chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy at rash area; Full body rash; hematoma is underneath; She states that the vaccine activated her psoriasis; both of her forearms were just itching like crazy; She looked at her elbows and it looks like a blister is underneath; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy), BLISTER (She looked at her elbows and it looks like a blister is underneath) and RASH PRURITIC (itchy at rash area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included AMITRIPTYLINE for Sleep problem, LORATADINE, FUROSEMIDE, SPIRONOLACTONE, VITAMINS NOS, COLLAGEN, MAGNESIUM, BIOTIN, POTASSIUM, VITAMIN D3, ZINC, VIBURNUM OPULUS BARK (CRAMP BARK) and MELATONIN for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy) and BLISTER (She looked at her elbows and it looks like a blister is underneath). On an unknown date, the patient experienced RASH PRURITIC (itchy at rash area) and RASH (Full body rash). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy), BLISTER (She looked at her elbows and it looks like a blister is underneath), RASH PRURITIC (itchy at rash area) and RASH (Full body rash) outcome was unknown.            Patient weight provided as 175, with no unit.  Patient was treated with two doses of prednisone, Antihistamine and Listerine.  Patient was given antihistamines, but symptoms just keeps getting worse and the rash was spreading all over. Patient had autoimmune disorder and psoriasis at baseline and did not take any medications for these conditions.   This case was linked to MOD-2021-242099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received that included added events, concomitant medications, patent weight, treatment information
Generalized hives, facial/lip swelling, ear swelling, fever, generalized muscle pain
Described as COVID 19 vaccine arm. Pt has reddened circular shape on arm of injected site that is medium in size. Pt denied itchiness.
This case was reported by a physician to a sales representative and described the occurrence of injection site burning in an elderly female patient who received hepatitis B vaccine recombinant (Engerix B). On an unspecified date, the patient received a dose of Engerix B (dose number and lot number not provide. The physician reported that the patient complained that the injection burns when being administered. The patient was seen at a physicians office. The outcome of the injection site burning was not provided. The reporting physician considered the injection site burning to probably be related to vaccination with Engerix B.
Patient received 0.25ml of Moderna Covid vaccine as a booster while under the age of 18
This spontaneous report as received from a Nurse Practitioner refers to a set of twins patients of unknown age and gender. On 23-AUG-2007, the patients were vaccinated with the first dose of RECOMBIVAX HB (dose, strength and route: Not reported). On 12-AUG-2008, the patients were vaccinated with the second dose of RECOMBIVAX HB (dose, strength and route: Not reported). On 12-SEP-2008 (4 weeks after the second dose), the patients were vaccinated with the third dose of RECOMBIVAX HB (dose, strength and route: Not reported). There was not concomitant medication reported. No adverse effects were reported. Patients outcome was unknown. Additional information has been requested.
Chronic myocarditis, reduced ejection fraction, severe LVH in previously healthy, athletic male.
chills--lasted 36 hours,  body aches, headache, sore throat, congestion, nausea, fatigue--continuing 72 hours later vomiting, diarrhea--30 hours
Persistent pain in upper left arm at site of injection. Pain radiating to wrist and shoulder. Stiffness and pain of arm requiring daily ibuprofen. Inability to sleep on left side w/out pain.
Began breakthrough menstruation (even though taking daily birth control pills) one day after receiving COVID-19 vaccine. Menstruated for 10 days with daily cramping. Called doctor on Monday.
Rash on abdomen and legs initially, followed by rash on scalp to soles of feet.
Two hours after the injection, pt reported SOB, coughing (productive), and tightness around his neck.   Pt's wife called RN around 1615 to report symptoms and RN instructed them to seek emergency care.   Pt's wife called ambulance and patient was treated at local hospital.
