chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate onset after receiving the vaccine on July 24th. I experienced severe headache, soar throat, a loose cough, nasal congestion, sinus pressure, injection site pain. Numbness and tingling from injection site in right arm radiating to fingers in right hand.  Generalized body aches. These symptoms persist to this present day (aug 18) I have had insomnia, inability to concentrate at work and while doing important tasks. I am experiencing a generalized mental fog. These symptoms have greatly impacted my daily living.
Expired dose administered; 0.25Ml/3rd Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25Ml/3rd Dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25Ml/3rd Dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25Ml/3rd Dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.
Colonoscopy; MODERNA BOOSTER AND HAD SLIGHT HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (MODERNA BOOSTER AND HAD SLIGHT HEADACHE) and COLONOSCOPY (Colonoscopy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 29-Nov-2021, the patient experienced HEADACHE (MODERNA BOOSTER AND HAD SLIGHT HEADACHE). On an unknown date, the patient experienced COLONOSCOPY (Colonoscopy). In 2021, HEADACHE (MODERNA BOOSTER AND HAD SLIGHT HEADACHE) had resolved. At the time of the report, COLONOSCOPY (Colonoscopy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Everything look good.         No concomitant drugs were taken.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Approximately 25-30 minutes post first Moderna vaccine (after pt was discharged from clinic with no issues) patient started experiencing feeling of throat thick and eyes heavy. Called 911. Patient transported via EMS to ER where she presented with feeling of thickness in her throat and tongue, swollen eyes and redness in the forehead. Pt received dexamethasone 10 mg IV x 1 and epinephrine 0.3 mg IM x 1. Pt was prescribed prednisone 10 mg tab: 4 po x 1 dose tonight, 3 po in am, 2 po qd x 1 day, 1 po qd x 1 day (total 10 tabs) upon discharge to home. Provider recommended no second COVID dose.
Information has been received from a pharmacy technician concerning a female patient who in" October 2008" was vaccinated with ZOSTAVAX (lot# 659408/0300X). "2 days after injection" "the patient's injection site became red and swollen after receiving ZOSTAVAX. The physician thought this adverse experience occurred because the lot of ZOSTAVAX was tainted with bacteria." The patient had sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and research was released. No additional information is available.
Immediate soreness at injection site that is still sore 24+ hours later. Lymph node on left side swollen. Very sore in armpit area. Entire  upper arm sore. Headache started around 9pm and was still present in AM. Took Tylenol which helped with soreness, but around 9am I realized the area was itchy and have a slight rash around injection area, but not directly over top. Woke up nauseous and queasy. Tylenol helped.
Bell's Palsy. 5 days of 40 mg. Prednisolone QD.
VERY TIRED Narrative:  PT REPORTED BEING REALLY TIRED BUT ALSO HAD SYMPTOMS OF BURNING ON URINATION, LIKELY DUE TO UTI; MALAISE LIKELY UNRELATED TO VACCINE DOSE, 2ND DOSE ADMINISTERED WITHOUT ISSUES
Pt. at the observation site felt difficulty breathing and anxious.  Paramedics assessed pt.   Once pt. symptoms subsided she was released by paramedics to leave.
I did not receive FluMist, but was the administrator of FluMist at an elementary school based clinic. The clinic started at approximately 9:00 am. While I administered FluMist, the other nurses noted that my face and neck were very red at approximately 10:00 am I stopped administering FluMist and left the clinic area. Symptoms progressed to include itching, wheezing, coughing, bronchospasms, chest pain, dizziness, and fatigue.  6 hours were spent in the emergency department.  Auto injectable epinephrine was administered in the emergency department.
