chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WOBBLY/SHAKY LEGS; DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included knee replacement, hip replacement, dizziness and concurrent conditions included arthritis, heart problem, broken leg, allergic to vancomycine, allergic to penicillin, and allergic to sulfas. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. Concomitant medications included vitamins nos for drug used for unknown indication and atenolol for heart problems.  On 24-MAR-2021, the subject experienced nausea. On 28-MAR-2021, the subject experienced wobbly/shaky legs. On 28-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 24-MAR-2021, and had not recovered from wobbly/shaky legs, and dizziness. This report was non-serious.
. Prior to vaccination client stated she was nervous and anxious. Client was placed in the anti-gravity chair while vaccine was administered. Client sat in chair for the remainder of the observation. At 233pm client was asked if she was feeling well and stated she felt lightheaded. Client was able to answer all questions, and when asked  if she usually gets lightheaded and anxious during a vaccine she answered, ?Yes?. Client confirmed she was able to swallow. Client denied shortness of breath, or any difficulty breathing. A juice carton was given. Client was drinking with no problem. Skin color was normal for ethnicity no paleness observed Fingers were cool to touch. Vital signs were taken 1441 BP  110/70 RR 18 HR 88. Client was observed for30mins.  Vital signs at 1446 taken BP 112/70 HR 81 RR 19. At 1451 client was asked how she was feeling and client states she felt weak and lightheaded. Client was drinking her juice in between vital sign check. 1451 BP 109/70 HR 80 RR 18. Vitals were stable. Last set of vitals taken at 1507 BP 108/69 HR 78 RR19. Client completed her additional observation and at 1510 client was assessed and was asked and client stated she felt better, and denied feeling lightheaded or any weakness. Client stated she had a mild headache, 2/10 pain scale. She also stated she has history of migraines. Client was ready to board bus. Emergency precautions were given to client as well as client?s brother, and chaperone. Emergency Precautions were given by to seek emergency care if symptoms worsen or experiences SOB, or difficulty breathing, and/or hives. She was instructed to see her primary care provider in 24hrs. Client, brother and Chaperone verbalized understanding. Client left observation area at 3:17pm in a steady gait accompanied by brother.
3 hours after vaccine woke from nap very irritable - lasted at least 2 hours at which point she was seen in office & given MOTRIN.
went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Postmenopause.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POSTMENOPAUSAL HAEMORRHAGE (went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication was not reported.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Headaches, muscle pain, chills, night sweats, joint pain, fever, swollen lymph nodes in neck and armpit left arm
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccine on 02/11/21, 3/11/21 and 10/27/21. Presented to ED c/o constipation. Admitted for colonic stricture and hypertensive urgency, Covid+ 2/1. Underwent colonoscopy 02/04/2022 w/evidence of a sigmoid mass, bx + adenocarcinoma. 2/5/22 laparoscopic converted to open sigmoidectomy w/resection of mass. Path report  Stage IIIB adenocarcinoma. Postop c/b severe Covid PNA, deteriorated in subsequent days required high flow O2.  Cardiopulmonary arrest 2/11/22 CPR, intubated, became more bradycardic and hypotensive. Transitioned to comfort care. Treated with decadron, remdesivir, and zosyn. Expired on 2/11/22. underwent CPR, intubated, then became more bradycardic and hypotensive. Pt was transitioned to comfort care. Treated with decadron, remdesivir, and zosyn. Pt expired on 2/11/22.
