chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved.            No concomitant medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment information was reported.  Company comment: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event had not resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event had not resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
2 inch diameter red lump at site, where Tdap was given. painful 8/10 pain scale, lasted 1 1/2 weeks long. Ice applied, but did not help, difficult to use R arm. Took Tylenol which helped.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated IM with a dose of RECOMBIVAX HB (lot # not reported). The patient did not convert after receiving the vaccine. The outcome of not convert after vaccination was unknown at the time of reporting. It was unknown if the patient sought medical attention. Additional information has been requested.
pt presented to the hospital with covid needed 2L of oxygen, and didn't need antibiotics.  pt discharged home
Right arm swelling and pain radiating from injection site distally to fingers within 6 hours of receiving vaccine.
Information has been received from a physician via a company representative referring to a 75 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date not reported). On an unknown date (reported as after receiving ZOSTAVAX), the patient had a "near stroke like event". The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Upon internal review, the event of "near stroke like event" was considered to be medically significant. Additional information has been requested.
Prolonged fevers, chest pains for 2-3 months post vaccine. Imaging suggested pericarditis.
Patient received incorrect does of flu immunization -- received FLUZONE QUAD and is not greater than 36 months. No adverse events.
Had tingling, itchy patches - no rash, all over body lasted 3 days. Now arthralgia - feet, wrists, hands and back where back surgery was performed 15 years ago. Aching muscle in arm. Still having arthralgia inj site still puffy aching muscle in arm.
After an hour to the next day, patient reported excruciating pain and limited mobility to the injected arm. Recommended otc analgesic treatment and patient's arm is feeling better  acouple days after using analgesic treatment.
Arm sore immediately after shot 24 hours after shot experienced extreme fatigue 48 hours after shot experienced headache and still tired. Not as bad of fatigue as previous day.
Myalgia, Fever, injection site pain, chills, fatigue Narrative:  Employee reports experiencing injection site pain/discomfort, chills, fever, body aches, and fatigue/sleepiness after receiving the second dose of the vaccine. Reports taking ibuprofen (no reported dose or frequency). Reports did see doctor for symptoms, though no further information provided in report.
Mild fever in the afternoon.  Up to 102.6 at 7:00pm.
No ADR, timing ERROR 2nd dose given 45 days after 1st Narrative:  No ADR, timing ERROR, 2nd dose given 45 days after 1st
The week after receiving the vaccination on my left arm I began to feel as if my right ear was plugged. I tried using drops thinking that it was ear wax. The plugged feeling continued for the rest of the day and morphed into ringing. The ringing in my ear has intensified through the week. It is worse when I am alone or when it is quiet. I also have a mild headache and have been experiencing food sensitivity. This is all new, I have never experienced anything like this before. I am generally healthy, and never have any physical issues.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 07-JUL-2017 the patient was vaccinated with an improperly stored dose of PROQUAD (lot # reported as N002336, expiration date 19-JUL-2018) for prophylaxis, which was reconstituted with properly stored sterile diluent. The vaccine was exposed from 15 Fahrenheit degrees (°F) to 46 Fahrenheit degrees (°F) for 15 hours. There was no previous temperature excursion. The call was made because there was a "data logger".
Swelling under left arm pit area.I received my shot in my left arm and I thought that may have caused the swelling,but the swelling is still there .
Monday, January 25, 2021 - swelling at injection site and extremely tender to touch. Unable to lift arm up or down easily. Tuesday, January 26, 2021- swelling and hardening at injection site and still very tender to touch. At approx. 10 am,  I began experiencing extreme nausea and exhaustion. By 1:00pm I was dry heaving and began a temperature of 99.9 (when I usually run 97.7) with a very bad headache. At 2:00pm I started vomiting very violently, my body was on fire and I was very faint.  Diarrhea  started at this time as well. The headache continued as well as the nausea. I continued to vomit on the hour up until about 8pm. (I have black and blues all over my knees from being on the bathroom floor.) The headache persisted as well as extreme nausea. Soaked through the bedsheets three times over the night while trying to sleep. Too exhausted to take temperature, but I am certain that I had one. Wednesday, January 27, 2021- Could not work. Went to doctor to get a Covid-19 test, just in case. Doctor says what I describe could be side effects of vaccine. Rapid test returns negative.  Extreme exhaustion. Woke up with nausea and a headache and no fever. Extreme exhaustion persists. Could not get out of bed, could not eat. I was only able to drink sips of water.  Diarrhea continued throughout the day. Nausea returned strong at about 5pm and dry heaving began again. Headache returned as well as temperature of 99.9. Soaked through the sheets again this evening. Thursday, January 28, 2021- Worked remotely and I do not know how I got through the day. Diarrhea  continues as well as nausea, headache and exhaustion. Still not able to really eat. Drank Pedialite and was able to eat 2 dry crackers. At about 3pm, dry heaving and nausea. Headache returns. Unable to get out of bed.  Friday, January 28, 2021-  Diarrhea stops. Still experiencing nausea and headache comes and goes. Still exhausted. By 4pm, back in bed with 99.9, body feels hot and headache returns. Soak through sheets once again.  Saturday, January 29, 2021- woke up with just enough energy to report these side effects. Headache is quiet... temperature is normal. Very, very tired. Feeling completely wiped out.
