chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first dose caused a huge reaction. Inflammation x's 1000; This is a spontaneous report from a contactable consumer (patient). A 38-years-old (Non pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported, on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history included (as per the reporter): after a year and half of suffering severe joint pain and undergoing four hand surgeries patient was contracted COVID-19 unknowingly. COVID-19 attacked patient joints. COVID-19 attacked patient weaknesses. COVID-19 created widespread inflammation, causing trigger fingers, De Quervain's and ganglion cysts in patient wrists that patient was never had before. The patient reported she have one child. The patient had Carpal Tunnel during the pregnancy. The patient reported she also had Pre-eclampsia during the pregnancy. The patient reported Carpal Tunnel went away after she gave birth to her daughter prematurely (2 months early). The patient reported it never actually went away. The patient reported, she underwent tests for all autoimmune diseases and the results were negative. The patient reported, her Vitamin D was low. On unspecified date, as per the patient, the first dose of bnt162b2 vaccine caused huge reaction - Inflammation x's 1000. The patient thought she was going to end up in hospital. The patient reported, she called the CDC. The patient reported, CDC and patient connected dotes that she must have caught the COVID-19 a long time ago. The patient reported, she was there when everything shutdown in 2020, many coworkers caught the COVID-19, COVID-19 was spread to her workplace. The patient reported, that is where she believes she caught it. The patient reported, the CDC told her to wait one more day before she calls the doctor. The patient reported, CDC said it may just solve all her issues. The patient reported, CDC were right, she cannot believe it, this shot is a true miracle. The patient reported, she is so grateful, she has photos of her reaction to the shot, and she was happy to share them. The patient reported, she is so much thankful for giving her life back. The patient reported, her story is a true success and people need to hear positive things about this shot. On unspecified date, the outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
I had no AE to the vaccine but around 9/13 I developed severe fatigue.  I developed a real nasty taste in my mouth when encountering various things.  Poultry begin to taste so disgusting tasting as if I had a piece of foil stuck in my teeth, the purple lettuce taste like dirt and the beef had the most awful taste  tasting as if it was spoiled, its as if my taste and smell got super sensitive resulting in me developing a lack of appetite also resulting in me beginning to loosing weight because I was not able to eat.  My taste and smell is still super sensitive to date.  This was only questionable because I ended up in the hospital later for a Collapse Lung which I feel is unrelated to the vaccine
No adverse event; gave vaccine  from a vial that was diluted  to a pediatric patient.; gave vaccine  from a vial that was diluted  to a pediatric patient.; This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.), POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. as1414b) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy.    On 05-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2022, the patient experienced PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.) and POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.), POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.) and POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.).    No concomitant medications were reported. No treatment  medications were reported. The AE did not cause patient to seek medical care. The patient did not experience similar event in the past.  Patient never had COVID+ test or diagnosis. Patient did not have any acute or chronic illness at the time of vaccination. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.
RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 33-year-old female with unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series  1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total administered (dose number in series 2) on left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported.  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL."(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211209551, 20211210160, 20211210058, 20211209843, 20211210549, 20211209775, 20211210159, 20211210610, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211210588, 20211210670, 20211210824, 20211209912, 20211210350, 20211210141, 20211210585, 20211210107, 20211210112, 20211210385, 20211210590, 20211210662, 20211210334, 20211210180, 20211210143, 20211210106, 20211210019, 20211209706, 20211209884,20211209874, 20211209798, 20211210733 and 20211210165.
Pt developed myalgia (generalized), swelling, pain and ecchymosis at injection site, fever, headache, rash & dizziness. All sx occurred 10 d after the injection. Fever, rash & adenopathy persisted 48 hours.
Fainting once for 1 min, came back and fainted again while EMT were trying to help him out. BP was 94/74, BS 88, EMT started IV, he was dehydrated after walking 4 mi and admitted to ER for one hour and released.
Cold  chills Headache Muscle aches Fever up to 101.9 F Nausea Body sweats
Pt was accidentally given the Pfizer vaccine for a booster dose after receiving an initial Moderna immunization.  No adverse events observed/reported at this time.
