chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reports pain in his right arm 10/28 when trying to sleep on right side.  He has an area on his right upper arm that is 8 inches by 5 inches anterior upper arm about 3 inches below injection site that is red and warm to touch.  Noted 10/29. Keflex 500mg one every 6 hours for 10 days.  Treatment started 10/30/08.
5 days after dose had pain in left calf. On May 8th went to the hospital with pain under my left rib cage. It was determined by testing that I had a blood clot in left leg and one in each lung. There was also heart arrhythmia. I was given blood thinners for the clots which I am still taking. I was also given medication to help with high blood pressure  and to help with heart beat.
Throat tightening (like the beginning of feeling like throat is closing from an allergic reaction); redness to the left and right of the Uvula.
lt arm swollen, wheal-like red rash around inject site & upperarm, soreness & arthralgia; resolving by day 3;
Increased and loud tinnitus (ringing in the ears) that is constant and elevated high pitch noise. Much worse than normal. This has increased since the second vaccine. It is very annoying and causing depression as I just want the ringing to stop.
Pt experienced a severe local reaction to the left thigh. Hives from 24 to 72 hours post injection on left and right leg.
Erythema of upper arm & few vesicles at the site of VARIVAX administration.
Hospitalized 10/11/2021; COVID-19 positive 10/10/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 10/11/2021 Discharge Date: 10/13/21 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Nausea [R11.0] Hypoxia [R09.02] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 62-year-old female who was previously vaccinated for COVID with Moderna vaccine.  She presented to the ER on 10/10/2021 with complaints of shortness of breath, nausea that was not relieved with home Zofran, weakness and fatigue. While in ER, COVID-19 swab was positive. While in ER, oxygen saturation was 88% on room air. Her oxygen saturation increased to 92% with administration of 2L nasal cannula. A Chest CT was ordered to rule out PE. CT showed evidence of bronchitis and small airway disease without evidence of consolidating or patchy opacities consistent with COVID-19.  It while in the ER, attempted to wean patient off of oxygen nasal cannula.  Patient was on room air and oxygen saturation went back down to 83%.  Patient placed back on oxygen nasal cannula 2 L. hospitalist asked to admit for further management of COVID-19 and bronchitis.  While inpatient, she was quickly weaned to room air without further oxygen desaturations.  No longer met criteria for remdesivir. Patient received IV Decadron with rapid improvement in symptoms.  At this time, patient is medically stable for discharge.  We will discharge patient with oral steroids due to her positive response to medication.  Educated patient on supportive therapy treatments for COVID-19 and educated patient on when to seek further care should symptoms become intolerable or more complicated.  Patient verbalized understanding.  Plan of care discussed with patient who is agreeable to plan.  All questions answered to patient's satisfaction.
fever; headache; body aches; colds; he can't even move his arm; This is a spontaneous report received from a contactable consumer (patient) via Team. A 62-year-old male patient received BNT162B2 (COMIRNATYsolution for injection; lot number and expiry date were not reported) via unspecified route of administration, on 12Aug2021, dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had a very hard time after his first dose further described as he can't even move his arm, fever, headache, body aches and colds. He's getting ready for his 2nd dose and he would like to know what to expect on the 2nd dose. The outcome of the events was unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a consumer and refers to a young female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with HPV vaccine (manufacturer unknown) (dose, route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. Since unknown date, after getting a HPV vaccine (manufacturer unknown), the patient became a wheelchair user. The patient's outcome was not reported. Relatedness between the adverse event an the vaccination with HPV vaccine (manufacturer unknown) was not reported. Upon internal, the adverse event of becoming a wheelchair user was considered to be disabling. This is one of several reports from the same reporter. Additional information is not expected, because there is no contact details with the reporter.
