chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PEDVAXHIB injection, lot# K015464, exp. date: 09-JUL-2017 and lot# K026533, exp. date: 07-AUG-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. states that after receiving the 1st dose of J&J 04/09/2021, started experiencing uncontrollable hiccups lasting 24/48hrs at a time 04/19/2021. Treated by Primary but no results of subsiding. Weakness, uncontrollable hand shaking, and nausea. Stress test recommended appt. not set. Still continuing to experience symptoms.
Excessive pain, redness and swelling near injection site the day it was given; hard, painful red lumps developed surrounding and well below the injection sight for 3 days, headache, difficulty breathing, fatigue, sore throat, sneezing, dry cough, difficulty swallowing. Self treated with Benadryl.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: eh9899), in right arm, on 12Jan2021 as dose 2, single (Lot number: ekl9899), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: ff2588) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Lot number: 259M2117), in left arm for covid-19 immunisation. The patient's relevant medical history included: "SP Prostate Cancer" (unspecified if ongoing); "currently throat cancer" (unspecified if ongoing); "MGUS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: On 16Jun2022, rebound post Paxlovid treatment. Home test strong positive 5 days post treatment. At 2 days post treatment, home test a reliable negative. Noticeable symptoms started on day 4 post treatment. COVID 19 Treatment: Paxlovid. Treatment start date: 08Jun2022 and stop date: 12Jun2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date : 18Jun2022.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown demographics. On an unspecified dates, the patients received either GARDASIL with confirmed lot# L040460 and expiration date 27-MAY-2017; or GARDASIL 9 with confirmed lot#L026602 and expiration date 19-OCT-2017 (dosing details unspecified) that were improperly stored. No adverse effects reported. No product complaints involved. No further information was provided. Additional information has been requested.
On March 7 I had shortness of breath while doing easy exercising. On March 8 I was breathing really hard on a 5-mile hike.  On March 10 I had trouble breathing while getting dressed (8 a.m.). Nurse said to go the Emergency room. My O2 sat was 87. I was put on oxygen. After multiple blood tests, chest x-ray, dye angiogram of my lungs, it was confirmed that I had massive pulmonary emboli in both lungs. My D-Dimers were 14,700.  Subsequent echo cardiogram and ultrasound revealed a strained right side of my heart and a clot in my right leg behind my knee. There were no indicators prior to the shortness of breath--no swollen leg, no pain, etc. I was put on a heparin drip and admitted to the ICU. I was discharged 30 hours later and have been taking Eliquis since then. My physician ran multiple tests and there is no familial history of this. We are puzzled as to why this occurred.
LITTLE TEMPERATURE; ARM SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 195 pounds, and height was 67 inches.  The patient's past medical history included: cold, covid-19 (Got covid toes. Patient was seen by the doctor, and she tested negative, and titer was negative but back then the titers weren't very good. Her purple toes, and did lots of cardiovascular studies and there was nothing wrong.), joint replacements, and flu (after getting the flu shot still got flu), and concurrent conditions included: paroxysmal atrial tachycardia (rapid heart rate), neuropathy, arthritic pain (joint pain), and drug allergy (get rapid heart rate from Robaxin a muscle relaxant, significant GI irritation from cipro, rapid heart rate and palpitations from allopurinol), and other pre-existing medical conditions included: The patient was nurse by profession. The patient was not pregnant at the time of reporting. Patient was healthy. Patient's sister had residual polio in one of her legs. The patient was not diagnosed with any autoimmune disorders or immunosuppressive disorders. The patient was previously treated with tetanus vaccine for prophylactic vaccination, and influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 66 years old. Concomitant medications included meloxicam for anti-inflammatory, gabapentin for neuropathy, metoprolol succinate for rapid heart rate, and famotidine.  On 11-MAY-2021, the patient experienced arm soreness. On 12-MAY-2021, the patient experienced little temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness and little temperature was not reported. This report was non-serious. This case, involving the same patient is linked to 20220832455.
