chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (1.12.22);  COVID-19 positive (1.12.22); fully vaccinated (no booster) Admitted 1.12.22 - 1.13.22 (32 hours - observation) CHIEF COMPLAINT: ALTERED MENTAL STATUS (per ems: found by coworkers on scene unreponsive on ground by them, last thing he remembers was feeling weak, inspiratory wheeze, was given duoneb in route that seemed to improve his symptoms, inititially Aox2 and is currently Aox4 with delays in respoinding, bs 162) DIAGNOSIS at time of disposition: 1. Syncope and collapse  2. COVID  MEDICAL DECISION MAKING: Patient seen evaluated by myself.  Electronic medical record was reviewed.  I did review prior emergency department visits for similar complaints.  I see that he were a ZIO patch in November 2021 for 14 days which was unremarkable.  At this time patient appears somewhat groggy.  Will do routine labs, urine drug screen, EKG, chest x-ray as well as CT head and neck and x-rays of the right shoulder from his fall. EKG shows sinus mechanism with sinus arrhythmia.  No ST elevation, depression or signs of acute ischemic change. Urine drug screen is negative Lactic acid is normal Troponin is normal BNP is normal Complete blood count and CMP are unremarkable Magnesium is normal CT head does not show any acute process CT cervical spine does not show any acute fracture Chest x-ray is unremarkable X-rays right shoulder did not show any fracture. At this time patient is re-evaluated.  His vital signs have been stable in the emergency department.  There has been no signs of significant cardiac ectopy. I discussed the findings with patient.  It is my concern that since he has had serial episodes of the last few months these potentially could be seizure in etiology.  The fact that he was altered after this last episode would further collaborate that.  He has remained neurovascularly intact in the emergency department during my observation as well as has stable vital signs.  I placed a call the observation unit for admission for likely echo/EEG/ MRI. Patient's COVID-19 screen did come back positive.  I did reinterview him.  Again he has had no cough, congestion or shortness of breath.  No fevers or chills.  He states he feels back to normal currently.  He denies any recent upper respiratory infection symptoms over the last few weeks.  He denies testing positive previously.  He is vaccinated. I did speak with the observation unit regarding this COVID-19 positive finding.  They have agreed still to take him for above workup. Blood Pressure Screening: Based on last blood pressure taken in the ED of 112/66, BP <120/80, routine follow up with PCP.
Patient was given flu vaccine that expired in June of 2022. This was not discovered until later in the day and patient was contacted. Patient stated she was feeling fine and had no symptoms.
Left armpit is swollen up in the lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Left armpit is swollen up in the lymph nodes) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LYMPHADENOPATHY (Left armpit is swollen up in the lymph nodes). At the time of the report, LYMPHADENOPATHY (Left armpit is swollen up in the lymph nodes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Case number PHHY2014US092088 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517845) website on 24 Jul 2014. Past medical history and concomitant medication were not provided. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: unknown) in 1993. Post vaccination she experienced sore arm. Seriousness, outcome and causality of the event were not reported.
Breakthrough COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Solid organ transplant.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough COVID-19) (seriousness criterion hospitalization). At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive for severe COVID-19..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BREAKTHROUGH COVID-19 (Breakthrough COVID-19) to be related.    Company comment: This is a literature-non-study case concerning a male  patient of an unknown age with medical history of solid organ transplant, who experienced the serious (hospitalization) unexpected event of Breakthrough COVID-19, on an unknown date after the  second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Clinical course and hospitalization details were not provided. Patient received non-monoclonal antibody therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitants and treatment were reported. Patient not received third dose. Patient received non-monoclonal antibody therapy. The only variable associated with presenting with severe disease was a shorter time from vaccination to diagnosis.   This case was linked to MOD-2022-590482 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2022: Live follow up received by safety on 16-Jun-2022 has Email with FTA and contains significant information includes significant information reporters details, literature information, medical history, lab data, hospitalization were updated.; Sender's Comments: Company comment: This is a literature-non-study case concerning a male  patient of an unknown age with medical history of solid organ transplant, who experienced the serious (hospitalization) unexpected event of Breakthrough COVID-19, on an unknown date after the  second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Clinical course and hospitalization details were not provided. Patient received non-monoclonal antibody therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. MOD-2022-590482:(Case-1: 11 patients cluster case)
Client received immunizations on 02/24/04 and reporst that on 02/25/04 am her left arm became very sore at injection site, swollen and very red.  Patient reports extreme pain in left upper arm that has not gotten better or has not been relieved by Tylenol or Ibuprofen.  Client instructed to place warm compress on injection site and to go PMD if worsens.   Client received on 01/27/04 (exactly 4 weeks prior) the following.  Client verbalizes no adverse side effects with the following series: (Listed below in box #14)  Follow up on 04/21/04: "Information not documented, not available."
