chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gout flared up; he had pain in his arm at the injection site; has a rash on the back of his arm and around his neck; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: first dose of EW0176 and expiry date not reported) via an unspecified route of administration, administered in Left arm on 10May2021 (at age of 56-years old) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension (he was diagnosed with high blood pressure over 10 years ago), ongoing gout (he was diagnosed with gout 5-6 years ago), Acid reflux (diagnosed with acid reflux well over 10 years ago), sinusitis (Sinuses), blood cholesterol (Pravastatin has been maintaining his cholesterol levels). Concomitant medication(s) included mometasone furoate (NASONEX) taken for sinusitis he has been using it for about 10 years; lisinopril taken for hypertension, he has been taking Lisinopril for over 10 years now; pravastatin taken for blood cholesterol, he has been taking Pravastatin for 10 years now; omeprazole (PROTONIX) taken for gastrooesophageal reflux disease he has been taking Protonix for well over 10 years; and colchicine (COLCHICINE A) taken for gout, start and stop date were not reported. Caller reported that he had pain in his arm at the injection site the next day after the Covid-19 vaccine, 11May2021 and the pain at the site went away on day 2, 12May2021, or day 3, 13May2021. His gout flared up the night of Thursday, 13May2021. Caller reported that he took some medication for his gout flare up so it's going away. Also reported that, the gout flares up got better the afternoon of Saturday, 15May2021 when he took his gout medication. Caller reported that he has been taking his medication for gout, so he doesn't feel the gout flare up as much now as he did. On unknown date in May2021, he had a rash on the back of his arm and around his neck that wasn't there before he got the Covid-19 vaccine. Caller reported that the rash began a couple of days ago. Caller reported that he has been taking one pill of Colchicine daily for his gout flare up. Caller reported that he only takes the colchicine as needed and that he normally avoids the foods that cause his gout to flare up. Caller stated that he needed to leave the house. Caller unable to complete vaccine supplemental form with agent. Therapeutic measures were taken as a result of gout flared up: treatment included Colchicine. The outcome of the events pain in his arm at the injection site and gout flared up was resolved on unknown date in May2021. The outcome of the event rash on the back of his arm and around his neck was not resolved.   Information on lot/batch number was available. Additional information has been requested.
Severe diarrhea, almost passing out had to lay on bathroom floor the next night after shot. Blood in stool for 3 days after. Still having pain in muscle at injection site, 13 days later.
He responded he had been administered dose #1 of Pfizer Covid Vaccine on Sept 21, 2021, from Pharmacy (verified in PFIZER Lot FC3182). He stated approximately 3 weeks after the vaccine, he went to a civilian ER in Oct 2021 w/ symptoms of: palpitations, elevated B/P (174/102), he felt "stressed out", and chest pain that felt like his heart was going through his chest. He had no prior issues to the vaccination as he had just had physicals exams approximately 3 months prior with no issues. He was discharged with ASA DX with: new onset heart murmur, pericarditis/myocarditis, virus or vaccine reaction and was told to f/u with his PCM. He saw his PCM and was ordered a stress test, ultrasound where it was detected he had an ascending aortic aneurism. He was given bed rest, light duty, and "heart meds". He was scheduled for procedures in Jan 2022 but ended up with a Covid infection and surgery delayed until Feb 2022; an angiogram was done, and a blockage was found at that time. March 18, 2022, he ended up with open heart surgery and had a stroke the same day. He now suffers from short term memory loss, bilateral loss of peripheral vision. Symptoms: CHEST PAIN, UNSPECIFIED (R079).
Patients husband came in letting us know that his wife (patient) had a reaction to a vaccination administered. The reaction was described as a "huge red rash over 6 inches covering her whole arm, with burning pain"
Sensitive skin on stomach and back for a week. Possibly shingles. Prescribed gabapentin 100 mg capsule and valACYclovir 1000 mg tablet (3 per day for a week). So far they seem to be helping.
