chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt chills and temperature after 18 hours and after 28 hours of the vaccination; I felt chills and temperature after 18 hours and after 28 hours of the vaccination; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202) via an unspecified route of administration, in right arm on 06Mar2021 at 10:15 (at the age of 59-years-old) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis. The patient had no known allergies. The patient did not receive any vaccines within four weeks prior to the vaccination. Concomitant medications included: rheumatoid arthritis medication. The patient previously received first dose of bnt162b2 (Lot Number: EM9809) via an unspecified route of administration, in right arm on 13Feb2021 at 17:00 as single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 07Mar2021 at 04:00, the patient felt chills and temperature after 18 hours and after 28 hours of the vaccination. The patient did not receive any treatment for the events. Since the vaccination the patient had not been tested for COVID-19. Outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
I received my initial Covid-19 vaccine on 03/09/2021. Two days following (03/11/2021), I received my annual exam from my OB/GYN Dr. She noticed I had a small, soft, node settling in my neck on my left side (the same side as vaccination). I was not pregnant at the time I received this dose. However, I am pregnant now, and I have received the second dose as well as the booster, and the node remains. I am concerned it may be related to another condition, but I have seen several providers and they all have said they believe it was caused by the vaccine. This is my first pregnancy, and my due date is June 22, 2022. I'm currently 13 week pregnant.
Patient with Pfizer COVID vaccinations who admitted to hospital with COVID positive test.  Provider discharge note below:  "Per HPI, an 88 yo female with pmhx as detailed below including CML on Gleevac which started in the past few weeks, CAD, CVA, seizures, HTN, hypothyroidism, afib being admitted with COVID and generalized weakness. She is a somewhat poor historian, but says that she has been feeling somewhat weaker over the past few weeks perhaps, but especially worse in the last week or so. Didn't know she had COVID- she is vaccinated and boosted. Weakness is diffuse and all over, and she has felt unsteady on her feet. Not dizzy or vertiginous, no focal weakness, no NT, no facial droop or speech changes. Just off balance. She has had a mild cough, no SOB, sore throat, fevers, HA, body aches. Patient denies chest pain,  abdominal pain, nausea vomiting diarrhea constipation, swelling, rash, fevers.     Hospital Course:  Aflutter with RVR: pt initially on diltiazem/amio gtt with eventual improvement, switched to oral form with recurrence. Patient eventually improved with resumption of beta blocker. She will be discharged on diltiazem, amiodarone, Lopressor and follow up with cardiology. Continue apixaban   Covid Positive -no covid pna seen on cxr or lung bases on ct abd, pt remained asymptomatic throughout the hospital stay"
BAD FLARE UP IN EYE (SCLERITIS); Rheumatoid arthritis flare up; Cold sores; This spontaneous case was reported by a consumer and describes the occurrence of SCLERITIS (BAD FLARE UP IN EYE (SCLERITIS)) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2021, the patient experienced SCLERITIS (BAD FLARE UP IN EYE (SCLERITIS)) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and ORAL HERPES (Cold sores). At the time of the report, SCLERITIS (BAD FLARE UP IN EYE (SCLERITIS)), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and ORAL HERPES (Cold sores) outcome was unknown.            No concomitant medication reported. No treatment information provided.  Action taken with respect to mRNA-1273 was not applicable.  Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Tuesday, Feb. 11th 2003, pt noticed soreness in the right deltoid (Tues. AM). Tuesday PM, pt's arm became reddened, swollen, hot to touch, low grade temp, and body aches were present. Symptoms persisted following day with redness/swelling remaining. Pt reports extreme soreness. The follow up states pt reports being fully recovered by 2/18/03.
One of twenty-one cases: A non serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in on nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
pt stated that about 2 days after getting the covid vax her upper left arm was sore and she developed a dry cough. She lost her voice since her throat was hoarse.  She had alot of mucus and nasal congestion.  On 1/29/2021 pt stated she was very very weak and could hardly function.  On 2/1/2021 she was worse and started running 101 temperature.  She contacted her PCP where he recommended for her not to take her 2nd covid vax dose but did not give her any medical advice.  She is still having periods of weakness at this time.
I am patients grandmother and have intestinal problems and suffered severe diarrhea for 2 week after my granddaughter who lives with me was vaccinated.  I did ask provider it there would be a possibility of a problem for me because of medical history and was assured it would be okay.
Headache started one day after injection. Headache severity increased with aural migraine on the third day requiring a dose of Nuretec OTC. Headache has resumed in a strong fashion each day. Treated with Tylenol. Six days after the shot, still having strong headaches.
reconstituted ACTHIB with sterile water and administered to a patient with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via the Agency (Reference number- 00862748).  This case involves a patient of (unknown demographics) who received reconstituted HIB (PRP/T) VACCINE [ACT-HIB] with sterile water and administered to a patient (product preparation error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (once, total, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution (same day).  It was reported "Caller states that someone in the office reconstituted ACTHIB with sterile water and administered to a patient. Caller is not in the office currently and does not have any event, patient, or product information."  At the time of reporting, no adverse event reported.  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.  There will be no information on batch number for this case.
Inject site swollen on 20JUN, 2 in diameter of redness, difficulty walking AM of 21JUN90, temp 102F AM of 21JUN90;
Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms lasted 0 days
no adverse effect reported; Nurse called to report a patient received improperly stored ROTATEQ on 8/4/2020; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 04-AUG-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally( lot # 1660981,expiration date: 13-APR-2021) (dose was not reported) for prophylaxis. The vaccine was stored in above 9 degrees Celsius (C) (8.9C)(47 degrees Fahrenheit) for a timeframe of 33 minutes. No additional adverse effect reported. There was no previous temperature excursions. Digital data logger was involved.
