chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brief History:  71-year-old male with restrictive lung disease, COPD, AFib, heart failure presenting with known COVID-19 infection in increasing oxygen demand.     Brief Exam:  On initial evaluation he did appear to be quite short of breath and was requiring escalating doses of oxygen from his baseline.  He was treated with nebulizer treatments with improvement.  However, due to his multiple comorbidities, known COVID diagnosis, and oxygen need he will be admitted for further management.  Was given IV dexamethasone here.  Mildly elevated D-dimer likely related to the COVID-19 and within expected range for age adjusted D-dimer.
Pt recvd vax 29AUG92 & exp pigmented purpuric dermatitis on legs;
She is real sick; My child that got the vaccine( got the vaccine under 18 years of age); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She is real sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My child that got the vaccine( got the vaccine under 18 years of age)) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She is real sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My child that got the vaccine( got the vaccine under 18 years of age)). At the time of the report, ILLNESS (She is real sick) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My child that got the vaccine( got the vaccine under 18 years of age)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
I had a breakthrough case of Covid-19 I had a runny nose and a cough then it got worse the cough and sore throat were terrible and lingering I had a fever as well I was prescribed Paxlovid and Prednisone.
3 weeks after receiving the first of the series of two injections, the patient developed SOB and CP. He presented to the ER with a R/O MI.
Started with a small rash on inner thigh.  By morning had spread to legs.  By mid afternoon, has spread to  buttocks area.
No known reaction. Pt was given expired medication. Expired on 10-24-08. (Hib)
Soreness in arm, slight fever, chills, body aches, severe dizziness (required pt to lie down, unable to work or drive), diminished mental capacity lasting 7 days (pt reported she was not at full capacity to complete her daily tasks at work which include counting money).
day following vaccination (vax administered around 1:44pm on 3/9), on 3/10 slight headache in morning, by around 1:30pm severe headache, could hardly open eyes, was very nauseous, severe diarrhea, slept for 16hours. Symptoms continued, less severe but not debilitating on 3/11.  Even today (3/16) if bend over get dizzy and head throbs.  Doesn't feel very secure if moves quickly -- affected her entire body, slowly improved each day, but not back to normal 7 days later.   Wasn't eating much due to nausea in days following.  slow improvement but unable to return to normal routine b/c still not feeling well.
Patient returned to pharmacy on 5/22/19 complaining of extreme pain, swelling, and erythema at the injection site. Patient reports dizziness, forgetfullness, memory lapses, and confusion in the 72 hours following the injection. Patient has treated the injection site with topical ice packs. Approximately 24 post-injection, the patient developed a mild fever that she treated with ibuprofen 400mg. On 5/22/19, a warm red circle approximately 4 inches by 3 inches in size can be seen on the back part of the arm.
Fever or Chills  Fatigue  Muscle or body aches  Headache
discoloration; Achy where she got the shot; headachy; extremely tired; rash near where she got the shot/until the 8th day and it was of around 2 by 2 inches when it started, then it spread to 3 by 4 inches in area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (discoloration), VACCINATION SITE PAIN (Achy where she got the shot), HEADACHE (headachy), FATIGUE (extremely tired) and VACCINATION SITE RASH (rash near where she got the shot/until the 8th day and it was of around 2 by 2 inches when it started, then it spread to 3 by 4 inches in area) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Rhinitis. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, AZELASTINE for Rhinitis, METOPROLOL for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced VACCINATION SITE RASH (rash near where she got the shot/until the 8th day and it was of around 2 by 2 inches when it started, then it spread to 3 by 4 inches in area). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (discoloration), VACCINATION SITE PAIN (Achy where she got the shot), HEADACHE (headachy) and FATIGUE (extremely tired). On 08-Aug-2021, VACCINATION SITE RASH (rash near where she got the shot/until the 8th day and it was of around 2 by 2 inches when it started, then it spread to 3 by 4 inches in area) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (discoloration), VACCINATION SITE PAIN (Achy where she got the shot), HEADACHE (headachy) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-291328 (Patient Link).
Itching all over with development of hives; wheezing; hoarseness of voice; coughing.