On day of vaccine, after returning home, mom noticed  right eye started twitching. This continued intermittently for short periods of time until around 9/3/22, and then stopped completely.
he had a mild sore arm for a few hours after the vaccine dose; This is a spontaneous report from a contactable other hcp (patient, self-reporting). A 70-years-old male patient received first dose for BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiration dates were not reported), via an unspecified route of administration on 29Jan2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he has been unable to schedule his second dose of the vaccine and has not been contacted about it. he wants to know what to do and if it's ok to get the vaccine later than 21 days on an unspecified date and he had a mild sore arm for a few hours after the vaccine dose on 29Jan2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Pt in usual state of health prior to receiving pneumocoaal vaccine #2 on 11 Dec 07 (first one was 19 Feb 2002).  States later that night developed large local reaction and temp spikes to 103.  Also describes that was "off" - spouse commented like acted as if "was demented".  LLR is resolving; temps normalized and currently pt feels at baseline outside of some discomfort about injection site.  Never had respiratory or GI sx.  No other skin lesions.  Pt did not seek medical care at the time of episode. No treatment given today, though did recommend that pt f/u with PCM or ER if again develops and neuro changes.
AFTER RECEIVING THE FLU SHOT THE PATIENT BEGAN EXPERIENCING SORE THROAT, RASH IN THE NECK AREA, NUMBNESS IN THE LIPS, DRY MOUTH AND SKIN HOT TO THE TOUCH.
Moderna COVID-19 Vaccine EUA Red, itchy rash all over body.  Has persisted for 7 days. Treatment: Initial- Cortisone Cream / Benedryl Dr. Appt. 02/22: Prescribed Claritin / Triamcinolone 0.1% Today is 02/25 - Symptoms persist - red, itchy rash on both arms, legs, and abdomen.
Patient was given her second dose of moderna on 12/06/2022 and the vaccine expired on 12/2/22
Experienced cold symptoms on June 12, got worse June 13, positive for Covid June 13, coughing a lot June14, taken to ER June 14,  admitted to hospital early morning June 15, after chest xray showed pneumonia, put on oxygen, released from hospital on June 20th.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE SLEEP APNEA 11/19/2022 &  11/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
"Moderna COVID-19 Vaccine EUA".  At the site of the injection, my left arm got very swollen, red, and hot.  It began itching right away and that became worse over the course of the day and the following days.  I felt deep exhaustion, and my body hurt all over especially my joints.   I had stomach cramps, diarrhea, and nausea.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient was vaccinated with live ZOSTAVAX (route, dose and lot # were unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient broke out with shingles on her left arm at the injection site 1 week after injection. No treatment was reported. The outcome of event is unknown. The relatedness for event is unknown for live ZOSTAVAX. The patient sought medical attention via seeing her doctor. Additional information is not expected.
PATIENT RECEIVED A 4TH DOSE OF PFIZER. PATIENT WAS NOT TRUTHFUL TO STAFF AND STATED HE HAD ONLY HAD ONE DOSE AND HE PRESENTED HIS VACCINATION CARD WHICH  SHOWED ONLY ONE DOSE WAS GIVEN.
Triggered mild symptoms of HSV1; This is a spontaneous report from a contactable consumer (patient herself). A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in right arm on 13Apr2021 16:30 (age at vaccination: 34-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration on 23Mar2021 04:30 PM, (age at vaccination: 38-years) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Facility type vaccine was pharmacy or drug store. Patients medical history included ulcerative colitis, IBS (Irritable bowel syndrome) and Hsv-1 (Herpes simplex virus conjunctivitis) from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient had no known allergies. No other vaccine in four weeks was administered to patient. Other medications were administered within 2 weeks (details not available). In 15Apr2021 15:00, patient triggered mild symptoms of HSV1. No treatment was received as a result of the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the event was recovering.   No follow-up attempts are required. Information about Lot/Batch number has been obtained. No further information is expected.