Patient presented with cough and shortness of breath. The patient was given steroids and remdesivir and was in the hospital for 2 days
Discharge Provider: MD Primary Care Provider at Discharge: PA Admission Date: 3/20/2023 Discharge Date: 3/22/2023   PRESENTING PROBLEM: Abnormal CT of the head [R93.0] COVID-19 [U07.1]   HOSPITAL COURSE: 93-year-old female presented to the emergency department after sustaining a fall at home.  Fall was unwitnessed and patient's daughter was concerned patient may have hit her head.  Patient was having some mild confusion so daughter had patient brought in to rule out possible concussion.  Patient did have some mild lightheadedness prior to the fall but otherwise had no further complaints.  Of note patient daughter and family have had recent COVID-19 infections.  Patient did test positive for COVID-19 in the emergency department.  Emergency department patient underwent CT scan of the cervical spine which showed no acute fracture.  A CT of the head did show the presence of a focal lesion within the left parietal area worrisome for vasogenic edema and possible neoplastic process.  There is also hyper low intensity noted within the right cerebellum.  Case was discussed with neuro surgery patient underwent MRI without contrast which again showed similar findings.  Neurosurgery wanted an MRI with contrast which again showed similar findings.  Patient with a 4 cm area of edema within the left temporal parietal occipital white matter concerning for neoplastic process.  There also separate areas of enhancement noted.  These findings were discussed with neuro surgery and they recommended a CT scan of the chest abdomen and pelvis.  This was done which did show evidence of a 4 mm lesion in the right lower lobe.   Results to testing discussed with patient, daughter, and son.  They are all in agreement that patient does not want aggressive intervention.  They will follow-up with primary care physician.  If warranted they can follow-up with Medical Oncology.  If patient's clinical condition continues to worsen then hospice referral would be appropriate.        Patient is clinically stable for discharge home with 24 hour care.
Woke up morning after shot feeling slightly unwell.  Then by mid-morning I was running a fever and had aches in my lower back, and chills.  Took temperature at 4:00 p.m. and it was 100.1.  Also had a sore left arm where shot was given.  Slept through the night and awoke 2nd morning after covid shot feeling fine and back to my normal self.
Two hours post vaccination it was reported by nursing staff that patient had difficulty breathing.  Pt shortly afterwards had a seizure
Bright red rash on cheeks (mallar rash) for 2 weeks. No other issues.
Had right knee pain on 5/21/21 then had right leg pain/ swelling/elevated labs starting on 6/11
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (felt crummy after his first Moderna COVID-19 vaccination) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In April 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient felt abnormal (feeling crummy after his first Moderna COVID-19 vaccination). At the time of the report, feeling abnormal (felt crummy after his first Moderna COVID-19 vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided.
This initial spontaneous case received from a pharmacist on 23-Aug-2017, concerning a 55-year-old male patient. The patient's medical history was not reported and he did not receive any concomitant medications. On 22-Aug-2017, around 2:00 pm, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported, batch number: 1720801, expiration date: Apr-18, trade name and manufacturer: not reported). It was reported that, the vaccine was shipped without a track of temperature. However, the pharmacist took the vaccine out of package and put right into the refrigerator, before administering the vaccine. The pharmacist wanted to know, if the vaccine was fine to use. No event occurred and no hospitalisation took place. The outcome of the events (incorrect product storage, drug administration error and no adverse event) were not reported. The health care professional reported this case as non-serious.
Approximately 6 hours after the vaccination, I started having pain at the injection site.  Based on my reaction to Dose 1 (6/17/20), I began taking 200 mg ibuprofen immediately after the injection.  At bedtime, I increased to 400 mg ibuprofen every 4 hours throughout the night and into the following date.  During the night and the following day, I had no chills, but did have a fever of 100.4 F, along with medium body aches, plus a painful headache. 400 mg of ibuprofen every 4 hours eased the body aches somewhat, but did not eliminate the headache.  Body aches and headache continue for 48 hours, gradually easing.
Extreme pain in arm at injection site for 3 days. Unable to lift arm above head. Not able to do routine daily activities as pain was so bad. Increased Advil intake to 600-800mg every 6 hours and that helped dull the pain.
From initial information received on 06May05 from a health care professional, it was reported that an 11 year old male pt received a booster dose of Decavac, lot number U1215AA, in the left deltoid and a dose of Menactra, lot number U1526AC, in the right deltoid on 04May05 at 5:00PM. Three hours later, on 04May05 at 8:00PM, the pt developed generalized hives throughout his body and lip swelling. He was seen by a physician and was treated with epinephrine and prednisone. At the time of this report the pt was improving, but had not yet recovered from these events.
Patient reports continuous pain at the injection site for over 8 months now. She reports that some days are good and she doesn't feel anything but most days she is experiencing some level of pain and discomfort since the injection.
5MAR97 had a rxn 6MAR97 inc temp, convuls, stop breathing for a second;to ER released saw MD took to MD 7MAR97 was rxn to DTP to pertussis only, fine now;
Got exposed to covid in school; Duration between 2 doses may exceed recommended; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got exposed to covid in school) and OFF LABEL USE (Duration between 2 doses may exceed recommended) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got exposed to covid in school) and OFF LABEL USE (Duration between 2 doses may exceed recommended). At the time of the report, COVID-19 (Got exposed to covid in school) and OFF LABEL USE (Duration between 2 doses may exceed recommended) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
2 days after getting the booster I had a migraine headache that was extremely painful and my speech was garbled. I couldn?t think straight enough to get words out. I took Tylenol and iced my head, and later in the day I took Benadryl to get some sleep. My husband had called his brother who is a doctor.  Today, day 3, my head feels foggy and I?ve slept part of the day. I have a milder headache this evening. I?ve never had a migraine before.
