chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin rash; Swelling; This is a spontaneous report from a contactable consumer reported for himself. A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date not reported) via unspecified route of administration on 06Mar2021 at 13:45 (at age of 40-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. There were no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. On 07Mar2021 17:00 (1 day 3 hrs 15 min after vaccination) patient experienced Skin rash, and swelling. Patient did not receive any treatment for the events. The Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient arrives and appears ill but in no distress.  Vital signs were concerning for fever.  Given history of receiving the COVID-19 vaccine yesterday and concerned about an inflammatory response to the vaccine especially given she had COVID-19 infection back in October.  Other residents at the nursing home are demonstrating similar symptoms after receiving the vaccine.  IV was placed and labs were drawn and sent.  The patient was given normal saline bolus as well as a dose of acetaminophen.  Lab work is reassuring for a CBC without leukocytosis, stable anemia which is chronic for the patient, no thrombocytopenia.  Electrolytes are only significant for borderline low sodium.  Kidney function normal, BUN normal
3 pts randomly chosen to be tested out of a group of 150 pts had no response or insufficient response;
At time of injection intense burning. Patient stays the pain has never left and feels like bone pain. When arm is moved it feels like a re-administration of the vaccine.
Pt received first dose Pfizer vacc approx 1027. Shortly after pt stated to staff she felt,  "hot" "weird" . pt appeared flush and left arm was hot to touch. Vitals taken  BP 204/148, HR 149, spO2 100% RA, RR 20
Pt called 10-7-10 and reporting itching sensation over body. It lessened over the night. Pt had no rash or whelps, difficulty breathing or swelling. Will f/u 10-8-10.
Light headed, nausea, hives 2 hours after shot, headache, extreme fatigue. Headaches, fatigue, and nausea lasted 5 days.
We  are not sure if these are related, to the vaccine but are reporting them anyway. Six hours after the vaccine, pt had a very rapid heartbeat that lasted an hour. Three days after the vaccine, patient had hours of extreme high blood pressure (190/100) but the pulse rate was normal.
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "94-year-old female past medical history of hypertension and hyperlipidemia who presented with 4 day onset of sore throat, increased secretions, and generalized malaise.  Upon arrival to the emergency department, she was afebrile, hemodynamically stable, and maintaining adequate oxygenation on room air.  Viral respiratory panel was positive for COVID-19, otherwise negative.  Other initial intake lab work was unremarkable, including sputum culture. CXR showed subtle interstitial opacities raise concern for COVID pneumonia.  She was provided supportive care including scheduled DuoNeb treatments, no steroids nor antivirals were given.  Overnight, she demonstrated improvement in her presenting symptoms without developing any worsening respiratory distress nor acute hypoxic respiratory failure.  She was medically optimized and subsequently discharged home in stable condition.   Hospital Course:    This 94-year-old female with a medical history of hypertension and hyperlipidemia presents with generalized body aches, weakness, and cough, COVID-19 rapid PCR positive.   COVID-19 Infection - suspect viral syndrome causing her generalized body aches and weakness - symptom onset 12/8/2022 - Respiratory panel only positive for COVID-19, otherwise negative - no known risk factors for decompensation - maintained adequate oxygenation at room air, afebrile, 0/4 SIRS criteria - supportive care - sputum sample collected and showed normal oropharyngeal flora - scheduled Duonebs twice daily - severe isolation precautions   Hypertension - resume benazepril given hemodynamic stability overnight, BP above goal   Chronic BLE edema - holding lasix on discharge for concern of limited oral intake with active infection   Hyperlipidemia - not on statin   Osteopenia - noted on DEXA scan 8/4/2021 with low bone mass in bilateral hips - calcium and vitamin D3 supplementation   Hypokalemia - trend, supplemented as needed   Constipation - Bowel regimen   History of iron deficiency anemia - hold supplemental iron in setting of infection   Chronic arthralgias, back pain - hold home ASA 325 mg daily, discontinued on discharge - lidocaine patch PRN"
