chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THROMBOSIS (RED PATCHES ON HANDS, ARMS, LEGS AND FEET); SEVERE MIGRAINES; SEVERE VACCINATION REACTION; This spontaneous report received from a patient via a company representative concerned a 3 decade 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 and expiry date: Unknown) dose, 1 total administered, start therapy date was not reported 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. The patient had a severe vaccination reaction, experienced red patches on hands, arms, legs and feet. The patient had visited the hospital and was diagnosed with thrombosis by the physician. Patient was monitored and later discharged. The patient had reattended hospital for severe migraines, also had contacted centers for disease control and prevention regarding vaccination reaction. The patient was unknown for company representative and had only this information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombosis (red patches on hands, arms, legs and feet), severe migraines and severe vaccination reaction was not reported.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0.20210455657- COVID-19 VACCINE Ad26.COV2. S -Thrombosis, severe migraines , severe vaccination reaction. This event(s) is considered unassessable. 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).
sudden onset of weakness, possibly fainted & poss had sz;pt was unresponsive to verbal and tactile stimulation x 2min;then became responsive & vomited x2;incident occurred @ work;pt was taken via amb to ER;
Sitting on lap, had sudden jerking movement and clenched eyes and would not open them and quit breathing; began rescue breaths to meet paramedics and they took over. Eyes were rolled up in head, she turned very white and would not respond to stimulation. Episode lasted approx. 20 minutes. Ran tests for 2 days and found nothing wrong. Was very fussy the previous day and only slept about 30 minutes during the day. A large knot developed at shot site and was warm on 9/7/00. Has not had anymore episodes and is now on a monitor.
Within 18 hours of vaccination I developed high fever (103F), shaking chills, arthralgia, head and neck pain, muscle pain, fatigue.  Symptoms lasted 2 days.
Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week. After a few days, fever, lack of appetite, and irritability began.
Had flu shot on Monday left leg is red and swollen not feeling well. Tuesday woke up and leg was red, today school call and said it was hot; hurt to touch,
8/4 generalized weakness, dizziness, nausea and inability to walk. Tetanus administered at provider - no local RX at left deltoid. Admitted to hospital. 9/5/08-records received for DOS 8/4/08-DC DX: Generalized weakness. Possible Guillain-Barre syndrome vs viral syndrome. Hypoxemia probably secondary to Guillain-Barre syndrome. Cellulitis of left foot. Stepped on a nail 2 days prior to admission, received tetanus toxoid in ED. Returned on 8/4/08 with C/O tingling of lower extremities became generalized to involve the entire body, weakness, dizzy, unable to walk, difficulty talking.Transferred to another facility.  9/10/08-records received for DOS 8/4/08-liver profile normal. Taking Keflex. C/O occasional dyspnea, dizziness and headache. PE:normal. Impression:Paresthesias and numbness in lower extremities and upper extremities and some generalized weakness that is completely resolved now. Normal neurological exam. Results of interaction between tetanus and Keflex side effects. Discharged home.
SWELLING AND REDNESS AT INJECTION SITE PER URGENT CARE 5 INCHES BY 6 INCHES
A spontaneous report has been received from Health Professional concerning a patient of unknown gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving nasal FLUMIST started on an unknown date. The reporter stated that three patients received FLUMIST and then got the flu. The outcome of event of flu was unknown. The reporter considered the event of the flu to be non-serious.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of VARIVAX (lot number unknown) on 18-JUL-2012. The VARIVAX (merck) had an expiration date of 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. It was unspecified if the patient has sought medical attention. Additional information has been requested.
Hives; This is a spontaneous report from a contactable physician. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 27Aug2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known medication allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient experienced hives on 29Aug2021, 48 hours after first dose of Pfizer COVID vaccine. The event resulted in emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were taken as a hives and included treatment with fexofenadine hydrochloride (ALLEGRA). The clinical outcome of the event hives 48 hours after first dose of Pfizer COVID vaccine was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1725-began complaint of swelling, tingling and numbness in Left cheek, 1730- Bendryl administered, 1730 Vital Signs- Blood Pressure 205/105, Pulse 105, Pulse Ox 95%, Respirations 22/min, Auscultated lungs, no audible wheezing, lung sounds clear. 1741-began complaining of tongue tingling, numb and swelling. 1743- Epinephrine 0.3 mg IM Right quadricep administered. Refused further vital signs and didn't want to take ambulance to hospital. 1802- Stat-EMS, ambulance arrived and offered treatment , patient refused. Stated she was going to get a ride from family and spending the night with family. Instructed patient that going to seek treatment in Emergency facility was best option, continued to refuse and ultimately stated she was staying with her mother.
