chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient reports development of peroneal vein thrombosis about 1-2 weeks after J&J vaccine. patient was on a flight at this time. she saw her PCP for swollen legs are was diagnosed with superficial thrombophlebitis. patient started asprin 325mg BID.  after an ultrasound was done, it was revealed that the patient had right peroneal vein thrombosis as well as superficial thrombophlebitis of the medial right thigh. she was started on Xarelto 10mg daily. since taking Xarelto "tender lumpy spot on right upper thigh has gotten much better". patient has been referred to hematology to follow up.
Fever  first symptom was heat flashes at 2am on 1/22/2021; then bodyaches, extreme fatigue, chills. All resolved now Narrative:
PT STATES 'ON 2-9-21 SHE STARTED SEEING AND TALKING TO DEAD PEOPLE, SHE WAS UNABLE TO EAT OR SLEEP FOR A WEEK'. SHE ALSO HAD FEVER, CHILLS AND A SORE ARM AFTER THE SHOT. SHE WEN TO THE ER ON 2-22-21 AND WAS RELEASED WITHOUT TREATMENT.  SHE ALSO SAW HER PCP ON 2-22-21 AND WAS GIVEN ZOLOFT WHICH HAS HELPED SOME. SHE STATES SHE 'TOOK HERSELF OFF ALL HER MEDS SO HER SYSTEM WOULD BE CLEAN FOR THE SHOT.' 2-24-21 9AM TC - STATES 'LEGS TINGLE TODAY'. ADVISED HER TO CALL HER PCP ABOUT GETTING BACK ON HER MEDS TO HELP HER FEEL BETTER, STATES SHE 'WILL CALL PCP TODAY'.
Slight left arm injection pain then 20 min later felt shocks along right leg down to feet. Then immediately after felt muscle spasms, twitches that started in feet and legs.  This continued through the night and spread to my fingers, hands, and arms. The next day spasms and twitches continued and went up my legs, thighs, buttocks, abdomen, chest, and head. Went to primary dr two days later for muscle spasms, muscle twitches and charley horse in my thighs. The spasms and twitches proceeded to go through the rest of my body.  Primary dr referred me to Nuerology .Only one day of left arm injection pain.  For The next week I had diarrhea, cold feet that wouldn?t warm, no appetite or hunger signals, fatigue, knee popping in joints right side , left knee very sore one day, and continued muscle spasms, twitches, and Charles horse, and fatigue that continue and are on going.  Nuerology dr ran labs and added vit d, magnesium, b complex to help heal my nerve endings. Still consulting Nuerology to find out what happened and why I am still having muscle twitches, muscle spasms, charley horse in thighs, and fatigue five months out from first Pfizer vax.
Headache, shivering, aches, slight fever throughout the night until about 5 AM 12/06/2018.
Patient received her first dose Pfizer vaccine (LOT#: EW0162 Exp:7/2021) on 4/16/21 at 14:24. Patient alerted EMT when she felt a rise in her BP and some chest discomfort. EMT took patients vital signs. BP: 109/88, pulse: 80, O2: 99%. Patient took BP tablet (Captopril/Lpyrol, 1, 25mg) at 1438. Patient was asked to stay an extra 30 minutes for further observation. EMT retook vitals at 14:54 BP: 160/78, pulse: 72, O2: 98%. Patient stated that she was feeling better. EMT retook vital signs at 15:10. BP: 120/56, pulse: 72, O2: 98%. Patient stated that she was feeling fine now and had no symptoms anymore. Patient asked for water. Patient received water. Patient left at 15:15, walked out of vaccination site unassisted with a steady gait.
pt recvd vax;fever & chills;6feb96 rash  appeared chest & abd;joint pain on 4feb;
Got the 1st moderna dose on 2/5/21. On 2/12/21 she became very weak and short of breath. She was seen by her primary who referred her to another Dr. From there she was sent to the hospital and was there for 6 days. States she is unsure if they ever determined the cause. She is still short of breath today (4/27/21).
Patient's spouse reports flu like symptoms and low grade fever x 1week since getting vaccine. Has contacted PCP and pulmonologist.
got the shingle shot, shingles / suspected vaccination failure; shingles for 3 months; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's sister friend. The age at vaccination was not reported. The patient got the shingle shot and now had shingles for 3 months. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Painful and swollen lymph nodes under right armpit the same side I had the shot on. I first noticed it a week after and it progressively got worse throughout that day. I went to a doctor because I have a family history of breast cancer. He did a manual exam at the time. He gave me a referral to a specialist in two or three weeks if the pain didn't go away. It took two weeks to go away.
Redness/swelling/pain/warm, right upper arm (RD). Pt was seen by one of the providers.
