chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced in mid August 2021, heart palpitations, I went to see my PCP Dr. got an EKG done and they he referred to my a cardiologist last Monday. They did a stress test and echocardiogram and he could not find anything wrong with me. the last time I felt a heart palpitations was last Monday 09-27-2021.   I was told to monitor the heart palpitations if they come back.
pt recv vax & 20 mins following vax pt exp nausea & vomited 3x & returned to MD ofc; pt was noted to have dry heaves, but no further vomiting; that evening pt reportedly vomited 2 more times;
Sensorineural hearing loss; Herpes Zoster Oticus/bilateral ear pain; Meniere's disease; Bilateral Transient Visual Loss/bilateral blurry vision; neuropathic pain/constant headache and fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 14-NOV-2016, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt. experienced hearing loss and bilateral ear pain therefore was diagnosed with sensorineural hearing loss (deafness neurosensory), herpes zoster oticus and Meniere's disease. The pt. also claimed suffered bilateral blurry vision, constant headache and fatigue which were diagnosed as bilateral visual loss (blindness transient) and neuropathic pain (neuralgia). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had resulted in physical limitations not presented prior to the use of the vaccine. Pt. also experienced mental and emotional distress due to resulting in physical limitations and seriousness of his 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. 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; and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered deafness neurosensory, herpes zoster oticus, Meniere's disease, blindness transient and neuralgia to be disabling events.  Upon internal review, the events deafness neurosensory, herpes zoster oticus, Meniere's disease, and blindness transient were considered to be medically significant.
Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Pt was sitting with wife about 10 minutes after vaccine became unresponsive.  Wife got my attention.  Had weak pulse, cold to touch, but was responsive to me.  Knew his surroundings but said didnt feel 100%.  Had NP from minute clinic look at him and called EMS for extra evaluation.  Pt was transported to hospital
None *Note - This was given in a clinic for people working in flood water.  Full charts were not available.  No adverse event occurred.  Out of licensed age range.
Both shoulder joints ached, the right more than the left. The left shoulder pain became minor. The right became stiff by the third day and the pain was 10/10. This lasted for two more days, then pain subsided a bit and some mobility came back. 10 days later the right shoulder is still limited in movement due to pain 6/10.
I was hot one minute & cold the next; I'm just in a state of disarray; I can't sleep due to arm pain; body aches/arm still hurts all the time; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (I was hot one minute & cold the next), FEELING ABNORMAL (I'm just in a state of disarray), INSOMNIA (I can't sleep due to arm pain), MYALGIA (body aches/arm still hurts all the time) and CHILLS (chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. "087871A") for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (I was hot one minute & cold the next), FEELING ABNORMAL (I'm just in a state of disarray), INSOMNIA (I can't sleep due to arm pain), MYALGIA (body aches/arm still hurts all the time) and CHILLS (chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (I was hot one minute & cold the next), FEELING ABNORMAL (I'm just in a state of disarray), INSOMNIA (I can't sleep due to arm pain), MYALGIA (body aches/arm still hurts all the time) and CHILLS (chills) outcome was unknown.             No concomitant medications  No treatment information was provided.
Patient received Td booster on 4/26/07. Following day, noticed redness at site and "just did not feel right". Later that day, developed chills and following day low-grade fever. All associated with progressive erythema at injection site spreading distally toward elbow. Took OTC NSAIDS and symptoms improved. Seen 4/30/07, mild swelling and some ecchymosis at site (posterior tricep area). Measured 4x6 inches. No streaking, abscess formation. Resched for TD booster given into tricep muscles. Treated for allergic reaction and mild cellulitis. Seen 5/4/07 Swelling and erythema resolved. Pt completed 10 day course of Keflex.