On 2/5/2021 I went to my doctor and they said I had developed a heart murmur. The on 05/03/2021 I had to get heart surgery. Then 3 months later on 08/03/2021 I had a stroke. I just got out of the hospital.
After 4 month absence due to menopause, menstrual cycle returned the day after the shot.
after recv vax pt devel very large red, hot swollen rt leg, hard lump.
Information has been received from a physician concerning a female who in August 2008, was vaccinated with the first dose of GARDASIL. In August 2008, the patient experienced pain for one month in the arm she received the injection. The patient sought unspecified medical attention. Additional information has been requested.
This case was received on 27 May 2011 from MILVAX under the MILVAX tracking number FDA-14 (no VAERS). An obese male patient (age not reported) received in 2011 the ACAM2000 (lot number and exact date not reported) and 10 days post vaccination experienced chills, diaphoresis and crushing/squeezing tight sub-sternal chest pain that increased with exertion and worsened on inspiration. The chest pain was not fully relieved with rest 8/10 scale and increased when lying down. The patient had 4-5 day prodromal history of malaise, fatigue, increased sleep and mild upper respiratory signs and symptoms prior to chest pain. Laboratory and diagnostic test 10 days post vaccination included: CK 613 and 705; CKMB 22; Troponin 1 1.12 and 30.09; abnormal 20:20; WBC 17.25; PT 13.0; ECG normal: no ST elevation or decrease, no bundle branch block and no T-wave inversions; Chest X-ray: no pneumonia, pneumothorax or cardiomegaly. Assessment plan 10 days post vaccination reports "due to increased Troponin, chest pain with normal ECG likely the patient is suffering from myocarditis however, cardiac thrombosis and MI are part of the differential diagnosis and require further work up." The patient was transferred to the hospital. On 11 days post vaccination, cardiac CT (computerized tomography) and ECHO demonstrated slightly reduced LV EF of 55%. The patient's temperature increased to 104 degrees. On 12 days post vaccination, the patient's chest pain was down to 3/10 scale and only on inspiration. Troponin levels were 1 to 3 to 3.7 to 12.4 to 9.04 to 14.0 to 7.8. On 14 days post vaccination, laboratory results included: Brain Natriuretic Peptide-B type 166, C Reactive Protein 2.4. The patient was discharged from the hospital on day 14 post vaccination after Troponin I levels decreased with no further chest pain or ECG changes. Follow-up appointment on day 15 post vaccination patient had no complaints, no fever and no signs or symptoms. He was treated with IBUPROFEN for one month. On 35 days post vaccination, "extensive labs were completed to discover an alternative cause for diagnosis." The only notable result was for a + Dengue IgG, which is of unclear significance given his negative IgM. The patient's final diagnosis was vaccine related myocarditis. The outcome was not reported. Note: Although the manufacturer was not reported in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Pain, redness, swelling itching knots where shot was giving fever in arms. Skin peeling in on arms.
chest pain, tightness, dyspnea, lightheaded, incontinence of urine
asthma has increased a little; itching; the glands under arms and breasts are pink; joint pain; headache; chills; Low fever; the glands under arms and breasts are swollen; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma has increased a little), PRURITUS (itching), ERYTHEMA (the glands under arms and breasts are pink), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Autoimmune disorder.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ASTHMA (asthma has increased a little), PRURITUS (itching), ERYTHEMA (the glands under arms and breasts are pink), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills), PYREXIA (Low fever), LYMPHADENOPATHY (the glands under arms and breasts are swollen), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, ASTHMA (asthma has increased a little), PRURITUS (itching), ERYTHEMA (the glands under arms and breasts are pink), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills), PYREXIA (Low fever), LYMPHADENOPATHY (the glands under arms and breasts are swollen), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.            No relevant concomitant medications reported. Treatment medication was not provided by the reporter.
