chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost 24 hours after vaccine booster, my arm started to hurt, I couldn't move it, I was in extreme pain, couldn't do anything.  I went into the Dr. office on an emergency basis as it was very painful.  The doctor pressed on my decollete in 3 different areas using her 2 index fingers. The first press was at the top of decollete and no pain, the second press was more inward then the first press and caused very bad pain.  The doctor indicated the vaccine had gotten into my joints and gave me a shot of cortisone.
Patient describes a small red spot and redness accompanied by a warm to the touch area under where the flu shot was administered.
This spontaneous report has been received from a pharmacist, referring to an unspecified infant patient whose age was approximately 2 to 3 months old, and gender was not specified. The patient's pertinent medical history, concomitant medications and information about any drug reactions or allergies experienced by the patient were not provided. The pharmacist reported that, on 25-MAY-2018, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23, for prophylaxis (drug administered to patient of inappropriate age) (concentration, dose number, frequency were not provided; route and anatomical location of administration, lot number and expiration date were unknown by the pharmacist). No adverse effects or product quality complains were reported by the pharmacist. Further information was not provided.
Severe pain on surface of skin.  At first, it felt as if my muscle was rip from my rib cage. Then the pain moved to my lower left chest. Doctors did an EKG and various blood test but could not pinpoint source. The same symptom moves to my left upper arm, then move to my upper abdomen.  Now it is in both arms towards wrist, which is causing severe shales in both arms.  In all cases my flesh is sensitive to touching, and the recovery times was an average of 3-to-4 weeks.  I am active person, and now this ailment which seems like some nerve damage, is crippling. I can only link these symptoms to some byproduct of the vaccine.
anaphylaxis; paralysis of her limbs; cognitively struggling; weak; her legs keep buckling; This is a spontaneous report from a contactable consumer (Patient mother). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 24May2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylaxis. Caller stated, reporter took her daughter to the ER because she keeps experiencing paralysis of her limbs that comes and goes. reporter spoke to the doctor who said to give the body a chance, it went through a reaction, gave the time it needed and it gets worse and worse. reporter stated her daughter was weak and cognitively struggling, that her limbs are very weak, and that she needs assistance because her legs keep buckling.The outcome of the events were unknown.  Information about batch/Lot number has been requested.
Quarter sized area of redness, swelling and warmth of skin around shot injection site. Mom and maternal grandfather have had similar reactions to tetanus shots in the past. Patient had not had previous reactions to the tetanus shot. This was her fifth tetanus vaccine.
Information has been received from a consumer concerning his 9 year old son with attention deficit disorder (ADD) diagnosed when he was very young who in approximately 2000 or 2001 was vaccinated with one dose of MMR II. There was no concomitant medication. In approximately 2000 or 2001 the patient's ADD became much worse and began to experience speech problems and many other developmental issues. At the time of reporting, the outcome was unknown. Medical attention was sought of several physicians. No further information is available.
Initial and follow up information has been received from a Nurse Practitioner (N.P.), who reported when she went to administered a dose of Gardasil (Lot # 0469U) from a prefilled syringe, it "shot off across the room" and hit the wall. The syringe fell apart. The NP confirmed that no patients were involved, and no one was injured. No further information is expected.
103 fever, nausea, chills, headache, abdominal cramps, diarrhea, bone aches, lethargy and dizziness.  The fever lasted 4 days, at day 8 now and still experiencing abdominal cramps and some nausea and lethargy.
Fever, nausea, diarrhea, extreme sore mouth, unable to eat, vomiting, dizziness, congestion, extreme headache.
rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: 7 people that have gotten COVID again.  Clinical Course: You need to update your records on rebound COVID after taking your antiviral medication. In my small circle I know 7 people that have gotten COVID again. I am wait too see if I do my husband has it again and I am still testing positive. I never would have taken it if I knew that percentage of peoples that get it again. It should only be given to very high risk people.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.;
Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered mental status, and a near syncopal episode upon arrival at the ED. Patient also reported some throat tightness and nausea. Patient received the first does of the Pfizer COVID vaccine about one hour PTA. Patient began having hypertension noted to be in the 180-215 systolics and patient reports baseline of 120s systolic. Patient was brought directly from the vaccine clinic to the ED. Upon arrival at the ED, patient experienced a syncopal episode and eventually came out of this but was confused. It was reported in the notes that patient was slightly dehydrated which could have contributed to her symptoms. Once the patient recovered from this episode and hypertension was resolved, patient was discharged home to follow up with PCP.
This case was reported by a physician via sales rep and described the occurrence of monoplegia in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced monoplegia (serious criteria GSK medically significant). On an unknown date, the outcome of the monoplegia was unknown. The reporter considered the monoplegia to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was not able to move their leg the following day after receiving their 1st dose of BEXSERO. Although, the reporter believed that the event was related to the BEXSERO, the reporter explicitly stressed that GlaxoSmithKline (GSK) not to follow up and contact them as they did not want to deal with the paper work and information related to the incident. This case was linked with US2019GSK030162, reported by the same reporter.
