chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer-BioNTech on 8/12/21, and 8/31/21. Presented to ED from hospice care 8/27/22 w/weakness and increased hand tremors. In ED noted to be in afib with RVR c/b elevated WBC, hypotensive and CXR showed PNA. Admitted to ICU. Initially Covid+ on 8/11/22 and remained + on 8/28/22. Cont'd to decline, w/worsening resp failure. Transitioned to comfort care/hospice care. Expired on 8/31/22. Tx'd w/zosyn and vancomycin.
Information has been received from a registered nurse concerning a 24 year old female patient with no known drug reactions/allergies or medical history who on 09-OCT-2008 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 658556/1060U) and on 18-DEC-2008 with the second dose of GARDASIL (lot # 661044/0548X). Concomitant therapy included LEXAPRO. On 19-DEC-2008 the patient developed swollen feet. The patient was told to take BENADRYL and to go to the emergency room if her symptoms worsened. The nurse did not know the patient's present status but said, "The patient was told that if her symptoms did not improve then she should call the office. The nurse had not heard from her so she assumed the patient was recovered". Additional information has been requested. This is in follow-up to report(s) previuslysubmitted on 1/16/2009. Initial and follow-up information has been received from a physician and registered nurse concerning a 24 year old white female patient with no known drug reactions/allergies or medical history who on 09-OCT-2008 was vaccinated intramusculary with the first 0.5ml dose of GARDASIL (lot #658556/1060U) and intramuscularly into the right arm on 18-DEC-2008 with the second dose of GARDASIL (lot #651044/0548X) intramuscularly into the right armat 11:45 am. Concomitant therapy included LEXAPRO. On 19-DEC-2008 the patient developed swollen hands and swollen feet. The patient was told to take BENADRYL and to go to the emergency room if her symptoms worsened. The nurse did not know the patient's present status but said, "The patient was told that is their symptoms did not improve then she should call the office. The nurse had not heard from her so she assumed the patient was recovered". In the follow-up information the nurse reported that the patient called because of swellilng in hands and feet, and slight itch. The patient recovered on 20-DEC-2008. Additional information is not expected.
Ten days after receiving the covid booster, I began experiencing swelling in the back of my neck, and in the right side of my face, including my cheek, jaw, sinus (right side of my nose under the eye) , gums, right roof of my mouth, right inner ear, and scalp/head near my ear. This sweling has resulted in pain and tightness in my right jaw, teeth, and gum and scalp tenderness on the right side, and generalized headache on the right side.  Also the swollen areas are warmer to the touch. I have been self-treating the pain/swelling with ibuprofen, acetominophen, and sometimes benedryl.  I have also been applying cold compress or an ice pack to my face and neck.  This is now the fifth consecutive day of these symptoms.
heart rate 140s 150; chills; nausea; threw up; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate 140s 150), CHILLS (chills), NAUSEA (nausea) and VOMITING (threw up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate 140s 150), CHILLS (chills), NAUSEA (nausea) and VOMITING (threw up). At the time of the report, HEART RATE INCREASED (heart rate 140s 150), CHILLS (chills), NAUSEA (nausea) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After receiving HPV #1 pt. felt dizzy and to be pale. Suddenly had stiffening of extremities and upward rolling of eyeballs for 30 sec. Vital sign normal. Pt. recovered rapidly. Pt. placed on bed and observed for about 20 min in the clinic and was also given sips of water. No emergency med given. Pt. sent home feeling better. BP 122/79, P 72, R 22.
Pt developed local reaction: Red and swollen arm from shoulder to elbow two days after vaccine was administered. Pt was advised to see Primary Care Doctor.
Headache; Fatigue; swollen lymph nodes; arm soreness; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscular in the left arm on 08Jan2021 08:15 at a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient is not pregnant. Concomitant medication included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN). The patient previously took tamiflu and experienced allergies. On 08Jan2021 10:00, the patient experienced headache, fatigue, swollen lymph nodes and arm soreness. The patient has not tested positive for COVID post vaccination. The patient did not received treatment for the events. The outcome of the events was not recovered.  Information on the Lot/batch number has been requested.
