chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First had COVID tested positive 11/26/22. Had largely mild symptoms (worst was a fever, headaches, and chills for a few days). Mild cough lasted 4-5 weeks though. Unclear whether adverse event related to catching covid or vaccine.  Preexisting condition venous malformation in right wrist (just decreased mobility and generally no daily pain unless use it a lot. Began (12/10/22) to have massive pain in the mornings in right wrist (same location as malformation) that rendered hand useless (although I had sensation still) until midday. After midday it was largely back to normal. After a week of tolerance, went to doctor who did a d dimer blood test and then sent me to the ER to check for a blood clot (12/16/22). They did an ultrasound but found no blood clot. Started wearing a compression sleeve starting 12/20/22 although didn't help so much. Was referred to a vascular specialist and they did another ultrasound and identified a blood clot in my right wrist (12/22/22) although they did not seem so concerned about it and told me to take aspirin daily to treat it. Since 12/22/22 have not had any intense pain and wrist has largely returned to normal before the intense pain. Since, still have been wearing an arm compression sleeve at night.
06/22/2022 I had traveled and had a return flight on 6/21/2022. I thought I had jet lag.  I was horribly fatigued and shorter of breath than usual. I had nasal congestion, a headache, a productive cough, no respiratory issues and I was not aware of any fever. My large muscle groups in both legs hurt. I developed a low-grade fever around the third or fourth day.  I felt maybe it was just my normal symptoms. On 6/28/2022 I tested positive for COVID with a home test. I called my primary care provider on 6/29/2022 and had a telehealth visit. They prescribed Monoclonal Antibodies Infusion, but I never received a call for the appointment. 0n 7/2/2022, I called my doctor back because my gout was bothering me.  I also developed night sweats and diarrhea. I was told by the doctor that she would call the center to get my infusion.  I was feeling better, and it was a holiday weekend, so I did not pursue the therapy. I was prescribed a steroid for the gout. The gout improved but did not go away. Last week my other symptoms improved. I still have a touch of the gout and feel a bit fatigued.
Information has been received from a pharmacist, referring to a 60 year old female patient. The patient's medical history and concomitant therapies were not reported. Concurrent conditions included seasonal allergy. On 24-APR-2017, the patient was vaccinated (unspecified arm) with ZOSTAVAX lot # M037015 with an expiration date on 22-NOV-2017, administered subcutaneously (dose and anatomical location were not reported) for prophylaxis. On 26-APR-2017 (reported as "two days later"), the patient returned to the pharmacy two days later with a welt that had a "raised border 2 inches long and was painful to touch at the injection site" of an unspecified arm. It was confirmed that the patient did not seek medical attention for the events. The outcome of all the events was unknown and the causality between the aforementioned events and the vaccination with ZOSTAVAX was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
I had tachycardia, a really high heart rate, even when resting. It lasted for multiple days. I went to the emergency room and they just recorded my heart beat and let me go home afterwards.
A few hours after my shot the spot I recieved it itched  mildly but soon went away. Nothing of note happened between then and now. I didn't take anything to treat the initial itch. Today after waking up I noticed my arm was hot and there was a hard raised almost circular area which was reddish. It felt kind of hard when I touched it too.  I have not taken or done anything about it almost 24 hours later. I just read benadryl was recommended so I plan to take some now. Just whatever a regular dose is.
2/7/01 hep A+B #1, yellow fever, typhoid-numerous canker sores in mouth. 8/9/01 hep A+B #2-numbness in extremities, joint pain, fleatgas in vision al, weakness, tendon pain. The 60 day follow-up states same effects as repeated originally.
On Day 8, for the first time, experiencing redness, swelling and itching at injection site. No treatment required.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Roughly 1 minute s/p injection(1200).  Bystander states patient should talk to pharmacist about that.  Bystander states patient fainted out of seat and hit face on floor and was awoken on impact.  vitals 100/86 bp 66 pulse.  pt then stated that she had history of syncope with injections upon further dialogue.  emts called onto scene.  patient declined transport and care.  pt stated "feelings" are gone and left scene at 1241.