Patient c/o intense itching shortly after MMR injection. Ice applied. Reaction remained local. Take to E.R. for evaluation.
This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored ROTATEQ, oral (dose, lot number and expiry date were not reported. No adverse effects were reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Hospitalized with severe hypovolemia due to 10 day history of vomiting and diarrhea due to COVID and pneumonia. Intubated and ventilated 1/1/2022, dialysis started 1/2/2022.  (COVID + 12/9 and remotely monitored, status post outpatient banlanivimab/etesevimab (12/9/2021))
Left testicle pain and swelling. I think Epididymitis. Felt similar to after my vasectomy, however this was two years later and started the night I got the vaccine. No impact trauma. It lasted approximately five days and pain/swelling gradually decreased. It was bad enough that I made an appointment with a urologist, however it went away before I was able to attend the appointment.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 28-OCT-2016, the patient was vaccinated with ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA014706:
moderate to severe flare up; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8731) at single dose via an unknown route on 10May2021 in right arm at 63-year-old for Covid-19 immunization. Medical history included epileptic, high blood pressure, and ongoing ulcerative colitis since 2012 and had been in remission for many years. Patient did not have covid prior vaccination. Patient had no known allergies. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0162) at 63-year-old via an unknown route on 19Apr2021 in right arm for Covid-19 immunization. Patient did not have other vaccine in four weeks. Concomitant medications in two weeks included eslicarbazepine acetate (APTIOM), mesalamine, atorvastatin, and triamterene. Patient had ulcerative colitis since 2012 and had been in remission for many years, but four to five weeks after the second dose , patient was having a moderate to severe flare up and having to take 40mg of prednisone daily along with 100mg/60ml nightly hydrocortisone retention enema and 4800mg mesalamine dr tabs, that had not resolved the problem. Adverse event start date was reported as Jun2021. The event resulted in doctor or other healthcare professional office/clinic visit. The event treatment was still going on as of 11Aug2021. No covid tested post vaccination. Outcome of the event was not resolved.
Shortly after injection daughter felt dizzy, went into a "mild" seizure. Upper body was rigid, eyes rolled into back of head, moaning. She has no medical history of seizures. Hours later she is sore all over with a migraine and is very nauseated.
12/31/20 extreme heavy drowsiness, sleepiness. Pt collapses and fell  asleep after arriving home, Pt awoke 5-6 hrs later, feeling unwell body aches, headache, sinking feeling, restlessness , flushed feeling, 106. fever, loss appetite, bad taste in mouth weakness, congestions and Phlegm in lungs, sore arm also . Symptoms continue, feeing extreme restlessness and headache persists. Tylenol and ibuprofen taken for fever.
Swelling at injection site moderate, with erythema and warmth. Has continued x 5 days after injection.
pt c/o persistent deep muscular pain in deltoid 2wk;no neuromuscular abn on exam;+ tenderness;rx aleve x 5-7d;
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FDO809), in left arm and on 02Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "ascending aortic aneurysm" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA, start date: Aug2010, stop date: Aug2010; HYDROCHLOROTHIAZIDE; ATORVASTATIN, start date: Jul2021, stop date: 10Jul2022; SPIRONOLACTONE; ASPIRIN (E.C.). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested positive again on 23Jul22 after at least 1 negative test; (23Jul2022) Positive, notes: tested positive again on 23Jul22 after at least 1 negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19   Clinical Course: Patient had no known allergies. Patient received other medications in 2 weeks. COVID rebound-symptomatic and tested positive again on 23Jul2022 after at least 1 negative test.Anti viral details, product: COVID 19 Treatment, brand: Pfizer, treatment start date and stop date: 11Jul2022 and  16Jul2022.
Arm pain Near Injection Site; arm swelling near Injection site; Redness Near the Injection Site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain Near Injection Site), VACCINATION SITE SWELLING (arm swelling near Injection site), VACCINATION SITE ERYTHEMA (Redness Near the Injection Site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm pain Near Injection Site), VACCINATION SITE SWELLING (arm swelling near Injection site), VACCINATION SITE ERYTHEMA (Redness Near the Injection Site) and HEADACHE (Headache). On 12-Feb-2021, VACCINATION SITE PAIN (Arm pain Near Injection Site), VACCINATION SITE SWELLING (arm swelling near Injection site), VACCINATION SITE ERYTHEMA (Redness Near the Injection Site) and HEADACHE (Headache) had resolved.            No concomitant medication provided. no treatmen taken.