chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No medical history was provided by the reporter.  Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 6 to 7 pain was at 6 to 7 on scale of 10..         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for RINVOQ(UPADACITINIB) with respect to the events of MIGRAINES and PAIN was not provided.   opinion was that there is no reasonable possibility that the events MIGRAINES and pain are related to RINVOQ(UPADACITINIB). No treatment medications was provided by the reporter.   This case was linked to MOD-2022-586870 (Patient Link).
3 days later rash started from top of feet to waist on both legs.  There are pronounced rash is like if was shot with BB guns.  It tingles like crazy just like shingles. On 9/23 had pre-scheduled appointment with dermatologist for something else.   For the rash, the doctor prescribed (triamcinolone acetonide cream); hives improved but it  took away the itching and tingles.    Started using cream yesterday. At 75% recovery, rash has improved; has residual elevated red bumps like if bitten by several hundred mosquitoes.  Patient has follow-up appointment with dermatologist for a different condition.  Patient was part of shingle trial.
Complained of throat discomfort and swelling. Speech became slurred and slow responsiveness to questions. Anaphylactic reaction: throat swelling. Benadryl 50 mg given IM. Epipen given. Symptoms improved with Benadryl and Epinephrine. Patient became more responsive and alert. She was transported to ER via ambulance for further evaluation and monitoring.
Client received a Janssen vaccine on 3/25/2021 and then received a "2nd Dose" of COVID vaccine (Moderna) on 4/22/2021
pt recv vax 31JUL95 & 30APR96 pt devel a chicken pox rash w/over 30 vesicles on the back, face, & neck & a fever of 101.3;pt recovered by 16MAY96;
rash at the injection site and it was swollen; Pain injection site; stiff arm; rash at the injection site and it was swollen/Swollen arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 10:28 (Batch/Lot Number: EL9262; Expiration Date: May2021) as single dose for COVID-19 immunisation. Medical history included a mild stroke 5 years ago, HIV positive, human immunodeficiency virus, from 15 years ago. Concomitant medication(s) included Abacavir/Lamivudine 600/300mg at once daily by mouth for HIV for 15 years and ongoing; Atazanavir 200 mg at two daily by mouth for HIV for 15 years and ongoing; multivitamin 200mg at one daily by mouth taking for six months and Ongoing; Vitamin D3 1000units at once daily by mouth taking for six months and Ongoing; Aspirin 81 mg at once daily by mouth for stroke taking for year and half and Ongoing. No History of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No Family Medical History. The patient had the first dose of the Pfizer COVID 19 vaccine 29Jan2021 at 10.28AM in the left arm and about half an hour later he had pain at the injection site so he went by the house and iced it for 40 minutes, then went to work. His arm was stiff and bothering him all day and when he came home he noticed a rash at the injection site and it was swollen. Now it had cleared up by about two thirds. He did not seek treatment for the rash. The patient was planning to receive the second dose on 19Feb2021 but wanted to know, considering his reaction should he get the second dose. AE(s) did not require a visit to physician or ER. No Relevant test. Outcome of the events rash, stiff arm was recovering; swelling, injection site pain was recovered on 30Jan2021.  Follow-up attempts are completed. No further information is expected.
Atrial fibrillation; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). On 23-Mar-2021, ATRIAL FIBRILLATION (Atrial fibrillation) 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.   Concomitant product use was not provided by the reporter.  Treatment for the event included apixaban started on 24-Mar-2021.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Patient was administered a moderna vaccine with published expiry date 10/15/21.  She was monitored for 15min after injection.  Patient tolerated the vaccine well, without complications.  She said she was going  to lunch with her husband and some friends after she left the office. No adverse effects were noted.
Caregiver was given her influenza vaccine by Flu champion on 10/9/17 immediately after vaccine was given, caregiver complained that she didn't feel right. Complained of light headedness, feeling hot and sweaty, tachycardia and nauseous. Caregiver felt better after rest and eating. Was placed in a quiet room to lay down and rest for a bit, O2 was at 98% and pulse between 114-122 which was taken by LPN. After about 20 mins Caregiver did sit up verses laying down as she felt the ceiling was making her more nauseous. After another 10 minutes caregiver did make her way back to her work area to shut down her computer and gather things to bring home as her husband was going to pick her up and she didn't feel comfortable to drive. Caregiver did contact MA about one our later and stated that she ate something and seemed to feel much better.
