chrisvoncsefalvay/vaers-outcomes huggingface dataset:
J&J Dose 8/5/21 (204A21A) COVID Positive 1/7/22  1/7/21: 55-year-old patient with multiple medical problems.  She has severe cardiomyopathy with ejection fraction of  20 - 25%, coronary artery disease with most recent stents in July 2021, ulcerative colitis which required Remicade infusions in the past, status post subtotal colectomy, hyperthyroidism, COPD chronic anticoagulation therapy and other medical problems.  She was previously seen in emergency department at end of October 2021. Had acute kidney injury with serum creatinine of 6 and was transferred to higher level of care.   She has high-output colostomy and takes Imodium as needed. She presented with nausea, multiple bouts of emesis of 1 day duration.  Poor p.o. intake.  She was reminded of previous episode in October 2021. Continues to have high output from ostomy.  Lab work again showed serum creatinine of 6.18.  Elevated BUN.  She is receiving IV fluids.  As noted above she has significant ischemic cardiomyopathy with EF of 20-25%.   She has seen endocrinologist for hyperthyroidism.  She was advised to increase dose of beta-blockade.  She has an appointment coming up with local endocrinologist on 1/13/2021 for further management of hyperthyroidism.  She is no longer on Entresto.  She tested positive for SARS-CoV-2.  Denied shortness of breath.  Remains on room air.  Had low blood pressures in emergency department which resolved with IV fluids.  1/13/22: 55-year-old female with a past medical history of coronary artery disease, ischemic cardiomyopathy with congestive heart failure, ulcerative colitis s/p subtotal colectomy, hyperthyroidism, COPD and degenerative joint disease presented to the emergency room with  nausea, emesis and high colostomy output and decreased intake. Patient was noted to have creatinine of 6.18 and elevated BUN.  Renal service was consulted and patient was admitted for acute kidney injury.  Patient was also found to have positive COVID-19.  Dr. has seen the patient and patient was started on IV hydration with bicarb.  Patient was later changed to lactated Ringer and was started on oral bicarb.  Patient started having cough and shortness of breath that she had to be put on oxygen.  She was also started on remdesivir and dexamethasone.  Patient apparently had 1 dose of Johnson and Johnson COVID-19 vaccine.  Patient's condition improved.  Patient was started on psyllium which helped with the decreasing the bowel motility and  decrease in colostomy output.  Patient had an increase in metoprolol dose due to tachycardia secondary to hyperthyroidism. Patient's TSH is low and free T4 is high and patient is planned to see an endocrinologist soon.  Patient has completed 4 days of remdesivir.  Her renal failure has resolved.  Patient was started on potassium supplements due to hypokalemia.  At today's labs showed hyperkalemia with potassium of 5.9 but renal function was normal.  Repeat potassium is 5.4.  Patient will not need any supplements of potassium. Her LFTs are mildly elevated but needs to be followed as an outpatient.  She will be discharged on oral redness own and Levaquin.  Patient did not qualify for home O2. Follow up with PCP.
RECIPIENT STATES THAT SHE AWOKE AROUND 10:00 pm EXCESSIVELY SWEATING AND FEELING DIZZY. SHE STATES THAT SHE WENT BACK TO SLEEP AND THE SWEATING STOPPED BUT THE DIZZINESS PERSISTED OVER 2 DAYS AFTER RECEIVING THE VACCINATION. SHE TOOK SOME TYLENOL AND THERAFLU ON 04/06/22 ONLY
Client received flu shot and then went home and using the arm he received the shot in, washed 3 large trucks. By the next morning he had a large hematoma covering his upper arm.
possible anaphylactic rxn manifested by angioedema, HTN, abd pains, & tightness in chest;resolved p/tx w/steroids;
Warmth, redness, slightly, swollen, Tx with Benadryl.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 70-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included Atorvastatin and vitamin D. On 23rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th March 2018, 12 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The pharmacist reported that the patient experienced rash around her eye. It was unknown which eye was involved. Limited information was provided by the pharmacist.
There was a mix up of expired product coming out of fridge and newly drawn product. Patient may have received product that was in syringe past the 6 hour recommended timeframe.  We contacted Pfizer, CDC and our Facility vaccine experts and it was determined the primary concern seems to be microbial contamination and revaccination was not necessary.  Patient was advised of the error and to monitor for signs of infection, i.e. redness at site of injection and fever. Patient reported some nausea, the usual arm pain, and fever around 100 degrees after vaccine.  At time of consultation all symptoms had resolved.
