chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOT OF ALLERGIES; HEADACHES; SHILREN'S DISEASE; SEVERE ATOPIC DERMATITIS (ECZEMA); PHOTOSENSITIVITY TO THE SUN ON ENTIRE BODY; AUTOIMMUNE DISEASE; This spontaneous report received from a patient via a company representative concerned a 45 year old female of unspecified ethnicity. The patient's weight was 140 pounds, and height was 62 inches. The patient's concurrent conditions included: penicillin allergy, and graves disease (in remission for 12 years), and other pre-existing medical conditions included: Patient was healthy before. The patient experienced drug allergy when treated with amoxicillin, topical steroid, atenolol, ciclosporin, erythromycin, and hydroxyzine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered at deltoid (unspecified) on 09-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 45 years old. No concomitant medications were reported. In 2021 (since vaccination), the patient had been sick for two years, and still sick from it. The physicians tried to figure out what happened for the past two years, and they were now saying it was from the Janssen COVID-19 Vaccine. The patient had contacted allergies to 12 different things (allergies to medication). The patient had a lot of allergies and lot of things were wonky. Laboratory data (dates unspecified) included: Graves antibodies were through the roof. In 2021, the patient got autoimmune disease which no one knew where it came from. On AUG-2021 (within two week of vaccination), the patient had photosensitivity to the sun on entire body, eczema, severe atopic dermatitis, and diagnosed with Shilren's disease. Since the vaccination patient had photosensitivity to the sun which patient never had before to the point the COVID vaccine caused all this. The patient went to phototherapy twice a week now to make sure she can go outside. The patient wanted to get better because patient was sick of the vaccine. The patient did not use topical steroid anymore since had an adverse event to the vaccine. On an unspecified date, the patient experienced headaches and had a lot of allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, severe atopic dermatitis (eczema), photosensitivity to the sun on entire body, lot of allergies, autoimmune disease, and shilren's disease.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230911709-Autoimmune disease. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Dizzy spell; Cannot walk without a walker or else they would fall; Got cold, couldn't get warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Got cold, couldn't get warm), DIZZINESS (Dizzy spell) and GAIT DISTURBANCE (Cannot walk without a walker or else they would fall) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING COLD (Got cold, couldn't get warm). On 22-Mar-2021, the patient experienced DIZZINESS (Dizzy spell) and GAIT DISTURBANCE (Cannot walk without a walker or else they would fall). At the time of the report, FEELING COLD (Got cold, couldn't get warm), DIZZINESS (Dizzy spell) and GAIT DISTURBANCE (Cannot walk without a walker or else they would fall) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Outcome of the event was updated from unknown to recovered
EDS FLARED ENTIRE BODY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: ehlers-danlos syndrome (eds). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced eds flared entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eds flared entire body. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in July 2016, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fussy, fever, runny nose, not easily consoled, sent to ER, admitted for dehydration/fever, home from hosp 9/23, beginning 9/21 would not bear wt on either leg. Sent back to ER 9/24 with increased sleepiness and refusal to bear wt. Kept in hosp until 9/27, cont. to have low grade fever, unsteady gait.
103 DEGREE FEVER; COULD NOT SLEEP OR ANYTHING; This spontaneous report received from a consumer concerned an 18 year old male. 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, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced could not sleep or anything. Treatment medications included: paracetamol. On 23-JUN-2021, the subject experienced 103 degree fever. Laboratory data included: Fever (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever on 24-JUN-2021, and the outcome of could not sleep or anything was not reported. This report was non-serious.
Rash to face/head and neck. Parent denied any other Sx's parent advised to take her daughter to a urgent care walk-in clinic for further evaluation, or to her PCP. Mother agreed.
Severe headache; Weakness; Fast heartbeat; Aches/Pain; Tiredness; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03Mar2021 at 19:00, the patient experienced severe headache, weakness, fast heartbeat, tiredness and aches/pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, weakness, fast heartbeat, aches, tiredness and pain was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Soreness at jab site; This is a spontaneous report from a contactable consumer reported that a 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient used the product and experienced soreness at jab site. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
At site of vaccination, right thigh was red and swollen, about 1 cm in diameter. She also had some fever overnight, according to her mother.
Patient states that left arm is red, swollen, and hard as concrete. Patient states she ran a temp of 102.5 during the night. Today patient states she feels like she is wheezing a little, is slightly dizzy, and has a headache. Patient states will see a doctor today.