Could not smell; a very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 14.00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history reported was asthma. Concomitant medication included sertraline (MANUFACTURER UNKNOWN) and DAYQUIL. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 16:00, the patient could not smell and had a very sore arm. The patient did not take any treatment for the reported events. The clinical outcome for the event loss of smell and very sore arm was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received 2nd Shot of Anthrax and had a Generalized Urticaria w/ breathing difficulty. The patient was administered Epinepherine and Benadryl Injection to control symptoms.  She was placed on 48 hour work limitations (quarters). She followed up 2 days later and continued to have generalized urticaria w/o breathing compromise.
Possible tingling on the side of my tongue; Dizzy; An extremely dry mouth with significant taste of metal; Significant taste of metal; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Possible tingling on the side of my tongue), DIZZINESS (Dizzy), DRY MOUTH (An extremely dry mouth with significant taste of metal) and DYSGEUSIA (Significant taste of metal) 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 PARAESTHESIA (Possible tingling on the side of my tongue), DIZZINESS (Dizzy), DRY MOUTH (An extremely dry mouth with significant taste of metal) and DYSGEUSIA (Significant taste of metal). At the time of the report, PARAESTHESIA (Possible tingling on the side of my tongue), DIZZINESS (Dizzy), DRY MOUTH (An extremely dry mouth with significant taste of metal) and DYSGEUSIA (Significant taste of metal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No treatment medication were provided.  No concomitant medication information was provided.   This case was linked to MOD-2021-244897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received on 02-Jul-2021 contains second dose administration details.
shingles; Hard pain in her spinal cord; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) and SPINAL PAIN (Hard pain in her spinal cord) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036ANA) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), PREDNISONE, CANDESARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced SPINAL PAIN (Hard pain in her spinal cord). On 14-Mar-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) and SPINAL PAIN (Hard pain in her spinal cord) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Patient states she has never received shingles vaccination, and she has Lupus.
patient said  she felt light headed. she had no problems breathing or swallowing    but said she felt as she described "funny" in the mouth. she wanted some water. Had no problems drinking or swallowing or speaking. she asked us to call an emergency ambulance to come check up on her. they came in about 3 minutes and took her blood pressure and pulse and said she was normal and did not seem to show any sign s of anaphylaxis. She said she was feeling a little better and walked out with the emergency crew to the ambulance vehicle outside accompanied by her husband. my tech went outside a little later and spoke with the emt personnel and he said that she was doing fine. I don't know the final outcome as of the time I am writing this report.
I normally wear a KN95 mask in public. I was in a school concert and didn't put my mask on. I assume that's where I got it because I got sick. I started out with a severe sore throat and headache. I had a drippy nose. I took a COVID-19 test and it was negative. Took another one a day later and it was positive. Called my infection disease doctor. My symptoms had worsened. I was running 101 temp and because of my past issues, my age, and my time span from being diagnosed from the first symptom, he put me on Paxlovid. Paxlovid is a total of 10 doses. After 4 doses, my temperature was back to normal and I felt 75% better.
Patient with 2 COVID vaccines who admitted with weakness and positive COVID PCR.  Provider d/c note:  "89 foreign speaking only YO female that presented to the ED with c/o GLF and difficulty walking. Chronic health conditions include T2DM  anemia  HTN  HLD chronic back pain on narcotic  CKD4  PAF  Pacer for T2 2nd degree . Patient/family  reports that yesterday morning she fell and ambulance came to help her up but she refused to go to the hospital. She had two small abrasions. This morning family checked in on her but she could not get off the sofa. Family stood her up and she had leg pain and she was shakey. Also she had breathing that sounded rattley. The family had COVID last week. Pain has improved since she was treated in the ED.  Treatments at home included taking her prescribed Norco.  Family reports that patient has taken all medications today except Pravachol and Norco which she normally takes 2x per day for chronic pain. (HPI per NP)   Hospital Course: No notes on file, patient is an 89yr old female with a history of HTN, DM. PAfib, Mobitz Type 2 on PPM, Chronic back pain, CKD who presented with difficulty walking following GLF and COVID.   GLF Multiple Compression Fractures - seen as progressed on CT Lumbar with most severe being at L4. MRI not done due to PPM. PT/OT recommending Home with 24hr supervision vs Home with HT vs Rehab. I contacted IR to see if patient is a candidate for kyphoplasty - need to know acuity of fracture, recommended bone scan. However today patient is denying any back pain and did well with PT without any limitation of movement attributed to pain. No need to bone scan or kyphoplasty and ok to discharge home. I discussed with patients son who agreed with plan.   COVID - Largely asymptomatic. No hypoxia and no indication for covid directed therapy   Discharge Exam: General - Elderly female, calm, not in obvious distress, appears to be confused HEENT - NC AT Heart - S1 S2 RRR, PPM in place Lung - Moderate air entry Ext - Left LE - dry scab over left heel             RLE - No overt sign of cellulitis Back - non-tender Neuro - AAO x3"
BODY PAIN; SHOOTING PAIN; COLD; PERSPIRING; HEADACHE; SLEEPY; WEAK; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included hodgkin lymphoma, and back surgery, and concurrent conditions included lung diseases, heart diseases, and arthritis, and other pre-existing medical conditions included patient had no spleen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sleepy. On MAR-2021, the subject experienced weak. On 27-MAR-2021, the subject experienced body pain. On 27-MAR-2021, the subject experienced shooting pain. On 27-MAR-2021, the subject experienced cold. On 27-MAR-2021, the subject experienced perspiring. On 27-MAR-2021, the subject experienced headache. Treatment medications included: clonazepam, hydrocodone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, shooting pain, and headache on 2021, and the outcome of cold, perspiring, weak and sleepy was not reported. This report was non-serious.