Felt more sickness; Symptoms of sicker stomach; Strange taste in the mouth; Feeling cold; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt more sickness), ABDOMINAL DISCOMFORT (Symptoms of sicker stomach), DYSGEUSIA (Strange taste in the mouth), FEELING COLD (Feeling cold) and ANOSMIA (Loss of smell) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (Felt more sickness), ABDOMINAL DISCOMFORT (Symptoms of sicker stomach), DYSGEUSIA (Strange taste in the mouth), FEELING COLD (Feeling cold) and ANOSMIA (Loss of smell). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Felt more sickness), ABDOMINAL DISCOMFORT (Symptoms of sicker stomach), DYSGEUSIA (Strange taste in the mouth), FEELING COLD (Feeling cold) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was pending for a Covid test report. Concomitant product use was not provided by the reporter.
Information has been received from a registered nurse concerning a male who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient developed nerve pain and numbness in his face. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
I remember walking from my apartment to the elevator to get into my car. I do not remember driving my car, but I woke up in the parking lot of a store. I was scared so I drove back home. I do not remember driving home either. I walked into my apartment building and felt like I was staggering drunk. I was not in control of my equilibrium or my body. I went to get into the elevator and I hit my head on the wall. I was able to hit one for my floor. When I got out of the elevator, I felt like I still did not have control over my body. I was going at full speed down the hallway with no control. I made it to the end of the hallway and fell hard. I had a hair appointment that day and called the salon to see if I went there. They said that I did, but I do not remember going to the appointment. Three people came out of the common room and got me into a wheelchair. They called the fire department for me and I was taken to the hospital by ambulance. At the hospital, I really cannot remember what happened in there. When my blood sugar was checked by the EMT, it was at 110.
Employee experienced a reaction after receiving a flu shot at our facility. The reaction occurred with-in two hours of receiving the vaccine. The injection site was warm to the touch and the employee had weakness and difficulty raising her arm. Notable swelling was noted on her left arm. Employee complained of chest pain and difficulty breathing. Employee was taken to the hospital ER for treatment next door to our facility. She was treated for the allergic reaction and sent home.
Fever, simple febrile seizure, and pneumonia for which patient was seen at Hospital / Emergency Department and discharged home.
71 yo F with RA and GERD, received the second Pfizer covid vaccine on 6/15, then was brought by the family on 6/23 with progressively worse symptoms of weakness, nausea and vomiting and  fall/near syncope at home.  Prior to admission, patient reported dizziness and weakness to the PCP, meclizine prn was prescribed, but this didn't help.  On admission patient was found to have NSTEMI and started on Heparin drip, ASA, Plavix, beta-blocker. Was to have a cardiac cath on 6/25 but noted to have change in MS/ acute confusion and right hemiparesis. CT brain followed by MRI brain showed extensive acute infarcts involving the b/l centrum semiovale, corona radiata, b/l cerebellum, b/l basal ganglia and b/l thalamus.  On 6/28 labs also show an acute increase in creatinine/AKI and patient had an episode of gross hematuria on 6/29.  Heparin drip and Plaxix were d/c'ed , ASA continued.  Heme evaluation is requested to comment on possible thrombophilia associated with Pfizer covid vaccine.   Exam - somnolent elderly patient in bed, answers some questions (name, place), but confused about time, with flaccid RUE, also some weakness noted in the LLE, normal S1,2 no n/r/g, clear lungs, soft abdomen w/o masses.   Imaging reviewed with Neuroradiology suggested a cardioembolic picture. Wonder if she also had embolization to the kidney with AKI and renal infarcts w hematuria?  CTA neck does not show significant ats disease to the aortic arch or neck arteries.  Renal US with doppler exam was also normal.  TEE was done on 7/2 and was a normal study, w/o PFO or intracardiac clot.  Patient also had a loop recorder to evaluate for occult arrhythmias.   This patient never had thrombocytopenia and/or a TTP-like picture reported with the Astra-Zeneca or Janssen vaccines.  Heparin induced platelet Abs were 0.158.
Patient came to nursing at 12:00 noon. Patient stated that he had a tetanus shot recently 2 or 3 days ago. Patients arm is red and warm to the touch. Vitals were obtained. Temp 98.6, B/P 138/80, pulse 110, Resp 20, PO2 was 98% on room air.
