chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient admitted with a diagnosis of myocarditis and encephalitis, currently still hospitalized at the time of this report.   From EHR note: Patient is an otherwise healthy 12yM with recent Lyme disease (erythema migrans) transferred to hospital for hyponatremia, encephalitis, myocarditis. Initially intubated due to aspiration risk, now s/p extubation and stable on RA. Broad workup so far including consultations from neurology, cardiology, immunology, and infectious disease with unclear etiology, s/p MRI and LP with c/f covid-vaccine related myocarditis/encephalitis vs lyme carditis/meningoencephalitis vs less likely MISC vs other. Infectious testing so far negative, patient otherwise has returned to baseline behavior without any current symptoms. He is transferred to general for further workup and evaluation and close monitoring. Diagnosed with Lyme 19 days prior to admission,  treated with amoxicillin; p/w headache, fever and vomiting so concern for encephalitis as above vs inflammatory process post-COVID or vaccine. Less likely meningitis given reassuring initial CSF studies. Negative COVID antibody.  Resolving hyponatremia, thought to be likely SIADH. Given presentation and maternal history of albinism with immunodeficiency, broad workup sent. Also with c/f possible inflammatory response/MISC-C vs vaccine myocarditis.
Diagnosed with Covid; This is a spontaneous report from a non-contactable consumer reported for a female patient.   A female patient of an unspecified age received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: unknown), via an unspecified route of administration on 11May2021, as first dose single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any concomitant medications. On 14May2021, the patient was diagnosed with covid. It was reported that the patient was scheduled for her second dose on an unspecified date. The patient later stated that she received the Pfizer vaccine, not the Moderna vaccine (mRNA-1273). The event was reported as non-serious. The outcome of the event was unknown. The reporter was asking whether the patient should get her second dose or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
It sounds like to be an allergic reaction; She passed out; Tachycardia; Nausea; Lightheadedness; This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at single dose to be vaccinated for her protection. Medical history was none. The patient's concomitant medications were not reported.  Patient took the Pfizer COVID-19 vaccine and next day she had a very serious reaction. She did not know that if it was due to the vaccine. But she had tachycardia requiring her to go to the emergency room and she passed out and she had nausea and lightheadedness as well. It sounds like to be an allergic reaction. Given the seriousness of tachycardia and passing out as well as the lightheadedness and nausea it sounds too severe just to be a mild immune response. So, it was sort of rare immune response or it was unrelated it was unknown at this time. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162B2 to the events 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.
COVID vaccine breakthrough case. Moderna 047A21A 3/24/21, 043B21A 4/22/21, and boosted 034F21A 12/13/21.
No additional AEs were reported; Nurse reported that an adult patient received PROQUAD instead of MMR II today 5/6/2022 due to a human error.   No additional AEs were reported, no further information provided.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 06-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status rHA) (PROQUAD) 0.5ml/once, lot # U028181, expiration date 08-MAR-2023 (route of administration was not provided) for prophylaxis, instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) due to a human error (wrong product administered). Other suspect therapies included sterile diluent, lot# t027316, expiration date 07-APR-2023 upon internal validation determined to be valid. No additional adverse events were reported (no adverse event).
administered vaccine to minor. Mother consented for 2nd dose. No reaction noted after 1st dose.
Information has been received from a registered nurse concerning a 9 year-old white male patient with reactive airway disease, who on 22-Dec-1995 vaccinated with a dose of varicella virus vaccine live (Lot number reported as unknown). On 17-Dec-2003 the patient experienced 20-30 macular, papules and one scabbed lesion on arms and trunk. The patient was treated with symptomatic care. The reporter mentioned the patient's sibling had chicken pox two weeks prior. It was noted that the patient has two siblings. The registered nurse reported the patient recovered. It was noted that no laboratory or diagnostic tests were performed. It was also noted, that it is unknown as to whether the patient had an illness at the time of vaccination, and unknown whether he had adverse events following prior vaccinations. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Apr2021 (Lot number: EW0175) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, No events), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 29Apr2021, outcome "unknown", described as "Dizziness". Additional information: The patient enquired whether dizziness was a common side effect. There was no expiration date. No follow-up attempts are needed. No further information is expected.
