chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complained of light-headedness, sat down, followed by paleness. When asked if ok pt set head back, eyes rolled back, got stiff, passed out for about 5 seconds. Myself and another person lifted him to floor where he awoke and became conscious and alert to person, place, time, day, and date. Later when EMS came was able to stand and walk on his own and sign AMA papers.
4PM 6/22/06 PC from pt's mother. Started with H/A and achiness around 11:00 last night, felt better till around lunch time today. Bad H/A, achiness, bad back pain, no fever, sore at injection site, no other symptoms. Mother gave ibuprofen and Excedrin with ASA. 5:10 H/A improving and aches not as bad per mom, taken a shower. 6/23/06 8:30PM no H/A, slept well, aches improved. 5:10 worked part of day, much better. 6/28/06 back to normal per mom per PC.
On April 06, 2021 10:01:20 EDT Patient scheduled for appt on 4/7/21 at 9:45am. Patient states he gets SOB with walking, and any exertion. Patient states his BP and other vitals are WNL.
Started breaking out from the shot while I was at work.  Started itching on my back, when I got home I took a shower.  IT got worse and spread through out my body.  I broke out in red hive like marks through out my body, they were extremely itchy.  I had to take benadryl every 4 hours to manage some of the pain and itching.  Monday I was able to see a doctor and they gave me steroids and an antibiotic.  It took several days to feel a bit better.  The whole process took around 5 days when I felt back to normal.  My primary care doctor told me not to take the second shot because I had adverse effects to the first shot and that it could present worse symptoms.
Directly /p vaccine pt lost color-pale & c/o feeling funny,weak legs lied down. Pulse 59-60. B/P 100/66 to 82/50 & remained low for 30-40 min. Pt's legs elevated,recoved.  Eaten only a piece of cheese for breakfast & was 2 days into period.
I was told it was PREVNAR 13 but not sure as on this visit summary say I did not received any immunizations documented. Don't know-I was not given any info. of this shot no paperwork recorded. No info! Became dizzy walking out of clinic. Had dizzy spell for a second 1/2 hour walking up stairs at brothers house-did not understand why? Let it go. Came home did not feel well 3 HRs later became sick vomiting - 6:30 P.M. felt week dizzy had to lay down. Equilibrium was out of whack. Felt like I had a fever did not want to move just wanted to lady still in bed. Hospital said they could not give help on phone. I don't think my Doctor did anything wrong! But the Clinic should keep better records of what they do! No info of the shot I was given and Records say I did not receive a immunization shot PREVNAR 13 that day? Why?
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds .5 mLVls 10 SDV, which had the lot # K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 88, 64, 200, 320, 184 and 152 hours. The lowest recorded temperature was 34 (1.111111111 Celsius degree), 33 F (0.555555556 Celsius degree), 32 F (0 Celsius degrees), 31 F (0.555555556 Celsius degree), 29 F (-1.666666667 Celsius degree), 30 F (-1.111111111 Celsius degree), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
This healthy 50 year old received her smallpox revaccination on 3/2/05.  Approximately 8-12 hours later her chest began to feel hot, as if having a hot flash.  She then felt as if someone had pricked her. She began to notice 1-2 fine flat circular red macules, 0.5-1cm in diameter to her chest with 1-2 macules on the right side of her neck.   She was able to sleep, but upon awakening this am, the rash had spread in a V neck pattern over her upper chest.  Benadryl 50 mg PO this am has resolved the itch and slowed the rashes spread.  She denies any fever, fatigue, itching, or use of new deodorants, soaps, cloths, food, or animal contact.  She reports previous skin reactions (see allergies above) including hives, swelling and difficulty breathing; so she took Benadryl 50 mg po this am as a preventative measure.
Injection site became swollen (about 1/2" raised). Within one minute of administration site went back to normal within 10 minutes. No trouble breathing. No pain at site.
1/6 vaccination 1/7 typical immune system response; recovered in 12 hours.  1/8 Woke up and my left hand was weak, numb and tingling in glove distribution. The right hand started to have problems as evening came. The right hand resolved within 12 hours. The left hand symptoms persisted for 6 weeks.  *unable to work for 6 weeks.  **Still having symptoms in middle finger, pointer finger; left hand.  1/8 I went to urgent care; referred to ED. They did put me in the clinical observation unit, discharged the next day.  I went to PCM 2 days later. Dr. didn't know what to think of symptoms. Had me try some steroids.  Hospital referred me to neurology; He had me do another MRI (1st in the ER). EMG. He didn't find anything unusual except some nerve damage; carpal tunnel  *Symptoms are still persisting. It has gotten better but the 2 fingers are still an issue.
