chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given Shingrix vaccine first dose on left upper arm on 7/22. Came home w/ left upper arm pain, then later in evening, about 8pm, developed itching at left upper arm, and bright red small bumps, subjective temperature elevation.             Took Tylenol on 7/22.             Took Benadryl 1 tablet once a day on 7/23 and 7/24.             Today, temperature and pain has resolved, still w/ itching and red bumpy rash only at upper left arm, not expanding to any other part of body.            No swelling, warmth, Difficulty breathing,swelling in tongue, throat, face, lips, rash all over the body or other new medications.  Home care advised, ice as needed for itching/pain,  OTC Benadryl as needed. Pt prescibed Triamcinolone 1% cream apply twice a day to left upper arm for itching/rash as pt requested.
I take a biologic called Simponi ARIA for control of my rheumatoid arthritis. I had just taken the infusion about 13 or 14 days prior to the COVID19 shot. Of course it lowers my immune system so that I don't get attacked by RA. About 2 days after getting the COVID19 shot I noticed that my RA symptoms were starting to return. Each day that went by they started to get worse and worse. It has been about three weeks now and I feel as bad as I did before I started the infusions. Horrible in fact. I feel as if the COVID19 really ramped up my immune system not only against the coronavirus; but it so got it going that it is not responding to the infusion that is in my bloodstream. The arthritis doctor didn't seem to agree; but from what I've seen in writing, and it's taking me days of searching. I think that's what it is. Now I really worry about getting the second shot. My doctor to start me on a three-day system of Prednisone to help stop the reaction of my immune system and he is going to put me back on methotrexate to also help.
Seven days after my 1st dose, I developed a large red swollen area at the injection site. The swelling was about 3 inches x 3 inches. It was red, hot to the touch, firm, and made my arm very sore. I took one dose of Bendaryl. The next day, it was less firm and not as swollen, but it was still hot to the touch, and the red color began to spread into a larger patch. It was also itchy. I took two doses of Advil. Today, it is much less swollen, but is still hot to the touch and a large red patch. I have taken ibuprofen to help with the achiness.
dementia; incontinency; passed out; 1 hour at home she was grabbing her head; She was responsive and was administered oxygen and taken to the Hospital; She was diagnosed as having low potassium; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), HEADACHE (1 hour at home she was grabbing her head), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital), BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium), DEMENTIA (dementia) and INCONTINENCE (incontinency) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).  Concomitant products included CARVEDILOL, AMLODIPINE, METOPROLOL, CLONIDINE and ATORVASTATIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant), HEADACHE (1 hour at home she was grabbing her head) (seriousness criterion hospitalization), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital) (seriousness criterion hospitalization) and BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium) (seriousness criterion hospitalization). On an unknown date, the patient experienced DEMENTIA (dementia) (seriousness criterion hospitalization) and INCONTINENCE (incontinency) (seriousness criterion hospitalization). The patient was hospitalized on 01-Apr-2021 due to BLOOD POTASSIUM DECREASED, DEMENTIA, HEADACHE, INCONTINENCE, LOSS OF CONSCIOUSNESS and OXYGEN CONSUMPTION. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), HEADACHE (1 hour at home she was grabbing her head), OXYGEN CONSUMPTION (She was responsive and was administered oxygen and taken to the Hospital), BLOOD POTASSIUM DECREASED (She was diagnosed as having low potassium), DEMENTIA (dementia) and INCONTINENCE (incontinency) had not resolved. Not Provided      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.   Patient was administered Oxygen by EMA, and taken to the ER (Emergency Room). Patient stayed over night at the Hospital. Patient is now admitted to a Nursing home.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded
No adverse effects; the patient was administered PROQUAD and VARIVAX on the same day; Information has been received from a physician referring to a one-year-old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date in May 2019 (reported as 3 months ago), the patient was administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (batch/lot #, strength, dose, frequency and route were unknown) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (batch/lot #, strength, dose, frequency and route were unknown) on the same day (overdose). No adverse effects were reported.
