chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received a standard injection for my booster shot in my upper right arm. The day after the booster shot the muscle region immediately underneath the injection site was very firm and sore. The soreness gradually went away after about 36 hours while the stiffness persisted. A large red rash also began to appear on the skin of the upper right arm under the injection site. Its dimensions are about 4 inches across and 3 inches in height in a roughly oval configuration. It is warm to the touch, slightly itchy, has some red bumps on the skin, and a large red patch with the dimensions mentioned. I did not have any such reaction - nor any other side effect - after my first two doses in March and April 2021.
12 days after vaccine the injection site became red and was hot to the touch.  The redness extended 5 cm. in length by 5 cm. in width.  It also itched.  There was also some swelling which developed extending to below elbow.   It had done this the day of injection but had subsided until May 28th.  Currently, on June 1st, the area is still red but not as intense and the heat in area is not as intense.  The area now measures 4.5 cm in length and 3.5 cm in width.   My Dr. prescribed antibiotic (doxycycline) and a steroid pack 4mg, 6 day regiment.
Within 1 hr, pt reported " flu like symptoms" increase fatigue, body aches, headache, chills.   Pt adv homecare, tylenol, rest fluid. Adv to call back if symptoms do not improve or worsen
About 5 days after getting my 2nd booster (4th Pfizer shot total), I had a herpes simplex outbreak on upper lip. I haven't had one in years so it was a surprise. Started today.
Sweating, paleness beginning <10 mins after giving shot, no loss of consciousness, unclear if patient was dizzy/lightheaded. Patient asked to sit in waiting area until symptoms subsided. Blood pressure checked and WNL. Patient given cold pack.
Information has been received from a physician concerning a pt who on 09/17/99 was vaccinated with one dose of varicella vaccine. On 06/19/00 the pt developed chicken pox with 300 lesions noted.
BODY TEMPERATURE OF 79 DEGREES F; MENTALLY CONFUSED; CRAMPING UP; DIZZY; CHILLS; This spontaneous report received from a consumer concerned a 33 year old male of an unknown ethnicity and race. 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: 206A21A and expiry: Unknown) dose was not reported, 1 total administered on 08-MAY-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAY-2021 (after vaccination), patient experienced chills, fever at 102.5 degrees F, cramping up and dizzy. It was reported that patient at the first had body temperature of 79 degrees F and later had 103 degrees F body temperature. On the same day, the patient was mentally confused, did not remember that had been married for five years. At the time of reporting the patient was being taken to the emergency room. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body temperature of 79 degrees F, cramping up, dizzy, and mentally confused. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516895-COVID-19 VACCINE AD26.COV2.S-Body Temperature of 79 Degrees F. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Approximately 11 hours after receiving vaccine fever went up and I experienced teeth chattering and shaking with chills. Temperature went from 98.6 to 101.7 over about 1.5 - 2 hours. Once I was able to get some ibuprofen the symptoms subsided to low grade fever only (99.3). This morning (day after) just feel general headache and some body aches associated with very low grade fever. From what I understand these are common reactions to 2nd dose and are not worrisome.
Patient received a 0.3ml Pfizer Bivalent booster for ages 5-12yo. No signs and symptoms of any adverse reactions, patient was in clinic for approximately 45 min after vaccine for an apt.
Case number PHEH2013US024422, is an initial spontaneous report received from a medical assistant on 19 NOV 2013. This report refers to a patient of unknown age and gender. The patient erroneously received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number, M12130), without being reconstituted with Men A lyophilized conjugate component intramuscularly in the first week of NOV 2013. No adverse event was reported following this administration error.
