chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the emergency department complaining of severe muscle cramps after receiving the Moderna Covid-19 vaccine at 8:30 this morning.  Symptoms started around 2:00pm.  Patient states cramping started in her hands and spread to other areas of the body including feet, legs, and neck.  Reports pain feels like a "charley horse."  Patient reports that pain does not feel like typical muscle soreness experienced after other vaccinations.  She report she has been staying well hydrated and did not participate in any strenuous activities.  She has been in her normal state of health and has been participating in her usual daily activities.  Laboratory work-up did not reveal a medical cause for the muscle cramps.  Patient was discharged from the ED with a prescription for methocarbamol.
(R.N.), R.N.    Start Time 3/29/2021  2:56 PM      Filed at 3/29/2021  3:10 PM   Status: Addendum    Late entry:  Patient c/o of tingling and a "weird sensation on lips and tongue approximately 30 post administration of Moderna vaccine #1.  Patient denies any SOB, chest or throat tightness. Vital signs stable.  Patient was taken to Nurse clinic for further assessment.   Dr. was called, report given. 2:50 pm Benadryl 50 mg given IM RUOQper V/O by Dr. Patient tolerated well.  Patient endorsed to RN in stable condition.        Patient is a 33 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - tingling or tongue and lips. Moderna COVID-19 vaccine# 1 in series administered.  o Action(s) taken: Another drug administered - Benadryl 50 mg o Allergy to COVID-19 vaccine documented in Allergies activity: Yes o Patient advised to discuss second dose considerations with a clinician   RN   (R.N.), R.N. at 3/29/2021  3:09 PM  Status: Signed    Pt endorsed to me by  RN at 1510.  Pt recived Benadryl 50mg IM at 1450 for lips and tongue numbness, pt reported she is feeling much better now, reported mild numbness on bottom lip, denies CP, SOB, hives/ itching.  VS stable.   1520 Gave report to Dr., per MD pt can be discharged, if new symptoms develop, go to ED.   1523 Pt given MD message. Moderna fact sheet provided in AVS.  Pt discharged in stabll condition, brother driving her home. Pt has f/u with pcp. Patient verbalizes understanding and agreement with this plan. Advised that we do not diagnose. Given opportunity to ask questions or make comments.    Future Appointments Date Time Provider Department Center 3/30/2021  3:30 PM (P.A.), P.A.   4/15/2021 11:00 AM (M.D.), M.D.  4/26/2021  2:00 PM OVID VACCINE MODERNA   Electronically signed by: RN 3/29/2021 3:30 PM
This spontaneous report as received from a medical assistant refers to a currently 12 month old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is fully vaccinated and boosted on 12/21/2021. 30-year-old female who presents to the emergency department complaining of one week of chest pressure, shortness of breath, dry cough. The patient tested positive for COVID-19 one week ago. She also has subjective fever and chills. Having nausea and diarrhea. Denies leg pain or swelling, denies history of DVT/PE. EKG normal. Ct 1.6. D dimer and troponin normal. CXR: no acute lung process. Vital signs were reviewed and found to be within normal limits. She was given IV fluids, Tylenol, Robaxin, Zofran. Discharged from ED.
bad h/a, unable to attend school given wrong vax booster needed but MMR given;
Left arm SQ- swelling warmth to touch called ER nurse line advise to put ice and give Benadryl or Ibuprofen sx worsened take to ER swelling got as large as grapefruit ER treatment with antibiotics.
Patient collapsed in the morning after the shot. Patient states feeling dizzy, nauseous  and her legs "buckled" spontaneously.
8" circle of redness around inj. site. Warm and itchy. Went to local nurse: told to watch area.
Abdominal pain, vomiting, headache, hypotension, syncope, coma, shock, death at 2:00 pm 03/08/2021
This non-serious medically confirmed report (initial receipt 29-Jan-2015) concerns an 85 year old male patient. On the 15-Jan-2015, the patient received AFLURIA (batch number 09649211A) 0.5mL annually via the intramuscular route. After administration it was realised that the multi-dose vial was two weeks expired (an opened AFLURIA vial was administered after 28 days of being punctured). The vial was discarded therefore the expiration date on the vial or the date the vial was punctured could not be provided. The patient was fine with no adverse events to report. Outcome was not reported.