MICROVASCULAR CORONARY ARTERY DISEASE; LEG CRAMPS; GUT PAIN; LOWER BACK PAIN; CLOTTING PROBLEMS; REPETITIVE YAWNING; BOTH CALVES AFFECTED FOR LEG PAIN; HEADACHE; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes mellitus, hypothyroid, autoimmune condition, and inflammatory disease. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 54 years old. No concomitant medications were reported.  On an unspecified date, about 3 months patient started experiencing chest pain when walking (dose number in series 1). After 6 months the chest pain presented intermittently. Patient was diagnosed with microvascular CAD (microvascular coronary artery disease) and prescribed with Imdur and Hydrochloroquine (dose number in series 1). Patient stated that her both calves were affected for the leg pain (dose number in series 1). Symptoms were most prevalent when she was exerting herself. She also displayed repetitive yawning (dose number in series 1). On an unspecified date, the patient experienced leg cramps, gut pain, lower back pain, clotting problems, and headache (dose number in series 1). The patient received additional non company suspect Moderna vaccine (dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on an unspecified date for prophylactic vaccination.  It was unknown if patient experienced any adverse reactions following administration of Moderna vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the both calves affected for leg pain, headache, leg cramps, gut pain, lower back pain, microvascular coronary artery disease, clotting problems and repetitive yawning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220517380-covid-19 vaccine ad26.cov2.s-Microvascular coronary artery disease. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received Shingrix. In June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: The GlaxoSmithKline sales representative called response center on the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix.  The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was somewhere in beginning of June, they were administered to 5 patients.  No further information was gathered by sales representative such as lot number, patients initials, patients genders, or route of administration.  The Vaccine Administration Facility was the same as Primary Reporter. HCP reported somewhere in beginning of June, 5 patients were administered only adjuvant.  The consented to follow up was given. Additional Supportive Information: The patient received Shingrix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022AMR100447:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter US-GLAXOSMITHKLINE-US2022101093:duplicate/deleted case
Left arm four inches below injection site became red, warm, and sore to touch. No fever and no swelling. The reaction started approximately 8 hours post injection and peaked 24 hours after shot. Within 96 hours arm is back to normal.
Nausea, Vomiting, Headache, body ache, fever, hot/cold sweats.
A lady received her vaccine and went over to sit in the waiting area.  A few minutes after receiving the vaccine the patient walked up to the counter and said she wasn't feeling well.  When I went over she said she was really lightheaded and was sweating and felt like she was going to faint.  I had her lay on the floor and elevate her feet.  I put an ice pack on her forehead.  She never lost consciousness and felt better after a few minutes. She eventually sat back up and stayed in the waiting area for a while longer to be monitored.  She did state that she felt a cold rush in her chest right before she became lightheaded. She ended up feeling fine and went home.
Dizziness, Headache, Myalgia, Arthralgia, SkinRash, Diarrhea, Nausea Vomiting, fatigue, chills Narrative:
Patient was administered a COVID vaccine approximately 26 hours after the vial was punctured.  The punctured vial was stored in the refrigerator between 36 and 46 degrees prior to and after puncture.  Patient was offered revaccination and declined.
Injection site became red, hard, swollen, very hot to the touch. Patient has a high pitched scream like I have never heard before, low-grade fever, lethargy.
Patient reports vaccine given at local pharmacy.  45 min later had rash and eye swelling.  resolved over the next couple of days with benadryl.  Currently undergoing allergy work up given this reaction and other allergies.
Intense stomach pain, off and on from the day after injection until the 14th, two full weeks.
Nearly immediately felt flush, developed hives and tachycardia. Was given benadryl by the vaccination team pharmacist which resolved reaction within a few minutes.
Chills, fever, muscle aches, starting 7 hours after injection, lasting on and off for the next 30 hours.  Horrible nausea starting 8 hours after injection and continuing on and off the following 24 hours. Mild versions of nausea and chills continuing through today (4/19/21), day 6. Day 4, headache, vertigo, dizziness, tinnitus. Tinnitus has not stopped since day 4.
Pushed my menstrual cycle to the right by three weeks along with heavy bleeding for 3 days and minor bleeding for 3 more days. Having minimal menstrual cycles prior to the COVID vaccination i know have had heavy bleeding, horrible abdominal cramping, dizziness and nausea during them.
