chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states he is experiencing a gout attack 12 days after vaccination.  He states he had a similar reaction in the same hand a few weeks after the first dose.  He states at that time he also had a cut on the hand in the same area so they treated him for cellulitis but had lingering issues so gave him colchicine to have on-hand in case it was gout.
c/o neck pain-very sore; some swelling noted on rt side neck; a/swelling, ear hurt but doesn't hurt today 6SEP94; pain goes gown to elbow; denies fever, rash, h/a; due to lg amt of pain has hard time being ambulatory; referred to MD;
Patient received her H1N1 injection at approximately 3:15 on 10/13/09 and returned to work. At about 3:45 she began to experiencing itching, "felt like it was crawling under my skin" which began with her toes and moved upward to her face, where it was the most intense. She did not experience any rash or hives. At 4:15 she took 2 BENADRYL. At 5:00 she began to feel tightness in her chest, "asthma-like symptoms, which I have with my allergies". She finished her shift and went to the ER at 7:15, where she received a nebulizer treatment, breathing improved, itching improved. Also received a shot but is unsure what is. She was sent home, and was to continue with BENADRYL every 4 hours, and return in AM if not better. Itching improves, but then woke up about 2AM with intense itching. Returned to the ER and treated her with oral prednisone which she is continuing. States yesterday itching came and went, today itching gone and hasn't needed to take BENADRYL. Was only to return to Dr. if needed.
Patient asked to stay seated immediately following vaccination, as he has a needle phobia. Shortly after (roughly 5 minutes), patient said he felt extremely lightheaded and shaky. He accepted a glass of water, but after taking a few sips said his vision was starting to black in and out. 911 was called immediately. EMTs checked that patient's blood pressure and heart rate, and eventually concluded the patient was okay after giving him more water and a banana to eat.
May have bladder infection; Possible COVID19 exposure; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (May have bladder infection), EXPOSURE TO SARS-COV-2 (Possible COVID19 exposure) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a female patient of an unknown age 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, the patient experienced CYSTITIS (May have bladder infection), EXPOSURE TO SARS-COV-2 (Possible COVID19 exposure) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, CYSTITIS (May have bladder infection) and EXPOSURE TO SARS-COV-2 (Possible COVID19 exposure) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.  It was reported that patient was due for second dose vaccination as she was not sure whether she had been exposed to COVID-19 and may ha bladder infection.   Reporter did not allow further contact
On 11/07/2022 Patient was administered a booster dose that had of 11/02/2022.  Patient had no reports of adverse events.  Moderna was notified and stated the dose administered maintained the activity necessary to provide protection.
The first night (2/1-2/2)the pain woke me up and this morning I had a bruise and big red swollen spot. I happened to have a doc appt and she said it looked like a histamine reaction.
Some vomiting after every feeding for about 2 days, occasional vomiting thereafter, explosive diarrhea once on 08/06/2011, ongoing crankiness and unwilling to eat solid foods.  Mother also affected with onset of vomiting and diarrhea on 08/08/2011.
Information has been received from a 72 year old male consumer reporting on himself with a history of seborrheic dermatitis without pain around the outer ear area and penicillin allergy who on 17-APR-2012, was vaccinated SC with 0.65 ml dose of ZOSTAVAX (Merck) (lot# not provided). Concomitant therapy included levothyroxine and unspecified vitamins. The patient explained that he began to develop a skin reaction after having his ZOSTAVAX (Merck) vaccination. The patient explained that he was told that the reaction was not a shingle outbreak by his physician. The reaction was diagnosed as seborrheic dermatitis. The patient did not feel that this diagnosis was accurate. He stated that the breakout started on an around his shoulders about 1 month after receiving the vaccine "approximately on 17-MAY-2012". The breakout spread down to parts of the patient back and torso and was not predominantly on either side of the body. The patient said that the breakout areas felt warm all the time. The breakout also affected the area around the patient's hair; he stated that in this area it not only itches it "it kind of hurts" like the area was bruised. The patient said that the skin itself was dry, however underneath the affected areas there was liquid and when scratched or punctured it started oozing. The patient also said that when pressure was applied to these areas it was slightly painful. The patient was treated with CLARITIN and unspecified topical creams. The patient had regular testing performed. Last laboratory test were taken in February and March 2012 (results not provided). At the time of the report, the patient had not recovered. He sought medical attention. Doctor visit and specialist visit. Additional information has been requested.
