chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately a few hours after my 3rd dose (booster shot) I experienced the following symptoms:  When I woke up the next day I heard a really loud noise  (both ears) - sounded like a really loud beep and I did not know where it was coming from. I would also get pain deep in my ear canal, I also developed Hypothyroidism (Felt very fatigued most of the time). My doctor diagnosed my ear infection as Tinnitus and nothing was prescribed as of the moment. As for my hypothyroidism I am prescribed with Levothyroxine (50mcg 1x/day).
Pt presented to ED on 12/15/21 after testing positive for Covid 19 at urgent care today. Pt states that his symptoms started with nasal congestion and cough on Monday. Yesterday he states he started to have more productive cough and fever Tmax 101. Pt is vaccinated x2 with last dose in April 2021 however he did not receive his booster yet. Pt also reports poor appetite. Pt denied any vomiting but noted that stool was more loose in his ostomy. He preceded to urgent care today for covid testing. Pt tested positive and was noted to have increased work of breathing so he was advised to go to the ED for further evaluation.CTA negative for PE and showed ground glass infiltrates within the right lower lobe consistent with covid pneumonia. Pt received dose of Rocephin and Zithromax as well as Decadron. He was admitted for further treatment of Covid pneumonia. The patient was discharged on 12/17/21 on o2 therapy, 2L only on exertion, RA on rest, prednisone for 3 days and azithromycin 3 days. Came back on 12/24/21 where he presented to the ED with complaints of SOB. Pt tested positive for COVID-19 on 12/15/2021 and was admitted and treated for COVID PNA at that time with Decadron and Azithromycin for 3 days. In the ED, patient was afebrile with a BP 127/62, HR 75, RR 16, 90% 2L NC. CBC showed no leukocytosis, CMP demonstrated glu of 134 slight AKI with a creatine of 1.7, procal 0.10, LA 1.64, serum ketones negative. Troponin negative. UA was normal. ABG showed pH 7.4, pCO2 41.8, pO2 51.8, and HCO3 27.1. CXR demonstrated worsening of RLL PNA compared to 12/15/2021. Patient was admitted for further treatment for COVID PNA. Pt had a home 02 requirement of 2L that was determined by a 6 minute walk prior to discharge from his last admission. Pt was saturating well on 2L throughout this admission and remained afebrile. Pt was not eligible for Remdesivir.He was started on Rocephin and Azithromycin. He completed 1 day of Azithromycin 500mg and 4 days of 250mg. He also completed 5 days of Rocephin. COVID labs were trended and Blood Cultures were collected. Initial Blood cultures grew micrococcus species likely due to contamination so repeat cultures were collected. At time of discharge, repeat blood cultures showed no growth for 3 days. A CTA was also performed to rule out PE (see results below). Pt was found to have an AKI due to poor oral intake and was placed on IV fluids. Patient's blood sugars were also monitored and home insulin level was increased due to elevated blood sugars in response to steroid therapy. Pt was initially started on decadron and completed 4 days of it before being switched to a Prednisone taper. Pt's blood sugars improved as steroids were decreased. Pt had a 6 minute walk performed prior to discharge, which showed that the patient requires no supplemental oxygen at rest, and 1L with exertion. Pt will be discharged to facility where he will complete the steroid taper. Discharged again on 12/29/21
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates (reported as since 31-DEC-2015), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L020003, expiration date 02-JUN-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to the temperature of 8F for an unspecified time frame. A defrost cycling was considered. The reason of the report was data logger. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
patient came in on 10/11 to report that she has stomach upset, below the injection site is very red swollen and itchy with white bumps, she felt fatigued and her legs gave out from underneath her and she fell and hit her head, her 20 year old transgemittal neurological pain came back and she felt feverish
I have been  itching all over for 3 days now; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I have been  itching all over for 3 days now) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (I have been  itching all over for 3 days now). At the time of the report, PRURITUS (I have been  itching all over for 3 days now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No Treatment medications were provided.  Patient experienced itching 2 week's after the shot.