Health worker came in to report a dull pain to center area of chest. states it happened the day after 2nd dose Pfizer and lasted for about half hour. Pain was 3/10 and happened while at rest (sitting). No medication taken to alleviate pain. States that it went away on its own. He also rubbed his chest and states that it seemed to help. HCW states that not too long ago (sometime within the year) he was seen by his PCP and they had ruled out angina. HCW came in at approx. 1230 pm 9/15/21 and states he is not experiencing the pain and that it has subsided.
Had pretty severe pain, swelling, redness at injection site.  Next day had fever of 102.4, pain in joints in my whole body, shivering, fatigue, stomach pain, nausea.
I started to feel injection site pain and a headache approximately 4 hours after the injection. I then went to bed. I woke up at 5 AM and couldn't get back to sleep. I had an extremely severe headache. shaking chills, fever (fluctuated between 101 and 102) and severe fatigue and muscle and joint pain. Muscle and joint pain was primarily in my neck, shoulders, back and chest. It hurt to open my eyes or even move. I had no appetite and wasn't eating or drinking, but I urinated a lot, so I knew I was getting dehydrated. I tried to drink sips of water and managed to keep it down, until 11 PM on the day following the shot, I vomited and became nauseated. I had a hard time sleeping again. I woke up on the second day after the shot with a lingering headache and fatigue, but my fever was gone and I could move more easily. I gradually improved throughout the day. It doesn't sound terrible as I'm reading/writing this, but for about 36 hours; I haven't been that sick since I was a child, I don't think. It made me not want to have a booster shot if it's needed later. If I have to; I'll definitely need to have it on a Friday. I'm so jealous of people who've said they had no side effects or very mild ones. I had to take two days off work. I have to say though that although the side effects were severe and came on fairly quickly; they were also nearly all gone 48 hours after the shot. I felt so awful, it seemed like longer than 36 hours of misery, but in reality it wasn't.
Case PHEH2016US025983 is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to 87 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618521) at a dose of 1.0 ml intramuscularly on 27 Sep 2016. No adverse event was reported following this medication error.
The evening after the vaccine I development fever, chills, body aches and a tremendous headache.  The next day all I wanted to do was sleep and my head and body still ache but fever had diminished.
rash at injection site; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 2E3EH, expiry date 31st October 2021) for prophylaxis.   On 7th November 2019, the patient received Shingrix and Boostrix. On 7th November 2019, less than a day after receiving Shingrix and Boostrix, the patient experienced injection site pain. On 13th November 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix and Boostrix.  Additional details were provided as follows: The patient was injected with both Shingrix and Boostrix on the same arm, but unknown arm. The reporter consented to follow-up.
Patient given Moderna booster shot from vial that was punctured greater than 12 hours before dose was given
After 6 hours my left arm was hurting a lot. After that I got the chills and heavy fever (102.7). A lot of headache, body aches and vomiting. I could not do anything else than staying in bed. Did not eat and was not able to take Tylenol or anything else. It last for a full 24 hours, fever and vomiting was gone, but after that I still had headaches.
Prior to receiving the vaccine the patient reported previously drops in blood pressure to vaccines in the past. 5 minutes after administering the janseen vaccine the patient began to feel lightheaded and dizzy and complained of blurred vision.
