chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Briefly, 8-year-old female with history as above with headaches now here with 36 hours of painful urticaria and swelling of the knees and arms.  She did get the COVID booster 3 days ago prior to this starting.  No other new exposures.  She has significant pain in her joints and is having difficulty walking.  She has had no fevers.  No difficulty breathing.  No syncope.  She has taken antihistamines however with no significant improvement.            My examination revealed the patient to be active, alert, and in no distress.  Has diffuse urticaria throughout her body which blanches and has some dusky central component to it.  Possible dermatographia some.  No purpura or petechiae.  No vesicles.  The HEENT exam was clear, no conjunctival injection, no ulcerations, the neck was supple, the lungs clear to auscultation, no abnormal cardiac sounds, the abdomen was nontender throughout.  Does have significantly swollen hands and joints of the hand bilaterally as well as left greater than right knee swelling.  Does have some pain with attempted range of motion.  Able to walk but gingerly.            ED course: 8-year-old female with concerns for urticaria and arthralgia/arthritis.  No systemic signs of fever.  Concern for urticaria multiform a or serum sickness-like reaction.  Trigger could be COVID-vaccine.  Other concerns could be acute rheumatoid arthritis.  No other signs of sepsis or other concerns at this time.  We will plan on labs, symptomatic management with antihistamines and NSAIDs with close reassessment and if not improving may consider consultation with rheumatology or dermatology.           12/27/2022:  Labs with mild leukocytosis and elevated CRP, normal ESR. Patient developed low-grade fever in ED Rheumatology team consulted, recommended naproxen and PCP f/u. Patient tachycardic and hypotensive in setting of fever, given fluid bolus with improvement in HR but no change in BP. Question post-vaccine hyperinflammatory syndrome vs. serum sickness like reaction vs. urticaria multiforme.  On assumption of care the patient had tachycardia and hypotension with fever. The hypotension had improved modestly after 20ml/kg NS. Our differential was serum sickness or urticaria multiforme though a more rare vasculitis was possible, as was a COVID vaccine reaction eg myocarditis. Less likely but possible are sepsis (fever, tachycardia, hypotension) which is less likely because it would not explain the urticaria and the patient does not have specific sepsis risk factors; and anaphylaxis which is unlikely because there is no clear trigger and the cardiovascular involvement of anaphylaxis would be unlikely to appear 2 days into the illness.   To investigate these possibilities, we obtained a bedside cardiac US (with normal function/no effusion), additional labs which showed ketosis but no signs of myocarditis. Given ongoing persistent tachycardia we admitted the patient for observation and rheum consultation. The patient was stable at the time of transfer.
Slight nausea, muscle aches, slight headache, tiredness.  All started around same time. No treatment except rest.
While in recovery pt complained of dizziness, weakness, became pale, near syncoable  episode. + nausea , no vomitting. Wheeled to recovery booth. no LOC, no SOB. VS 138/88, HR 74 strong reg, resp 18 regular non labored, SpO2 99%.  Left deltoid site benign - redness, - swelling. reported 1st done went well no side effects. Pt Stated , "I was very anxious getting the 2nd vaccine with my recent diagnosis of heart issues".  Monitored 30 min, gave water for hydration, husband at side. Provided reassurance. After 10 min felt much better color to face, no reports of further dizziness. After 30 min Ok'd to exit with husband.
On September 20, 2022, my husband received the vaccine. Then on September 22,2022 he tested positive for COVID-19 (at home test). Friday September 23, I tested positive myself. I did call his neurologist that he was COVID-19 positive. Patient didn't have any real obvious symptoms because with him having MS he naturally has fatigue no runny nose, no coughing, or fever. On September 24, 2022, a little after 4 PM he had cardiac arrest we then called the ambulance and while waiting I performed CPR. The medics arrived and removed me from the room and continued CPR and started using the defibrillation Advanced care for ventricular fibrillation. Patient had slow breathing and weak pulse and was taken to the hospital. All the way until Oct 19, he remained in the care of the hospital. Unsure if this was caused by the vaccine or the positive test but patients' doctors believe he may have always had a weak heart that was undetected and that the vaccine or the COVD-19 made it worse. He now has a ICD implant and now takes heart medication.
BODY ACHES; CHILLS; FATIGUE; INJECTION SITE PAIN; NAUSEA; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from injection site pain, chills, and body aches, and the outcome of nausea was not reported. This report was non-serious.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 04-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
On Sunday 03/07/2002 pt developed fever for 2 days. She also had rash on face, then to abdominal area, legs, and arms. The rash progressed to roof of mouth with itching. On Wednesday, ears started to itch down inside. On 03/21/2002 face, eyes, and lips started to swell. On that day, the pt was advised to see a physician and the physician informed the pt that she had a viral illness besides MMR reaction. It was noted that on 03/24/2002 the pt was still sick and ill. Pt's mother states that the pt got very sick  after pt received MMR vaccination.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Per Dr.'s notes: He was admitted with right upper extremity as well as left preseptal cellulitis.  He started on IV clindamycin as well as p.o. cefdinir.  Wound cultures obtained growing staph aureus with penicillin resistance. Of note he had elevated blood pressures while in the hospital.  He was subsequently started on Norvasc which was titrated up to 10 mg.
