chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night of the first dose, I woke from my sleep due to tightening of my muscles all over my body. I tried to bush it off. I went to use to bathroom. When I sat in the toilet I felt ill, like something was wrong. I rushed to get up to wash my hands and get to bed. When I pumped the soap, I went numb and my arms started to tremor. I felt like I was going to faint, so I rushed back to my room to wake my spouse. I laid down and couldn't shake the feeling. My arms kept shaking and then my chest began to feel cold inside. After a while I started to feel a bit better so I tried to sleep. As soon as I would drift into sleep the same thing would happen. The tightening of my muscles and arms shaking and cold chest. This lasted until about 2 am. The next day I was extremely fatigued. My body felt weak. I tried to do my part and get the vaccine for myself and those around me. I can honestly say getting the second dose worries me.
approx 15 dimes sized, welts appeared over chest, abd & scalp;started out resembling a pimple, progressed to having a fluid filled head, scabbed over & was very itchy;welt appeared over inj site;fever, enlarged cervical lymph node;weakness;
Heavy arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Heavy arm".  Additional information: Heavy arm after first dose and still that way 4 months later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20Q) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) 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.
Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.; Vaccine administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 3:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 3:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 24.40.  No concomitant medication was reported by reporter.  On 24-Feb-2021, The vial with batch number 014M20A was moved to fridge. On 27-Feb-2021, Product moved to clinic, underwent temperature excursion with temperature 33 degrees fahrenheit at 9:00 AM, 35 degrees fahrenheit at 11:00 AM, 12:00 PM, 13:00 PM and 14:00 PM. 34 degrees fahrenheit at 15:00 PM and 16:00 PM and 35 degrees fahrenheit at 17:00 PM. Beyond use date for the vial was reported as 26-Mar-2021.  The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree fahrenheit. Temperature recordings were taken by using a fisherbrand brand traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Caller stated that she received his first vaccine on 4/13/2021 and on 4/13/2021 member's started having pain to his armpit with tenderness to his lymph nodes. He denies having other symptoms.
A 70 year old male pt was treated with OncoTICE for bladder cancer. Since treatment start he experienced problems with urinating and burning during urination after each instillation. After the second instillation  he also presented with fever, which resolved with treatment. After the last instillation he was barely able to hold it for the prescribed 2 hours. He had extreme burning during urination and was prescribed antibiotics and the burning subsided after 1 week. On 26Jul04 a red spot in the area of the surgery was seen during a cystoscopy. His treating doctor is not sure if this is related to Oncotice treatment. Aspirin for fever, antibiotics for dysuria
Vaccine given 7 days early.  Second vaccine due on December 7,  2021.  No adverse effects reported
Two weeks after receiving my vaccine, I had a mini stroke while driving. I was able to get to my destination safely thank goodness. A friend took me immediately to the Er where I was admitted for 4 days. I experienced another stroke somewhat similar as the first but less intense  2 days after the first one.
optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurological damage; unable to speak; changes in her eyes; Her right eye was bulging; Neither eye looked in the same direction, or able to track objects; known allergies: Apparently the Covid Vaccine by Pfizer; This is a spontaneous report from a contactable consumer. The consumer reported two reports for two separate vaccine doses for the same patient. This is the first of two reports. A 74-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included advanced stages of Multiple Sclerosis, Diabetes, depressant, covid prior vaccination. The patient's concomitant medications included diabetic meds (pills), anti-depressants, etc. The patient previously received the first dose of BNT162B2 in Dec2020 at age of 74 years old for COVID-19 immunization and experienced neurological setback and it wasn't terribly obvious at that time. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. The patient (mother of the reporter) suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time, in comparison to what occurred after she received the second vaccine. The patient suffered major neurological damage after the second vaccine; unable to speak, followed by an inability to move, chew, eat, etc. The reporter also noticed optical neuritis or changes in her eyes. Her right eye was bulging. Neither eye looked in the same direction, or able to track objects. The patient was currently in a long term acute hospital (pending clarification) with a tracheostomy and a food peg. She had advanced stages of Multiple Sclerosis. Reporter had since learned she had been advised by her MS doctors NOT to receive flu shots. The reporter had known this and would not have listened to the doctors at the nursing home, who recommended she receive the Covid Vaccine. This was serious. The reporter was awaiting medical records, which would provide exact dates, times, etc of the administration of the vaccines. Adverse events resulted in Disability or permanent damage. Known allergies: Apparently the Covid Vaccine by Pfizer. If treatment adverse events: unknown. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included unknown covid test: negative in Jan2021 (post vaccination). The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Two days after receiving the first Pfizer vaccine, I had irregular heartbeats that later turned out to be Arrythmia and it lasted for two days. I didn't say anything to anybody as I was scared and was hoping it would subside which it did. However, I received the 2nd dose and the same thing happened two days later, but this time did not go away. I went to the local emergency room in which I was subject to an EKG that showed "Sinus rhythm with premature atrial complexes" as well as borderline "ECG". The irregular heartbeats eventually went away after about a week but still persist or happen periodically throughout my daily life. I've had an echocardiogram done that shows no signs of heart damage or other heart related diseases.
Hard, tender lump, joint pain, pain in hands, pain with walking, high fever, body aches, nauseous, dizzy, fainting. I developed cellulitis after being told to simply hot pack it when I called into the doctors office. I then went to urgent care the next day.  I wish I was hospitalized. I have never been so sick in my life.
Vaccines recd 11/12/13. Developed fever 101.6 that evening with body and headache. Called doctor 11/14 to report. Cont to have "achy", temp 99.2.
First day-(11/30 about 11am) my arm just itched and was sore. Last night I ran a low fever of 100-101.2, my arm is still sore and now (12-1)  it is red and hot (size is about 2 3/4?x 1 1/2? ) I also have a head ache.
Pediatric Havrix dose to adult patient; Pediatric Havrix dose to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 76-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 06-MAY-2023, the patient received Havrix. On 06-MAY-2023, an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: Pediatric Havrix dose to adult patient) and adult use of a child product (Verbatim: Pediatric Havrix dose to adult patient). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2023 The pharmacist reported that a pediatric dose of Havrix was administered to an adult patient. The reporter consented to follow up via email. The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Pt experienced mild tingling and itching on legs bilaterally. 25 mg Diphenhydramine liquid orally.. pt monitored for 30 min  then reported itching and tingling subsided. Pt went home with mother and was not driving.
Patient falsified covid questionnaire and reported they had not received any previous covid vaccinations.  That was determined to be false after medication administration it was determined patients had received both doses of moderna prior to receiving the dose of Pfizer.  Patient contacted and he did not have any adverse effects.
headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and MYALGIA (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039a21a and 036b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (sore arm). On 28-Mar-2021, MYALGIA (sore arm) had resolved. On 29-Mar-2021, HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment with ADVIL was provided.   This case was linked to MOD-2021-089200 (Patient Link).
Lightheadedness / dizziness; High fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness / dizziness), PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea). On 17-Mar-2021, the patient experienced DIZZINESS (Lightheadedness / dizziness). The patient was treated with ACETAMINOPHEN for Fever, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Nausea, at a dose of Tea. On 17-Mar-2021, PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, DIZZINESS (Lightheadedness / dizziness) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 (High) 101 F and 102 (High) 102 F.         Concomitant product use was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
11-14-09 back of neck began to itch in the PM.  Then when woke up 11-15-09 legs and arms were itching resemoline hives, welts/redness on bilateral legs & arms.  On CTD use BENADREL to control itching & to call physician if become worse or no improvement
After booster shot in October, had a phasic reaction to booster after day, could not communicate, struggling to form basic sentences, also had strong flu-like symptoms. Doctors believed it was a TIA, sick with flu like symptoms for five days (very severe)
Upon waking in am on 1/7/21 noted rash had developed on chest and neck. Experienced extreme pain length of spine as well as in left arm. Pain to excruciating to stand, walk or sit. Was physically able to move legs but anything that required movement felt extreme pain in spine. Went to physicians office on 1/7/21, Prednisone was ordered. Blood work done which revealed elevated liver enzymes, will return to physician's office on 1/11/21 for repeat labs. Rash on chest and neck is better on 1/8/21 however remains blotchy.  All treatment orders were Prednisone, lab work, Tylenol, and heating pad.  Return to physician on 1/11/21.
