chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large area of swelling under armpit to front of lat and left ribs; swelling moved down the third day to left side of abs and down to waistline area; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 04:15 (at the age of 17-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 4 weeks prior to the vaccination. Concomitant medications included minocycline (MANUFACTURER UNKNOWN) and dexmethylphenidate (MANUFACTURER UNKNOWN), both taken for an unspecified indication from an unknown date and unknown if ongoing. On 26Apr2021 at 09:00, the patient experienced large area of swelling under armpit to front of lateral and left ribs. The third day, swelling moved down to left side of abs and down to waistline area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were 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 swelling under armpit to front of lateral and left ribs, moved down to left side of abs and down to waistline area was unknown at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Right Thigh: Swelling 31cm in diameter -marked area. 28cm diameter of left thigh and palpation of the thigh revealed tenderness. Left Thigh: Left thigh was normal, no swelling, and the thigh was not tender on palpation.
PATIENT VOMITED 3 TIMES OVERNIGHT AFTER SHOT AND HAS KNOT ON HER ARM
Initial and follow up info has been received from a licensed visiting nurse concerning a 17 month old healthy male pt with no past medical history and no known drug allergies who on 4/3/02 was vaccinated with a dose of MMR II, via SC injection (640728/1376L). There was no concomitant medication. On 4/12/02 the pt's mother stated that the pt had a fever of 100 deg F and little spots, not itchy, on his chest and back. Unspecified medical attention was sought. Follow up info revealed that the pt was seen by the physician on 4/23/02 and the pt was "now much better." The pt recovered from the rash and fever. Additional follow up info from the licensed visiting nurse stated that the pt's mother took the pt to another physician who claimed that the pt did not have a reaction from the MMR II. Additional info is not expected.
administered dose of ROTATEQ underwent a temperature excursion prior to be administered; No known adverse effect; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # S004251 with expiration date: 22-SEP-2020 (exact dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was stored in 8.9 Celsius degrees for 30 minutes. There was no previous temperature excursion. The storage was recorded by digital data logger.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-FEB-2007, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of severe herpes zoster. On or about 02-APR-2010, the patient was treated by a dermatologist for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She was prescribed valacyclovir (VALTREX) and acetaminophen (+) oxycodone (PERCOCET) for her painful symptoms. As a direct and proximate result of these malfunctions, 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.
Patient called into Family Healthcare 11/26/02 reporting she got a flu shot 11/21/02. On 11/22/02 she woke up with hives on her upper thighs and feeling warm. Patient had no trouble breathing or any other reported symptoms. The hives were gone by 11/23/02 patient stated.
Patient noted a tingling or burning sensation that seemed to run down the forearm. This continued for several weeks after receiving Zostavax. She did not feel she required any medical workup and has since reported the sensation has diminished.
Positive pregnancy test; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Positive pregnancy test) in a 35-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Social). Concurrent medical conditions included Allergic to cats (Cats). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) from October 2019 to an unknown date for Pregnancy.    On 02-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 20-Jul-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Positive pregnancy test). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Positive pregnancy test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, Pregnancy test: positive (Positive) Positive.     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.   Estimated date of conception was on OCT-2020. Number of fetus was unknown.  Patient had three previous pregnancies.  For first pregnancy, end date of delivery was found to be  on OCT-2015, which resulted in live birth.  For second pregnancy, end date of delivery was found to be on an-2020, which resulted in miscarriage.  For third pregnancy, end date of delivery was found to be on Jun-2020, which resulted in miscarriage.  In 2021, lab test included ultrasound scan; however, the result was not provided.  Treatment information was not provided.
Headache  First headache around 4am, pain at injection site, loss of apettite  Narrative:   Other Relevant History:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 09Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovered" (07Jan2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative; (28Dec2022) Positive; (07Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not received other medication in 2 weeks of vaccination. Anti-viral details included Product: COVID 19 treatment, brand: Pfizer, started on 21Dec2022 to 25Dec2022. The patient tested negative on 26Dec2022 (day after Paxlovid treatment ended). Tested positive on 28Dec2022. Finally tested negative on 07Jan2023. Device timestamp 12Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired dose administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Reporter confirmed an expired dose on 16Apr2022 was administered to 1 patient on 18Apr2022.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow-up received includes previous dosage of suspect
March 18 , 2921:Fever 100.9,9:40 p.m. Chills 11:30 p.m., Fever 101.9,  12 a.m.  Took 2 Tylenol March 19, 2021: Fatigue all day, sore arm getting worse, injection site getting redder and larger, hot to touch, Fever morning: 100.2,  Fever afternoon 101.8. Sore all over body.  Took 2 Tylenol in afternoon March 20, 2021: Fatigue until afternoon. Then mostly better. Fever 99.9.  Injection site still very red and hot to touch
About 3 hours atter 1st shot. I became very hot and my whole body feels flushes. I have a tingle all over my uper body. My face neck chest and sholders feel as if the shin is crawling. It has been happening now for about 35 min. I took Tylenol after like they said. I also feel like my heart is skipping or having a change in the rhythm and beat. Its going. Boom boom with normal spacing then my heart beat is going fast and out of rhythm. I almost feel as though im having some sort of panic attack. Im remaining calm and still. And i just wanted to report this feeling because i dont know if it has anything to do with receiving the vaccination. However my husband feels fine..  I feel like im trying to catch my breath.. I do have copd and high blood pressure. Ill continue to evaluate my feelings and all.