This spontaneous report as received from a pharmacist refers to approximately 66 year old female patient. The patients medical history included prior case of shingles. There was no drug reactions/ allergies included. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, one dose, subcutaneous (anatomical location, lot# not reported). No concomitant medications reported. The pharmacist reported that today (date of report that is 22-MAY-2014) came into the pharmacy with a rash on her forehead, experienced approximately on 20-MAY-2014 (calculated based on date adverse event first reported from that subtracted 2 days, because it was also reported as couple of days ago by the reporter). The patient also stated that the rash was also tingling, and therefore patient believed that it may be the shingles. The patient sought medical attention (contacted pharmacist). There was no treatment for the adverse event given. The outcome of rash was also tingling and rash on her forehead was reported as not recovered/not resolved. The outcome of patient believed that it may be the shingles was unknown. The patient was not hospitalized due to experience. The experience was not life threatening. There was no persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality complaint was not involved. Additional information has been requested.
One of our NP's gave pt a PCV 13 instead of the PNEUMOVAX. Pt had already had the PCV 13 the year before.
shortness of breath; coughing; Congestive heart failure; her heart had a virus; fluid under lungs and heart; fluid under lungs and heart; had a skipping heart beat; very weak; low pulse rate; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158) at the age of 63-years, via an unspecified route of administration, administered in right arm on 12Apr2021 at 12:00 at single dose for covid-19 immunisation, at pharmacy or drug store. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, was not pregnant at time of vaccination. There were other medications the patient received within 2 weeks of vaccination. On 09Aug2021 she had shortness of breath and coughing. Thought she had COVID again but got tested and was negative. Went to ER. Congestive heart failure. Never had a past history of any type of heart problems. After a 4 day hospital stay, she was told her heart had a virus. Still taking furosemide (LASIX) and Beta blocker to remove fluid from her under her lungs and heart. She was currently wearing a heart monitor and had a skipping heart beat. Will be seeing a EP cardiologist once reports are all in to monitor her heart. Very weak and low pulse rate. These adverse events started on 09Aug2021 at 10:00, result in emergency room/department or urgent care. The patient underwent lab tests and procedures, which included test for COVID was negative. Outcome of the events was not recovered/not resolved. The events were reported as life-threatening and hospitalization for 3 days.   Follow-up attempts are completed. No further information is expected.
I got the Pfizer vaccine in my left arm and the next day I woke up with an incredible stiff neck, shoulder and back - all in my left side. It has lasted three days so far. I went to a doctor to and her said he could feel my muscles all knotted up. He did what he could, but it doesn't last. Getting a massage helps for a little while, then I'm right back to tight and stiff with limited mobility in my neck.
hives from neck to elbow swelling and inflamed headache severe fatigue neck and arm pain
Woke up at 4am the next morning with a wave of dizziness.  When I got up around 8 , I was very dizzy and my blood pressure was 174/118.  I called my primary around 8:15am and was instructed to go to their walk in clinic.  When I got there they took my blood pressure , which was high.  They asked why I didn't take the Clonidine and I replied I didn't know.  They proceeded to do a EKG.  The PA came back and informed me that it was different from one that was taken in January. He proceeded to call my heart doctor which wanted to see me at 11. The PA also ordered a ct scan of my head at1:30 that afternoon.  I saw the Heart Doctor around 12 {he was delayed}. They took at least 3 EKG's while I was waiting for him.  He has ordered a stress test for next Thursday.  The PA has ordered a  carotid artery ultra sound for tuesday.    My blood pressure had been normal for the last three months (I forgot to mention).  Yesterday, the 5th of March I was still dizzy, but not quite as bad.  The pa had ordered Mecizine 25mg for the dizziness.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), COUGH (Cough that it was like when you have bronchitis¨), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Had fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AMA) for COVID-19 vaccination. The patient's past medical history included COVID-19 in September 2020. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Body aches), COUGH (Cough that it was like when you have bronchitis¨), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Had fatigue). The patient was treated with NAPROXEN on 24-Mar-2021 for Adverse event, at a dose of 500 mg. On 25-Mar-2021, PAIN (Body aches), COUGH (Cough that it was like when you have bronchitis¨), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Had fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication reported included Blood pressure medication and Cholesterol medication.