COVID Arm  Rash, stiff lump, pain/soreness and intense itching at injection site Single hive appeared on thumb with itching Joint pain similar to arthritis, mainly in left wrist  Feeling hot to touch wrist and injection lump  Palms and soles itching first night  Intense body aches   Benadryl 2x  Ibuprofen 800mg 1x
No AE reported; The vaccine was administered 17 days after expiration; This report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On approximately 14-MAY-2021, also reported as 17 days after vaccine expiration, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot number R027946 with expiration date 27-APR-2021, 0.5 milliliter for prophylaxis (expired vaccine used).  No product quality complaint or adverse effects were reported.  At the reporting time, the patient's outcome was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Vomiting-Severe
This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. Their medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, an unspecified number of patients received improperly stored doses of ZOSTAVAX (lot # M037654-valid [expiration date 29-NOV-2017]) (dose and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature was reported as 15 degrees Fahrenheit (F) to 46 degrees F (15.3 degrees F) for a time frame of 40 minutes. Previous temperature excursion was 15 degrees F to 46 degrees F (15 degrees F) for 3 hours and this was reported as a data logger. This is one of the multiple reports from the same reporter (US-009507513-1707USA006549 and US-009507513-1707USA008649). Additional information has been requested. Sender's Comments: US-009507513-1707USA006549: US-009507513-1707USA008649.
Moderna COVID-19 Vaccine EUA: Vaccine recipient reported symptoms/signs of persistent urticaria (non-oozing welts) all over body that occurred 11 days after 3rd dose of Moderna. No changes in diet or new use of body products. Vaccine recipient is also a physician. Currently not taking medications to treat urticaria.
After waking up in the morning baby became limp, pale and has low reaction, for about 10-15 minutes.
cold sweats (drenched in sweat); fatigue; headaches; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats (drenched in sweat)), FATIGUE (fatigue) and HEADACHE (headaches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COLD SWEAT (cold sweats (drenched in sweat)), FATIGUE (fatigue) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COLD SWEAT (cold sweats (drenched in sweat)), FATIGUE (fatigue) and HEADACHE (headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: initial additional document. Outcome of event updated.
Chills, fever, night sweats severe, neck pain, overall complete fatigue for 5 days, then just complete fatigue for another week.
chest pain, shortness of breath, fast beating heart, fatigued for 2 hours or so
p/vax pt exp a medical deviation of the rt eye including ptosis & h/a;MRI & a complete blood count were negative;
swelling of face & eyes w/extravasation of blood around eyes;epi & DPH given;
Fever, night sweats, chills, fatigue, pain and soreness for two days post vaccine.
At first I had some aching around the injection site.  The following week I had aching in my arm but not terrible.  The second week the aching was spreading in the upper arm.  The third week, I noticed my arm was swelling and retained water gaining 10 lbs in one day.
Covid-19 Diagnosis.  Urgent care reported is for Adverse Event, Vaccination was received at Pharmacy.
Initial misuse report received from a healthcare professional on 08 April 2013. ADACEL was given to a patient 65 years old patient. No adverse event was reported. List of documents held by sender: none.
Client reports she received second COVID vaccine on 3/12/21 and next day developed an itchy, red rash at the injection site.  Denies any shortness of breath, trouble breathing or swallowing, no chest tightness.  Client reports rash lasted 2 days total, did not take nay medicine for it and did not follow up with primary care provider.
SHE STATED THAT SHE LOST BREATH AND COULDN'T WALK. HAD TO GO THE ER AND THEN SAW HER PCP ON 12/13/2022 AND WAS TOLD SHE IS ALLERGIC TO FLU SHOT NOW.
Scattered papules in various stages: crusted with some vesicles. Vesicles on soles of feet.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 02/04/2021 and 03/04/2021.   They became symptomatic for COVID-19 disease on 12/03/2021. They presented to emergency dept and tested positive for COVID-19 via PCR test on 12/03/2021. They remained hospitalized until their death on 12/04/2021.
Information has been received from a nurse concerning a 9 month old male with no pertinent medical history or drug allergies who on 26-JUN-2007, 04-SEP-2007 and 02-NOV-2007 was vaccinated PO with his first, second and third doses of Rotateq (lot# 656099/0433U, 657660/0972U, 657657/1151U). There was no concomitant medication. On 23-FEB-2008 the patient experienced diarrhea and was dehydrated. The patient was brought to the emergency room and was placed on intravenous fluids and was subsequently admitted to the hospital for observation. A stool culture was performed which was positive for rotavirus and was diagnosed with rotavirus. The patient was discharged after one night in the hospital. The patient was seen in the office on 10-MAR-2008. The patient was noted to be hydrated and fully recovered at this time. There was no product quality complaint. Additional information has been requested.