With in a few minutes of the injection on 04/14/2021 I got a metal taste in my mouth, the left area of my lower jaw became numb, my throat felt itchy, my pulse skyrocketed and my chest constricted. I have a similar reaction with contract during a CT scan and didn't think much of it and assumed it would dissipate. As the day continued my chest began to feel tighter and I was having a difficult time breathing. I became easily winded walking 100 feet.  About an hour later I was nauseous, had abdominal pain, fatigued, dizzy, pain at injection site and felt itchy everywhere. The numbness of my face disappeared about 3 hours later. My symptoms are still continuing as of 04/15/2021. As of 4/15 my breathing has been more labored, I've dizzy standing and sitting and eating has become more difficult. When I eat, I get the sensation that my throat is about to close. Otherwise, the rest of my symptoms have not gotten worse, but they also have not gotten and better. As of the afternoon of 4/15 I've begun taking Benadryl, if this does not lessen my symptoms, I will be speaking with a doctor.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case is linked to cases 2018SA297838 and 2018SA297828 (same reporter). This case involves a 31-years old female patient who was inadvertently administered 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UJ030AB and expiration date: 05-May-2019) via intramuscularly in the right deltoid on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose because the vaccine was inadvertently given to a 31 year old patient. It was unknown if any adverse event occurred or not following the administration of the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Information has been received from a registered nurse concerning a 12 month old male patient with no medical history or allergies who on 30-APR-2007 was vaccinated SC with 0.5 ml dose of Proquad (Lot # 656642/1556F). There was no concomitant medication. On 07-MAY-2007 the patient started experiencing an "on and off" fever of 100 F for about 1 week. The patient also developed a rash on the left thigh that looks like a group formation of 5 red bumps together. Unspecified medical attention was sought. No diagnostic laboratory procedures were performed. At the time of report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Cellulitis, lt anterior thigh; t103.8 ax in AM 14DEC91; temp in ER 104.1 R 14DEC91 @ 13:43;
48 hours after vaccines, pt had increased aggressive behavior and heightened sensory issues which lasted 2 weeks, then back to baseline. Teacher called family on 4/11/18 to alert them that he was acting different.
Early period; Breast sensitivity; This is a spontaneous report from a contactable consumer (patient).   A 21-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8729), dose 2 via an unspecified route administration, administered in left arm on 13Apr2021 as dose 2, single for covid-19 immunization (at the age of 21years). Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955), dose 1 via an unspecified route administration, administered in left arm on 23Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included birth control. The patient's concomitant medications were included ethinylestradiol, ferrous fumarate, norethisterone acetate (AUROVELA 24 FE) taken for birth control. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. The patient had mild spotting after first dose. This was abnormal as she has been perfect on birth control pills for 6 months. The patient had not taken any treatment for reported events. The patient experienced early period and breast sensitivity start after second dose on an unspecified date in Apr2021. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
memory loss but its also time loss; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6207; NDC and expiration date: unknown) via an unspecified route of administration on 13Mar2021 (at the age of 20-years-old) as dose 1, single and second dose of BNT162b2 (Lot Number: EW0150, NDC and expiration date: unknown) via an unspecified route of administration in left arm on 17Apr2021 as dose 2, single for COVID-19 immunisation. Vaccine was not administered at military facility. The patient medical history includes Crohn's disease from 2013 and unknown whether it's ongoing and chronic fatigue and never officially diagnosed. Family medical history includes mother has colitis and grandmother struggled with strokes. The patient was on immunosuppressant. Concomitant medications include adalimumab (HUMIRA) taken at 40 mg and sertraline taken at 50 mg. The caller was told to skip the Humira the week before the vaccine. On an unspecified date the patient experienced memory loss but it's also time loss. Additional context reported as, the patient was calling about the covid vaccine. The patient believes he had a possible adverse event to the vaccine. The patient has Crohn's and was using Humira. The patient thinks that and it's possible that the Humira and the vaccine caused memory loss. The patient had the shot back in March and he didn't become aware of this event until recently. The patient has memory loss but it's also time loss. The patient can't remember anything from the end of 2020 to May2021. Adverse event require a visit to physician office and not to emergency room. No investigation assessment reported. This event was still relevant. Outcome of the event was not recovered.
PER FAMILY CARE GIVER PT WAS GIVEN VACCINE AT 1PM, SHORTLY AFTER ARRIVING HOME CARE NOTED PT SEEMED CONFUSED AND LETHARGIC, UPON ARRIVAL TO ER PT WAS UNRESPONSIVE AND INTUBATED
Breakthrough case admission after 2 vaccines Moderna 1/28/21 Lot# 007M20A;  Moderna 2/25/21 Lot# 010A21A
Dizzy; Fever; This is a spontaneous report received from a contactable consumer (wife).  A 39-year-old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: FA6780) via an unspecified route of administration on 21Jul2021 ;9:30 as (At the age of 39 year) dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EW0196) via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunization. On 21July2021 the patient had experienced fever. On 22july2021 about 36 hours after the vaccination patient had experienced dizzy. Reporter stated, yesterday at 9:30 in the morning his husband and Reporter received our second dose of the Pfizer COVID-19 vaccination, and his husband got a strong reaction at night he had a fever (distorted voice and incomplete sentence). When paraphrased the concern, reporter stated, yes, and about 36 hours after the vaccination he is now dizzy and concerned that he is dizzy. When confirmed if the reporter had the reaction? Reporter stated, I said, I am fine I had no reaction. When asked to probe further questions, Reporter stated, I just would like to know before all of that if there is anything I can do to help him. It was reported that Treatment: Reporter stated, He took two Tylenols. Therapeutic measures were taken for the AE and treatment was given with two Tylenols. The clinical outcome of the event fever was unknown and outcome of event dizzy was Not recovered.   Follow-up attempts are completed. No further information is expected.