erythematous rash & swelling entire rt arm;seen in clinic 5/6/99;
4/8/21 - 2pm. - sore arm 4/8/21 - 630pm - body aches 4/8/21 - 730pm  - fever of 100.6 4/8/21 - 900pm - fever of 103 (ibuprofen and tylenol taken to alleviate symptoms) 4/8/21 - 10:15pm - fever broke.  Still have minor body aches and headache.   **waiting to see if fever come back after meds wear off**
No other adverse events reported; one dose was administered on 12Oct2021, the patient's chart for some reason was not updated prior to patient getting extra dose on 14Apr2022 which contributed to the extra dose being administered; This spontaneous report was received from a nurse referring to a 5 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided.   On 12-OCT-2021, the patient was administered with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number T035410 and expiration date 14-APR-2022; strength, dose detail and route were not provided) for prophylaxis.   The patient's chart for some reason was not updated prior to patient getting extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number U031564 and expiration date 06-APR-2023; strength, dose detail and route were not provided) on 14-APR-2022 which contributed to the extra dose being administered.
Patient was experiencing tenderness and sensation of discomfort in his arm.  No pain.  No swelling.  No rash.
patients received dose from vials beyond 30-day use by date; patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (patients received dose from vials beyond 30-day use by date) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (patients received dose from vials beyond 30-day use by date). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-364908 (Patient Link).
it was a horrible, horrible, horrible flu; Initial information received on 31-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Social Media.  This case involves male patient (unknown age) who had non-serious event "it was a horrible, horrible, horrible flu" (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "it was a horrible, horrible, horrible flu" (influenza) (unknown latency) following the administration of vaccine.  It was reported "My dad never had flu except the one year he had a flu shot.And it was a horrible, horrible, horrible flu, the sickest he'd ever been. so no, I don't think flu shots are necessary or are safe. The ingredients are disgusting, so how can it be beneficial? Impossible."   It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
fevers; night sweats; aphthous ulcers in his mouth; difficulty eating; difficulty eating and talking; This is a spontaneous report from a pharmacist.  This adult male patient of unspecified age (18-64 Years) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was not reported) on 22Dec2020 15:15 (at unspecified age) as single dose, unspecified route for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  Concomitant medications were not reported.  Since the vaccination, it was unknown if the patient has tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to BNT162B2. On 25Dec2020 began having fevers, night sweats, and aphthous ulcers in his mouth so severe that he has difficulty eating and talking. It was unknown if the patient received treatment as a result of the events.  Lab data included Covid swab on 28Dec2020 which was negative. The outcome of event fevers was unknown, night sweats was unknown, and aphthous ulcers in his mouth so severe was unknown, he has difficulty eating was unknown and difficulty talking was unknown.
Red splotch all the way around the injection site, about 2 inches long; Little headache that lasted about an hour/ Mild Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red splotch all the way around the injection site, about 2 inches long), HEADACHE (Little headache that lasted about an hour/ Mild Headache) and PAIN IN EXTREMITY (Sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Allergy. Concurrent medical conditions included BPH since 1990 and GERD. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, FINASTERIDE and DOXAZOSIN for BPH, RABEPRAZOLE and FAMOTIDINE for GERD.   On 14-Jan-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (Little headache that lasted about an hour/ Mild Headache) and PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red splotch all the way around the injection site, about 2 inches long). On 14-Jan-2021, HEADACHE (Little headache that lasted about an hour/ Mild Headache) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red splotch all the way around the injection site, about 2 inches long) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 19 Apr 2021 includes patient details; height, weight, race ethnicity details.Current condition; BPH, GERD, allergies.Concomitant medication; rabeprazole, famotidine, finasteride, doxazosin and Flonase.The mild red splotch with no real rash or itching or anything else just a red splotch that the patient experienced caused no issues and faded away in about five days.
The emergency room said it was a vasovagal event:  I felt fine one minute, and passed out and vomited quite a bit out of nowhere.  I was at a baby shower and an ambulence had to be called to take me to the emergency room.   I was released after blood work was taken and a few test performed again stating that it was only a vasovagal event not related to the vaccine.  However, my bloodwork came back the following day and my blood work confirmed that I had a very low lymphosyte level and high Neutrophil level as well as a very high immunoglobin level.  My Primary Care physicians office confirmed that the event and blood results must be a reaction to the vaccine.