Client states that evening itching, redness, and soreness started at injection site and lasted for 1-2 days.  States resolved, but then on day 8 after injection, it became itchy, red, and inflamed again, resulting in a Dr. visit.  She states was diagnosed with cellulitis and given antibiotics to take.
Stomach cramps; Diarrhea; Cold sweats; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Ep6955) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced Diarrhea, cold sweats and stomach cramps. The patient was not treated for the adverse events. The clinical outcome of the events Diarrhea, cold sweats, and stomach cramps was resolved on an unknown date at the time of the report. No follow-up attempts are needed. No further information is expected.
This case was reported by a healthcare professional, via a GSK sales representative, that described the occurrence of injection site burning in an unspecified number of adult subjects of unspecified gender who were vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date (s), the subject (s) received an unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject (s) experienced injection site burning. A nurse reported that she has noticed an increase in the number of subjects experiencing burning after administration of TWINRIX. The nurse had no patient specific information, but stated that the subjects were adults vaccinated in the last few months. At the time of reporting, the outcome of the event was unspecified. Follow-up information was received on 18 July 2008 via a nurse, who reported that over the past few months, approximately one in four subjects complained of burning and pain with injection. The nurse stated that this is a tend she has noticed, as she had not previously heard those types of comments from vaccination subjects. The nurse further stated that these events are not related to time of day, injection with other vaccines, age or sex of the vaccination subjects.
Approximately 52 hours after administering VZV and DTAP in patient's Right arm, Patient's Mother returned patient to clinic to have arm checked.  Redness, edema, warmth to the site and pain were reported by the patient.  The changes were noted by Mother when removing bandaids applied to sites upon administration approximately 30 minutes to 1 hour before returning to the clinic.  Affected area was approximately 10cm round near the location of VZV injection. Patient also received IPV, MMR, and HAV in Left arm at the same time the other vaccines were administered.  No changes noted to Left arm.  Mother was told to give Benadryl as tolerated, apply Neosporin to area and apply warm moist heat.
Patient came to the clinic for her first dose of Pfizer, which she received at 0921 (lot# EWO185-H). Shortly after her vaccination, she c/o nausea to observation area RN. She reported that she hadn?t eaten anything yet today and accepted water and juice offered by RN, but she declined to lay down. RN took her vital signs at 0928, reporting that her BP sitting was 90/70, HR was 89, and SPO2 was 98% on RA. RN alerted this writer, RN, to assess the client. When asked, she denied dizziness, but did c/o feeling ?tired?. No diaphoresis or pallor was noted.  At 0930, patient transferred herself to the cot, rising and walking without difficulty and with a steady gait. At 0939 she was assisted to elevate her legs and reported that this positioning helped to reduce her nausea. At 0939, her BP laying was 90/50, HR was 74, and SPO2 was 98% RA. She and her father reported that they do not know her baseline BP. Her BP at 0943 was 94/60 laying. She was able to sit at 0945, reporting that she felt ?good? and continued to drink juice and water. She reported that her nausea was mostly resolved, but that she still felt tired (although she did note that she had been tired before vaccination r/t staying up late). She reported that she felt ?80% normal?. This writer obtained her vitals at 0951: BP sitting was 96/62, HR was 71, and SPO2 was 100% on RA.  She attempted to stand at 0954, but reported that this worsened her nausea, at which point she laid back down with feet elevated until 0957 when she elected to sit on the edge of the cot. She ultimately laid back down again a few minutes later. Her vitals at 1002 were: BP 104/64 sitting, HR 67, and SPO2 was 98% on RA. However, her BP fell to 96/58 when she stood a moment later, causing her to sit again. She continued PO intake of fluids and, by 1012, she reported that she felt ?fine? and rated her nausea at 4/10, compared to a peak of 7/10.  At 1012, she stood and walked without difficulty. Her BP standing was 98/60, HR was 92, and SPO2 was 99% RA. At 1013, her VS remained stable with a standing BP of 96/58, HR at 85, and SPO2 at 98% on RA. She reported that her nausea was mostly resolved, she denied dizziness, and she continued to present with no pallor or diaphoresis. She and her father were educated on vasovagal responses and when to seek out medical care, encouraged to eat breakfast after leaving the clinic, to report this reaction the next time she presented for vaccination, and to be sure to eat before vaccination. Both she and her father verbalized understanding. She exited facility at 1020, driven in a private vehicle by her father, who will monitor her throughout the day.
