chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches, sore arm at injection site, severe shivers and profuse sweaty and freezing  during sleep, upset stomach headache stomach pain
Mom states that after patients first covid vaccine on 07/28/22, that within 30 minutes he became lethargic, within an hour and half he was vomiting and proceeded to vomit 5 times within a 24 hour period. Mom also states he spiked a 102 fever within that time as well.   Patient was taken to urgent care for observation and then sent home.
PPD like reaction, 4cmX6cm red, hot, indurated wheal. As of today (1/19/21), smaller indurated wheal, but redness is markedly fading.
Arm is getting redder today and sore. Was not red or sore yesterday after the injection.; Arm is getting redder today and sore. Was not red or sore yesterday after the injection.; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 59-year-old female patient received first dose of bnt162b2 (BNT162B2), via unspecified route of administration on Left arm on 20Dec2020 07:45 AM at single dose for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history included known allergies to medications, food, or other products: PCN, cedar, mold and Hashimotos disease. Concomitant medications included other medications the patient received within 2 weeks of vaccination:ibuprofen (ADVIL [IBUPROFEN]), Levothyroxine and ergocalciferol (VIT D). Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Arm is getting redder today and sore. Was not red or sore yesterday after the injection from 20Dec2020 07:45 AM. The outcome of the event was not recovered. No treatment received. No Covid prior vaccination.  Covid tested post vaccination. Covid test type post vaccination was Nasal Swab on 15Dec2020 with result of Negative. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Vaccine Facility information available.  Information on the lot/batch number has been requested.
Feeling poorly; Scratchy throat; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling poorly), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-May-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced FEELING ABNORMAL (Feeling poorly) and THROAT IRRITATION (Scratchy throat). May 2021, the patient experienced COUGH (Coughing). At the time of the report, FEELING ABNORMAL (Feeling poorly), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Reporter contact details updated.
38 y/o F pt with a PMH of DVT, CVA, presents to the ED with complaints of left thigh and calf pain.  Diagnosis of DVT in left leg.
This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On 02-JUL-2007, the patient was vaccinated with the first dose of GARDASIL  (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not reported. The licensed practical nurse stated that on 19-JUN-2013, the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength, dose, lot number and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Initially (20 minutes after shot) felt numbness in toes on both feet.  Chills were next felt within approx an hour.  Intense muscle aches were later (approx 6-8 hrs after shot) along with overall fatigue.  A medium grade headache began 8-10 hrs after shot and continued throughout night - lowering to a slight headache within 24 hrs after shot.  Headache ended 28-30 hrs after shot.  Developed a post nasal drip and mild congestion in sinuses about 1.5 days after shot (and continues).  Numbness in toes appears to have returned with some stiffness felt in my calf muscles.
Feeling of having too much of a medication like benadryl - within a few hours after injection  Sleepy- within a few hours after injection  Very cold - within a few hours after injection  Hard lump at sight of injection- 12 hours after injection
MMR given 3/7/17; Varicella 4/4/17.
missed 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 18 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
10/06/2021, I suffered several strokes with no history or risk. I was admitted to the hospital the following day and received multiple tests. I have confirmed tests offering no evidence or explanation for multiple thrombus generation, other than the Pfizer COVID vaccine. I have no blood clot disorders, neither genetic or otherwise. I have zero atrial fibrillation events, confirmed via lync loop recorder since Oct 2021. Due to multiple tests, doctors discovered I have a PFO. In Dec 2021, PFO occluder was successfully inserted via heart catheterization. I was started on heavy blood thinners in Oct of 2021. In May of 2022, doctors confirmed the final thrombus noted in my lower heart chamber was gone via cardiac MRI.  All blood thinners medications were stopped in May of 2022, however I continue ?baby? aspirin as a safety precaution due to my new medical history. My language processing was severely adversely affected by the strokes, as well as fine motor skills, such as handwriting. I work as a professional Sign Language interpreter, and I am nationally certified. Due to language processing affects of the strokes, work is extremely difficult and ability and effective language processing is unpredictable at best. Some days are just ?bad? and nothing makes sense.
Whelps on the injection site arm; Swelling on the injection site arm; Redness on the injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE URTICARIA (Whelps on the injection site arm), VACCINATION SITE SWELLING (Swelling on the injection site arm) and VACCINATION SITE ERYTHEMA (Redness on the injection site arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE URTICARIA (Whelps on the injection site arm), VACCINATION SITE SWELLING (Swelling on the injection site arm) and VACCINATION SITE ERYTHEMA (Redness on the injection site arm). At the time of the report, VACCINATION SITE URTICARIA (Whelps on the injection site arm), VACCINATION SITE SWELLING (Swelling on the injection site arm) and VACCINATION SITE ERYTHEMA (Redness on the injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
By the end of the first hour after receiving the vaccine in my left arm (injection arm) I could not raise my arm any higher than halfway between my side and shoulder-level - probably a 45 degree angle.  There was also a huge lump at the injection site that was really warm - way warmer than usual.  It lasted approx. 4 days.   I also had a 4 day migraine and was really sleepy.   Since the injection, I haven't slept through the night and I take a prescription sleeping medication.   I just dealt with all of it; it wasn't severe enough to warrant a Dr's office visit.