Dizziness  BP:108/64 P: 66 O2: 99%    #21 Went home
pt recv vax 13JAN97 & on 23JAN97 pt exp fatigue & resp sx; 24JAN97 pt devel a diffuse exanthem clinically consistent w/varicella;pt had no known outside exposure of varicella;
Got flu shot 10/22/13 (Tuesday). No pain at time. 10-23-13 - woke up and could not move arm. 10-24-13 - came to pharmacy to report. Pt told to see doctor.
Fever 101, myalgias, neck supple, nausea lasted on and off 24+ hours treated with Tylenol.
Information has been received from a physician concerning a 9-year-old male who was vaccinated with Varivax on an unspecified date. On 18-MAY-2006 it was reported that "in the last few days" the patient showed signs of varicella virus. Unspecified medical attention was sought and the patient was hospitalized. No lesion count was reported. No length of admission was reported and at the time of the report the patient had not yet recovered. No product quality complaint was involved. Follow-up information was received on 05-OCT-2006 from a physician indicating that the patient's rash was a varicella-like rash which was experienced 8 years after vaccination. The rash appeared as a super-infected varicella rash; however, it is not certain whether the rash is varicella related. The physician noted that there were no serological reports to support it. It was also reported that the patient was hospitalized twice. No recovery information was reported. Follow-up information was received on 12-OCT-2006 indicating that the patient was 7-years-old (not 9 as previously reported) and he received the Varivax as a toddler. As of 16-MAY-2006, he was treated for what was thought to be superinfected varicella after an exposure to shingles. However, the IgM was not at all elevated indicating no current infection and the IgG was elevated, likely indicating immunity. Hence, the reporter noted that this was unlikely varicella, more likely a variant of atopic dermatitis, superinfected. The patient was hospitalized for seven days. The following laboratory or diagnostic tests were performed: Herpes simplex and varicella zoster boil specimens negative; and negative for clostridium diff toxins in feces. Additional information is not expected.
A lump at the injection site with redness and soreness and some itching.  The lump is slightly smaller but does still exist on 5/6/2021 and there is redness and warm to touch.
Temperature of 100-102F; nausea; dizziness; itching at the site of injection; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 12Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID from Jun2020 and not ongoing; and headache and anxiety issues, both from unknown dates and unknown if ongoing. Concomitant medications were not reported. The patient received the COVID vaccine yesterday (as of 13Mar2021). It was reported the patient had a temperature of 100-102 Fahrenheit (F), nausea, dizziness and itching at the site of injection; the reporter inquired if that was something to be worried about. The reporter stated the patient had COVID in Jun (2020) and never got a fever; she had a headache and anxiety issues. The clinical outcomes of temperature of 100-102F, nausea, dizziness, and itching at the site of injection were unknown.   Follow-up attempts are completed. No further information is expected, information about lot number cannot be obtained.
Mother and daughter, both had Twinrix# 1 on 7/6/07. Next day, both had headache, nausea, diarrhea, achy muscles, slightly better by 7/10 but still achy with headache.
Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swelling, redness. Extremity swelling. Coughing and chest pain. Extreme fatigue. Today, the pain is so bad I am on the couch. Doctors visit tomorrow
5 or so small red circles formed on my belly. The next day there were more. Everyday for the next 10 days small red circles formed on my belly, back, sides, chest & inner upper arms. The spots would itch the day after forming. I saw a nurse practitioner at my primary doctor office on April 23 who said they should go away on their own. Spots continued, was told to increase my daily Zyrtec to two a day. As of today new spots have stopped popping up, oldest ones are fading, but some are still red and itchy.
This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified date in 2008, the patient was vaccinated with the first dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported). On 03-JUN-2015, a second dose of GARDASIL (dose, strength, anatomical location, lot number and expiration date were not reported) was administered. Concomitant medication was not reported. No adverse event was reported. Additional information has been requested.
Patient reported itching, local rash, and tachycardia several minutes after vaccination of second dose Moderna vaccine. Patient reported no SOB or no throat closing. EMS was called, already onsite, to respond to reaction. No Epi was administered. Patient self-reported previous allergic reactions to antibiotics. Due to panic attack, EMC gave 2 L NC oxygen and observed patient for 30 minutes. Pulse was initially at 150, then decreased to 90. Patient called a friend and took back to home.
Shot- red and swollen. Treatment- cool pack and to watch for s/s of infection.