chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme Pain in both upper arms (elbow to shoulder) started just a few hours ago. It?s incredibly harsh, I am taking 600-900mg of Ibuprofen. I do not know if it is a possible tension from working at home and at a computer but I have only had that pain in my hands and lower arm and upper arm pain is new to me.
FEVER , CHILLS, BODY ACHES, MILD SWELLING AND REDDNESS AT INJECTION SITE.
Patient reports having a small area after recieving the vaccine. States noticed her arm had more redness yesterday evening with some pain radiating up the arm to her neck, also c/o headache. Area appears to be around 3 inches diameter, raised, and red. Advised patient to take Benadryl as directed until reaction subsides. Also to alternate warm and cold compress as needed. Advised patient if area worsens to seek medical care.
10 mins after shot-was paying, felt dizzy and passed out. Was pale-color improved then became pale again. Pt not awaking for few seconds with 1-2 jerk. Heart rate OK then color improved.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Additional Details: Patient complains of tenderness at injection site as well as itching. She also complains of a knot in her shoulder at the injection site.
Around time of first vaccination, pt reported heart burn, belching. Approx 2 weeks after 2nd vaccine, pt reported difficulty breathing and had doctors visit and was placed on oxygen. Pt now oxygen dependent. Pt did not require supplemental oxygen prior to covid vaccination.
First dose (12/30/20): Vivid dreams and frequent nocturnal awakenings upon receiving the first dose. Experienced tiredness the next day, unsure of whether it was the vaccine or lack of sleep. Second dose (1/19/21): Awakened every hour to1.5 hours that night with markedly vivid dreams in between awakenings. Upon trying to take a nap, the same situation occurred, with a vivid dream and awakening within 1.5 hours.  I have had vivid dreams in the past, but not with that frequency before. The dreams and difficulty sleeping improved the next night and had resolved within 24 hours.
This spontaneous report was received from a consumer regarding her 60 year old husband with no drug reactions or allergies. The patient's medical history included atrial fibrillation. On 22-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and route were not provided, lot number was reported as L000448, expiration date 08-MAR-2016). Concomitant therapies included COUMADIN and unspecified cardiac medication. On 23-MAY-2015, the patient developed weakness, difficulty breathing, wheezing and elevated heart rate. The patient sought medication attention, he was evaluated by his unspecified physician on 26-MAY-2015. A chest X-ray was performed but the results were not available. The patient was prescribed unspecified oral steroid medications. At the time of the report, the patient was recovering from the adverse event. Additional information has been requested.
Vaccine was given outside of the Beyond Use date. The vaccine was to be used by 7-19-2021, and was given on 7-20-2021
sinus problems; headache; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), SINUSITIS (sinus problems) and HEADACHE (headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 10-May-2021, the patient experienced SINUSITIS (sinus problems) and HEADACHE (headache). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at a dose of 1 dosage form. On 23-Apr-2021, PAIN IN EXTREMITY (sore right arm) had resolved. On 13-May-2021, SINUSITIS (sinus problems) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter.   This case was linked to MOD21-105978, MOD-2021-200945 (Patient Link).
SC fullness in both arm (11/09/04) 11/10/04 redness 2x7cm on both arms, minimal periorbital eczema. Mom treated with Benadryl. Resp Rate 28mm. Tx with Zyrtec, Prolex PD, and Steroids added.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II, K010318 22-JUL-2016, K003806 13-MAR-2016, K024036 26-NOV-2016, K010318 22-JUL-2016. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
This is an observational study case, concerning a 30-year-old, adult pregnant female, subject of body mass index: 26.1, weight: 182 lbs and height: 70 in, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with AFLURIA QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject did not have any history of offspring with major congenital malformation. The subject had no maternal/paternal history with major congenital malformations. The father did not receive any medications prior to conception. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 22-Feb-2018. On 18-May-2018, the subject underwent nuchal translucency scan and first trimester screen test performed showed, no major congenital malformations. On 16-Jul-2018, the subject underwent targeted ultrasound which showed no major congenital malformations. On 18-Oct-2018 (34 weeks gestational age), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, expiry date and anatomical location: not reported). On an unspecified date in 2018, the subject developed gestational hypertension and had intrauterine growth retardation (reported as history). The subject's estimated date of delivery was reported as 29-Nov-2018.