Pulmonary embolism with pulmonary infarction; Pulmonary embolism with pulmonary infarction; This is a spontaneous report from a contactable physician. A 38-year-old male patient received second dose of BNT162B2 (Batch/Lot number was not reported), intramuscular on Apr2021, at 38 years old, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 intramuscular on Mar2021 at 38 years old as single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced pulmonary embolism with pulmonary infarction and patient was hospitalized for 1 day. The events resulted in Emergency room/department or urgent care and Hospitalization. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination and medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Apr2021.  Therapeutic measures were taken as a result of pulmonary embolism with pulmonary infarction which included anticoagulation. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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 Committees, and Investigators, as appropriate
PT given 3rd Anthrax Vaccination,  Left arm swelled to twice normal size.  First two vaccinations recieved no unusual reaction.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
A father, who is a physician, reported that his 14 month old daughter received Prevnar, Hep-B and HIB vaccines on 10/18/00. Thirty-six hours, post vax, she developed a persistent low-grade fever and a runny nose that started as a clear discharge and has changed to yellow-green in color. She also developed a maculopapular rash on her legs, trunk and scalp. The rash was "very, very fine" on her face and spared the diaper area. On 10/27/00, her white blood cell count was reportedly normal and a "strept test" was negative. The treating pediatrician is presuming a viral infection, possibly a sinus infection. She was treated initially with a course azithromycin and then IM ceftriaxone. Of note; this pt's grandmother became ill, following receipt of pneumococcal vaccine. See report HQ4704411DEC2000. Additional information received 12/28/2000 indicated that the rash resolved after 2 weeks.
Syncopal event while after walking 1 mile on beach. Felt strange, could not focus and fell. Transported via ambulance to hospital. Admitted for 2 nights observation. Discharged on atorvastatin and ASA. I had not prior cardiac or neuro history prior to syncopal episode on 2/6/21  ****Had 2nd episode on 4/14/21 with similar feeling-passed out and taken to hospital.  Admitted for 2 days. Cardiac and neuro workup.  See below
Patient received PNEUMOVAX 23 on 11/3/15 returned to clinic due to redness and warmth from shoulder to elbow on 11/4/15.
Shortness of breath; Fast heart rate with just activity/increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received her 1st dose of BNT162B2 lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 10:00 at 0.3 mL, single (0.3ml constituted dose) on left deltoid for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fast heart rate with just activity, shortness of breath. It was further reported that she had a fast heart rate and shortness of breath after receiving the vaccine. Reporter seriousness for Shortness of breath was Medically significant. This patient reported shortness of breath that resolved within hours and fast heart rate with just activity. Fast heart rate with just activity: In the morning around 08:00. It had resolved. Shortness of breath: In the morning as well. Resolved by the evening. Vaccination Facility Type was Hospital and Vaccine Administered . There was no additional vaccines administered on same date of Pfizer Suspect that caller was aware of. The adverse events didn't Require A Visit To. Relevant Tests: Did a COVID-19 test and it was negative. patient should not get a second dose. Wanted to know if this was true. Caller further reported that the patient receiving the COVID-19 vaccine experienced shortness of breath and an increased heart rate for a prolonged period, and was now stable. Caller saw recommendation from the indicating that the patient should not receive the second dose of the vaccine, and wanted to validate the information. The case safety report was considered as non-serious by the reporter in the further reported information. The outcome of the events was recovered on 20Dec2020.  Follow-up (22Dec2020): new information received from this same contactable nurse (patient, Nurse, RN) included reporter identify (also the reporter) and event details.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event shortness of breath cannot be excluded.  The follow-up information received does not alter the previous company clinical evaluation.  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.
Severe GI pain; gastritis; ulcers; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 35 years age), dose 1 via an unspecified route of administration, administered in arm left on 29Jan2021 14:00 (Batch/Lot Number: EL9262) as a single dose for COVID-19 immunisation. Medical history included allergy from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy, start and stop date were not reported. The patient had no COVID prior vaccination. The patient experienced severe GI pain, gastritis and ulcers, all  on 05Feb2021 with outcome of recovering. The patient was hospitalized for the events on the 6th day (Feb2021) after initial COVID vaccine dose (as reported). The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events; patient was given ulcer medicine. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) with negative result on 16Feb2021. The patient took dose 2 of vaccine on 19Feb2021.
The same day I received this shot, I developed a rash on my left hand. To this day I still have it on my hand. It does not itch or bother me though.  I have also been experiencing a burning sensation at the injection site and tingling/prickling from the injection site down my arm into my wrist, hand and fingers. I also have nerve pain down my arm into my wrist, hand and thumb. I don't know the exact day of when this started, but it was after the shot and it's only been from the injection site down. I've had no other trauma or injury to my left arm/hand. The pain severity is sometimes not too bad, but other times hurts enough that I can't use my wrist for opening a jar or twisting the lid off a sippy cup for my child.  I did email my doctor about this to make sure this was documented in my medical files.
The Patient reports general malaise, fever, acute diarrhea and pain in the left deltoid arm.