Fever over 101.9F; Severe headache; Body aches; Feel the kidneys heavy, and now has severe pain on the kidneys; Feeling very bad; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever over 101.9F), HEADACHE (Severe headache), MYALGIA (Body aches), RENAL PAIN (Feel the kidneys heavy, and now has severe pain on the kidneys) and FEELING ABNORMAL (Feeling very bad) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension. Concomitant products included INSULIN and METFORMIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (Fever over 101.9F), HEADACHE (Severe headache), MYALGIA (Body aches), RENAL PAIN (Feel the kidneys heavy, and now has severe pain on the kidneys) and FEELING ABNORMAL (Feeling very bad). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, PYREXIA (Fever over 101.9F), HEADACHE (Severe headache), MYALGIA (Body aches), RENAL PAIN (Feel the kidneys heavy, and now has severe pain on the kidneys) and FEELING ABNORMAL (Feeling very bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that these patients received improperly stored GARDASIL (lot# not reported, 0.5 ml, once, intramuscularly) between 17-DEC-2014 and 05-JAN-2015. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 27 month old female with no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination who on 21-FEB-2008 was vaccinated with the first dose of VARIVAX (Merck) SC (lot # 659737/1783U). Other vaccine received on 21-FEB-2008 included MMR II SC (lot # 657117/1312U). On 25-FEB-2009 the patient developed on upper left arm a cluster of papules scattered down arm - shingles. She saw the doctor with instructions to cover the arm and take BENADRYL and TYLENOL. Subsequently, the patient recovered from shingles. No further information is available.
vaccine was out of date, expiration date was 2/12/23, dose was given 3/2/23
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (Lot # K021933, expiry date: 10-NOV-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
received second covid vaccine at 1710, patient upset and crying prior to vaccine, dad noticed red rash/hives on belly five minutes after vaccine given, no resp distress. Seen by CRNP, Benadryl given at 1725, hives resolving by 1745.
Patient came by to request the third those of Pfizer, Pfizer was processed but a Moderna 0.25ml was administered.
Crushing fatigue that has now lasted six weeks. Hives that began four days after vaccine, several eruptions each week six weeks later. No energy and constant struggle to stay awake.
Extremely heavy period, lots of big blood clots. Not normal.   Didn't see doctor, but pretty sure it made me anemic
Patient has red bump, size of softball at injection site. Told her to ice it, take BENADRYL & Ibuprofen.
Patient reports a rash on her buttocks similar to rash she experienced when previously diagnosed with Shingles a few years ago. She also states she has experienced general malaise and fatigue since vaccine administration.
felt like little bit sick; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "felt like little bit sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given pediatric Hepatitis A, as opposed to scheduled Human Papilloma Virus vaccine.
Patient got injection at 8:02 AM patient states that 15 mins after injection he started to notice throat tightness. He notified the clinic staff at 830 AM about the symptoms he was having. At that time he was having wheezing, stridor, continuous coughing. 0.50ml Epinephrine IM was given in his left thigh at 0835. 2 puffs albuterol was given at 0835.  Vital signs were stable during reaction. Oxygen level was over 98% the whole time. Blood pressure was 132/86 at 0840. Pulse ranged from 132-154. EMS was called at the time Epinephrine Injection.
Patient potentially received 2 doses per month for 1st and second dose.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.).    No concomitant medications were reported. It was reported that vaccine system patient was vaccinated with Moderna monovalent vaccine on 9-Jan2-021, 13-Jan-2021, 06-Feb-2021, 17-Feb2021. Patient informed that she did not received 2 vaccines in the same month, and presented the card which shows 9-Jan-2021, 06-Feb-2021, and 30-Oct-2021. No treatment information was provided.
After leaving clinic riding down road, mom noted "hives" & "blotching" of face.  No breathing problems, MD treated with NS per IV- 12.5mg solumedrol and 1cc Decadrom IM with resolution- home with Benadryl PO prn and to followup with Allergist.