Headache, Myalgia, Arthralgia, NauseaVomiting, chills, sweats
Moderate - severe dermatographic uticaria.   Treatments with avoiding allergens, otc antihistamines, and a prescribed 1 week course of oral prednisone (about 1 week after symptoms began)  provide minimal to no relief.  Calamine lotion provides temporary relief from itching.  Began approximately 2 weeks after COVID booster, although I did not connect the two as being possibly related until reading a few case studies that were very similar to my own situation.  I started feeling itchy everywhere, and would break out in hives with scratch marks.  Still break out in itchy hives after contact with sharp objects or rubbing my face, etc, and overall feel an uncomfortable generalized itchiness especially noticeable when trying to sleep.
the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; I had a short episode of disequilibrium; awoken by intense bilateral leg pain; my legs felt weak the following day; This is a spontaneous report from a contactable Physician who reported for herself.  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231)  for COVID-19 immunisation on 07Jan2021 at 15:30 at single dose in Left arm. Medical history included allergy to penicillin , clindamycin, azathioprine (IMURAN) (known allergies: penicillin, clindamycin, Imuran) , allergy to glove powder and autoimmune disorder (unspecified). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, mycophenolate mofetil (CELLCEPT), folic acid and magnesium. On 07Jan2021 at 17:30 , approximately 2 hours after she received the vaccine, she had a short episode of disequilibrium, then an hour after that (at 18.30) the left side of her face felt heavy, stiff and was palpably warmer than the right side of her face. There were no visible changes to the appearance of her face, and she had normal motor control. This episode lasted for approximately 1-2 hours then gradually diminished. In Jan202, approximately 36 hours after the vaccine, patient was awoken by intense bilateral leg pain. The pain gradually diminished after approximately an hour, but her legs felt weak the following day. Legs were fine on 10Jan2021. In the evening of 09Jan2021 though 10Jan2021, the skin overlying the injection site had an intense prickly "itchy" sensation, there was no rash. Events were all non serious. No treatment administered and final outcome for all the events was reported as recovering.
Day 1 - Nauseous/ fever/ extreme HA/ lower back pain. Day 3 - Swelling of all extremities / blood pooling in hands especially. Day 5 - Still swollen slightly with slight HA
Fever, Chills, low appetite, muscle/joint pain, lethargy, migraine headache, dizziness.   Took Tylenol thought-out the day with no relief.   Took one Ibuprofen at night and symptoms subsided and I was able to get sleep.  After sleeping symptoms resolved the next day.
This spontaneous report as received from a physician refers to a 37 years old female patient. The patient current conditions included with type 1 diabetes and asthma. The patient experienced anaphylaxis with TEQUIN. On 20-NOV-2012, the patient was vaccinated with a dose 0.5 milliliter (ml) PNEUMOVAX23 (lot # (672368/1849AA) and Expiry date was 28-JUL-2013)intramuscularly on the left deltoid. Concomitant medications included LANTUS, NOVOLOG, VENTOLIN HFA and PREDNISONE. On 21-NOV-2012, the patient had called the physician and reported that the arm in which she received her dose of PNEUMOVAX23 was swollen, red and painful (disability)which began on 21-NOV-2012 (reported as yesterday). The patient also reported that the event seemed to be worst at the time of this report. The patient sought medical attention (consulted the physician) and the physician advised to use ice, elevation, also to take ibuprofen as needed in addition to cetirizine. The outcome of the reported events was not recovered. Additional information has been requested.
