chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate pain at site. Felt like needle "hit something". MD appt 2 wks later after continued pain, limited range of motion. Needle went into tendon instead of muscle. Cortisone injections, physical therapy, ultrasound treatments. MRI 12/2015 showed spot where vaccine entered tendon. Over next months, Increased pain and increased limited range of motion. MRI 8/2016 showed rotator cuff tear where vaccine injection broke down tendon. Had Rotator Cuff Repair of left shoulder on 09/06/2016.
p/vax pt devel bloody vomiting & diarrhea which was intussusception unable to be reduced by enema;pt went to surgical reduction & has done well since;
Patient experienced swelling, redness, and pain in the arm that the Pneumovax vaccine was given.
Shot in left arm.  No side effects until three days later began having nausea, fever, chills, aches.  Next day noticed heat, redness, increased swelling, tenderness of RIGHT arm that has Lymphedema.  Called doctor today and was prescribed  Keflex 500 4x a day for 7 days for suspected cellulitis.
She is also currently pregnant; Sore L arm at site of injection; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (She is also currently pregnant) and INJECTION SITE PAIN (Sore L arm at site of injection) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Vitamin D deficiency. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ASPIRIN [ACETYLSALICYLIC ACID] from 06-Jan-2021 to an unknown date for Prevention, VITAMIN C [ASCORBIC ACID] for Symptomatic treatment, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.    On 15-May-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 15-Nov-2021. On 15-May-2021 at 3:15 PM, the patient experienced INJECTION SITE PAIN (Sore L arm at site of injection). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (She is also currently pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 18-May-2021, INJECTION SITE PAIN (Sore L arm at site of injection) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (She is also currently pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Additional info appended
Pt vaccinated with DTP/OV 15min /p leaving clinic experiencing vomit & "go limp", & turn pale - episode lasted few seconds. Child quickly recovered & returned to clinic. MD saw child. No treatment given.
Fever; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (COMIRNATY), on 05Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset Jun2022, outcome "unknown"; HEADACHE (non-serious) with onset Jun2022, outcome "unknown".  Additional information: There were no known allergies. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
extreme fatigue and sleepiness - began 2 days after shot and is still no better 15 days later
Left arm pit Lymph Node became swollen after the day of receiving the second dose of the Pfizer Vaccine. I was unable to use that arm for a total of 5 days because of the pain. It's been a year now that I have been limiting using my left arm because my day to day activities hurt my left arm and make my lymph node swell. I cant even open a pickle jar without hurting my left arm. I went to see my doctor yesterday and they will be sending me to get an ultrasound soon.
Inappropriate schedule of vaccine administered; No additional AE; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 13-DEC-2018, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). 21-FEB-2019, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).; Sender's Comments:  US-009507513-2307USA010113: US-009507513-2307USA009252:
Small red rash appeared next to the injection site, my arm was sore. I felt achey, had a headache and a slightly upset stomach. I felt better within 24 hours.
Cellulitis right arm due to 3 injections given in same arm. Has been given 2 antibiotic PO for cellulitis.
Varicella eruption on V1 distribution on left face.  Was receiving immunosuppression at time of eruption (daily steroids and monthly canakinumab).  Admitted to the hospital and received IV acyclovir with resolution of symptoms and no resultant morbidity or mortality.  Admitted from 12/17/2014 to 12/24/2014.
I had a 105 degree fever that lasted 2 1/2 days. I tried Tylenol to bring it down and it didn't work.
Nausea, vomiting, diarrhea, persistent fatigue and leg weakness, headaches.
Received ZOSTAVAX on 7/26/20o12. Started having symptoms about 1 week after receiving the shot. Having tingling & burning sensation at waist on left side, same itching and mildly hurting. No rash that she noticed. Came of Pharmacy on 8/13/12 and reported this. Said was bothering her yesterday but no symptoms today - has never had shingles before taking shot.
Patient become light headed, lost consciousness and struck head. He rest under observation, ice pack and drunk juice. He recovered and discharged home Pulse : 67 SPO2 : 99% BP: 110/58
24hr p/vax pt devel rash;started on chest back spread to legs & arms & tops of feet;itchy;pink-red color;fine pinpoint;lasted 1-2wk;
Booster (half dose) - had Pfizer for first 2 doses. Fever, body aches, chills, nausea, fatigue. Duration 48 hours
flat bullseye non-painful bruise onfront of left hip.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number=EJ1685) via unspecified route of administration on 12Dec2020 at 12:30 as a single dose for COVID-19 immunisation. The patient had also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number=EK9231) via unspecified route of administration on 22Jan2021 at 13:15 as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC), fluticasone (MANUFACTURER UNKNOWN), niacin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) for an unspecified indication from an unspecified date. 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 had been tested for COVID-19. After vaccination, on an unspecified date, the patient experienced flat bull's eye, non-painful bruise on front of left hip. No signs or knowledge of any bug bites and exposure to ticks. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for flat bull's eye, non-painful bruise on front of left hip. The patient underwent lab tests and procedures for COVID-19 virus test (saliva in a tube) on 15Mar2021, and the result was negative. The clinical outcome of flat bull's eye non-painful bruise on front of left hip was not recovered at the time of report.   No follow-up attempts are possible; No further information is expected.