break through cases after the Pfizer vaccine; break through cases after the Pfizer vaccine; got sick with resp symptoms; got sick with resp symptoms; This is a spontaneous report from a contactable Physician. This physician reported for a female patient and other two patient. A male patient (lady's nephew), of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced break through cases after the Pfizer vaccine on an, Got sick with resp symptoms on an unspecified date in 2021. Reporter was curious if this was for the variant only or for the wild type one as well. The outcome of the events was unknown.   Information about lot/ batch number is requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
wiped out; dizziness; problems with ears; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (wiped out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting hypersensitivity (anaphylaxis after bee stings). Concomitant products included METOPROLOL, BUDESONIDE (PULMICORT) and ZOLPIDEM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (wiped out) (seriousness criterion medically significant), DIZZINESS (dizziness) and EAR DISORDER (problems with ears). At the time of the report, FATIGUE (wiped out), DIZZINESS (dizziness) and EAR DISORDER (problems with ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-065503 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
FELT REALLY TIRED; SORE THROAT; COUGHING; FELT CHILLS; POSSIBLE FEVER; SINUS CONGESTION; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 210 pounds, and height was 71 inches. The patient's concurrent conditions included: non smoker, and alcohol user, and other pre-existing medical conditions included: The patient had no known drug or non-drug allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced sinus congestion. On 19-SEP-2021, the patient experienced sore throat. On 19-SEP-2021, the patient experienced coughing. On 19-SEP-2021, the patient experienced felt chills. On 19-SEP-2021, the patient experienced possible fever. On 20-SEP-2021, the patient experienced felt really tired. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, coughing, possible fever, felt chills, sinus congestion and felt really tired was not reported. This report was non-serious.
Information has been received from a RN concerning a 6th grade student in an elementary school who on 07/03/1995 was vaccinated with a dose of varicella virus vaccine live and developed Chickenpox in mid December of 2004. According to the school nurse 58 other elementary school students who developed chicken pox and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no information regarding the present status of the student. No product quality complaint was involved.  Addition information    has been requested.
Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, coughing, tingling in the tongue. Itchiness progressed down arms, as did hives. EMS arrived and administered 0.3 mg Epi IM and IV Benadryl. Vitals obtained.
Breast Cancer - two types in one breast, two surgeries, radiation - 30 treatments, Anastrozole for the next five years, mammograms every three months
Sore arm 3 days, redness 3 days and growing, swelling 2 days, headache, chills (all 1 day), fever 2days, fatigue 2 days, runny nose 2 days, mild flu like symptoms 2 days
Reports arm numbness approximately 5 minutes post vaccination. Applied ice, instructed on comfort measures. Instructed to schedule an appointment with "Health care" if symptoms persist or worsen.
swollen lymph nodes in neck, 1/30--generalized red rash with little bumps all over  body-resolved with benadryl,  throbbing headaches still persisting 5 days post vaccine
Information has been received from a registered nurse concerning an 18 year old female who on 12-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Got the vaccine at 3:30pm after that got very thirsty and at 11:00pm started to have a very strong metallic flavor, even felt the tip of the tongue a little numb.
Systemic: Fainting / Unresponsive-Mild, Additional Details: After administering Fluzone & Moderna Booster, Patient became clammy & pale. His eyes rolled back in his head & he lost consciousness. He emptied his bladder while unconscious & was unresponsive for approximately 30 seconds.  I held him up by his shoulders as he was rolling forward so he would not fall out of the chair or hit his head.  I shook his shoulder several times & shouted his name to rouse him.  He came to and was disoriented.  EMS came and evaluated him and released him to go home.
no adverse event; Medical assistant reported VAQTA was administered after temperature excursion. See full details below. The operator of the device was a healthcare provider. HCP provided lot number that did not appear to be similar to other Merck vaccine lot numbers;; This spontaneous report was received from Other Health Professional (HCP) and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-SEP-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, Lot 3Y3ME2, expiration date: 23-FEB-2025 (confirmed to be an invalid lot number for hepatitis a vaccine, inactivated (VAQTA)(strength, route of administration, and indication were not provided). The HCP provided lot number that did not appear to be similar to other Merck vaccine lot numbers; confirmed with the multiple times with HCP that this was the correct lot number and the product was a Merck branded vaccine.   The medical assistant reported hepatitis a vaccine, inactivated (VAQTA) was administered after temperature excursion. The operator of the device was a healthcare provider. Temperature excursion occurred at 8.9 degrees Celsius on 14-AUG-2023 during a time frame of 12 hours 20 minutes; and at 9.4 degrees Celsius on 28-AUG-2023 during a time frame of 8 hours 20 minutes. No previous temperature excursion was reported.   No additional adverse events were reported.
Body rash. Red, painful welts on abdomen, some welts on back with a spotted rash over entire back. Took Benadryl and used Cortizone-10 cream.   Rash subsided but scaled and peeled. Since the December Vaccine different areas of the body, elbows, waste-line, portions of back, eyelids become red, inflamed and swollen, then scaly and peel. Dermatologist prescribed Pimecrolimus but it caused burning and increased irritation. Second cream prescribed Flucticasone Propionate
.  Sensorineural hearing loss in my left ear.  Happened 4 days after receiving  the Moderna booster for Covid-19.