After receiving the second dosage of the Pfizer vaccination my menstrual cycle accelerated from a consistent every three weeks to 3 weeks at a time, with multiple heavy flows during that time, with only a week break in between. From the shot in March through July I had my menstrual period 75% of the time. Because of this I had to have an Ablation to my uterus.
Extreme nausea; Vomiting 2x per day for 5 days following vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to shellfish and peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 13:00, the patient experienced extreme nausea and vomiting 2 times per day for 5 days following the vaccine. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme nausea and vomiting 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.
Patient has had persistent pain in her left shoulder since getting her flu shot. It's getting better but still aches with full extension of the arm.
eye had swelled up; eyelid had swollen and underneath her eyelid, her face was swollen; eyelid had swollen and underneath her eyelid, her face was swollen; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 13Jun2021 (Sunday) as dose number unknown, single (at the age of 60-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jun2021, probably about Tuesday, patient eye swelled up, eyelid had swollen and underneath her eyelid, her face was swollen. Patient talked with her doctor and she just want to see what she needs to do. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (in 2000, left breast and in 2001, right breast). On 8th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 12th June 2018, 35 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the patient experienced product supply issue. The patient was treated with non-drug therapy (Mastectomy). On 18th July 2018, the outcome of the breast cancer was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the breast cancer to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on an unknown arm. The patient's breast cancer returned and she found out because on 12th June 2018, she had a bilateral nuclear magnetic resonance imaging (MRI), sonogram and core biopsy performed. On 18th July 2018, the patient had a bilateral mastectomy and on 31st October 2018, she had another surgery to get permanent breast implants. The patient was on the waiting list with her pharmacy to get the 2nd dose of SHINGRIX so the patient did not receive the 2nd dose of SHINGRIX till the reporting time. The patient required emergency room visit.
Upper arm was bright red and inflamed, patient stated was sore. Advised to go to doctor right away.
"2nd Moderna 2/10/2021  (032L20A) Brain fog in 12hrs. Started experiencing headaches, neck/throat pain, fatigue, lightheaded/dizzy, adrenaline rushes, nauseated, muscle aches, chills/sweats, light sensitivity, intermittent bloody nose, one episode of face numbness, SOB, arm swollen and sore. Sunday late afternoon some symptoms were leaving some continuing. Monday the snow/ice hit. Normally I would walk to work but still feeling, dizzy, SOB, adrenaline rushes, jittery, brain fog and fatigue I didn't feel safe to walk, called out. Went to work Tuesday and Wed still feeling off. It was suggested by my TL to get a Covid shot. I did and went home. I called employee health left a message. Thursday Covid results negative"
About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left side only, started tingling.  My tongue felt fat but didn?t appear fat.  However, I slurred about six words.  Then one tip of finger started tingling.  I had no other symptoms.  I immediately took one child Benadryl  pill (half an adult dose).  I had an epi-pen ready but didn?t need it (I?ve never had anaphylactic reaction before, but my throat has tightened  from malic acid before, so I wanted to be prepared).  I went home and slept rest of afternoon, probably because of the Benadryl.  I had no respiratory issues; no hives; throat did not swell.  Just lip  tingling, ?fat? feeling tongue, and finger tip tingling.
2/5 1:30pm Palpitations(198-201bpm)3-4 hrs, fatigue headache 2/6 fatigue 2/7 fatigue
Nurse from doctor office called and said patient has experienced bilateral hives/rash & pain in arm and bruises in scalp.