10/25 Upset stomach, nausea, gas, sore left shoulder, chills, shaking, heartburn, chest ache, ceased when in bed. 10/26 chest tight, ache returned, hurt to breath. 10/27 same as Tues. Stomach better. Evening ache returned lasting all night.
Erythema, Induration-approx 12mm in diameter, vesical/pustule approx 2mm in diameter, arthralgia,myalgia, headache.
Breakthrough COVID case, positive for COVID 10/19/21, symptomatic, ICU.
Approximately 5-10 minutes after receiving 1st dose of Pfizer COVID-19 Vaccine, while being seated patient fainted. 911 was called and responded. Pt was not transported and fully recovered before EMS arrived. Pt was evaluated by EMS and released. Pt left on own accord
Reported 2 days later on 07/03/2021 over the phone. Swelling  starting from elbow and extended to arm pit and a knot was formed in armpit. Lungs hurt and are tight.
New non itchy non painful non tender shallow maculopapular circular erythematous non blanchable lesions densely packed on abdomen and low back, less dense on chest and upper back, scattered on forearms, with only a few on legs, none on face or neck.  >>  I am referring to Dermatologist.
Erythema, edema, 6x6 at site inject. Seen Dr 6/28/07 (was started RD Keflex Benadryl was given, LA also, Varivax #2 given 6/26 and Menactra.
Patient has it charted in medical record that he received 1st dose by Moderna on 3/12 but it wasn't documented in Zotec. Received Pfizer dose on 3/26.
pt recvd vax & c/o extreme pain in rt upper arm inject was withdrawn sl redness was immed observed-ice pack applied-w/in 20 mins redness spread to rt upper shoulder area & was warm to touch; pt was then seen by MD & recvd DPH;
Fever for 3 days - 102.3 degrees F was highest temp. with maculopapular rash on entire body and face, no other signs with irritability. Lymph nodes on posterior side of shins bilaterally.
Documentation on internet, local state vaccination reporting system, states the patient received a 0.5 mL dose of Moderna for their 1st booster dose. The patient came into local vaccination clinic requesting 2nd booster dose and this error was discovered.
Headache, Arthralgia, Fever, CoughWheeze, FATIGUE, CHILLS, PAIN TO INJ SITE Narrative:
I woke up on morning and saw that I had a blood clot that was an inch and a half long and inch wide. The doctor took a an ultrasound and it showed two blood clots. I am now taking Eliquis for it.
Patient is not experiencing any symptoms; improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection, lot number S007811 (verified to be a valid lot number) expiration date 14-MAR-2021, (exact dose, frequency and route of administration were not provided) for prophylaxis, that was reconstituted with properly stored (STERILE DILUENT) lot number S026842 (verified to be valid lot number), expiration date 19-MAY-2022. It was reported that the patient did not experienced any symptoms.  Administered dose of vaccine experienced the temperature excursion of 47.1 degrees Fahrenheit for 32 minutes. There was previous temperature excursion of 48 degrees Fahrenheit for 4 hours and 5 minutes. Data logger was involved.
Pain and burning at injection site that has lasted over a week now that has increased to involuntary muscle spasms and difficultly in raising arm without increasing pain.
itch; rash; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), RASH (rash) and URTICARIA (hives) 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 PRURITUS (itch), RASH (rash) and URTICARIA (hives). At the time of the report, PRURITUS (itch), RASH (rash) and URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided include allergy medicine.
soreness, aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness, aches) and HEADACHE (headaches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (soreness, aches) and HEADACHE (headaches). At the time of the report, PAIN (soreness, aches) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Fatigue, nausea, vomiting, loss of appetite, fever, blisters.
per mother pt has a 4 inch knot with redness, hot to touch and site tenderness
Heavy and very long menstruation! My period started fairly on time 6 days after my shot, and still going heavily (today is day 8, my periods are normally 5 days and very predictable). I am not on any birth control and had my most recent gyno check up three weeks ago and everything looked good!
Patient is part of our health care team. Adverse effect: Bilateral antecubital rash/eczema, back, and posterior knees began 6 hours after receiving Moderna vaccine #1 on 8/20/21. Also loss of smell, and severe fatigue which lasted x 7 days. Previously tested positive for Covid19 in December 20, 2020. History of hypersensitivity to TDAP vaccine.