pregnancy test was done and it was positive, with no reported AE; Initial information was received on 15-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old female pregnant patient who was exposed to vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] in context of pregnancy test was done and it was positive, with no reported ae. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known occurred at unknown gestation period, the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy/ies Unknown.  Concomitant medications included influenza vaccine (fluzone) for Prophylactic vaccination (Immunisation); and meningococcal vaccine b for Prophylactic vaccination (Immunisation).  On 19-Dec-2022, the patient received a  dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection at dose of 0.5 ml total once (1X) (lot number: U745OAA, expiration date: 10-Oct-2024, dose, strength, route: Unknown) in the right deltoid for Immunization (immunization).  On an unknown date the patient developed a non-serious event of pregnancy test was done and it was positive, with no reported ae (maternal exposure timing unspecified) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  Relevant laboratory test results included: Oestrogen receptor assay - On an unknown date:  [does not have the results] Pregnancy test - On an unknown date: Negative; on an unknown date: Positive  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event pregnancy test was done and it was positive, with no reported ae. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Acute pain in shoulder for a month where shot was administered.  Furthermore, after the third shot, within a couple weeks patient developed severe joint pain all across body.  However, at this time the worst reaction has been gastro-intestinal with bloating, cramps, and gas that developed within two weeks.  The onset of the gastro-intestinal problems required immediate healthcare attention as patient was losing consciousness over the severe abdominal conditions.  Note that after each of the first two shots there was extended pain and gastro problems though not to the extent after the third shot.   On a different note, there has been muscle/fat loss in certain places on body that have occurred since the first shot.  It is not known at this time whether this is gasto-related, a neuro-muscular problem, or other cause.  Lastly, note that none of the above symptons had ever been seen in prior 35 years.  An "auto-immune"-like mechanism is suspected as both the direct and indirect cause of the above symptons.  Tests are being done to baseline the patient and track whether or not health further declines. Nausea/Diarrhea. Follow Up: Pt still has chronic problems with stomach and muscles (weakness, etc.). The patient was lied to with respect to taking the vaccination. Pt was told that it was a state law, however the patient, as a gruaduate student, was not required to take the vaccination. The law goes into effect for 2005; patient vaccinations began in 2002. Furthermore, patient has very low/non existent risk for acquiring Hep B. There need to be a better way of doing this: someone who is 35 and at no risk should not be lied to and then told to take a vaccination. the policy is dicriminatory as well as non-student aged 35 are not forced to take the vaccination.
Fever, nausea (severe), chills, aches/pains, dry mouth. Took Tylenol/aspirin for 2 1/2 days. Also had stomach pain.
The patient's concomitant medications were not reported. The reporter stated that she received the first dose of the Pfizer Covid-19 vaccine on Sunday (25APR2021) and she did not feel much on that day, on the second day she had a sore arm and the next day she had a headache and felt exhausted, also had a feverish feeling on an unspecified date. The Patient took some ibuprofen and by the time she took her temperature she did not present fever. Therapeutic measures were taken as a result of sore arm, headache, exhausted and feverish feeling and treatment included ibuprofen. The outcome of the event feverish feeling was recovered on an unspecified date, and other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two weeks after the first Pfizer shot, I experienced labored breathing, congestion, fluid around my heart and left side numbness and stabbing head pain.
Pt said she felt her throat tightening, tingling of extremities, face felt tight, "like I had novacaine". Called 911 for transport to hospital via ambulance.  11/12/09 ED records received. Service date 11/5/09. Assessment: Adverse reaction to H1N1 vaccine, doubt true allergy. Patient reports 5 minutes after receiving vaccine felt a cooling sensation over body. Face and extremities felt numb and tingly. Flushed. Tongue felt thick, cotton-like, throat constricted. Received epinephrine and Benadryl from EMS. Symptom free on arrival to ED. Pregnant. Fetal heartbeat obtained. Patient to consult with PCP or OB.
Not sure if related, but was asked to fill out due to adverse effects in the following weeks.  Nausea, diarrhea, headache, inflammation, fatigue, tightness of breath
Seizure less than 5 minutes, 06:30 08/30/2005.  Resolved on own.
c/o dizziness, severe h/a pulse 84, BP 120/70; amb called pulse 140;BP 178/70;
Received tetanus shot on 09/30/2003.  I felt a little itching, nothing was there, then a couple days ago the area I scratched the redness started appearing.
GOT 2 PFIZER SHOTS AFTER GETTING THE JANSSEN VACCINE; OFF LABEL USE WITHOUT AE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the subject experienced got 2 pfizer shots after getting the janssen vaccine, and off label use without ae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use without ae and got 2 pfizer shots after getting the janssen vaccine was not reported. This report was non-serious.
The reaction started within 5 minutes of receiving the vaccine.  It started with my heart rate racing like I have never felt, and feelings of dizziness.  I was monitored and told I was having a strong immune reaction and sent home.  My heart rate would go up for no know reason frequently for several days and then continued for several weeks.  I went to immediate care in the first couple of days and had several tests run with no known reason. My symptoms progressed to fatigue and continued dizziness as well as numbness and tingling in my hands and feet.  The heart rate stabilized after a couple of months but the numbness and tingling in the hands and feet continued for an additional 3 months.  I am 6 months post vaccination and now still have numbness and tingling in my feet.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1,single (Batch/Lot number: unknown), on 09Apr2021 as dose 2,single (Batch/Lot number: unknown), on 18Oct2021 as dose 3,(booster) single (Batch/Lot number: unknown) and on 17May2022 as dose 4,(booster) single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: None. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 29May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29May2022) Positive, notes: 5 days after finishing course (29May2022), I developed new Covid symptoms and tested positive. Therapeutic measures were taken as a result of covid-19 and drug ineffective.  Clinical Course: There were no known allergies. It was reported that patient had  initially diarrhea. 5 days after finishing course (29May2022), he developed new Covid symptoms and tested positive. Subsequently symptoms worsened and he ended up in the hospital with shortness of breath/chest pains. After 2 separate hospital visits (31May & 2Jun), doctors diagnosed Covid Rebound due to Paxlovid course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient felt left arm tingling and dizzy within 15 minutes of vaccination.  He slumped to the floor (syncopal episode).  He felt better after resting and drinking some water, and was released to home.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 19-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N027002, expiration date 28-SEP-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Difficulty breathing, hoarseness, weak. Taken to hospital and diagnosed with bronchospasm. Received 3 respiratory therapies. Dexamethasone and therapies with albuterol.