Pfizer COVID -19 Vaccine EUA Patient's wife reported to facility, upon contacting for 2nd dose appointment,  that the patient passed away from COVID-19. This patient did not pass away at facility, as there are no records of this patient in our EHR.  Per patient?s wife, patient was vaccinated on 2/3/21 at the clinic with the initial Pfizer COVID-19 vaccine. The patient passed away on 2/22/21 from COVID-19 (3 weeks after the initial dose, but prior to the booster dose).  Pfizer/BioNtech NDC# 59267-1000-2 Pfizer/BioNtech Lot # EL9269 Lot Exp: 05/30/2021 Site: left Deltoid Time of vaccination: 2/3/2021 6:15:53 PM
At 9:55 AM she complained that her throat felt funny the nurse administered Benadryl 25 mg liquid.  The pharmacist  and physician were called to  evaluate  her. She  said she felt better initially but then complained of difficulty swallowing and  emergency response was called an arrived within  5-8 minutes. Blood pressure was evaluated at 145/98 with a heart rate of 78 and pulse ox 99%. The patient was able to talk and reported  no trouble breathing throughout event and also when first responders arrived.  She was able to walk to the ambulance and was taken to Hospital with her husband.  She went to the emergency room at hospital to be evaluated . I followed up with the patient that afternoon at 4:00 PM and she was home. She was treated with IV Benadryl  per the patient in my follow up discussion with her and she also received a dose of oral prednisone taper along with oral Benadryl liquid to take at home.  I followed up with her again The  next day at 3:45 pmand she was having no side effects at that time.
Red itchy rash and hard lump on left arm measuring 4"x3". Using Bendryl, cold compresses, and Sarna creme.
Fever, shakes, headache, nausea, pain in chin bones, severe arm pain, redness and swelling to injection site
Swollen lymphnodes, coughing, headache, fatigue,  sinus drainage
Experienced my heart fluttering in May. doctor appt on July 7 did EKG and heart rate was 113 dx with Atrial Fibrillation. Doctor sent me to ER and they dx me with atrial fibrillation with rapid ventricular response. ER again on 7/14/21 with adverse reaction to medication Diltiazem and was given new medication Metoprolol Succinate. ER on 7/24/21 by ambulance due to heart attack symptoms released after heart rate and blood pressure reduced. ER on 8/3/21 per Dr. request because heart rate after EKG was 132/139. In ER was given a cardioversion which did not work ordered Amiodarone IV drip and converted my heart to sinus rhythm. ER 8/7/21 High blood pressure. taking meds to hopefullkeep heart in sinus rhythm. 8/9/21 - Visit with Dr to discuss possible Atrial Flutter Catheter Ablation. 8/13/21 - Visit with Dr to discuss my current medications and follow up visit to ER. Dr suggested getting off of the Amiodarone long term to discuss with my cardiologist 8/17/21 - Visit with Dr to discuss changing to a new Arrhythmia medication. Dr prescribed Propafenone 8-18-21 - ER visit with high blood pressure due to new Propafenone Adverse Reaction and suggested not taking subsequent doses & to see my cardiologist. 8-19-21 - Visit with Dr to discuss my high blood pressure with Arrhythmia medications and she took me off that med. She discussed Atrial Fibrillation Catheter ablation also. My heat was in sinus Rhythm. Dr wanted to keep me on Lisinopril for blood pressure and Metroprolol for my heart rate. I will see her again in November unless I have more high blood pressure or high heart rate issues. This has been a nightmare for me. In and out of ER & hospitals and numerous Dr visits. My heart has not liked these various medications and I have been through lots of stress. In January, February & March of this year I had a perfect heart rate & blood pressure until after the second dose of the covid vaccine. Heart Rate was 72 BPM, BP was 117/77
Patient said that right after the vaccine she felt "pins and needles" at her fingertips.  She did not feel any pain during the injection and otherwise felt fine.