Received shots yesterday, 5/2/22 at 5 p.m. Sore arm was noticed about an hour after the shots (I also received a COVID-19 booster at the same time, in the same arm as the pharmacist instructed). Other than that, I felt fine until late morning, I began feeling chills, body/joint aches, feverish (but no fever), headache, mild nausea. I am still feeling these symptoms, but do not feel the need to call my doctor or seek treatment.  Ibuprofen was taken.
hives all over the body including the soles of the feet; This case was reported by a consumer via call center representative and described the occurrence of hives in a 19-year-old female patient who received HAV (Havrix adult) for prophylaxis.   Concomitant products included escitalopram (Lexapro), sertraline hydrochloride (Zoloft), benadryl (nos) (Benadryl) and cetirizine hydrochloride (Zyrtec).   In August 2018, the patient received the 1st dose of Havrix adult (intramuscular). In December 2018, less than a year after receiving Havrix adult, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Havrix adult.  Additional details were provided as follows: This case was reported by the patient's mother. The reporter stated that, the patient developed hives but at the time had also had dose of Zoloft increased for treating anxiety. The reporter stated that, the patient had hives since then was seeing allergist to try and determine root cause. The reporter did not consent to follow up. The reporter declined follow up with the patient's healthcare professional.
3 hours after receiving vaccine I started to feel dizzy, unable to think correctly, queasy, on and off chills accompanied with warmth.  5 hours after the vaccination I started to feel flushed and had hives on my chest area. I also started feeling tightness in my chest during inhalation. I took 2 Acetaminophen pills, 500mg each.  It helped with the flu like symptoms yet the injection site was (and still is a week later) warm, raised, very tender and itches.  One week after the vaccination I started feeling malaise and queasy. I took Tylenol again to help symptoms (two 500mg each) and did help. I did that twice, 5 hours apart. A week and one day right now and still don?t feel completely back to normal, no change to my left arm.
Information has been received from a physician concerning a 19 year old female who was vaccinated with a dose of Gardasil. Subsequently the patient developed amenorrhea. Unspecified medical attention was sought. It was reported the patient planned to discontinued the series of injections. Additional information has been requested.
Just mild arm soreness day 2 and 3.  No symptoms through the entire week and weekend after, then Monday afternoon (1/11/21) I noticed a pain developing on the underside of the arm, just around from the injection site (if you drew a line from the top of the arm where the injection was delivered to the underside immediately under site).  As the afternoon progressed in to the evening the pain became even greater.  When I used that arm to steady myself over the sink while brushing my teeth it was definitely greater while my muscle was flexed.  It feels deep inside my arm, almost deep center, and is heading up in to my armpit.
Tachycardia (see above, tachycardia) Narrative:  Recipient immediately felt "bad" s/p vaccination - vitals demonstrated HR 133. No other signs or symptoms of anaphylaxis. Tachycardia resolved within 1-2 minutes of rest without intervention to HR of high 70s-low 80s. BP 131/91, SpO2 98% on room air, temperature 98.4F. Recipient able to ambulate on own to exam room. Exam benign, including recipient's HR observed prior to/during/after exam to be high 70s. Tolerated oral intake without issue, no further intervention indicated. Recipient observed for 30 minutes after vaccine administration without further issue.
Agitated, uncomfortable, possible hallucinations, short of breath, pain in extremities, throat closing.
I started having a sore throat on 5-12-2022. I done a home test for Covid on 5-14-2022 and it came back positive. The sore throat got worse and I started getting head congestion, runny nose, watery eyes. I woke up on 5-16 and I took some Benadryl, Sudafed and ibuprofen/Tylenol. I called the doctor on 5-17 and I went in that day to be tested and it was positive as well. They did not prescribe anything. They told me they would prescribe something if I was not better by today. I am feeling better. I used a home test for Covid yesterday which still showed positive. I then used a Covid home test today and it was negative. I am reporting my breakthrough case of Covid.