a little sore arm; some fatigue; This is a spontaneous report from a contactable consumer (patient), from a Pfizer-sponsored program. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and developed chills and loss of appetite and went to the emergency room, Was ill for nine days. The patient reports that she had her second dose of the Pfizer-Biontech Covid19 vaccine on Friday (23Apr2021) and all she ended up with was some fatigue and a little sore arm. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
8 hours after vaccine (lasting 24 hours)- headache, fatigue, body aches 2 weeks after vaccine (lasting several weeks)- pain to the left of my left breast under my arm; aggravating previous pain in that area, which had gone away
11:25AM Pt complaining of feeling hot and feeling as she was going to pass out.  Lightheadedness.  Denies dizziness, denies SOB.   SO2 99%, BP: 138/78, HR:80, Hx of DM2, Ate a small breakfast this AM. " High reading of sugar this AM, about >300"  Transferred to wheelchair, feet elevated.  Water encouraged.  Call to PCP.  Notified of incident.  11:55AM BP: 138--70
large local swelling and tenderness, involving upper arm and axilla, mild redness. Had chills, subjective fever, malaise, myalgias first night only
Lethargic; No energy; cannot put one foot in front of the other; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lethargic, no energy and cannot put one foot in front of the other on an unspecified date. Caller reported that patient got her second shot and has been lethargic, no energy, cannot put one foot in front of the other. She has been in bed for two weeks. The clinical outcome of the events was unknown.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
On 03/07/2021, a couple of days after I got the shot I experienced axillary swelling under my armpit, round, ball-like, on the same side the shot was administered. I could not put my arm all the way down because it was protruding under my armpit. Like someone put a tennis ball under my armpit. I saw a doctor as soon as the issue occurred. They told me to take anti-inflammatories, like Advil or Aleve. They also said it was an immune response. That my body was trying to tolerate the vaccine. They said it was not anything to be concerned about at that moment. It just seemed scary. It resolved after a few days.
Unable to walk Sunday night, severe pain in food, visual lump, shooting and burning pain. Went to urgent Care after taking Aspirin and was starting to  feel better. Told to take more aspirin that I had been on my feet too long. However, I'm a school teacher and used to standing for long periods of time, and this day I had been off and seated. Told I was being silly when I asked if it could be connected to my vaccination. Two days later the vaccine was suspended for Blood Clotting issues. I believe this was what I was experiencing.   Then in April my vision started changing and getting worse in my left eye, it go very severe end of August and I was diagnosed with MEWDS (white dot syndrome). Now 8-9 months later my vision is finally returning and my doctor is hopeful that in the next few months the condition will resolve. I have never had MEWDS before, nor was the cause viral.
After receiving 1st dose of covid vaccine (by pfiser), patient was asked to sit down in the waiting area. Patient hit the floor because she passed out/fainted for a moment. Patient was conscious. We asked if patient is able to breathe and would want medical help and call 911. She stayed seated for a while and didn't seek further help.
She got the vaccine, within the first night she woke up around 9:00 to 10:00 as she felt more fatigued.  She had pulsing ringing (already has tinnitus), really loud ringing.  Her skin was really hot (sunburn hot), tongue was sore, her eyes hurt (tissue burning sensation) feeling.  Heft left arm was extremely painful, but went away.  The headache all through the front, part of her forehead, eyes, head, and took 2 Tylenol.  About 3 days after that her right wrist started hurting, throbbing pain.  She has never had any joint pains.  She has been taking Turmeric, the right wrist is still hurting.  She did have body aches, throat, and all symptoms, felt like she had a flue/cold.  She is completely dizzy, disoriented and not able to use her phone.  She is not able to regain her balance at this point.  The lingering effects are she cannot read, she always feels like she has been lost in space.   The pain is improving, but is still present.    When she looks down the dizziness is a lot worse.  She has pushed back the 2nd vaccine.   She has called her doctor and reported this who told her to call us.   She took Claritin and it stopped a lot of the symptoms.
Information has been received from a physician and registered nurse (RN) concerning a 9 yr old white female who on 01Aug97 was vaccinated with a 0.5mL dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant therapy included a dose of tuberculin purified protein derivative administered on that same day. On 01Jan06, the pt developed a mild case of breakthrough chickenpox characterized by 59-269 lesions. The pt was noted to be afebrile. Unspecified medical attention was sought. At the time of this report, the outcome was unk. The pt's brother (WAES0601USA01873) and sister (WAES0601USA01839) were noted to have developed chickenpox after vaccination with varicella virus vaccine live. Additional information has been requested.
