chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt brought in by mom and grma. A few red dots noticed on arms and face at bedtime on 11/7/22. Woke with much more rash in AM of 12/8/22, with most dense rash on face. No new known evironmental exposures.  Pt with pruritis of scalp and posterior neck. No SOB, no lip swelling, no diarrhea.  Tactile fevers at home. Temp 99.0F here in clinic.  On exam he is scratching his scalp.  No facial swelling. Mucous membrans moist.  Lungs clear, no wheezing. Heart RRR w/o murmurs. Cap refill < 1 sec.  Injection sites on deltoids w/o redness, tenderness or swelling. Starting in the upper leg and groin area he has a blanching macular papular red slightly raised rash that becomes more confluent the closer you get to his scalp and face where it is mostly confluent.  No vesicles or ulcers.  No petechiae. Pt had a Biofire nasopharyngeal swab done and was prescribed oral diphenhydramine for the pruritis and acetaminophen suppositories to replace the liquid form with f/u as needed.  Despite the negative NP swab I  do think it is more likely this is a viral exanthem rash, but because I can't find a pathogen, I am reporting this to VAERS.
Sever body aches and joint pain, swelling of the left arm, not just at injection site. Patient was bedridden for 5 days with fever, chills, night sweats, lethargy, shortness of breath, headache, nausea, and loss of appetite. little relief was provided by alternating NSAIDs and Acetaminophen. 9 Days post vaccination patient is still lethargic, and has painful injection site reaction and swelling.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No thyroid due to thyroid cancer" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, Pfizer COVID 19 Treatment from 09Mar2023 to 13Mar2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
woke up to vomiting, loss of appetite, dizziness, severe tinnitus, head congestion and pressure, headaches. Went to emergency room 3 days after and got IV fluids and prescribed prednisone and anti nausea meds. still having nausea and extreme tinnitus that will not stop. appetite is getting better but nausea still comes and gos.
Patient stated that she received a flu shot on 11/08/21, got a massage on 11/11/21, and then on 11/12/21 started experiencing muscle weakness and neurological issues. Stated she could not walk normal, could hardly pick her feet up, and has had ongoing muscle weakness and problems that have gradually gotten better.
My arm was real swollen, red, puffy, and tender. I had chills, bad headaches, and tiredness. On the second day I had nausea. I had uncomfortable pain in my arm. I put a compress, cold pack, and some heat on my arm to relieve symptoms from it. I couldn't even drive my car because my arm was so sore and stiff. I took some Extra Strength Tylenol 600 mg for the arm pain and headaches. I also put a wrap on my head to help with headaches. I took some nausea medicine as well. The feeling of nausea has subsided. After the injection the pharmacist didn't ask me to wait. When she injected the shot in my arm it had hurt this time. I couldn't even cook for myself or go to the gym. I was off work for this week. I am getting better but I still have a sore arm. I can't see my doctor until May 13, 2022.
Broke out in hives from head to toe; Difficulty breathing at night; Got both COVID 19 updated booster and Flucelvax shot the same day; Got both COVID 19 updated booster and Flucelvax shot the same day; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 61 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 14Sep2022 as dose 1, single (Lot number: 942404) intramuscular for immunisation. The patient's relevant medical history included: "Known allergy: Latex" (unspecified if ongoing); "Known allergy: Preservatives" (unspecified if ongoing), notes: Known allergy: Preservatives. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Sep2022 at 11:00, outcome "unknown" and all described as "Got both COVID 19 updated booster and Flucelvax shot the same day"; URTICARIA (non-serious) with onset 15Sep2022 at 20:00, outcome "recovered" (Sep2022), described as "Broke out in hives from head to toe"; DYSPNOEA (non-serious) with onset 15Sep2022 at 20:00, outcome "recovered" (Sep2022), described as "Difficulty breathing at night". It was unknown if therapeutic measures were taken as a result of urticaria, dyspnoea. Additional information: Patient got both COVID 19 updated booster and Flucelvax shot the same day at the pharmacy, on Wednesday 14Sep2022. She said she broke out in hives from head to toe and had difficulty breathing at night on 15Sep2022. Events were reported as non-serious.   No follow-up attempts are possible. No further information is expected.
