chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother reports constant crying, non-stop, for several hours, Redness and swelling to all immunization sites
pt recv vax 10NOV97 10AM & itching of body began same day & cont through 12NOV97;no rash, no hives reported;thinks chilled for approx 1hr Tuesday PM;took DPH;woke up during noc 11NOV97 x2 w/hands asleep;swollen joints of hands, knees;
sore stiff arm 2-3 wk worsening by 3rd wk pain so severe can't move arm some movement slowly returning p/6 wk; p/2mo arm has dull ache & sharp pains during certain movements or pressure; some movements still impossible; tx heat, exercise
Chills, fever, exhaustion,  soreness in arm and shoulder, headache, and soreness in the body.  I rested for two days and drank fluids.  I treated it like the flu and used a heating pad on the injection site, and soaked in an Epson salt bath.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date in 2009, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). The patient received the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported) on 20-JUL-2015. It was confirmed that the third dose of GARDASIL was not administered to the patient. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Morning after patient received vaccine she states she was itchy all over (mentioned face and arms). Later in the day she states she developed hives on face. No trouble breathing/swelling of tongue/throat. Advised BENADRYL, and cool compresses on facial hives.
4/5 - 2nd Moderna shot 4/6 - expected minor flu-like symptoms 4/7 - recovered, tinnitus louder 4/16 - woke in middle of night with intestinal distress, feverish with little or no fever 4/17, 18 - Feverish, GI upset, pressure under right rib, shaky, hot and cold. Bloodwork. 4/19 - woke middle of night uncontrollable shaking, loose BM, shaking stopped. Shaky, weak, tired, nauseous, feverish feeling. Muscle twitches drifting to sleep. Lack of appetite. PCP virtual 4/20 - Feverish, muscle twitches upon waking. 4/21 - Muscle twitching upon waking. Right side pain. BM urgent and very soft. 4/22 - Muscle twitching when at rest, especially in legs. Morning BM urgent very soft, thin. Nausea. Able to eat. PCP and rheumatologist virtual. ANA 1:80. 4/23 - Muscles twitches, shaky, weak, pain on right side, GI upset, nausea, can?t eat. Morning BM urgent and unformed, undigested food.  BP 137/90 (normal 115/75) 4/24 - Tired but a bit better. Ate. BM skinny, soft. Twitches again at night. 4/25 - Quite sick, 2am urgent skinny stool, muscle twitches mostly legs, butt, abdomen. Feverish with no fever, nauseous, can?t eat. 4/26 - A bit better. Ate in afternoon and evening. Was able to walk dog. Bloodwork 4/27 - Very sick. A.M. ultrasound. Confined to bed, weak, can?t eat, feverish with no fever, nausea, soft urgent BMs (no blood). Call from doctor that my creatinine is going up - is now 1.68 from baseline 1.4 last week.  Called nephrologist. Anticipate ER. Difficulty making GI apt.  Overall, major gastrointestinal distress, nausea, cannot eat, feverish without fever, muscle twitching, getting weaker, losing kidney function.  Not resolved. Getting worse.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Procainemide, reaction(s): "known allergies: Procainemide", notes: known allergies: Procainemide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Insomnia, exhaustion, headache, shaking, chills, fever, body aches, shooting pains
Headache, Myalgia, NauseaVomiting, fatigue Narrative:  Employee reported moderate headache, muscle pain, fatigue, chills/shaking occurring 02/05/21. mild nausea 02/05/21. resulted in 1 day  work missed. Did not seek medical attention for symptoms.   Other Relevant History:
Patient went to ER. and saw Dr. was noted to be distended and had been vomiting. X-rays showed bowel obstruction. Sent to Hospital for evaluation. 5 days after her 2 mo - WCC and immunizations. 5/19/08-records received for ED visit 4/13/08-C/O sleepy all day, Grunting and irritable, small solid stool first BM in 3 days required glycerin suppository. One episode of vomiting bilious. Lethargic. Decreased appetite.Transferred to another facility.  6/2/08-records received for DOS 4/14-5/3/08-admitted with bowel obstruction. Tachycardia. Surgery noted to have abdominal compartment syndrome and obstructing intestinal duplication cyst of ileocecal valve. ileum resected and primary anastomosis performed. 48 hours later developed septic shock, second surgery showed patchy ecchymotic bowel and areas of hemorrhage and necrosis, 43 cm of jejunum removed and colostomy and mucous fistula placed. Abdomen left open. Third surgery with total 70cm of bowel removed. NG. Intubation, mechanical ventilation. Fever.