PATIENT REPORTED EXPERIENCING A SEIZURE WHILE AT WORK. PATIENT LOST CONSCIOUSNESS FOR UNDER A MINUTE AND WAS THEN TRANSPORTED TO THE ER. PATIENT REPORTS HITTING HEAD DURING THE SEIZURE.
Extreme chills followed by vomiting every 30 minutes and a rotating headache. Lasted for one day. Then just an upset stomach. Went to ER. They said possible stomach ulcers due to vomiting.
Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) had resolved.            No Concomitant product use was reported. No treatment information was provided.  It was stated that, patient received 3 doses of Moderna and only had sore arm and more fatigue for a while.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients. 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: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612634, 20210612779 and 20210614876.
Pt received ORIMUNE, DTP, PROHIBIT and  was not focusing, in a daze, pale but not rigidly seizing.  Seen in ER was febrile.  Hospitalized for observation & placed on monitor. MD impression is seizure.
HEART RATE WENT UP TO 186; GOT COVID; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in JUL-2022, the patient got covid (duration was 5 days). On an unspecified date, the patient experienced heart rate went up to 186. Laboratory data (dates unspecified) included: Heart rate went up to 186. As per reporter, "I am a one and done also. 1 J and J vaccine 3/6/202. My heart rate went up to 186. I am done with the vaccines. Got covid in JUL-2022. Mild case took the antiviral meds was better in 5 days. I was lucky. God was watching over me." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from got covid on 2022, and the outcome of heart rate went up to 186 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230104518- heart rate went up to 186.Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
~2 weeks following my 3rd moderna shot I developed migratory urticarial rash (no angioedema or difficulty breathing). There is definite dermatographism (have photos from different time periods since then). With H2 antagosist (loratadine, certrizine) this controls it but for the first 2ms I was taking this q24h. I went to my internist to make certain I did not have CML. He and DR (virtual consult) agreed that this was likely post-vaccination related and continue with H2 antagonists. I still have the hives 4ms later (although less frequent - taking  Loratadine or certrizine only ~3x/ week now).  I am a pediatric Infectious Disease doctor and am constantly exposed to Covid when on service in the hospital so I may be getting natural boosting repeatedly over the past months. Good news is that everyone in my household got COVID but I did not so I probably have a high titer with all thee Hives :)
About a week after the vaccine the patient reported feeling extra fatigued, blurred vision, vivid dreams, and a depressed mood.  Patient is following up with per primary care physician and eye doctor
Pfizer-BioNTech Covid-19 Vaccine EUA.   Increased heart rate, severe headache, vomiting (due to nausea from headache).  Warm but did not take temperature.
Patient reports still having arm pain and trouble extending and putting on seat belt or reaching to back of kitchen cabinet.
Soreness of index and middle finger of the left hand. Difficult to bend index finger. Fingers are still sore but not difficulty in bending. No numbness. Circulation fine.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JUL-2018, the patient received one dose of M-M-R II, lot # N023150 and expiration date on 24-AUG-2019, for prophylaxis, via the intramuscular route rather than the recommended subcutaneous route (anatomical location was not reported). No adverse effects were reported.
Sickest I felt in half dozen years. Terrible headache and fever and chills started 9 hours after injection and 36 hours after vaccine I'm stuck in bed and can't function.
Developed pain lateral aspect of Right thigh then waist then lateral aspect torso. Then on 12/3/06 he developed a rash on right thigh. Clusters of small gray macules scattered in dermatone L3+4.
Beginning in late April and lasting several months I experienced frequent menstrual cramping and spotting to heavy bleeding. This was not limited to my period but throughout the months that followed vaccination.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 04-JUN-2019 00:00, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000885:
On 10/5/99, the pt's mother called the physician to report a blister at the vaccination site. On 10/6/99, the pt returned to the physician's office for observation of the site of IZ. The physician noticed small vesicles, 5-6 mm, which were clear and fluid filled with no underlying induration. The pt was afebrile with no pain or tenderness. The pt's mother was instructed to keep the area clean and covered and to return to the office at a later date if the vesicles were still present. The physician noted parents reported that vesicles dried and resolved completely in approximately one and half weeks.
Chronic Spontaneous Urticaria 14 days after vaccination that remains unresolved.  Chronic Spontaneous Dermatographia 14 days after vaccination that remains unresolved.