Pt reported two episodes of shaking all over entire body lasting 1 min 30 sec the other lasting 5 mins; eyes closed skin cold & clammy, t101; Seen by MD ? poss sz;
soreness at injection site; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062620A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker complication and Hypothyroidism. Concurrent medical conditions included Seasonal allergy and Constipation. Concomitant products included LEVOTHYROXINE, LUBIPROSTONE (AMITIZA), SODIUM CHLORIDE and ATORVASTATIN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
While patient walking to observation area after vaccine, observation nurse noticed patient self-administer dose of HHI and complain of SOB. Observation nurse called to EMT and MD for evaluation. Patient moved to EMT via wheelchair. O2 Sat and other Vital Signs monitored and within normal limits. IV placed in right hand. Patient given 2 more doses of HHI Albuterol in Triage Area.  Paramedics assumed care and transported to Medical Center for evaluation .
Patient started to experience some soreness the following day. They have tried aleve once and have not tried icing in. The soreness has gotten better, but is it not completely gone.
Dermatitis on the face: flush, hot, scaly skin, itchy, inflamed. When I finish medication, the flush returns like the first day. I still have it.
parents of daughter immunized w/OPV (2 different immun/episodes) & had adverse events; pt's father exp muscle cramps, stiffness & tightness in legs & arms following daughter's last OPV immun; afebrile; blood studies neg;
Initial unsolicited report received from a pharmacist on 03-Nov-2017. This case involves a male patient (age reported as more than 65 year), who was vaccinated with a dose of FLUZONE HIGH-DOSE (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Patient's medication history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced the worst vertigo and almost to the point of syncope. Lab data and corrective treatment were not reported. Event outcome was not reported. List of documents held by sender: none.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-FEB-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N023024 with expiration date 23-AUG-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373: US-009507513-1907USA010303:
Jansen COVID-19 vaccine EUA. Chills/fever until about 05:30 am today, headache yesterday and today
This spontaneous report was received from a health professional refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were inadvertently vaccinated with improperly stored GARDASIL 9 (unspecified lots/expirations) (incorrect product storage). This is one of the four reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to 13 month old patient of unknown gender. On an unknown date in April 2014, betweeb 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hives appeared on right forearm first, then left forearm. Lasted approx. 15 min.
Pt become weak, Diaphoretic, and almost passed out. Pt was assisted to the laying position. Vitals were taken, Juice was offered and declined. Pt stated she just had a smoothie.
Sudden onset tinnitus in the right ear and decreased hearing Not sure if related, but if there is an increased incidence of these types of reactions, wanted to report.
I contracted COVID-19 on 06/30/2022 with symptoms runny nose, sore throat, fever of 101 at highest point, and congestion. I was prescribed PAXLOVID on 07/03/2022. My symptoms began to improve after I began taking PAXLOVID. I am fully recovered, and my symptoms resolved after 5 days. I did experience diarrhea after I began taking the PAXLOVID, but it has improved as of day 4 of medication.
Follow up telephone call to patient after recieving the Johnson & Johnson (J&J) Janssen vaccination on 3/31/21 was made 4/15/21. Patient was screened for warning signs of blood clots and patient answers yes to having severe headache and shortness of breath. Denies any abdominal pain and leg pain. Patient states symptoms began 4/6/21 at around 6pm in the evening and continue to the day of telephone call. Transportation arrangement was made for patient due to lack of transportation to go seek medical attention in ER. Patient was transported to ER for medical evaluation. Upon review of patients chart, patient was seen 4/15/21  in ER. Patient did not report any symptoms of severe headache and shortness of breath. Patient complains of having common cold in ER.
Participant noticed a knot after 2nd dose and she had a tendinitis flare up in her left shoulder which is the same arm where the shot was administered. 12 hours after vaccine she noticed she had a fever and after 48 hrs, she  was feeling normal. She had been advised by her doctor to take Benadryl so there was not any itching experienced as there was with the first dose. She took Tylenol for the fever for a few days and was fine.
Headache, stomach cramps, dizziness, shaking, fatique, joint pain, nausea
inflammation that was now all over my body; swollen; cold which hurting; sweating; Diarrhoea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating) and DIARRHOEA (Diarrhoea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included MS, Penicillin allergy, Allergy to plants (Poison Ivy reaction), Pain and Drug allergy (Darvocet allergy). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating), DIARRHOEA (Diarrhoea) and VOMITING (throwing up). At the time of the report, INFLAMMATION (inflammation that was now all over my body), SWELLING (swollen), NASOPHARYNGITIS (cold which hurting), HYPERHIDROSIS (sweating), DIARRHOEA (Diarrhoea) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received with significant information patient initials updated, past medical history updated,new events were added.