Appears to be generalized vaccinia; diffuse maculopapular rash with intense pruritis; some lesions coalescing into larger papules - especially around site of smallpox vaccination, has systemic symptoms of a viral syndrome as well (nausea, sub F/C, myalgias, malaise, sore throat; lesions cross hairline and are on all parts of body essentially.
patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions). On 27-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medications were provided   This case was linked to MOD-2021-423303 (Patient Link).
Chills; lymph knot by the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and VACCINATION SITE LYMPHADENOPATHY (lymph knot by the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills) and VACCINATION SITE LYMPHADENOPATHY (lymph knot by the injection site). At the time of the report, CHILLS (Chills) and VACCINATION SITE LYMPHADENOPATHY (lymph knot by the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Deathly ill with chills, fever, hot/cold flashes, abdominal pain, nausea, muscle aches
Rapid heartbeat; Chills; Body aches; Fatigue; Fever; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 120 beats per minute. On 09-MAR-2021, the subject experienced rapid heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heartbeat, and the outcome of chills, body aches, fatigue and fever was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 15-OCT-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-NOV-2014, the patient was treated by a physician for a painful vesicular rash that was diagnosed as shingles. The patient was prescribed famciclovir (FAMVIR) to manage her persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the shingles is unknown. Additional information has been requested.
EXTREME FATIGUE.    Prior to this date, I was extremely active. I have never felt this type of fatigue.  I have always been very active, I was able to hike elevation of 1000ft, 5-7 miles, advanced yoga, run on treadmill, etc.  Since 1 month after the second shot I had experience extreme fatigue with chest pressure and sometime hard to get air. The fatigue lasted 12 weeks, improving slowly. To date of this form, I will have an occasional relapse of fatigue that will come on. I am back to yoga (very beginner level). I am slowly gaining strength but there is nothing else to explain this. Nothing has been different in my life but for receiving the Covid vaccine.
Patient is 16 years of age and received Moderna covid vaccine. Vaccine is licensed for 18 and up currently.
I got a really bad migraine within 10 minutes and they transported you to the ER.  I have had a Stroke in the past so migraines do scare me a bit.  In the ER they gave me numerous medications and nothing worked, I was there for about 5 hours before they discharged me. When I got  home I went straight to sleep and when I woke up in the morning I was feeling better.
pt recvd vax & was seen in ER a few day later w/an area of erythema @ the inject site, blotchy red rash on trunk, swelling in the extremities & face; pt also reported flu sx (n&v, achiness, fever), joint swelling, malaise; phlebitis @ site;
Cough; Scratchy throat; This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the first of two reports.   A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiration date were not reported), via an unspecified route of administration on 18Dec2020 at single dose for the frontline healthcare workers/COVID-19 immunisation.  Medical history included arthritis.  Concomitant medication included ibuprofen. The patient stated, "I got the COVID vaccine on Friday the 18th from my work and I started having like a scratchy throat on Sunday (20Dec2020) and then yesterday, the 23rd I developed cough and my employee helped and said I should report to you guys and then the CDC. That I have the side effects, even though it's common to get after the vaccine." Patient received treatment: of MUCINEX, zinc and Vitamin C. The outcome of scratchy throat was unknown and other event was not recovered.   Information on the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513781 same reporter, same drug, same event, different patient.
Loss of appetite, fever (102/103) and night sweats for the first 3 days.  my chest pain on the left started the night of the shot around 2 am. The pain kept getting worse and worse each day. I finally had to drive myself to the emergency room (5/4/201)  to get it checked out. It felt like something was squeezing my heart.  i was super light headed and felt like i was going to drop on the floor dead.  They gave me a chest x ray and took blood work.  Everything cam back good and the doctor said if i kept getting those chest pain i should return. so they let me go.  i still kept getting my chest pain for another week. however i didnt go back to the ER, because i was scared of getting a second bill as im not insured.
Pt presents pouchs with 4 x 4 inch erythema (R) deltoid on 9/24 with some redness/warmth.
Information has been received from an 91 year old female with atrial fibrillation, diabetes and drug reaction/allergies with cortisone shot, who " 3 months ago" on approximately 16-DEC-2008, was vaccinated with a dose of ZOSTAVAX (Merck).  Concomitant therapy included generic atorvastatin calcium (LIPITOR), metoprolol, warfarin sodium (COUMADIN), insulin and lorazepam.  The patient reported that "the same day after received ZOSTAVAX (Merck)"  her blood sugar went up.  On the same day "right away",  the patient recovered.  The patient sough medical attention with the physician.  Additional information is not expected.
RN did not receive the wheel during administration.  Repeated the dose.  Both doses were lot number FDP00014.
I started feeling dizzy, and then later on i had the worst headache for 2 days and it felt like i was catching a cold, i got really hot, and was and still very sluggish after the second day. My chest also felt very tight and body aches, i feel terrible.I couldn?t even get out of the bed to use the bathroom and a little runny nose.