Patient called 3 days after vaccination c/o injection site swelling, red, muscles ache, and headache. Generally not feeling well.
uncontrolled chills (6 hours); fever (8 hours); headaches (8 hours); overall body soreness (2 days ongoing); fatigue (2 days ongoing); loss of taste/smell (4 hours)
no symptoms; a patient was administered improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 13-APR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (lot# S028926, expiration date 16-SEP-2021) (exact dose and site of administration were not reported) reconstituted with properly stored diluent for prophylaxis. The administered vaccine was stored in temperature of 10.4 Fahrenheit degrees for 1 hour and 32 minutes. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms.
The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022; administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient had received first booster.  Pharmacist reported that they administered 7 doses of the COVID-19 vaccine that had been stored in the refrigerator for more than 30 days. The vaccine was initially stored in the refrigerator on 15-Jun-2022 and administered on two dates 3 doses on 19-Jul-2022 and 4 doses on 20-Jul-2022.  Treatment details were not reported by the reporter.
Minutes after vaccination symptoms reported were "hot, dizzy, clammy". Denied difficulty breathing, did not lose consciousness. Sitting when symptoms occurred. Reports ate lunch, drank water today. Given juice in office. Left with mother. Denied above symptoms. To seek care for further or similar symptoms.
Patient feels fine.   Patient came to pharmacy and requested 2nd shingrix. She was accidently given a pfizer covid shot instead. She had already had a J&J shot as her primary as well as 2 doses of Moderna as 2 boosters. She reported no adverse effects and got her 2nd shingrix 6 days later at another pharmacy.
Vertigo; Left arm at shot site turned pinkish for about 4 inch area with itching; Left arm at shot site turned tomato red and itched about  one week aftr first shot; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo), VACCINATION SITE PRURITUS (Left arm at shot site turned pinkish for about 4 inch area with itching) and VACCINATION SITE ERYTHEMA (Left arm at shot site turned tomato red and itched about  one week aftr first shot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     No medical history and laboratory data are provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 81), FOLIC ACID and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm at shot site turned pinkish for about 4 inch area with itching) and VACCINATION SITE ERYTHEMA (Left arm at shot site turned tomato red and itched about  one week aftr first shot). On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo), VACCINATION SITE PRURITUS (Left arm at shot site turned pinkish for about 4 inch area with itching) and VACCINATION SITE ERYTHEMA (Left arm at shot site turned tomato red and itched about  one week aftr first shot) had resolved.            No treatment medications were reported.  No acute illnesses at the time of vaccination and up to one month before.   This case was linked to MOD-2021-059663 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received- on 15 JUL 2021: event outcome was updated.
Information has been received from a physician concerning a 7 year old male who on 29-NOV-1999 was vaccinated with a 0.5 ml SC dose of Varivax. On 06-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning a 63 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # 667274/0883Z, route and injection site not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
Pain, redness, soreness at site lasted about 5-6 days, redness was about 4? by 5? Fever up to 100.7. Lasted about 2-3 days. Chills about 4-5 days. Headache about 4 days. Muscle aches about 4 days.  Stomach pain evening after the injection. Nausea, diarrhea about 2 1/2 days after the injection lasted less than one day. Fatigue, continues after two weeks but not as severe.
Hours later after the injection I had extreme diarrhea and my arm and fingers was sore. The symptoms got worse and I started to use a Ice pack but that didn't work. I went to the doctor on 3/7 and it was nothing he can do but told me to monitor it. Numbness is now going down after about a week but still a on going issue along with the slime like diarrhea.
Chest pain, headache, shortness of breath. Now with convulsive movements and periods of unresponsiveness. Work up for seizures and encephalopathy in progress. Dx studies: troponin, BNP, EKG, chest CT, head CT (all negative), CRP (elevated). Currently in Pediatric ICU and work up in progress (6/7)
Patient came back to the pharmacy about an hour after her injection. She reported that she was feeling itchy and she started getting red blotches/hives/rash on  her chest, neck, upper arms, and back. She had no signs of shortness of breath, tightness in chest, or difficulty breathing.  Patient had Benadryl at home so she stated that she was going to go home and take some Benadryl.