This spontaneous report as received from a pharmacist refers to a 61 years old male patient. The patient was vaccinated subcutaneously right upper tricep with a dose of 0.65 ml live ZOSTAVAX (lot# reported as H019036, expired date: 17-JAN-2014) once on 27-DEC-2012. On 28-DEC-2012 the patient experienced redness, swelling and pain at his injection site over 24 hours following receipt of the dose of live ZOSTAVAX. At the time of this report, the patient stated that his injection site was still red, swollen and painful, but it had improved since he first noticed the reaction. The patient had been taking ibuprofen, which he reported had been helpful with the swelling and pain. The patient denied a rash at the injection site. At the time of reporting, the patient was recovering. The pharmacist did not know if the patient had consulted his healthcare provider. The patient sought medical attention by consulting pharmacist. Additional information is not expected.
lump w/o abscess @ DTp site, temp 104.6, wheezing; difficulty swallowing (mild) beginning 6hrs p/inject;
I woke up one morning getting dress, when I notice my lymph nose was swollen and hurting. I went to my doctor and receive care.
7 hours later fever, flu-like symptoms, irritability, tiredness, inability to sleep. Approx 11 days later, very awful period - cramps, heavy blood.
This is a spontaneous report from a contactable nurse reporting on a patient. A 76-year-old female patient received a dose of PREVNAR 13 (Lot number: J80525; Expiration date: 01Apr2016) 0.5ml single dose, intramuscular in left deltoid on 25Jan2015 at 2:00 pm. Medical history included allergic rhinitis, cause unspecified, asthma, atrial fibrillation on 11Jun2014, benign neoplasm of colon on 19Jul2013, cellulitis and abscess unspecified site on 27May2014, contact dermatitis with eczema on 27May2014, cough on 19Jul2013, diabetes mellitus type 2, dizziness and giddiness on 21May2014, essential hypertension unspecified on 11Jun2014, female stress incontinence on 21May2014, GERD, heartburn on 25Oct2013, irritable bowel syndrome, malaise, fatigue, obstructive sleep apnea, urinary incontinence, hyperlipidemia, overweight, palpitations on 04Oct2012, colonic polyps, reflux esophagitis on 02Apr2014, spinal stenosis, syncope on 10Jul2014, unspecified backache on 25Oct2013, unspecified sleep apnea on 02Apr2014, unspecified urinary incontinence on 04Oct2012, wheezing on 25Oct2013. The patient was allergic to the following drugs: aspirin, FELDENE, GLUCOPHAGE XR, LEVBID and NAPROSYN. Concomitant medications included betamethasone-clotrimazole 0.05%-1%, cream, topical, BID from 19Jul2013; calcium carbonate, 600 mg, tablet, oral once a day; DETROL LA, 4 mg, capsule extended release, oral, daily from 26Sep2013; FLONASE nasal, 50 mcg inhaler, 2 puff once a day as needed from 30Dec2013; FLOVENT, 110 mcg inhaler 2 puff 2 times a day as needed from 30Dec2013; glucosamine hydrochloride once a day; IMODIUM MULTI-SYMPTOM RELIEF, 2 mg/125 mg, oral, as needed; JANUVIA, 100 mg, tablet, oral 1/2 tablet once daily from 30May2014; pantoprazole 40 mg daily, delayed release tablet, oral, from 28Apr2014; simvastatin, 10mg once a day, tablet, oral from 03Mar2014; tolterodine L-tartrate ER 4 mg daily, capsule extended release, oral, from 02Jul2014; TUMS, 500 mg as needed, tablet chewable, oral; XARELTO tablet, oral, once a day, from 11Jun2014. The patient called office on 29Jan2015 with complaints of left upper extremity redness 3" in diameter, fell hard and tender to touch. Also had some axillary swelling and swelling occurred on her clavicle and up into her neck on the left side, extreme tenderness with severe itching at injection site. No difficulty swallowing or breathing. Patient was instructed to apply ice to affected areas and started CLARITIN and ZYRTEC daily. Patient called back on 02Feb2015 swelling along clavicle had turned to 2 hard lumps and neck fell stiff axillary lump was unchanged. Still taking cetirizine. Physician prescribed MEDROL and KEFLEX 500 mg tid x 7 days. On 11Feb2015 patient called back to report axillary and clavicle lumps were slowly resolving, no longer painful or itchy and slowly shrinking in size. Follow-up (27Feb2015): Additional information reported from the same contactable nurse includes age of the patient, route of administration, date of vaccination, anatomical location, clinical outcome of the events and information on concomitant and medical history. Events added.