dont feel well; fever; CHILLS; back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), MALAISE (dont feel well), PYREXIA (fever) and CHILLS (CHILLS) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Chronic sinusitis. Concomitant products included AZELASTINE for Chronic sinusitis.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BACK PAIN (back pain). On 01-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (CHILLS). On 02-Feb-2021, the patient experienced MALAISE (dont feel well). On 01-Feb-2021, CHILLS (CHILLS) had resolved. On 02-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, BACK PAIN (back pain) and MALAISE (dont feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient uses topical steroid spray for chronic sinusitis No treatment information was provided.; 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.
Worsening of dementia symptoms 3 to 4 weeks after receiving vaccination (increased confusion, new onset paranoia and hallucinations).
This spontaneous report has been received from a physician via a company representative, referring to a male patient on his 50's. Information regarding medical history drug reactions, allergies and concomitant therapies was unknown by the reporter.  On an unknown date, the patient was vaccinated with ZOSTAVAX  (strength, dose, frequency, route of administration, (reported as injection), lot# and expiration date were not provided) to prevent shingles. On an unknown date, "reported as 2 weeks later", the patient developed a bad case of chickenpox, which was confirmed by the physician  because the itchy rash was "everywhere on his body, including hands, feet, head, face and neck". It was unknown by the physician if the patient received treatment or if laboratory diagnostics studies were performed. At the time of reporting, the outcome of chickenpox was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Some patients are in bed for days; This case was reported by a physician via call center representative and described the occurrence of bedridden in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced bedridden. On an unknown date, the outcome of the bedridden was unknown.   It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per vaccine indication. The physician stated that after receiving Shingrix, the patients were in bed for days.  No further details were provided. The reporter consented to follow up. The physician was in a hurry as patients were waiting, and she did not provide any further details after making this general statement, but she did give permission to follow up at the following address. This case has been linked with US2019162773, reported by the same reporter.
Healthcare & Rehabilitation did not notify the pharmacist supervising the offsite-clinic that the patient already received the third (booster) vaccine. A fourth dose was given to the patient.
day after shot on the 7th had fever all day and arm swelled up at vaccination site. Not sure if it is connected, but I have shingles that blisters appeared on the  16th after a weekend (3/12- 3/15) of pain in leg prior to blisters appearing. Pain and blisters are still ongoing.
Soreness at injection site; Elevated temperature; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Elevated temperature"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for the vaccine, [Comirnaty], was not provided and will be requested during follow up.  Follow-up (26Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
80 y/o F presents for tingling sensation to B/L hands and high blood pressure after receiving the 2nd dose of the Covid-19. Patient was taken to the ED for monitoring; she denied any allergic reaction, CP, fever, chills, lightheadedness, dizziness, N/V/D/C, abdominal pain or other symptoms aside from tingling of all fingers. Her blood pressure was 197/92 at the time. EKG was performed, which was normal. No medications were administered. After 2 hours, the blood pressure normalized to 140/80 and patient was discharged.
Seen at ER 05/09/04 for swelling and redness of left arm.  Diagnosed with DTAP reaction vs. Cellulitis. Treated with Cephalexin 250mg per mouth four times daily for 7 days.  Much less red, swollen and hard today (05/10/04).  Had DTAP #5 in left arm 05/07/04.
redness and hardness at the injection site day2 and day 3.  Delayed redness, edema and mild itching at injection site, day 8.
