chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/29- 3/22/2021- Redness, and swelling at injection site, warm to touch; all localized 4-5 inches in diameter at the injection site- Still occurring 3/22/2021- Itching at site of injection- Resolved 03/25/2021  Pt called Moderna and they advised pt to contact primary doctor.
Pt woke up and her arm near the injection site was red, swollen and hot to the touch. Pt felt sluggish/fatigued that day and had a sore throat.
On May 17th I returned from traveling and woke up 2 days after with sore throat and slight cough. I was fatigued. They were mild symptoms. They lasted 3-4 days. The Doctor prescribed Paxlovid.
Pt exp a large area of erythema & induration, along w/bruising, @ inject site p/receiving Td;
Polyarthralgia 6 days post vaccination: cervical/lumbar vertebrae, knees, elbows, shoulders, tinnitus. Inflammation/pain increased over 4 months, then slow partial reduction in inflammation except for cervical vertebrae and shoulders. X-ray: arthritis of the neck w/ mild spondylosis C3-4, C4-5; degenerative disk disease/spondylosis C5-6,  6-7. NMR: multilevel degenerative changes, C3-4 myelomalacia. Facet joint injection, RFA (3X), physical therapy, heat/ice with minimal relief. NSIADs avoided due to stomach issues. Tried several muscle relaxants, gabapentin, and Cymbalta with minimal success. Only Tramadol and carisoprodol found to ameliorate some of the pain. Still suffering from neck pain, inflammation/headaches.
Syncope, vomiting. Patient stated 60-70 minutes for observation and was transferred to ER.
2:25pm Checked child after 20 minute wait per HD policy after receiving immunizations. HIB injection site slightly red. No redness or swelling noted at other injection sites. Child was awake. Mother complained that child was not acting normal.  Stated that "he usually is more active and would be wanting down to play". Noticed fine red rash around mouth that had not been there when giving vaccines. Mother stated that she had been noticing redness on child's face during the 20 minute wait, but didn't notify anyone. Examined pt. further.  Fine red rash extended down neck and and on back across shoulders bilt. 2:28 Brought child back to exam room. 2:30 child awake, but listless. PO Benadryl given without difficulty. Hives increasing on face, trunk, abd., and back. Nickle to half dollar sizes. NO SOB or difficulty breathing noted. 2:32 Dr. , MD (covering for Health Officer) notified. Orders received to administer epinephrine sq. 2:35 .10 (1:1000) epinephrine sq administered Rt. arm.  Breath sounds clear bilt. all lung fields upon auscultation. 2:38 Child more alert. Redness decreasing. 2:44 R. 30 HR120 Breath sounds clear. Child drowsy and falling asleep. Swelling noted Rt. lower leg. Fine red rash continues from neck down to toes. 2:50 child sleeping. R.26 easy and regular.HR 120. Breath sounds remain clear. Redness continues to decrease. 2:54 Sleeping.  Startles when touched or moved.  Some hives disappearing on abdomen.  Fine rash around neck is lighter. 2:55 Called Dr's office to update. Updated on hives decreasing, but continue to appear and then disappear on back and abd., and that the fine, lighter, red rash continues from neck down to feet. Did Dr. wish to repeat epi? Orders received to have child come to his office immediately (office on floor above). Mother updated and she and child were taken to Dr's office.  Child then seen by his regular FMD.  Spoke with mother 9:00pm at home.  She stated child is acting "as his normal self now".  Following doctor's orders to continue benadryl PO next 24-48 hours.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 93-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: A nurse reported that a female patient received an expired dose of Havrix. Additional Supportive Information: The patient had Havrix on 6th July 2022, which had an expiration date of 22nd May 2022, which led to expired vaccine used.
