chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). An 19-year-old female patient (not pregnant at event onset and time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 11Feb2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included Ewing Sarcoma which was not ongoing (Diagnosed at 5 years old, treated with chemotherapy for 1 year, cancer free for 13 years). There were no known allergies. Concomitant medications included low dose ethinylestradiol, norgestimate (TRI-SPRINTEC) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 20Jan2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. Starting 15Feb2021 at 12:00, the patient began to have shortness of breath that got progressively worse throughout the week. On 22Feb2021, she woke up with severe shortness of breath and her O2 saturation was 82%. She went to the hospital emergency department and was given a chest CT, and diagnosed with large bilateral pulmonary embolisms. She also had severe right ventricular strain due to the PEs. She was rushed into an EKOS procedure and a IVC filter was also put in. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), and Life threatening illness (immediate risk of death from the event). COVID test (test type: Nasal Swab, test name: Novel Coronavirus PCR) post vaccination was Negative on 22Feb2021, and Negative on 29Mar2021. Therapeutic measures were taken as a result of the events and included Heparin drip, EKOS and IVC filter procedure. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Was given a GARDASIL vaccine in (Rt) Delt. stood up to change into clothes from gown and passed out. Pt woke up and was fine. Kept eye on her till she went home.
Fever blister. I have never had a fever blister prior to injection. Also had burning shooting pain in nerves going down arm injected for 4 days like when I had shingles.
Pt recvd vax 10DEC93 & on 18DEC93 devel pityriasis rosea; rash had cont to spread; PA also reported 2 other pts;
heart failure exacerbation; COPD exacerbation; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. On or around 16-NOV-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the patient suffered and was hospitalized with chronic obstructive pulmonary disease (COPD) exacerbation and heart failure exacerbation. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   COPD exacerbation and heart failure exacerbation were considered as disability. Upon internal review, heart failure exacerbation was determined to be medically significant.
On 1/26 at breakfast table began vomiting.  Continued thru am when at noon a caregiver did his O2 saturation and found it was 75%.  This was confirmed, and resent sent to ER .
Narrative:  COVID infection following COVID vaccine series 01/16 COVID vaccine dose #1 02/06 COVID vaccine dose #2 08/23 Pt c/o SOB, COVID test negative 12/07 COVID vaccine dose #3, COVID positive, pt c/o loss of taste or smell, rhinorrhea, congestion 12/08 pt c/o cough, fatigue, loss of taste or smell and rhinorrhea; reports was exposed to coworker on 11/30 12/16 clinical resolution
Sudden onset fatigue, mildly labored breathing, palpitations. Slept on/off from 12:30 PM on 10/10 to 7 PM. Slept regualar hours that night (10:30 PM to 7 Am). Mildly labored breathing and palpitations persisted throughtout the day. Fatigue still present on 10/11, but less. Slept for 2 hours in the afternoon with generally less energy throughout the day. Breathing normal, palpitations mild. Today, 10/12, mild decreased energy and mild palpitations.
Stye; This is a spontaneous report from contactable nurse. This nurse reported similar events for 4 patients. This is one of the 4 reports (for reporter's sister son). An adult male patient received bnt162b2 (BNT162B2), Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included hordeolum from an unknown date and unknown if ongoing (patient's grandmother (his mother's mother)). The patient's concomitant medications were not reported. The patient experienced stye (medically significant) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the event Hordeolum and suspected drug cannot be excluded.  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,Linked Report(s) : US-PFIZER INC-202101375744 Same reporter, drug and event, different patient;US-PFIZER INC-202101375851 Same reporter, drug and event, different patient;US-PFIZER INC-202101375859 Same reporter, drug and event, different patient
Information has been received from a licensed vocational nurse concerning a 21 year old female who on 28-MAY-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL in the left arm. Concomitant therapy included PROZAC, WELLBUTRIN and TRI-SPRINTEC. On 29-MAY-2008, within 18 hours of vaccination the patient developed hives to her arms, legs and trunk. The patient had an office visit with her primary physician. At the time of the report the patient was recovering. Additional information has been requested.
After few hours, First a mild sore on my back near the right kidney area Next day muscle sore on my entire body, following two days (Saturday and Sunday) I felt very very tired  Monday I started having sore throat, nauseas and at night I had 101.6F? of fever. Tuesday I woke up with a very bad posterior back pain (around shoulder area) it was so sore that I couldn?t even drive Tuesday evening. I took two advil at night and then next morning (Wednesday) I was feeling much better.  I felt miserable for 5 days and I dont wish it to anyone.
Immediately after getting the shot I felt a little nausea, had a headache and soreness in the area that I received the shot. The soreness remained for about 3 days and I was fine after.  At about January 25, is when I started noticing heart palpitations. My heart felt like it was constantly fluttering unevenly and every now and then I could feel a "squeezing" sensation on my heart that would result in a "tingling" in my left hand. It occurred on and off for days.   Before scheduling my appointment to see the doctor, my significant other mentioned that I seemed a lot more of of breath lately when speaking and doing regular tasks.   When I went to the doctor and explaining the situation, they ran an Ekg/ECG to monitor my heart and everything came out normal. Several other blood work tests were ran to look at my levels and all of them came back good. My Potassium was .1 below what was considered the norm so I was given a small dose of Potassium to take over the next few days.  At this time, I am currently not having any palpitations. The last I had them was on 2/5/22.
preliminary rpeort baby died in car ride home, no preceding sx, signs;EMS called @ 942AM autopsy currently being done;
102.2 fever, chills, nausea, tiredness, fatigue, headache, site sore, blotchy rash across chest, neck, torso
9/10/03 4 PM Mom brought child into clinic.Pain to left upper arm with swelling.  Hot, red color.  Left upper arm hot,distended to touch. Distal CSM WNL.  Cap refill less than 2 seconds. ROM of arm WNL. Denies fatigue, lethargy or any other symptoms. C/O local upper arm pain. Advises cool compresses and tylenol or children's motrin.  Will TC PMD if symptoms worsen. 9/11/03 10 AM Mom back into PHD. Has used cool compresses and given motrin.  Also has kept child home from school.  Child states that his arm does not hurt as much.  No redness at this time. Still some swelling.  Mom will TC if does not continue to abate.
Primary notified observation, experiencing symptoms of weakness, confusion, nose bleed with clotting (lasting 3 days).
After the second dose I had a feeling of being tired and wiped out. I have never recovered from that feeling of being tired . I went t my doctor in April of 2021, they noticed irregular rhythm in my heart. The started doing different test for my heart.  I get chest pains from time to time, they do not last long for me to call 911 or anything. They said my heart looked healthy and the can not explain why I having irregular heart beats.  They have not given me any answers as to why this is happening. I know that it has occurred after the vaccine.  I am very tired and can not do the same activities I used to do.
tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events.  Information on the lot/batch number has been requested.
'covid arm'.  Around a week after injection the injection site started itching and my lymph node in my armpit on that arm was very painful. Two days after that started a large (3" diameter) red swollen splotch appeared at the injection site.
Hypotension, Tachycardia, coughing, tightness in chest, itching eyes, frequent urination.
Reports burning and tingling to left upper extremity, neck and face. Visible raised red welts noted to left side of neck. Denies shortness of breath. Mother reports family history of anaphylactic shock. Mother returned with patient 15-20 minutes after injection reporting these symptoms.
Had mild allergy symptoms; Arm pain; Fatigue; Migraines; Hemiplegic migraine; ekg was weird; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "recovered", described as "Had mild allergy symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines"; HEMIPLEGIC MIGRAINE (non-serious), outcome "unknown"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "ekg was weird". The events "had mild allergy symptoms", "arm pain", "fatigue", "migraines" and "hemiplegic migraine" required emergency room visit. The event "ekg was weird" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Normal; Electrocardiogram: Weird; Electrocardiogram ambulatory: Unknown results, notes: 30-day Holter monitor. Therapeutic measures were taken as a result of hypersensitivity, migraine, hemiplegic migraine. Clinical course: Patient got first shot on 01Apr, had mild allergy symptoms that resolved with benedryl, arm pain and fatigue for about half the next day 2 migraines that week following then started cycling through nonstop hemiplegic migraines since a week after the shot. Patient went to the ER 6 days ago, the CT scan was normal but ekg was weird. The migraine cocktail helped for a couple days but patient was back to cycling through again. Patient's doctor gave samples of Ubrelvy and Nurtec to try. Patient was already on 20mg of nortriptyline for prevention and relpax as needed. Patient was scared to get the second dose this coming Thursday. Patient had to see a cardiologist because of the weird ekg and now have a 30-day Holter monitor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 4pm patient c/o of lightheaded. Patient report did not eat all day and has been seating in the heat for long time. Vital was normal BP: 107/79. HR: 77. Nurse practitioner on site cleared patient.
Pt states arm became red, swollen, and warm to the touch from shoulder to elbow the next morning when she woke up. She was instructed to take an antihistamine and continue to watch the area. She stated her arm does look a little better since she first noticed it.
Swelling and redness of the upper right deltoid with some pain. Patient went to clinic and received some prescription steriod. She was also advised to take some BENADRYL and TYLENOL. Patient came to the pharmacy the next day and said the swelling was much better.
7/26/21: Patient is a 66-year-old female with past medical history of current COVID-19 infection, diabetes, recurrent nephrolithiasis, GERD who presents to the ED with chest pain for 1 day.  Patient reports her and her husband recently traveled, upon returning from her trip patient began to feel cold-like symptoms which prompted patient to visit urgent care on 07/20/2021 were patient subsequently tested positive for COVID-19.  Patient reports initially feeling better then developed sudden onset diffuse chest pain yesterday, described as left and right-sided dull chest pain nonradiating exacerbated by exertion and deep inspiration. Diagnos NOte: patient received Moderna COVID-19 vaccine in Dec 2020. Diagnosed with COVID-19 pneumonia.  7/27/21: patient discharged.