Diagnosed with hemophagocytic lymphohistiocytosis on 5/7/2021 after bone marrow performed on 5/5/2021.  Presented to our office on 5/5/2021 for evaluation due to the finding of pancytopenia on 4/28. Mom states he received his second COVID vaccine on the 10th of April and since then he has been hurting head to toe, complaining of his throat, and feeling dizzy. He has had low grade temps mostly from 100-101, but it has gone as high as 103.6 deg F. They presented to urgent care 1 week after the vaccine and was told that it was likely due to the vaccine, he had fluid in his ears and he was prescribed an antihistamine. He went back to urgent care a few days later and saw the same NP who told them to go to their PCP. At their PCPs office he tested "faintly positive for Flu A" and was given tamiflu and zofran which has since completed.   No bruising, bleeding, gum bleeding, nose bleeds. He has been having leg pain/difficulty walking and his friends brought him a cane to use. He has had possible night sweats, mom reports he "burns up constantly." Decreased appetite, lost 4lbs, hasn't eaten much since last week.   Labs were performed at the PCPs office on 4/28/2021: WBC 1.7 Hgb 10.3 Hct 30.1 Plts 118K ANC 500   Mono was negative.   A referral was placed to our office on 5/4/2021 and he was brought to our clinic today for evaluation.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX (batch number 723BG, expiry date 13th July 2020) for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 31st May 2018, the patient experienced malaise, listless and fainting. On 31st May 2018, the outcome of the fainting was recovered/resolved. On 1st June 2018, the outcome of the malaise and listless were recovered/resolved. On 4th June 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain, malaise, listless and fainting to be related to SHINGRIX. Additional details were provided as follows: One day after receiving SHINGRIX, the patient experienced malaise, listlessness and also fainted the following day after receiving the vaccine. The symptoms made the patient feel as though he couldn't do anything, and persisted for 2 days after vaccination (the pain persisted longer- approximately 5 days).
PATIENT CAME TO THE PHARMACY AND CLAIMED SHE HAD REACTED TO THE VACCINE ON 4/14/2021 1ST MODERNA AND 5/12/2021 2ND MODERNA BY EXPERICING ITCHING AND REDNESS OVER HER SKIN AND BODY. ON 1/11/22 SHE RECEIVED A PFIZER BOOSTER AND CLAIMED THAT BHER BOSY REACTED WITH RED RASH AND LOTS OF ITCHING, SHE USED BENADRY AND ALSO GOT CLOBETASOL CREAM FROM HER SISTER WITH NO IMPROVEMENT. I ADVISED HER TO SEE A DOCTOR IMMEDIATELY TO GET BETTER CARE AND I CALLED BACK. SHE SAW DR ON 3/21/22.
Initial health care professional (medical assistant) report received on 10 Feb 2011: These 3 patients were vaccinated with MENVEO (batch number: M10030) intramuscularly. The patient were inadvertently administered with only the MenA lyophilized conjugate component of MENVEO reconstituted with a sterile diluent; the patients did not originally receive the MenCYW-135 liquid conjugate component of MENVEO. The patients were revaccinated with another dose of MENVEO.
Chills, body aches, shaking that last for 8 hrs. Extreme arm soreness (worse than any other vaccine) for 48 hrs
At approx. 0200 in the morning I woke up diaphoretic and my pulse was over 200bpm. I drove to the VA where I was placed on a monitor and my heart rate was 220-240. An EKG was done shortly after I arrived which showed I was in atrial fibrillation with RVR. I received several doses of Cardiazem IV push and my heart rate eventually decreased. I was discharged on Metoprolol and the following week I had a stress echo completed and I am currently wearing a heart monitor until next week. I was suggested that I be admitted to the hospital but I could not stay because I am caring for my mother who has cancer.
Approx 2 hours after receiving vaccine, experienced dizziness, difficulty breathing, arm swelling, dry mouth, fever. Approx 5 hours after, chills, nausea, fever, tiredness. Approx 6 hours after, went to hospital ER. There for 4-5 hours, symptoms resolved. 24 hours after, continues feeling tired, no appetite. ER said they think it was a viral event.
Swollen lymphnode neck/shoulder region occurred jan 4th. Painful to touch and light pressure. Saw PCP on jan 1/14/2021.
I woke up early that morning and both of my legs were aching and cramping. It was very painful. Lasted about a hour and stopped. I have burning in my throat still from the first injection.
Sharp Pain in shoulder at injection site moving down to  below elbow.  Almost feels like a pinched nerve or something similar.