HTN (210/110),  would not decrease to less than 190/100.  Took anti-anxiety medication,  and old Rx of Avapro (off med for 1 year), went to EC.
Developed prominent facial urticaria and periorbital angioedema 5 days after MMRV vaccine. Urticaria and angiodema was antihistamine responsive (cetirizine and diphenhydramine). When antihistamines were discontinued two weeks later, he had return of urticaria and angiodema (this time including abdomen in addition to face). Urticaria responded again to antihistamines. When scheduled antihistamines were discontinued after an additional 2 weeks, he had no return of urticaria or angiodema. He did not have immediate symptoms after vaccination. No recent illnesses. No hives, vomiting, difficulty breathing, or hypotension. He did not have a fever.
My shoulders and hips became so stiff and painful that I could not sleep. It was difficult to complete normal duties.  The soreness lasted a five days, and then tapered off. I have not had any issues once the pain left.
Violently ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in an unspecified number of patients who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter knew several adult people that got violently ill when getting the vaccine. The reporter asked what had done with these vaccines to make them so unhealthy.
Urine pregnancy test was positive; no additional adverse effects were reported; This spontaneous prospective report was received from a nurse concerning to a female patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Tdap), influenza virus vaccine (unspecified) and hepatitis A virus vaccine inactivated (+) hepatitis B virus vaccine rhbsag (yeast) (TWINRIX).  On an unspecified date on January 2020, the patient reported her last menstrual period (LPM).  On 26-FEB-2020, the patient was vaccinated with measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  recombinant Human albumin (rHA) 0.5 milliliter, subcutaneously, once (lot # S013719, expiration date 05-MAY-2021), for routine immunisation and varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, once, lot # S005080, expiration date 19-FEB-2021, for prophylaxis (route not provided). Both vaccines were administered using the Merck sterile diluent.  On 09-MAR-2020, the patient was seen by the nurse, and on that day, a urine pregnancy test was positive (vaccine exposure during pregnancy). No additional adverse effects were reported.  At the time of the report, the outcome of the event was not provided.
2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 032M20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had COVID before receiving any vaccinations). Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was provided by the reporter.   This case was linked to MOD-2022-538945, MOD-2021-034786 (Patient Link).
Horrendous headache Tooth pain Neck pain Joint pain Chills Nausea Insomnia
I have experienced intense migraines and early period since working around women that have all been vaccinated. I work with 8 women that have all been vaccinated but I have not been. I have been around 2-3 at a time and last couple had intense unexplainable migraines and early period
RASH, TACHYCARDIA, HYPERTENSION, DIAPHORETIC Per follow-up: Sumitted a report earlier today and I did not notice place to but the treatment that was administered after the reaction. I was treated with an epi-pen Jr, 5o mg of BENADRYL and O2.
This is a spontaneous report from a contactable consumer, reporting on  behalf of her mother. A 72-year-old female patient received PREVNAR13, intramuscular in the arm, on 31OCT2014, at 0.5 ml single. Relevant medical history included allergies to a lot of stuff for which the patient took something and acid reflux for which the patient took something. The reporter said that her mother was on other medications but she did not know the names of them. On 31OCT2013, the patient experienced extreme itching for 48 hours after receiving PREVNAR13. The patient completely recovered from the event on 02NOV2014.  Follow-up (26DEC2014): Follow-up attempts completed. No further information expected.
pt got hives that afternoon;did use Johnsons lotion on baby for first time;seen by MD in afternoon 1MAY97;
Rash all over body 3-4 days after vaccine. Legs, chest, back, arms, face, etc. Lasted more than a month (very itchy). About 2 months later, a different rash started but it was just a 24 hour rash. It did not look the same as the first one
Neuropathy; intermittent numbness in fingers; nerve pain; feeling pins and needles sensation going into limbs including both arms and legs; nerve pain, muscle pain, and joint pain at the site where she received her  vaccine; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Fibromyalgia since 11-Apr-2020, Allergy to antibiotic (Bactrim), Allergy to antibiotic (Erythromycin) and Osteoporosis. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) from 12-May-2012 to an unknown date for Osteoporosis, CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), HYPOAESTHESIA (intermittent numbness in fingers), NEURALGIA (nerve pain), PARAESTHESIA (feeling pins and needles sensation going into limbs including both arms and legs), VACCINATION SITE PAIN (nerve pain, muscle pain, and joint pain at the site where she received her  vaccine), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), HYPOAESTHESIA (intermittent numbness in fingers), NEURALGIA (nerve pain), PARAESTHESIA (feeling pins and needles sensation going into limbs including both arms and legs), VACCINATION SITE PAIN (nerve pain, muscle pain, and joint pain at the site where she received her  vaccine), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20 JUL 2021. Reporter information added, Patient's demographics added, Medical history added, Dose route and anatomical location updated, Concomitant medication added, Vaccination facility information added, One Event  Neuropathy added.; Sender'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; however, concurrent medical condition of Fibromyalgia could be a contributory factor for the events.