AE: local swelling at injection site , redness and tender to touch. Treatment: cephalexin 500mg tid for 10 days and medrol dose pak 6 day taper.
Patient describes after receiving the vaccine around noon she started not feeling well later on in the evening. In the middle of the night she was experiencing extreme flu like symptoms and severe nausea (no vomiting reported) around this time she reported "passing out" and needing to be taken to the emergency room via ambulance. Patient was feeling better and I believe discharged from the hospital. No treatment information was reported.
5/7: headache, took Tylenol and zinc  5/8: site hot to touch, headache, body aches, nausea, chills, fatigue, shooting pains in extremities (come & go), fever (99.8). Took Tylenol ea 4hrs all day, zinc 1ce, rested, drank extra fluids. 5/9: site hot to touch. Minor headache, took Tylenol 1ce and zinc  5/10: patchy red spots near injection site. Still hot to touch.
arm soreness; body ache; lethargy; fever; sore throat; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Dental surgery NOS. Concurrent medical conditions included Hypothyroidism since 2019, Allergy (Septra) and Allergy to antibiotic (Septra allergy). Concomitant products included LORATADINE from 2015 to an unknown date for Allergy, LEVOTHYROXINE from 2019 to an unknown date for Hypothyroidism, ASPIRIN [ACETYLSALICYLIC ACID] from 2015 to an unknown date for Prevention, VITAMINS NOS (MVI [VITAMINS NOS]) from 2015 to an unknown date for Supplementation therapy.   On 07-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat). On 23-Feb-2021, PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat) to be possibly related.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-012397 (Patient Link).
Pt reported welts (hives) around injection site that started 2 days after injection. Also, large red ring around the hive that stretched from injection site to elbow. Pt came in after MD office closed so instructed pt to get hydrocortisone 1% cream, BENADRYL/ZYRTEC, and use ice - also call MD in AM, but to go to ER if got worse or pt had trouble breathing. F/U on 2/25 - pt states she started ZYRTEC/hydrocortisone/ice. Rash not worse, seems to be getting better, more red. 2/26 - No answer called lm (3 attempts).
Nausea, vomiting, headache, fatigue, diarrhea that started about 24 hours after the vaccine and lasted about 3 days
A report was received from a health professional on 11Oct02, concerning 3 vaccinees who were inadvertently admin Fluvirin from a partially frozen vial on an unk date. On an unk date, 3 vaccinees were inadvertently administered Fluvirin from a partially frozen vial: no adverse events were observed. There was insufficient information to determine the reporters causality assessment.
the patient did not receive the full dose with no reported adverse event; Initial and live follow up information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who did not receive the full dose with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 11-Oct-2022, the patient received a  dose of 0.25 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ663AAA, expiration date: 04-May-2023, via intramuscular route in unknown administration site as Immunization.  On 11-OCT-2022 the patient did not receive the full dose with no reported adverse event (incorrect dose administered) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The caller reported the needle was displaced and the medication squirted out. The caller inquired does the patient need to be revaccinated. The patient may have gotten a partial dose but they were not positive. This situation was reported as a medication error due to not securing the needle properly for the injection.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (the patient did not receive the full dose with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm is swollen and very painful; Arm is swollen and very painful/pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 24Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Flu shot. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "not recovered", described as "Arm is swollen and very painful"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "Arm is swollen and very painful/pain in arm". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity.  Follow-up (29Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.