chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous PREVNAR 13 on 02Dec2016 at single dose  for immunisation. Medical history included high blood pressure, narcolepsy, apnoea. The patient's concomitant medications were not reported. On 02Dec2016 few hours after vaccination, the patient experienced headache, was feeling tired, had generalized muscle pain throughout the body and was feverish (no temperature) with chills. Patient was treated with ADVIL on 02Dec2016 and 03Dec2016. On 03Dec2016 he was still tired and had a slight headache (which was relieved by ibuprofen), other symptoms are gone. Final outcome of feeling tired was not recovered, outcome of the other events was recovered on an unknown date.
PATIENT HAD ALL OVER RASH-REQUIRED BENADRYL. LASTED WEEKS
Head ache and low grade fever (99.5) took 3 Advil.  Tried and achey. The morning of 3/28/21 was feeling better.
Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recovery within 10 hours
Cold; J&J COVID shot and Moderna booster made her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (J&J COVID shot and Moderna booster made her arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (J&J COVID shot and Moderna booster made her arm hurt). At the time of the report, NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (J&J COVID shot and Moderna booster made her arm hurt) outcome was unknown. Not Provided          It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
9/7- office visit -positive for strep 9/9-office visit - ekg- heart palpitations  9/15- emergency room visit for severe chest pain 9/20- follow up visit  10/5 - stress test cardiac lab
This initial serious spontaneous case, was received on 16-Nov-2017, from a consumer, concerning 64-year-old adult, female patient. The patient's historical condition included asthma and had no concomitant medications. On 11-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, anatomical location: left upper arm, batch number: 179905P, expiry date: May-2018, route of administration: not reported). On 13-Nov-2017, after 3 days of vaccination, the patient lost hearing of both ears (described as clogged). It was pronounced in left ear. The patient was treated with prednisone. At the time of the report, the patient had not recovered from the event.
Been laid up since/ saying how terribly he feels/ is sorta in limbo; Not moving at all; Can't even get up; Having flu like symptoms; Feels malaise; He sleeps 12 hours; Pain; Muscle aches; Got the second dose early before 22 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MALAISE (Feels malaise) in a 67-year-old male patient 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 COVID-19 in January 2020. Concomitant products included METOPROLOL for an unknown indication.   On 19-Mar-2021, the patient received second 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 19-Mar-2021, the patient experienced FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms), MALAISE (Feels malaise), SOMNOLENCE (He sleeps 12 hours), PAIN (Pain), MYALGIA (Muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose early before 22 days). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose early before 22 days) had resolved. At the time of the report, FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms), MALAISE (Feels malaise), SOMNOLENCE (He sleeps 12 hours), PAIN (Pain) and MYALGIA (Muscle aches) outcome was unknown.            Treatment medications not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and reported event terms updated.
Pain under right breast; Itching; Shingles right abdomen dermatone; Pain in abdomen; A spontaneous report was received from a consumer concerning a 72, year old, female patient who developed pain under right breast, itching, shingles, and pain in abdomen.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 30-12-2020, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    On 02-JAN-2021 the patient went to an urgent care for pain under the right breast, itching, shingles, and abdominal pain.  On 03-JAN-2021 the patient went to the hospital for pain under the right breast, itching, shingles, and abdominal pain. The patient was discharged the same day 03-JAN-2021. Treatment for the event included Lyrica twice daily, Valtrex twice daily, Tramadol and two rounds of Prednisone.  The patient self -administered Advil and Tylenol.   There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and was administered on 27-JAN-2021    The outcome of the event(s) not reported.     Follow up: No follow up provided.; Reporter's Comments: This case concerns a 72, year old, female patient who developed pain under right breast, itching, shingles, and pain in abdomen. Very limited information of this event has been provided at this time. Further information has been requested.