hives in all of her body; itchy in a spot in her neck; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (hives in all of her body) and PRURITUS (itchy in a spot in her neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ATORVASTATIN, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and VITAMINS NOS for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-1902, the patient experienced PRURITUS (itchy in a spot in her neck). On 14-Jan-2021, the patient experienced URTICARIA (hives in all of her body). The patient was treated with METHYLPREDNISOLONE for Urticaria, at a dose of UNK dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK dosage form. On 20-Jan-2021, URTICARIA (hives in all of her body) had resolved. At the time of the report, PRURITUS (itchy in a spot in her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Red swelling  spot on arm where vaccine was administered, after 2 days the size of the spot increased
Patient was brought in to urgent care for "bumps on both arms". Mother states he received immunizations in the leg and each arm 6 days ago. Provider documents 0.5cm intramuscular mass in right deltoid under vaccination site. Mother was instructed to apply warm compresses and follow up in the clinic in 2-3 days.
Sprained left upper back during exercise on March 7.  The discomfort it caused was nearly gone when I saw DR. on March 9 for annual physical.  During exam blood samples were taken (all subsequently found normal) and   I was given Prevenar 20 pneumonia vaccine.  Later that day mild discomfort in left upper back turned into severe pain and by morning this had spread across entire upper back. The back pain interferes with neck movement. Neck movement causes pain. It began March 9 and continuing to today March 13.
The last day of my menstrual period was 5 days ago. Within one hour of the vaccine, I experienced severe cramping in my lower abdomen that felt like PMS cramps.  Within two hours of the shot, I began to bleed heavily as if my menstrual period had begun again, passing clots ranging in size from a sesame seed to a quarter.
Severe headache, severe nausea, elevated temp 101.9, severe body aches...In bed all day, so sick just like I was so  very sick when I had covid-19.  2 /13/21 woke up feeling normal.
Client developed a few small, non itchy papules in left axilla after J-Vax 1. Denies itching and throat/airway swelling. Developed hives on back in axillary area 5 days after 2nd J-Vax (given on right arm).
I developed a runny nose on 1/27 and tested positive for COVID on 1/28, 6 days after the 2nd vaccine.
I became pregnant mid April 2021 after 3 uncomplicated pregnancies and suffered a miscarriage at approximately 10 weeks.
Information has been received from a physician concerning a 9 year old male, with a prior history of vaccination for "chickenpox," who on 17-DEC-1998 was vaccinated with varicella virus vaccine live (Oka/Merck). On Thursday night, 01-MAR-2007, the patient developed a rash that blossomed over the next day and a half. On 03 MAR 2007, the patient was alert and cooperative, when he was seen for an office visit. He presented with "what definitely looked like chicken pox lesion" on his chest, back and extending up into his hairline. There were about 20 lesions in total. The patient was diagnosed with chickenpox at that time, and supportive care as well as signs and symptoms requiring a call back were discussed. At the time of reporting the patient was recovered. Additional information is not expected.
This spontaneous report as received from a physician refers to a 19 year old, non pregnant female patient. On 18-AUG-2014 the patient was vaccinated with second dose of GARDASIL (dose and route of administration were not reported). Date of administration first dose of GARDASIL was unknown. A patient experienced fainting after an initial GARDASIL administration and then dizziness, nausea, vomiting and headache following a second GARDASIL administration on 18-AUG-2014. No treatment was given for adverse events. Patient sought medical attention. The outcome of headache, vomiting, nausea and dizziness was reported as recovered/resolved on 19-AUG-2014. The outcome of fainting was reported as recovered/resolved on unknown date in 2014. Relatedness between evens and vaccination was not reported. Additional information has been requested.
I had breast cancer twice in my right breast. My left breast nipple was hurting really bad, and I started worrying. At dinner, I took ALEVE because my whole breast was hurting, and I was extremely worried. I called the hospital to see if they would give me any information and they told me to come in. There was a possibility of a pulmonary embolism. They performed a CAT Scan with contrast, they did not find anything. They found like broken glass in my lung, and they gave me a 7-days' worth of antibiotics. They told me to give it 7 days and I did and it cleared. I never had any symptoms that felt like pneumonia. My chest X-ray was clear when I went in for a follow up about 3 weeks later. I contracted COVID-19 on 05/2022, I thought it was allergy symptoms. I tested because I was going to be with family. I tested positive with a COVID-19 home test. I called the doctor, but I was not having any problems. I did not need treatment. December 2022, my husband tested positive for COVID-19 infection, so I tested, and I tested positive for COVID-19 infection, again I did not have any symptoms, so I did not need treatment.
pt recvd MMR vax on 15SEP91 & shortly p/vax pt exp an anaphylactic reaction; face turned pure white, fainted, pulse slowed & oxygen was required; paramedics were called & pt was hospitalized overnight for observation;
A mother reported that her 20 month old son received his third dose of Hib-Titer on 3/27/00. On an unspecified date the mother reported that the child developed delayed speech and feels that this could be due to a vaccine he received as an infant. No further information was available at the date of this report.