Heart attack; I also have memory problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101731179 (Pfizer).  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Family history included: "One heart attack" (unspecified if ongoing), notes: "My parents, both died form heart attack.". The patient took concomitant medications. The patient had no prior vaccines (within 4weeks). Vaccination history included: Bnt162b2 (Dose no: 1), administration date: 20Jan2021, when the patient was 78 years old, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Heart attack"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "I also have memory problem". The patient was hospitalized for myocardial infarction (start date: 2021, discharge date: 2021, hospitalization duration: 10 day(s)). Therapeutic measures were taken as a result of myocardial infarction. After second Pfizer shot, the patient had a heart attack and then after that at 16Nov2021, he had a booster shot. The next day (17Nov2021), patient read the information sheet that was given to him with the shot and that was when he discovered the side effects and record contacts and next week, his 3 weeks which occurred on my second heart attack would be coming up (3 weeks from 16Nov2021 will be next week). The patient wanted to know there was anything he could do so that he would not have another heart attack. When probed for the event is worsened, improved or persisting, Consumer stated, he was taking medications, blood thinners. What he was worried about was the Heat attack coming up from the Pfizer Vaccine. Consumer stated he had memory problem from the heart attack. The patient was in the hospital for 10 days. That was when they told the patient that he would have memory problems. If that sounds big because it was difficult to remember exactly.  The lot number for bnt162b2 was not provided and will be requested during follow up.
DID NOT TAKE DOSES ON TIME; A spontaneous case report was received from a nurse on 17-Oct-2019 for four consumers.  Based on the information obtained from the nurse four individual case safety report PVX201910-000804 (PVX2019-2599; first consumer), PVX201910-000805 (PVX2019-2600; second consumer), PVX201910-000806 (PVX2019-2601; third consumer), and PVX201910-000807 (PVX2019-2602; fourth consumer) were created and cross-linked in the database.  This case (PVX2019-2600) described a consumer who "did not take doses on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif and then did not take the remaining doses for several days.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take doses on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201910-000804:
This case was reported by a nurse via call center representative and described the occurrence of bursitis worsened in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included bursitis (in her right arm or shoulder started on Saturday, 28th July 2018) and pain (bursitis pain started on 28th July 2018). On 30th July 2018, the patient received SHINGRIX (intramuscular). In July 2018, less than a week after receiving SHINGRIX, the patient experienced bursitis worsened and injection site erythema. On an unknown date, the outcome of the bursitis worsened was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved. The reporter considered the bursitis worsened to be unrelated to SHINGRIX. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in the left arm. The bursitis pain had gotten worse over the week but the healthcare professional (HCP) did not believe it was related to SHINGRIX. This was how it presented the last time the patient experienced bursitis. The patient did develop redness around the injection site on left arm the day after receiving SHINGRIX but this had since resolved. The HCP called to see if steroids could be administered after SHINGRIX for the bursitis.
Patient presented to the ER on 10/9/05 with c/o headache, chills, and burning at smallpox vaccination site. Afebrile at time of visit however c/o recent fever history. Mild cough present at time of ER visit. Followed up on 10/11/05 with continued c/o chills, HA. Also presented with new onset chest tightness, and difficulty breathing. L axilla and R neck swollen. CXR done, Diagnosed with bronchitis and febrile reaction to smallpox vaccination. Clindamycin 150mg qd was started on 10/8/05 from previous clinic visit. Smallpox vaccination site redness was reported as improved following antibiotic treatment.
menveo vaccine to 6.5 week old; menveo vaccine to 6.5 week old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-week-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were provided as follows: The 6.5 week patient received Menveo, which led to inappropriate age at vaccine administration and off label use. The reporter stated that, next week patient was going overseas. No more information was available. The reporter did not consent to follow-up.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 08:00 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "injection site pain". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: It was reported that there was no other vaccine administered in four weeks from vaccination. The treatment was taken as some ibuprofen. patient was not tested for Covid post vaccination. Facility type Vaccine: Hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.