middle son got the pediatric Pfizer covid 19 vaccine; middle son got the pediatric Pfizer covid 19 vaccine; Joint pain/ knees and ankles; back pain like charley horses in the lower back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 13 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious), outcome "unknown" and all described as "middle son got the pediatric Pfizer covid 19 vaccine"; BACK PAIN (non-serious) with onset 04Nov2021, outcome "unknown", described as "back pain like charley horses in the lower back"; ARTHRALGIA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Joint pain/ knees and ankles".  The lot number for bnt162b2 was not provided and will be requested during follow up.
just had some tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "just had some tiredness".  Additional information included Reporter states he took the Pfizer-BioNTech COVID-19 Vaccine primary series 1 and 2. He states he" just had some tiredness" and then received his first Pfizer booster dose and "got a headache for 4-5 days, 2nd booster had no side effects. Patient got "3rd Pfizer booster dose last week on 05Jan2023, I felt very bad after 3 hours my shoulders, arms ached and I had headaches and at night I got a fever and woke up at night with chills and fever and took Tylenol and then I was sweating." caller states he Got up in morning. "Just tired and had a little pain over my left chest and 3rd or 4th day my heart was beating very fast and then went away. Yesterday, the chest pain came back and lasted all day and my BP (Blood pressure) was 179/96 and last night the pain went away at 12:00 and at 3am I went to (Withheld) and for an hour or so I had chest pain. I just wanted to call and see if anyone else had these symptoms, then I wouldn't worry so much."   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024856 same patient and reporter, different dose and event;US-PFIZER INC-202300024855 same patient and reporter, different dose and event;US-PFIZER INC-202300024857 same patient and reporter, different dose and event;
Muscle ache; eye infection; Chills; Nausea; swollen and closed eye; eye that was numb; itching in the eye; eye painful; Loss of appetite; Headache; Pain in the right shoulder; swelling in the right arm that was similar like a baseball; pain in right arm; weakness in right arm; A spontaneous/solicited report was received from a consumer who is 74 year female who experienced a  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection.  The patient's medical history was not provided. Concomitant product use provided was Lamotrigine 100 mg,  On 22-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 23-FEB-2021, the patient states she started experiencing  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, and pain in the right shoulder. On 24-FEB-2021, she woke up with swollen and closed eye that was numb, itching and painful, Additionally she was experiencing nausea, loss of appetite, headache, chills. Patient states that she made an appointment with eye Dr to get her eye checked up. The eye Dr ended up diagnosed her with an eye infection and prescribed an eye drop called Erythromycin. Patient said her symptoms continue on and on Friday she had muscle ache, muscle pain, pain went from right side to left side. On Saturday, the pain was left arm and going back forth between left and right arm, itching, and chills. On Sunday and Monday, experienced the same symptoms until Monday afternoon or evening started felling better.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events,  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection is 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 and a causal relationship cannot be excluded. Very limited information regarding the event (Eye infection bacterial, hypoaesthesia eye, eye pruritus, and eye pain,) has been provided at this time. Further information has been requested.
After the 2nd dose the next following day I experienced pain in my right under arm. Also after my 1st dose my period cycle changed.
Early the next morning (3:00 AM) I woke up with severe leg cramps and nothing would make them go away. I experienced sweating and chills every night for a week. On the early morning of 04/20/2021 at around 1:00 AM I experienced spasms in my face and tongue which made me see my doctor on 04/22/2021. Doctor ordered a comprehensive metabolic panel because he thought I might be dehydrated causing the cramps.
Information has been received from a registered nurse (RN) concerning a 15-month-old male who on 16-JUL-2001 was vaccinated with a dose of varicella virus vaccine live. On 19-SEP-2001 the patient experienced breakthrough varicella. The patient had less than 50 lesions and no treatment was necessary, though unspecified medical attention had been sought. The patient's present status was unknown at the time of reporting. No product quality complaint was involved. Additional information has been requested.
lymphadenopathy left arm and breast  started approximately 36 hours after initial injection that lasted 60 hours or so, that then turned in to a cough that progressed to wicked cough over the next 3 days just like what I had when I had covid the month earlier.  I sound like a smoke of 40 years...and I don't smoke.