Employee forgot that she already received COVID19 (Janssen) back in 6/17/21 and gave this reporter consent to administer her first dose of COVID19 (Pfizer) on 9/13/21.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Alcohol addiction (1-2 drinks, 3 times per week) on 22-Jun-2020. Concurrent medical conditions included Hypothyroidism and Penicillin allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for GERD, LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 12-Apr-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 02-Apr-2021, which was reported as Premature. For neonate 1, the birth weight was 2268 grams (5lbs). The outcome was reported as Pre-Term Birth NOS. Baby was conceived through IVF, Low AMH is culprit of infertility. Water broke and chose to do a C-section. Live, pre-term birth. Length - 18 inches. Pregnancy related complication was Baby was measuring small- labeled as IUGR. On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound Doppler: normal (normal) Good chances for having early delivery. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. LMP was reported as JUN-2020, Date of positive pregnancy test was 06-JUN-2020. Relevant Lab test included: weekly NST and result was normal. Patient reported there is no adverse event for first dose. This case was linked to MOD-2021-256756, MOD-2021-269190, MOD-2021-269190 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up received on 14-JUL-2021: Patient demographics, ethnic group, Race , pregnancy details were  added. Historical condition was added. Concomitant medication, new event were  added. On 28-Jul-2021: Significant FU - Narrative updated.
developed intense nausea for 30 minutes just less than 7 days after booster. Then intermittent queasiness for 7 weeks.  19 days after booster developed intense lower leg pain (left ) for 30 minutes which resolved. 23 days after booster, developed a superficial thrombophlebitis in the left upper thigh at the site of a large varicosity. Was treated with high dose NSAIDS Aleve 2 bid for 5 days and on follow up visit, the clot was confirmed to have spread to a more proximal superficial vein. Eliquis 5 mg bid was started and continued for 2 weeks. No further progression was noted and I underwent a surgical procedure for left saphenous vein ligation and removal of the affected veins.
bulging on her side; pain/It hurts; symptoms of acute pancreatitis; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 62-year-old. Lot number was EN3318, expiration date 31Mar2021. Relevant medical history and concurrent conditions included ongoing Primary immunodeficiency syndrome, ongoing lupus, ongoing Type 2 diabetes since 2001, sleep disorder. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation (lot number was lot number EJ1686 or EJL1686). Past drug history included HIZENTRA for Immune system disorder (for years). Concomitant medications included ongoing sitagliptin phosphate (JANUVIA) for Type 2 diabetes, ciprofloxacin, trazodone and alprazolam for sleep disorder, methocarbamol as muscle relaxant. On 06Feb2021, the patient experienced symptoms of acute pancreatitis. The patient has spoken to a Doctor and a Nurse practitioner. The patient refused to go to the hospital. She was drinking an incredible amount of fluids, and she was taking stuff for pain. The patient took Tramadol too, but it did not do anything; it did not ease any pain; she did not seem to respond to it. The patient was bulging on her side, it hurt. The patient did not recover from acute pancreatitis, the outcome of other events was unknown.
Pt got Adacel shot 9/25/14 @ 6PM - Friday PM restless while sleeping - had a big red mark 2 in below injection site. It hurt and got worse w/pain radiating to head and neck and tissue swelling. She felt sick and went to ER. Diagnosed with cellulitis and given antibiotics/pain med. MD couldn't say for sure what caused it.
around 1AM mom reported pt fussy w/t106;APAP & cool baths cont through the noc;
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and concurrent condition were not reported. On unknown dates the patients received improperly stored oral, ROTATEQ (dose, frequency and route were unknown, lot# K016263, expiration date 26-JUN-2016; lot# K012432, expiration date 20-MAY-2016). No concomitant medication was reported. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
she is tired with no energy; feeling so exhausted/feeling tired all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and administration date 26Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "she is tired with no energy"; FATIGUE (non-serious), outcome "unknown", described as "feeling so exhausted/feeling tired all the time".  Additional information: It was reported that Caller has received both doses of Comirnaty and wanted to know if it is necessary to receive the booster dose. Caller stated lately she has been feeling so exhausted, feeling tired all the time. She mentioned she took the flu shot and repeated she is tired with no energy. Caller asked if this is a bad sign or is this a norm. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with difficulty breathing around 10-12 days after second dose of vaccine .   2 days later in the ER,  patient found to have definative segmental and subsegmental pulmonary emboli in the left lower lobe.  Treated with admission, heparin drip, anticoagulation.
Developed a lesion at the site of the injection.  Lesion was removed and sent for pathology.  Pathology shows squamous cell carcinoma.