She had swelling in the arm, hearing loss, pale skin, light headed, with discoloration of lips, an EPIPEN was given and BENADRYL while perimedics were called.
a fever of 104F; This spontaneous report was received from a physician via company representative and referred to the 5-year-old male patient. The patient's concurrent condition, concomitant therapy, medical history and drug reactions/allergies were unknown.  On an unknown date, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dosage form, lot #, expiration date, route and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient developed a fever of 104 Fahrenheit degree (F) after he received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The customer said the patient's family took him to the emergency room. It was unknown if the treatment was given for event. The patient south medical attention. The outcome of fever was unknown. The causality between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and fever was not reported.
This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 26-NOV-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K012918, Expiry date: 28-FEB-2016 (dose and route not specified). No adverse effects were reported. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Patient arm became numb on Saturday, and her lymph nodes became swollen. She could hardly move her arm.  She went to her PCP on 12/12/2022 and was given Medrol dose pack and Doxycycline 100 mg BID.
Patient developed red bumps on body (face, neck, arms, legs chest and abdomen) and swelling of both ankles.
This spontaneous report as received from a physician via company representative refers to a non-pregnant 14 year old female patient. No information regarding the patient's medical history and concurrent conditions was provided. On 28-APR-2016, the patient was vaccinated with the GARDASIL 9 injection, in the upper arm deltoid area, (dose, route of administration, lot number and expiration date were not provided) for routine HPV vaccination. There were no concomitant medications reported. On the same date, the patient experienced swelling in her hand "in the arm where she got the injection". The patient sought medical attention via calling her physician who provided "support over the phone". No laboratory diagnostic studies were performed. It was reported that the physician intended to contact the patient again the next morning (on 29-APR-2016). At the time of the report, it was unknown whether the patient would receive her two remaining doses of GARDASIL 9. The outcome of hand swelling was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Nephrotic syndrome; immediately began to swell all over body/swelling was so bad I could not put a shirt on; feet swelling; face swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROTIC SYNDROME (Nephrotic syndrome), SWELLING (immediately began to swell all over body/swelling was so bad I could not put a shirt on), PERIPHERAL SWELLING (feet swelling) and SWELLING FACE (face swelling) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and OMEPRAZOLE for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced NEPHROTIC SYNDROME (Nephrotic syndrome) (seriousness criteria hospitalization and medically significant), SWELLING (immediately began to swell all over body/swelling was so bad I could not put a shirt on) (seriousness criterion hospitalization), PERIPHERAL SWELLING (feet swelling) (seriousness criterion hospitalization) and SWELLING FACE (face swelling) (seriousness criterion hospitalization). The patient was treated with PREDNISONE for Nephrotic syndrome, at a dose of 80 mg for 10 weeks. At the time of the report, NEPHROTIC SYNDROME (Nephrotic syndrome), SWELLING (immediately began to swell all over body/swelling was so bad I could not put a shirt on), PERIPHERAL SWELLING (feet swelling) and SWELLING FACE (face swelling) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01-May-2021, the patient reported that he was rushed to the Emergency room and hospitalized for treatment due to the events.  At the time of the report the patient stated  his symptoms are ongoing but he did experience sporadic remission while he hospitalized. He was diagnosed with nephrotic syndrome.  He was currently taking 80 mg Prednisone for 10 weeks.  Treatment included steroids and diuretics.  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. Further information has been requested.   This case was linked to MOD-2021-211527 (Patient Link).; 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. Further information has been requested.