I copied and pasted my symptoms and reactions on our neighborhood blog.  Some had asked if they had any reaction or side effects so I replied with the following:   I took pictures of my fever, too.   My experience has been the complete opposite from most of the others here.  I received my first Pfizer March 2, 2021 and the 2nd Pfizer on March 25th.  First vaccine, zero reactions.  2nd vaccine, felt very tired , a sore arm and a low grade temp.  Fast forward to last weekend, Oct. 30th.  My son just turned 12 so we decided that together, that he would receive his 1st Pfizer vaccine while I received my 3rd Pfizer  Booster.  The appointments were at 11:45am that morning.  By the time 5pm rolled around, my son only had a sore arm.  My arm was sore but not at the injection site but on my elbow.  The pain felt like that feeling you get when you knock something on your funny bone/elbow.  Later that night, he and I both took some Tylenol and went to bed early.  The next night, is when things got bad very quickly.  I took my son out to go Trick or Treating and went only lasted an hour.  I became very weak and dizzy and had the worst case of chills I have ever had in my entire life.  We decided to head home and I immediately took my temp right when we walked through the door.  I had a low grade fever that initially started at around 100.7 or so.  30 minutes later, it started to go up, little by little until eventually, in the middle of the night,  my fever reached just over 104 at its highest.  I was so sick and feeling crazy cold, that I didn't think to snap a picture of the reading.  I did take one picture of my  temp then as it was slightly lower... about 103 is (see pic).  Obviously, like my doctor told me, for some reason, I was having a very severe reaction to the Booster.  Although, the vaccine has been approved by the CDC, it is still too new to for doctors to know how to treat someone like me, that had such a bad reaction.  Don't get me wrong, I do not regret taking the 3rd vaccine, as I believe this is helping to become one step closer to immunity.  It has now been a week or so later and I still have low grade fevers here and there, still feel very tired and like I am living inside a foggy room.  And the most worrisome side effect I have is that the day after the Booster, my blood pressure has continued to rise at dangerous numbers.  I already take medications for this, as I suffered a stroke several years ago.  But this really concerns me, as I don't know if this  a normal reaction?  So to play it safe, I have scheduled an appointment to see my doctor next week and review my medications and see if any adjustments need to be made.  Sorry for the long post.  Hope no-one goes through what I went through!!
Vaccine administered to patient post expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  It was reported that patient received the additional dose.  No treatment medications was provided.   This case was linked to MOD-2022-531880 (Patient Link).
Fatigue, mild fever, chills, rash not at injection site, muscle ache, pain and swelling. Worst symptoms appeared the day after the injection.
Patient developed locally disseminated shingles complicated by Ramsey-Hunt syndrome (prominent facial nerve palsy). History of childhood chickenpox. No prior episodes of shingles.
Patient received a diagnosis of shingles on 12/28/20 after experiencing ear pain on 12/27/20.  Patient reports shingles located on/in her left ear.  Patient also received the Moderna COVID-19 vaccine in her left deltoid two days prior on 12/26/20.
Elevated heart rate, temp of 102, chills, headache, muscle and joint pain, fatigue
she has serious vertigo after taking the first shot and can't get out of the bed; she has serious vertigo after taking the first shot and can't get out of the bed; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had serious vertigo after taking the first shot and could not get out of the bed. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Redness and swelling at site of injection approx. 19x21mm. Normal white count.
Pt has DVT/PE 3 days post vaccination. Pt is being treated with Eliquis.
Patient and her sister both got Varicella vaccine on the same day.  About 3 weeks later their 10 month old brother with a history of severe eczema presented to the clinic with a possible case of varicella. A specimen was collected from one of the lesions which was sent to the lab for identification/verification.
Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 at 10:00 as dose 1, single (Lot number: EL9264), in left arm and on 25Feb2021 at 10:00 as dose 2, single (Lot number: EN6198) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Jan2022 at 14:00 as dose 3 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (16Jul2022) Positive, notes: 10 days after taking Paxlovid tested positive for Covid 19 and symptoms returned. Patient received treatment of Paxlovid for COVID-19  from 01Jul2022 to 06Jul2022.10 days after taking Paxlovid tested positive for Covid 19 and symptoms returned.Adverse event started on 14Jul2022 at 06:00 PM with outcome not recovered. Therapeutic measures were taken as a result of vaccination failure, covid-19.
pt recvd vax 230PM 10OCT95 & exp arm soreness;next morning devel raised welts which itched appeared to be hives;applied alcohol to area & an ATB cream;no addtl hives devel & had disappeared by 12OCT95;saw MD on 12OCT;