I started with a large rash at the injection site. I had pain inside my bicep. This lead to muscle weakness, myositis. This started in my left arm, moved to my right and then to my legs. I was diagnosed with a blood clot on the injection site and inflammation of the muscles. I went to a neurologist and was diagnosed with the blood clot with an ultrasound. The blood clot is small so they did not prescribe anything. I did blood work and it was high with inflammation so was hospitalized for the blood clot and muscle weakness. I was in the hospital for 5/26/2022-05/29/2022. The blood clot was small so they suggested physical therapy and follow up test due to the pending lab results. I am scheduling an EMG procedure and also physical therapy.
Swelling and pain in left armpit lymph nodes, left breast, and nipple. Previous breast implant incision site tender/painful to touch despite being over 4 years old.
I started with headache about 4pm. I had fever and chills, tried to drink water before a dr appointment and projectile vomitted everywhere. I ended up not going to the doctor and stayed home for a few days. Called my pcp and scheduled endoscopy.
inconsolable crying, fever, stopped talking & cooing for quite some time p/vax; (approx 3wk);
Lump as big as silver dollar, warm, raised, itching, painful and fever of 104.4 patient reports. Went to doctor and got steroid shot is taking ibuprofen as well.
This spontaneous report as received from a license practical nurse refers to a 42 months old male patient who was inadvertently vaccinated with a 0.5 ml dose of GARDASIL (lot # 672547/1745AA) on 13-AUG-2012, due to staff error. No adverse effects reported. Additional information has been requested.
Moderate pain at site, then swelling and redness several inches across affected upper arm x 1 week to date, now moderate itching
Woke about 3 am itching put anti itch cream, gave ibuprofen and BENADRYL. No itching today. 6 raised area on face 2 on neck rt side right now not itching few areas on both legs around ankles.
Systemic: None-Fridge excursion-Mild, Additional Details: Fridge excursion a few degrees too cold for a few hours on 10/29 discovered 1/9
I start seeing blood spots with passing tissues since then. no pain or any feeling. just slight bleeding. Called the doctors. they are monitoring
redness to right arm and anterior chest wall began shortly after vaccine administration and spread to chest wall area within 2 days of vaccine
7:00 PM Muscle aches. 9:00 PM Chills and fever. 1:00 PM Fever broke. Followed by continued muscle aches and headache. Injection site is red and swollen and painful.
Developed muscular aches and stiffness for months subsequent to vaccination that affecting spinal joints in cervical, thoracic, and lumbar spinal regions.  At times also had severe inflammation of peripheral joints including right hip.  Had anterior uveitis in my left eye starting  04/30/2021.  Eventually diagnosed with ankylosing spondylitis by May 2021; was addressed with various courses of medication, including NSAIDs, oral steroids (prednisone).  Eventually started on Humira to improvement  and relief of symptoms; currently still taking  40 mg intramuscular injection once every 2 weeks.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 14-Jan-2014. Registered nurse reported that on 14-Jan-2014 they had four siblings that inadvertently received expired FLUMIST QUADRIVALENT. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
I got the vaccine at 3:30 pm. My right arm where the shot was started to itch extremely bad around 4:30. Then around  4:50 my throat was swelling up and my ear felt congested. A few minutes later it was hard to breathe. I let my staff know ( i work at urgent care) that i was not feeling so good from the vaccine. i was checked into the urgent care and i had hives and i was itching all over.
