chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of indication not provided). The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date [reported as shortly after receiving the ZOSTAVAX], the patient developed a painful rash accompanied by persistent pain. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. At a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the events was considered to be not recovered. ZOSTAVAX did not prevent shingles and persistent strain of herpes zoster were considered to be disabling. Additional information has been requested.
This case was reported by a consumer and described the occurrence of nausea in a 63-year-old female patient who received TWINRIX adult (batch number HZ9Z9, expiry date 3rd March 2017). Co-suspect products included Hepatitis B vaccine for an unknown indication. The patient's past medical history included needle stick/puncture (occurred at job). Concurrent medical conditions included allergy. Concomitant products included ZOSTAVAX, Pneumonia Shot, Influenza Shot, cholesterol and Anti-Cholesterol Medication, Blood Pressure Med and Hormone Cream (Nos). On 30th November 2014, the patient received the 1st dose of TWINRIX adult 1 ml. On an unknown date, the dose was an unknown dose. On 13th January 2015, the patient received Hepatitis B vaccine. On an unknown date, less than a day after receiving TWINRIX adult and an unknown time after receiving Hepatitis B vaccine, the patient experienced nausea, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. The reporter considered the nausea to be almost certainly related to TWINRIX adult. Additional information received: Female patient received TWINRIX vaccine on 11/30/14 followed by Merck's Hep B vaccine on 01/13/15. Also stated that patient experienced nausea following TWINRIX injection. Occurred the day of injection and resolved within one day. Reporter also mentioned unrelated event of a occupational needle stick at the patient's job (placed in past medical history). No further details to provided.
Llittle redness; Confusion; sensitivity at the injection site in her arm; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), INJECTION SITE HYPERSENSITIVITY (sensitivity at the injection site in her arm), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Llittle redness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included LAMOTRIGINE for Bipolar disorder.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CONFUSIONAL STATE (Confusion), INJECTION SITE HYPERSENSITIVITY (sensitivity at the injection site in her arm), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Llittle redness). At the time of the report, CONFUSIONAL STATE (Confusion), INJECTION SITE HYPERSENSITIVITY (sensitivity at the injection site in her arm) and VACCINATION SITE ERYTHEMA (Llittle redness) had resolved and CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            Patient took 10 medications for unknown indication reported by reporter. Patient took a nice shower and that did the trick. The redness is gone and no longer is sensitive to the touch as before   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18MAR2021, updated patients date of birth and additional events little redness and sensitivity at the injection site in her arm and treatment done for those events. On 27-Apr-2021: Follow up received on 27FEB2021, no new information.
Based on googling around, I think I have "COVID arm" a.k.a. delayed cutaneous hypersensitivity - about 30 hours after receiving the second dose of the Moderna vaccine, I noticed that the area around the injection site was red and swollen. It was even more red and swollen the next day (as I write this, approximately 48 hours after receiving the vaccine). It is not itchy, and it is not particularly soar (my arm was much more soar from the first shot, which did not result in this same swollen redness). Only the appearance is noteworthy.
This case was reported by a consumer via call center representative and described the occurrence of blister in a 75-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (around the age of six or seven years). On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 10 days after receiving SHINGRIX, the patient experienced blister and varicella-like rash. On an unknown date, the outcome of the blister was unchanged and the outcome of the varicella-like rash was not recovered/not resolved. The reporter considered the blister and varicella-like rash to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient remembered that in the year 1972 or 1973 that his kids had chickenpox and he developed similar blisters at that time. His children's pediatrician told him that he had the chickenpox, too. The patient received SHINGRIX on the left arm. Approximately 10 to 14 days after receiving the SHINGRIX vaccine, the patient noticed four blisters on the inside of his upper left calf, about an inch below his knee. The patient said they looked like the chickenpox. Three to four days later they appeared to be filled with water. Three to four days after days after that the blisters were almost gone. A day before reporting, on 10th July 2018, the patient noted that he had three to four blisters on the left side of his neck, one blister on his left cheek, one blister on his right cheek, and one in the inside of his left ear. All of these new blisters are filled with fluid. On the date of reporting, the patient noticed a fluid-filled blister on the top of his left thigh. The reporter gave permission to contact his physician.
Patient developed sarcoidosis within 3 weeks of obtaining vaccine. Inflammation was contained mostly to ankles/feet. Initial blood work  showed a marker for inflammation. Follow up bloodwork ruled out Lyme disease and other reasons for inflammation. X-rays of feet and chest were normal and CT scan of chest showed inflammation in lungs. Patient was put on prednisone which was tapered after 7 weeks.
Dr. reported to us signs of allergic reactions of fever, swelling & oedema at site of injection (back of right arm).