Patient came into work today complaining of severe pain from injection site running into her chest. She complained of difficulty breathing and went to the ER.
I received my second dose of the COVID 19 Moderna vaccine on Tuesday morning. By Tuesday night I started to have virtually every side effect that Moderna listed including; fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and extreme fever. The next morning as I woke up in attempt tp get ready for work, I was not feeling any better and began to feel light headed, and felt the need to vomit. As I had the feeling of needing to vomit, I turned to do so and fainted. From accounts by my family, I was told I woke up, and quickly passed out a second time. As I was awoken, there was probably a minute before I fainted for a third time. All three times I was told I lost consciousness. I was awoken and by that point my family had contacted emergency responders. Paramedics arrived and took all necessary vitals. I did not pass out after that third time. As I expected all side effects Moderna listed, I did not expect to feel as bad as I did and I thought it was worth reporting what happened to be the next day. It caused a panic and I was scared and nervous as I was unsure why that was happening. I've tried to look up articles and links between passing out and the vaccine and all I can find is people fainting as they get the vaccine (which is common for any shot) but nothing for fainting that long after the vaccine was administered. I just wanted to report my incident.
It was reported that a 19 year old female pt received a Menomune vaccination in the left forearm on 10/04/2000 at 2:07pm. Reportedly at 4pm, the pt complained of onset of mild, less than 2 inches erythema area and slight pain (scale 3 of 10). An ice pack was applied and swelling and pain decreased within 30 mins. Pt offered no other complaints. Pt was encouraged to follow-up if symptoms progress. Pt verbalizes understanding, as does so. Reportedly the pt recovered from this experience.
Within 15-minutes of vaccination, the patient reported feeling dizzy and nauseous. EMS manages the patient's care on-site.
The patients arm was sore 4-5 days after vaccine, 11/30. It began to hurt again to touch or lifting arm above head. The patient continues today 12/04/00. Prescribed Tylenol; the site with out warmth, redness, or edema. Did notice 15 minute episode of tingling in fingers.
"moderna arm" reaction.  Red and warm 7x8 cm around injection site that starting 3/21/2021
Child developed fever 101.6, unconsolable crying, vomiting. Child was taken to ER to pediatrician x2. Parents states this lasted a week. Child now fine.
Felt lightheaded, fast heart rate, chills, weakness. Symptoms started the evening of the vaccine lasted 48 hrs no treatment.
Case number PHEH2014US020575, is an initial spontaneous report from a nurse received on 10 OCT 2014. This report refers to a 52-year-old female patient. Past medical history and concomitant medications were not reported. On 10 OCT 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN 2014/2015 (batch number: 1412121) intramuscularly. It was reported that the patient received FLUVIRIN from open multiple dose vial (MDV) that reached 72 F overnight. No adverse event was reported following this medication error (incorrect storage of drug).
Nausea/vomiting/diarrhea, weakness, "feeling foggy" approx 8hrs post vaccine admin. S/s improving 48hrs post vaccine.