MYALGIA, FEVER, HEADACHE, COUGH, RUNNY NOSE;  SYMPTOMS LASTED 36-48 HR, EMPLOYEE MISSED 2 DAYS  OF WORK  Narrative:  TEMPERATURE 102 deg; DURATION OF  SYMPTOMS 48 HR   Other Relevant History:
PATIENT WAS TESTED ON 8/3/21 AND TESTED POSITIVE TO COVID
Severe headache began on 1/20/21 at 9 PM. I took Benadryl, Tramadol, and ibuprofen for relief and to sleep, asleep by 11 PM. Had a very restless sleep and woke up with severe sweating around 3 AM. Woke up at 9:30 AM with severe, pounding headache. Attempted to walk around at 10 AM, pounding headache was a 10/10 pain scale when upright. Nausea set in as soon as I was standing, ran to lay down to avoid vomiting. At 10:30 AM I sat up attempted to drink water and the vomiting began. Severe vomiting for about 30 minutes, then intermittent vomiting throughout the day until 6 PM. Headache did not let up all day, no response to medication (acetaminophen, ibuprofen, rizatriptan, magnesium). Headache subsided around 8 PM and  I was able to sleep. No symptoms today 1/22/21.
Vesicles and ulcers over scrotum, trunk and scalp, >100 lesions.
Soreness at injection site of the left deltoid with increased soreness running down the arm and in the shoulder. Some numbness running down the arm and into the hand.  Feels a sore lump at injection site.
Developed redness at inj site on L leg covering 1/2 of thigh. Warm to touch, but receding when she came in.
redness at injection site; swelling at injection site; joint pain/bursitis/ pain in elbow/ pain in the joint of the left hip / knee pain; started in the shoulder then in the elbow; bursitis; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included skin peeling (had skin pealed after contact cold tablet). Previously experienced adverse reactions included rash (had rash after contact cold tablet). Previously administered products included Contact cold (Received contact cold tablet).   On 14th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, joint pain, shoulder pain and bursitis. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the shoulder pain and bursitis were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, joint pain, shoulder pain and bursitis to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The patient did not have medical history of joint pain, did not fall or hurt. About 40 years ago, the patient took ontact Cold tablets and broke out into a rash in the groin area such that the skin pealed. The patient belived that this was due to a sulfa ingredient. After vaccination, the patient had injection site reaction of redness and swelling which resolved. a few weeks after vaccination the patient experienced joint pain. It started in the shoulder then in the elbow. The patient was working out and got severe pain in the joint of the left hip so stopped exercising for 4-5 weeks and that resolved. 3 weeks ago from the date of reporting, the patient had severe pain in the right hip and knee and these have not resolved and was diagnosed with bursitis. The bursitis pain has spread across his right leg between the knee and the hip.  The reporter did not consent to follow up.
Extreme fatigue, muscle weakness, brain fog. He cannot run any longer, he now has shortness of breath as well. He went from 8-10 miles a day, to not being able to run .5 mile. His heart beats very erratic heartbeat when he is trying to do cardio. You can see his heart beating outside of his shirt. Ortho stated that he has some kind of inflammation, then went to a rheumatologist and they stated that somehow, some temporary arthritis has been triggered. He also saw  Dr..
First had very sore arm at site for 3days. Since then mostly later into the day and late at night I am breaking out into very itchy hives in the arms, legs, groin area and neck along with lips swelling and becoming numb. I have taken Benadryl for it to help relieve itching. Will be contacting doctor for advice.
Currently pregnant- 33 weeks 5 days   Woke up in a rash all over my butt, armpits, under chest, groin. Most prevalent on  my butt cheeks. Extremely itchy
Significant bruising at injection site.  Mild discomfort -relieved with ice and Tylenol.  No loss of mobility. Able to do her ADL's. Started 48 hurs after vaccine given.
Could not walk for four days. Was bent over in an L-shape. Massive pain in my lower spine. After four days it moved to my upper back shoulders. It ached for a day, then it moved to my left hip aching for a day. Then it went up to my neck for a day, (which was aching and stiff) then it caused headaches for a day. It seems to be gone now. But after the lower back pain I experienced, I thought I was going to be crippled in a wheelchair literally. I doubt I will be getting any booster shots after that.
My grandpa's urine is red; This spontaneous case was reported by an other caregiver and describes the occurrence of CHROMATURIA (My grandpa's urine is red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced CHROMATURIA (My grandpa's urine is red). At the time of the report, CHROMATURIA (My grandpa's urine is red) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was not provided.