Caregiver complained of a "heavy" throat and had redness and itching to her neck and chest area
having covid; having covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP).  A 42-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 was not reported. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "unknown" and all described as "having covid".  Clinical course: Patient reported, missed 5 days of Xeljanz last week due to him having Covid, No longer has any symptoms of Covid. Md not aware.   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 given in narrative, the causal relationship between the event Drug ineffective and COVID-19 and the suspect drug BNT162B2 cannot be excluded.
on 10/16 Return of symptoms - Double Vision-  of Myastenia Gravis  - which had been previously under control with 7.5 mg of Prdenisone daily. required dose increse to 20mg to re gain control  11/13 and 11/24/09 Medical records receoved. PCP notes for DOS range 7/20/09 through 11/23/09. C/O problems after vaccine.  Diplopia returned.  Steroid tx. Back to baseline.
Very sore deltoid area of arm.  The vaccine was administered a bit too high in my arm.  When I move my arm and my deltoid is used in the movement, a sharp pain travels through my deltoid. I saw my physician on 09/24/2013 because the pain was not getting any better.
inject site surrounding area became red itchy not warm; rx-Atarax, Elison oint;
The whole upper body broke out in a rash. After 48 hours the rash was completely gone. It was a red rash, the patient was not itchy at all.
10cm x 12cm area of raised, shiny, well demarcated erythema w/warmth, over rt deltoid region began 36hr p/vax in this arm;tx as probable cellulitis w/keflex;lt arm swollen/red/warm to touch, sore;mild discomfort, sweaty & feverish;
Last Friday, October 9, my daughter was vaccinated at about 12pm, during the day she reported strong headache episodes, she took paracetamol 750mg, on Saturday she felt tired and weak for the whole day, but at night she felt a little better so she decided to go out a little, she came back home due to a fever, on Sunday, she had high fever, the whole day so in the evening she entered the emergency room they found her white cells very low, so she went straight to clinic, on Wednesday she was discharged but she is still hospitalized we are treating her with antibiotics but she is still has a fever, I would like to know if her condition has any relation with the vaccine, if there are other cases reported and how it is been treated.  I am looking forward to hearing from you asap.
Information has been received from a physician, via a company representative, concerning a female patient who was vaccinated with the first dose of Gardasil (date unspecified). The physician reported that before the needle was withdrawn, the patient developed substantial swelling at the injection site. At the time of this report, the physician confirmed that the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
I get sick every time; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-DEC-2020.   This case involves a patient of unknown age and gender who experienced I get sick every time (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.  On an unknown date, the patient reported that the patient got sick every time the patient was forced to take it.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Woke up Monday, 3/8/21, at 8 am and noticed that my whole right side of my body is tingling as if I slept funny.   The level was 8 at the beginning of noticing it - but then has down-graded to a constant level of 5. Today is Friday, 3/12/21, and the doctor advised me to set up an appointment with her at 1:40 pm today.
Nausea began on 7th; 8th nausea, vomiting, fever 101-102 degrees all day; 9th fever broke about 3 PM. Red welt continued to grow in size from approx 3" to 4 1/2-6 1/2". Patient to MD on 11/10/03.
I had a little arm swelling and turned bright red for a couple of hours,Trunk, arms, and head were bright red. Only turned red, for two to three hours. Took half a Benadryl when I got home. No itching/no hives, just red.
pt recvd vax 15FEB96 & that same evening grandma called nurse to report that pt had been crying x 2hrs & was jittery;nurse told them to take pt to ER & they did;ER MD prescribed DPH
headaches, body aches, painful sharp pulsing ticklish feeling on right side of right foot; numbness on left foot with occasional sharp electrical light pain shooting up the leg. This kept me up for 2 nights. Currently, I am still feeling mild tingling under the left foot which has spread to the entire left foot. Both feet are numb.
I arrived home and my arm was throbbing really bad and broke out all over with hives (looks like measles).
Patient reported that 3 weeks after having the FLUZONE HD vaccine she started to experience muscle pain in the same area as the injection.  Since then she reports that the pain has worsened and has difficulty now raising her arm as well as sleeping due to the pain.
Suspected vaccination failure; flu; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   In February 2019, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: This case was reported by the reporter's father. The age at vaccination was not reported. The patient recently received a dose of an unknown flu vaccine. After vaccination, the patient had flu. The reporter probably contracted it from the patient. This case was considered as suspected vaccination failure case as the laboratory tests and time to event onset were unknown at the time of reporting. The reporter did not consent to follow-up.
