chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had some residual pain in the arm the second day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had some residual pain in the arm the second day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006H21A and 03H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (He had some residual pain in the arm the second day). At the time of the report, PAIN IN EXTREMITY (He had some residual pain in the arm the second day) outcome was unknown.            No concomitant medications were reported.  It was reported that patient got first booster shot on 08-Nov-2021 (lot:034F21A), second booster on 20-April-2022 (lot: 065J21A-B) in the left deltoid.  No treatment medications were reported.   This case was linked to MOD-2022-547026 (Patient Link).
Patient was hospitalized for Covid and died of same 6 months after being vaccinated for Covid.  69 y/o female with PMH significant for end stage COPD who had been on hospice but improved and hospice was discontinued last year. At baseline required 3L supplemental oxygen. She presented to hospital on 10/4/21 with one day history of worsening shortness of breath and diarrhea. She requred BiPAP and was initially admitted to critical care with sepsis due to COVID 19 PNA. She was treated with dexamethasone and remdesvir but continued to worsen. On 10/7 in the setting of severe respiratory distress she elected to be transitioned to comfort care measures only. She was admitted to general inpatient hospice on 10/13/21. Her family attened to her at the bedside and she remained peaceful and comfortable until she passed away just after midnight on 10/15/21.
Changes in menstrual cycles including heavy bleeding, large blood clots, longer cycles, and spotting between periods. This has continued for four months since receiving vaccines (I?ve completed the series now).
Painful lump, swelling, rash/hives at injection site 8th day after getting shot. Spot is getting progressively painful.
Moderna COVID?19 Vaccine EUA Injected at 8:20 am; 3+ hours later excruciating pain, rapid onset, at injection site.  Continued unabated until treating with ibuprofen 600mg at 12;30 pm.  Continued nsaid therapy until the following morning, with relief but not elimination of pain.  Unable to lift right arm to horizontal, or to use the arm to lift or carry anything over a pound or so.  Has continued to present, although mostly reduced as of today.  Issues with sleeping, as pain increased with prone position and inactivity.  Other attempts at reducing pain and soreness have included light exercise and stretching.
Patient became sweaty, lightheaded, nauseated and reports uterine cramping (patient is on her menses and states this is typical). No LOC. Does report history of this with vaccination
Information has been received from an RN concerning an approximately 70 yea old male pt who on 16DEC2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently in approximately December 2003, the pt developed right arm swelling, tenderness and cellulitis. Medical attention was sought. the pt was treated with an abx. A product quality complaint was not involved. Right arm cellulitis was considered to be an other important medical event. The reporter also mentioned a female pt who experience an adverse event post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Information has been received from a consumer concerning her daughter who was vaccinated with four different vaccines at 3 months of age, in approximately Jan 2008, is including a dose of ROTATEQ (manufacturer unspecified).  It was reported that after the vaccination the patient experienced diarrhea for 3 to 4 weeks and was only able to eat hypo-allergenic formula.  Later she developed reflux which the reporter considered to be not related to formula.  The patient was now 1 and a half year old and had to take PREVACID every morning.  At time of reporting the patient's outcome was unknown.  Additional information is not expected.
patient reported developing pain in lymph nodes of right arm and developing numbness in arm and into neck about 6 hours later.
On 8/3 pt experienced chills & body aches & fatigue. On 8/4 pt had pain & redness at injection site. On 8/7 or 8/8 pt began to experience pain that radiated from arm which she had the vaccine up to her neck. On 8/12, pt saw an urgent care md who took an x-ray of her neck & ekg. the x-ray showed oseteo-arthritis of the neck (which pt was unaware of) and the ekg was clear. Dr prescribed a medrol dose pack which she plans starting 8/14 after getting kidney dr's approval that it won't interfere with 24 hour urine collection for kidney stones. Pt is still experiencing fatigue & pain in her neck today (8/13).