34 y.o. female with h/o anaphylaxis, allergic rhinitis and asthma with allergic reaction to second dose of COVID-19 Pfizer vaccine. Patient had anaphylactic reaction to first dose in April requiring 3 day admission to ICU and epinephrine drip (not intubated). Patient tested outpatient by allergy & immunology for components of COVID-19 vaccine which were negative and it was deemed safe for patient to receive 2nd dose of vaccination today in supervised environment. Patient states vaccine appointment was at 10:30AM and about 15 minutes after she developed hives and shortness of breath. Denies difficulty swallowing or facial swelling. She received epi, benadryl and zyrtec which relieved her symptoms. Upon presentation here she endorses some chest tightness but denies difficulty swallowing, breathing, facial swelling. Patient has minimal hives on UEs. Discharged from ED following observation for 4hours. Patient with epi-pen at home and follow-up with immunology clinic next month.
No additional AE; adverse event regarding an expired dose of PNEUMOVAX 23 that was administered to a patient; This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 11-OCT-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (0.5 mL, lot #U035117 was valid for formulation prefilled syringe, expiration date 18-AUG-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Nurse confirmed that the patient involved had not reported any symptoms or medical concerns related to the administration of the expired dose. No additional information provided regarding this adverse event. No additional adverse event (AE)/product quality complaint (PQC) reported (No adverse event).
This spontaneous prospective pregnancy report was received from a pharmacist, and refers to a currently 34-year-old pregnant female patient. No information regarding the patient's medical history was reported. Concurrent conditions included drug reactions/allergies on penicillin and macrolides. Concomitant therapies included TOPROL XL TABLETS 25mg, daily. On 29-JAN-2018, the patient was vaccinated with VARIVAX injection, lot# N008077, expiration date 09-MAR-2019 (exact dose, indication and route of administration were not provided). On 13-FEB-2018, the patient found out about being pregnant by performing pregnancy test. The LMP and EDD was not reported. It was reported that the patient did not have any visible rashes and no product quality compliant (PQC) and no adverse event was reported.
BLOOD PRESSURE INCREASED 147/60; TACHYCARDIA; ACHINESS; FATIGUE; SEVERE LEG PAIN; UNABLE TO WALK LONG DISTANCES; SORENESS IN ARM; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced soreness in arm. On APR-2021, the patient experienced unable to walk long distances. On APR-2021, the patient experienced severe leg pain. On 01-APR-2021, the patient experienced fatigue. On 05-APR-2021, the patient experienced achiness. On an unspecified date, the patient experienced blood pressure increased 147/60, and tachycardia and his EKG came back clear on a suspected heart attack. His blood pressure was normally low. On 19-APR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 147/60 mmHg, 110/60 mmHg. Treatment medications (dates unspecified) included: sodium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure increased 147/60147/60, had not recovered from soreness in arm, unable to walk long distances, fatigue, achiness, and severe leg pain, and the outcome of tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Blood pressure increased, Tachycardia, Unable to walk long distances and Achiness. This event(s) are considered unassessable. The event(s) have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Soreness in arm, Severe leg pain, Fatigue. This event(s) are labeled per RSI and are therefore considered potentially related.
This spontaneous report as received from a physician refers to a 13 months old male patient with Downs Syndrome and penicillin allergy. The patient was vaccinated with lot # (655267/0971F) dose 1 PROQUAD (Merck) (dose and route not reported) on 04-APR-2007. No concomitant medications were reported. On 05-APR-2007 the patient experienced breathing problems, a "high"fever, chills, a severe headache, and foaming of the mouth. The patient sought medical attention. No lab diagnostics study was performed. The outcome of chills, a severe headache, a "high" fever, breathing problems and foaming of the mouth was reported as recovered/resolved. Additional information has been requested.
