chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticaria large indurated at site of injection 8 x 10cm. Not infected. Headache.
Awoke unable to catch my breath. Oxygen levels were normal. Heart rate was normal. Went to emergency room where all tests were normal. My cardiologist changed my diuretic from diazide to torsemide my weight went from 141 lbs to 132 lbs.
Eye swelling in both eyes, eye drainage, sinus congestion, itchy rash on left hip, muscle fatigue  Symptoms lasted 24 hours, treated with Benadryl & symptoms subsided fully after 48 hours post vaccination
she came down with COVID-19; she came down with COVID-19; Off label use; Interchange of vaccine products; This is a spontaneous report based on the information received by Pfizer from a regulatory authority, on behalf of Moderna (Reference: MOD21-158058). A female patient of unknown age received an unknown dose bnt162b2 (COMIRNATY, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, on an unspecified date in Jan2021, as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was inoculated with Moderna with second dose at the end of Apr2021. Only side effect was waking up thirsty the night of the shots. In September, the reporter had lunch with someone, vaccinated with Pfizer in Jan2021, that we thought was having allergy issues. They sat across the table from her for over an hour in close contact, and we even kissed when we departed. Two days later she came down with COVID-19. This was diagnosed by two tests and by a physician. The reporter never came down with covid-19. The reporter calls that a success and was very grateful. Outcome of the events were unknown.  The lot number for the vaccine (bnt162b2), was not provided and will be requested during follow up.
I started out having a sore raw throat, and a mild fever. This continued for about three weeks. I went to my doctor and he gave me a prescription for nasal spray. After 5 days with no relief I again called him and he prescribed Azithromycin tablets. I have developed a bad cough and sinus infection. I have had flu shots for three years and have never had a bad reaction to any of them. I am not saying the shot caused my discomfort, but in the three years that I got the other shots I never once had a cold or any other adverse reactions to any of the shots.
Narrative: Patient received Moderna Covid #1 on 3/6/21 and #2 on 4/2/21. No scanned records or notes that indicate what happened between his second vaccine and date of death on 4/4/21. Noted his ESRD on dialysis and was on the kidney transplant list. Time from second vaccine to date of death was 2 days. no autopsy report available.
Vaccinated 10/10 - reported to RPh 10/13/12. Reports initial swelling & redness of entire upper arm & itching. At time of patient report, swelling diminished - now 2-3 inches of redness & swelling around injection site. Patient was examined by dermatologist. Advised Hydrocortisone cream & ice pack (per MD) - helping - per patient.
Herpes zoster (Shingles) diagnosis on day 5 due to immune response to Pfizer vaccine, rash appeared overnight day 4 to day 5. Emergency room visit evening day 3 for extreme numbness in hands and feet in addition to the following: Shooting pains like a wasp was flying around in my body 30 minutes after and still occurring 5 days later.  Intense skin itching from day 1 and still occurring 5 days later. Pins and needles sensation in extremities from day 1 and still occurring 5 days later. Hands and feet feel as if they are asleep/numb from day 1 and still occurring 5 days later.  Lymph nodes swollen from day 2 and still occurring 5 days later.