Had the Johnson & Johnson, woke up Monday am feeling like I was under anesthesia a little bit, had hard time thinking at work so took day off to rest.  Tuesday still feeling foggy and very very tired.  It's not horrible just don't feel like my brain is working all the way so wanted to report.
Initial information received from a health care professional on 15 November 2013. A female patient (date of birth reported as 7.4.21) whose medical history was not reported had received FLUZONE HD (batch number, route and site of administration not reported) on an unspecified date. After vaccination the patient was sick for three days after vaccination. Lab investigations and treatment medications were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none
not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable Pharmacist (patient).  This 41-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140), via an unspecified route of administration, on 06Jan2021 at 01:30 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at hospital, age at vaccination was 41-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included sambucus nigra (ELDERBERRY), colecalciferol (VITAMIN D), camellia sinensis (GREEN TEA). On 08Jan2021 at 12:00 AM, the patient experienced nausea, diarrhea, chills, not feeling well overall. The events were reported as non-serious. The patient was tested for Covid post vaccination however it was also reported that she was not tested (to be clarified). Outcome was recovering. No treatment was received for the events.
A 12 year old patient received FLUBLOK QUADRIVALENT vaccine with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other-healthcare professional via consumer/non-health care professional via Medical Information (Reference number- 00790998) and transmitted to Sanofi on 29-Sep-2021.  This case involves a 12-year-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient had no other vaccine.   On 25-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2109, expiry: 31-May-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  No other adverse event was reported.  It was reported "reporting that she administered FLUBLOK QUADRIVALENT to a 12-year-old patient. she monitored the child for 20 minutes post injection, she states that the child is showing no adverse reactions and that his weight is the weight of an adult, she is also questioning if another flu vaccine should be administered to the patient"   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.
devel a fine red rash which began @ inj site w/in 24hrs & spread to limbs & trunk;rash lasted approx one month;pvt MD thinks it was an allergic rxn;
Patient stated that later the same evening after she received her second Moderna Covid vaccine her heart began racing. She IS treated for high blood pressure but this racing was not a normal feeling for her. She reports that intermittent racing continues to this day. I advised she see her physician and she has an appointment scheduled for June 2.
Information has been received from a physician concerning a 16 year old male with no pertinent medical history who on 03-JUN-1998 was vaccinated with a first dose of VARIVAX subcutaneously.  On 03-NOV-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 661856/1222X) 0.5 mL, subcutaneously.  There was no concomitant medication.  On 04-NOV-2008 the patient experienced an injection site reaction.  The patient experienced a rash that was itchy, red, swollen, and warm to the touch.  At time of reporting, the patient was recovering.  The patient sought medical attention and saw the physician.  In follow-up information, the physician reported that on 03-NOV-2008 the patient received a dose of FLUZONE IM (lot # 02769AA).  The physician reported that the patient's adverse events occurred on his right arm.  The patient recovered on 07-NOV-2008.  The patient had no illness at time of vaccination.  The patient also had an adverse reaction after vaccination with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (WAES # 0812USA00480).  No further information is available.
Induration ulcer at site of injection, erythema (blanching) and some color across left upper arm to distal position. Rx'd OTC Benadryl and NSAIDS. Temp 98.1.
LOSS OF APPETITE; LETHARGIC; MUSCLE WEAKNESS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polycystic kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.   No concomitant medications were reported. On 26-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced loss of appetite. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced muscle weakness. On 27-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 27-MAR-2021, and chills, and had not recovered from headache, lethargic, and muscle weakness. This report was non-serious.
Client reported having white patches to back of throat beginning 2 days following COVID-19 vaccination.   Client  seen by PA, ND on 5/26/21.  PA contacted this nurse to add information to VAERS - stated diagnosed as thrush and prescribed Nystatin gargle.