This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 71-year-old female patient who received SHINGRIX. The patient's past medical history included biopsy (showed Grover's lichenoid dermatitis). Previously administered products included CHLOR-TRIMETON (did not tolerate BENADRYL). Concurrent medical conditions included rash (a chronic waxing and waning rash), mast cell activation syndrome, dermatitis lichenoid, drug hypersensitivity (allergy to CELEBREX, CIPRO, sulfa) and bee sting. On 7th March 2018, the patient received SHINGRIX. On 7th March 2018, 5 hrs after receiving SHINGRIX, the patient experienced headache and nausea. In March 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site pain, injection site inflammation and emotional distress. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site pain, injection site inflammation and emotional distress were unknown and the outcome of the headache and nausea were recovered/resolved. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site pain, injection site inflammation, headache, nausea and emotional distress to be related to SHINGRIX. Additional details were provided as follows: This information was submitted to afterhours via web form. The patient had bad headache and nausea in evening on the day of vaccination (that were better next morning), and pain and erythema and induration (2 by 4 cm) surrounding the injection site. It looked minor to physician, but the patient found with the inflammation badly painful and very upsetting. The patient was on a number of medications. The patient's tryptase was abnormal, then normalized. The physician suggested the patient to take alternate ice and local heat. The physician saw a historical conditions and local rash were in the label as common adverse effects. The physician considered it minor and unremarkable, but the patient considered it as painful and a problem. The patient wanted to proceed with the 2nd shot, as she was very afraid of developing shingles. The physician advised her to wait the full 6 months, in part for there to be more clinical experience with SHINGRIX. GlaxoSmithKline was yet to speak with healthcare professional. The office was called, but it was closed. Follow up would be done and the report would be updated.
Per TC to HD on 6/3/02, the care-giver stated that child developed redness (L) thigh. 1 week later, developed 2 red swollen areas. 1 week after that, was referred by MD to another facility who had child in hospital 2 days and drained a cyst (abscess) on (L) thigh. MD felt the immunization caused the abscess.  Diagnosed with cellulitis at Medical Center. Annual follow up states unable to contact parent at present house that she lived in has been torn down to make way for the new school. However, the child ant parent were seen leaving store not long ago and parent has made no further contact re incident.
81-year-old male with a history of stage IV renal disease, breast carcinoma status post mastectomy last year, hypertension, diabetes, hyperlipidemia presents to the ED via EMS complaining of general weakness and tiredness.  Patient also had 2 episodes of vomiting prior to arrival to the ED (one time this morning, and one time on the EMS ride).  He denies any abdominal pain, he denies any fever, he denies any chest pain, denies diarrhea or urinary symptoms.  Of note, pt is 3 days post op from left upper extremity AV graft placement.  Denies any pain or excessive bleeding at the site, but site is noted to be bruised appearing.  He had lung infiltrates.  He has been on doxycycline. He was also found to be positive for Covid 19. He was seen by multiple consultant including nephrologist, cardiologist, infectious disease specialist.,  Diabetes management, vascular surgery, Pulmonology.  Due to his comorbidities, he was given bamlanivimab 700, etesevimab 1400 mg monoclonal antibody infusion on 4/29/2021.
entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places; lymph nodes in my throat are swollen; pain; gums all cracked open; feeling like everything was going black; chest pains; pounding headache; intense pain in my right arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 at 17:00 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 at 14:00 (Batch/Lot number was not reported) both as single dose (at the age of 63-year-old) for covid-19 immunisation. Patient was non pregnant at the time of vaccination. Medical history included allergies to codeine, adhesive glues/chemicals. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 01Apr2021 21:00, the patient experienced chest pains, pounding headache, intense pain in my right arm, nausea, entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places, lymph nodes in my throat are swollen, pain, feeling like everything was going black and gums all cracked open. It was reported that, patient initially had chest pains and a pounding headache within about five minutes after receiving the vaccine, along with feeling like everything was going black. After being stabilized, she went home and was okay for about 4-5 hours. When she went to bed, she became incapacitated for the next 40 hours with intense pain in her right arm and nausea. The following day, her entire mouth swelled up to the point where her gums all cracked open, along with the roof of my mouth splitting open in several places. The lymph nodes in her throat were swollen as well. It had now been 6 days and she was still in pain. No treatment was received to treat adverse events. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Patient was administered only half dose (0.25 milliliters) of the recommended (0.5milliliter) moderna bivalent dose. No adverse reactions reported