adm to hosp 18OCT95 @ approx 630PM, t99.8 pt having szs
31OCT, flu like illness,fever,abd pain, aching joints,vomiting;to MD on 4NOV or 5NOV;V cont w/ fatigue,can eat only popsicles & mom concerned about dehydration;4DEC new Sx:h/a,muscle aches,nausea;28DEC 15 # wt loss;twitch;Dx fibromyalgia
Still experiencing symptoms from COVID, like the long haul/ Got COVID; Lost his appetite; He doesn't think his body is strong enough; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Still experiencing symptoms from COVID, like the long haul/ Got COVID), DECREASED APPETITE (Lost his appetite) and ASTHENIA (He doesn't think his body is strong enough) in a 34-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Still experiencing symptoms from COVID, like the long haul/ Got COVID) (seriousness criterion hospitalization), DECREASED APPETITE (Lost his appetite) (seriousness criterion hospitalization) and ASTHENIA (He doesn't think his body is strong enough) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to ASTHENIA, COVID-19 and DECREASED APPETITE. At the time of the report, COVID-19 (Still experiencing symptoms from COVID, like the long haul/ Got COVID) had not resolved and DECREASED APPETITE (Lost his appetite) and ASTHENIA (He doesn't think his body is strong enough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Got COVID.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient was wondering if he still be experiencing side effects a month later. The patient was in the hospital for 6 days, had lost appetite. Patient did not know if it was from the shot. Patient's work mandated it and was not sure if should take the second dose, but patient might lose the job. The patient was still experiencing symptoms from COVID, like the long haul. Patient wants to know how long it was between the first and second dose and asked if he can wait a little more before getting the second dose. Patient do not think his body is strong enough to get the second dose and asked which arm patient should get the second dose: same arm or different arm.  Company comment: This spontaneous case concerns a 34-year-old male patient with no reported medical history who experienced the unexpected serious (Hospitalization) events of COVID 19 (AESI), Asthenia, and Decreased appetite which occurred unknown days after first of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 34-year-old male patient with no reported medical history who experienced the unexpected serious (Hospitalization) events of COVID 19 (AESI), Asthenia, and Decreased appetite which occurred unknown days after first of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient fainted after receiving the vaccine. Gave patient a smelling salt which woke him up.  He urinated and became sweaty after passing out.
Starting 5 days after shot large joints (shoulders and hips) became extremely sore and painful.  Pain was constant bur worse if joint was flexed at all.
Within 30 minutes of receiving the vaccine, the patient felt hot, was dizzy and fatigued.  At 2238, the patient was given Benadryl 25 mg po.  Patient went home at 2246.
G62.9 PERIPHERAL NEUROPATHY 7/8/2022 DM 2 W DYSLIPIDEMIA I95.9 HYPOTENSION 4/22/2022 DM 2 W DYSLIPIDEMIA
the knot has increased in size to that of a baseball; tired feeling that went away but returned several days later; large, hard, round knot the size of a golf ball in arm that received injection; red, puffy face that went away but returned several days later; red, puffy face that went away but returned several days later; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (large, hard, round knot the size of a golf ball in arm that received injection), ERYTHEMA (red, puffy face that went away but returned several days later), SWELLING FACE (red, puffy face that went away but returned several days later), VACCINATION SITE MASS (the knot has increased in size to that of a baseball) and FATIGUE (tired feeling that went away but returned several days later) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 667M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE MASS (large, hard, round knot the size of a golf ball in arm that received injection), ERYTHEMA (red, puffy face that went away but returned several days later), SWELLING FACE (red, puffy face that went away but returned several days later) and FATIGUE (tired feeling that went away but returned several days later). On an unknown date, the patient experienced VACCINATION SITE MASS (the knot has increased in size to that of a baseball). At the time of the report, INJECTION SITE MASS (large, hard, round knot the size of a golf ball in arm that received injection), ERYTHEMA (red, puffy face that went away but returned several days later), SWELLING FACE (red, puffy face that went away but returned several days later), VACCINATION SITE MASS (the knot has increased in size to that of a baseball) and FATIGUE (tired feeling that went away but returned several days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.