Have been keeping track of my body and symptoms/Is there someone I can send some details to?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?). At the time of the report, VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Wednesday afternoon, real tired, headache, body aches and chills. Thursday, I was okay. I felt fine and went to work but in the afternoon, I started not feeling too well and my arm was hurting where the injection was and it was very swollen. Friday, 9th,- I went to Urgent Care - the physician assistant said the injection was given too low in the arm. It wasn't in the muscle. It created a rash and cellulitis. I had a big bump on my arm. She told me to wait and see. Friday afternoon I experienced diarrhea and  had that through Monday. Treated it with Imodium on Friday night - (two doses) and one dose on Saturday. On Sunday, I didn't take any. On Monday, I did take one dose of Imodium. From Friday through Sunday I was real sick and couldn't go anywhere and stayed in bed. I couldn't even do a telephone video Dr. visit because I was sick. I went to a different Urgent Care on Monday. He said the injection was a fail. It should have been up in my arm muscle and it was too low in the arm. He said it looked like it might be infected. He prescribed something but said I could wait a day or two first to see if it went away.  I waited for two days first before starting the prescription and I started using the prescription on Wednesday the 14th. My arm is starting to feel a little better today but it's itchy around the bump. He also  said that my diarrhea might have been from a flu virus - he didn't know if it was from the vaccine. The diarrhea went away on Monday, the 12th, if the afternoon.  (Note - They ran out of the vaccine and a new dose of the vaccine was needed to be obtained from Walgreens while I was waiting in line. - when the new batch came they said that this new dose was the same lot number. But Just wanted to note this in case the lot number was different with this batch.)
Painful shots; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that, he/she had shingles vaccine some time ago. Painful shots but well worth it. Additional supportive information: Follow-up would not possible as no contact details were available.
Left arm red and swollen from shoulder to elbow. Talked with her provider and gave client Tylenol and applied heat for 2 days. School nurse observed on 10/24 and was still sl red and swollen she applied cool packs and stated looked improved by end of day.
This spontaneous report as received from a licensed practical nurse refers to her 12 month old son with no pertinent medical history and with no drug reactions or allergies. On 24-JUL-2013 the patient was vaccinated with the first dose of VARIVAX (Merck) (Lot# H020671, exp. 14-NOV-2014, dose and route not reported). There was no concomitant medication. On 30-JUL-2013 the patient experienced chicken pox after receiving VARIVAX (Merck). The patient visited office for medical attention. TYLENOL was given for treatment. No lab diagnostics studies were performed. At the time of this report the patient was recovering from chicken pox. Additional information has been requested.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 27-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection, lot # M042498 with expiration date 17-APR-2018, therapy type: human recombinant albumin (RHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 15 minutes and to 27 degrees Celsius for 30 minutes. There was no previous excursion. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA013407: US-009507513-1710USA013406: US-009507513-1710USA007631:
Temperature of the fridge used to store the vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Hives, extremely itchy, red and bumpy skin, worse at night, almost like chicken-pox
Information has been received from a lawyer regarding a case in litigation a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-DEC-2015, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On 24-DEC-2015, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Initial and follow-up information has been received through the Merck pregnancy registry through a physician concerning a 17 year old female with a reoccurrence of sinusitis headaches who on 24-MAY-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 654535/0960F).  On 24-MAY-2007, the patient was also vaccinated with MENACTRA.  On 24-JUL-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 654535/0960F).  On 22-OCT-2007, the patient had a urine pregnancy test which was positive and on an unspecified date the patient had an ultrasound.  The date of the patient's last menstrual period was 28-JUL-2007 (also reported as 04-AUG-2007).  The patient sought unspecified medical attention in the office.  The estimated date of delivery is 03-MAY-2008.  Follow-up information was received from the physician via telephone on 20-JUN-2008.  The patient delivered a healthy and normal, full-term male, "with no physical anomalies".  The baby did develop transient hyper-bilirubinemia after birth and was transferred to another hospital where the baby was successfully treated and discharged after 3 days.  The physician reported "he's absolutely fine".  Upon internal review transient hyper-bilirubinemia required hospitalization for the baby.  Additional information is not expected.
diarrhea several times a day; Sleepy lot; Hiccough; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea several times a day), SOMNOLENCE (Sleepy lot), HICCUPS (Hiccough) and FATIGUE (feeling tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced DIARRHOEA (diarrhea several times a day), SOMNOLENCE (Sleepy lot), HICCUPS (Hiccough) and FATIGUE (feeling tired). At the time of the report, DIARRHOEA (diarrhea several times a day), SOMNOLENCE (Sleepy lot), HICCUPS (Hiccough) and FATIGUE (feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment information provided.
