 0 days. Fetus was viable with + fetal heart rate of 165 at 13 weeks 5 days at routine prenatal visit.
extreme body aches/less body aches; running high fever; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (extreme body aches/less body aches), PYREXIA (running high fever) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (extreme body aches/less body aches). an unknown date, the patient experienced PYREXIA (running high fever) and HEADACHE (headaches). At the time of the report, MYALGIA (extreme body aches/less body aches), PYREXIA (running high fever) and HEADACHE (headaches) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
I developed tinnitus in my left ear in the days following the booster shot to my left arm. I never had tinnitus before that.
After 2nd Injection. I was dizzy, nauseous, tired and unable to move about 3days.Since then, I have been feeling light dizziness and tiredness all the time and from July 17th, I am suddenly feeling pain in my chest. It is located near the left side heart area and still having a pain.
Initial back pain 2 days after shot which lead to nausea, then fever and vertigo.  Back pain worsened considerably.  Didn't eat for 3 days, and was not hungry.  Had to force myself to drink and was  not thirsty.  3 days after initial fever had hearing loss.  Fever subsided after 5 days, nausea after the first day, vertigo after the second day, back pain became manageable after a week.  Hearing loss recovey after 5 days.
Pt vaccinated with DTP became very quiet & motionless & pale immediately after shot crying episode. Was not limp but not as active as before shot. Was fine within a few minutes.
10 minutes after the vaccination the pt became sweaty, flush, dizzy and hot.  I asked if she was diabetic?  She said no.  She just felt it come on fast.  I asked if she wanted a cold rag or water.   She drank 2 bottles of water.  We contacted EMS and they came.  Her vitals were all fine and she refused to go to the hospital.  The pt sat a little longer and felt better.  It lasted about 20-30 minutes.   I told her for her next dose she needs to stay seated for 30 minutes with us in the pharmacy.   I will call and check on her later today.
Patient received Pfizer vaccine dose one on left arm around 10:20am. No immediate reaction. Onset at 10:40am  of numbness in right arm. Nurse assessed patient and decided to call 911 for possible TIA. ambulance arrived at the scene around 11am and transported to ED shortly after.
He woke up the morning after the vaccine and was so achy he couldn't get out of bed, then he noticed his R ear had lost all hearing and left lost some. Has seen an audiologist and is requiring steroid injections and oral prednisone to reduce the inflammation they think caused it.  Audiologist hopes it will return but unsure if will be permanent.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 23 March 2007 from a health care professional. A 33-year-old female patient, with no concurrent illnesses and no known allergies, had received a left deltoid, intramuscular injection of Adacel, lot number C2559AA, on 24 August 2006. On 29 January 2007, 158 days post-immunization, the patient developed cold-like symptoms, shortness of breath and persistent cough. She was evaluated in the physician's office four days later on 02 March 2007, and had a serology test for Bordetella pertussis IGG/IGM. The result of the IGG was 24 and IGM was 13. She was started on a "z-pack" for five days. No cultures were done. At the time of this report, the patient had recovered.
My sugar was up; it was like 215 in the morning and it is usually 107 or 110; my sugar went crazy after that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "insulin dependent diabetic" (unspecified if ongoing), notes: I am insulin dependent diabetic. The patient took concomitant medications. Past drug history included: Insulin for insulin dependent diabetic, notes: I am insulin dependent diabetic. Vaccination history included: Bnt162b2 (first dose), for Covid-19 Immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "My sugar was up; it was like 215 in the morning and it is usually 107 or 110; my sugar went crazy after that". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: The patient received second dose on Monday and day before report she noticed that her sugar was up. Since, the patient was insulin dependent diabetic hence, just wanted to inform. She read side effects and it was never mentioned elevation of sugar on the paper that she got. Patient took Insulin as treatment. The patient reported that, she do take her medication and do have high blood pressure but confused for the name of other medications as it could be the Irbesartan, or it could be the cholesterol, or it could be Atorvastatin since patient did not knew which one is for high blood pressure (further clarification unknown).  No follow up attempts are possible. No further information is expected.