Severe urticaria all over body, for approximately 48 hours, relieved somewhat with  claritin but not fully.
This case was reported by a consumer via out of hour services and described the occurrence of chills in a male patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were unknown. It was unknown if the reporter considered the chills, general body pain and fever to be related to FLUARIX QUADRIVELENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. The patient had to miss a day at work due to the reported side effects.
Worsening of seizures; "Speech getting worse"; 2nd dose Jan2021, Dec2021 shingles/suspected Vaccination failure; Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 21st December 2021, 11 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced convulsions aggravated (serious criteria GSK medically significant) and speech disorder. On an unknown date, the outcome of the vaccination failure, convulsions aggravated, shingles and speech disorder were unknown.   It was unknown if the reporter considered the vaccination failure, convulsions aggravated, shingles and speech disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 2nd dose of Shingrix in January 2021 and she was with shingles outbreak (lack of drug effect). Less than 2 years after receiving vaccination, the patient had worsening of her seizures and that her speech was getting worse. The patient provided very limited information and refused to provide demographics or answer questions related to adverse event.   No further information or details were provided by the caller. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation were unknown at the time of reporting. The reporter did not consent to follow-up.
Fever 104.7; loss of consciousness; high heart rate; cardiac ischemia; low sodium; This is a spontaneous report from a contactable consumer (patient). An 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 17Aug2021 18:00 as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included pyridostigmine (PYRIDOSTIGMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Pyridostigmine medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever104.7, loss of consciousness, high heart rate, cardiac ischemia, low sodium on 18Aug2021. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included heart rate: high, pyrexia: 104.7, sars-cov-2 test: negative on 28Aug2021 and blood sodium: low, Ct, MRI, ekgs, echocardiogram, blood tests. The patient received treatment for the events with IVs. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
muscle soreness in her arm (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (muscle soreness in her arm (injection site)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (muscle soreness in her arm (injection site)). At the time of the report, VACCINATION SITE PAIN (muscle soreness in her arm (injection site)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient came in for her second dose, and said 8 days after her vaccine on 03/29/2021, she got a rash on her arm.
Felt ill the night she received the immunization with allergy type symptoms - tightening in throat and took Allegra. The next morning, she vomitted, had stomach cramps, temp. 100.5. Had some troubling swallowing but no trouble breathing. Saw personal physician who told her that she had a stomach virus and this did not appear to be an adverse reaction.
Fever of 101-102F, fatigue on 11/19/19 and 11/20/19  Large local reaction- red- raised, hot to touch, size of deck of cards, painful and itchy- lasting several days.  No cough, congestion, or signs of URI.  Has had yearly flu vaccines, 1st time had reaction.
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 5:29 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 5:29 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  Patient received the vaccine in deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions reported for the patient.  No treatment medications were reported.
Patient Fainted for few minutes and looked like she was seizing. Few minutes she was back up to normal and stated that she fainted every time after a shot
Patient states 12 hours after receiving the vaccine on 5/6/2021 she became short of breath, had nausea, diarrhea and fatigue. Fatigue lasted 4-5 days
felt sick after opening the bleach; rapid heartbeat/Fast heart rate feels different than her a-fib; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat), HEART RATE INCREASED (Fast heart rate feels different than her a-fib) and ALLERGY TO CHEMICALS (thinks she now has allergies to bleach) in an 82-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. Last menstrual period and estimated date of delivery were not provided. On 27-Feb-2021, the elderly was diagnosed with HEART RATE INCREASED (rapid heartbeat). 27-Feb-2021, the elderly experienced HEART RATE INCREASED (Fast heart rate feels different than her a-fib). On 15-Mar-2021, the elderly was diagnosed with ALLERGY TO CHEMICALS (thinks she now has allergies to bleach). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  Not Provided          Treatment Medications include natural supplements to thin out blood,  concomitant medicines were not included   Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
I had the regular symptoms on 04/14/2021 which was the day after I got the vaccine. Then my period was very late, like 50 days late. I did 6 pregnancy tests, 4 came back negative and 2 came back positive. I went to the doctor on 05/26/2021 and they did blood work and it also came back negative. I got my period back the same day I went to the doctor. It resolved itself.