chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hive; rash on her torso area, lower hip area.; red bumps; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "hive"; RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on her torso area, lower hip area."; RASH MACULAR (non-serious) with onset 2021, outcome "unknown", described as "red bumps".  Additional information: The patient states she got the first Pfizer Covid vaccine on 05Aug2021 and not had really anything, it was pretty uneventful, but she had a slight rash on the torso area, near the lower left hip. After receiving the vaccine patient had noticed a rash on her torso area, lower hip area. A "few red bumps, 2-3 raised like a bite or hive maybe, patient don't know. Then a little around it." The rash starts before her hip starts; she states as per her husband it was the length of her hand. She states she has a small hand and estimates it to be about 5 inches and 2 inches down. The patient would like to know if this was something she was concerned about or if this was normal as well as if this was an urgent matter. She wants to know if there was any issues for concern with that or what. The patient wants to know after a rash after getting the vaccine, would this mean that she cannot get the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6-10-10 1030 a.m. got up with right arm swelling, at 1100 p.m. mouth swelling, rash on (R) am - given steroids, BENADRYL and EPI in ER, condition improved released to home 0615.
Started getting terrible headache in early evening the afternoon I received the vaccine.  Next morning (6/16/20) woke up with fever of 100.3 (my normal temp is 97.4) with sharp pains in my head, achy and exhausted.  I got up for one hour and went back to bed.  It felt like I had a terrible case of the flu.  Slept most of the day and could only eat applesauce and chicken noodle soup.  Fever went down 2 degrees by 9:00 PM.  Very slight fever when I woke up but it subsided as of 10:30 AM
A non-serious spontaneous report of back is covered with a rash has been received from a consumer in the USA concerning a 4-year-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient has no known allergies.  Medical history and concomitant medications were not reported.  On 12-NOV-2008, at 12:00 noon, the patient received FLUMIST at a military naval base.  On 13-NOV-2008, the patient woke up with a rash from his neck to his waist both front and back itched. The rash was described as "little red bumps". He had no other symptom and no problem breathing. The patient experienced the same reaction when he was one year old from the varicella vaccine. The patient was seen by a physician in a navy clinic but was not treated with anything. The following day, the rash was better and fully resolved by 15-Nov-2008. Additional information received on 05-Dec-2008 was incorporated into the narrative and included date of birth additional details about the event and outcome.  The patient had no problems breathing.  The outcome of the event was not reported. This is in follow-up to report(s) previously submitted on 11/13/2008. The patient has no known allergies but did experience the same reaction when he was one-year-old from the Varicella vaccine. The patient was not taking any concomitant medications. Additional information received on 07-Jan-2009 from a nurse in the immunization clinic included the lot number and expiration date at the FLUMIST and confirmation that the patient was seen in the clinic and was not treated.
Approximately 6:00 pm on 1/11/21 began experiencing muscle aches and fatigue.  On 1/12/21 these continued but became progressively worse with headache starting around noon. By 3;30 pm, symptoms were: fatigue, muscle pain, severe headache.  Body chills around 6 pm and temperature at 7 pm was 100.5.   By 6:00 am on 1/13, all symptoms resolved.
Extreme pain at injection site. Fever of 100.1 degrees upon waking the next morning.
This case was reported by a lawyer and described the occurrence of arm pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included hysterectomy and knee pain. Concurrent medications included SYNTHROID, LUVOX, CRESTOR, Solgar GTF Trivalent chromium, Travacort, VESICARE, LUTEIN, Glucosamine chondroitin complex, Biotin, B-12 and Calcium. Also mentioned were resue medications 1250 and LDL. On 8 May 2000 and 10 April 2000 the subject received 2nd dose and 1st dose of LYMERIX (unknown). In July 2000, after vaccination with LYMERIX, the subject experienced pain in both arms, pain between the shoulders, and elbow pain. Aspirin and TYLENOL gave no relief and she was prescribed RELAFEN. RELAFEN was not effective and Prednisone was prescribed which worked. These symptoms have improved but reportedly continue to come and go. Also in July 2000, the subject developed fatigue for which she takes PROVIGIL, muscle pain and memory problems. In December 2000, the subject was admitted to the hospital with gastro-intestinal problems including some pain and bleeding. She was fed and medicated intravenously. The pain resolved one week later and she was put on ASACOL to manage this condition. The pain reportedly returned with increased severity in June 2004 and she was put on COLAZAL which effectively managed the symptom. An additional symptom that developed in 2000 was elbow swelling which has since resolved.