This spontaneous report as received from a female consumer reporting on herself with history of herpes zoster/shingles. On an unknown date "several years ago" the patient was vaccinated with ZOSTAVAX, subcutaneous for previous shingles reaction. (dose unspecified) (lot# and exp date unspecified). The reporter inquired as to appropriateness of reintroduction of ZOSTAVAX, since her physician recommended that ZOSTAVAX, be re-administered. Caller stated that she previously experienced an adverse reaction with ZOSTAVAX, to prevent herpes zoster (neuralgia). The outcome of herpes zoster neuralgia was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Pt developed facial numbness about a week and a half after receiving the vaccine.  He was diagnosed with Bell's Palsy
child slept for 7 hrs /p immunization, woke up to eat, for 15 min, then slept for another 7 hrs, T of 101, no Tylenol given, rousable during episode & well by next day.
Reaction not he first dose; Arm swelled; arm was red and painful for a few days; arm was red and painful for a few days; Did not take the second shot due to this reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Reaction not he first dose), PERIPHERAL SWELLING (Arm swelled), ERYTHEMA (arm was red and painful for a few days), PAIN IN EXTREMITY (arm was red and painful for a few days) and PRODUCT DOSE OMISSION ISSUE (Did not take the second shot due to this reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction not he first dose), PERIPHERAL SWELLING (Arm swelled), ERYTHEMA (arm was red and painful for a few days), PAIN IN EXTREMITY (arm was red and painful for a few days) and PRODUCT DOSE OMISSION ISSUE (Did not take the second shot due to this reaction). At the time of the report, VACCINATION COMPLICATION (Reaction not he first dose), PERIPHERAL SWELLING (Arm swelled), ERYTHEMA (arm was red and painful for a few days) and PAIN IN EXTREMITY (arm was red and painful for a few days) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not take the second shot due to this reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
First a headache then body aches then fever of 103 for 6 hours with uncontrollable chills.  Lasted about 12 hours from onset
15 months old admitted to Hospital on 12/18/15 with a four-day history of vomiting, diarrhea and a 2 day history of abdominal distention.  On admission had ascites, elevated liver enzymes and elevated LDH.  Child is still in in the hospital and is improving. Pediatric gastroenterologist diagnosis is most likely post infectious enteritis.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment Medication was available. No Concomitant Medication was available.
Admitted to ER with complaints of generalized weakness and report of insomnia for 4 days to getting his second covid shot. He reports having one episode diarrhea and emesis pta. He reports there was no blood in his stool , no black stool, no blood in emesis tonight pta. He reports he saw blood in emesis one day prior
Fine maculo-papular non-pruritic rash both shins, right>left. Unresponsive to Hydrocortisone 1% cream. Has persisted until today, day 5 after onset.
On August 9th, 2022 woke up to drooping left side of my face unable to smile fully. Also, unable to close my left eye or raise my left eyebrow. Went to the Emergency Room because I thought I was having a stroke. It was the Emergency room. I was seen by Dr. and was diagnosed with facial paralysis/Bells palsy with no known cause on 08/09/2022 around 1 pm. I have no previous medical history. I have been  prescribed glycerin-hypromellose-PEG 400 0.2-0.2-1% solution for my left eye since it cannot close fully. prediSONE 60 MG once a day for 7 days. valACYclovir 1 g tablet 3 times a day for 7 days. I am still unable to close my eye fully, raise my eyebrow, nor smile like I used to.  Will be going to an acupuncture clinic on 08/12/2022 after researching ways to get my facial nerves back.
Rec'd varicella #1 between ages of 1 & 2, mom reports records lost.  Rec'd #2 11/07, Needed a verified second dose for school, so # 3 given 9-10-08 at 9am.  Pt reports at 1pm began itching at site of injection (Rt upper arm).  Today site was examined by school nurse who sent her back to the Health Dept for evaluation.   Reddened, raised area approximately 6 cm in diameter noted at injection site.  Denies pain, "just itching". Denies fever, illness, dyspnea or any other problems.  Instructed mom to give Benadryl to help with itching.  To call HD or MD if site worsens.  To go to ER immediately for difficulty breathing.  Call HD for questions.
Reported by mom on 5/7/07 that pt have cramping and gas for 2-3 hours after vaccine. No diarrhea or blood in stool, no vomiting.
Patient started having chest pain the day after getting his 3rd Pfizer vaccine.  He noted that the pain felt different than just feeling anxious and the pain persisted.  Chest pains come and go over the past month and are not linked to any specific activity.  A week after receiving the vaccine we went to the ER to get the pains checked out.  He was put on ibuprofen 3 times a day and a diagnosis of pericarditis was given.  We were referred to a cardiologist which the patient saw today. (1/24/22)
Hypertension was seen when I went to donate blood in May, it may have started bwtween March and May but I only get my BP taken every 2 months at my blood donations. Since then it has been tested monthly and been high and now I gets it daily and the diastolic pressure is rarely below 90.
Pt received vaccine (FLUZONE HD) on 11/24/15. Came today complaining of sore left arm! Pt received vaccine on right arm. Informed pt to see Dr. May not be correlated to vaccine.