This spontaneous report was received from an unspecified reporter via a company representative concerning two patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, after the vaccination, patients experienced blurry vision. The outcome of blurry vision was unknown. The relatedness for blurry vision was unknown for GARDASIL. Additional information is not expected.
admitted with unstable angina, underwent coronary artery bypass, developed acute kidney injury requiring dialysis.
This case was reported by a consumer, and subsequently confirmed by a physician, that described the occurrence of prolonged crying in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and (PEDIARIX, GlaxoSmithKline) for prophylaxis. Concurrent vaccinations given on 08 November 2007 included HAEMOPHILIUS INFLUENZAE type B vaccine; manufacturer unspecified; (ROTATEQ, manufacturer unspecified); (PREVNAR, manufacturer unspecified). On 08 November 2007 at 10:00, the subject received the 1st dose of PEDIARIX (dose and route of administration unspecified, unknown thigh). Three hours after vaccination with PEDIARIX, the subject experienced prolonged crying. The child's mother reported that the event resolved after 7.5 hours. Follow-up information was received on 10 March 2008 via a physician, who reported that the subject was treated with Tylenol. At the time of this report, the subject had not received the 2nd dose of PEDIARIX. The reporting physician considered the event to be almost certainly related to vaccination with PEDIARIX.
1014 Patient alerted nurse to redness and itchiness with hives to Right arm that spread to the left arm along with itchiness of the throat. No complaints of shortness of breath or difficulty breathing. Alert and oriented, tolerating water. Patient given 25 mg of Benadryl. Vitals, BP 163/103, Respirations 21, Pulse 63, SaO2 98%. Patient guided to the floor and lied down. Nurse/ LVN stayed with patient throughout time in observation. Patient stated that itchiness has subsided in her arms and her throat. No more visible redness or hives noted on the patients arms. Patient alert and oriented. Vitals at 1030, BP 151/101, Pulse 62, SaO2 98%, Respirations 20. Patient states she has a history of celiac disease, only known allergy she suffers from. Patient experienced no side effects after first dose. Patient able to tolerate standing and walking unassisted. Vitals at 1045, BP 159/98, Pulse 68, SaO2 97%, Respirations 18, Temperature 97,8. Patient educated to seek medical attention if symptoms return and/or worsen. Patient stated understanding. Patient left site with partner without further incident.
Pt devel pain, edema, erythema, induration, warmth @ the inject site;
Approximately 45 minutes post vaccination patient complained of diarrhea, tightness in the throat, dizziness.  On site assessment of clammy hands, no angioedema, hive or injection site reaction.  Pateint has history of receiving flu shot with no reactions, last flu shot was 5 years ago.  Patient demonstrated strong pulse and elevated blood pressure.   No treatment administered, 911 was activated and patient transported to hospital. Outcome unknown at this time.
No addtional AE, no report of symptoms or medical concerns; Sterile diluent vial that was frozen; Nurse calling to report adverse event regarding a patient who was administered a dose of MMR II using a STERILE DILUENT vial that was frozen and then thawed prior to use.  Nurse stated that the STERILE DILUENT was transported inappropriately in a fro; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 24-OCT-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL (lot # W028735, expiration date: 08-SEP-2024, therapy type stablished as rHA) (route of administration, anatomical location not provided) as prophylaxis; which was reconstituted with sterile diluent vial (lot # W029959, expiration date: 24-APR-2025) that was frozen and then thawed prior to use (product storage error, wrong technique in product usage process). The reporter stated that the sterile diluent was transported inappropriately in a frozen environment to a vaccination event, where this one patient received the vaccine. It was confirmed that there was not reports of symptoms or medical concerns from the patient.
Started getting  white sores on my tongue (mostly on the sides with a couple on top). Went to ENT, Dentist and Dermatologist with all saying they have never seen this before. Tested for Thrush-negative.  Now going to see an oral surgeon for a biopsy at the end of July. Taste buds are off,  pain while chewing food, and brushing teeth .
c/o extreme fatigue within 1 hour of vaccination. Within 10 hours c/o nausea, dry mouth and continuing fatigue. Fatigue lasted about 2 weeks. No fever, rash or vomiting. Rec'd vaccine 11/12/2002. Missed work 11/15/2002 due to fatigue.
After 5th dose of DTaP, my son's entire leg swelled up where the shot was given - the day after shot was given - this effect lasted 1 day - he did limp all day
Around 12/1/2021, I began to see red spots on my neck filled with fluid.  I would touch it with my finger and the skin would peel away easily and the fluid would leak out.  I also began to get thick crusty lesions on my scalp that were gray colored (it was not blood crust).  That continued in severity and numbers and by around February 1, 2022, I had over 40 lesions on my body.  The sizes of the lesions varied, some were 4" x 6" to 2" x 2".  The crust on my scalp continued, my hair was falling out when the crusts fell off my head.