Severe headache, dizziness, electric shock feeling body aches in legs and arms.. Chills, hot flashes, had a laughing attack for 1/2 hour followed by waves of crying. Severe arm pain at site with redness and itching. tiredness and anxiety .. severe lower back pain and shock like sensation at temple area.
pt recvd vax 2nd dose of vax 25APR92 & last menstrual period was APR92; between 2nd & 3rd dose pt became pregnant; while pregnant devel toxemia (WAES93060962); child devel apnea & blood in one of ventricles of the brain;
This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. ON 03-JUN-2015 the two patients missed prescribed doses of unspecified  frozen vaccine which may have been (Oka/Merck) VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication due to improper storage. NO concomitant medications were reported. No adverse events were reported. The action taken with the therapy with (Oka/Merck) VARIVAX was unknown. The outcome of the event was unknown. The relatedness of the events to the therapy with (Oka/Merck) VARIVAX was unknown. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Vasovagal response; <1 min p/vax, pt fainted; recovered w/ammonia inhalant promptly;
mild headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-025425 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Digestion" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; SIMVASTATIN taken for blood cholesterol abnormal; SERTRALINE taken for depression; OMEPRAZOLE taken for dyspepsia; VITAMIN D3. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "mild headache".  Additional information: It was reported that the patient only experienced a mild headache after receiving the Pfizer vaccines. The patient had no allergies (medications, food and other products). The patient had never had COVID positive test or diagnosis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200076049 same patient/event, different dose number;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: AFTER GETTING PFIZER COVID VACCINES,PATIENT  GIVEN INSTRUCTIONS TO SIT DOWN FOR 15 MIN TO MONITOR,AFTER 2 MIN,PHARMACITS (MYSELF) OBSERVED THAT HE IS FALLING DOWN,HE FELT DIZZINESS,I WAS ABLE TO REVIVE HIM IN 3O SEC,HE WAS RESPONSE AND TALKING,I LET HIM SIT DOWN ON A CHAIR,HE ASKED FOR WATER,GAVE WATER,HE FELT VERY GOOD,HE LEFT THE PHARMACY AFTER 40 MINUTES,THEY DIDNT HAVE A PRIMARY CARE DR YET,BUT SPOKE WITH DAD,AFTER 6 HRS,PATIENT DOING VERY WELL,DIDNT HAVE TO GO TO HOPSPITAL!
Narrative; 7/23- ED visit for non-COVID reason, was told there were lots of COVID pts in the ED 7/25- onset of COVID sc 7/28- COVID positive; diarrhea, fever, cough, sneezing, fatigue 8/2-Sx mostly resolved, slight congestion and runny nose
Prediabetic; Blackout; Foamy urine; Pain in feet; Lost Quality of sight; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS (Prediabetic) and LOSS OF CONSCIOUSNESS (Blackout) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, ALBUTEROL [SALBUTAMOL] for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2020, the patient experienced URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight). On an unknown date, the patient experienced DIABETES MELLITUS (Prediabetic) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (Prediabetic), LOSS OF CONSCIOUSNESS (Blackout), URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight) outcome was unknown.        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.   The concomitant medications were reported were aolrapadine Allergy and  Cpap Machine for apnea. The treatment information was not provided.  Company Comment:  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. Further information has been requested   This case was linked to MOD-2021-237497 (Patient Link).; 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. Further information has been requested
This spontaneous report was received from a nurse referring to multiple patients of unknown age and genders. The patients historical condition, concomitant medications and drug reactions or allergies were not reported. On unspecified date, the patients were vaccinated with an improperly stored dose of  LIQUID PEDVAXHIB lot # N003698  and expiration date 31-OCT-2019, and lot number R013573 and expiration date 22-MAR-2021 for prophylaxis (dosage schedule, route, anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit  for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Follow up information has been received from the nurse via telephonic call on 21-MAR-2019. The nurse clarified that, only one improperly stored lot (# N003698  and expiration date 31-OCT-2019) was administered to 9 separate patients between July 2018 to March 2019. Patient ID number was provided for each individual patient. This case refers to a patient of unknown age and gender, who was vaccinated with improperly stored lot on 17-SEP-2018.  This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1903USA010363: Original Case : 1903USA004795 US-009507513-1903USA010364: Original Case : 1903USA004795  US-009507513-1903USA010365: Original Case : 1903USA004795 US-009507513-1903USA010362: Original Case : 1903USA004795 US-009507513-1903USA010359: Original Case : 1903USA004795 US-009507513-1903USA010358: Original Case : 1903USA004795 US-009507513-1903USA010361: Original Case : 1903USA004795 US-009507513-1903USA010360.
Woke up Sunday morning with a blinding headache, couldn't get relief with Tylenol. Tried warm towels, cold towels, shower, etc. Felt like sinus pressure. Lasted most of the day. Woke up Monday morning with clots of dark black blood in my nose. But no more headache.