THERE IS NO ADVERSE EVENT BUT THIS IS CONSIDERED A VACCINE ADMINISTRATION ERROR DUE TO THE LACK OF INFORMATION GIVEN TO US WHEN THE DOSING CHANGED WITH THE REMOVAL OF THE MONOVALENT VACCINE. WE DID NOT RECEIVE ANY UPDATED DOSING INSTRUCTIONS UNTIL THIS WEEK WHICH DID NOT GIVE CLEAR OR APPARENT DIRECTIONS INVOLVING CHANGE IN VIALS AND AGE INDICATIONS. THERE SHOULD HAVE BEEN A COMPLETE HALT IN VACCINATING UNTIL CLEAR AND CONCISE INSTRUCTIONS WERE MADE AVAILABLE TO THE HEALTHCARE INDUSTRY. CLEAR AND CONCISE DOES NOT MEAN SIFTING THROUGH 72 PAGES AND CLICKING ON MULTIPLE LINKS TO FIND THE NEEDLE IN THE HAYSTACK.  NOW WE HAVE A VACCINATION ERROR DUE TO THE LACK OF INFORMATION FROM THOSE IN CHARGE WHO DROPPED THE BALL. WE TAKE NO FAULT IN THIS ERROR. THIS PATIENT SHOULD HAVE RECEIVED THE BLUE CAP GRAY LABEL BIVALENT BUT RECEIVED THE YELLOW LABEL PINK TOP BIVALENT. (WHO USES THESE DESCRIPTIONS TO CLEARLY INSTRUCT PEOPLE ON WHAT TO DO?) THIS IS UNSAFE AND UNCLEAR. YOU ALSO ASSUME THAT WE HAVE KNOWLEDGE OF ALL THE VIALS AND DIFFERENT FORMULATIONS OUT THERE WHEN WE DON'T. YOU TOTALLY DROPPED THE BALL AND THIS ERROR RESTS ON THOSE WHO MAKE THE RULES AND INSTRUCTIONS.
Blood pressure was all over the place going from low 81/56 to 210/101. It was jumping everywhere. Also blood sugar was doing same thing going really 280 and then really low 56. Was really dizzy and extremely  bad headache so bad could feel my heart in my head and it would have burning sensation.
On Friday May 27th I started to feel a little under the weather. On Saturday May 28th I woke up with a fever of 102. I tested myself for covid-19 with a home test which was positive. I called to find out how I could get some antivirals, because it felt like I was getting bad fast. They told me to go to the emergency room. So I went to hospital emergency room, and the doctor gave me paxlovid.  I took paxlovid for 5 days. For the first few days after testing positive for covid-19 I had trouble controlling my fever even with Tylenol and Advil. On day 4 of Paxlovid I started to feel like I was coming out of it.
Information has been received from a physician concerning a 19 year old female who in early May 2001 was vaccinated with the first dose of varicella virus vaccine live. The physician reported that two weeks later, the patient developed a 20 to 30 varicella lesions scattered on her body and adenopathy, but was not ill. The physician reported that the condition has resolved. Unspecified medical attention was sought. Additional information has been requested.
Headache, Fever, weakness Narrative:  missed work following the second dose due to symptoms
inadvertently administered DAPTACEL to a 64 year old patient instead of Tdap  with no adverse event.; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old and unknown gender patient to whom inadvertently administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of tdap with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was inadvertently administered  a  dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (dose, frequency, batch lot number, expiry date: not reported) via unknown route in unknown administration site for Immunization instead of tdap (wrong product administered) (unknown latency).  Action taken : not applicable.   At time of reporting, the outcome was Unknown for the event inadvertently administered daptacel to a 64 year old patient instead of tdap.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
tiredness/fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness/fatigue) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history is reported.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Apr-2021, the patient experienced FATIGUE (tiredness/fatigue). On 09-Apr-2021, FATIGUE (tiredness/fatigue) had resolved. On 10-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.            Treatment information was not provided, for first dose.   This case was linked to MOD-2021-132189 (Patient Link).