Sore swollen injections site like a baseball Mild fever. Body aches all over and lack of energy
Adminis. Lt deltoid IM within 2-10 seconds pt unresponsive-eyes closed and arms legs extended with faint jerking of legs-pt open eyes within 20 seconds, but continued to be very slow to respond pale and skin moist this gradually improved over the next hour.
Tdap given at other office. Induration to left arm noted, looks like it was given below landmark. Treated for cellulitis.
The night after my first Pfizer vaccination I experienced vivid, crazy dreams all night and experienced a bad night's sleep. I usually do not dream much and these were extremely vivid and real.
On April 5  after my second shot (April 3rd), a grapefruit sized welt appeared with itching. It lasted for about 20 min but a small raised area around the injection site , about 1/4 inch was still present at bedtime. I also noticed   a red rash about 3? x5? on my shoulder above the injection sight.  Itchiness  was mild and seemed to come and go.   The following morning, 4/6/2021, on the second day after my second vaccine, I woke up to an itchy abdomen with hives. These lasted about 5-7 min.  That whole day I felt artificially ?tall? and  slightly loopy and?woozy?.  As the week went on, these wooziness symptoms  seemed to come and go becoming less and less . I didn?t notice the point it quit happening  but it was for at least 2-3 days.
Redness/ redness has spread; Swelling on the inside about the size of an orange; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness/ redness has spread) and SWELLING (Swelling on the inside about the size of an orange) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced ERYTHEMA (Redness/ redness has spread) and SWELLING (Swelling on the inside about the size of an orange). At the time of the report, ERYTHEMA (Redness/ redness has spread) and SWELLING (Swelling on the inside about the size of an orange) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown.
Narrative: Patient contacted PCP to report tinnitus began around same time as second Covid Vaccine. Patient also started losartan around this  time and has been taking OTC NSAIDS
like the flu; body aches; ran a temperature 5 hours later/ next morning she had 101 temperature; She had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like the flu), PAIN IN EXTREMITY (She had a sore arm), MYALGIA (body aches) and PYREXIA (ran a temperature 5 hours later/ next morning she had 101 temperature) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L21A and 011J00A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Skin disorder NOS and Hair disorder NOS. Concomitant products included DOXYCYCLINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm). 10-Feb-2021, the patient experienced PYREXIA (ran a temperature 5 hours later/ next morning she had 101 temperature). On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (like the flu) and MYALGIA (body aches). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (like the flu), PAIN IN EXTREMITY (She had a sore arm), MYALGIA (body aches) and PYREXIA (ran a temperature 5 hours later/ next morning she had 101 temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: high (High) She ran a temperature 5 hours later. On 11-Feb-2021, Body temperature: 101 (High) She had 101 temperature.         Other concomitant medications included patient taking medications for blood pressure, skin and hair condition medications. No treatment details were provided.   This case was linked to MOD-2021-304944, MOD-2021-301915 (Patient Link).
6/05/2022  That evening I began having terrible body aches, it hurt so bad.  The next morning and my nose felt funny, strange. I felt strange. I took a home COVID test and it was positive. I called my cardiologist and my PCP.  My cardiologist referred me to my PCP.  My PCP could not give me Paxlovid because it was contra indicated with 3 of my heart medications.  He also told me there was no point to have the Monoclonal Antibodies Therapy Infusion, it was not very effective with Omicron.  I was really sick for 7 days. It finally started to get better, a little bit.  I have been unable to take another home COVID test because I am unable to open the bottle. I still have not recovered even though I am not getting new symptoms every day. The aching has stopped, but my nose is still stopped up.  I am also terribly weak.
pt recv vax & exp inj site rxn characterized by redness & swelling extending from the shoulder to the elbow;pt also devel a fever of 105 which was treated w/APAP & resolved;erythema @ inj site persisted @ the time of this report;
Rcied FluMist about 11am 11/2.  At 4am on 11/3 2 sudden onset rigors & fever, muscle aches/fatigue & extreme high fevers 103+ in spite of Advil.  Tamiflu began about 3pm & symptoms reduced by about 1/2.  Rash also developed in morning on 11/3 (macular & transient).  Rash spread on 11/5 on extremities, myalgias, increased Medrol Dose Pak & Claritin began. Symptoms slowly improved over next couple days.