29MAR93 pt recvd #2 series of immun mom said 2 hrs later pt started high pitch crying, cried all noc; also was breathing funny; temp 101; mom just now reporting when pt ready for 6 mo immun;
Patient hospitalized within 6 weeks of receiving COVID vaccination. He has been admitted since 4/13/21.
My COVID-19 symptoms started on 12/22/2022 in the evening at 07:00PM. I had fever of 102.08, scratchy throat, runny nose, and chest congestions. It was mostly on my upper respiratory. I went to the urgent care on 12/23/2022 they did COVID-19 test and Flu. I was positive for COVID-19 infection. At the urgent care they prescribe me with PAXLOVID for 5 days. I self tested with a home COVID-19 test on 12/30/2022 which was negative. On 01/03/2023 I had a runny nose and a slight headache. On 01/05/2023 I tested positive for COVID-19 again. I am not taking any medication just trying to stay hydrated. I did not take any COVID-19 tests yet.
two days of left side dull pain and tenderness from the base of my skull to my elbow
About 9 months after receiving these vaccines, my son started having chronic joint and muscle pain in right thigh/groin area.  The pain was so debilitating, he was often unable to walk,  he would limp or crawl due to pain.  Almost a year later and after extensive testing,  a muscle biopsy revealed Macrophages and Aluminum crystals striated throughout my son?s right thigh muscle, in the same area her received his vaccines.  The biopsy results showed that my son has Macrophagic Myofasciitis (MMF),  caused by the aluminum in his 2017 DTaP vaccine.  He has chronic, debilitating pain that has spread throughout his body and now he also has pain in both legs, arms, feet and hands.  He?s been living with this pain for almost two years.
This spontaneous report was received from a physician and refers to a 70 year old female patient. The patient did not have any pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 16-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, site and dose were not reported), subcutaneously. On 27-SEP-2016, the patient noticed rash and lesions on right chest area. On 29-SEP-2016, she experienced pain in the right chest area. The patient sought medical attention, she came to the physician's office but no treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
On the day after the first Moderna vaccine, I was extremely fatigued, had chills and generally felt bad. I stayed home from work and slept most of the day. I was able to go back to work on the following day, but still had fatigue, which never really went away. Starting on 1/22/21 I developed a cough and shortness of breath. I had to call in sick for a week of work (1/25-1/29), and call in for my air national guard drill (1/23-1/24/21). I had a covid test on 1/23/21 and 1/26/21, both of which were negative. I also called in sick on 2/5/21 and 2/8/21 and 2/18/21 due to fatigue and cough. I have bee prescribed Augmentin for 7 days, Advair and Albuterol inhalers, and am currently taking doxycyline. Achest xray was taken with no specific findings, and blood work was done, which was normal except for high WBCs. I have not had the second injection of Moderna vaccine due to illness.
Rash all over the body; Was really sick; A spontaneous report was received from a Consumer concerning a 72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, rash all over the body, was really sick.  The patient's medical history was not reported. No relevant concomitant medications were reported.  It was reported that the Patient had a cellulitis and she had been on antibiotics for 6 weeks.   On 8 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, Rash all over the body. Rash started on the arm and everything.  On 11 Feb 2021, the patient experienced the event, was really sick and she went to the ER.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events, rash all over the body, was really sick was not reported.   On an unknown date the outcome of events include, rash all over the body and was really sick was not reported.; Reporter'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.
Information has been received from a registered nurse (R.N.) concerning a 26-year-old female employee with no medical history and no allergies, who on 23-MAY-2007 was vaccinated with her third dose of a 1 milliliter intramuscular injection in the left deltoid of RECOMBIVAX HB (lot# 655810/1160F).  No concomitant medications were given.  On 31-MAY-2007 the patient experienced soreness at the injection site.  Medical attention was sought and no laboratory or diagnostic tests were performed.  The R.N. estimated that the patient had a 60 millimeter induration which was not red, but sore and painful.  The patient was recommended to use a heating pad and take Ibuprofen.  It is reported that 8 days later it still had not resolved.  No product quality complaint was involved.  Follow-up information has been received from the RN stating the patient was white who did not have any birth defects or medical conditions and did not have any illnesses at the time of vaccination.  A 60 mm induration at the injection site occurred on 02-Jun-2007, 10 days post-vaccination (previously reported as 31-May-2007).  The site was red, warm and sore.  The patient recovered on an unspecified date.  It was reported that the patient and her siblings have not had any adverse events following prior vaccinations.  Additional information is not expected.