Received second vaccine on 2/5/21 and woke up the next morning with HA, body aches, chills, nausea, and palpitations. Went to ER on 2/6/21.
Information has been received from a consumer concerning her daughter who several years ago was vaccinated with a dose of hepatitis B virus vaccine. The reporter indicated that after vaccination, the patient suffered seizures. Unspecified medical attention was sought. It was noted that the patient has not had any more seizures and has subsequently recovered on an unknown date. A product quality complaint was not involved. Upon internal review, the seizures were considered to be an other important medical event (OMIC). No further information is available.
nasal congestion, sore throat Narrative:  reported congestion and sore throat following vaccine
Headache and muscle aches the following day. Swollen and tender lymph node in the armpit of the arm the vaccine was administered in on the second day following the vaccine.
Multiple papules/pustules, erythematous, discrete spreading from right deltoid to upper back to left trapezius area. Also cervical and supcaclavicular and axillary LAD. Over 24 hr period resolving w/in 48 hrs.
Auto-immune inflammatory disorder brought on by the influenza vaccine. Severe joint pain, lupus-like s/s etc. Steroids - PLAQUENIL.
Vaccines were both given in right arm in deltoid muscle at least 1 inch apart. Pt says she experiences a rash from about 40 minutes after vaccination. It was on her arm looking the most prominent around SHINGRIX site (which was lower on arm than PREVNAR). Pt said rash went up her neck. No swelling of lips or trouble breathing. Pt is taking BENADRYL and will go to the ER if gets worse or starts having swelling of lips or trouble breathing. Pt will call doctor tomorrow as well. I attempted to call doctor today but they are closed and no way to leave msg. Will call and inform Dr. in the morning on 7/10. Pt will let us know if anything changes.
Guillain Barre Syndrome. Leg  weakness one week following vaccine. Hospitalized. Treated with IVIG. Improved with leg weakness only sequela.
Information has been received from a healthcare worker referring to an adolescent male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route not reported). On an unknown date the patient experienced "oversleepiness: since receiving unspecified dose in GARDASIL series. The outcome of the event was not recovered. The mother of the patient contacted the doctor's office to seek medical attention. Causality assessment was not reported. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-OCT-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-AUG-2016, she was treated at a clinic for a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX and tramadol for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I developed bodyaches and skin hypersensitivity about 8-9 hours after the vaccine and about 13 hours after the vaccine had some lightheadedness which faded away fairly quickly. The aches and skin hypersensitivity were resolved within 36 hours of vaccine administration
I woke up with a slight headache, sore throat, nasal congestion, and cough. The next morning I had chills, and I had a fever of 101.3. I took a COVID-19 test that came back positive. I called my doctor that day and they gave me PAXLOVID. The next morning I felt tired but my symptoms had improved. My symptoms lasted about 5 days, and the next weekend I woke up and all my symptoms started again. I took at another COVID-19 test and it came back positive. I am still currently experiencing symptoms.
Report extreme reactions to 2nd Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Report extreme reactions to 2nd Moderna vaccine) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report extreme reactions to 2nd Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Report extreme reactions to 2nd Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
This spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and genders. The patients' pertinent medical history or concurrent conditions were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB intramuscular Injection (strength, dose, route, anatomical location, lot number and expiration were not reported. Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. It was reported that the therapy was not discontinued. There was no product quality complaint (PQC) involved. This was one of several reports received from the same reporter. Additional information has been requested.
Tachycardia, arrhythimia, elevated blood pressure, abnormal EKG readings
Muscle soreness, weakness, and limited mobility in the area of the injection, peaked in intensity 10 hours after the dose was administered. Soreness is still ongoing as of this form submission, but isn't as intense.  Insomnia, occurred 12 hours after the dose was administered, it took me about 2.5 hours to fall asleep after going to bed (12:00AM - 2:30 AM)
When I got my first Shringrix vaccine, I was in bed with fever and chills for 3 days and under the weather for 3 more. I took the second one because the pharmacist said it would not be as bad. Still spiking fever up to 102 and haven't gotten out of bed for 2 days. I am dizzy, weak and have severe body aches.  I am healthy, rarely get sick and have never had any kind of adverse reaction to a vaccine. Don't know how much longer I will be sick this time. I missed 3 days of work the first time and we'll see how many this time. Do not know how long I will be sick. The pharmacist told me he has heard many stories like mine and I am angry and also worry of elderly that are getting these shots.