I had stomach and abdominal pain, tenderness around the right side of the stomach area, bloating, nausea. I called and made an appointment to see my doctor who ordered a CBC blood panel work up that I am awaiting the test results on. I was advised to go home, rest and wait for the results of the blood test to see where we would proceed from here.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
After receiving the first shot of the Moderna vaccine I experienced nothing more than a sore arm on the first day. The next day I developed a headache, on/off fever, and muscle aches, dizziness and slight nausea. On the third day after receiving the vaccine I started to feel a tightness in my chest, specifically on the left (heart) side of my chest. With this I also starting having tiny shooting pains on my heart side, heart palpitations and irregular breathing- as if I was short on breath. The headache lasted for two weeks, the chest pain/ tightness and palpitations still remain happening three weeks after the first shot and I still catch myself gasping for air once and a while. Before getting this vaccine I had zero health issues, no trouble breathing, no chest pain or heart palpitations. I do not take any medications and have no underlying known health issues. Now I am having trouble with my normal activities such as working out, or simple house cleaning. I feel tired, and my chest pain is constant. I am terrified that my heart is working overtime and that I may have a heart attack or a stroke because of this vaccine. * to note about taking Claritin D the day of getting the Vaccine- I have not taken it since.
body ache; fever 100.9; chills; A spontaneous report was received from a pharmacist concerning a female patient, unknown age, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced chills, body aches and fever.   The patient's medical history was not provided. Concomitant product use was not provided.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient was unable to work, experienced chills, body aches, and had a fever of 100.9 °F. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, chills, body aches and fever, was unknown.; Reporter'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.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 16-year-old patient of an unspecified ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose, and MENACTRA via an unspecified route of administration, both on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever for 3 days, 101, all over body aches that lasted for 3 days, had trouble walking even by 3rd day. The outcome of the events was unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
head congestion; sick all over; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head congestion), ILLNESS (sick all over) and HEADACHE (headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (head congestion), ILLNESS (sick all over) and HEADACHE (headache). At the time of the report, HEAD DISCOMFORT (head congestion) and ILLNESS (sick all over) outcome was unknown and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is on concomitant medication, but does not specify which ones. From first dose, the patient had a pretty strong reaction to it, such as headache, head congestion, sick all over. The patient reports no fever. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-474799, MOD-2022-474811 (Patient Link).
Information has been received from a physician, via a company representative, concerning an 18 year old female patient, who on 30-JAN-2007 was vaccinated IM, with the first dose of Gardasil, and on 04-APR-2007 with the second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 04-APR-2007, following the vaccination, the patient developed "band-like swelling around her arm at the injection site," which continued for two days and then resolved. On approximately 25-APR-2007, the swelling around her arm returned; the patient had been applying cold compresses to relieve the swelling around her arm returned; the patient had been applying cold compresses to relieve the swelling. On 27-APR-2007, the physician saw the patient and reported there was no visible discoloration or bruising of the arm, though the swelling was still present. At the time of this report, it was unknown if the patient had recovered from the recurrent swelling of her arm. Additional information has been requested.
States last night had fever, chills and arm swelling. This AM (6/25/16), had erythema and arm pain. Redness expanding from deltoid to mid axillary area. Cephalexin 500mg TID.
Chest pain 3 days after vaccine, evaluated 4 days after vaccine and found to have evidence of pericarditis without myocarditis. As no myocarditis and symptoms mild, was discharged with plan for cardiology follow up in 1 month.
Attending Physician:    Date of Admission:  1/23/2022   Chief Complaint:  Shortness of breath   Source of Information:  Patient and available chart review    History of Present Illness:  This is a 64y.o. male with a PMHx of essential hypertension, type II diabetes mellitus, osteomyelitis of LLE, right BKA, PVD, and DVT who presents to the hospital with a chief complaint of shortness of breath and hypoxia. Patient was found to have low SpO2 at his ECF this morning and states he had an acute onset of shortness of breath that started to occur last night. He states his SOB was present at rest. He is currently denying any active chest pain, palpitations, n/v/d, fever, chills, abdominal pain, lower extremity pain, headache, lightheadedness, dizziness. He does admit to a non-productive cough, which started yesterday. Patient was placed on 4L NC at that time with improvement of SpO2 to 97% per EMS. Patient does not require any oxygen at baseline. Patient denies any recent travel or sick contacts. He is vaccinated x3 for COVID-19 with his booster completed in October 2021. Of note, patient was recently seen at our facility and discharged on 1/14/22 for acute osteomyelitis of his left lower extremity. He underwent debridement on 1/3/22 and incision and drainage on 1/7/22. He was discharged on 1/14 to ECF with wound VAC changes every other day.
hearing loss; nerve damage; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around October 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, dose number, lot #, expiration date, site 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, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered from hearing loss and nerve damage. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the pt 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. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of hearing loss was determined to be medically significant. The events were considered as disabling by the reporter.