body and muscle was very tensed-made it hard to get up in the morning; metallic taste in her mouth; wicked chills; Light headedness; inside of her mouth became dry; dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth; inside of cheeks were peeling; tongue was tingling; lips got dry; body aches; sweating profusely; HR elevated to 100bpm; BP dropped to 90/77 mmHg,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling) and PARAESTHESIA ORAL (tongue was tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,) and CHILLS (wicked chills). On an unknown date, the patient experienced MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning) and DYSGEUSIA (metallic taste in her mouth). At the time of the report, DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,), MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning), DYSGEUSIA (metallic taste in her mouth) and CHILLS (wicked chills) outcome was unknown. Unknown          Concomitant information was not provided. Treatment information was not provided.  patient had partial pressure of oxygen ( blood O2) as 99% and treated with Tylenol and Ibuprofen.   Reporter did not allow further contact
Information has been received from a 16 year old female patient with no drug reactions/allergies, who on 09-DEC-2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  On 15-DEC-2008 the patient experienced joint pain, swelling fatigue and pain in her legs.  The patient spoke to the physician,  At the time of reporting, the patient had not recovered.  Additional information has been requested.2/5/09-records received-12/9/08 received 1st Gardasil injection in left deltoid. No C/O illness or fever. Parent on 12/23/08 stated child might have mono.2/4/09 called MD office C/O possible reaction to vaccine, seen by pediatrician with C/O joint pain, fatigue, pain and swelling of legs.
About 12 minutes after my injection my head and neck started tingling. I alerted the staff at the site. They checked my blood pressure. It was 160/110.  I was taken to lie down on a cot. My blood pressure was checked three more times at the site. The lowest it went was 147/97.  I was allowed to leave so I went home . I was waiting for the tingling head and pounding heart to go away. It stayed so a few days later I went to the emergency room as I thought I was having a heart attack. The paramedics checked my bp and it was still 160/108.  At the emergency room I was given nitroglycerin. After about 6 hours my blood pressure came down to 147/90. I was discharged , prescribed omeprazole,  and told to follow up with cardiologist.  I went to cardiologist. My blood pressure was 164/98 in left arm and 148/102 in right arm. He scheduled tests but gave me no medication.  The next day I still felt really bad so I called  my primary and he prescribed blood pressure pills. They brought my blood pressure back under control.  Ramparil 2.5 mg
On 12/16/13, the mother reported that days after each of the three HPV vaccines on 1/29/13, 4/2/13 and 7/31/13, the patient developed crying, school refusal and anxiety that lasted several weeks. After the dose # 1, patient presented to office on 2/19/13 reporting onset of crying 2/14/13. He was referred to behavioral health specialist and diagnoses with anxiety and depressive disorder.
starting slowly on the day of the injection and then more severely on the morning after the injection; i experienced severe, sometimes debilitating joint pain on days #2 and #3. It was so bad that i had trouble walking, On day #4 it went away.
High fever 1.5 days, horse throat 3 days, tenderness around thumb joints/finger. Have caught 2 colds this year - normally once a year more than normally. Coughing more than normally.
Information has been received from a physician concerning a patient who was vaccinated with a 2 ml PO dose of ROTATEQ. Subsequently, the patient developed diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered from diarrhea after a couple of days. There was no product quality complaint involved. Additional information has been requested.
SWELLING AT INJECTION SITE - 6 CM BY 6CM, RASH COMES AND GOES ON ARMS, TINGLING IN FINGERS
VEIN IN LEFT LEG/SPIDER VEIN; TINGLING IN LEG; LOW IMMUNITY/ANTIBODIES AGAINST COVID-19; LUMPS IN LEFT LEG THAT POP OUT IN CALF/ANKLE; SWELLING IN THE ANKLE AND CALF; INFLAMMATION; DIZZY; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: tumor on meninges/benign brain tumor, leg pain, tinnitus, and anxiety, and concurrent conditions included: prediabetic, sciatica, loss of taste, and neurological problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination.  On AUG-2021, the patient experienced dizzy. On NOV-2021, the patient experienced lumps in left leg that pop out in calf/ankle, swelling in the ankle and calf, and inflammation. On DEC-2021, the patient experienced low immunity/antibodies against covid-19. Laboratory data included: Blood test (NR: not provided) low immunity. On an unspecified date, the patient experienced vein in left leg/spider vein, and tingling in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lumps in left leg that pop out in calf/ankle, swelling in the ankle and calf, and inflammation on JAN-2022, had not recovered from low immunity/antibodies against covid-19, and the outcome of dizzy, tingling in leg and vein in left leg/spider vein was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000210916. The suspected product quality complaint has been confirmed to be this record indicates medical adverse events for the patient. while the patient reported "low immunity" this report does not state the patient has no antibodies or that the vaccine did not work and does not meet the criteria for lack of efficacy. based on the PQC evaluation/investigation performed.