Approx. 1-2 hrs post injection, the arm became very painful.  About 6hrs later it was impossible to lift, and the pain extended to the shoulder and chest and back muscles.  It became harder to breath due to the pain with the back muscles.  I then took ibuprofen approx 800mg without any reaction and was not able to sleep and still having difficulty with breathing and not being able to move the left arm well with muscle twitching to the fingers on that arm.. The next day the neck muscles and leg muscle on the left became week with contractions noted.  I phoned the doctors office and received a prescription for vicodin.  I did have intermittent sleep that night and my spoused stayed up to make sure that I was able to breath.  I continued to have pain, and was now applying heat to the areas that could not be touched due to pain.  When I did have to report to work 6 days later on Monday, after about 30min of being on my feet became exhausted.  After working about 10 hrs I began to cry due to pain and exhaustion and the left arm hurt to badly to move.  I went to sleep as soon as I got home.  I continued to return to work the next day, because I do not get paid for sick time and had to take off already the rest of the week before due to the shot.  That day also I became so exhausted and was having problems breathing.  The left arm and shoulder felt about 50lbs. and continued to hurt.  The next day I called in anyway due to the inability to work.  Thursday I was outside and after trying to plant some flowers could not breath due to exhaustion and now was having neck muscle spasms, I then called the doctors office back to see them on Friday.  Friday I went in to see the Nurse Practitioner at which time she tried to contact many different avenues. (infectious disease and the CDC) To no avail.  That day I was given decodran and toradol IM and was written a script for prednisone and torodal po.  Today is Saturday and the lower extremity pain is nearly gone.  The left inner arm continues to hurt and feel heavy, after doing some work outside with my son for about an hour, I am exhausted, my neck hurts, as does my back and the left arm.
This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (had the other shingles vaccination several years ago with no adverse effects). On 20th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired. On 20th February 2019, the patient experienced exhaustion. On an unknown date, the outcome of the exhaustion, poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired were unknown. It was unknown if the reporter considered the exhaustion, poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the SHINGRIX injection was pain free and she was not sufficiently warned of the adverse effects. After receiving the first dose, the patient went to gym shortly and suddenly became overwhelmed by exhaustion while on treadmill. She went home, cancelling activities for the rest of the day. The night was horrific and she experienced impaired quality of sleep, flu-like joint pain, sensation of fever without actual fever, no appetite (skipped lunch and dinner). Next morning, she could barely get out of bed and could barely function. She was asking about how long would the adverse events last. She could not imagine subjecting herself to a second shot in 2-6 months.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer, the patient. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 08Mar2021, the patient tested positive for COVID-19. The patient's second dose was scheduled for 16Mar2021, and she had requested to reschedule the appointment. The clinical outcome of "tested positive for COVID-19" was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269588 same reporter/product/events, different patient.
Patient developed red itchy eyes about 3-4 hours after vaccine was given. She said they felt very scratchy. Took Benadryl for the itchy eyes. Upon follow-up at 6:30PM patient stated she was feeling more flu like symptom. Chills, weakness, stuffy nose, and tiredness. Unknown if she had a fever.
Abnormal excessive urination disproportionate to amount of liquids consumed.   Urine initially clear, then dark (like dregs from bladder), finally entirely bloody (hematuria); was then cleared by drinking large amounts of water.  Continue to have urgency to urinate, although less than when the urgency first arose, with a continuing feeling of irritation and very slight burning the discomfort from which is relieved by urinating.
13 year old received the pediatric Covid-19 Pfizer dose when they should have received the adult dose.
Hx. "stroke" with influenza vaccine (5 days after) years ago. Researched online & found no documented correlation. Gave influenza vaccine and c/o left arm pain & inability to ambulate which resolved in 12hrs. Diagnosed with TIA.
pt recvd vax & exp ailing & tired & nausea, abdo cramps, belching, h/a;
Patient came in with mother for the TB test reading and mom wanted his leg looked at because he woke up with it red and swollen (R leg).
Intermittent cyclical crying/ screaming with knees drawn up to chest about a few mins.  X about 3 hours post ROTATEQ given
PATIENT REFERS THAT SINCE JANUARY OF 2010 (A MONTH AFTER VACCINATION) SHE BEGAN EXPERIENCING: PAIN IN THE LUMBAR AREA IRRADIATING TO THE GLUTEUS, INVOLUNTARY MOVEMENTS IN LOWER EXTREMETIES. UNKNOWN CAUSE.
Presented to ED (8/8/21) with chest pain x1 day after receiving the second dose of COVID-19 vaccine 3 days prior (8/5/21). He woke up the day before (8/7/21) with chest pain that resolved after a few hours, but then returned. Denies fevers, dizziness, syncope, shortness of breath, cough, congestion, nausea, vomiting, diarrhea.  -- Troponin downtrending (8/9: 3.72, 3.39 8/8: 4.38, 6.01)
Headache, Fever,  Chills, L arm soreness and numbness  Narrative: