chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Late period like a clock 27-29 days and was 2weeks late which was extremely unusual; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on an unknown date (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum state (Overall healthy. 7mo postpartum (period was back 1mo postpartum with consistently 27-29 days length, except after the vaccine). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in May2021, the patient experienced late period. she usually like a clock 27-29 days and was 2 weeks late which was extremely unusual. There were no other changes in lifestyle, diet, stress level or exercise. It was the first time in life. The patient was this late and could not think of anything else but the effect of covid vaccine. The patient wishes more trials has been done that focus on the effects on women's health. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event late period. she usually like a clock 27-29 days and was 2 weeks late which was extremely unusual was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hives; itchy, prickly, hot sensation (all over body) and shorted menstrual cycle.
Has a bruise like pain in the back of their arm that is triggered by touching the area or moving the arm up and down.  Nothing makes it better, touching it makes it worse.  Had soreness after the injection and the bruise like pain is still there 2 months after.
Patient was given vaccine and was doing well with no issues after I left the room to document the vaccine she stood up to hug her mom and fainted. She  came to within one minute of fainting and was shaky and clammy. Our RN was called into the room. The patient was put on the exam table to lay down and was given a popsicle after laying for several minutes. She continued to sit on the table until she felt better and left with no further incidents.
administered 1st dose of the moderna vaccine to a 11-year-old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of the moderna vaccine to a 11-year-old patient) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of the moderna vaccine to a 11-year-old patient). On 09-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of the moderna vaccine to a 11-year-old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The HCP stated that the patient did not have any adverse reactions.
11/10/2021- I was going to the bathroom through the night and was getting weaker and weaker and by daybreak, I could hardly walk. 11/11/2021-Called the ambulance that morning and was taken to the emergency room-fever and hydrated.
1135 patient had c/o of throat clearing and was evaluated by MD. Airway was open, no signs of respiratory distress with clear lungs. Benadryl 25mg PO x1 and monitored for 30 minutes. 1210 Patient reassessed, throat clearing resolved. Discharged home and advised patient if symptoms came back or worsened to go to ED.
5/1/03 L very swollen with redness down the entire bicep-cannot stand anything touching it. "H/O baby shot got infected and had to be lanced" states has scar on elbow area. Deltoid area (not biceps) and was swollen down arm to elbow; now localized 4x6cm erythematous swelling with pustules at site of Td 8d ago and less swollen than 2d ago but pustules are now. No fever/chills. Dr saw also we agree on plan. ? forming abscess without L axillary adenopathy. Alcohol cleanse; open pustule with sterile needle, swabbed pus with culturette. Probable sterile abscess rxn to Td shot. Diclox 250 qid #30. Tx'd culturette for bacterial G stain, CBS, surgeon for IRD. 5/6/03, pt is a very pleasant 60 year old pt of Dr who had a tetanus injection in her left deltoid about 10 days ago. A couple of days ago she saw Dr. It was obviously developing an infection in this area. She was started on some antibiotics yesterday. A culture of a pustula was taken yesterday. He saw her today and requested an urgent surgical consultation. She comes in today to be seen and evaluated. She is on Verapamil, Wellbutrin and Imitrex prn for headaches. Add Duricef 500mg po bid for Dr's treatment and give her Darvocet N 100, 15 of those for pain.
it has been 48 days since first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it has been 48 days since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has been 48 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it has been 48 days since first dose) had resolved.        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.   Treatment information not provided. List of concomitant medication were not given.
Tinnitus after 4 hours shot one. It went away after two weeks.  Shot two it came back again.   Golf ball size knot in lymph nodes
Up (L) arm swelling with redness and itching. 1 day after vaccine was given. BACTRIM DS x 10 days. MOTRIN x 5 days.
On 8/21 I had a fever toping at 104.5, very lethargic, and had a sore throat. Took an at home COVID-19 test, which was positive. Went into doctor on 8/22, doctor performed COVID-19 PCR and Strep test. Both were positive. Prescribed PAXLOIVD. Fever broke within an hour of taking first dose all the other symptoms disappeared within the next hour. During the time while I had COVID-19 I experienced tinnitus. Tinnitus made sleeping difficult while actively infected. Once COVID-19 resolved, the tinnitus diminished to about 20% and currently holds there. This was confirmed 2/14/2023 that I had upper end hearing loss when tested by an ENT.
The second dose bivalent Covid vaccine  given on 7/29/2023 was outside of the recommended schedule. With the most recent guidelines, patients 5 years and older that have been vaccinated with a bivalent vaccine are considered completely vaccinated until they are 65 years old unless they are moderately or severely immunocompromised. This patient did not have  any exception noted for the second dose.