Tested positive today on asymptomatic screening for SARS-CoV2; Tested positive today on asymptomatic screening for SARS-CoV2; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration in Arm Right on 22Feb2021 (Batch/Lot Number: EN6203) as 1st dose, single dose, and dose 2 via an unspecified route of administration in right arm on 17Mar2021 (Batch/Lot Number: EN6208) as 2nd dose, single dose for COVID-19 immunisation at hospital. Medical history included Crohn's disease and COVID-19. Concomitant medication received within 2 weeks of vaccination included ustekinumab (STELARA) taken for an unspecified indication. The patient previously took vedolizumab and experienced drug hypersensitivity. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to COVID vaccine. On 29May2021 the patient reported as, 'He was fully vaccinated with Pfizer and tested positive today on asymptomatic screening for SARS-CoV2. The infection leads to rescheduling a surgical procedure'. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29May2021 Nasal Swab. No treatment was received. Outcome of the events were unknown.; Sender's Comments: The event COVID19 is mostly likely an intercurrent condition. Based on temporal relation, the association between onset of event COVID 19 and vaccination cannot be ruled out.
Patient fully vaccinated in April 2021. Now presented to ED and has been hospitalized with COVID-19 infection.
Dizziness & HYPERtension Narrative: Employee received dose #2 Covid-19 Moderna vaccine and while being monitored c/o dizziness and stated her BP reading was elevated for her. Readings done in right arm and are as follows, 143/90, 144/84, 137/84 and 139/82. Pulse rate was 86 and O2 sats remained at 100% on room air. Employee was assisted to wheelchair and transported to ED via RN.
Information has been received from a pharmacist via field employee referring to a female patient of unknown age. The patient had no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot# unknown). No concomitant medications. The patient developed a burning sensation throughout her entire back soon after the administration. No treatment and no lab given to the event. The patient did not seek medical attention. The outcome of burning sensation was unknown. No PQC (product quality issue) involved. Additional information has been requested.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Brain fog, malaise, fatigue, swelling and pain at injection site.  Sore/scratchy throat.  Arm pain occurred first. Exhaustion a few hours later and exists two days later. Throat became scratchy and swelling came on the next day.  Second day (today) brain fog as evidenced by a lack of energy and poor test taking .
L arm beginning hurting at injection site 3 days post injection of PREVNAR 13. Arm then became more swollen surrounding the injection site, spreading out about 5x8 inches over dorsal surface of arm, with erythema and pain, all which increased over next 12-16 hours with more pain. No fevers, but significant malaise experienced. Symptoms improved with ibuprofen. Still with swelling although improved 2 days after symptoms began.
The morning after my second dose of the Pfizer vaccine, I fainted. Immediately after I awoke, I felt so ill that I had to continue lying down so that I didn't faint again. I don't have a history of fainting, so this was the first and only time I have ever fainted. I called the nurse on-call at my university and was told that I should seek medical help if it happens again. After that, I had the more usual symptoms of fever and chills, and everything was resolved within 24 hours. I'm not sure if this qualifies as a significant adverse event, but it did incapacitate me for a day.
Patient developed expected mild swelling at site of administration within 24 hours but then at 36 hours developed swelling of the axillary lymph nodes and swelling of the anterior left chest.
Nothing serious but the roof of my mouth and back of my throat felt numb for about an hour and then was tingly.  This happened about 30 minutes after the shot. I also was very nauseous the next morning.
pt recv vax 10JAN97 & 23JAN97 pt exp fever & devel a single lesions on brow;
Patient came in to receive their first pfizer covid shot. They instead received the new pfizer updated bivalent booster. patewint reported no adverse reactions. They only needed to verify they would be able to get fully vaccinated before they leave on a cruise trip
I was exactly 4 weeks pregnant at the time of my second vaccination. On March 23 I started to develop cramping in uterus. On March 25 or March 26 (I cannot remember exactly which day here) I started spotting, and then by the next day I was bleeding. On March 29 I saw my OBGYN who diagnosed me with a miscarriage. I continued to bleed for approximately 10 days, as well as dizziness, and feeling very faint. I have had 2 very healthy pregnancies in the past and no health issues. This could be absolutely unrelated, as early miscarriages are almost impossible to pinpoint, but I did feel this should be reported for researching purposes.