A 30 year old female was reported she was raped 2 days ago came to clinic to get checked. Client last period was X/X/11, client stated having history of regular menses. tdap and hep A/B vaccine given. Client then sent to lab for HIV/RPR test. Referral by clinician was made to another clinic after STD visit for plan B where they did a preg test which tested positive 4 wks pregnant. I then called CDC concerning giving the pt TDAP and TWINRIX. CDC reported TDAP was ok to pregnant women as of June 2011, hep B ok to give no risk factors and hep A vaccine risk to fetus very low. Spoke with CDC. Client was informed about the vaccines and its low risk via phone call and she voiced understanding. The vaccines given was TDAP .55 CC IM (LD) # C3837 by ADACEL and TWINRIX 1.0cc IM (RD) # AHABB204BA GlaxoSmithKline. There was no knowledge of client being pregnant at the time of vaccination. Client's last period was on such a date and next menses (month later).
Dry mouth and throat  Narrative:  Mouth and throat felt extremely dry. Water given with little relief.  Airway appeared intact and no breathing issues. Watched for 45 minutes and  patient took Benadryl caps with her if needed. Patient felt safe and wanted no  further support  Other Relevant History:
Diarrhea started approximately around 4:30pm and continued throughout the night. 10/06/18 started the day with no diarrhea but nausea that lasted until about 11:30pm.
Transient numbness; Skin on outside of throat got white; Soreness on outside of throat; Felt chills; Felt lousy; Shaking; Weak; Tired; Nausea; This is a spontaneous report from a contactable health care professional, the pharmacist. A 71-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) intramuscularly in left arm on 13Mar2021 at 18:30 (at an age of 71-years-old) as first single dose for COVID-19 immunisation. Medical history included carotid artery disease and CVS. It was unknown if the patient had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included TOPROL XL, CRESTOR, PLAVIX for an unknown indication. On 13Mar2021, couple of hours after receiving vaccine, the patient experienced soreness on outside of throat. On 14Mar2021, the patient experienced transient numbness and skin on outside of throat got white. On an unknown date in Mar2021, few days later, the patient experienced chills, felt lousy, shaking, weak, tired and nausea. The patient did not receive any treatment for the events. The clinical outcome of soreness on outside of throat was recovered on 13Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of transient numbness and skin on outside of throat got white was recovered on 14Mar2021. The clinical outcome of chills, felt lousy, shaking, weak, tired and nausea were recovered on an unknown date.   Information about lot number cannot be obtained. No further information is expected.
Unconscious; body was sore; This serious case was reported by a consumer via interactive digital media and described the occurrence of unconscious in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced unconscious (Verbatim: Unconscious) (serious criteria GSK medically significant) and general body pain (Verbatim: body was sore). The outcome of the unconscious was not reported and the outcome of the general body pain was resolved.   It was unknown if the reporter considered the unconscious and general body pain to be related to Shingrix.     It was unknown if the company considered the unconscious and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-AUG-2023 The case was received from the patient via interactive digital media. The reporter stated that after receiving the first shot of Shingrix hours after patient was unconscious in ambulance. She do not know if it was related or not to Shingrix. The patient body was sore for a while. The follow-up would not required per process.
Pt recvd Engerix-B & 30MAY90 & 12SEP91 pts had neg titers; A 4th dose was administered & pt non-responder; Reporter indicated that 5th & 6th dose will probably be given;
The patient went horseback riding after the vaccine. When she got home about 3 hours after the vaccine.  She started feeling bad with extreme anxiety, dizziness, trouble breathing, joint pain, vomiting. She went to Medical center and was given IV fluids and nausea medicine.