My throat started constricting air passage and it was hard to breathe in air through my mouth.  I went to the emergency room and was given an IV of steroids, Benadryl and pepsin.  They watched me for 2 hours and discharged me with prescriptions for steroids and Benadryl and pepsin.
10/30/22 presents to ED for "chest pain, shortness of breath". PMHx of "CAD, HTN, diabetes"
TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from tired. This report was non-serious.
Fever, painful swelling redness and bruising since 5 hours after administering vaccine.
ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI HYPOXIA
On Dec 3 my 23 yo son had moderna covid vaccine number 1. On January 1 2022 he developed COVID. He had COVID and recovered. Per his PCP guidance he had moderna vaccine number 2 on 1/20/2022. He had some unpleasant side effects that started the date of his vaccine. On 1/23 developed shortness of breath and chest pain and was brought to the hospital where he was diagnosed with myocarditis. His troponin topped to 16000, his echo showed EF of 50%. He was admitted, treated and released home on Motrin and metoprolol. He is home recovering and will have a repeat echo on Feb 5.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's husband. The patient received the first dose of the Shingrix vaccine around May of 2019 and had headache. The reporter was not willing to provide any additional information. The reporter did not consent to follow up. This case has been linked with case US2019145715, reported by the same reporter.
Patient was administered the Pfizer bivalent as the second dose in the primary series.   No adverse reactions reported.
This spontaneous report as received from a physician refers to a 17 year old male patient. In 2013 (reported as four and a half years ago) the patient was vaccinated with his first dose of GARDASIL for prophylaxis. Other suspect therapies included GARDASIL 9. On an unknown date the patient experienced interchange of vaccine products, wrong drug administered and product use issue.  No adverse effect reported.
I did not have an adverse reaction to the vaccine. In 02/2023 I began having stomach issues. I had a visit with my provider and was referred to a gastroenterologist. I had a colonoscopy and results are in normal range.
Initial report received on April 10,2006, from a health care professional. An 18-year-old female patient with a history of allergy to bees, had received an administration of Menactra, on January 06,2006. The lot number, route and site of administration were not reported. Seventy days post vaccination, the patient donated blood and the blood tested positive for syphilis. The patient spoke with her physician, and she was subsequently tested for GBS, Lyme Disease, Mono, Hepatitis A, B, C and MMR to rule out other possible causes for a positive syphilis test. The results of the laboratory testing was not provided. Per the reporter, the syphilis test was thought to be a false positive. The patient's status at the time of this report was reported as "unknown".
Nausea; couldn't get out of bed for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (couldn't get out of bed for 3 days) in a female patient of an unknown age 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 NAUSEA (Nausea) and FATIGUE (couldn't get out of bed for 3 days). At the time of the report, NAUSEA (Nausea) and FATIGUE (couldn't get out of bed for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  The report on 17-May-2021 clarified that the original reported events were those she read about in the paper; she did not experience any of those events. The patient did experience nausea and that she "had no power" and thus couldn't get out of bed for 3 days.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-138795 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional information added on 17-MAY-2021 provided clarification on the events experienced by the patient and provided outcome.; 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. US-MODERNATX, INC.-MOD-2021-138795:2nd dose case
Pt has had of fainting and felt faint post-injection. She was assisted to the ground to lie down. Denies any other s/s. Remains awake and alert, aware of place/ time/ location. Pt observed for total of 45 mins, left site in stable condition.
fever, injection site swelling, headache, neck ache, backache, rash, injection site pain, fatigue, nausea
Tdap inadverently given instead of Pediarix by mistake.  No reaction to vaccine noted did not answer question 9 and 11.  Will recall patient to receive Pediarix
INFECTIONS IN GUMS; CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) was received on 23-JUL-2021 and concerned a female of unspecified age of unknown race and ethnicity.  The patient's height, and weight were not reported. The patient is not immunosuppressant but immunocompromised with other health conditions.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in end of APR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. One month later after the vaccination on an unspecified date in May-2021, the patient did the antibody test which turned out to be negative (confirmed immunological vaccination failure). Laboratory data included: On May-2021, Antibody test (NR: not provided) Negative.  On an unspecified date, the patient experienced infections in gums. The patient had dental appointment.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccination failure and infections in gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210760475-covid-19 vaccine ad26.cov2.s-Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient with 4 COVID vaccines with esophageal cancer admitted to acute care for ventricular asystole and had pacemaker placed.  Patient then admitted to Rehab unit and tested detected for COVID prior to discharge.  Provider d/c note re COVID:  "1. Symptomatic Covid 19 detected the evening before planned discharge.  He was given 3 days of iv remdesivir and had an oncology appt rescheduled.  He will be seen next 12/21  by oncology and has f/u with cardiology and sleep medicine.  He has remained afebrile and on room air (except for evening cpap/bipap - which is baseline) for over 48 hours. 2. He feels safe and ready to dc home today.  He has been room independent for over 48 hours and has done well."
facial swelling for 3 days ,had to go to to the emergency room., hives all over the body for eight weeks.
pt develop myalgias, anthralgias, subjective fever, headache and nausea one day after receiving anthrax vaccine. Symptoms improved and are continuing to improve with symptomatic care.