Patient appeared anxious prior to vaccine administration.  When asked if she felt like she was going to pass out, patient advised she did not pass out from needles/shots before, but has fainted because of extreme anxiety; but did not feel like she would pass out at this time.  After shot was administered, pt. was more relaxed, and advised she was feeling ok.  Patient was ambulatory, with no complaints of light-headedness or adverse feelings, and walked to the observation area.  Approximately five minutes following vaccination, patient told companion that she did not feel good, and laid down on the floor.  She then experienced a syncopal episode.  Patient did not hit head, or have any injury as a result of the syncopal episode.  Patient was breathing normally, but was unresponsive for approximately 15-20 seconds.  Following episode, patient regained consciousness (COAx3), and was upset from incident, but confirmed no injury or other illness, following episode.  Patient was evaluated by EMTs on site, and was able to sit up and transfer from the ground, to a chair, and the chair to a wheel chair without issue.  Further evaluation was conducted by EMT on site.  Blood pressure was 110/80, SPO2 was 98% room air, and pulse was 66 at approximately 13:22 hours.  Patient laid on gurney/cot on-site for approximately 20 minutes, to rest, and to be monitored for additional side-effects.  During monitoring, patient advised the only thing she had eaten today was "one peanut butter cup."  Patient was provided water and a juice box during monitoring time.  Patient was released from monitoring area at 13:45 hours, after she advised she was feeling ok.  She was wheeled into the parking area as a precaution, and left with her companion.  Patient was the passenger of the vehicle.
Very sore arm - lasted two days Next day after vaccine - EXTREME fatigue, body aches, could not get out of bed for 24 hours
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation;  BNT162b2 (BNT162B2), on 28Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 07Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 13Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of UPPER AIRWAY OBSTRUCTION (swelling of upper airways) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0296208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hives. Concurrent medical conditions included Sulfonamide allergy (Sulfa). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (Dizziness), DRY MOUTH (mouth is dry), DYSPNOEA (shortness of breath), SNEEZING (Sneezing/Runny nose), RHINORRHOEA (Sneezing/Runny nose), TASTE DISORDER (Unusual Taste), DYSPHONIA (hoarseness), PARAESTHESIA (prickling/tingling), ERYTHEMA (redness/erythema), SWOLLEN TONGUE (tongue swelling), UPPER AIRWAY OBSTRUCTION (swelling of upper airways) (seriousness criterion medically significant) and TREMOR (trembling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing from January 2021 for Adverse event, at a dose of 1 dosage form once a day; PREDNISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYTREC) ongoing from January 2021 for Adverse event, at a dose of 1 dosage form once a day. At the time of the report, DIZZINESS (Dizziness), DRY MOUTH (mouth is dry), SNEEZING (Sneezing/Runny nose), RHINORRHOEA (Sneezing/Runny nose), TASTE DISORDER (Unusual Taste), DYSPHONIA (hoarseness), PARAESTHESIA (prickling/tingling), ERYTHEMA (redness/erythema), SWOLLEN TONGUE (tongue swelling), UPPER AIRWAY OBSTRUCTION (swelling of upper airways) and TREMOR (trembling) had not resolved and DYSPNOEA (shortness of breath) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. The patient visited a PCP, dentist, allergy doctor and dermatologist for consultation and treatment. The patient had blood work several times. Specific tests and Test results were not specified.  The patient had 150 mg shot of a steroid for treatment. Type of steroid was not specified. The patient continued to experience dizziness event but it improved for a while. This case was linked to MOD-2021-213901 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant Follow-up; 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. Also, there is a Product dose omission event.
Fever, chills, profuse sweating.  Pain and swelling in arm.  Unable to sleep for 2 nights due to chills and sweats.  Fatigue. Recovered after 4 days of symptoms.  I had COVID in December 2020 through January 2021.
5 Days after vaccine, redness occur around injection site, then subsided. 2 Weeks later, patient still experience muscle soreness.
Moderna COVID-19 Vaccine EUA Pain and heat at the injection site, nausea, chills
vaccine stored in fridge beyond 30 days at time of administration; reported to pt; recommended repeating vaccination; pt repeated on 10/3/21; reported no adverse effects from either
I95.9 HYPOTENSION 6/23/2021 DIFFUSE LARGE B-CELL LYMPHOMA, EXTRANODAL AND SOLID ORGANS T78.40XD ALLERGIC REACTION, SUBSEQ 6/23/2021 DIFFUSE LARGE B-CELL LYMPHOMA, EXTRANODAL AND SOLID ORGANS