chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US028813, is a spontaneous report initially received from a pharmacist on 01 Nov 2016. This report refers to a 65 year old female patient. Medical history was not reported. Concomitant medication included losartan 100 mg. The patient was vaccinated with single dose (this was first application) of FLUCELVAX QUADRIVALENT (batch number: 185327 and expiry date: Apr 2017) at a dose of 0.5 ml. intramuscularly on 18 Oct 2016. It was also reported that, the patient had tolerated the vaccine in the past. On 19 Oct 2016, the patient had pain at injection site/ muscle soreness at injection site. On 16 Nov 2016, the patient recovered from pain at injection site/ muscle soreness at injection site. The outcome of the event pain at injection site/muscle soreness at injection site  was complete recovery. The seriousness and causality of the event pain at injection site/muscle soreness at injection site were not reported. Follow up information was received from a pharmacist via a fax on 17 Nov 2016: Report media (fax), FLUCELVAX toleration detail, concomitant drug (losartan 100 mg), event verbatim, event coding and event outcome were updated.
May 27, 2021 - Patient Sent to ER due to platelets = < 2K. 1.  Moderna COVID vaccine: 1/16/2021 & 2/13/2021.  Since 8 April Several large ecchymoses / Purpura over arms/hands, bruising & petechiae on legs/calves knees; May 25 Blood spots in mouth & 3 centralized (hard bumps) hematomas under skin on back of hands and the one on forearm-has not dissolved to date. Admitted in-patient.  Received one unit of platelets, dexamethasone, IVIG inpatient.  Interim diagnosis:  possible Immune Thrombocytopenia (ITP).  Adequate platelet levels not maintained:  Rituximab - 4 infusions with IVIG prior to last infusion.  Platelets as of 22 July = 139K - not sure this will be maintained.
03/16: Developed red papule left breast. 03/17: Red lower eye lid left-red area hemmorage eye no visible.  Lesions erules-used erythromycin epthemia 03/18 states had similar episodes 2 wks prior.   03/19: 2nd red papule and pustule left neck reappeard -10 am.
positive Antigen; positive Antigen; cough; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SEQIRUS taken for immunisation, on 28Sep2021 as dose 1, single. The following information was reported: NASAL CONGESTION (non-serious) with onset 18Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 18Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "positive Antigen". The events "positive antigen", "cough" and "congestion" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Negative, notes: on 18Apr but negative Antigen test; (20Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, nasal congestion.  Clinical course: Patient had received other vaccine in four week and the dose number of vaccine was 1. Patient had Traveled on plan 14Apr & back on 17Apr, on 18Apr negative Antigen test then cough and congestion and positive Antigen on 20Apr.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vaccination failure, COVID-19  and the use of suspect product BNT162B2 cannot be fully excluded.
Too nervous about second dose of Covid-19 vaccine to drive to vaccination facility; A little shaky; This is a spontaneous report received from a contactable consumer (patient's wife). A 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 19Jan2021 10:20 (at 82-years age) as single dose for covid-19 immunisation. Medical history included high cholesterol a long time ago, at least 10 or 15 years, high blood pressure a long time ago, at least 10 or 15 years, high triglycerides a long time ago, at least 10 or 15 years. Concomitant medication(s) included hydrochlorothiazide(HYDROCHLOROTHIAZIDE) taken for high blood pressure from an unspecified start date to Apr2021; eicosapentaenoic acid ethyl ester (VASCEPA) taken for high triglycerides from an unspecified start date to Apr2021; atorvastatin (ATORVASTATIN) taken for high cholesterol from an unspecified start date to Apr2021 and Multi vitamin. Patient underwent laboratory test including a CT scan and MRI, a spinal tap on the patient, and all the tests the medical staff could possibly run to try to find out what the problem was with the patient and the doctors didn't find anything on 2021. On 19Jan2021 patient experienced a little shaky following his first dose of the Covid-19 vaccine and patient was too nervous about second dose of Covid-19 vaccine to drive to vaccination facility on Feb2021. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Chills, low grade fever (100-101 degrees), muscle and joint aches, headache
Patient received shingles shot on 1-19-2015 3 days later had patches on right side, under ribs, by waistband area - were both internal and external and were bilateral - had increase of pain, rash, itchiness, tiredness for weeks after (approx 7 weeks). Note patient told me of this on March 25, 15.