About 10 min post injection the Pt said they were not feeling well. Shortly after that the pt looked dazed, eyes dilated bilaterally, and would not verbalize a response to commands. About 2 min later the pt acted as if they woke up. The pt stated that they had not been able to see or hear. The pt said their hearing and vision was still altered. The hearing and vision improved to near normal over then next 5 min.
Swelling, bruising, weakness in limb, muscle weakness, redness, pain, chills.
Pressure on throat, wheezing, coughing, dizziness, weakness, sore eyes, exhaustion, hoarseness
Developed symptoms on September 21. Initially started out with cold like symptoms, runny nose, sneezing, ear ache, congestion, sore throat, upper chest cough. Then 24 hours later I started running a fever of 102 with extreme chills, I've never been so cold in my life, as well as extreme body ache. The third day my temperature topped out at 103 and developed nausea and diarrhea, and my cough deepened. On the 4th day my fever broke but I still felt horrible. I finally had enough strength to take a COVID19 test and it immediately came back positive. I was able to call my doctor and she prescribed Paxlovid. I took that for however long I was supposed to take it. Most of the symptoms went away except for the cough and the weakness. It was a solid two weeks before I got my strength left. I felt really washed out, I just didn't have the energy, didn't leave the house for almost two weeks. In October I had a really bad upper respiratory infection. I tested negative for Influenza and COVID19 so they surmised I had RSV. I feel like I am only now getting back to normal, not quite there yet.
About 15 minutes after administration of vaccines, mother stated that he started getting runny nose, itching in back of throat/nose.  No difficulty breathing, no stridor.  Patient was sent to ER for anti-histamine/further treatment.  Mother then stated that this had happened before at another clinic.  Patient had redness and swelling to right deltoid region only 24 hours later.
Pt recvd vax & 24 hrs post vax exp egg-sized swelling of the upper arm;
24 hours after injection of Dtap (Daptacel) observed to  have swelling in L upper leg down to knee.  Hard Lump at site of injection.  Cranky and restless last night per mother
HARD, WHITE, NON-PAINFUL LUMP ON HER UPPER GUM ABOVE HER FRONT TEETH WHICH PATIENT REFERRED TO AS MOUTH ULCERS; A COUPLE OF HOT FLASHES; TIREDNESS; SORE ARM WHERE VACCINATED; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031,  expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 in left arm  16:45 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced a couple of hot flashes. On 09-MAR-2021, the subject experienced tiredness. On 09-MAR-2021, the subject experienced sore arm where vaccinated. On 12-MAR-2021, the subject experienced hard, white, non-painful lump on her upper gum above her front teeth which subject referred to as mouth ulcers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a couple of hot flashes, tiredness, and sore arm where vaccinated on 09-MAR-2021, and had not recovered from hard, white, non-painful lump on her upper gum above her front teeth which patient referred to as mouth ulcers. This report was non-serious.
it felt like it developed a cold in head; the side if my ear like a fluid which gonna like it would be draining and now it feels like the blood vessels in the side of my head feel strange; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0182) 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "it felt like it developed a cold in head"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "the side if my ear like a fluid which gonna like it would be draining and now it feels like the blood vessels in the side of my head feel strange".  No follow-up attempts are possible. No further information is expected.
scratchy throat; felt lightheaded; rash flare up to a medication which stopped after the vaccine.; big knot on arm near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratchy throat), DIZZINESS (felt lightheaded), RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (scratchy throat), DIZZINESS (felt lightheaded), RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site). At the time of the report, THROAT IRRITATION (scratchy throat) and DIZZINESS (felt lightheaded) outcome was unknown and RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site) had resolved.            Consumer states it also opened up her sinuses where she could smell better. consumer reports that she felt lightheaded after 2nd dose of the vaccine  No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-272980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Sig- Follow Up received-TCR--Events outcome was updated.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that  underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
MODERNA BOOSTER - 24 HOURS AFTER HAD CHEST DISCOMFORT, WEAKNESS, AND COULD NOT WALK - WENT TO ED - DISCHARGED 8 HOURS LATER WITH NO FINDINGS AND WAS TOLD IT WAS A SIDE EFFECT OF SHOT, BACK TO NORMAL 72 HOURS LATER
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # K016154, expiration date 24-SEP-2016; lot # K024824, expiration date 02-DEC-2016; lot # L009214, 17-MAR-2017; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had diabetes, breast cancer and hypertension. Presented to the ED with a fever of 104, productive cough, shortness of breath, loss of taste, fatigue, and low oxygen saturations. She was diagnosed with COVID one week ago.  Patient was admitted with COVID PNA and was placed on a ventilator on 8/22/2021. Patient developed significant bradycardia due to COVID myocarditis. She had only received her first dose of Moderna 8/3/2021. She continued to deteriorate and family chose to terminally extubate her and she expired on 9/4/2021.