Weak; Felt awful the rest of the night; Nausea; Slightly red; Fever; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036AZ1A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included drug allergy (Aspirin, Daypro).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches). On 28-Mar-2021, ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) to be related.    No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-040652, MOD-2021-040652 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain she had almost 7, 8 days after receiving the shot) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain she had almost 7, 8 days after receiving the shot). At the time of the report, PAIN (Pain she had almost 7, 8 days after receiving the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 4-06-2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a retired 65 year old female with a history of cutaneous lupus erythematosus, and allergies to topical antifungals, who on 01-APR-2008 at 2:00 PM was vaccinated with the first dose of 0.5 ml PNEUMOVAX 23 (LOT# 658075/0962U), to the left deltoid.  There were no reported acute illnesses at the time of vaccination.  Concomitant therapy included "Hydrochloraquine" (therapy unspecified) and "Thyroid Pill" (therapy unspecified).  The patient stated "that after she got the vaccine the injection site swelled up to the size of half a baseball, and it hurt lake mad."  There was pain and redness at the injection site which started within 1 day of vaccination, 02-APR-2008.  The patient saw her doctor in the clinic on 07-APR-2008 and was given prednisone.  On 30-APR-2008 the patient reported pus draining from the site and was seen in the clinic.  She had a wound culture that was positive for methycillin susceptible staph aureus.  The exam was consistent with an abscess and she was seen by a plastic surgeon for an Incision and Drainage (I and D).  The patient was followed by the plastic surgeon and was healing and would not need skin grafting.  At the time of the report the patient was recovering.  Upon internal review the surgical intervention was considered an other important medical event.  Additional information has been requested.
This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored ROTATEQ, exposed to 8.4 degree for 20 minutes and also to temperature of 9.7 degree for 6 hours 20 minutes, oral (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000848 and 1408USA000853. Additional information has been requested.
Pt recv vax on 11/11/98; post vax pt exp itchy eyes, cough, respiratory stridor; bruising at vax site
PUSTULE SPREAD FROM LEFT DELTOID TO RIGHT WRIST. PATIENT PRESCRIBED ANTIBIOTICS AND A F/U ON MONDAY 04FEB19.
Pt developed red blotches beneath the injection site.  She received the injection on 08/03/2020. She reported it to the pharmacy on 08/05/2020. Recommended oral benadryl  and to follow up with her physician if symptoms do not resolve or worsen.
leg cramps in upper leg; muscle aches in his upper legs at night; This is a spontaneous report from a contactable consumer (patient's sister). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer said the patient took the COVID shot, and has taken the second shot and on his first one had muscle aches in his upper legs at night, the second shot didn't bother him. She said that with the first shot he had some leg cramps at the top of his legs at night and that was it.  He had it for like 2 nights and then it went away. She stated that she didn't know his age when he got the 1st vaccine because she didn't know when he got it, but that it was sometime in March (Mar2021). She stated he did receive the vaccine at hospital. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachache are still happening as I write this report today April 5, 2021.
Body aches, sore throat, runny nose, and sore arm beginning 1/14/2021.  Took OTC medication on 1/14/2021 with improvement.  Symptoms have since resolved.
An 81 year old man with MDS (for which he has received many transfusions over the past 2 to 3 years) received Shingrix vaccine on 12/26/2019. The next morning he was so weak he could not get out of bed or even sit up. 911 was called and took him to the ER. Although the doctors were told about the Shingrix shot the previous day they diagnosed him as having an 'underlying infection' and started him on IV antibiotics. The next day 12/28/2019 he felt much better, could walk unassisted. The doctors then said his white cell count was normal, stopped the antibiotics and discharged him home the next morning 12/29/2019. I do not have access to the lab tests done. It is unknown whether or not Shingrix caused the severe weakness that he experienced but no other cause is known. His hemoglobin was 10 which for him is good.
Crouch area swollen.  Parent took her to physician.  Physician prescribed Benadryl.
Kinrix given in left thigh on Friday, June 28, 2013. Site is now red, swollen, measuring 10.5cm. Proquad given in left upper arm subcutaneously. Site is now red/bruised and 2cm. Patient has also been running a fever of 102.0. Patient started on Septra.