Nausea, lightheaded, dizziness, brain fog, neck pain, mild tongue tingling
Headaches, body aches, body chills, joint pain, chest pain, rash, trouble breathing, blurred vision, swollen spot at injection site.
BASCIALY A RASH AND BODY ACHES, I CONTACTED MY DOCTOR AND HE GAVE ME STEROIDS AND IT WENT AWAY WITH THAT.
Pt experienced syncope immediately following Pfizer Covid 19 vaccine administration for approximately 5 minutes.  Pt exhibited additional signs and symptoms including, pallor, sweating, nausea and vomiting for approximately 30 minutes following Pfizer Covid 19 vaccine administration.  Pt remained under supervision until signs and symptoms resolved.  Pt left clinic and was provided a ride from partner.
Sharp pain on the same side as the vaccine administration (left). Pain ran from shoulder down the back to the hip.
So after the vaccine, I had a headache, fatigue, brain fog, and pain at the injection site, I did not take my temp that evening but I may have had a fever at that time. Some time before dawn I woke up with chills, I took Tylenol for pain and got some water  and laid down, that morning when I got up to go to the rest room, everything  from my head down hurt.  I was in extreme pain and my husband had to help me with everything including taking my meds.  By 11 in the morning I started feeling better, with chest pain and shortness of breath, but at 12 noon I went out for a while and come back, I had a slight fever and went to bed.  Saturday I had night sweats, I was able to get up and eat and go out but I was not able to stand for a long period of time. I went home and had a fever of about 100.1 and took some Advil and went to bed.  Sunday I woke up in sweats, I had a very rough night and I woke up late in the morning, I had extreme brain fog, and I was looking forward to going out, I did have a fever about 2PM and took some meds and did go out around 4, came in about 8 and I still have a fever and I took some Advil and went to bed.  I still had a rough night, and still had the night sweats and woke today with brain fog and I am still not feeling well as of now.  I called to speak with my Dr. this morning and I am waiting for a call back.  I did take some Advil this morning sand I am resting as much as I can.  I did have the flu vaccine the same time I got the 4th dose but I don't have any info on that vaccine at this time.
Patient was administered a covid vaccine on 3/17/2023 that was expired on 3/14/2023. Pfizer and CDC was contacted and confirmed that the stability of the vaccine is good until 3/19/2023. No adverse event occurred and Pfizer and CDC does not recommend re-vaccination.
Pt received a combination vaccine but doesn't know which one.  At night Pt. had a set of seizures, taken to ER stay a few hours and released next day. Had another set of seizures on the 2/5/06. Doctor advised to observe pt. since had appt with neurologist the next day. Went to neurologist on the 2/6 and tests were run.
01/21/22 presents to ED for "Abdominal Pain fistula". PMHx of "complex entercutaneous fistula, TPN dependent, NASH cirrhosis s/p liver-kidney transplant"
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt recv vax on 10/23/98; 5 hr later pt exp weakness.
Swelling at injection site 13cm X 12.5cm. Treat with cool compresses and Benadryl po.
As bad as when I had Covid; Covid sick 10 days, each shot 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (As bad as when I had Covid) and ILLNESS (Covid sick 10 days, each shot 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (As bad as when I had Covid) and ILLNESS (Covid sick 10 days, each shot 24 hours). At the time of the report, VACCINATION COMPLICATION (As bad as when I had Covid) outcome was unknown and ILLNESS (Covid sick 10 days, each shot 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Follow up received included updated event  information
Woke up Tuesday 3:00 am (2.5 days later) with sever upper abdominal pains.  Went to the ER.  They gave me fluids and pain meds.  They ran labs, EKG, chest x-ray, gallbladder ultrasound and CT scan with contrast.  The one element they saw that was abnormal was the Lipase was > 600
low grade fever noted following day  x 1wk-noted swelling & hurt & site approx 3 days p/shot;elevated T103;instructed to to to ER given med;had blood work done-infect @ site;
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA264036 (same reporter). This case involves a 11 years old male patient who received 0.5 mL dose of vaccine FLUBLOK QIV lot QFAA1805, expiry date- 02-06-2019 via unknown route in the left deltoid (Frequency-once) on 18 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 for Immunisation. It was an actual medication error due to Inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.