2 day history of erythema, swelling and discomfort and itching involving entire right upper arm (right deltoid to elbow). Treated with cephalexin, cool compress and BENADRYL and allergy referral.
Pt positve for covid did not require antibiotics. Experienced a mechanical fall while at home.  Hit his head. Pt d/c home after evaluation completed.
Patient had throat swelling. Gave 0.3mg EpiPen, called 911, patient taken to ED. 2nd dose cancelled and scheduled Johnson and Johnson appointment.
Painful swollen lip on the following dates, 5/28, 5/29, 6/4, 6/20,  7/14, 8/6,9/1, 11/3.   was occurring close to every 3-4 weeks, tapering off to once every 2 months now.  swelling and pain has been less severe during the last 2 occurrences.  This has only happened twice in my life before this, both were a reaction to anti-biotics, which I immediately stopped taking.  I have not taken antibiotics for years
Recieved the vaccine on 8/30/21 at approximately 4 p.m. The next morning I had sinus like drainage from eyes with a slight runny nose. During the course of the 1st twenty four hours, I started to feel worse. I was lethargic and felt icky. When I got up on the morning of 9/1/21, the icky, flu-like feeling and symptoms had worsen. In addition, the injection site and along my left arm (to just above my elbow) was severely swollen and hot. I was quite fearful that I might have been having a stroke. This feeling last for about the next 2 days accompanied by sore shoulder and neck muscles and a floating headache. The arm and muscle soreness finally subsided on about day 3 - 4. However, I still have the floating headache.
This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 01-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (route, dose, frequency, and anatomical location were unknown) with lot # R018741, and expiration date 06-APR-2020 for prophylaxis. The pharmacist reported that since the vaccination, the patient experienced swollen arms and hands, and also developed tingling in his hands, and consulted the pharmacist. It was unknown if the patient had seen a physician regarding this issue. At the time of the report, the outcome of tingling hands and swollen arms and hands was reported as not resolved. The pharmacist did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination.
Colitis ulcerative aggravated/ulcerative colitis condition was getting worse; Ache/achiness; Headache; Fatigue; This is a solicited report based on information received by Pfizer (Manufacturer Control Number#: 21K-163-4126630-00). A contactable consumer (patient) reported that a 57-year-old female with events of non-serious ulcerative colitis condition was getting worse, headache, achiness and fatigue with adalimumab (Humira) subcutaneously from unknown dates then in 2020 until unknown date with unknown dose and frequency for moderate to severe ulcerative colitis. There was no reported medical history and concomitant medications. On unknown dates, the patient experienced ulcerative colitis condition was getting worse, headache, achiness and fatigue. On unknown dates, headache, achiness and fatigue resolved while outcome for ulcerative colitis condition was getting worse was unknown. Pfizer Biontech COVID-19 vaccine (tozinameran) was received intramuscularly on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response with the adverse events for adalimumab was permanently withdrawn on unknown date.  The reporter's causality for the event(s) of ulcerative colitis condition was getting worse, headache, achiness and fatigue with Humira (adalimumab) was no reasonable possibility while causality for the event of ulcerative colitis condition was getting worse with PFIZER BIONTECH COVID-19 VACCINE was not reported while not related for headache, achiness and fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The events of Colitis ulcerative, pain, headache and fatigue are related to the suspect product BNT162B2 based on plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The morning after my vaccine, on 10/6/21,  I began to have fasciculations in my left index finger and thumb.  By that afternoon I had significant axillary pain and fullness.  I self medicated with Motrin intermittently.  The fasciculations/twitching persisted intermittently in my left index finger and thumb for the next 10 days.  The only other symptom I noted was a mild headache on awakening  for 1-2 days. Overall except for very mild ongoing axillary discomfort and the odd sensations in my left hand I felt otherwise well and was able to hike 10 miles on 10/17/21. On October 18 I noted that I developed generalized twitching in my entire left hand and a sense that my grip was weak and my hand was  slightly tingling.  The morning of the 19th I noted that my R hand was also twitching slightly. I received a flu shot in my right arm on 10/19/21 at 2pm. Between 10/19/21 and 11/6/21 I have continued to have fasciculation in both hands although left is greater.  I have also note occasional fasciculations in my lips.  I was surprised to note that raking leaves on 11/3 I seemed to have fatigue in my upper arms and had to rest every 5 minutes or so.  When I go to bed at night I continue to note a vague sense of "restless arms" and by day I feel like my upper extremity strength and stamina is slightly decreased.  In the last 2 days I have also sensed mild fasciculations in my legs.