Information has been received from a health professional concerning an adult patient who was vaccinated with MMR II as a child and had a negative titer in the Fall of 2007. The patient was vaccinated subcutaneously with a 0.5 ml booster dose of MMR II (Wistar RA 27/3 0.5 ml in the fall of 2007. A titer was redrawn in December 2007, and the patient remained negative for rubella. No additional information is available.
48 hrs after the vaccine the site became red itchy swollen with scattered hives around the site & on trunk.
Patient states she has left shoulder pain that started right after receiving the flu vaccine on 10/17/22 and this pain has persisted.  Patient is seeing Dr. (phsyical medicine and rehabilitation) who has diagnosed her with SIRVA.
This spontaneous report was received from the patient's mother and refers to a 21 year old female patient with sulfa allergy. The patient did not have any pertinent medical history and did not take any concomitant medications. In 2007 (reported as "sometime in 2007"), the patient received the 3 dose regimen of GARDASIL (dose, route of administration, lot # and expiration date were not reported) (exact dates were not specified). On an unknown date in June 2014 (reported as "sometime in June 2014"), the patient experienced fever, blood clots in her hand, as well as aches in her body. On 15-AUG-2014, the patient was admitted to the hospital (duration of stay not specified) with swollen feet, a rash on her lips and sores on her body. The patient was treated with antibiotics as well as PERCOCET and two weeks later the patient was not getting any better. On unknown dates, the patient experienced heart attack, stroke, brain bleed and lost sight in both eyes. She also suffered from anxiety and wore a heart monitor (exact dates were not specified). The patient was also taking medication for an unspecified autoimmune disease, as well as, she was taking physical and occupational therapy. The patient's outcome at the time of the report was reported as not recovered. Relatedness between all of the events and GARDASIL was not reported. Upon internal review the events of heart attack, stroke, brain bleed, loss of sight in both eyes and insertion of heart monitor were considered to be medically significant. Additional information has been requested.
Body ache; Pain at injection site; Chills; Fever; Headache; SOB; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (SOB), MYALGIA (Body ache), VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive in August 2020.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DYSPNOEA (SOB), VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 26-Jan-2021, the patient experienced MYALGIA (Body ache). On 28-Jan-2021, VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 02-Feb-2021, MYALGIA (Body ache) had resolved. At the time of the report, DYSPNOEA (SOB) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
the following morning my neck was stiff and sore and the injection site. My lymph glad was swollen so I had difficulty turning my head. three days after the injection my lymph glad still swollen, and my feet started swelling. This is day 10 post injection. my lymph glad still enlarged, my neck still sore, although less, and my feet are swelliing yet.
Pt gained 53 pounds in 4 weeks, tired, exhausted. sleeps 12-14 hours, has foamy urine, went to MD and urine tests show high protein in urine 9000-10,000 referred to kidney specialist for biopsy. Prescribed PREDNISONE, ZANTAC, H2O pill, K+, BP meds.
Day 1 - Immediate small hives all over body for 1 hour, flush, fever, shaking, nausea, then hives lef. Day 1 evening - Fever 103, blurry eyes, severe headache, swollen tongue, severe pain all over, all major surgery sites spasming, vomit and diarrhea  , hard to breath and blackout. Day 2 - Fever, eyes blurry, Blood pressure spike, headache severe, tongue swollen, severe hives, vomit, and diarrhea, cannot move body, pain increased tenfold Day 3 - Worse than day 2, hives are severe and can barely move body, Blood pressure spike, off to the ER. They admitted me and gave me different combos of steroids, pain killer, lorazepam, etc. to figure out the right combination to keep me steady. Day 4 - evening I was able to go on home care with the correct combination of medication.  If my numbers don't stay steady I would have had to go back.   During the rest of this time - Severe pain throughout body, fever, shortness of breath.  The hives are now just my my skin flushing.  Heat flashes. My fever has just gone down to normal degrees today. My Blood Pressure has gone from 175/111 back and forth to normal. My headache is still there and body pain.  Hives are now just flushed skin.  Swollen Lymph nodes in throat. No more vomit or diarrhea.
Local rxn-red, hot, hard swollen painful-area of inject; duration 21NOV91-24NVO91 dec in sx as time passed;
Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was examined in ER. CT of chest  showed "questionable minimal small airway inflammation in upper lobes".  Patient was discharged from ER home with Methocarbamol 750mg PO Q12 hours as needed.