Blister type rash with surrounding redness at the site of injection along with systemic symptoms of myalgias and low grade fever.
Child received FLUMIST via nose and three hours later she returned with quarter-sized raised wheals on abdomen and anterior thighs. Examined by Dr. prescribed OTC diphenhydramine and sent home. Per mother at 9:30am child completely recovered.
vaccine vial was diluted with 1.6 ml instead of 1.8 ml so patient received larger dose than expected.
Itching on my neck/extremely itchy; Neck reddish; Neck bumpy; Rash on my right wrist which was also very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on my right wrist which was also very itchy), PRURITUS (Itching on my neck/extremely itchy), ERYTHEMA (Neck reddish) and SWELLING (Neck bumpy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) for Arthritis.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH PRURITIC (Rash on my right wrist which was also very itchy). On 27-Jan-2021, the patient experienced PRURITUS (Itching on my neck/extremely itchy), ERYTHEMA (Neck reddish) and SWELLING (Neck bumpy). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency; ALCOHOL at an unspecified dose and frequency and ALOE VERA at an unspecified dose and frequency. In January 2021, RASH PRURITIC (Rash on my right wrist which was also very itchy) had resolved. At the time of the report, PRURITUS (Itching on my neck/extremely itchy), ERYTHEMA (Neck reddish) and SWELLING (Neck bumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient got a rash on her wrist few days later which was also vert itchy and she scratched it which led to bleed. The bleed lasted for a day.
large (3x2  1/4 inch) warm, red, slightly raised local reaction on right upper arm.
red, rash, swelling under skin, hard bump size of silver dollar, sore throat, runny nose, watery eyes, hard to breathe;
Father said child received imm. shot on 6/19/03 of DTaP, MMR and hep A, and three days later, she broke out with ring warm like rash on face, jaw was swollen. I highly advised him to take her to the physician and if he don't have a phys. to take  her to the ER to be look at. FAther stated pt is doing just fine.
12 days after inoculation pt presented to sick call with pruritic rash to borsum of both hands.  Initially treated with hydrocortisone.  Two days later came back with erythematous maculopapular rash with some coalescing to hands, arms, and thighs.  Treated with Benadryl 50 mg PO Q6 for 4 days and released when RASH subsided.
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration from 11Sep2018 single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient developed body aches, pain up to her shoulder and a low grade fever (99.7 degrees F but it might have been higher) on an unspecified date. Outcome of the events was unknown. Information about the lot number has been requested.
Very bad back ache through my body, chills, 100.2  temperature. And very bad body aches. I would say severe. Big rash, itching, and very painful on my left arm where I got the vaccine. That was Friday. I did take two benedryl last night, and it started again this morning, so I am going to take another Benadryl. I did not go to the doctor.
Initial unsolicited report received from a consumer (Patient's parent) on 06-Feb-2018. This case involves a male patient (Age was not reported) who was vaccinated with a dose of FLUZONE VACCINE (Batch number, expiry date, dose, dose series route and site of administration were not reported) on an unspecified date at a Sanofi Pasteur clinic last fall. The patient's medical history and concomitant medication was not reported. On 06-Feb-2018, post vaccination the patient was diagnosed with flu (A strain). It was also a case of vaccination failure. Other lab test and corrective treatment were not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: flu (A Strain) (Influenza A virus infection). List of documents held by sender: none.; Sender's Comments: A patient who had received FLUZONE vaccination was diagnosed with Flu (A strain). Time to onset was compatible as there was considerable difference between vaccine admininstration and diagnosis. Based on the available information this is case of suspected vaccination failure. Further, confirmatory laboratory reports and additional information regarding patient's medical history, immune status, concurrent condition and are need to further assess the case. Based on the information available, a role of the vaccine cannot be assessed.