Runny nose after his second dose of the Moderna vaccine; Wasn't feeling well after his second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose after his second dose of the Moderna vaccine) and MALAISE (Wasn't feeling well after his second dose of the Moderna vaccine) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose after his second dose of the Moderna vaccine) and MALAISE (Wasn't feeling well after his second dose of the Moderna vaccine). At the time of the report, RHINORRHOEA (Runny nose after his second dose of the Moderna vaccine) and MALAISE (Wasn't feeling well after his second dose of the Moderna vaccine) outcome was unknown.            No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: No new information was added
Mother telephoned school nurse and reported pt woke up in the middle of night and could not move. Had pain all over, crawled to bathroom. Temp 101.5 all day 9/28/2000 but feeling fine and no muscle problems. Returned to school 9/29/2000.
Swelling and redness from top of arm to elbow are, no cellulitis.  Arm very sore. Patient came into office on 8/1/17 and was also noted to have lyme rash on his abdomen. He was sent to local ED, had labs drawn, tick panel pending.
About 10 minutes after receiving the shots my left arm went numb and I was unable to move it without concentrating on the action for about 15 minutes. 5:00 PM began feeling nauseous within an hour I had developed a low grade fever. By 9 PM I had a fever of 100, I took 2 Ibuprofen 200mg and went to bed. I woke up sweating and shaking at 10:59 PM. The next morning I didn't have an appetite, but ate oatmeal for breakfast. By 10:30 AM I was feeling dizzy with a headache and extreme nausea when standing. The low fever returned around 2 PM. By 6PM my temperature had returned to 100 this time with body aches I took 2 more Ibuprofen. The next day I still didn't have an appetite, but the fever and nausea were gone.
Focal erythema and edema at site of injection from 1/1/21-1/5/21. On 1/5/21, started having nausea, vomiting, lightheadedness. On 1/6/21, had worsening nausea, vomiting, anorexia, lightheadedness, bilateral eyelid erythema, eyelid and periorbital swelling (difficulty opening eyes), lip swelling, and maculopapular rash covering both arms, chest, abdomen, and back.  On 1/6/21, started taking benadryl 200mg every 8 hours, tylenol 650mg every 8 hours,  ibuprofen 800mg every 8 hours, and loratadine 10mg every 12 hours. Rash resolved within 24 hours of taking medication. Eye/lip swelling resolved within 72 hours of taking medication. Nausea, vomiting, and lightheadedness resolved 24-48 hours within starting medication.  No personal history of allergies or previous reactions to medications or vaccines. No new medications and no new exposures.  COVID-19 NP swab after symptoms was negative.
I was like tired; Headaches which comes and goes; Straight at 99.5 and it went to 99.9; Joint Pain from head to toe; Foggy/ Weird feeling/ Back of my neck, upper-lower back my elbow it was just like my legs which is just in a lot of joint pain/ just didn't feel quite like myself; t was all expected the painful site; This is a spontaneous report from a contactable Nurse (patient). The 59-years-old female patient received first of bnt162b2 (BNT162B2, lot nunber: EH9899), unknown on an unknown date in Dec2020 at SINGLE DOSE on Left Deltoid for covid-19 immunisation. Medical history included Patient History: No. The patient's concomitant medications were not reported. It was reported "I had this vaccine, my dad gave it to me Thursday about noon and last night I became very symptomatic, I am feeling a little better today and it said to report the symptom, I mean it was all expected the painful site but I feel very fatigue I mean I was like tired, headaches which comes and goes through on 01JAN2021 and not sure I don't normally have unless it's my sinuses so this is the headache I believe the Tylenol didn't do anything for it (Further clarification was unknown) and I have been taking Tylenol and Ibuprofen, a fever I experienced last night went from straight at 99.5 and it went to 99.9 just kind feel foggy, it was just a weird feeling I experienced, Joint Pain from head to toe, I mean back of my neck, upper-lower back my elbow it was just like my legs which is just in a lot of joint pain and just didn't feel quite like myself I guess pretty much just to say. I was due to get it the 2nd one on the 19th and I was told you may have more symptoms with that one, is that correct?" The patient took Tylenol and Ibuprofen for joint pain and fever. The outcome of the events was unknown.  No follow-up attempts are needed..
Body ache; swollen lymph node on injection site; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: QL9262, Expiration date not reported), via intramuscular route of administration in arm left on 03Feb2021 13:00 (at the age of 35-year-old) as single dose for COVID-19 immunisation. Medical history included Pre diabetic, hypertension, PCOS and allergic to Macadamia nuts; all from an unknown date and unknown if ongoing. The patient had COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced body ache, swollen lymph node on injection site and fatigue on 04Feb2021 14:00. The seriousness of all events was reported as non-serious. The patient underwent lab tests and diagnosis which include: COVID-19 prior to vaccination. The patient did not receive any treatment for the events. The outcome of all events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.