1/19 arm sore 1/20 achy  1/22 tightness in chest
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M041514, expiration date: 11-OCT-2018) (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.29 degrees Fahrenheit) for 44 hours and for 44 hours and 1 minute. Data logger was involved. There were no previous excursions reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005634:
About 10:00 pm on Saturday evening of noon injection, injection site was painful--at the same time got intensive, but very brief headache, very dry eyes and, within minutes, (no idea if it's related) I noticed weird sensation in my nether regions, which felt like my underwear was knotted and pressing on it.  Went to check and found big kind of oblong lump (abscess) on outer labia extending to inside thigh--quite painful.    It came out of nowhere--hadn't noticed it at all before that moment.  Goggled it and thought it was probably Bartholin's Abscess and treated it as such.  (Later realized it couldn't be because it wasn't inner, but outer labia.)  Took sitz bath, and continued taking sitz baths next day and applying heat.  Abscess extremely painful, fever 100.3--quite high for me., rash on chest and abdomen.  It started draining while sleeping Sunday night and continued draining slowly on Monday with fever down to 99 and now down to 98.1.  Rash has disappeared.  Arm no longer sore.  Abscess still painful but less so
S/P t d injection 1/4/10. MDR stated had increased numbness and warm and pain L deltoid. 1/7/10 was seen by Dr - ADVIL, compress and BENADRYL
pain in arm and big swollen; Irregular heartbeat, heart rate went up, rate was under 140; Blood pressure was high; Heart rate increased; mild headache; couldn't breathe; regular pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (pain in arm and big swollen), HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140), HYPERTENSION (Blood pressure was high) and HEART RATE INCREASED (Heart rate increased) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (Shingles) on 16-Dec-2020. Concomitant products included FISH OIL, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], SELENIUM and VITAMIN B COMPLEX for Supplementation therapy.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was high) and HEART RATE INCREASED (Heart rate increased). On 12-Jan-2021, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140). On 18-Jan-2021, the patient experienced PERIPHERAL SWELLING (pain in arm and big swollen). On 09-Jan-2021, HYPERTENSION (Blood pressure was high) had resolved. At the time of the report, PERIPHERAL SWELLING (pain in arm and big swollen) outcome was unknown and HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140) and HEART RATE INCREASED (Heart rate increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Blood pressure measurement: >150 (High) blood pressure was high over 150. On 09-Jan-2021, Heart rate: <140 (High) Heart rate went up and was below 140.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that on the third day after the shot, her heart beat was 42 per minute to 85 per minute. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient demographics, medical history, product information, concomitant medications and event details updated; 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.
flair up of asthmatic bronchospasm; used  albuterol sulfate hfa inhalation aerosol inhaler and took 20 mg of prednisone
pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 74 -year-old female patient received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration (on left arm) on 27Jan2021 13:30 (at the age of 74-years-old), single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the vaccine last Wednesday. Since then she has had pain on her arm mostly on the upper side of the arm. She took Tylenol and it went away. Adds she felt so tired and generally unwell, like the flu. Mentions it is like muscle pain in her left arm that come back whenever she moves around. All of this started on Wednesday. Adds it is not that severe, like if you have the flu. Mentions she does get muscle pain sometimes when she is working around the house but this is different. She is scheduled for the second dose of the vaccine 17Feb2021. She is starting to get worried about taking the second dose of the vaccine if it is going to be like this and wants to ask about that. She received the first dose of the vaccine  on 27Jan2021 at 13:30PM in the left arm. That night, Wednesday night she noticed the pain in her upper arm. She took Tylenol and then the morning it went away. Friday it came back and she took Tylenol again and it went away. But when she works or walks around there is pain again. Seriousness not provided. The event pain in her arm was assessed as recovering, other events recovered on 31Jan2021.  Information on the lot/batch number has been requested.