Patient came in for 2nd Pfizer covid-19 vaccination and had marked that she had an allergic reaction after getting the 1st Pfizer vaccine.  Patient states that she got very red around her neck and that she was itching while in clinic after receiving the vaccination.  Patient states that the NP that gave her the vaccine told her to go home and take Benadryl.  Patient states that she went home and after she got home her neck started swelling and she took Benadryl and states that it improved.  Patient states that the hives were behind her ears until 1 day ago.   Patient was informed that she could not receive the 2nd covid-19 vaccine due to having an allergic reaction and that if she did receive it, her reaction could be much worse.  Patient informed that she should have received some immunity from having only one vaccine but to continue to wear a mask and social distance.
This spontaneous report as received from a 62 year old female patient refers on herself. The patient's current conditions included thyroid, migraines, depression and shingles - described by the patient as "on and off for years". There was none drug reactions/allergies in patient's medical history. On 06-DEC-2011, reported also as "6 months after last shingles occurred" the patient was vaccinated with a dose of ZOSTAVAX (one time vaccine) (Dose, Route, Lot number and Expiration Date not provided). Concomitant therapies included amitriptyline hydrochloride, SYNTHROID, IMITREX and trazodone hydrochloride (reported as TRANZIDONE). In November 2012 reported also as "a year later" after vaccination the patient "broke out with shingles". The patient sought medical attention and was prescribed acyclovir by her doctor. Blood and urine test were done "6 months ago" (in approximately September 2013)-no results were provided. The outcome of shingles and relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
04/04/2022, I started with a scratchy throat, and it progressed throughout. I started having chills and felt fatigued. I did a rapid test, it was negative. I felt worse throughout the night. I had low grade fever, chills, body ache, severe headache, loss of appetite, weak. These symptoms lasted for several days. I retested on 4/6/2022 with a rapid test and it was positive. I called my doctor to let her know I had tested positive. She ordered paxlovid. I started it that evening. I felt well enough to work from home on 04/08/2022. I continued to have fatigue, headache and muscle aches for the next 3 weeks. I feel I have recovered.
76yo M w/ myelofibrosis s/p allotransplant 2014, hypothyroidism admitted for failure to thrive, with progressive weakness, weightloss and poor PO intake. Significant hyponatremia on labs. Tested COVID19 positive on admission.   #acute respiratory failure with hypoxia #COVID19 pneumonia -Patient requiring oxygen after saturation dropped to 87% while sleeping.  -supplemental oxygen as needed -dexamethasone  -remdesivir -strict intake/output; keep neutral or net-negative fluid balance -PRN rescue inhaler -incentive spirometry     Discharge Disposition/Condition Disposition: Home with Home Health Condition: Stable (s/sx potential problems absent or manageable)
cried vigorously, pale, limp, unresponsive, dark rings around each eye-3 purple spots on head one remains-responded only to painful stimuli;eyes not opened completely, would not nurse x 1hr;extremities cool & clammy-head & trunk hot, sweaty
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL, lot number L038135, expiry date 27-MAY-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Developed suddenly rash neck, papular macular, cough and fever day 9 after vaccine, rash trunk upper extremity non blanching.
Abnormally sore arm, low-grade fever for two days, silver dollar sized red mark (slightly raised: hot) about 1/2" below injection site. Flu shot on Monday, fever on Tuesday and Wednesday.
Onset 3 hrs after vaccine headache, throat "closing", nausea, eyes "cloudy", stabbing feeling in chest, body pains throughout body, hands "freezing", lasted 15 hrs, residual effects in AM.
Patient developed fever and began seizing. Diagnosed with otitis media at this time. Has continued to have febrile seizures and had none before given these immunizations.
On December 13, 2022, I woke up and my knees were locked, and it was painful. I had to slowly unfurl my knees, especially my right one. I visited my doctor on November 23, 2022. I had an X-Ray. The pains began to spread to other parts of my body. I visited my orthopedist on December 8th. I had an MRI for my lumbar back. But the pains were now in my lower back, right hip, and shoulders. The pain is sharp to dull ache, especially when I move. I am using topical ointments to help relieve the pain. I have a follow-up appointment with my orthopedist on January 19, 2023.