Fever, shivers, body aches, and headache started around midnight, about 16 hours after injection and gone within 24 hours.  Also had redness and swelling after injection, worsened after 24 hours and still present at 48 hours.
After 2nd dose of covid, she had significant nausea and vomiting about 30ish hours later. Vaccine 3:45pm Friday Vomiting started about 30ish hours later 11:00pm Saturday.  Approximately every 2 hours for total of approximately 4 episodes.  Nonbloody nonbilious emesis.   Diarrhea started at same time as vomiting.  Both vomiting and diarrhea gradually improved by the next day. Temp 103. No rashes.  No difficulty breathing. No swelling at injection site.
little annoying the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (repeated shingles every year).   In MAR-2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: little annoying the arm). The outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.   It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2023 This case was reported by a patient via interactive digital media. 2 weeks ago from the day of reporting, he/she got the shingles vaccine and in May the second dose.  The reporter stated that a little annoying the arm nothing else. The patient hoped he/she never had again. The follow up would not possible as no contact details were available.
pt recvd vax & during the noc exp a sz;pt was taken to the hosp by ambulance & had a resp arrest in route;pt was adm to hosp ICU;sz activity was persistent & required several drugs to bring it under control;pt recovered from sz;
Covid-19/Breakthrough Infection; Covid-19/Breakthrough Infection; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hematologic malignancies" (ongoing). The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19/Breakthrough Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: positive.  Follow-up (25Jan2022):This is a literature report. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: reporter and literature information were updated; medical history, lab data were updated; product indication and dosage was updated, outcome of the event was updated as recovered.  Patient is a 63-year-old male with a history of high-grade myelodysplastic syndrome, diagnosed 22Jul2019 and treated with nice cycles of a clinical trial with magrolimab in combination with azacytidine, completed 12Jun2020, followed by matched unrelated donor allogeneic stem cell transplantation on 21Jul2020. His transplant course was complicated by chronic GVHD requiring prednisone and ECP twice weekly (last session 29Jul2021) along with post-transplant cyclophosphamide, rapamycin, and mycophenolate mofetil. After his last session of photopheresis, the patient was hospitalized for a Cutibacterium acnes bacteremia, treated with a planned 14 days of ceftriaxone. But two days after this hospital discharge, the patient presented to the hospital with ongoing fevers of 103.1oF. His physical exam was noteworthy for tachycardia and mild hypoxia with an oxygen saturation of 94%. A comprehensive nasopharyngeal respiratory viral panel was obtained, which was positive for SARS-CoV-2 by PCR. Chest radiography showed a possible peribronchial wall thickening, and hazy basilar opacities suggestive of atelectasis. Based on the patient's clinical presentation, he was diagnosed with moderate COVID-19 infection and was deemed an appropriate candidate for casirivimab/imdevimab infusion. With a history of completing amRNAvaccine series less than 6months prior at an external site (with unclear specific dates of the vaccinations), COVID-19 IgG (spike), semi-quantitative antibodies were obtained, and returned as undetectable three days later. The patient has remained outpatient without subsequent complications secondary to his COVID-19 infection.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of BNT162B2 to the reported event drug ineffective cannot be ruled out based on the limited information provided.,Linked Report(s) : US-PFIZER_INC-202200063708 Same article/ drug/event and different patient.
The pt experienced erythema multiforme that was diagnosed by a physician. Additional information has been requested.
Fully vaccinated, not boosted.   Asymptomatic COVID breakthrough infection upon admit to deliver a pregnancy. Vaginal, Spontaneous delivery on 1/8/2022 1738 at Gestational Age: 40w1d  Apgar Scores: 9 , 9  Birth Weight: 3.1 kg (6 lb 13.4 oz)
Muscle soreness, general weakness...  'Feels like the disease I attributed to coronavirus.   'Causes distress because I feel as if I will never get better.
Itchy and red rash on arm around the injection site. Itching subsided with topical Benadryl spray. Itching spreading to left side of face.
High heart rate, chest pain, skin felt like it was on fire with the skin on my chest hurting the worst, but no rash or redness.
2 days after injection ny knuckles started to hurt in my hands, came to Urgent care and they prescribed Benadryl and rest