An 82 year old male patient has received 3 series of Tice BCG for treatment of Bladder Cancer.  The patient is a participant in a clinical trial with Schering-Plough since 02/26/2002, using Interferon with Tice BCG.  He initially received 6 weekly instillations of full-strength BDG with Interferon alpha @B, from 02/26/2002 through 04/12/2002, which he tolerated well.  Per study protocol, he received a "maintenance" series of 3 weekly instillations of 1/3 Strength Tics BCG with Interferon, from 06/25/2002 through 07/17/2002, and from 09/26/2002 through 10/10/2002.  Immediately following the instillation on 10/10/2002, the patient experienced urinary burning and extreme frequency of urination.  He reported this to his MD on 10/14/2002, at which time Cipro was prescribed for 7 days.  On 10/16/2002 the symptoms were still persisting, and a urine culture was obtained and Macrobid was added to the continuing Cipro therapy.  However, there was a problem with the Lab test, and the results of the urine culture were not available.  On 10/18/2002, the patient reported the need to void every 20 minutes; Flomax was prescribed and Cipro was extended for an additional 7 days and Macrobid for an additional 4 days.  On 10/21/2002, the patient reported voiding every 10 minutes, "60 times/day; at this time, Ditropan XL was prescribed and Flomax continued.  On 11/05/2002 the patient reported that immediately after starting Ditropan, he had 2-3 days during which he was able to hold his urine for 2-3 hours at a time, but the frequency has again worsened, despite continuing Ditropan and Flomax.  10/14/2002: Started with Cipro; 10/16/2002: Started with Macrobid and continued with Cipro; 10/18/2002: Started with Flomax and continued with Cipro and Macrobid; 10/21/2002: Started with Ditropan XL and continued with Flomax;
This spontaneous report was received from a male patient currently in his 40's (reported as 40 plus years old) reporting on himself. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient received injections from multiple bottles and he belief that one of them may had been a dose of GARDASIL route reported as injection, as prophylaxis (Strength, dose, lot # and expiration date were not reported), however, it was also reported that the physician told the patient that he was not given GARDASIL. On an unknown date, the patient experienced joint pains (arthralgia), his hands were painful and disabled for over 20 days (pain in extremity), he experienced tingling in his arms and they tense up (paraesthesia), when he was asleep, his muscles tighten up (muscle tightness), he developed human papillomavirus (HPV 1) (papilloma viral infection), genital warts (anogenital warts) and pimples (acne), when he exercises he felt like his body was being injured (feeling abnormal), autoimmune issues (autoimmune disorder) and nerve problems (nervous system disorder). The patient was given 2 bottles of (VALTREX) for the HPV 1 but it did not work. The patient received unspecified treatment for the other events. The outcome of autoimmune disorder, arthralgia, paraesthesia, muscle tightness, acne, anogenital warts, papilloma viral infection, feeling abnormal, nervous system disorder and pain in extremity was unknown. The reporter did not provide the causality between the events and GARDASIL. The event autoimmune issues was determined to be medically significant. Additional information is not expected as no contact details were provided.
No adverse symptoms noted at this time.  Intranasal questionnaire was also utilized and completed by the patient.  The patient indicated on that questionnaire that she was between 2-49.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8734) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication Treatment of COVID-19; (20Jul2022) Negative, notes: Had a negative home test on 20Jul2022; (21Jul2022) Positive, notes: Did another home test and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: COVID 19 Treatment with Pfizer brand from 12Jul2022 to 16Jul2022 for the treatment of COVID-19, Oral route of administration. The patient did not receive no other medication in two weeks. No Known allergies. Other medical history: none. No other medication received in 2weeks.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shins. Extreme fatigue resulting in shortness of breath when I walk a very short distance. Coughing up very small traces of blood. Muscle and joint pain. In particular sore abdomen, back and upper shoulders. Pain is sharp when I cough or move a certain way. Sometimes it is just a persistent aching.