Fever, SWELLING, red and warm. KEFLEX 500MG 1TAB tid X7DAYS.
This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age. On an unknown date the patients received doses of improperly stored VARIVAX (lot # M025871, expiration date: 24-MAY-2018 and M028553, expiration date: 07-JUN-2018) that were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # N016995, expiration date: 08-OCT-2019) for prophylaxis. No adverse effects were reported. The vaccines were stored under 13.5 Fahrenheit for 10 minutes. It was called because of a "data logger" and no previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA000172:
On the morning of 04/23/21, patient went to get out of bed and could not walk. Stated equilibrium was off and had to walk with assistance of a cane.
Chills; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
I have no memory of what happened. I am repeating what I have been told. I was in the car with my Dad at a job(work) we left for lunch and I started calling for God and attempted to exit the vehicle. He pulled over were I could get out of the car.  I had a seizure and they got me home where I continued to have seizures and got fluid in my lungs. I ended up getting pneumonia. I was on a ventilator for 6 days. I was in the ICU for at least 10 days. Long story short, I have been diagnosed with epilepsy.  I have brain fog and It has affected me in massive ways. I can't even drive my child anywhere.
Patient is a 93 y.o. female patient of local MD with history of CAD, HTN and AS who presented to Hospital with a cc of progressive DOE      Acute pulmonary embolism with RHS  COVID 19 infection  P/w acute onset DOE.  Etiology likely multifactorial given findings below   CXR: relatively unremarkable  CTPA with RLL PE w/ RHS, e/o Pulm HTN  Echo outlined below   LE duplex negative for DVT  Started on heparin, transitioned to warfarin with lovenox bridge.    CRP elevated, will monitor while in house.  Decadron and remdesivir per COVID 19 protocol with plans to discharge on decadron for 10 total days of therapy   Stable on RA at time of discharge    Acute macrocytic anemia  Baseline hgb 12-13, dropped to 10.7 today in the setting of anticoagulation  Macrocytosis concerning for acute bleed however no melena, hematochezia or hematemesis   iron studies, B12 level reviewed.  Continue PO iron on discharge  Repeat CBC in 1 week in outpatient setting    New onset systolic heart failure  Severe tricuspid regurgitation  Severe aortic stenosis   Pulmonary HTN   NSTEMI, unable to determine type as refused ischemic w/u  Echo obtained in the setting of PE and e/o RHS on CTPA  Echo: LVEF 39% (down from 60%), severe AS, severe TR and multiple WMA noted. RVSP 80mmhg   EKG w/ LBBB which is chronic   Evaluated by cardiology, patient has declined any ischemic w/u at this time and has opted for medical management   Continue statin, BB and ACEi as well as plavix on discharge  RX for PRN lasix on discharge given EF and valve disease    Cancer screening  No recent mammogram.  Last colonoscopy 2016.    Will defer cancer screening to the outpatient setting though unlikely to change management    Urinary frequency  Noted today, UA pending collection  Will f/u UA and send RX for abx if indicated.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received half dose booster instead of first full dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received half dose booster instead of first full dose). On 06-Dec-2021, ACCIDENTAL UNDERDOSE (Received half dose booster instead of first full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. It was reported that patient has not received the primary series. Pharmacist was trying to get him to come in to administer the other 0.25 ml to make up a 0.5 ml first dose on the same day. No treatment medication details was reported.
NauseaVomiting HX of migraines. Started having nausea  followed by vomiting within 15 minutes of vaccine.
Vaccine received at 4pm on 1/31. Nausea, headache, fatigue, marked arm soreness, and injection site lump started the following morning. Normal temperature. All symptoms, including arm soreness and lump, resolved in 48 hours. 7 days post vaccine, on 2/7, Injection site lump returned, and became larger than initial reaction. Area around lump (~6in in diameter) was red and extremely itchy. Area was painful, but much less so than initial reaction. Resolved on own within 3 days.
