chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 64 year old male with no medical history or allergies, who on Mar 08 2005 was vaccinated subcutaneously into the right upper arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). On Mar 10 2005 this morning, the patient was seen at the doctors office with a 5 inch diameter sized swelling at the site of the injection. He was treated with fexofenadine hydrochloride (Allegra) and he will have a follow up visit, At the time of the report, the patients adverse event had improved, but he had not recovered. No product quality complaint was involved. The nurse requested a lot number check. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P) and developed adverse events (WAES0503USA03372).
I had redness, swelling, and itching and sore to touch, as time has gone by, now having achiness in my muscles and bones all over worse as day goes on, blurred vision, unsteady gait at times, fogginess, tiredness, difficulty speaking, sometimes swallowing tingling in hands and feet.
Patient felt nauseated, dizzy, lethargic, and cannot eat solid food from the day she received the vaccination (12/30/2021). She informed the doctor's office and the doctor gave her anti-nausea medication.
This spontaneous report was received from a 64 years old female consumer reporting on herself who in September 2009, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 05-JAN-2013, the patient experienced patient came down with shingles in spite of being vaccinated. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient came down with shingles in spite of being vaccinated was unknown for ZOSTAVAX. Additional information is not expected.
3SEP93 mom noticed pt staring blankly on 4SEP93; pt had a sz- rt arm & leg shook & then body went limp;
Resident became SOB, congested and hypoxic requiring oxygen, respiratory treatments and suctioning.  Stabilized after treatment and for the next 72 hours with oxygen saturations in the 90s.  On 1/3/2021 was found without pulse and respirations.  Resident was a DNR on Hospice.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient came into the phamracy on 11/18/22 to complain of immense pain, shoulder injury and bruising to her left arm. Patient says she has limited range of motion and cannot use her arm as freely with pain radiating to her left breast.
Tingling & numbness of the Rt fingers & right arm & nose 2 weeks seen by 5.26.09. No symptoms after 6-12-09
Fever  Chills Headache Body aches Fatigue Metallic taste Nausea
Patient arrived to the Emergency Department with altered mental status on 10/26/21 at 11:40am. Patient was admitted to the hospital, given supportive care, and quickly improved and was back to baseline prior to discharge.   Discharged Diagnoses:  1. Fever, acute metabolic encephalopathy. Suspected to be due to the side effect of COVID-19 vaccine. Extensive infection and stroke work-up were negative.  2. Mild hyponatremia 3. Chronic anemia, thrombocytopenia 4. History of stroke, mild to moderate cognitive impairment 5. Type 2 diabetes mellitus
Has soreness in the injection site. No fever. Started to loss volume of speech. It got worse over time. Sometime, was difficult to breath when trying to speak.
Headache. Body ache. Fatigue. Mild fever. Rash under injection side on arm.  All but rash resolved but not worsening.
5 day after the vaccine I woke up in the middle of the night with a headache, and vomited. The next morning I had a headache and sore throat.
This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 58 year old female with no allergies and a history of a previous case of shingles  05-JAN-2006 and a history of chicken pox who on 02-MAR-2007 (also reported as January 2007) was vaccinated in the left arm with a 0.65 mL dose of ZOSTAVAX (Merck) y(lot # 656609/0015U). There was no concomitant medication or illness at the time of vaccination. "Shortly after" vaccination, in approximately March 2007, the patient experienced herpes zoster. It was noted that the patient had a lesion the size of a quarter on her left cheek. The physician described the lesion as weeping, crusted, and similar to a chickenpox lesion. It was also described as a herpes zoster vesicular rash on the left face on the C1 or C2 dermatome. The lesion was still present on the patient's face on 20-APR-2007, seven weeks after vaccination. A rash did not occur at the site of injection post-vaccination. The patient's temperature was noted to be normal. Unspecified medical attention was sought. At the time of the report, the patient was on unspecified therapy and was recovering. A product quality complaint was not involved. Additional information has been requested. Additional information indicated that on approximately 05-MAR-2007 the patient developed a rash on her cheek that looked like chickenpox: weeping blister then crusted and at the one point looked like pimples. Entire outbreak was never larger than a quarter. It was slightly irritating, not painful and she never had systemic illness. Subsequently on 02-MAY-2007 the patient recovered. No laboratory tests were performed. No further information is expected.
