chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports she received Moderna Covid 19 vaccine lot #039K20A on 12/31/2021. Patient reports she developed fatigue, T 100.8, swelling and hardness at injection site 24-48 hrs after receiving vaccine. Patient self managed with Tylenol and rest. The following week, patient reports she had intermittent odd heart sensation. On 1/12/21 patient noticed a 5-6 inch red itchy mark at injection site. That night, patient developed tinnitus in the right ear. On 1/13/21 patient went to Urgent Care, then saw her otolaryngologist. Patient reports she had an ECG and labs. These tests were normal. On 1/15/21, patient went to PCP. Patient had halter monitor and is awaiting results. PCP submitted referral. Patient is awaiting appointment with allergist and employee health provider. Patient missed 3 days of work. Patient states "redness at injection site is fading and tinnitus is better."
Within one hour an anaphylactic reaction, acute emesis, red rash, pruitis-extreme hives-red-rash diffuse, stable vital signs, negative oral swelling, negative respiratory distress, negative wheezing, negative diarrhea
Reporting is for administration error: patient was given dose outside of current recommendations.  Patient was given what was thought to be a first dose of Shingrix, but discovered to be a third dose during submission of vaccination into registry.
Exposed to chicken pox 1 month ago; pox started on Jan 13 started on trunk, spread all over; new lesions as of Jan 19; some starting to scab; no temp, very pruritic.
1. Uncontrollable shaking right hand and leg (on and off/mostly when being still). 2. Pain in veins (especially the wrist) on the right side (from shoulder to the palm of my hand). 3.  Burning/tingling sensation in soles of feet and palms of both hands.
1 anxiety, 2 allergy, 3 poor sleep, 4 panic, 5 upset stomach or irritation, 6 sexual dysfunctional
Changes to my menstrual cycle (breakthrough spotting within a week), then a much longer time frame before my next period happened (46 days?)  Additionally, started experiencing significant hair loss within 2-3 weeks of 1st shot that has continued. However, I also received the 2nd, and 3rd Moderna booster shots so they could also be contributing to continued hair loss.
Patient woke up yesterday 11/27/2019 with a big red swelling on hand and itchy red palm. As day went on, knees became very hot, swollen and itchy. Red welts appeared all over arms, then last night red, swollen, hot and itchy areas at the base of both thumbs. Welts continued to appear on arms. shoulders, legs and hip areas. This morning patient woke up with very swollen hands and itchy all over and knee soreness.
was administered deptacel in error only dt portion was given without Pertussis with no adverse event reported; Initial information received on 11-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who experienced was administered deptacel in error only dt portion was given without pertussis with no adverse event reported while receiving vaccine Diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, mumps vaccine, rubella vaccine (mmr) for Immunisation.  On 08-Apr-2022, the patient received Diphtheria-15/tetanus/5 ac pertussis vaccine at a dose of 0.5 ml  lot C5733AA  (expiry date : 22-MAY-2022) via intramuscular route in unknown administration site for immunization.  On 08-APR-2022 the patient developed a non-serious was administered deptacel in error only dt portion was given without pertussis with no adverse event reported (wrong product administered) following the administration of Diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (was administered deptacel in error only dt portion was given without Pertussis with no adverse event reported).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event was administered deptacel in error only dt portion was given without pertussis with no adverse event reported.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient had Menactra injection Thursday. Yesterday he began to have swelling under left arm. The injection site on left arm is also red and swollen. he left school yesterday had a headache and slept most of the day.
Information has been received from currently 34 year old female consumer concerning herself with psoriasis, diabetes, polycystic ovary disease and bipolar disorder. The patient was not pregnant. In 2007, the patient was originally vaccinated with a dose of VARIVAX (Merck), 1 shot (lot # and expiration date unspecified), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), insulin, risperidone, unspecified birth control medicine and unspecified nasal spray. On an unspecified date, after receiving the vaccine, she began to experience itchiness and pain in her arms which had been afflicted with a severe case of psoriasis since childhood. The next day she noticed that the psoriasis had cleared largely from her arms, with pustule and plaque removal. Over time she noticed the psoriasis in her arms began to return, so she began to take VARIVAX (Merck) to clear flare ups and hoped to remove the psoriasis from the rest of her body. On an unknown date, she also experienced weight loss, and a faster metabolism which had helped her diabetes. No treatment was given for weight loss and faster metabolism. On an unspecified date, blood and urine studies were performed, but the results were not provided. After administered 10 shots of VARIVAX (Merck) (detail information concerning the dose and frequency unspecified) over the subsequent years, her psoriasis had been in remission and had not returned as a result of any normal triggers such as stress or diet. The patient had been sharing the results with her doctor. The outcome of weight loss and faster metabolism was not resolved (It was also reported that the events reappeared after reintroduction of VARIVAX (Merck)). The patient reported the events in hopes of having her results shared and that the product could be investigated for use in treating psoriasis and other inflammatory related issues and also wanted to submit her documentation. The patient also noted that after receiving GARDASIL, she experienced alleviation of her symptoms from Polycystic Ovarian Syndrome (capture into MARRS # 1601USA000100). Additional information has been requested.