26FEB91 rash starting on face - extremities; 1MAR91 lethargy, sz, changing MS admitted - tx w/Rocephin; 2MAR91 status epilepticus-intubation x 24 hrs; 5MAR91 complete recovery & home: DX: Probable meningo-encephalitis w/sz.
Patient is immunocompromised and should have received 3rd full dose in primary series.  Patient only received booster dose (half dose).  Patient to return to injection clinic to receive remaining dose.
Severe vestibular conditions, vertigo, migranes, depression, exhaustion, nausea.
Following day was hypotensive with blood pressure 70/65 and had syncope with fall and laceration to face. Received CT scans, IV fluids in ER . Had another episode of syncope in ER.  On days 2 severe pain abdomen with bloating, myalgia and fatigue that lasted fir 2-3 days.
Pt recved Hep B vax & exp unspecified rxn which left the pt bed ridden for 2 yrs; No further details were provided;
Severe pain in right arm starting about 1.7 hours after injection and lasting for approximately 36 hours, although the very worst of the arm pain was about 12 hours. Symptoms progressed so that by 3:00 pm on day of vaccine I was also experiencing nausea, weakness, fast heartbeat and felt like I was going to faint. Called husband home from work in case I fainted. Called Nurse Care Line and they advised me to call 911. Did NOT do that as I felt symptoms were very significant but not life threatening as I could still breathe and didn't have hives. l started to take ibuprofen and that helped immensely. As soon as ibuprofen wore off the symptoms would reappear exactly as described above. Continued with ibuprofen for 48 hours and by then symptoms were almost completely gone.
Narrative: COVID infection following COVID vaccine series 02/09, Pfizer, dose #1 03/02, Pfizer, dose #2 07/23 COVID swab, result: Not detected 09/17 COVID swab, result: detected 09/12 pt cc: cough, diarrhea, fatigue, headache, loss of taste or smell exposure: daughter teacher
Breakthrough case admission after three vaccines Pfizer 2/15/21 Lot# El9267;  Pfizer 3/8/21 Lot# EN6199;  Pfizer 3/10/22 Lot# FJ9943
Mild fever bout 100° chills, spinning and diarrhea  fever and chills ceased after about 5 hrs
This case was reported by a nurse and described a 55 year old female subject who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included diabetes and "one-half pack a day" smoker. On an unspecified date in November 2005, the subject received an injection of influenza virus vaccine (unknown manufacturer). On 06 February 2006 the subject inadvertently received a dose of Fluarix (lot AFLUA132EA). This represents 2 separate immunizations for influenza in the same flu season. It is recommended to administer one dose of Fluarix annually. On 07 February 2006, the subject experience arm pain and arm redness. The events resolved on 27 February 2006. The nurse consider the events to require intervention or to jeopardize the subject. The nurse consider the arm pain and redness to not be related to vaccination with Fluarix.
Janssen COVID-19 Vaccine EUA - Tingling started on left side of face, left arm and left leg. Paresthesia worsened to both sides of my face and has not gone away; have experienced this for 10 weeks now. Also experiencing sporadic parethesia in right forearm down to fingers, and right calf down to toes.  I have also experienced intermittent bouts of muscle fatigue/weakness in arms and legs, as well as lightheadedness.
Soreness, body aches, chills and fever lasting from about 16-24 hours after vaccine 2nd dose. Left collar bone area lymphadenopathy for about 6 days.
Severe debilitating headache lasting one week require 2 ER visits and IV tramadol.  Severe reactionary arthritis making me unable to bend or straighten one knee or bear any weight on my right leg for 3 days (as of now).  Less severe arthritis appearing in all other joints.