Patient reports headache times three days before hospitalization. On Wednesday, February 26th patient experienced vomiting and diarrhea and was hospitalized overnight and received IV fluids and Rocephin. Also reported swollen lymph glands under left side of neck and under the left arm.  Spoke with patient on 2-28-03 and feels recovered but wanted to report this per her doctor.
Seen by MD in office 4/27/11 with 3 day history of rash on trunk and spread to his neck and arms. No fevers or other concerns. Had received MMR vaccine two weeks ago. MD. ASSESSMENT: Rash, likely a reaction to the MMR vaccine.
red dots around the injection site, and on the 15th it; arm pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain) and VACCINATION SITE RASH (red dots around the injection site, and on the 15th it) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m201a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and NECK PAIN (Neck pain). On 13-Feb-2021, the patient experienced VACCINATION SITE RASH (red dots around the injection site, and on the 15th it). At the time of the report, PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain) and VACCINATION SITE RASH (red dots around the injection site, and on the 15th it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history  and relevant concomitant medications weren't reported.  Treatment information was not provided
I was sick as heck and thought I needed to go to the hospital.  My doctor told me that it would pass in 24 to 48 hours.  It did.
Janssen COVID-19 "Vaccine EUA.  patient  was noted to have flushing followed by severe redness and itching of the neck and chest area.  complaints of tongue itching, but no complaints of swelling or shortness of breath. this occurred within a few minutes of receiving the vaccine.  Patient was brought into physicians room at which time he examined her and ordered Kenalog 60 mg IM in addition to Diphenhydramine 50 mg IM.  Patient continued to complain of severe itching that later involved upper extremities.  Patient also developed nausea.  Vitals were noted as 140/100, Pulse 70, O2 100%, temp 98, respiration 12.  physician ordered Ondansetron 4 mg IM for nausea.  approximately 45 minutes after initial injection of Kenalog and Diphenhydramine, patient reports a decrease in itching and redness has improved on neck and chest, but nausea has been persistent.  Physician ordered a second dose of Ondansetron 4mg IM.  Patient was continually monitored and her nausea started improving after the second administration of Ondansetron.  Patient was evaluated and released by physician with improvement in symptoms approximately 10 am- 2 hours after administration of the vaccine.
I tested positive on 6/24/22. I developed a throat tickle that evolved to a sore throat. Spoke to the Dr. on the 24. Wasn't able to take PAXLOVID because I was taking ELIQUIS.
Description: Large area of redness with blisters, swelling and itchy of upper arm 2 days after receiving yellow fever vaccine. Denies fever, SOB, chest or joint pains, headache, nausea or vomiting. Reports slight amount of swelling evening of the injection that progressed the following day to include advance of the redness and swelling from triceps area to just below his elbow with blister formation along the outer aspect of his arm. Also had 3 blisters along inner aspect of the arm with redness extending upward to @ 4 inches below left axilla.
Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) had not resolved. Not Provided          No Concomitant product was reported.   No treatment information was provided.
presented to MD 14DEC95 w/redness, induration & warmth to rt deltoid;started on Keflex;seen in ER 17DEC95 w/same sxs instructed to cont keflex & take Motrin
nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; VOMITING (non-serious), outcome "unknown", described as "vomiting".  Additional Information: This Physician reported 2 pediatric patients. Patient number 1 experience nausea & vomiting following vaccination for Covid. Patient 2 was not vaccinated by this office but child reported shortness of breath and chest discomfort following vaccination for Covid. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 14OCT98 1130AM & noticed soreness hr p/vax & noted redness following evening;the redness & local tenderness has persisted today;takes motrin for other reasons;
This spontaneous report as received from a certified medical assistant refers to a 51 year old male patient with no pertinent medical history and nor drug allergies/reactions. On 29-OCT-2014, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot # 670178/0468AA, expiration date 31-MAR-2013 (also reported as 30-OCT-2015) 0.5 ml, subcutaneous. The medical assistant was reporting that the patient was diagnosed with chickenpox on 17-NOV-2014, 20 days after onset of therapy. The patient was prescribed acyclovir for treatment. Laboratory diagnostics studies were not performed. The patient sought medical attention by an office visit. No further information provided. The outcome of chickenpox was reported as not recovered. Additional information has been requested.