Hospitalized with shortness of breath.  See note. Patient is a 73 year old male with a history of coronary artery disease, COPD, kidney cancer, hypothyroidism, type II diabetes mellitus, a CABG, a nephrectomy with ESRD on HD, and a prostate resection who presents to the ED with a chief complaint of shortness of breath that began about 2 days ago. Patient states he was admitted to facility from 4/14/22-4/18/22 for pneumonia and pleural effusions. During this stay he had a thoracentesis performed. He states that since being discharged he has continued to experience chills, diaphoresis, and vomiting. Patient states that 2 days ago, he had the onset of shortness of breath and ?chest discomfort?, which he feels is similar to the last time he had ?fluid on his lungs?. Due to concerns for his symptoms, patient made the decision to return to the ED for evaluation today. Patient's wife additionally notes that he was supposed to receive dialysis yesterday, although he missed this appointment due to his symptoms. He rescheduled this appointment for today, although he wanted to be evaluated in the ED prior to this. He denies use of anticoagulants or fever. The patient is a former smoker and has no further complaints at this time.         Patient is a 73 year old male with a history of coronary artery disease, COPD, kidney cancer, hypothyroidism, type II diabetes mellitus, a CABG, a nephrectomy with ESRD on HD, and a prostate resection who presents to the ED with a chief complaint of shortness of breath that began about 2 days ago. Patient states he was admitted to facility from 4/14/22-4/18/22 for pneumonia and pleural effusions. During this stay he had a thoracentesis performed. He states that since being discharged he has continued to experience chills, diaphoresis, and vomiting. Patient states that 2 days ago, he had the onset of shortness of breath and ?chest discomfort?, which he feels is similar to the last time he had ?fluid on his lungs?. Due to concerns for his symptoms, patient made the decision to return to the ED for evaluation today. Patient's wife additionally notes that he was supposed to receive dialysis yesterday, although he missed this appointment due to his symptoms. He rescheduled this appointment for today, although he wanted to be evaluated in the ED prior to this. He denies use of anticoagulants or fever. The patient is a former smoker and has no further complaints at this time.  Patient discharged on 5/4/22
Intense and continuing hair loss for 14+ months (at the time of reporting). Reported to Family Doctor and Dermatologist. Rogaine, Ketoconazole 2% and Fluocinonide 0.05% prescribed. None of the prescribed medication helped or improved this condition.
2nd day swelling/erythema/warmth.  Almost completely resolved by date seen (10/23).  no pain, no s/s cellulitis/abscess.  Supportive
Patient developed upper neck and jaw area lymph node pain and enlargement, fever to 102 degrees F and malaise. By one week after vaccination the symptoms were significantly improved yet not completely resolved. Mild worsening of multiple sclerosis symptoms.
Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who presents with acute onset early this a.m. nausea vomiting and change in mental status.  History was obtained from the husband as patient is minimally responsive to verbal stimuli at this time.  He states she was in her usual state of health until when she awoke this morning.  Yesterday in usual state of health that she did have her 2nd COVID vaccine with the Pfizer variant.  He states that day she was in her usual state of health with some mild arm pain on the left where she received the vaccine.  This morning she awoke with a headache, fever, chills however was ambulating and conversing appropriately.  She had no appreciable focal deficits at that time per the husband.  She ate breakfast however she subsequently began vomiting.  She progressed to a change in mental status with minimal responsiveness.  She would say 1 or 2 words and that was it.  They then presented emergency department. Diagnosed with severe sepsis, acute encephalopathy, acute meningitis, liver shock, autoimmune hepatitis, ascending cholangitis, acute pancreatitis.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-SEP-2010, the pt was inoculated with ZOSTAVAX injection (lot number, dosage, vaccination site and route of administration were not provided), as recommended for routine adult health maintenance for its intended purpose: the prevention of shingles. On 12-SEP-2016, the pt presented to the doctor with shingles, which caused a painful rash on his body. He was treated with acyclovir hydrocortisone cream, and gabapentin. The pt returned to the doctor several more times for help with neuropathic symptom concerns, reporting on 14-DEC-2016 "feels the shingles again and would like refill of acyclovir". The outcome of the events was not recovered. The pt suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the pt had suffered and incurred damages, including medical expense and other economic and non-economic damages. Upon internal review, the event of neuropathic symptoms was determined to be medically significant. Additional information has been requested.
Acute hair loss, starting 4/2016, 5 weeks after meningitis B vaccine. Progressed to alopecia totalis over 6 months.
Tongue lesions - onset 3 days after first vaccine; have been waxing and waning since.
Patient was administered COVID 19 vaccine, patient is 11 days away from being 18 years old. Patient was not eligible at the time for Moderna vaccine (requirement of being 18 years old). No known adverse reactions to vaccine at this time.
Patient recieved 2nd dose after 47 days of 1st dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 2nd dose after 47 days of 1st dose of vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 2nd dose after 47 days of 1st dose of vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 2nd dose after 47 days of 1st dose of vaccination) had resolved.            No concomitant medications were reported.  No treatment medications were reported   This case was linked to MOD-2021-307830 (Patient Link).
During the night my right arm got extremely sore from the injection site. The next day I was achy with  cold chills, low grade fever headache and tiredness until about 4pm.  My arm stayed sore for several more days and finally subsided.