chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From history and physical on 12/26/21:  Patient is a 63 y.o. female with medical history significant for allergic rhinitis, anxiety, arthritis, T2DM, GERD, HTN, depression, OSA on CPAP, chronic back pain w/ h/o back surgery/spinal fusion, Raynaud's who presents to the ED via EMS for evaluation of shortness of breath. She is known COVID positive. Has been symptomatic for ~ 1 week, husband at home also positive; + test 6 days ago, had monoclonal antibody infusion on Friday 12/24/21. Describes worsening shortness of breath yesterday, has been using nebulizer at home with little improvement; worse shortness of breath today, called EMS w/ oxygen sats low 80's on arrival, placed on 4 liters w/ sat up to low 90's. She describes no loss of taste or smell, has a headache and soreness in her neck; has chronic back pain which has been worse from lying around. No fever or chills. She has had nausea, diarrhea and decreased PO intake. She has been fully vaccinated but has not had her booster. Currently feeling her breathing is better with supplemental oxygen
Initial side effect was swelling and pain at injection site 18 days after vaccination, could not raise arm, tingling sensation to the finger tips.  Following this, I was having tightness of the chest, shortness of breath, dizziness, and unable to exercise.  This lasted about 45 days.  My blood pressure which is normally 105/70 went to 155/105 for a few days.  I have since had an ECG done and waiting on further work up.  Around 30 days, I had profuse blood coming from my rectum for 36 hours.  My temperature regulation is still not back to normal.  I get extremely hot, especially at night ever since the vaccination and I am still heat intolerant, sweating profusely and get overheated easily to the point of feeling like I will pass out.  Just the past couple of weeks I can actually jog a little bit but still tire very easily.
Very drowsy; Light headache that lasted through the next afternoon; Light nausea; Dizziness; Fuzzy head feeling; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 10:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, graves disease and vascular problem. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate (EMERGEN C) and unspecified fiber supplements; both for unknown indication from an unknown date and unknown if ongoing. On 11Mar2021, the patient was great for the first hour. Then very drowsy, light headache that lasted through the next afternoon, light nausea, dizziness, fuzzy head feeling. Over the counter medications (unspecified) helped and all good now. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with over the counter medications acetylsalicylic acid/chlorphenamine maleate/phenylpropanolamine bitartrate (ALKA-SELTZER COLD) and paracetamol/acetylsalicylic acid/caffeine (EXCEDRIN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very drowsy and light headache that lasted through the next afternoon was resolved on 12Mar2021. The clinical outcome of the events light nausea, dizziness, fuzzy head feeling was resolved on an unknown date in Mar2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented with bright, flushed face; nausea; chest pressure; medic on-scene performed EKG; patient refused transport
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Pertinent medical history or drug reactions/allergies were not provided. The registered nurse reported that on 02-SEP-1994, the patient was vaccinated with a first dose of RECOMBIVAX HB (route, lot and expiration date were not provided); on 20-SEP-1994, the patient received the second dose of RECOMBIVAX HB (route, lot and expiration date were not provided); and on 10-MAR-1995, the patient received the third dose of RECOMBIVAX HB (route, lot and expiration date were not provided). No adverse effect was reported. Additional information is not expected.
Pt received vaccine in LUE.   Pt c/o pain in LUE, shortly after stopped responding and eyes rolled back in head, became diaphoretic and warm w/ seizure-like activity noted w/ hands contracted and UE/LE rigid and not immediately responsive.  Pt was laid down on back and responsive shortly after.  VS obtained and stable.  Pt had no recollection of event.  Continued to monitor and obtained stable orthostatic VS prior to allowing pt to leave.   1149 - lying down - BP 160/82,  HR 59,  O2 99% RA 1152 - lying down - BP 118/76,  HR 75,  RR 13,  O2 99% RA 1159 - sitting - BP 121/80,  HR 66,  O2 100% RA  Orthostatic VS Lying @ 1210 - BP 118/75,  HR 63,  O2 100% RA Sitting @ 1212 - BP 129/84,  HR 55,  O2 100% RA Standing  1215 - BP 120/84,  HR 66,  O2 98% RA
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size  larger than a golf ball. Pain radiates down my inner arm to my forearm.
Employee was being monitored post Covid19 vaccine, approximaetely 10 minutes after recieving vaccine she complained of feeling dizzy and light headed and then became unresponsive. 911 was called and employee was taken to ER
Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness". It was unknown if therapeutic measures were taken as a result of pain in extremity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
soreness in my left arm that has continued to the present. It has continued to get worse, up until the present. I finally returned home to have it looked at. Have gone to 3 different types of drs in the past few days. I have been told i have frozen shoulder and i believe it is from that shot.