Red and itchy injection site, left deltoid, left arm tingly into fingers, itchy left side and back, no hives noted, c/o thirsty with "harder to swallow" though able to swallow and no SOB.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-SEP-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot # and expiry date was not reported) for prophylaxis. On 22-FEB-2018, the patient was vaccinated with second dose of GARDASIL 9 (lot # N022727, Expiry date: 12-JUN-2020) for prophylaxis (inappropriate schedule of drug administration). There was no adverse event reported. There was no product quality complaint involved.
Beginning at 2 am the next day I experienced muscle aches, headache, chills and a fever of 102.8*F, I alternated ibuprofen 800mg and tylenol 100mg for treatment and around 12pm that same day started feeling relief. Then later in the evening at around 4 pm began feeling muscle spasms in my chest and abdomen area which I had not experienced before, so around 7:30pm I went to the hospital for treatment and was given ibuprofen again and also a lidocaine cocktail which relieved my symptoms.
Pt recvd vax & 5-6 hrs later exp cramping, nausea, sweating, pain in lt flank area, & weakness;
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celsius) for greater than 10 weeks.  Vaccine was stored for a total of 8 days past its beyond use date in the refrigerator.  Patient did not experience any adverse events.
This spontaneous report as received from a Registered Nurse refers to a 18 years old male patient with no pertinent medical history. The patient was intramuscularly vaccinated with the second dose of 0.5 ml GARDASIL (lot # 671463/1359AA, Exp date 23-JUN-2014) in December 2011. There was no concomitant medications therapy. Then the patient developed a rash on an unknown date after his second dose and reported in July 2012 during his routine physical examination. Medical chart now noted "Allergic to GARDASIL". Reporter stated physician in the office did not intend to administer third dose. The patient did not sought medical attention. No lab diagnostics studies performed and no treatment was given for the event. The outcome was reported as recovered/resolved. Additional information has been requested.
No adverse effect reported; patient received an improperly stored dose of GARDASIL 9 on 23-MAY-2019.; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 03-OCT-2018, the patient was vaccinated with the first dose and on 15-JAN-2019, received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, anatomical location, lot # and expiration date were not reported) intramuscularly as prophylaxis.  On 23-MAY-2019, the patient was vaccinated intramuscularly with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) which was improperly stored (strength, dose, and anatomical location were not reported) involved lot # was R003557, expiration date reported as 10-NOV-2020, but upon internal validation established as 20-NOV-2020. The administered dose of the vaccine experienced a temperature excursion for an unknown time frame. It was unknown if a previous excursion occurred, and this call was not placed because of a data logger. There was no adverse effect reported. No product quality complaint was involved.
neck pain; arm pain; 3 troponin levels at 200/203/204; chronic LBBB; PAF; This is a spontaneous report from a contactable nurse (reporting for mother). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) dose 2 via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 taken for COVID-19 immunisation. The patient was admitted to the hospital with neck/arm pain with 3 troponin levels at 200/203/204. Echo did not show wall motion abnormalities. Could she have had a delayed inflammatory process causing her symptoms? Myocarditis. There was no indication of an acute MI: EKG showed chronic left bundle branch block (LBBB). She did develop paroxysmal atrial fibrillation (PAF) on day 2, lasting only 12 hours. The outcome of events was unknown. Events were reported as non-serious.  Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
First shot: Tingling in my fingers, toes and lips.  It started about 30 minutes after receiving my shot and stopped about an hour later. No pain, just tingling.   My 2nd shot a month later I had body aches, sore muscles and was very tired. I did NOT have a temperature.  The symptoms lasted for approximately 1 day. I felt normal the next day which was 2 days after my vaccination.
extreme muscle cramps, joint pain. Felt like every muscle and joint in my body was seized up tight. Couldn't sleep because I was in so much pain. lasted from late Tuesday night (about six hours after vaccine) through until Thursday morning when I woke up. About 36 hours. Did not have anything like this on previous covid shots or boosters.
Loss of taste and smell of some foods and smells 14 days after first dose. Heightened sense of vinegar/metallic scents. Loss of flavor. IE can taste sweetness but no differentiation between flavors like chocolate or vanilla.
Shortness of breath starting last week. Whet to doctor. On Steroids and antibodies.  Never felt this short of breath in my life.