This is a spontaneous report from a contactable consumer.  A 69-year-old female patient, started to receive PREVNAR 13, via an unspecified route of administration in her gluteus medius right on unspecified date on 2016 at single dose for immunisation.  Medical history included joint dislocation occurred about four or five maybe six times max from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from 2004 and ongoing, meniscus injury for a torn meniscus occurred twenty years ago from an unknown date and unknown if ongoing and carpal tunnel syndrome in her right hand from an unknown date and unknown if ongoing. Occurred twenty five years ago, drug hypersensitivity from an unknown date and unknown if ongoing developed a severe rash, asthma from an unknown date and unknown if ongoing when she was around 13, passed out at school, does think she still has it, overweight (she does not think she is obese) from an unknown date and unknown if ongoing, encephalitis in her fifties from an unknown date and unknown if ongoing; went on for a month she looked like a freak, cardiac disorder from an unknown date and unknown if ongoing and loss of consciousness when she was around 13 from an unknown date and unknown if ongoing.  Concomitant medication included ranitidine and ASPIRIN.  The patient previously took flu shot, does not remember exact date she received the product; occurred several years back after she received the flu shot, she got deathly ill, was literally bedridden, had to go to urgent care.  The patient experienced could not move left arm at all on 2016 with outcome of recovering, felt shoulders and hips and knees being stiff or something like arthritis or something on 2016 with outcome of not recovered, lethargic on 2016 with outcome of recovering, arthritis on Sep2016 with outcome of not recovered, could not sleep because her arm was hurting so bad on 2016 with outcome of unknown, her arm was hurting so bad  on an unspecified date with outcome of unknown, things she cannot do now that she could do before on an unspecified date with outcome of unknown and the events reported got worsened on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: extremely low on vitamin D on 2016, blood test and urine analysis tests: everything was coming back all ok on 2016 and blood test: arthritis on Sep2016.  The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  Therapeutic measures were taken as a result of could not move left arm at all (hypokinesia), felt shoulders and hips and knees being stiff or something like arthritis or something, lethargy, arthritis and her arm was hurting so bad.
Rash began and blossomed to larger indurated, pruritic macule 48 hours following the vaccination.
Well I started getting an arthritis flare, it started on my right wrist and it swelled up tremendously and I could not bend my right wrist and it just kept continuing over time. It started my wrist was red hot and more swollen than ever, my hand then started swelling up and my fingers stiffened and then over time it spread to other joints. I haven't had an arthritis flare for many years and then this happened. So are this time I cannot make a fist, close my right hand, it is affecting my index and middle fingers especially on my right hand. My right knee, my shoulders and my left elbow has been highly affected, I cannot straighten my arm at all. It is really bad in the middle of the night too and I had some prednisone treatments and I felt temporarily better and the DR put me on Orencia which I have been on for five weeks and it is not helping. I had contacted my DR on March 19th, I know I had an appointment and at that point my wrist was better but my hands were stiff and all that. My DR didn't know much about the Covid shot and side effects. I also had more virtual appointments and then another in person on June 25 2021. She told me that some patients had flare ups that lasted about two months after the vaccination but it is now August and mine started in February.
Facial flushing and dizziness, symptoms resolved with time. Observed by Dr. Pt discharged home.
Complaints of feeling a lump in her throat and "an itchy scalp". No swelling noticed in her throat/lips. BP higher than normal 153/84 HR 78 O2 98%. Pt appeared anxious but alert and oriented. Own Zyrtec taken by patient due to an allergy to Benadryl. Further care refused and pt discharged home.