FEVER; This spontaneous report received from a parent concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored dose of VARIVAX lot # M005973, expiry date: 02-FEB-2018 for prophylaxis. Concomitant therapies included sterile diluent. The dose of VARIVAX was exposed to a temperature of 15 degree Fahrenheit (F) to 46 F for a time frame of 4 hours 35 minutes. There were no previous temperature excursions. The call was due to a Digital data logger. No adverse effects reported. No Product Quality Complaint (PQC) was involved.
I already had tinnitus before I got the vaccine, but the second dose made my ears ring twice as loud. I noticed it the next morning, but there is no treatment except to wear specialized hearing aids that cost over 4,500.
1320 Patient reports tingling lips and throat 1335 Administered 50mg PO 1400 Symptoms stable; patient released
polycythemia. Now anemic with no  clear issue. requiring oral iron & possibly iv iron.
pt recvd vax & approx 30 mins later RR inc w/difficulty breathing; given DPH, Epi & Solumedrol;
7 days after vaccine, arm at injection site has become painful, red, swollen, and hot.
ACUTE STROKE DUE TO OCCLUSION OF RIGHT CEREBELLAR ARTERY ACUTE HYPOXEMIC RESPIRATORY FAILURE  12/17/2021, 5/30/2022,  7/11/2022,  8/9/2022 - -RECURRENCE OF SAME SYMPTOMS
Fever for 7 days, extreme fussiness, tremor initially in hands only and muscle weakness. Progressed to full body tremor, hypotonia, loss of speech, ability to swallow, speak and smile and intractable seizures. Responsive to pain only. Possible vision loss.
I was notified by the health department that the patient had already received a covid 19 vaccine of a different manufacturer on 4/9/21. The patient told us he had not gotten any type of covid 19 vaccine before. He was given the Janssen vaccine on 4/9/21.
PT FELT HOT AND DIZZY.  HER EYES WERE ROLLED BACK AS IF SHE WERE GOING TO FAINT, BUT SHE DID NOT.  VITALS WERE WNL.  AFTER DRINKING WATER AND SITTING FOR ABOUT 10 MINUTES, THE PATIENT FELT BETTER.  SHE STOOD UP AND WAS OKAY TO LEAVE.
there was needle leakage; patient did not receive full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FH3BB, expiry date 23-MAR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: patient did not receive full dose). On an unknown date, the patient experienced needle leak (Verbatim: there was needle leakage). The outcome of the incomplete dose administered and needle leak were unknown.   Additional Information: GSK receipt date: 30-OCT-2023 The HCP (health care professional) reported that patient received the Arexvy after the syringe was loose and there was needle leakage, so patient did not receive full dose, which led to incomplete dose administered. No reactions reported. The reporter consented to follow up.
In addition to the normal side effects of the Moderna vaccine ( chills, fever, muscle aches, headaches) I also experienced syncope; I completely blacked out and fell on my face.
Terrible taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 10:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included lupus SLE (systemic lupus erythematosus), hypothyroidism, narcolepsy and penicillin allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), hydroxychloroquine sulfate(PLAQUENIL) and armodafinil (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 27Mar2021 at 17:00, the patient experienced terrible taste. It was reported that the patient experienced terrible taste in mouth since a little while after the vaccine was given, vaccine administered around 10:00 and the taste developed later that day around 17:00. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event terrible taste was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Initial report received from a health care professional on 07-Oct-2013.  A 9-month old patient (gender unknown) had received FLUZONE (batch number: unknown, dose number and site of administration not reported) on 25 SEP-2013. The patient's medical history was unknown. The patient had no illness at the time of vaccination and concomitant medications. Patient did not have minimum internal between doses. No laboratory tests were performed and corrective treatments were not reported. List of documents held by sender: none.
Ongoing & continued hip joint pain....followed by low grade fever and lethargy and slight vomit. Joint pain started about 9/14 and reached peak 9/21. My son could not walk and in severe pain.