Began experiencing mild chilling approximately 8 hours (6pm) post vaccine. Chills progressed and became more severe, by 11 hours post vaccine (9pm) chills were very bad and fever began to spike. I did not have a thermometer, so did not get an accurate temp, but guess it was in the 102 - 103 range. Took Tylenol to reduce fever to no effect. Fever persisted until 2am or so on 4/2/2021. Woke up 4/2/2021 at 7am and felt better, slight headache but no chills or fever. Too Advil to alleviate headache, which worked.
Swelling and redness with fever started on Thursday morning on 8/16/01. Ice applied. By Friday 8/17 09:15  AM significant swelling  X 3 size of left upper arm with redness and warmth. Rash  started today with itching.
Mom noted hives on stomach, torso and neck when she gave bath at 19:30 on 3/20/01. Pt had redness from shoulder to elbow on right arm. Redness was the size of a 50 cents piece at the top of left arm on 3/22/01. No hives when he awoke on 3/22/01. Arm is still red. Called the doctor and gave Benadryl and Motrin at 02:00.
Large red swelling at site of inject - > than 5 cm. Sm amt of pain when touched. Redness lasted for two weeks.
Presented with a low grade temp (100) for 2 days then started to develop a chicken pox like rash all over that started around the face, then spread to stomach and back and finally to extremities.
Heart attack on May 15 2021! defillibrator installed may 28, 2021
Friday (Day of shot): Fairly typical symptoms (soreness in arm, cough and sore throat, headache, and fatigue) Saturday (24hrs): Same symptoms as above, but slightly worse than day before. In addition, both feet (on top) began itching later into day. Sunday (48 hrs):  Typical symptoms began disappearing, itch on feet became more intense, bottoms of feet and ankles started to itch as well. Monday (72 hours): Typical symptoms virtually disappeared. Itching became progressively worse throughout the day on feet/ankles, and various small areas of body (abdomin, back of knees, inside of elbows/forearms) became itchy. Hives and rashes noticed over entire body later in afternoon. Hives/rashes were either single (unraised) isolated red dots, clustered and raised red patches, or clusters of small "braille-like" bumps (clusters and bumps area-size ranged anywhere from quarter-sized to palm-sized). Most noticeable areas were upper left back/shoulder, both sides of abdomin, groin, front/inner thighs, behind both knees, inner forearms, and both ankles and feet (top and bottom). Sore throat also came back on Monday afternoon, and over ~2 hr became itchy, then constricted with trouble swallowing, then restricted/strained breathing. Went to ER after noticed trouble swallowing, given epinehrine shot in  left leg. Throat slowly went back to normal over the next 1-2 hours. From 05/18 through today (3 weeks, and still ongoing),  rashes and hives have been diminished in size and amount, but are present both in pre-existing and new areas of body. Rashes/hives may last 1-2 days after developing or be on-going (feet and ankles). No prior history of allergies. No change in diet, lifestyle, soaps/detergents, environment at time of reaction.
she feels really achy and uncomfortable; she feels really achy and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (ORANGE CAP), SINGLE), administration date: 07Nov2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "she feels really achy and uncomfortable".  Additional information: Pediatrician is calling about two patients: 5-year-old female and 10-year-old male, who were accidently administered the adult gray cap bivalent formulation of the Pfizer BioNTech Covid 19 vaccine at their (Withheld) instead of getting the pediatric 5-11 bivalent orange cap booster. They received their primary series of the monovalent orange formulation on 07Nov2021 and 04Dec2021. He is not worried so much about repercussions of the vaccines, he is more concerned as to whether or not this will affect the series going forward. Physician states that five-year-old is getting her butt kicked, that she feels really achy and uncomfortable as reported by her mother. No fever, no headache, no respiratory distress, no chest pain. Seriousness was reported as no.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Patient here  at hospital since 12/15,started to develop sore throat, started getting worse, then developed a runny nose, tested for COVId and came back positive
Headache, Arthralgia, Fever, Rhinitis, fatigue, chills, injection site pain and swelling Narrative:
No other adverse events reported.; patient received Rotateq after it bad been stored outside of the recommended storage range; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 01-SEP-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered (lot number 1661000 which has been verified to be valid, expiration date reported and validated as 13-MAY-2021) (dose and frequency were unknown by the reporter; vaccination scheme was not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 47.1 degrees Fahrenheit, during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No other adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA006671: US-009507513-2010USA006870:
Red spot on arm appeared a week after injection, itchy and tender, 2-3 inches in diameter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 11Oct2021 as dose 3 (booster),  single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 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) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: Known allergies: Sulfa; "Cephalosporins allergy" (unspecified if ongoing), notes: Known allergies: Cephalosporins. Concomitant medication(s) included: TIROSINT taken for thyroid disorder. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) Negative, notes: Rebound if symptoms 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti-viral Paxlovid drug for COVID 19 Treatment started from 08Jul2022 and stopped on 13Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
02/13/21  Headache, fatgue, shortness of breath, pain at injection site 02/14/21  Same 02/15/21  Fatigue, shortness of breath increased and dizziness
Patient developed fever, vomited twice, was irritable, had limited range of mov't. in right arm with red warm hard indurated swelling painful.