I went in for my flu shot and a MMR titer on 10/18/2017 at 9:00 am at Health Clinic. I received my flu shot at about 9:15 am and within a minute to two minutes, my heart rate jumped through the roof and I started feeling dizzy. I asked the doctor if this was normal and she replied that it can be. She instructed me just to take some deep breaths and then left it alone. When I got home and looked up side effects from the flu shot it said that a fast heartbeat was a severe allergic reaction and to report it. When I talked to the doctor about it, she said that allergic reactions only happen on the skin and that it had to be anxiety, but my vitals were all normal right before I received the flu shot. When I talked to the office today 10/19/2017 they told me that the severe side effects only pertain to people who are getting the flu shot for the first time in their life and that it was probably anxiety.
Pain throughout body, particularly in the hands, knees, and midback. Exacerbation of Psoriatic Arthritis symptoms . Nose Bleeding intermittently
No reaction noted after first dose.  Pt sts woke up on morning after first dose sweating, similarly profuse from past experiences as if he was sick and feverish.  Also had "pain" in his throat, a tightness in his chest, and intermittent chills.  14JAN21, condition the same, with worsening in tightness in chest and throat pain.  15JAN21 chest tightness has subsided but throat pain worse, no trouble swallowing.  PT sounds congested when speaking.  DNS SOB.
Reported redness over her body and swelling in hands and feet. Did seem to get better w/BENADRYL.
pt had onset of lethargy, irritability, inc temp 9 hr p/vax;pt adm to hosp to r/o sepsis;as of 8MAY97 pt remains irritable;
This spontaneous report received from a consumer via a company representative concerned an adult female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was had all the mobility before getting the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, frequency 1 total, start therapy date were not reported administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, It was reported that the patient after being vaccinated lost all of her mobility that put her in the ICU unit (intensive care unit)(Hospitalized) (dates unspecified) for unspecified days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss all mobility was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211130149-covid-19 vaccine ad26.cov2.s- loss all mobility. 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).
Patient received his vaccine in the afternoon of 6/24 and by the early evening, was feeling nauseous. Patient spent the next two days in bed resting and was too nauseous to eat anything more than tea and crackers. Patient was taken to the hospital for evaluation in the afternoon of 6/27.
Pt received COVID vaccine booster 1/9/22@ 8AM. At 4AM on 01/10/22, pt had chills, quickly moved from bed to toilet & had syncopal event. Suspect Vasovagal Response.
fibromyalgia; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or around 06-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered fibromyalgia and balance issues. As a direct and proximate result, the zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events fibromyalgia and balance issues were determined to be disabling.
Fever (99-101), chills, headache, body aches, loose stool, swollen and burning arm 1st and second day. Felt like a terrible case of the flu.
Pain at the site of injection. It has been getting worse over time,  and now after two weeks it is severe. He pain makes in unbearable to move or use the arm. The pain gets worse when laying down. Doctor?s office is no help. PLEASE HELP!
Patient began to have swelling, redness, warmth, itching,  pain the next day.
Feeling flushed and dizzy, which lasted for approximately 20 mins. EKG performed, normal. Provided environment for rest and hydration.
Heart fluttering; Resting heart rate increase when sitting down; Tightness in chest; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7485), via an unspecified route of administration on 03Aug2021 (age at vaccination: 46 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart fluttering, resting heart rate increase when sitting down and tightness in chest; all on 07Aug2021. It was reported that received first dose on 03Aug2021. Before vaccine she was fine. Resting heart rate is increasing when just sitting down. Having fluttering sometimes throughout the day. Get little tightness in her chest, not extreme, just a little it. When sitting down, the highest heart rate got to was 210. Heart rate was 170 when she works out. Average heart rate is 170-210 when it spikes while she is sitting down. It spike today and while resting heart rate was 134. Right now heart rate was 82. Really her heart rate should be 90-100 resting. Heart rate spikes throughout the day. Medical Intervention/treatment include she is going for an echocardiogram next Thursday. She hasn't worked out since this started because she is concerned. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
It started (7/2021) with a small rash and in a short amount of time turned into red dots from my feet to my hips and on my arms and trunk, major swelling, blisters, skin deterioration, difficulty walking, and cellulitis in my right foot. Dx given of leukoclastic vasculitis by a dermatologist. An antibiotic was taken for the cellulitis, colchicine was taken for a while but did not fully take care of the broken vessels. Gabapentin for the pain as Tylenol and Ibuprofen had no effect. Currently still taking Dapsone 100mg QD with break through flare ups of the vasculitis. Currently still swelling. Skin is scarred.
facial and tongue swelling, as well as tightness in her chest; treated with loratadine