Vaccination nodule: a hard knot at injection site. Feels solid with no pain, redness or warmth. Present for longer than a week.
Client reported nausea, vomiting, hot flashes, and vertigo on the day after receivine vaccine. Is using Antivert w/ some relief of symptoms.
BODY ACHE; LIGHT HEADED; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 01-APR-2021 approximately at 11:00 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced body ache. On 01-APR-2021, the subject experienced light headed. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fever on 02-APR-2021, and light headed on 01-APR-2021. This report was non-serious.
Pt recvd 3rd dose of Engerix-B on 24JUL90 deltoid & on 21AUG90 HBsAb showed a titer of 0.9RU ratio unit;
Pt presented to urgent care with c/o rash on left arm as a result of PCV13 given 1/29/15 appointment. Patient evaluated 1/29/15 by Dr. for adverse reaction.
Having runny nose; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as COVID VACCINE; unknown lot number and expiration date), via an unspecified route of administration on Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she has been administered the first dose of COVID vaccine yesterday (Jan2021) and she reported having runny nose and fatigue all day. The representative reported it within 24 hours of his wife's persistent symptoms. The outcome of the events was not recovered.   No follow-up attempts are possible; Information about Lot/batch number cannot be obtained.
A nurse reported that a female resident of a long-term care facility received a dose of Flu Shield (2001-2002 formula) in 11/01. In 1/02, the resident developed a "severe" respiratory infection characterized by congestion and fever. A dx of influenza A was confirmed by rapid antigen testing. She recovered. No further information was available at the date of this report. This is 1 of 8 residents of this facility who experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038. The reporter also indicated that 7 employees of the facility experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038.
Patient reports rash for 2 weeks, treated with benadryl.  Small welts still remain.  Itching resolved.
Sepsis; Been 52 days for second dose of vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SEPSIS (Sepsis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Been 52 days for second dose of vaccine). At the time of the report, SEPSIS (Sepsis) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Been 52 days for second dose of vaccine) had 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.   No concomitant medications were reported  The patient was hospitalized for almost 3 weeks for sepsis after receiving first dose. At the time of report, the patient was on 52nd day since receiving first dose.  Treatment information was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Three weeks and one day following my second vaccine, I had three episodes of disequilibrium followed by a drop in body temperature. I went to the ER and was admitted for a day for tests. CTs, MRIs, echocardiogram, PT consult, neurology consult showed nothing. I believe it may be vaccine related because the exact same thing happened to a friend across the country 3 weeks after her vaccine. We have been gone since.
Noticed reaction 11-17-07. 1 cm red vesicular patch at injection site (L) upper arm local reaction to Varicella vaccine. To use Eucerin and oral Benadryl.
Fever, arm pain, jaw pain, nausea, mild SOB, possible diarrhea
24 hours after administration got hives at the site. This along with intermittent pain lasted for 4 days
Parent called pediatrician at 12pm reported was seen in ER last night after 3 episodes of hallucinations lasting 10 mins saw red and green lights and monsters. Attacked father trying to get rid of "monster" on face. Remembers event fully. To ER who recommended calling pediatrician to report.
Patient called after leaving the facility regarding the rash on neck left side and right side little bit going towards the both ears. No Itch or puffiness. recommended to take some over the counter Benadryl
The day after vaccination, I woke up delirious and did not know where I was. I could not move. I had a fever of 104.0 and I remember getting water then back to bed, unsure if I took Tylenol. I stayed in bed with weakness and fever all day. I had fatigue the next day but did not notice fever. I did not go and see a doctor. I have fully recovered.
no adverse event----just to want to inform than multi dose diluent vial was used more than once to mix with covid vaccine
Approximately 5 minutes after administration the patient reported an itchy rash at the site of injection that was spreading and intensifying. One 25mg tablet of Benadryl was administered, 911 was called, and an epi-pen was kept at the ready until EMS arrived and took over. The patient was very anxious throughout but maintained adequate ventilation and never lost consciousness.
I had experienced several Adverse Events after getting the Covid 19 Vaccine.  I had Pain at the Injection site on my Left arm a few hours after receiving the vaccine at 11:00 am on 6/5/21.  Initially I did not feel anything.  However the Pain got worse thruout the day until I went to bed at night.  The Injection site also was a little swollen after a few hours of getting the vaccine.  I had experienced some fatigue and tiredness on 6/5/21 after getting the vaccine.   When waking up in the morning on 6-6-21 I must of had fever at night because in the morning I was sweaty.  I also felt tired and fatigued when waking up.  The pain at the injection site seems to have gotten a little better.  Also there is no fever or sweating after i woke up.