RADIATING PAIN; LEGS TENDER; SEVERE HEADACHE RADIATING TO NECK; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included blind, disabled, hypertension, and mushroom allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204AZIA expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced radiating pain. On 22-MAY-2021, the subject experienced legs tender. On 22-MAY-2021, the subject experienced severe headache radiating to neck. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from legs tender, severe headache radiating to neck, and radiating pain. This report was non-serious.
This spontaneous report as received from a nurse refers to a unspecified child patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. The unspecified amount of children were vaccinated with improperly stored M-M-R II from an unknown date in October 2014 to 25-NOV-2014. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information is not expected as the reporter did not wish to contact.
Patient reports 1 week after 1st dose - small itchy rash.   She applied ice to site and it disappeared.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE 12/17/2022 &  2/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Swelling, redness, severe rash, itching started 6 days after vax. Severe pain in muscles of arms & legs. Dr recommended CPK test.
right neck swelling; tenderness; it was a lymph node thing; right sided Neck Pain; Right sided armpit pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received the first dose of BNT162B2 (lot number: EH9899, Expiry Date: 15Dec2021) via an unspecified route of administration in right arm on 20Dec2020 at single dose for COVID-19 immunisation. She received the second dose on 11Jan2021. There was no medical history. There were no concomitant medications. The patient got the first dose on 20Dec2020. It was after the second dose she had symptoms. The second dose was on 11Jan2021. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She further clarifies that she actually had this symptom on Dec2020 after the first vaccine dose also, she had the right neck swelling and tenderness, the same side as where she got the vaccine on. When she got the First Dose on 20Dec2020 she had the right sided neck pain and arm pain on Dec2020 she received the vaccine on the right side, she was going to the ear doctor asking about it, it occurred about 2 days after the first vaccine dose and hung around a long time, it lasted more than a week, she guess it was a lymph node thing. She has never been tested for COVID or had any Antibody tests. She has had no issues with vaccines in the past. The patient was not pregnant. Events outcome of right sided Neck Pain and Right sided armpit pain was not recovered, while for others was unknown.
numbness in middle of upper and lower lip and tip of tongue.  Started approximately 15 minute after vaccine administration and continued to increased for the first 30 minutes after that.  Then stayed the same for 24 hours and then resolved.  Lips felt swollen but were not visibly swollen.  Also felt increased secretions in throat.  1 dose of zyrtec taken 2 hrs after receiving vaccine.
PATIENT SAID THAT THE INJECTION SITE WAS SWELLING AND ITCHING (3/31/2016).  I CALLED AND TALKED TO PATIENT TODAY (4/1/2016), AND SHE SAID THAT SHE IS GETTING BETTER.
At 6:46 pm on 06/16/2021, 23 year old male patient was vaccinated for his first COVID vaccine by Pfizer. Within 30 seconds, while getting up, he felt dizzy and sat back down. Cool towel was provided, and head was supported. He turned extremely pale. Store PIC arrived. We helped patient lay on the floor of the clinic room. He had a pulse, 911 was called and paramedics arrived. They checked vitals and performed EKG, determined he was alright. Patient waited in waiting area for 45 minutes, was provided a Gatorade drink and glucose tablet after he was fully conscious. Then he drove home (called at 8:45pm) to check on patient, he was fine.
@ approx 9PM on 5MAY98 pt c/o pain & stiffness of lt elbow joint;pt was unable to fully extend forearm;no redness or swelling present;
Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine) outcome was unknown.      No concomitant medication reported. No treatment medication details reported.   This case was linked to MOD-2022-580197, MOD-2022-580196 (Patient Link).
dry cough, chills, sweating, fatigue, headache, pulse ox lower than normal
Nausea; chills; headache; This is a spontaneous report received from a contactable pharmacist (patient) and contactable consumer (patient's husband) via medical information team. A female patient of an unspecified age, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an 14Feb2021, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 07Apr2021, patient underwent antibody test and it came back as negative. The husband reported that his wife had nausea chills and headache after getting the vaccine on an unknown date in 2021. Outcome of the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complaint of bad headache across his forehead. Temperature 98.6. No wheezing or complaint of shortness of breath. Apical 94 BP 124/82 10:10 AM.