bad itching, lot of bumps, redness on the arm she received her shot on/ injection site itchy with little red bumps; bad itching, lot of bumps, redness on the arm she received her shot on/ injection site itchy with little red bumps; Swelling/ arm swelling where she got the needle; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient reported that her arm was and it was a little swollen but that went down and it was still itchy with like little red bumps in the area where she got the needle. The patient did not know what to do for it, and did not know what to put on it, she applied cortisone on it and it seemed to irritate it and itch more. The patient also applied cool compression on it and stated she was warm and irritated. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain limp the night of vaccination and erythema 10 X 10 cm left thigh. Left thigh 31.5 cm (Compared to right 31 cm) No limp, no pain, no fever, no limp today.
Headache, Myalgia, sweating, chills, abdominal pain Narrative:
Pt recvd vax on 19MAY92 & 22MAY92 devel urticaria, fever to 102, arthralgia, angioedema;
I had no pain at time of injection on 8/5 or even the day after (8/6). I woke up on 8/7 with pain deep in my shoulder and it was painful to move my arm overhead. By the next day, the pain had worsened and since then I have been unable to move my arm behind my back.  As of today (8/11), in addition to the shoulder pain, I now have pain radiating up my neck on the same side as the injection site.
Left upper mid forearm-Left lower mid forearm, erythema, swelling and pain. Tx: Doxycycline 100 mg BIDx7days.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 12-MAR-2015, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate- result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Headache, neck stiffness, fever, confusion, visual changes, change of mental status, jaw pain, chest pain.
pt recvd vax in 1994 & became pregnant;LMP 19JAN95 & estimated delivery date was 26OCT95;MD reported in JAN96  pt consumed 1 to 2 alcoholic drinks per wk during pregnancy & pt's pregnancy resulted in a spontaneous abortion;
12/01/04: about 4-5 hours after influenza mom ran 100.5 degree temp with chills lasted about 24 hours. Also nausea and vomiting, dizzy, "hives" and itching in spots. 12/02/04: TC today much improved.
A sore arm developed around 8 PM on the day of the vaccine. The following AM, I felt weak, feverish and had a headache.
Vaccine adminstered around 4 p.m on 2/23/21.   At 7 p.m. I was feeling unusually tired.  Symptoms on the 24th, 25th, 26th and 27th:  weak, tired, nausea off and on.  The afternoon of the 27th, I developed a fever and my heart rate increased.  I went to bed around 9 p.m. and woke up around midnight.  My resting heart rate was 108 bpm.  I felt miserable, and I was concerned about my heart.  I went to the ER.  They did a complete workup.  I was discharged about 3 hours later and spent the next few days feeling ill.  I called my GP and requested an anti-nausea drug, which he ordered for me.  Many tests were performed in the ER.  I've subsequently had an echocardiogram and a Holter Monitor.  I can't explain this, but my heart occasionally hurts or aches, particularly when I lay on my left side, which I avoid doing because of the achy feeling.  I am otherwise back to normal.
Breakthrough case admission after 2 vaccines Janssen 4/10/21 Lot# 042A21A;  Pfizer 12/15/21 Lot# FD0809
Pt recv vax on 11/13/98; on same day pt exp swollen, red LA; tx=Benadryl
Pt's mom contacted office on 08/07/20, report pt has bLister on (R) thigh, unsure if rxn to vaccine or not. BLister is about 1 cm from injection site, pt. seems to be unaware of bLister, ~ 1/4 size of a penny. Improving by the next day, now using antibiotic ointment.
p/receiving a dose of Typhoid vax, pt devel cellulitis @ site of inject; pt treated w/unspecified ATB;
A few minutes after receiving the shot I began to feel nauseous, almost like being car sick while looking at my phone. I also began to feel tightness in my chest. After my 15 minutes were up I asked the administrator of my shot if it was normal that I felt dizzy/chest tightness. They said it was probably fine and just to monitor my  symptoms. I went and sat in my car a few min and I began to feel very strange, it seemed very bright out, I felt weak, and my eyes felt very heavy. I wanted to get home so I started driving but on the highway, my heart beat was very fast and I began to feel like I couldn't swallow. At one point felt as though I might be about to choke so I pulled over because I thought I was going to have to dial 911 as my throat was feeling like it was closing up. I tried swallowing a few times with great effort and after a few minutes the sensation started to lessen. My throat hadn't closed up completely, however it did feel like it had swelled up.