Hospitalized 12/9/2021-still admitted currently; COVID-19 positive 12/9/2021; fully vaccinated  Assessment/Plan:   1) Acute on hypoxic respiratory failure: - secondary to COVID-19 PNA in the setting of single lung transplant for IPF  - presented with hypoxemia warranting HFNC on 12/9/21; intubated for increased work of breathing while on HFNC - continue mechanical ventilation; on volume control PEEP 8 to achieve lung protective ventilation; continue - wean Fio2 for sats >/=90% - await ABG on above settings to determine if will warrant proning - continue treatment of COVID-19 PNA as detailed below - treat for possible superimposed infection; especially in setting of immunosuppression with vancomycin, azithromycin and cefepime; continue ppx as detailed below; will obtain BAL, BLCX and UA/UCx and de-escalate abx per results  - VQ scan low probability for PE; check venous dopplers of upper and lower extremities to rule out any DVT   2) COVID-19 PNA: - vaccinated - developed symptoms 12/4/21 - presented on 12/9/21 - risk factors: immunosuppression - will start solumedrol 40 mg BID - not a candidate for remdesivir secondary to AKI - will make arrangements for monoclonal Abs - will determine if can receive tocizulumab Plan for today - Covid PNA - CXR slight improvement , methylpred weaned to 40 mg daily 12/14, on HFNC FIO2 40% - Volume status: Dry. Hypernatremic, metabolic alkalosis > D5.45 @ 75 cc/hr started. Stop Lasix. Repeat BMP at 1400 to follow sodium trend - HFpEF - hold lasix, HTN - Immune suppression - no change to tacrolimus, goal 4-6; methylpred 40 mg daily, no CCI due to leukopenia and infxn - Nutrition - failed SLP eval again today, corpak to be placed, promote ordered - Remove ART line and central line - PT/OT  - transfer to floor   Acute on chronic respiratory failure with hypoxemia S/P right lung transplant complicated by bronchial stenosis s/p stent placement. Recurrent diastolic heart failure.  Chronic hypoxemic respiratory failure on 2 L of oxygen.  Acute decline likely due to COVID-19 pneumonia and decompensated heart failure.  Pneumonia due to COVID-19 virus 12/4/21: fevers, dyspnea, continued to worsen over several days 12/9/21: hypoxemia, admitted, intubated, COVID-19 positive D-dimer 1870, VQ scan negative, lower extremity doppler negative Per ID not a candidate for MAP.,  AKI limiting Remdesivir use.  Methlypred 40 mg bid > daily 12/14 for 10 day course 12/15 - extubated to HFNC
Patient sitting on side of the bed. The patient had slurred speech and was unable to form his thoughts. The patient was last seen by a nurse's aide and was speaking clearly. Patient alert. Attempted to take one pill and had difficulty swallowing and began coughing. No other medications were given. Assisted patient to lying position. The patient is able to move all extremities. The patient was able to state he just didn't feel right.
HYPOTENSION 8/28/2021 LONG TERM ANTICOAGULANT THERAPY  HYPOTENSION 8/28/2021 DIARRHEA  HYPOTENSION 8/28/2021 ACUTE PULMONARY EMBOLISM  HYPOTENSION 8/28/2021 ADENOCARCINOMA, BODY OF PANCREAS  HYPOTENSION 8/28/2021 ACUTE PULMONARY EMBOLISM  HYPOTENSION 8/28/2021 ADENOCARCINOMA, BODY OF PANCREAS
Patient reports feeling short of breath, nauseous, clammy, and chest tightness. This RN assisted patient to wheelchair and wheeled her to the private observation area. Assisted patient into recliner with feet elevated. Vital signs at 1410: BP 125/81, P92, RR 20, 98% RA. Patient reports a similar reaction to the second Gardisil vaccine approximately 10 years ago. Patient reports being 17 weeks pregnant, but the symptoms she is experiencing do not feel pregnancy related. Patient reports getting the ok from her OB to get the Covid vaccine. Patient also reports not eating or drinking anything in a while. Provided a Gatorade and granola bar. After about 20 minutes patient reports she is back to her baseline. Patient reports her husband will be picking her up.