Discharge Provider:  MD Primary Care Provider at Discharge: MD  Admission Date: 8/14/2022 Discharge Date: 08/17/2022  PRESENTING PROBLEM: Hypoxia [R09.02] End stage renal disease on dialysis [N18.6, Z99.2] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 50 y.o. female with past medical history significant for pulmonary hypertension, asthma, chronic hypoxemic respiratory failure oxygen dependent, ESRD on HD, morbid obesity, chronic diastolic heart failure, OSA on CPAP, hypothyroidism, mood disorder, hx DVT on warfarin, and non-insulin dependent DMT2 who presented to the emergency department with shortness of breath, headache, chills, nausea, sore throat, fatigue and productive cough.  She took a COVID test at home that resulted positive.  She has been fully COVID vaccinated with 1 booster. At baseline patient is on 2-3 L nasal cannula at rest and 5 L with any activity or while lying flat.  Patient reported that her home oxygen concentrator broke after falling a few days ago. Pulmonary rehab worked with supplier to replace however there is a supply shortage and will provide oxygen tanks until concentrator available. Patient is on hemodialysis for end-stage renal disease, her last dialysis session was 08/17/2022. She has new isolation chair arranged and Dr phoned dialysis orders there.      While hospitalized she also complained of bilateral flank pain. She has had intermittent flank pain previously and this was recently evaluated at Hospital. She was evaluated with urinalysis which was abnormal and urine cultures are pending at discharge. She did receive one dose of ceftriaxone in patient. Ultimately a CTABP was obtained to evaluate for hydronephrosis, renal calculus, or signs of pyelonephritis. This returned without any acute pathology and was reassuring. She did note not having a BM for several days and I suspect this is underlying cause of discomfort. She does have known gastroparesis, passing gas and follows with clinic for pacemaker. May be exacerbated by narcotic use.   Patient was initially treated with oral dexamethasone.  Patient was continued on supplemental oxygen at baseline. Therapy was consulted, who recommended home with assist.   Pulmonary Rehab was consulted for home oxygen.
Still experiencing Shingles outbreaks after completing Shingrix series; Still experiencing Shingles outbreaks after completing Shingrix series; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments:  The reporter was the patient. The reported completed 2 dose Shingrix series several years ago. The patient still experiencing Shingles outbreaks after completing Shingrix series. The patient believed that they were immunocompromised had contributed to the recurring Shingels outbreak, despite being vaccinated. The reporter did not consent to follow-up. Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding the laboratory confirmation was not reported.
Cellulitis at injection site.  Penicillin intramuscular, Augmentin by mouth.
Raised red area after injection, hive adjacent to MMR site with center induration. Doctor prescribed Benadryl 12.5/5ml. On 02/23/05 call placed to dad at 2 pm, he states area is going away after taking benadryl. Called dad 4 pm, child sleeping no respiratory distress noted.
A mother reported that her 4-month-old son received his second doses of Prevnar and haemophilus influenzae type B (manufacturer unknown) vaccines on 09/21/2001. The patient developed a generalized rash "like tiny bubbles" He was seen by the physician on 09/24/2001 and a diagnosis of chicken pox was made. No treatment was prescribed. See related report; HQ6379125SEP2001. Additional information received 10/09/2001 indicated that the patient received his second doses of Prevnar and Act-HIb (Aventis Pasteur SA) on 09/21/2001. The reporter also indicated that the patient was exposed to chicken pox
45minutes after 2nd Moderna shot.  bp bels palsy. lasted an hour.   numbness I/face droop. tongue and voice affected speech
I was really tired for 3 or 4 days, sleeping 12 hours at night and 6 hours during the day. Then that went away but the thing that bothered me the most was shortness of breath. It is not unusual for someone my age but unusual for me. I would go up my steps, which is 14 steps, and I was out of breath. I would also have night sweats. I ended up going to the ER and they did a bunch of tests on me. They took blood twice, they were checking to see if I had a heart attack. I was there for 5 hours.
(R) arm cellulitis seen at hospital-ER 10/3/07 give IV-Clindamycin 260 mg Seen PCP Dr 10/4/07 Given-Ceftrixone 250 mg, IM
Covid19 and Flu vaccine were given on Nov 17,2021. On Dec 6th patient started to endorse severe headaches that waxed and waned for 7 days and somnolence . On Dec 13 was admitted after MRI confirmed signs of acute disseminated encephalomyelitis. Patient was started on high dose steroids for at least 5 days inpatient with steroid taper following.
Headache, joint swelling and pain, chest tightness and congestion. Severely short or breath. Dizziness. Rapid heart rate with continuous premature ventricular contractions. Dangerously elevated blood pressure.
pt recv vax 08feb97; 21feb97 pt devel varicella-type rash in the diaper area