This case was reported by a consumer via call center representative and described the occurrence of injection site mass in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included SHINGRIX. On 11th November 2018, the patient received the 2nd dose of SHINGRIX. On 20th December 2018, 39 days after receiving SHINGRIX, the patient experienced injection site mass. On an unknown date, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site mass was unknown and the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site mass and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's husband. The patient received SHINGRIX in left arm. On 20th December 2018, the patient did have an ultrasound and they found a mass at the site. Less than a year after receiving SHINGRIX, the patient experienced severe muscle pain in the arm where the needle was inserted. The reporter wanted to know what should they do as the patient had bad side effects from the Shingles shot.
Pt. developed abdominal pain a few days afterward and ended up in ER with CT abdomen/ pelvis with bulky lymphadenopathy on 6/3/18. Biopsy has confirmed the above findings are consistent Follicle center cell lymphoma. I have no idea if related but feel it is important to report in case a pattern emerges.
I became sick with flu like symptoms, fever, arching, nausea for 2 days
COAGULOPATHY, UNSPECIFIED TYPE 11/22/2021 ATRIAL FIBRILLATION, UNSPECIFIED HYPOVOLEMIC SHOCK 11/22/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Hives all over my body. It started a week after I got the shot. I have no allergies of any types. I had to go to the ER, and it has been happening for a week and a half with no signs of getting better. The breakouts happen randomly throughout the day, and it itches a lot. Allergy pills like Allegra and Montelukast are not helping much.
LOWER BACK HURTING; AWAKE SINCE MID-NIGHT; RAPID HEARTBEAT; This spontaneous report received from a consumer concerned a female of unspecified age. 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,  and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced rapid heartbeat. Laboratory data included: Heart rate (NR: not provided) rapid. On 01-APR-2021, the subject experienced lower back hurting. On 01-APR-2021, the subject experienced awake since mid-night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heartbeat, and lower back hurting, and the outcome of awake since mid-night was not reported. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard operating procedure as case was assessed as non-serious
Client received vaccine on 3/15 and felt extremely weak by 4/19 when she saw Health Clinic. Her platelets were 34 and she was admitted to Hospital from 4/29 to 05/01/22. She did not receive a transfusion or blood product but states that she was given steroids in the hospital. She states she had labs drawn this week, which are still pending, and received a referral to a hematologist. She presented for her second vaccine and this nurse deferred until cleared by hematology.
27 y/o male was sitting in a chair when he started feeling lightheaded 10 minutes s/p 2nd COVID vaccine. He experienced LOC, which lasted less than 1 minute, and fell on his left side onto the floor. Patient came to immediately and was alert when medical response team arrived. Patient was mildly pale and diaphoretic, which improved as he laid down supine on bed. He endorsed some nervousness but lightheadedness seemed to be getting better. Patient had only had a banana and some water prior to his appointment. He denied chest pain, palpitations, and shortness of breath at the time of syncope.  Due to the abrasions on his left maxillary area and ear, patient thought to have hit head on the floor. EKGs done by paramedics showed sinus rhythm with ST elevation in leads V3-V6, repeated twice with same finding. Patient then mentioned that he has been having sharp chest pain intermittently over the past few months that would go away on its own. He had not seen a medical professional for those symptoms. IV line started in left antecubital area. Patient was given baby aspirin by paramedics.   Patient?s first COVID vaccination was uneventful. He denied any medical conditions, allergies, or medications. Family history includes diabetes, hypertension, and thyroid disease.
Patient has had several ED visits where he was subsequently admitted. On March 10th, 2021 patient presented to the ED and was subsequently admitted, as well as on 3/18/21 and 3/29/21. On 3/23/21 patient presented to the ED but was not admitted. These visits were all within 6 weeks of receiving COVID vaccination.
Really sore arm all the way to my hand, around my neck and shoulder where the shot was given.  Tired and fatigued really bad. Barely get moving every day since shot.
As pt reported thick tongue, left arm discomfort, hives after 1-1 1/2 hour by phone. Instructed to go to ER. 12/08/00, pt recovered but still has welts on leg which are diminishing.
Short of breath; little bit of chest pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 17-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30135BA), via an unspecified route of administration on 21Sep2021 (Age at vaccination: 17-years-old) as single dose for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 on 20Aug2021 (Age at vaccination: 17-years-old) for covid-19 immunization. It was reported that patient stated he currently got the second dose of Pfizer vaccine. having some short of breath and a little bit of chest pain. Therapeutic measures were taken as a result of events with Tylenol. The outcome for the events was reported as not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected
Whole body myoclonic jerks that last for a few seconds.  It starts with the arm and proceeds to involve the whole body.  Patient is fully aware of what happens but is unable to stop it.
Muscle aches in whole body, Arm sore at injection point, did not appear red but very sore, nausea, threw up twice, Shakes, cold feet but fever of 100.1f. headache.  Started to feel better after a day or so.