I received the Moderna COVID -19 Vaccine EUA, and it resulted in severe adverse reactions which continue to persevere to this date; one year later. The day of the vaccine I had extreme dizziness and headache. Fatigue was also severe along with my left arm hurting so badly that I contacted my primary doctor right away. She instructed me to take some Benedryl to help me feel better. I also took some tylenol to help with the pain. Then over the next couple days, my right leg felt like stiff as a board. It was really painful and I had a hard time walking normally. The more I walked my balance was off and my coordination was such an issue I was tripping over my own feet. It was getting worse, along with so many other issues that I went to see my primary doctor on March 18, 2021. The other symptoms I had included the following: pins and needles in my fingers, toes , hands and feet shooting and stabbing pains in both my arms and legs burning sensations everywhere in my body extreme squeezing sensation around my ribcage to the point where I felt like I couldn't breathe numbness in my right leg first then it went upward to my right arm body wide blowing up; like my whole body was swelling up; I can visible see it too extreme weakness in right leg first then up my right side then left side was affected weird electrical shocking feelings all inside my body muscle twitching all over
Morning of 4/6 (4 days after shot), woke to sore throat; Swollen lymph nodes; Joint/muscle aches; Joint/muscle aches; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine.  Allergies to medications, food or other products were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Apr2021, at 05:00 in the morning 4 days after the shot the patient woke up with sore throat, swollen lymph nodes, joint/muscle aches, and slight dizziness. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events sore throat, swollen lymph nodes, joint aches, muscle aches and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
A report has been received from a Pharmacist concerning a 20 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose FLUMIST in one nostril on 11-Nov-2013 at a mobile clinic. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Swelling at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site) and CHILLS (Chills). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.   This case was linked to MOD21-067488 (Patient Link).
Patient experienced brief (15-30 second) episode of syncope; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Lot number: EW0150) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 06Apr2021, immediately following injection of 1st dose of vaccine, patient experienced brief (15-30 second) episode of syncope. She was sitting in chair and slumped forward momentarily. It was unknown if patient had Covid prior vaccination and unknown if tested for Covid post vaccination. No treatment received for the event. The outcome of the event syncope was recovered.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
One day post vax, pt developed a red, itchy rash on his trunk, arms and legs.  He was treated with prednisone and recovered after 2 weeks.
The Moderna COVID-19 vaccine was administered to patient.  After vaccine administration, it was discovered that patient had indicated on his vaccination screening form that he had received the Shingrix vaccine 12 days ago on 03/15/21.  This vaccine was given within 14 days of the administration of the COVID-19 vaccine.  Clinical supervisor was notified of this incident right after it was discovered.  According to the current CDC guidelines if a COVID-19 vaccine is given less than 14 days from another vaccine it is does not need to be repeated.  Clinical supervisor provided counseling with this recommendation to patient along with her contact information in case he had additional questions.
Excessive menstruation bleeding, 12 electrical shocks in my heart, allergic reactions welts on arms and chest area, hives.
Patient was accidently administered Varivax instead of the intended Vaxelis; This non-serious spontaneous safety report was received by Agency on 25-Aug-2021 and forwarded to Agency on 31-Aug-2021 from a physician.  On 23-Aug-2021, the patient had been accidentally vaccinated with Varivax instead of the intended Vaxelis.   The causal relationship between Vaxelis and the event of wrong vaccine administered was assessed as not applicable due to the nature of the event.  Further information is expected.  FOLLOW-UP INFORMATION was received by Agency on 25-AUG-2021 and forwarded to Agency on 15-SEP-2021. Narrative was provided by Agency as follows:  "This spontaneous report was received from a consumer via field representative and refers to an 11-month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-AUG-2021, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter (formulation, route of administration, lot#, expiry date were not reported) for prophylaxis instead of intended diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS). It was reported that there was no further adverse event.  The causal relationship between Vaxelis and the event of wrong vaccine administered was assessed as not applicable due to the nature of the event."  Further information is not expected since Vaxelis was not administered.