Got shot on 3/31 then had rash next day in afternoon.  4/1, on 4/2 reported rash  under her breasts and behind neck (and on arm?). rash not raised itching spreading.   2pm Pt advised to go to urgent care/ shes off island.  refused to said will take benadryl.   Again urged her to reconsider.   2:30pm called back and said i spoke with nurse and she agreed she should go to urgent care.                   gave Her clinics  phone
feeling crappy/feeling unwell; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling crappy/feeling unwell) and MYALGIA (Myalgia) 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 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MALAISE (feeling crappy/feeling unwell) and MYALGIA (Myalgia). At the time of the report, MALAISE (feeling crappy/feeling unwell) and MYALGIA (Myalgia) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: TCR was received Contains No New Information
Covid Arm.  Red, Hot Itchy . Started 12 days after receiving first shot.
This case was reported by a consumer via call center representative and described the occurrence of back pain in an unspecified number of adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced back pain, walking difficulty and muscle spasm. On an unknown date, the outcome of the back pain, walking difficulty and muscle spasm were unknown. It was unknown if the reporter considered the back pain, walking difficulty and muscle spasm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured adult as per vaccine indication. The patients had no history of back pain. During conversation with the reporter, the reporter mentioned that he and his wife talked to their physician and physician was concerned about the back pain, muscle spasms and difficulty walking after receiving the SHINGRIX. The physician said to the reporter that, he had seen similar symptoms in other people. The reporter did not have specific demographics of other patients to report. This is 1 of the 4 cases reported by same reporter.
Facial swelling, Diffuse facial rash- 24 hours after vaccine administation Extreme fatigue- immediately following vaccine  x2 days  Evaluated by PCP and given IM Benadryl and Decadron
Patient developed diplopia, eyelid ptosis, muscular weakness and fatigability within 24 hours of receiving the SHINGRIX shingles shot. Symptoms have persisted and patient was diagnosed with myasthenia gravis.
Within 48 hours after I received my vaccination, I started to experience severe back pain.  I then noticed that I had two bruises on my back.  I put a ThermaCare patch on each of the bruises to help with the pain.  Within two days, the pain started to go away and the bruises started to fade.  The next day, I started to experience severe back pain again and I noticed that I now had three different bruises on my back.  I put a ThermaCare patch on each of the bruises and started to take some Tylenol for the pain.  I also called my Primary Care Physician.  I went in to see PCP on April 1, 2021.  During this visit, doctor indicated that I seemed to have burst blood clots in my back.  I currently have a little back pain but, I still have the three bruises.  They are starting to fade but, they are still very noticeable.
forearm of injection site broke out in a large rash, very red, and very itchy. a few days later , my right hand started to welp up. my knee had a small rash and my shoulder where the vaccine was injected had a rash and whole left side was just itchy.
Low-grade fever, headache (2-3 days), muscle pain (2-3 days), loss of appetite, nausea, fatigue, abdominal discomfort, diarrhea (2 days), bleeding in stool (5 times since July 2).
Rash started 5/13/12 on trunks. By the next day rash all over. Also had cough, sneezing the previous week. Low grade fever.
Dad stated pt became limp & ran a high fever for several days p/last DTP; MD told them not to have any more DTP's;
Acute local inflammation w/in 5-6 hours with associated fever 101 p.o., malaise, anorexia.
Nov. 4: ER for pain, edema at vacc. site, bruising to elbow. heat with ibuprofen Nov. 6: visit to Clinic.  edema of entire arm, bruising to wrist, large indurated area at vacc. site.
adverse event for patient had symptoms listed on the website; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fever and adverse event. On an unknown date, the outcome of the headache and fever were recovered/resolved and the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the headache, fever and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had headache and fever had for 2 days. The reporter asked how long the symptoms would last and ruled in for adverse event.  No patient demographics, LOT or EXP provided other than the patient being a female. The HCP information not obtained.
Got the Moderna COVID 19 vaccine Fatigue, crusty eyes, sore throat, stuffy/runny nose, feeling really hot/cold. Started feeling fatigue at 9:00pm (04/02) stuffy/runny nose at 10:00pm (04/02) crusty eyes and feeling hot/cold at 9:30am (04/03)
This spontaneous report was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored RECOMBIVAX HB (lot# L027733 and expiry date: 13-SEP-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Slight cough from 6:00 p.m. to 8:00 p.m.  09/29/09  Fever from 9:00 p.m. to 12:00 a.m. 09/29/09.  No treatment sought or taken.