Bell's Belsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Belsy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 031B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ELETRIPTAN for Migraine, VITAMINS NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (Bell's Belsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Belsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event treatment information was not provided by the reporter.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
COVID vaccine breakthrough case. Moderna 4/19/21 043B21A, 5/17/21 041C21A and boosted 11/16/21 067F21A.
My daughter was vaccinated May 26. When her period started the following week she had a cycle unlike any she's had in the previous 3 years since she started menstruating. Her cycle was sporadic, heavier than ever and lasted longer. Simultaneously, she felt faint constantly for over 4 days, was unable to stand for more than 15 minutes, and was nauseated constantly for 5 days during her period. The ONLY thing that is different in her life this month is that she received her first dose of the vaccine. Her doc had bloodwork done and her results were perfectly normal, meaning there is no other reason to point to other than the fact that she had the 1st vaccine dose.
deaf in my left ear; This case was reported by a consumer via media and described the occurrence of deafness unilateral in a 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 deafness unilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the deafness unilateral was unknown.   The reporter considered the deafness unilateral to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient stated that, Shingles vaccine made him/her deaf in left ear.
pt devel confluent, erythematous, macular rash on neck & all 4 extremities 4-8hrs p/initial vax given; no resp involvement given DPH x 1; t99.3 R; 48 hrs later t100.3;
This case was reported by a physician via sales rep and described the occurrence of macular rash in a 39-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus (patient with mixed connective disease or lupus who also has autoantibodies to single stranded DNA), immunocompromised (immunocompromised state) and mixed connective tissue disease. On 18th March 2019, the patient received SHINGRIX. In March 2019, 1 day after receiving SHINGRIX, the patient experienced macular rash, papular rash and pustular rash. On an unknown date, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the macular rash, papular rash and pustular rash were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and off label use were unknown. It was unknown if the reporter considered the macular rash, papular rash and pustular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a macular, papular, pustular rash 1 day after vaccination and it is still present 5 days post vaccination. The reporter understands that they vaccinated off label at an inappropriate age, but her rheumatologist wanted her vaccinated due to her immunocompromised state. The reporter stated that he would be seeing this patient in about 19 minutes when he spoke to GlaxoSmithKline and reported that they would be filing a VAERS report so the reporter did not feel the need to provide any additional details.
POST COVID ISSUES IN LUNGS; CONFIRMED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID INFECTION; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 20 year old not. Initial information was processed along with the additional information received on 19-OCT-2021. 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 not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the reporter noted that the patient had fever and chills when having the vaccine initially, which was severe and lasted a few days. On AUG-2021, the patient experienced confirmed clinical vaccination failure. On AUG-2021, had a breakthrough covid infection. The patient received the positive test result in London while visiting her parents. Reporter was unsure of how severe the symptoms were, confirmed that the patient have covid symptoms. The patient did not get hospitalized, still has post-covid issues in terms of lungs. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid infection, and chills, and fever on APR-2021, had not recovered from post covid issues in lungs, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000198165.; Sender's Comments: V0; 20211038430-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a nurse concerning a 7 year old patient with no pertinent medical history or drug reactions/allergies who on 30-DEC-2003 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided). There was no concomitant medication. On 10-MAY-2010 the patient came into the office and was diagnosed with varicella. The nurse reported that the patient had less than about 100 vesicles on the left knee to the hip. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Follow up information has been received from a registered nurse. It was reported that the male patient with attention deficit disorder and depression, on 30-DEC-2003 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). The nurse reported that the patient was diagnosed with chickenpox on 10-MAY-2010 with less than 100 vesicles. The lesions began on 08-MAY-2010. The lesions cleaned up on 15-MAY-2010. On 17-MAY-2010 the patient returned to school with out complications. The patient did not required an emergency room/doctor visit. This is one of several reports received from the same source. Additional information is not expected.