Pain at injection site, 103 degree fever, tiredness, headache, shivering, body ache, dizzy, nauseous, elevated blood sugar Range of (275 to 375) when my normal weeks prior was average of 176.
mom noticed pt to have a red circle 12SEP96 around lt thigh shot of DTH given 11SEP96;pt itching lt leg & reddness 9x7mm large red circle, hardness noted under reddness;
This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is the second of three reports. A patient of an unknown age, race, ethnicity and gender received PREVNAR 13 (lot S06823, expiry date May2018) at single dose for immunisation on an unknown date. Medical history and concomitant medication were not reported. On an unknown date the patient experienced cellulitis. The outcome of the event was unknown. It was reported that some pneumococcal 13-val conj vaccines contained a white substance, however it was unknown if the patient had received or not the same lot which had the white substance. Sender's Comments: Linked Report(s): US-PFIZER INC-2017327795 Same reporter/drug/event, different patient; US-PFIZER INC-2017327829 Same reporter/drug/event, different patient.
Information has been received from a medical assistant concerning a 24 year old female with no other relevant history reported. On 19 Oct 2006, the patient was vaccinated with the first dose of Gardasil (yeast). There were no other concomitant medications reported. On 19 Oct 2006, the patient developed some initial itching at the injection site that resolved (date unknown). On 02 Nov 2006, the patient reported that she awoke with a large red bump at the injection that was itchy "this developed about 13 days post dose". The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Information has been received form an office worker concerning a 19 year old female with allergies to bees, FLEXERIL and CECLOR who on 25-MAR-2009 was vaccinated SQ into the right arm with a first 0.5 ml dose of PNEUMOVAX (lot # 661577/1161X). Concomitant therapy included albuterol inhaler. On 26-MAR-2009 the patient developed cellulitis after the vaccination. The patient experienced swelling, induration, immobility and redness of her right arm. She also had a fever. The patient sought medical attention at a physician's office. She was treated with antibiotics (unspecified). No lab tests were performed. As of 30-MAR-2009 the patient was recovering. Additional information has been requested.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 72-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 20-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
arm was swollen; arm was very itchy; arm was red; arm was fevered to touch/hot to touch; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 26Feb2021 09:45 (Batch/lot number: EL9266), at age 72 years old, as dose 2, single, for COVID-19 immunisaiton, at a clinic. The patient was not pregnant at the time of vaccination. Relevant medical history included Hashimoto disease and known allergy to some band aid products both from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine taken for an unknown indication, start and stop dates not reported. The patient previously took bacitracin and ciprofloxacin (CIPRO) and experienced allergies to both. Historical vaccine included BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, on 05Feb2021 09:45 (Batch/lot number: EL9264), at age 72 years old, as dose 1, single, for COVID-19 immunisation. The patient did not have other vaccines in four weeks. On 28Feb2021 09:45, 48 hours after the second injection, the patient's arm was red, swollen, fevered to touch/hot to touch and very itchy. At the time of the report, it was still very itchy a little swollen but not hot to the touch. No treatment was given for the events. The patient recovered from "arm was fevered to touch/hot to touch" on an unspecified date and was recovering from "arm was swollen" and "arm was red". The outcome of "arm was very itchy" was not recovered.  No follow-up attempts are possible. No further information is expected.
eczema; rash under my breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash under my breast) and ECZEMA (eczema) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced RASH (rash under my breast). On an unknown date, the patient experienced ECZEMA (eczema). At the time of the report, RASH (rash under my breast) and ECZEMA (eczema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Tenderness, increased warmth, slightly edmatous. Area at site of injection began to sting almost immediately after injection per client
Pt called 2NOV93 to state had pains in the back of legs starting 1-2 days p/flu vax, referred to PMD on 9NOV93; pt devel joint inflamation as a direct result of vax;
flu; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case is linked to cases 2020SA296404 and 2020SA296404 (same reporter).  This case involves patient (age and gender unspecified) who experienced flu (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
5-2-08 Body Aches, 5-3-08 Fever, Body Aches & shortness of Breath  took advil symptoms resolved by 5-4-08. Had developed increased Redness, swelling and brusing at the injection site (right deltoid) 5-2-2008.  The patient called the family physician and he recommended taking benadrylx2.
HIGH FEVER 103-106. NO PHYSICAL FINDINGS. FEVER STARTED A DAY AFTER THE SHOT WAS GIVEN