3/11/22 58 yr/o  female with a history of CHF, CAD, hypertension, diabetes, end-stage renal disease on hemodialysis, COPD presenting to the ED for shortness of breath with cough, fatigue, generalized weakness, nausea, one episode of vomiting 2 days ago, and diarrhea over the past 3 to 4 days.  States symptoms began after known COVID-19 exposure, states her niece recently tested positive and she was exposed.  Has been vaccinated against COVID-19.  Wears 2 L nasal cannula oxygen at home at baseline.  Current smoker.  Denies chest pain, hemoptysis, leg swelling, syncope, fever, abdominal pain.  States she did slip and fall 2 days ago with head injury, denies LOC.  States she has had some mild to posterior neck States she has had some mild to posterior neck and soreness to her right hip but has good range of motion has been ambulatory without assistance.  Denies other injuries.  Denies anticoagulation use. Denies headache, syncope, paresthesias. Review of Systems  Constitutional: Positive for fatigue. Negative for chills and fever.  HENT: Negative for sore throat and neck pain.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough and shortness of breath. Negative for chest tightness.   Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Positive for diarrhea, nausea and vomiting. Negative for abdominal pain.  Genitourinary: Negative.   Musculoskeletal: Negative for myalgias.  Skin: Negative for rash.  Neurological: Positive for weakness. Negative for syncope and headaches.  Psychiatric/Behavioral: Negative for agitation and behavioral problems.
Rash is located on the arms, legs, and on the torso anterior and posterior. Rash developed over 2-3 days.
This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated post supported temperature excursion with VARIVAX (Merck) 0.5 ml, subcutaneous, lot # reported as K0007974 with expiration date 30-JUN-2015 and lot #K010339 expiration date 22-JUL-2016. No adverse effects noted. Lot number K0007974 is an invalid lot number for VARIVAX (Merck). This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: The patient felt pain for a day but severe flu like symptoms below the waist for 2 days.
Pediatric patient got vaccinated; A spontaneous report was received from a nurse concerning a 16-year-old, female pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, pediatric patient got vaccinated.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28 Dec 2020, the pediatric patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, reporter stated, she, and her 16-year-old daughter both received the Moderna COVID-19 vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, pediatric patient got vaccinated, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of drug administered to patient of inappropriate age. This event occurred the same day of vaccine administration. The reporter did not provide the causality assessment for the events. The event is assessed as unrelated to Moderna COVID-19 Vaccine.
I am an RN and know that side effects are usually headache, elevated temp, and fatigue. I had the temp (not much as I take Tylenol for arthritis tid) and fatigue but my other symptoms were gastrointestinal. Epigastric distention, abdominal pain and nausea. It was over in approx. 12 hours. I had similar but more severe symptoms last April that I thought were food poisoning. Now I wonder if they were COVID-19 related.
Symptoms as described by the patient: "goop in my RT. eye  and feeling kind of weird/tired the day of the shot, next day called in sick and sleep most of the day, I've been waking  up every morning with crust in both my eyes, feeling very tired all day and a little cough and congested and headache." Treatment: none Outcome: resolved as of 9/22/17.
metal taste in my mouth; Right eye started twitching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 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: DYSGEUSIA (non-serious), outcome "not recovered", described as "metal taste in my mouth"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "Right eye started twitching".  Additional information: About five minutes after the injection patient had a metal taste in the mouth and that lasted mmm for probably about five hours mmm then sometime in the afternoon maybe two hours after she vaccinated her right eye started twitching and it is still twitching today and patient did not known how long this will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heart fluttering (palpitations), increasingly frequent as time passes. Occuring off/on intermittently daily.