Patient asked for help from an employee and within seconds passed out while seated in a chair. Emergency was called immediately. Moved pt to a forward leaning position in chair and he came to but was disoriented and confused for a moment. Pulse was somewhat low when paramedics arrived.  Skin was pale and sweaty. After about 5 more minutes the patient vomited twice. Pt was now coherent and asking to use the bathroom. He was acompanied to restroom by paramedics.
Approx 2 hours after 1st dust became nauseated with diarrhea. This persisted for 5 days with several liquid stools per day. and mild nausea. Stopped RX after 1 dose. Seen by PMD who RX'd immodium for diarrhea which subsequently stopped after 2 doses.
Through quality checks it was discovered that the patient likely did not receive a full dose. Patient notified that it is recommended that they are re-vaccinated.
This case was reported by a nurse and described the occurrence of whole body rash in an 11 year old male pt who Engerix B. On 16 June 2004, the pt received the first dose of Engerix B in the right arm (lot ENG5570A2). On 16 June 2004, the pt also received injections of MMR II and tetanus toxoid absorbed. At an unspecified time following the administration of Engerix B, on 16 June 2004, the pt experienced rash and hives "covering the entire body." The pt was seen in an emergency room and was treated with Benadryl. The rash and hives remained unresolved. On 19 June 2004, the pt was seen again in an emergency room and was treated with medrol. The events resolved on 30 June 2004. the immunization series with Engerix B was discontinued. The nurse considered the events to possibly be related to vaccination with Engerix B.
pt recv vax & devel an inj site rxn characterized by redness, swelling & soreness w/in 24hr of receiving inj lot# 4978165;this is 1 of 4 pt from this facility to exp this rxn;
pt had a cold & mild infect several wks prior to flu vax 7OCT93; exp malaise p/immun; 9OCT93 devel SOB was hospitalized & adm to ICU for 2-3 days; Dx: acute pulmonary edema;
sore arm; was red / for few days; swollen / for few days; This case was reported by a consumer via (Facebook )  interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 pain in arm, erythema and swelling. On an unknown date, the outcome of the pain in arm, erythema and swelling were unknown.   It was unknown if the reporter considered the pain in arm, erythema and swelling to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was the patients wife. The patient received 1st dose of shingles and experienced sore arm ,redness and swollen for few days. No further information was reported. The follow up was not possible as no contact details were provided. This case has been linked with US2021AMR151903 and US2021AMR151908 , reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151903:Same reporter US-GLAXOSMITHKLINE-US2021AMR151908:Same reporter
After shot had some local soreness after 3 months still hurting whole upper arm muscle cannot raise arm or put behind back really sore and getting worse. Whole upper arm now hurting. ALEVE or TYLENOL not working for pain. She reported to us first time 6/15/2010.
patient stated the night after she received her injection the site where she received her injection felt like it was throbbing and it felt warm to touch, red and it felt like "an egg"
WITHIN 3 MINUTES PATIENT STATED HE COULD NOT BREATHE OR CATCH HIS BREATH. ALSO BROKE OUT IN A RED, FINE RASH ALL OVER HIS BODY. PATIENT WAS GIVEN 30MG OF PREDNISOLONE AND HIS SYMPTOMS SUBSIDED WITHIN 20 MINUTES. FOLLOWED UP WITH MOM TODAY, AND PATIENT NO LONGER HAS ANY SYMPTOMS.
Stevens-Johnson synd started w/fever, malaise, anorexia for 2 wks p/immun about 3OCT; Developed rash that spread over entire body; Tx Benadryl; Rash cleared w/in few days lasted at least 2 wks;
pt exp fever, chills, SOB, conjunctivitis, productive cough, grad resolved over noc followed by a confluent fine rash on neck & trunk;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, lot # K026386, expiration date: 15-DEC-2016  (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse the dose were exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015 for a total of 17 hours at 5.5C. This is one of several reports from the same reporter. Additional information has been requested.