Fluzone 10/10/2005, 10/11/2005 itching right hand and head, ears swollen, 10/12/2005 hives problem itches, worst head, right hand severe red swelling, 10/13/2005 left hand arm red itchy, hives worse waist and chest.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no medical history who on 05-APR-2013 was vaccinated with ZOSTAVAX (lot # J000432, exp 10-APR-2014), single dose, subcutaneous in the left arm. Drug reaction/allergies included BENICAR. There were no concomitant therapy. On 06-APR-2013, the patient experienced redness, induration, and warm at the injection site. The patient sought medical attention and she came to pharmacy. The patient self-treated with BENADRYL but the symptoms were "getting worse". The outcome of event was reported as not recovered/not resolved. Additional information is not expected. Additional information is not expected.
Sanofi flu vaccine/Proven by doctors that I am allergic; Initial information was received on 07-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.   This case involves a patient (unknown demographics) who was allergic to flu vaccine (proven by doctors) (allergy to vaccine), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient had allergy to flu vaccine a (proven by doctors) (allergy to vaccine), (unknown latency), following the administration of INFLUENZA VACCINE.   Details of laboratory data not reported.  Corrective treatment and outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.se.
Information has been received from a registered nurse concerning a 24 year old male with no past medical history who on 03/20/1990 was vaccinated intramuscularly with hep B vaccine recombinant for the first dose. There were no illnesses at the time of vaccination. The registered nurse reported that subsequently the pt developed flu like symptoms. On 07/06/2000, the pt was vaccinated intramuscularly with hep B vaccine recombinant for the second dose. The registered nurse reported that several hours after the injection of the second dose, the pt's skin was cold, clammy, the pt developed headache, lightheadedness, nausea without vomiting, vertigo, tachcardia and his blood pressure fell (hypotensive). The registered nurse reported that the pt was treated with Advil times two, fluids were forced two liters, a candy bar and the pt sat in a chair for an hour. The registered nurse reported that no rash, respiratory distress or hysphagia were noted. The pt recovered from the cold, clammy skin, nausea, vertigo, headache, tachcardia, lightheadedness and hypotension on 07/06/2000 and 07/07/2000. No further info is available.
The rash is back and itchy and very swollen. There is a bump; After 8 days rash is back and itchy; Had a slight rash when I got the shot; This is a spontaneous report from a contactable consumer (patient). An adult, non-pregnant female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Solution for injection, Lot number: EN6199 and expiration date not provided) via an unspecified route of administration, in left arm on 08Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication details were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On the day of vaccination (08Mar2021), after the shot the patient had a slight rash and that went away. 8 days after the shot, on 16Mar2021 the rash was back and itchy and very swollen. There was a bump. The patient was not treated for the events. The patient recovered from the event rash on 08Mar2021 and the clinical outcome of the events itchy rash and swelling was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated suspect vaccine details (suspect vaccine recoded as BNT162B2, added stop date as same date; 08Mar2021 00:00), treatment as no for the events and leading sentence updated to a contactable consumer.
Extreme shortness of breath (utilized rescue inhaler several times through the night and through the next 4 weeks), severe foot, leg, arm  cramps (not aches - cramps), foot was curled into a C and prevented sleep, chronic headache which dissipated after 8 weeks.  Asthma flare up dissipated after 5 weeks.
During a review of the Department of Healths internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
On Friday July 16,Patient was wrongly administered 0.5ml of Pfizer Vaccine Intramuscular instead of 0.3ml by the Medical Center. Management was informed ,Incident report filed and patients are being notified by medical staff.
This serious solicited report (USASL2022002347) was reported on 07/JAN/2022 by a consumer from a commercial program (PSP00086) and involves a 56 year old female patient who did not feel well/ vaccination made her RA (rheumatoid arthritis) worse/pigmentation/dry eye [PT: rheumatoid arthritis], dehydration [PT: dehydration] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. The patient states on an unknown date, she went for her eye exam the physician asked if she had rheumatoid arthritis. He states could tell because dry eyes and pigmentation that can be related to the rheumatoid arthritis or auto immune issues and dehydration. She also reports that she had the Covid vaccination, the first one went fine but she did not feel well after the second one. Since then she was not at the top of her game with energy and activity. She really does not take the booster because she feels the vaccination made her rheumatoid arthritis worse then it was been in a while and Enbrel had been a life changer for her. No treatment information was received. The outcome of the events rheumatoid arthritis, dehydration were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events dehydration and rheumatoid arthritis. The causal relationship between the events dehydration, rheumatoid arthritis and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Comment: This individual case report does not change the safety profile of the product. Causality Assessment for Rheumatoid arthritis aggravated, Dehydration Per Company (Amgen): not related. The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Etanercept (ENBREL) is under agreement with RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: The reported event of RA aggravated was assessed as possibly related to BNT162B2. The event dehydration is likely intercurrent and is not related with vaccine used. The events RA aggravated and Dehydration were unrelated with etanercept use.