A non-serious spontaneous report of sprayed H1N1 LAIV in the eye was received from a registered nurse/healthcare professional concerning a female child. No relevant medical history was reported for this patient. On 22-Dec-2009 H1N1, Intranasal was sprayed in the patient's eye as she jerked her head back while the vaccine was administered. Her eye was washed out and the patient was evaluated again after 30 minutes with no symptoms. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
JAUNDICE, BODY ACHING, FEVER, NAUSEA, VOMITING, FATIGUE, GENERALIZED MALAISE, SORE THROAT, PRODUCTIVE COUGH
Janssen COVID-19 Vaccine EUA. Headache, nausea, and vomiting. Beginning about 12 hours after injection, I was throwing up for about 24 hours.
Child was 3 years old (DOB 05/29/2006) and received a vaccine for 4 years and older.
Patient reported tingling sensations all over body, heavy sweating, and *feeling like fainting* 5 minutes after injection during observation period.  One dose of epipen was administered and patient immediately started feeling better after 2 minutes
Dermatographia/hives. Happened two weeks after 2021 Moderna booster as well. Now realize this is what it is. Started 12 days after, itching and raised welts with pressure.
Patient passed away suddenly (heart failure) on Feb 15th, 11 days after receiving the 1st Pfizer shot.  I know he had other health issues, but he had a good bill of health from his doctors prior to this. I thought this should be reported.
Face went immediately numb. Over the next several hours felt numbness in whole body. Facial drooping. No paralysis, was able to move, minimal pins and needles, primarily a loss of sensation. It's 6 days later and I'm getting the sensation back but it hasn't fully returned.   Facial flushing which continues to come and go, as well as flushing in hands and feet.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-549388 (Patient Link).   Reporter did not allow further contact
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2019SA004547. This case involves a 11 years old female patient who received 0.5 ml of vaccine FLUBLOK QIV (lot number: QFAA1804, expiry date: 06-Jan-2019) via intramuscular route in left deltoid on 14-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error due to inappropriate age at vaccine administered. It was not reported if any adverse event occurred or not following 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.
I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain in my whole life.   It was difficult to do anything and laying down hurt the most.  This has been 8 nights now that I cannot sleep through the night because I wake up with shooting pains in my shoulder blade/shoulder/arm area.   Even with ipruprophen and/or Tylenol - the pain still comes back.  As of yesterday, I can use my arm better as the day goes by but lifting my arm over should height is extremly difficult and painful without the assistance from my other hand.  I believe this is called a Shoulder Injury Related to Vaccine Administration.   I writhed with pain the first night and got no sleep.  I took 2 days off of work and even working today is difficult to write on the board, lift things or reach higher than my shoulder.  Even last night I woke up 4 times because of the pain.  I couldn't get back to sleep for about 1 hour each night since this happened 8 nights ago. When I visited my Doctor 2 days ago, she said maybe it was Shoulder Injury Related to Vaccine Administration.  She said to come back for another visit if the pain lasts for a few more days.  Physical Therapy, Steroids or ?   I just want to be able to sleep, be able to dress myself and to wash my hair without pain.
I got severe vertigo.  I was dizzy and had naseau.  This was approximately 60 hours after the shot.
Patient had a very red, swollen area around administration site. Still persisting after a week. Her doctor prescribed VALTREX as treatment.
Approximately 2 hours after the vaccine she reported a "spot on her arm" where the vaccine had been given, a headache and back ache. She did go to the chiropractor on 1/4, but states it did not help. She saw an allergy specialist on 1/5. As of 1/7/20 0830am she still had a headache.
11/11 left arm swollen and hot to touch at shot site Recv'd 11/9/07
Itchy, burning,painful,fine papular rash,dry and rough.10 intertriginous areas.