developed an eruption on his arms and legs, and he thought it was related to the cold weather; itchy eryption; eruption kind of resembles a Shingles rash but not exactly; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (single dose received 2-3 years ago before reporting).   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a month after receiving Shingrix, the patient experienced painful rash, itchy rash and vesicular rash. The patient was treated with topical antibiotic (nos) (Antibacterial Cream). On an unknown date, the outcome of the painful rash, itchy rash and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the painful rash, itchy rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient developed an eruption on his arms and legs, and he thought it was related to the cold weather. The eruption kind of resembles a Shingles rash but not exactly.  He said that the eruption is painful (the pain comes and goes), itchy and that he still had one area on the thigh that was 3 months old. He stated on that one, he has tried using a band-aid as it is below the pocket area of his pants.  He stated the eruptions range from being the size of a dime to the size of a quarter and that he had used three types of cream including an antibacterial cream.  He said that the eruption from December 2020 did not completely clear up. For tolerance with 2nd dose of Shingrix, refer linked case US2020054996.
he felt bad, so he took two Percocet; This is a spontaneous report from a contactable consumer. A male patient of 94(unit unknown) received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, on 05Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient (the reporter's friend) who is 94 (not clarified) and the patient had his first yesterday(05Feb2021). Then the patient went into the yard and started gardening for 5 or 6 or 7 hours. And the patient felt bad in Feb2021, so he took two Percocet. And the reporter brother-in-law is a pharmacy doctor and he, through the reporter's sister told the reporter not to take any. So, the reporter was a little worried about the patient and does it have any effect on the efficacy of the COVID-19 Vaccine. The outcome of the event was unknown.  Information about batch/lot number has been requested.
WHEN CALLED TO SCHEDULE 2ND DOSE, FAMILY STATES HE IS DECEASED.
First Moderna vaccine given on 12/22/2021 - nausea headache and body ache couple hours after shot was minister, and lasted till the next day. Second vaccine minister on 1/19/2021 - couple of hours after the vaccine I had chills that turn to a fever of 101.8 through the night till all day the next day, nausea headache, really bad body aches, a red rash allergic reaction on my upper left arm a little below where the vaccine was minister, and fatigue.
Three days later the male patient had a headache and fever (temperature unspecified).; Three days later the male patient had a headache and fever (temperature unspecified).; Information has been received from a physician and a nurse via a field representative, referring to a 15 years old male patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was unknown.     On 19-MAR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The patient did not have any adverse effect after the first dose. On 03-JUL-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis.         On 06-JUL-2019 (reported as three days later), the patient had a headache and fever (temperature unspecified). The male patient was leaving for vacation and was not seen by the physician but was given instructions over the phone to take ibuprofen for fever or headache. The outcome of the events was recovering. The causality assessment was not provided by the reporter.
Came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included nerve pain and pruritus. Concomitant products included gabapentin.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had 1st shot and experienced shingles. The patient was due for the second shot when Covid hit hard. For the tolerance of second dose, refer case US2021AMR176125.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176125:Same reporter.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Additional Details: PT WAS IN AISLE FOR MONITORING ADRS FOR 3-5 MINS AFTER SHOT.  HE WAS SEATED AND PASSED OUT FALLING FACE FIRST OFF HIS CHAIR.  HE REGAINED CONSCIOUSNESS AFTER 10-15 SECS AND SAT DOWN AGAIN BY HIMSELF.  WE TOOK BP READINGS OF 80'S/60'S, 90'S/70'S. HE AGAIN LOST CONSCIOUSNESS WHILE SEATED AND LEANING FORWARD TOWARDS HIS WIFE.  HE AGAIN REGAINED CONSCIOUSNESS IN 10-15 SECS.  HE NOTED ONLY DRINKING A COFFEE TODAY.  HE REMAINED SEATED IN THE STORE FOR ANOTHER 20-30 MINS AND BEGAN TO FEEL BETTER.
I received the shot around 9am on 4/6/21 around 10:00pm that night I started having a bad headache and feeling overall not well, so I went to sleep. I woke up in the morning at 7:30 and couldn't stand up very long without throwing up, I was freezing cold and couldn't stop shaking. That lasted about 7 hours. Then , I started my mensural cycle 9 days early and have had severe cramps and very heavy bleeding for 6 days. This is not at all normal for me. the problem has yet to subside