Expired vaccine administered. I miss read the expiration date as 26MAY2022. The correct  expiration date is 26MAR2022.
Vaccine underdose; Syringe Leaked; 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 UNDERDOSE (Vaccine underdose) and SYRINGE ISSUE (Syringe Leaked) 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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced UNDERDOSE (Vaccine underdose) and SYRINGE ISSUE (Syringe Leaked). On 16-May-2021, UNDERDOSE (Vaccine underdose) and SYRINGE ISSUE (Syringe Leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-091127 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Followup received on 11-may-2021, contact details updated.; Sender's Comments:  MOD21-091127:
I am breastfeeding and my daughter developed a mild on her cheeks.; I am breastfeeding and my daughter developed a mild on her cheeks.; This is a spontaneous report from a contactable consumer. This consumer (mother) reported for a female patient (daughter).  This is the baby case report. A female patient of an unspecified age (child) received bnt162b2 (BNT162B2, formulation; Solution for injection Lot Ew0153),  via transmammary, on 10Apr2021 at 14.00, as an unspecified dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. on 11Apr2021, it was reported that mother was breastfeeding to her daughter and developed a mild on her daughter cheeks. The outcome of events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021401593 mother case
This solicited report as received from a consumer (also reported as mother), as a part of marketing research program, refers to a patient of an unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot#, expiration date and route of administration were not reported). the reporter stated that her family knew the patient and his/her health was severely negatively impacted by GARDASIL. the outcome of the event was not reported. the reporter considered the event as related to GARDASIL. Additional information is not expected as there was no consent for further contact.
Chest heaviness and Extremely bad leg pain; lower leg (calves) hurt the worse. I have been feeling the pain since Monday, March 15.  I went to the Urgent Care on March 16; I was sent to the ER where I stayed overnight. They ruled out heart related issues and blood clots. I had a follow up appointment on March 26; he said that he had seen patients who experienced the same, and it was due to the vaccine. Unlike them, my pain remained. He thinks that the vaccine triggered something else in me. After his appointment, I saw my orthopedist who prescribed meds to help with leg pain. If pain is not better in a month, then he will order a MRI. I saw my rheumatologist Monday, April 5. She is going to work with my orthopedists to treat me. Currently, I am doing the exercises that were prescribed for me to do at home, and I am on pain meds.
Hives started 1/1/2022> Broke out in massive hives 1/15/2022 with left sides shingles.  Now chronic idiopathic uticaria.  Angioedema with lips swelling  every few weeks.  Pressure hives with pain.
2/9/09 = Red swollen left arm painful. 2/10/09 = Reddened area on arm, spreading painful. 2/11/09 = cellulitis. Pt has prior Hx staph infections.
JOINT PAIN IN NON-VACCINATED ARM. JOINT PAIN IN KNEES AND ANKLES THAT IS NOT IMPROVING. NO TREATMENT.
devel immed redness @ site of inj rt thigh w/redness spreading quickly to 6x5cm area;also devel 3 scattered hives-2 on trunk, 1 on rt arm;tearful but no cough, wheeze or resp distress;given APAP & DPH;leg swelling dec, hives receded;
REACTION TO SECOND COVID VACCINE; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (REACTION TO SECOND COVID VACCINE) and PYREXIA (FEVER) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (REACTION TO SECOND COVID VACCINE) and PYREXIA (FEVER). At the time of the report, IMMUNISATION REACTION (REACTION TO SECOND COVID VACCINE) and PYREXIA (FEVER) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Non-stop screaming. Refusing to eat and screaming when trying to feed. Sore at spot of injection.
Pain left deltoid to midsternal down to below left breast: down to finger tip. Achy pain.
Vasovagal episode 5 minutes following vaccination administration (became hot and diaphoretic).  HR 44, SBP 100.  Received IVF enroute by ambulance to emergency department.  Evaluated in emergency department, asymptomatic, and discharged home.