Patient reported as breakthrough infection requiring hospitalization. Received dose #1 of Pfizer on 3/4/21 and dose #2 on 3/25/21. Patient hospitalized from 7/12-7/15. Below is copied from discharge summary:  Pt is a 64 y/o M with pmHx of Afib on eliquis, HTN, chronic HFpEF, anxiety/depression, chronic pain who presented with c/o generalized weakness x 2 days after having an exposure to COVID-19 from a family member. He also reported fever and chills with reported temperature of 102F. He completed COVID vaccine back in March. He tried tylenol with mild improvement. He denied chest pain, cough, SOB, n/v/d, loss of smell, LE edema, orthopnea. He was found to be meeting sepsis criteria in the setting of COVID 19. CXR showed bilateral hazy pulmonary opacities and left sided pleural effusion. Initial vitals showed sinus bradycardia and home amiodarone and coreg were held. He was not requiring oxygen on admit. He was admitted for further management. Procalcitonin was elevated at 0.33 and pt was started on azithromycin and ceftriaxone for possible superimposed bacterial PNA. On 7/14, pt was found to be hypoxic and required 3L of oxygen and was started on Dexamethasone. An echo was done showing mild concentric LVH, EF 50-55%, moderately enlarged RV. He did receive a few doses of IV lasix while inpatient. His home coreg and amiodarone were resumed. He was seen by PT/OT who recommended HH services which was ordered. He was feeling well on 7/15 and back on room air. He passed a walking desaturation study. He had completed 4 days of azithromycin and ceftriaxone and was discharged with Augmentin to complete a 5 day course.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 01Jul2022 to 05Jul2022 (oral), for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
2 days after immunizations given, mother noted redness and swelling of left upper arm, approximately 4x4inches.  No fever, pt's complaint.  Recommended Tylenol every 6 hours as needed.
Pt noted she "tingling" in her left hand and her arms/face/neck became very hot and flushed  approximately 20 min after injection . This progressed into red itchy bumps she described as  "hive - like" 3 hours after vaccine administration. She did not seek medical attention and denies any tongue swelling or difficulty breathing. She took benedryl that helped with the itching. She notes the "tingling" resolved in 6 hours, "flushing" improved in 9 hours and the  hives resolved as of 02/01/2021 at 1130 AM.
Onset of symptom began 2 hrs. post-vaccination; headache, mild fever, malaise, swelling and arm pain at injection site. Over the next 28 hours pt. had nausea, vomiting, chills, fever 100 F., insomnia, severe headache and lymphadenopathy in L axilla (side of injection).  Presented to our clinic 48 hrs after injection and was evaluated by our Occupational Medicine Physician; given Rx for Ibuprofen 600 mg. t.i.d. and Phenergan 25 mg. po q 4-6 hrs. and sent home to rest, push fluids. Pt. was vaccinated due to his his employment by a construction co. His vaccination history is unknown.  He was born and raised in another country, unable to obtain records.
This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The healthcare worker noted that on unspecified dates, the patients were administered improperly stored M-M-R II injection (dose, route, albumin status, lot number and expiration date were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
lightheaded; developed hives on my legs; dizzy; My arm hurt extremely badly; fatigued; This is a spontaneous report from a non-contactable consumer. A 39-years-old female patient received bnt162b2 (Formulation; Solution for injection; Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:30 as dose 2, single for covid-19 immunisation (at the age of 39 years). Medical history included fibromyalgia from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC), amitriptyline (AMITRIPTYLINE), cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa 12, Levaquin, scopolamine [hyoscine] for unspecified indication and experienced drug hypersensitivity. The patient was previously received first dose of bnt162b2 on 27Mar2021 at 10:30 HR for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Consumer stated that on 17Apr2021 04:00 PM after my second shot I was lightheaded and dizzy. This has lasted into the 3rd day after the shot. My arm hurt extremely badly, and I was fatigued. I have also developed hives on my legs. The outcome of the events was recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.
Pt came to the pharmacy to show me his left arm where he received two vaccinations for Pneumovax 23 and Fluzone HD on 9/4/19.  His arm was swollen, light red and very warm to the touch from the injection sites to the elbow.  He said that his arm is still sore but getting better than it was yesterday.     He said the redness began about 24 hours after receiving the shots.        Plan - Pt said he would monitor his condition and if he felt like the condition wasn t improving, he would see his Dr.  Told pt if he sees his Dr to make sure that he notifies us.
This spontaneous report as received from a physician's assistant refers to a 28 years old female patient, who was vaccinated with the first dose of GARDASIL (lot# and dose not reported), intramuscularly in 2007. The patient was now 28 years old received the second dose in GARDASIL series (lot# and dose not reported), intramuscularly on 18-JUL-2012. No adverse effect reported. Additional information has been requested.
a few days p/vax pt devel a rash which covered 40% of face & 20% of body;the rash resembled psoriasis;pt was seen by MD;rash persisted as of 15DEC1997;
SHINGLES RASH ON LEFT ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shingles rash on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles rash on left arm was not reported. This report was non-serious.
Site of injection became very itchy, burning, warm to touch and hard. Size was about 1 inch in diameter. These symptoms lasted about 4 days.
Flu like symptoms with headache, body aches, hot and cold spells, nausea, just overall don't feel well
Pain in right shoulder and mid clavical area.  Weakness in right arm and recently, in the last week, numbness and tingling in all fingertips of  right hand (except pinky finger), especially while sleeping.  Limited range of motion in right shoulder/arm.  Have been taking x 2 Aleve morning and night without pain relief.