3-11-19 shaking, headache and nausea. 3-12-19 fever, vomiting, and syncope. 3-13-19 fever. 3-14-19 sore arm.
Started with rash/ hives on face Tuesday 1/26/21, 7 days after receiving vaccine. Have taken Benadryl and is not getting better. Rash/hives are spreading . Have scheduled a doctors appointment today to be seen,
Swollen joint; Depression; Headache; General body pain; Joint pain; This case was reported by a physician and described the occurrence of swollen joints in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for rheumatoid arthritis and pneumococcal vaccine (Prevenar) for product used for unknown indication.   On an unknown date, the patient received Shingrix. On 6th July 2019, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. On an unknown date, the patient started Prevenar at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced swollen joints, depression, headache, general body pain and joint pain. The patient was treated with prednisone. The action taken with Humira was unknown. The action taken with Prevenar was unknown. On an unknown date, the outcome of the swollen joints, depression, general body pain and joint pain were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the swollen joints, depression, headache, general body pain and joint pain to be related to Shingrix.  Additional details were reported as follows : The patient received shingrix and prevenar and experienced swollen joints, depression, headache, general body pain and joint pain. Less than 2 years, after receiving humira, patient experienced swollen joints, depression, headache, general body pain and joint pain. The patient had no medical history. The patient did not receive any concomitant medication. It was unknown if the reporter considered the swollen joints, depression, headache, general body pain and joint pain to be related to prevenar and humira.
This spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# reported as L034660 with an expiration date 04-FEB-2018 (doses and route of administration were not reported). Administered doses of RECOMBIVAX HB experienced temperature excursion of 34.3 degrees Fahrenheit for 24 hours and 15 minutes, on an unknown date. No adverse effect were reported. Digital data logger was involved. On an unknown date, reported as currently, there was a second temperature excursion of 48 degrees Fahrenheit for 3 hours but none vaccine was administered to the patient. Lot number L034660 is an invalid lot number for RECOMBIVAX HB. Additional information has been requested.
Loss of balance,coordination,brain fog, dizziness, tinnitus, nausea..
Patient experienced a rash and itching in the upper right arm.  Ice was applied and Benadryl 25mg PO was given with good effect.  Within 10-15 minutes rash had resolved.
mom notified clinic that pt had red, swollen lt leg & was screaming p/vax;pt cry was described as high pitched & crying went into noc w/some intermittent periods of relaxation;pt had no fever;
BLOOD CLOT; This spontaneous report received from a patient concerned a patient of unspecified ethnicity, age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the patient developed a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210531990-COVID-19 VACCINE AD26.COV2.S-Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sore arm; Had 4 red spots, dime size rash at injection site; Rash starting from my elbow to wrist; Rash at injection site; Fatigue; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Had 4 red spots, dime size rash at injection site), RASH (Rash starting from my elbow to wrist) and VACCINATION SITE RASH (Rash at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), VITAMIN B COMPLEX, NIACIN, CALCIUM, MAGNESIUM, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), VACCINATION SITE REACTION (Had 4 red spots, dime size rash at injection site), RASH (Rash starting from my elbow to wrist), VACCINATION SITE RASH (Rash at injection site) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, RASH ERYTHEMATOUS (Red rash), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Had 4 red spots, dime size rash at injection site), RASH (Rash starting from my elbow to wrist), VACCINATION SITE RASH (Rash at injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt presented to the ER on 3/22/21 c/o sudden chest pain and fever of 101.1. She was transferred to the hospital due to concern for possible acute MI. She was ultimately found to have idiopathic pericarditis after further work up and discharged home on colchicine 2 days later.
first dose 3 or 4 years ago, second dose was not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date 3 or 4 years before date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: Pharmacist reported second dose was not administered at the time of reporting. HCP had no information regarding patient´s demographics or the exact vaccination date. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Narrative:  Patient received 3 doses of the Moderna vaccine 2 shots and one booster. Patient tested positive for Covid 19 on 9/23/2021 presented to the hospital on 9/30/2021 for SOB and respiratory failure; then his covid symptoms improved during his stay. He then passed away of other complications due to a bowel obstruction. Reported per EUA
Anaphylaxis with hypotension, pallor, sweating, cold extremities. Given epinephrine 1 mg/ml 0.3 ml IM with immediate response, BP normalize a within 1 minute, full recovery 5 minutes