Information has been received from a healthcare worker concerning an 11 year old male who on 28-MAY-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) instead of his second dose of VARIVAX (Merck). This was related to staff error and not product confusion. No adverse effect reported. The healthcare worker also reported the same events for patient's sister (refer to WAES# 0806USA02203). Additional information has been requested.
Buzzing in left ear started a few  hours after receiving the vaccine in March 24th and the buzzing has been on going since.  All day every day.
Patient developed hives all over body. Symptoms began a few hours after shot was given, symptoms include not feeling well. MEDROL dose pak was given, 4 mg.
Case number PHEH2013US010828, is an initial spontaneous report received from a medical assistant on 14 May 2013 and a follow up report from the medical assistant received on 05 Jun 3013. This report refers to a patient of an unspecified age and gender. The patient inadvertently received only Men A lyophilized conjugate component of MENVEO (batch number: M12013) reconstituted with sterile water intramuscularly on an unspecified date instead of Men C, Y, W-135 liquid conjugate vaccine component. It was reported that, the patient who received half the dose initially was re-vaccinated with the fill dose on an unknown date. No adverse reaction reported following this administration error. Follow up report from the medical assistant received on 05 Jun 2013: The information related to the revaccination of MENVEO was updated.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 20-MAR-2013 the patient was vaccinated with a dose of expired ROTATEQ (dose, route not reported)(lot number 670539/0678AA, expiry date 15-MAR-2013). No adverse event reported. It was unspecified if the patient had sought medical attention. Action taken and causality of ROTATEQ were not reported. Additional information has been requested.
stomach issues for a day and a half and then it went away; This is a spontaneous report received from a contactable reporter(s) patient's sister, (Consumer or other non HCP) reported for a patient that:  A female patient received bnt162b2 (BNT162B2) (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: GASTRIC DISORDER (non-serious), outcome "recovered", described as "stomach issues for a day and a half and then it went away".  Additional information: one of the callers two sisters that she mentioned while providing her own Covid 19 vaccine experience. The caller reported that her sisters had stomach issues with her Covid 19 vaccine. She had stomach issues for a day and a half and then it went away. When probed for information regarding the callers sisters experience with the Covid 19 vaccine she declined to file safety report. She stated she did not know much about them, they were not in her area.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed rash and hives 20 mins post vaccine administration. Pt was given Benadryl .
patient is complaining of pain and inflammation in the arm where the injection occurred. additionally, she states she is itchy all over
4 mo old rec'd the 2nd sets of vaccinations on 11/21/13: developed, increased T and SZ last night: referred to ER.
On 12/09/2014 patient experienced weakness and nausea.  He described his body as going from cold to hot. Temperature was 99.9.  He visited his physician the next day and placed on Tamiflu and flu cultures were performed.  Cultures were negative for flu.
Fever of 100.1, fatigue, slight injection site pain, mild joint pain, mild muscle pain, feeling hot.
Patient was vaccinated on 3/27/2018 with MENACTRA because he was going for a work-related trip. He returned to the clinic the next day with symptoms of fever, fatigue, muscle and joint weakness. Temp at clinic was 100 degrees F. Was given TYLENOL, 325mg at time of office visit and instructed to take TYLENOL q 4 to 6 hours as needed for fever relief. Emailed individual today to find out how he was doing. He called to say that the fever peaked to 103.8 degrees on Thursday night, 3/29/2018. Continued to have joint and muscle weakness. No other symptoms. Fever abated by Friday and resolved completely by Sunday. He is completely well today, 4/3/2018.
This spontaneous report as received from a 61 year old female consumer refers to herself. No medical history or drug reactions/allergies were reported. On 25-JUL-2013, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and indication not provided). The patient reported that since 25-JUL-2013 (approximately), her arm was still red from shot. Additional information has been requested.
Heart skipping (extra beats) multiple times in a row, light-headed, room spins on standing, fatigue, blood pressure drop All this began around April 9th. By April 12th, early that morning, I called my doctor who had me come in immediately. When I got there it was so severe, he was fearful of a possible heart attack and sent me to the ER.  The ER sent me home and the issues continued for me. On 6/4 I was sent to the ER again for the same issues. On 6/7 I saw a cardiologist. He did an ultrasound and found no problems with blood flow or the valves.
Covered in a raised, red and itchy rash (bumps). All over arms, shoulders legs, back, chest (not breast or stomach area).
optic ischemic neuropathy; blind; This case was reported by a physician via sales rep and described the occurrence of ischemic optic neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced ischemic optic neuropathy (serious criteria disability and GSK medically significant) and blind (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the ischemic optic neuropathy was unknown and the outcome of the blind was recovering/resolving.   It was unknown if the reporter considered the ischemic optic neuropathy and blind to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter stated that patient of one of his friends experienced optic ischemic neuropathy after getting Shingrix and was now permanently blind. The physician declined to provide any additional information.