I stayed  tight or /hard I do not  know  the time  because  I was unconscious  I also peed a little while  unconscious  then I felt  okey  and tried  to    walk to   my bedroom but       then I  fainted.  My daughter  called  911.  When  they arrived   I  was  Ok.  they  offer  to  take  me to  the  hospital  but  I  refuse  because  I was feeling OK.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Left arm redness and rash, (same as first 2 doses)  Extreme fatigue slept over 13 hours, fever 103.6, severe headache, eye pain, nausea, intense dreams, severe bilateral foot pain , inflammation of hand and feet, joints body aches. Both feet have been sore and inflammed since last dose x 5 months. Arthritis stated bilaterally in both feet  continual extreme daily fatigue and body aches brain fog
LT arm got swollen Friday morning and throughout the day it started to increase. It felt hot with a sting to it. Saturday AM It was hard to breath and I was unable to take deep breaths since I felt like my inside were really swollen/Inflamed. Sunday AM the swollen had got down leaving a bruise as big as the inflammation had been.
pt recv vax 20MAR97 & 7APR97 pt devel a rash on face, neck, trunk & upper arms;pt is now breaking out w/varicella-like rash;
I had increased heart rate and chest pain. I had fatigue and it was moderate. I had muscle aches. The chest pain and the rapid heart rate, I got an EKG done. I still have the chest pain, but it's gotten less frequent and less intense. Today is the first day that I haven't the increase heart rate and severe fatigue. I still have some muscles aches - they are mild now. No treatment. Mostly recovered. Flu shot was received: I think it was the first week in October 2021. I don't remember the day. That was in my left deltoid. Received it at a Family Health Center.
This is a spontaneous report from a contactable physician who reported similar events for 4 patients. This is 4th of 4 reports. A patient of unspecified age and gender received PREVNAR 13, on an unspecified date, at single dose for immunisation. The patient's medical history and concomitant medications were not reported. A failure of efficacy of pneumococcal 13-val conj vaccine occurred on an unknown date; the patient had a condition in association with his/her pneumococcal infection and then had hemolytic uremic syndrome. The outcome of the events was unknown. The information on the lot number has been requested.; Sender's Comments: 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-2018410904 Same reporter/drug/event, different patient.
So my throat went numb and my mouth was numb and headaches and the next day I had chest pain and got progressive worst and by the second day I had fatigue chest pain. I went to the ER and they ran some test and gave me fluids. It went away 8 days after the shot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 08Feb2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "POCS" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ALBUTEROL HFA; SINGULAIR; CITALOPRAM; TELMISARTAN; METFORMIN ER; POTASSIUM CHLORIDE; NAPROXEN; ATORVASTATIN. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing negative on the 5th day on the medication; Positive, notes: got two positive test; Positive, notes: got two positive test; Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Adverse event: Took the Paxlovid and now having rebound symptoms and got two positive test after testing negative on the 5th day on the medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
rash on both sides of body and chest and crotch area./buttocks/ slightly itchy/externalized rash that was slightly itchy; Rash erythematous; This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were recovered/resolved.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed an externalized rash on both sides of body, on mid axillary line sides of chest, crotch and buttocks that was slightly itchy. Not hive like, but slightly raised erythematous rash that resolved over 48 hours. The reporter (Allergist) saw rash and said it was not hives like, not chickenpox-like.  There were no pustules and no fluid lesions. It resolved in 72 hours. The reporter consented to follow up.
8/18/10 skin around injection site became blotchy, reddened and warm to touch. 8/19 warmth, swelling and redness around injection site has extended above and below injection site. Pt prescribed prednisone 5 mg tab 1 po q am for 5 days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In February 2016 (reported as starting on or after 14-FEB-2016), the patients were vaccinated with the improperly stored doses of PROQUAD (Merck) (lot # L006390, expiration date 25-AUG-2016; dose and route of administration were not reported). No adverse effects were reported. The vaccines were stored in -14 degrees of Celsius for 12 hours and 45 minutes and in -14 degrees of Celsius for 17 hours on unknown dates. This is one of several reports received from the same reporter. Additional information has been requested.