Rash on her torso, front and back that was itchy; This is a spontaneous report from a contactable consumer (Reported for herself). A 55-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Dec2020 (at the age of 55-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Dec2020, the reporter stated that after the first dose same evening, she got a rash on her torso, front and back that was itchy. Reporter states that she does not know if the rash was from the vaccine, or if it was just bad timing. Reporter states that the rash remained for a about a month. reporter states that she did have a virtual appointment with her doctor, and they talked about recommendations for the second dose. Reporter states that her doctor told her that it is up to the caller if she wants the second dose or not, but that if she does get the second dose, she should ensure she gets it in a hospital setting and wait for 45 minutes, instead of the standard 15, after receiving the dose. Reporter decided ultimately to not get the second dose, as the event scared her. Reporter states that here she has, and it is early on an unspecified date in Feb2021, and she did not get the second dose because of the event she experienced, and now she is just trying to seek out more information or guidance. Reporter states that she also did get an antibody test this week and it came back as negative, non-responsive, with something like a .44 protein spike. Reporter was not sure of exact results as she has not seen the results herself, they were just provided to her over the phone. Reporter just thought she would call Pfizer directly and see what information was available on her reaction, and on getting just one dose of the product. Reporter states that she has no other medical issues, she takes no medications, there were no other red flags. Patientstateed that the funny thing was, when she went back to the hospital to have the second dose done, she spoke with the doctor who was overseeing the COVID administration stuff, and he was the one who told the caller that it was up to her if she wanted the second dose because of the reaction she had after the first, but the caller does not think that doctor ever reported this event to anyone. The patient underwent lab tests and procedures which included antibody test: negative, 44 protein spike on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information on the lot/batch number cannot be requested. No further information expected.
Rash, Pityrisasis Rosea, Treated with Clobetasol mixed in Cerave Cream
Date of vaccine 7/19/11 - Temp 102, headache between eyes (like flu), chills, TB skin test at same. On 7/23 broke out hives all over except face. Taking BENADRYL. Hives get worse 5:30-6:00 pm, then BENADRYL helps lower hives. Cheeks get bright red - ZYRTEC started 8/15.
9 days after receiving the first dose of the Pfizer vaccine, the patient developed superficial thrombophebititis in her right lower extremity that extended despite compresses, elevation, and aspirin use.  A 2nd ER visit showed clot above and below her knee and in her greater saphenous vein which is a risk for deep venous thromboembolism and she was started on rivaroxaban (anticoagulation).
Client became short of breath, felt throat closing, "felt hot inside - even eyeballs", heart was pounding. This happened as he was driving back to work; had not stayed the recommended 20 minutes post vaccination. When arrived at work, co-worker called here. I advised "calling 911 and send vaccination papers with client." Went to hospital by ambulance, responded favorably to O2. Saw PCP as follow up.
4-5-21 at 6:00 p.m.:  stiff neck, fatigue 4-6-21 at 2:00 a.m.:  Migraine, stiff neck, pain in  right cheekbone, leg cramps, pain in arm 4-6 thru 4-7:   Fever, migraine, muscle cramps, throbbing pain in legs and hips, unable to lift left arm, fatigue, chills, nasuea, cold sores and mouth liasons (on pallate and bottom gum, left side, hoarse voice 4-7 thru 4-9:  Only Hoarse voice, cold sores and mouth liasons 4-10:  Only cold sores and mouth liasons remain
right arm was itching; the right side of jaw was sore, and it hurt to chew; right arm was immobile; could not lift her am; very faint rash; had redness and a slight swelling at injection site; Nausea; injection site pain; swelling at injection site; swelling; She had pain and it was excruciating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching) and SWELLING (swelling) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (She had pain and it was excruciating), SWELLING (swelling), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site). On 18-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile) and MOBILITY DECREASED (could not lift her am). On 21-Feb-2021, the patient experienced PAIN IN JAW (the right side of jaw was sore, and it hurt to chew). On 28-Feb-2021, the patient experienced PRURITUS (right arm was itching). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in February 2021 for Swelling, at a dose of UNK, bid. At the time of the report, PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching), SWELLING (swelling), MOBILITY DECREASED (could not lift her am), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided. The patient feels that no further follow-up is needed for the 2nd shot because she does not have any further information. She is fine now and has full mobility of her arm. She reiterated that she will not take the Moderna shot again   This case was linked to MOD-2021-021353 (Patient Link).
HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.