Immediately following administration all sites appeared very red and swollen. Mother was advised to take child to ER.
Hardness around the Vaccination area; Headache after the second dose; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness around the Vaccination area), HEADACHE (Headache after the second dose) and FATIGUE (Tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0211A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness around the Vaccination area), HEADACHE (Headache after the second dose) and FATIGUE (Tired). At the time of the report, VACCINATION SITE INDURATION (Hardness around the Vaccination area), HEADACHE (Headache after the second dose) and FATIGUE (Tired) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-031409 (Patient Link).
Discharge Provider: MD Primary Care Provider:  DO Admission Date: 1/7/2023 Discharge Date: Jan 10, 2023 COVID positive date: 01/07/2023 PRESENTING PROBLEM: Acute on chronic diastolic congestive heart failure (HCC) [I50.33] Acute cystitis without hematuria [N30.00] Acute respiratory failure with hypoxia (HCC) [J96.01] Acute on chronic respiratory failure (HCC) [J96.20] Community acquired pneumonia, unspecified laterality [J18.9] Sepsis with acute hypoxic respiratory failure without septic shock, due to unspecified organism (HCC) [A41.9, R65.20, J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: 91yo female w/ h/o aortic stenosis and A-fib who presents from skilled nursing facility for shortness of breath. Of note, she had recently tested positive for COVID-19 on 1/6. The patient wears O2 at night.   In the ED, initial labs were remarkable for BNP of 1930, WBC of 13.9, and procal of 0.27.  CXR showed some cardiomegaly with pulmonary vascular congestion.  High sensitivity troponin was elevated but flat and there were no EKG changes; troponin was discussed with cardiology and it was thought to be related to demand ischemia and not ACS.  Patient was started on ceftriaxone and azithromycin, remdesivir, as well as steroids and lasix and admitted to the hospital.   Patient was quickly able to go down to room air during the day.  No bacterial pathogen was isolated and it was thought to be less likely that she was suffering from a secondary bacterial illness. She had a urine culture that had come back positive for klebsiella pneumonia and ABX were continued in the form of ceftriaxone.   Patient had a good diuretic response to lasix but with her history of AS and avanced age, decision was made to to keep her on diuretics indefinitely as she appeared overall euvolemic.     As the patient clinically improved, decision was made to transition her back to her skilled nursing facility.  As she was on room air during the day, she was not continued on steroids.  As she had completed 4 days of ABX for a UTI and there was less suspicion for a bacterial pneumonia, ABX were not continued.  Lasix was continued for 3 more days.  Patient was discharged in stable condition.
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA), SALBUTAMOL SULFATE (PROAIR HFA), ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-328706 (Patient Link).
subjective fever, malaise, right upper quadrant abdominal pain, pain, cough, sneezing, poor appetite, decreased smell and taste
Approximately 9 hours after receiving the 2nd COVID-19 vaccination, a fever developed that reached 99.8F. This was accompanied by chills, severe fatigue, and moderate soreness in the left deltoid. Sleep was disrupted by shaking due to chills, moderate headache to the frontal and occipital areas, and sweating. The fever and chills improved the next day but persisted until around 36 hours post-vaccination. Headache, fatigue, and a "hung over" feeling persisted until 72 hours post-vaccination.
Fatigue  Headache  Muscle pain Joint pain Chills Fever Dizziness and weakness
Sometime after the shot I had a blood clot the size of my fist and this concerned me. So I contacted my OB/GYN to find out if this could be a health issue. At the doctors office they did an Ultrasound and possibly other test (blood work, physical). Doctor told to take 2 Aleve twice a day for 5 days at 1-2 days before period. This is currently ongoing. And I'd say I have recovered from the event.
inconsolable crying /p by febrile seizure (T 105), neg-URI, neg-OM, neg-S/Sx menigitis. F/U 30Jan91 "Ok" T.C.