Around lunchtime the day following my second dose of the vaccine I started to have a humming in my ears and the sensation of sound inside my head that was not caused by external sounds in my environment.  It feels like a hum or vibration that is constant.  I feel like external sounds are muted because of the constant hum.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 18-AUG-2014, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-MAY-2016, the patient was treated in the emergency room for an ongoing painful rash which was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
slumping in chair; briefly unresponsive to question; moved to stretcher; rapid response called; vital taken; EMS arrived; w/o symptoms at 10:40am and discharged by physician; pt left stable @10:40am
Past due 42 daysfor the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past due 42 daysfor the second shot) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past due 42 daysfor the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past due 42 daysfor the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and medical history details are not provided by the Reporter.
ED visit for COVID  (primary encounter diagnosis) and Multiple sclerosis exacerbation; treated and released. ED to hospital admission 7 days later for Multiple sclerosis with Acute exacerbation.  LE weakness improved after Solumedrol 1g Infusions, he completed for 3 days. MR brain and Spine done and did not show new lesions.  Neurology Evaluated the patient and recommend On Outpatient Steroid Taper and DC with  Follow up in 6 weeks. Pt is stable for discharge and will follow up with PCP in 1 week for diabetes Management and With Neurology In 6 weeks. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolved within 12 hours
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Nauseam low grade temp, itchy at site, 3" lump at site, stomach upset.
Reddened inderated area around injection site approx. 6-7cm in diameter.
covid arm.....rash 5 inches long beneath vaccination site, 3 inches wide appeared at day 13 after 1st moderna vaccination shot did internet search , decided to wait it out, and not go to doctor.
The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73; The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73; flu-like symptoms; headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Primary immunization series completed), for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; HEADACHE (non-serious), outcome "unknown".  Additional information: Pharmacist was calling about the Pfizer COVID-19 vaccine bivalent that was left in the fridge and used beyond use date of 70 days. The vaccine was administered to a patient on 73 days so she wants to know if the patient should get vaccinated. The COVID-19 vaccine gray cap bivalent was stored in the fridge 73 days instead of 70 and it was administered to a patient on the day 73. The patient has had flu-like symptoms and headache, but no fever. Caller would like to know when the patient can be revaccinated, if at all.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
$ hours following the vaccination, I felt very faint and dizzy and nearly passed out. I checked my blood pressure, which was normal. My pulse rate was low (58). I remained dizzy and weak for the rest of the day, with some nausea, but no vomitting. My dizzyness and weakness gradually dissipated over the next 3 days.
Swelling, bruising at site for almost 6 months.  Intense stomach pain on left side, had to go to emergency (had this after my allergic reaction to flu vaccine too where my arm went paralyzed)   My vocal chords swelled up and I couldn?t speak for 2-3 weeks until a series of steroids. I?m a news anchor and 9 months later Im still having voice problems (range, hoarseness, sometimes pain in vocal chords)
Patient lost consciousness, had tonic clonic movements of both upper extremeties and whole body rigidity, lost bladder control.  Woke up after approx 30 seconds disoriented to time and place. Evaluated by pharmacist and paramedics. Transported to Hospital of via private vehicle per paramedic response team.  Per father, patient evaluated with several tests in the emergency department.
pt recvd vax; 5mar spasms lt arm, lasting 4 min in duration; shooting pains to fingers; 13mar95 no more problems;
Developed severe pain in the big toe on the right foot. He went to the clinic and she prescribed prednisone and indomethacin. Symptoms slowly improved over the next few weeks.
Reported on 9-20-2019 that beginning 1-2 days after receiving flu vaccine on 9-13-2019, of gradual spread to overall torso and extremities pinhead to pinpoint sized raised reddened bumps, with slight itchiness. Stated was diagnosed by own dermatologist with "angry skin". Bumps remain 1 week after injection but diminishing.
Pt had pain/soreness in his right knee. Pain started about 4 hrs after vaccination and worsened at bedtime. Pain resolved after 48 hours. Thought it was vaccine related per patient.
Chills; Headache; Muscle aches; Pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm  on 10Apr2021(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products Concomitant medications included losartan (MANUFACTURER UNKNOWN) for an unknown indication received within 2 weeks of vaccination. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the  left arm on 20Mar2021 at 11:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 12:00 the patient experienced chills, headache, muscle aches and pain at the injection site. No therapeutic measures were taken as a result of the events. 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. The clinical outcome of the events chills, headache, muscle aches and pain at the injection site were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
people who got Moderna, their arm was red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (people who got Moderna, their arm was red) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (people who got Moderna, their arm was red). At the time of the report, ERYTHEMA (people who got Moderna, their arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-024374, MOD-2021-024374, MOD-2021-329115, MOD-2021-329194 (Patient Link).
Physicians exam reveals 3" X 2" area of redness on left leg and 3" X 3" area redness on right leg.
non severe Leg spasms - ultrasound showed clear 4/16 and 4/19, started 4/14 and still continuing in both legs but predominantly left Briefly had a spasm in left arm, but did not repeat  Sensation of Pulling on hair and pressure in left side of head   D-Dimer Elevated 1084, platelets and fibrinogen normal from test on 4/16
Sleepy; swollen; soreness; red; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), SWELLING (swollen), PAIN (soreness), ERYTHEMA (red) and PRURITUS (Itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), SWELLING (swollen), PAIN (soreness), ERYTHEMA (red) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SOMNOLENCE (Sleepy), SWELLING (swollen), PAIN (soreness), ERYTHEMA (red) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.