Patient states he had a strange taste in his mouth after the vaccination. He was so fatigued the next morning that family members had to wake him (very unlike him). He had a headache, felt sick to his stomach/nauseous. Rash appeared during the day, with a significant local reaction where he received the immunization.
her daughter began to experience "bloody stool".; her daughter began to experience "extreme lethargy"; her daughter began to experience "bad gas"; the patient "would not sleep on end"; her daughter began to experience "bad diarrhea"; This spontaneous report was received from a consumer (who was also the patient's parent), referring to a two-months-old female patient.   No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-AUG-2017, the patient received a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (dose, lot number and expiration date were unknown by the reporter) as prophylaxis.  On 26-AUG-2017, within hours of the vaccination, the patient began to experienced extreme lethargy, bad diarrhea, bad gas (flatulence) and bloody stool (hematochezia); also, it was also reported that for about two weeks, the patient "would not sleep on end" (insomnia). The consumer reported that medical attention was sought; however, no treatment was given for the adverse events and no laboratory or studies were performed.  It was reported that two to three weeks after vaccination, the patient started to improve her symptoms, however, in approximately October 2017, the patient had a full recovery from lethargy, diarrhea, flatulence, insomnia and haematochezia. The reporter confirmed that the patient did not receive any more doses from the vaccine, after this first dose.   The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the aforementioned events, was not provided.   Upon internal review, hematochezia was determined to be medically significant.
Patient had redness and hot sensations in arm below injection site 2-3 days later. 3-4 days after injection went to Walk-In Clinic and stated she had several egg shape bumps in arm below site with hot and painful sensations. Day six, pt. stated she had  a lesion on her leg and got a prescription for Valacyclovir.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of PEDVAXHIB (lot number reported as M010439 and expiration date 08-DEC-2018, dose and route of administration were not reported). The temperature of excursion was minus 2 Celsius degrees and the time frame was 20 hours. The conditions were back in range at the time of the report. There was no previous temperature excursion. It was stated that it was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient passed out face first into the chest and arms of her father which then I assisted her down on the floor and yelled out for help to the other clinicians. She lost color and her eyes rolled up and to the back of her head. Head was placed on a pillow and legs elevated on a chair and ice packs were applied to back of head and forehead. Orange juice was given to the patient. Patient was helped off the floor into a nearby chair once symptoms subsided.
The patient as of now has no adverse reaction. This is being reported because we discovered that the vaccine given was not diluted correctly.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Feb2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated lipids" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "Bipolar Disorder" (unspecified if ongoing); "brain subarachnoid hemorrhage" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL, start date: 01Jan2006; LAMOTRIGINE, start date: 07Jan2006; LIPITOR, start date: 03Dec2018, stop date: 28Jun2022; LORAZEPAM, start date: 02Jan2006; WELLBUTRIN, start date: 01Jan2006. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
vertigo; fatigue; swelling; pain; This spontaneous case was reported by a consumer and describes the occurrence of   in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details: The patient self administered Ibuprofen TID consulting a HCP on 19jan2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I have had NO adverse effect from the 5 Pfizer vaccines that I had taken. Also no adverse effect from the  day PAXLOVID pack that I just finished.  I had a mild case of COVID which I have recovered from and had a negative test on March 21, 2023
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route, lot number and expiration date were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 41 year old female patient. On an unknown date in 1999 (reported as about 15 years ago), the patient was vaccinated with M-M-R II, intramuscular. The pharmacist reported that the patient had titers drawn on 01-AUG-2014 for work purposes and the results of the titer showed that she had a low titer to rubeola. She reports that she was administered a dose of M-M-R II, 0.5 ml, intramuscular (lot number J016233, with an expiry date of 19-DEC-2015) on 05-AUG-2014 due to the low titer of rubeola. The outcome of low titers to rubeola was unknown. Additional information has been requested.
New onset seropositive (acetylcholine receptor antibody positive) myasthenia gravis, symtpoms included ptosis, diplopia, fatigue, proximal muscle weakness, symptoms starting 2-3 weeks after intitial vaccination date.
There was no allergic reaction but on the next day I had increased temperature (99.2 degrees F), chills, stomach and intestinal upset, could not digest my breakfast the whole day-for example- the apple I ate kept coming back up, abdominal pressure (possibly gas), loose stool, uterine contractions.
Severe muscle spasms in various muscle groups including, calf, paraspinal, neck, back etc. Each group taking 4 weeks to resolve
8/14/07 noted fatigue in evening. 8/15/07 noted body aches, headache, cough, sore throat and fever. Physician diagnosed him with sinusitis. He was prescribed Augmentin to treat his symptoms. All his symptoms have resolved.
Paresthesias in  left side of  back and left leg  outside calf area  occurred in morning afternoon and night. Did not disturb sleep. Occurred 3/26  multiple times and 3/27  in same areas. Pins and needles sensations   I applied ice pack and it reduced the pain