I experienced around 12 hours after the vaccine, low grade fever, chills pretty extreme body and severe joint pain. The joint pain really would not go away.  It was difficult to hold a cup of coffee, had to use two hands. My hips, knees, and toes hurt real bad, had a lot of soreness sensation all over my body.  I also had muscle weakness and fatigue.  On two occasions I had done minor exercises, I had extreme muscles pain afterwards.  The doctor dis lab work which was normal, she did not prescribed any medication.  I am a doctor and I called Prednisone 20mg mediation and by the next day my symptoms were gone.
Initial report received from a nurse on 10 Dec 2009: This patient received initial vaccination with FLUVIRIN (batch no 102136P1A) on 20 Nov 2009. The second dose was given on 03 Dec 2009 which was only fourteen days after the first dose. No adverse event was reported.
administered the expired Fluzone with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer non health care professional via Agency number: 00814651.  This case involves a 38 years old female patient who was administered an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: QFAA2017 expiry date: 30-Jun-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, sweating, and nausea for 30 hours. Feel weak and tired now.
Decreased appetite, fatigue, watery diarrhea onset 48 hr. after vaccines. 12-24 hr after vaccines given, developed induration with erythema at injection site of Tdap - (L) deltoid. Dr feels GI symptoms may be unrelated.
On 8/9/2007, patient presented to office with fever to 102F, refusal to walk or crawl for 2 days, irritability.  He was sent to Hospital Emergency Room. He was hospitalized from 8/9-8/14, with pelvic myositis.  He was seen in office on 8/17 for follow up, not weight bearing yet but on oral clindamycin.  He was seen in office for 8/24 for follow up and still refusing to bear weight (walk).  He was sent from the office back to ER, where he was admitted again from 8/24-8/30, diagnosed with osteomyelitis of the left ileum and sacrum, with peripherally inserted central catheter placed for IV antibiotics on 8/28.  He is receiving antibiotics at home with home health care following currently.  10/05/2007 MR received for 2 hospitalizations DOS 8/09-14/2007 and 8/24-30/2007.  D/C DX for 1st admit was L pelvic myositis and fascitis.  D/C DX for 2nd admit was Osteomyelits, Pyomyositis, muscle abscess s/p drainage and septic joint s/p drainage. Initially presented to the ER with refusal to bear weight on the R leg.  Had fever night before.  PE significant for T'=101.4, minimal soft tissue swelling of the R knee. PMH: none noted.  Txd with toradol and abx and D/C 8/14/2007. Child presented again to the ER on 8/24/2007 with resusal to bear weight on the R leg.  Ortho and ID consults this admission.  Pt had an aspiration of the L SI joint and a PICC placed for IV abx. Clinical improvement shown on IV abx. Gait improved..
Swelling and firmness to both thighs from injection site to the knee area (approx 3-4cm). Swelling to right calf also. No other symptoms noted by RN. Hep B vaccination and Hep B immune globulin given IM the night before and swelling first noted next morning at 0730.
I was have fevers/body aches/hot flashes/neck/left shoulder pain/itchy/numbness/tingling. Has red spot on site area with swelling & heat.
This spontaneous report was received from a Licensed Practical Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history and historical drugs were not reported. On 25-APR-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot number L013826, expiration date 21-APR-2017 (dose and route were not reported) for prophylaxis. The patient's concomitant medication included sterile diluent (STERILE DILUENT) which was not post expiry. The reporter also confirmed that the VARIVAX and sterile diluent (STERILE DILUENT) did not have a temperature excursion. No adverse effects were reported. Additional information has been requested.
Several hours after receiving injection, began to feel very fatigued. Within 1 hour after the fatigue, experienced severe body aches, chills, joint pain, fever (102f) and headache. Symptoms lasted until the next morning 6am.  Continue to have horrible headache and fatigue during day 2.