Patient given vaccines at 1145 after 15 minute wait went to facility where patient reported feeling light headed and then proceeded to vomit and feel cold. Reported back into clinic at 1235 to be seen by PCM.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:09 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 68.08 years.  Concomitant products were not provided.  On 20-Mar-2021, At excursion time 09:00 AM, temp was 34, at 10AM temp was 37, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were moved to clinic. Vaccine BUD date was 08-Apr-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
On 3/27/17- Rt arm swollen and erythematous, at the injection site tender/some pain. Local reaction area circle. Reviewed again on 3/30 less swelling.
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 13:00 as dose 1, single (Lot number: EN6700), in left arm, on 25Mar2021 at 13:00 as dose 2, single (Lot number: ER8733), in left arm, on 06Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 25Apr2022 at 08:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "History of Ovarian Cancer" (unspecified if ongoing); "Lichen Sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known Allergy: Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Sep2022, outcome "recovered" (11Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2022) Positive; (11Sep2022) Negative, notes: Tested negative on Sunday 11Sep. Therapeutic measures were taken as a result of vaccination failure, covid-19 from 06Sep2022 to 10Sep2022. Clinical course: Patient began taking the Paxlovid as soon as she was Covid positive on 06Sep2022 through Saturday 10Sep2022. Tested negative on Sunday 11Sep2022.
Pain; Nausea; Headache; Weakness; Injection arm is sore; Last night she had redness on her deltoid area; She was completely exhausted; Three little pink blotchy areas; Fever; she started to feel sick; she was sweating; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EC9267, Expiration date: unknown), via intramuscular, administered in left arm on 19Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history include COVID 19 from unknown onset and concomitant medications were not reported. On 20Feb2021, after the vaccination, the patient experienced fever, and on an unspecified date patient experienced pain, nausea, headaches, and weakness, Injection arm is sore, on 22Feb2021 patient experienced Three little pink blotchy areas. she had redness on her deltoid area, which she knows is normal from the things she read. She has three little pink blotchy areas that came up yesterday and hoping those go away. Her arm is still sore. Asked if that is going to impede her next dose in two weeks. She doesn't want to trigger another reaction. she started to feel sick, temperature went to 100.8, she was sweating. She had headache and nausea off and on. She was completely exhausted. She felt as though she did when she got her issues from the actual COVID virus. The patient lab data includes body temperature with reading of 100.8-degree Fahrenheit. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
4 days p/vax recvd, pt began having high fever 105 x 5-6 days; one febrile seizure;
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on10/28/21 and the second dose of Moderna COVID-19 Vaccine on 11/18/21 which is earlier than 28 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Pt recvd DTP/OPV @ approx 2 months of age; no reported events; 4 wks later pt recvd HIB-titer & mom reported that pt exp a blotchy rash 2 hrs p/vax, lasting 2 hrs; no tx initiated; not seen by MD;
The night of the injection, I had severe pain in my neck, back of my head and right arm.  The pain was so severe that I could not move my head or arm all night.  I took Advil but could not sleep from the pain.  When I did manage to sleep, I would have horrible dreams.   By morning, I was feeling better but still sore from my neck and arm.  I felt very tired and rested the entire next day.   Pain has not returned.  It was very scary.
Spouse reports husband reported not feeling good, nervous after got home & later that night he fell backwards, "knees collapsed", did not lose consciousness, face hot, no fever, shaking a lot - lay there awhile before, had chills. Went to bed. Shakes BP went up 148/98s. Next day was ok.
for weeks, I was at home and occasionally went out to a store but usually with someone. mostly did curbside pickup. in the week prior to 1/9/22, I was taking extra precautions like wear the mask every time and sanitize my hands regularly. on 1/9/22, I received my 2nd dose of Pfizer vaccine. I did not have any side effects whatsoever accept about 48 hrs later I developed COVID-19 symptoms. around 6 hrs prior to the symptoms, I had an rtPCR COVID test done. the results of this test were positive. there is too much coincidence here and I think the vaccination had a lot to do with me getting the disease. It may not be directly from the contents of the vaccine but something there caused it. I thought through where else it could come from but can't figure it out. Others that went with me at stores did not develop COVID-19 symptoms.
6/1/2021 I developed mid epi gastric pain I?ve never experienced before , along  with 5 days of diarrhea. Pain lasted 1.5 weeks. Second episode started Friday 9/10/2021, same trajectory of symptoms to a T.  I?ve had increased headaches/migraines. Increased brain fog (more than post covid in December) and new onset of dizzy episodes.