Broke out in Hives / welts on arms, legs , lower back and rump; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 11Apr2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included small stroke in 2018. The patient had no known allergies to medications, food or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and sildenafil (MANUFACTURER UNKNOWN); both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 22:00, the patient broke out in hives while sleeping, it continued nightly through 23Apr2021 with welts on arms, legs, lower back and rump that went away during the day and flared up while asleep. The patient reported that he had contacted his dermatologist. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the event hives with welts on arms, legs, lower back and rump were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received doses of  MMRV and Kinrix on 1/7/2022. Received another dose of MMRV and Kinrix on 2/7/2023.
On 11/8/2022, I experienced some soreness in the right shoulder. I noticed that it was red and felt just sore. Then I realized that it was the site of the fifth vaccine dose injection. It lasted for a couple of days and went away, but then I started experiencing an increase in my essential tremors. I had pre-existing tremors, but they suddenly got worse. They continued to worsen, and I visited my neurologist. The neurologist diagnosed essential tremor, idiopathic peripheral neuropathy, and benign fasciculation syndrome. I have undergone various blood tests, and I am now awaiting a blood test for a neurological autoimmune disorder. I don't know if there is any relationship between my symptoms and the vaccines I received, but I have heard that there have been reports of neurological issues from some people who have received mRNA vaccines. I also think it's pretty coincidental that I had pain at the injection site two months after getting the injection and shortly before the beginning of the worsening of symptoms. I believe in the vaccines and believe that they are necessary, but I also feel that I have a responsibility to report this. These symptoms have caused me a great deal of difficulty. Before I developed the symptoms, I was very active and health-conscious. I intentionally lost 70 lbs. over the past few years by exercising and dieting. I regularly rode my mountain bike 10 miles a day. As of 3/1/2023, I was riding my bike 10 miles a day, but as 3/6/2023, I am very fatigued all the time. I have low energy and feel like I'm in a fog. I have been having difficulty sleeping for the past six weeks, because I'm very anxious. I have been prescribed Lexapro to treat the anxiety; as of yet, I have not noticed any changes, as I have only been taking it for two weeks. I went to the ER on 3/7/2023, 3/8/2023, and 3/10/2023, because I had pain in the left side of my side, exhaustion, tiredness, sweating, and rapid heartbeat. I underwent a brain CT scan, blood panels for heart-related enzymes, complete metabolic panels, and CT scans of the chest and pelvis. The results of all these tests were normal, so I was discharged and never admitted overnight.
circular red raised rash around vaccine location. Didn't develop until a week or two post vaccine. No other symptoms and doctor cleared it.
Headache, low-grade fever, nausea, and muscle aches began a few after injection and continued until about 72 hours after injection
Pain in back of left knee 8 hours after Flu vaccine injection. Pain and noticeable swelling in left calf by morning. Severe pain upon walking and standing. Saw Dr on 11/17/2015; he sent me to radiology at Medical Center where a blood clot (DVT) was detected in left leg from calf to groin. Admitted into Emergency Room immediately. Treated with LOVENOX and oral warfarin. 4 days in hospital. XARELTO prescribed.
per patient, about 30 minutes  after receiving a shot, patient still have problem hearing on his left ear. The problem continue until now 04/25/2022 which is the day of the reporting
Dizzy getting worse as time progresses, Nauseous for two hours, Light-Headed when standing, Headaches throughout, Sweating for thirty minutes.
Spot when vaccinations happened begain to become hot and a sore/ulcer developed about 4 days after vaccination. It eventually scabbed over but it still soft to the touch 4 weeks after the vaccinations.
This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unknown date in 2015 (after 02-JUN-2015), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # J013394, expiry date 25-AUG-2016. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA013290 as it was received from the same reporter. Additional information has been requested.