Redness, edema, and warm skin b/L arms at injection sites.  Left arm > right arm.  Patient instructed to take Tylenol and apply warm compress.  Also, go to ER if s/s worsen.
Extreme muscle soreness in left arm; large welt, itching and burning around injection site starting the day after injection and lasting approx. 8 days; treated with ice packs and pain reliever. 16 days following injection, left arm is still painful to the touch with redness at injection site. Fatigue for one week following vaccine.
As part of my annual physical, I was administered a Shingrix vaccination. Forty-eight hours after the Shingrix injection, I developed a very painful rash (with blisters) on all sides of my left thigh. The next day I saw my doctor and he concluded that it was indeed a case of Shingles. I was prescribed 10mg of prednisone (on a declining daily dosage) and one gram of valacyclovir three times a day. While the rash and blisters have started to heal, I still have the same degree of pain and hypersersensitivity.
Didn't sleep all night. At 07:00 AM on 10/07/2012 had flu symptoms without fever: sneezing, lethargic, coughing, and aching body. No treatment. Couldn't sleep until 11:30 PM on 10/07/2014.
1530:  Localized erythema bilaterally at injection sites, irritability. IZ's given at ~11am, slept about 1 hour, took 6 oz & for part 45 minutes difficulty consoling, crying. Mom states legs seem tender.
nausea; vomiting; diarrhea; poorly timed stomach bug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 13:30 (Lot number: EN6205) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Diagnosed at least 15 years ago; "allergies" (ongoing). Concomitant medication(s) included: PROAIR HFA taken for asthma (ongoing); ALLEGRA taken for hypersensitivity, start date: Jan2021 (ongoing). The following information was reported: NAUSEA (non-serious) with onset 03Mar2021 05:15, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 03Mar2021 05:15, outcome "recovered" (03Mar2021 11:30), described as "vomiting"; DIARRHOEA (non-serious) with onset 03Mar2021 05:15, outcome "not recovered", described as "diarrhea"; GASTRIC DISORDER (non-serious) with onset 03Mar2021 05:15, outcome "not recovered", described as "poorly timed stomach bug".  Additional information: Patient received other unspecified concomitant medications (reported as other products). The patient did not receive any other vaccines on same date of the Pfizer Suspect. It was also reported that some of the symptoms had stopped such as vomiting (vomited twice) but nausea and diarrhea continued. Patient was trying to understand if this was a result of the shot or a poorly timed stomach bug. All events did not result to physician or emergency room visit.  No follow-up attempts are possible. No further information is expected.
Patient presented to hospital on 4/9 with worsening dyspnea on exertion and fatigue and brown colored urine. Patient was diagnosed by hematology service with warm autoimmune hemolytic anemia (Evan's disease).  It was refractory to high dose steroids, rituximab, cyclophosphamide and required splenectomy.  He has required multiple blood transfusions.
The main symptom was upper abdominal pain, mostly on right side and slightly on left side and center. Loose stools. The symptoms were not constant. They came and went but were consistent.
Severe chills and shaking Nausea Fatigue Unable to sleep Headache Mild cognitive impact: confusion
Patient experienced soreness at injection site, numbness in hands and feet, and itching throughout body, especially the hands and feet. Patient initiated therapy with diphenhydramine 50 mg  tablet shortly after symptoms occurred the night of March 30, 2021 and then on March 31, 2021, the patient was instructed by her physician to take one diphenhydramine 25 mg tablet every 8 hours until symptoms resolved. The patient reported that this therapy helped with her symptoms.