It started off with a bad flu then 4 days later I could not urinate from a swollen prostate. A week after my prostate swelling went down I had trouble walking which later in the day I could not walk on my own.  After 3 MRI's and a spinal tap I was diagnosed with Guillaine Barre Syndrome. This led to my legs never recovering  and had to go through life suffering major atrophy in my legs. Leaving me with  limp legs forever. This has caused many problems in my even 2 back surgeries.
In June, I started to experience pain in my lower abdomen. Pain started 5 am, it was more intense. The pain was really sharp, to the point i felt like something was really stabbing me. This isnt something that I have ever experienced before. When I went to the hospital, they said it was more of constipation. I dont think so. They gave me a shot, like a pain shot, and it went away, that was at hospital. Then I went to another Hospital, 3 weeks after that visit was when I started to experience that same pain. It comes and goes like contraction. I take ibprofen 600 mg. I couldnt take it anymore and I went and checked in at the hospital. I wanted doctor to do a CATSCAN, because it wasnt right. When they did the catscan, they said I had a cyst (Follicle Cyst) and it comes and goes, after looking at the scans. They said I'd have to control it with horomones, and I dont take contraceptives. So now, I have these sharp pains before my period starts and it lasts about 2-3 days.
Patient states that, 24 hrs. after she had the varicella injection in her right arm, she developed large skin reddening about 70 mm in size with a dime size wheal. The next day it gradually waned and signs & symptoms disappeared on the 3rd day. She experienced no itching and generalized symptoms.
Fever 100- Congestion & phlegm. Crying for 3 hours non-stop 5 min break for 2.
Unknown if the above is the exact type of quadrivalent influenza vaccine, but it was one of them. About 24 hours after receiving it, I came down with a series of somewhat non-specific but all very unusual symptoms, starting with each arm independently becoming very cold and almost numb, followed by general malaise and feeling "off", heart palpitations/heart racing, excessive thirst and urination (requiring drinking 24oz water bottles every 2 hours or so, much much higher than baseline - no matter how much I drank, I remained extremely thirsty and with dry mouth), excessive sweating on palms and soles of feet, chills and difficulty maintaining a comfortable temperature, inability to sleep, pallor, minor/occasional dry cough, stomach discomfort/mild nausea, loose stools x 2, all lasting from 4PM that afternoon the day after the vaccine until about 9-10AM the next day.  Symptoms seemed to fluctuate a little bit but were at a persistent level of malaise throughout. I had never previously experienced anything like this before and felt about the worst I have ever felt physically in my life.  I am a physician and had my vitals checked when I arrived to work around 7:30AM near the end of it, with elevated blood pressure to the 146/86 range (baseline systolic is 110-120s), afebrile.  I had a difficult time making it through work, but was able to do so starting to feel a little better.  By the time I proceeded to my physician's office that afternoon, I was feeling much better. In the proceeding 1-2 days, I have had a few much more minor episodes since of 30-60 min of feeling off sporadically.  The family physician and I both agreed these symptoms were most likely a delayed reaction to the influenza vaccine given time course and diffuse nature of symptoms.  I was tested for other possibilities such as a thyroid condition, with bloodwork unremarkable.  I do plan to continue receiving the flu vaccine in the future though of course this raises some natural concern.
On 12/6/21, I broke out with full body hives starting as spontaneous  round, intensely itchy red wheels that spread to parts of my body throughout the day, especially if I scratched them. I have not changed soaps, detergents, or anything about my daily living prior to this event that would signify a new allergy. Every inch of my body broke out, with the worst being my scalp and ears. This reaction continued for two days, maintained with some Benadryl every 6 hours. On 12/8/21, I experienced intense throbbing chest pain over my heart while also still dealing with the hives. Since this chest pain was unchanged by antacids, I was afraid of internal swelling, so I went to the Emergency Department. They found no cause for the hives and chest pain, placed me on 5 days of 50mg Prednisone and recommended daily Zyrtec and  Pepcid to contain the itching and hives. I am still taking Zyrtec to this day but have been able to reduce from 10mg a day to 5mg a day. I cannot go without a dose of Zyrtec or the itching comes back so intensely that I can?t focus on working.  I have notified my PCP of my condition but have not been seen by her due to the Zyrtec and Pepcid offering relief.