My arm, I can hardly lift it all the way up; Arm hurts; Nauseous; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3249and Expiration Date was not reported) via an unspecified route of administration on 27Jan2021, as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that patient had the (incomplete sentence) she went on this morning and took snap shot. she put everything on but it says she got the vaccine today but she didn't get it today, she got it yesterday. So, patient wanted to tell them about what she feeling because her arm, she can hardly lift it all the way up and she was nauseous.  Patient stated but she can't on the site. It says she was all set, it has a wrong date, and you are not assisting me. It says she got the injection today but she got it yesterday and she can't change that from her profile. She want to know how she registered that she having side effects. Patient took two Ibuprofen last night. Patient have an issue, her arm hurts. She would like to speak to somebody about that.  The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Blood clump fell out Saturday morning and began period, much heavier than usual, but previous cycle ended only 6 days before
This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # not reported) in JAN-2012 and a second dose of PNEUMOVAX23 (dose, route, lot # not reported) on 19-OCT-2012. No adverse effect reported. Additional information has been requested.
10/15/21 around 10pm generally feeling ill blood pressure 121/79 heart rate 78 went to bed to rest.  Woke up multiple times during the night to urinate, started experiencing body aches, headache and chills around 1am.  Felt like I was burning up at 4 am. 10/16/21, 7:07am heart rate 135, SpO2 96%, temp 100.2, at 7:09am blood pressure 134/85, heart rate 120.  7:30pm heart rate was between 113 and 125 SpO2 98% with headache, body aches, dizziness upon standing and short of breath with mild exertion.  Went to Urgent care at 8:20pm and was told to go to emergency department.  Was seen at ER; blood work drawn, ECG, chest x-ray, 1 Liter fluids and Covid test was discharged and sent home.
Narrative: COVID infection following COVID vaccine series 04/15 MODERNA, dose #1 05/13, MODERNA, dose #2 09/07 pt cc: cough, fever, headache, loss of taste or smell, nausea, sore throat exposure: unknown 09/10 SARS-COV-2 Variant Sequencing result: pending 09/10 COVID swab, result: detected
9MAY92 lethargy, glassy-eyed, dopey, & dec appetite;
This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported) that was exposed to temperatures outside of the proper storage range. There was no adverse effect. This is one of the four reports from the same reporter. (Linked to 1411USA002768, 1411USA002890 and 1411USA002892). Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (Lot#, dose, route were unspecified) in 1992. It was reported that the patient then developed a "wheal and redness at the injection site". The patient then recovered on some unspecified date. It was unspecified weather the patient had sought medical attention or not. No treatment information was reported. Additional information has been requested.
4 year 7 month old male presents with c/o Skin Check: for 4 days had Immunizations on 4/17/09 and now has a red, hard, warm to touch area below injection site.
PATIENT DEVELOPED HIVES LATER THE SAME DAY AFTER RECEIVING VACCINES. HIVES WENT AWAY AFTER APPROX. 1 HOUR. 24 HOURS AFTER VACCINE PATIENT IS EXPERIENCING JITTERINESS AND UNABLE TO HOLD A PENCIL IN HER HAND. PATIENT WAS ADVISED TO GO TO ER FOR EVALUATION.
Left Chest wall was red, inflamed and swollen; resting heart rate was 140 beats/minute; high fever up to 102 degree Fahrenheit; severe body aches; lethargic.