She is allergic to PNEUMOVAX 23 vaccine; Tingling; Numbness; Flushed face; This spontaneous report was received from a company representative, reporting on herself, a 61 year old female patient. The patient's concomitant medications included rosuvastatin calcium(CRESTOR), famotidine(PEPCID), montelukast sodium(SINGULAIR) and fexofenadine hydrochloride(ALLEGRA). The patient's pertinent medical history included anaphylaxis shock in January 2020, the cause was unknown, but might have been the intravenous (IV) dye, azithromycin (Z-PAK) or ceftriaxone (ROCEPHIN). The patient underwent a computed tomography (CT) scan.  On 16-JUN-2020 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular for vaccination (dose, frequency, anatomical location, lot number and expiration date were not provided). On the same day, within 20 minutes after she received the vaccines, she noticed tingling (paraesthesia), numbness (hypoaesthesia) and a flushed face. She was still in the provider's office when the reaction occurred. The provider gave her fexofenadine (ALLEGRA) and was sent home. The patient reported she cleared up the same day.  On 22-SEP-2020, her provider did a "challenge test" on her and confirmed she was allergic to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine. Other laboratory diagnostics/studies performed were mediator test blood draw and complete blood count (CBC).  The outcome of paraesthesia, flushing and hypoaesthesia was reported as resolved. The outcome of allergy to vaccine was unknown. The causal relationship between therapy with Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) and paraesthesia, flushing and hypoaesthesia was not provided. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Rash on various locations on my body including: arms legs back butt ankles abdomen   Sometimes itchy. Getting more rash spots each day since the first day it appeared  I?m taking Benadryl
BOTH administration/doses this man has similar reactions.  The first dose, he passed out completely.  Both he endured low heart rate in the 30s/40s, low blood pressure systolic on the low 90s, diaphoresis, nausea, pallor.  The first dose he had a second episode after recovering from the first after 30 minutes rest.
On 5/12/21, approximately 5 weeks after my J & J Covid vaccine, I noticed muscle fasiculations/twitches  throughout my body. I have also experienced muscle weakness in my arms and legs, and tingling sensations in my feet at rest. I have an over excitable nerve feeling/agitation. On 5/19/21 I started to experience hypnic jerks at night, which I have never experienced before and are very distressing.  I have bouts of diarrhea and nausea/loss of appetite, weight loss, lighter periods.  I developed some anxiety due to the distressing nature of these symptoms. I saw my primary care physician on 5/14/21, who did a full panel of bloodwork. Vit D deficiency was only thing found. I began supplementing without symptom
ACUTE RESPIRATORY FAILURE 10/9/2021 ATHEROSCLEROSIS OF AORTA         ACUTE RESPIRATORY FAILURE 10/9/2021 ATHEROSCLEROSIS OF AORTA  ACUTE RESPIRATORY FAILURE 10/9/2021 DYSPNEA  ACUTE RESPIRATORY FAILURE 10/9/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE RESPIRATORY FAILURE 10/9/2021 ENCEPHALOPATHY
Patient went back to work after receiving his second Moderna shot. He works remotely from his desk from home.  He stood up at his desk and fell on the floor.  When he awoke, he had a hemotoma and cut on his right face and top of head.  He was disoriented and I offered to take him to the ER.  His tongue had been bitten down on by his jaw teeth and left a huge open gash wound the length of his tongue. I wanted to have his tongue sewn back together it was that deeply cut through on his tongue. Date of Death: 09-22-2021
A non-serious spontaneous report of "we gave FLUMIST to a 55 year old female" has been received from a registered nurse concerning a 55-year-old female patient, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. On 28-Dec-2009, the patient was inadvertently administered FLUMIST in the reporter's facility. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved as of 29-Dec-2009.
Large (baseball size) area of redness and swelling. Area was hot to the touch and very tender/painful.  This started on Wednesday morning (the injection was received Monday evening. As of Friday morning, area is still swollen, redness is improving but still feels hot to the touch. Treated with ice packs and Tylenol. Was seen at urgent care for an unrelated issue but I asked the physician her opinion. She felt this is an adverse reaction to the vaccine and encouraged me to report it. The injection was given approximately 1 in above my left elbow.
Dull headache on Day 1 of receiving vaccine. Day 2 was primarily a sore arm (moreso than with influenza shot)
Soreness at injection sight; This is a spontaneous report from a contactable consumer. A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 40113/ej1686), via an unspecified route of administration (anatomical location: left arm) from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE for an COVID-19 immunisation.  Medical history included diabetes, asthma and overweight. The patient's concomitant medications were not reported. On 04Jan2021, the patient experienced soreness at injection sight. Outcome of the event was unknown.
Pfizer was reconsituted with 0.8 ml diluent instead of 1.8 ml.  Pt received a 0.3 ml dose before error was discovered.