Flu-like Symptoms-Temp, achy, chills, sweats, joint pains. Flu symptoms lasted throughout the day, joint pain would come and go and are present now.
pt had tightness in her chest  and shortness of breath.  BP-122/84, O2sat-99%, Pulse 102
Patient received Moderna vaccine 1/6/21 at 12:00 pm.  At approximately 5:00 pm, patient stated her left arm was hurting, tender and hot to the touch.  at 11:00 pm, patient began chilling with body aches.  Pt felt dehydrated and very thirsty.  No fever.  On 1/7/21, patient still had body aches and slept most of the day.  Pt took Tylenol throughout day.  On 1/8/21, chills and body aches improving, but patient had no appetite and arm still very sore and uncomfortable.  On 1/9/21, patient feeling much better.  Body aches and chills gone, only symptom now is arm still tender at injection site.
Moderna Covid-19 Vaccine EUA  Rashes on both arms and (L) side of the body
pt recvd vax & next day off & on x 1 wk had t of 104; seen by PMD 14feb94; recvd apap & DT for following immun; pt started coughing after a few days;
Hep B #3 administered on 3/9/04 outdated. Hep B #3 re-administered on 5/4/04.
Fainted initially second and third dose; third dose; chest pains and persisting achiness and fever at night; chest pains and persisting achiness and fever at night; chest pains and persisting achiness and fever at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 17:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, arm left), administration date: 01Mar2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (dose 2, arm left), administration date: 21Mar2021, when the patient was 25 years old, for Covid-19 Immunization, reaction(s): "Fainted initially second and third dose". The following information was reported: SYNCOPE (medically significant) with onset 21Dec2021, outcome "not recovered", described as "Fainted initially second and third dose"; IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "third dose"; CHEST PAIN (non-serious), PAIN (non-serious), PYREXIA (non-serious) all with onset 21Dec2021, outcome "not recovered" and all described as "chest pains and persisting achiness and fever at night". Therapeutic measures were not taken as a result of syncope, chest pain, pain, pyrexia. It was also reported that since the vaccination the patient was not diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858912 same patient, different vaccine dose/AE.
Information has been received from a licensed visiting nurse concerning her 20 year old daughter who about 3 years ago was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Within minutes of the vaccination, her daughter's whole arm began to itch.  Unspecified medical attention was sought.  She was treated with over the counter Benadryl.  It was reported that all symptoms resolved.  No additional information was available at the time of this report.  No product quality complaint was involved.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 28-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Motor Paresis: 10-Sep-09.  11/16/09:  Medical Center contact information provided. 11/18/09 DC sum and medical records received for dates 9/10/09 to 9/19/09. DC DX: GBS. Secondary DX: sinusitis. Chief Pt. c/o tingling in feet, hands, weakness in abdominal muscles. Pt. states unable to exercise. Sx began x3 days ago. Ptosis of rt. eye began 1 day ago. Sinus congestion noted x5 days ago then improved. Diarrhea x1 wk ago, now resolved. Pt states was given a "peanut butter shot" 8/4 which is standard for recruits. Pt unable to run, do push-ups, or sit-ups. Pt states feet feeling as "if they are about to fall asleep". Admitted for progression of sx. Assessment: ptosis rt. eye, areflexia, nerve conduction test abnormal-preserved latencies, ataxic, reflexes were present in AM and absent in PM. IVIG started. Pt improved at dc. 12/10/09 Outpatient Medical Records received for DOS 09/22/09 Pt. requesting return to full duty; reports feeling better DX: Guillain-Barre syndrome, resolved.
pt recvd vax;devel chills & local irritation; apap taken;5 days later, devel axillary lymphadenopathy & muscle spasms in the neck & arm extending down to the fingers & to the back;
Hives on legs and arms on the first day; each day hives got progressively worse for the next five days, spreading all over body, face, hands and feet;
pt recvd vax & pt devel a rash that MD felt was measles; No further details were provided;