Systemic: Headache-Mild, Systemic: Joint Pain-Medium, Additional Details: Joint pain: TMJ
I noticed red splotches on my legs starting about the 08/20/2021 from the knee down on both legs. I also started to develop a productive cough that kept getting worse. Finally went to Urgent Care 09/13/2021 to try and find out what was going on with the spots and why cough didn't develop then. 09/20/2021 I went to see my Dermatologist per recommendation due to the weird splotches. Gave me a prescription for a Z-pack for my cough because It was worse and getting worse. 09/21/2021, cough did not improve, finally went back to urgent care sometime in October. 11th or 12th because I was still coughing and red splotches were getting worse On arms as well and were sensitive, swollen and achy. Urgent care doctor couldn't explain anything about the splotches and also said I probably had some kind of bronchitis, only coughing during the day, never at night and always productive. I woke up on 10/24 felt ridiculously sick, went of urgent care and had a CBC done, Urinalysis and Chest X-ray, and the Urgent Care doctor sent my PCP a message about how I needed to be seen as soon as possible. 10/29/2021 saw Dr., urinalysis was clear, lung x-ray clear, c-reactive protein was elevated and liver enzymes were also elevated. Everything else was completely normal. That's when A) I was supposed to go back to Dermatologist for a biopsy because they were getting more painful. B) prescribed Prednisone that I couldn't take until 11/09/2021. Also scheduled for Liver Ultrasound because they were worried about the enzymes and took another blood sample to rule out hepatitis. ALT and AST was elevated and everything else was fine. Liver ultrasound came back normal, nothing wrong with Liver or Gallbladder. Biopsy came back normal, narrowed it down to Erythema Nodosum. That's the possible diagnosis. I have still been coughing that entire time and started the prednisone and finally took care of the redness of the splotches and coughing. 40mg every day for a week. Went back to weight-lifting which caused spots to be irritated in the sense that a couple are nodular and they get hard and hurt (one on each leg) and ankles swelled. We then tried another dose of Prednisone for a longer tapering regime over 12 days and Meloxicam 7.5mg twice daily. Since then, when I lift heavy, it causes my ankles to swell. Usually the meloxicam can control it, but I have periodically taken prednisone to help when the swelling doesn't go away. If my ankles don't go down to a specific size, I have to take it again until it's back to normal. Cough is also coming back and I'm currently waiting to hear from doctor because my spots are not going away and cough is coming back and trying to get an appointment with a gastroenterologist and need to look at my elevated liver enzymes. I also had another blood draw and ferritin was elevated at 450. That's where we currently are. For my blood work, the inflammation markers: C-reactive proteins still elevated, but went down, sed. Rate: back to normal, and liver enzymes were still elevated (done on 12/21/2021). Still ongoing.
Daughter was irritable, not drinking a full bottle and started to develop red bumps all over her torso. By morning it had further spread to the neck and face
Information was received from a licensed practical nurse regarding a female patient of unknown age, who on 21-OCT-2014, was vaccinated with a dose of MMR II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a 56 year old male pharmacist, reporting on himself. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous in the upper arm; dosage, dose number and lot number unknown). The pharmacist reported that on an unspecified date in 2013 he and his wife (MARRS case no. 1411USA013480) experienced an injection site reaction that "was mild" when they received ZOSTAVAX. He stated that they received the same lot number of ZOSTAVAX on the same day, but he does not have access to the documentation of the lot number report. He states that he and his wife both experienced a "quarter-sized" injection site redness with no pain or swelling. Neither he nor his wife sought medical attention nor received treatment. The pharmacist indicated that "injection site reactions are common" with ZOSTAVAX, and he observed many injection site reactions (MARRS case no. 1411USA013481). The outcome of the injection site redness was reported as recovered in an unspecified date in 2013 (reported as: within a couple of days). Relatedness between use of ZOSTAVAX and the adverse event was not reported. This is one of three reports from the same source. On 16-DEC-2014, a phone call was placed to the reporting pharmacist. He stated that he had no access to the lot number for the ZOSTAVAX vaccine he and his wife received. Additional information has been requested.
sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip in the waiting area in the first 15 minutes but I wasn?t too worried about that.  Uncontrollable laughter 11:45 AM the next morning. Forgetting where I was going on day two at 2 PM when I went to pick up lunch for the family totally got the wrong lunch. Again with uncontrollable laughter for 8-10 minutes. Sharp pain 05/14/2021 in the ovary area where I have a cyst in my ovary. Words messing up all the time. Right upper chest pain, freezing cold nose and nose  tip feels like it?s freezing and has numbness and a runny suddenly on day 3.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 17:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Alopecia" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: Jun2018; ATORVASTATIN CALCIUM, start date: Dec2018; CELEBREX, start date: Jun2016; GLIPIZIDE, start date: Jun2020; JANUVIA, start date: Jan2018. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated, began having a slight metallic taste in her mouth on 20Jul, the second day of treatment. On 21Jul the third day, the metallic taste grew much worse & was gagging her. Roof of her mouth swelled, diarrhea began. Stopped doses with 2-1/2 taken & took an antihistamine. Used her Albuterol inhaler. Roof of mouth returned to normal & metallic taste in mouth subsided. Diarrhea stopped later that evening. Total doses taken was 2.5, half of the 5 day prescription. Covid symptoms were much better with 2.5 days of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.