Received first dose of COVID vaccine 3/9/2021.  on 3/22/2021 developed loss of taste/smell, rhinorrhea.  Tested positive for COVID.
pt recv 10 mcg dose for prophylaxis; w/in 3 hr exp hives on back and back of leg; treated with benadryl as noticed; sx resolved w/in 1 or 2 days
chills, headache, fatigue, generalized aches, intermittent nausea (no emesis)  -all symptoms lasting around 24 hours at this time
Initial pregnancy report received from healthcare professional on 30 January 2014.  A female patient, whose date of birth, age, medical history and concomitant medications were not reported, had received dose of ADACEL (batch number, dose number, route and anatomical site of administration were not reported) on 30 January 2014. The patient's last menstrual period and the expected date of delivery were not reported. List of documents held by the sender: none.
Developed a golf ball sized painful lymph node in my left axilla after getting the 2nd Pfizer vaccine in my left arm.  Associated with shooting sharp nerve pain radiating down the left arm in the medial nerve distribution, likely from nerve impingement. I am self treating with advil since I am a physician and giving it time to resolve
Febrile seizure occurred approximately 12 hours after vaccinations. Parent awoke and found pt seizing and foaming at the mouth. Mother called EMS and pt was brought to ER for examination.
Bodyaches, fever, headache, nausea (loss of appetite), extreme fatigue, chills, sweating, swelling at injection site, redness at injection site, warmth on the injection site
MUSCLE SPASMS FINALLY STOPPED 2 MONTHS AFTER VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced muscle spasms finally stopped 2 months after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasms finally stopped 2 months after vaccine. This report was non-serious.
I had a doctors appointment with that day at 2:30pm. She told me that because of my age, weight and medical history I should get the vaccine.  I came home, had lunch and went to get the vaccine.  Later on my left arm became very sore.  I went to bed and woke up about between 3 and 4 am ( Aug. 18th) with severe cramps in my feet. My left was the worst because the cramps went half-way up my left calf.  I woke my husband to come and pray for me. They lasted about 5 to 10 minutes. Since then my rt. thumb has been painful and this morning my rt.  wrist above my thumb has been hurting me.  I have never experienced this symptoms before.
Fatigue, chills, body ache, vomiting.  All night into next day
I broke out in full body hives for 6 days or so. I started taking prednisone after first day. I took 40mg of that for 2 days and then 50mg 3 days. I was recommended to take Zyrtecs, I took that in the first 3 days.
After 1:00 pm the day, I started warming up. I felt like I was getting sick. Had a little fever and joint aches. My knees and all my joints were hurting. And that happened until the end of the night and the next day there was nothing, I felt okay. I am having a really bad cold now. It started last Tuesday. A little sneezing, runny nose and dry cough and now it's a lot of mucous and feeling tired in general. Me and my partner also got it at the same time and had the same Johnson and Johnson at the same time. I talked to Kaiser (e-visit) and they told me to start using Cold and Flu - and prescribed an antibiotic - Doxycycline Monohydrate - 100 mg for 7 days - 2 caps per day. It's the worst cold that I've had - it's a really, really bad cold. Never had one this bad before.  I'm still not 100%. I still have dry cough, mucous and a little tired.
syncope; This spontaneous report was received from an administrator via company representative and refers to an 11-year-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in June 2020 (reported as last week), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as series of adolescent vaccines (exact dose, route of administration, lot number and expiration date were not provided), with a dose of an unspecified meningococcal vaccine (manufacturer unknown) and with a dose of an  unspecified diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine (exact dose, route of administration, indication, lot number and expiration date were not provided).  On the same day, the patient had syncope. He sought medical attention and he was in doctor's office. The patient was observed but no treatment and no lab diagnostic or studies were performed.  The patient fully recovered and he went home on the same day as administration. The causality assessment was not provided.   Upon internal review, the event of syncope was determined to be medically significant.
Systemic: he said his chest felt hot but no pain or issues with his heart-Mild, Additional Details: The hotness in his chest was there, and then it wasn't, then came back again. I told his mom to keep an eye on him and make sure it didn't get worse and if his heart started to be affected to get him to the dr. I took his temperature and it was the same as before I gave the shot.  The hotness started a few minutes after receiving the shot. Still felt a bit hot he said before they left the store.