I think I have "covid vaccine arm."  I got the shot on 1/28 in the afternoon.  I was tired and my arm a little sore the next day.  Then I was fine.  On 2/4/5 at 8 at night a noticed my arm was itchy, red, lumpy, and warm at the injection site.  This morning 2/5/5 it is still itchy, warm - almost hot.  There is a two inch diameter red spot at the site.  There is still the flatish lump at the site.  I reported it to my regular doctor who gave me your contact information.   I got the shot at a workplace clinic.
Tetanus site at deltoid reddened and swollen 8x8.5cm.
Menstrual cycle came unexpectedly, and only 12 days after the last day of my menstrual cycle. My menstrual cycles have never been out of sync before (except when pregnant) and have been very regular..
Increased heart rate; Pain in back; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate), BACK PAIN (Pain in back) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced HEART RATE INCREASED (Increased heart rate), BACK PAIN (Pain in back) and CHILLS (Chills). At the time of the report, HEART RATE INCREASED (Increased heart rate), BACK PAIN (Pain in back) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
received Menveo powder reconstituted with sterile water at the end of June 2023; received Menveo powder reconstituted with sterile water at the end of June 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In JUN-2023, the patient received Menveo. In JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Menveo powder reconstituted with sterile water at the end of June 2023) and inappropriate dose of vaccine administered (Verbatim: received Menveo powder reconstituted with sterile water at the end of June 2023). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 14 August 2023: Pharmacist reported a patient received Menveo powder reconstituted with sterile water at the end of June 2023. The reporter consented to follow up. The patient received Menveo powder reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
w/in 1hr of vax pt c/o itchy tingling feeling head to toe;no visible rash;c/o severe h/a, nausea devel into emesis x 1;sx resolved w/in 12hr;
This spontaneous retrospective pregnancy report as received from a 23 years old female patient with pertinent medical history of asthma(untreated at this time) and with no drug reactions/allergies, for GARDASIL, a Pregnancy Registry product, concerning herself, who was vaccinated with the first dose of GARDASIL (intramuscular, standard dose, lot#, dose unspecified) on 20-NOV-2012 while pregnancy (patient was currently about 12 weeks pregnant) with an LMP of 09-NOV-2012 and an EDD of 16-AUG-2013. No other co-suspects were reported. Concomitant medications included Prenatal vitamins. Initial exposure to GARDASIL was at 1 week(s). The patient was exposed GARDASIL during trimester 1. Patient was scheduled to receive the second dose of the product 2 weeks ago. On 29-JAN-2013, patient felt sudden pain in her stomach and almost miscarried. Patient did seek out medical attention; however she did not tell the treating medical staff that she had received the vaccine during her pregnancy. Unspecified blood tests taken after the event(result not provided). No treatment was given for the events. Patient explained that she now felt better, but still had some pain. Patient also stated that she did not receive her GARDASIL injection from her current treating physician, listed in this case. At the time of the report, the patient's outcome of pregnancy was unknown. The relatedness for "sudden pain in her stomach and almost miscarried" was unknown for GARDASIL. Additional information has been requested.
Subacute thyroiditis, treated with propanolol, dexamethasone, tylenol, ibuprofen.
My left side was feeling heavy and my head and neck were feeling swollen and sore. It felt like a head ache but only on my left side which is the side where I received the vaccine. I ignored it and by the end of the day I took a Tylenol but it did not do anything. I felt like something was compressing me inside my head and ear. On Monday I went back to work and I still had that. It was very uncomfortable. On Tuesday I was already nervous and I went to the clinic where I usually go and they told me not to worry that is was just my body reacting to the vaccine and creating antibodies. They said that they did feel the swelling and they said it was a swollen lymph node. It was very uncomfortable. They told me I could take Tylenol or Ibuprofen every 8 hours but they were not sure if the pain would go away since this is a new vaccine. I followed their instructions and on 02/07/2021 I still had that pain and it got worse. I was feeling very bad. That day I decided to take both Tylenol and Ibuprofen and that hurt my stomach. On 2/10/2021 I had to go to the ER and the doctor asked why did I take so many analgesics, and I said that I could not take the pain anymore. The dr said they did not know if this was something normal since the vaccine is new. They did blood tests and a CT scan and on Friday I am having an endoscopy. All the tests were normal. Sometimes I have nausea and even throw up. Its been 4 months and I am still feeling the same way. After getting the second dose the head pain was gone for a while, sometimes it comes back but not as bad as in the beginning. They think I might have an ulcer in my stomach.
Hives under arms and in groin area. Treated with Benadryl pill and cream