chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme arm pain, sore index finger of same left arm felt like top of finger had a cut or sunburn with nothing looking unusual in the finger , arm or injection site.  Chills that night and body aches getting very bad, I couldn't sleep with lots of blankets on because I was so cold and room temp was 72 degrees, my usual.  No fever.  Tylenol extra strength didn't help at all.  This went on 7 days.  Dizzy the second day,very itchy skin, no rash, ear ache in right ear only that day.  Very bad headache and photophobia for 5 days.  No desire to eat or drink 6 days, but I could keep water down.  Third day severe gas pains, like labor pains with lots of gas, cramps.  I thought I'd faint from the pain.  Nausea and dry heaves at the same time with diarrhea.  I hadn't had food in 3 days or any bowel movements to this point.  Felt very tired and weak.  Not able to sleep, comfortably  until the seventh day. Had a stiff neck. I did have a positive Covid result, asymptomatic 1 month before my first vaccine
Injection site sore for about 5 days - then 5 days later shoulder became very sore and achy.  Arm now aches continuously and is very weak.  Mobility without pain is limited.  Have not contacted my doctor yet - but will do so soon.   No doctor visit planned yet.  (Suspecting this is SIRVA????)
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA injection (strength and dose were not reported) (lot # M027879, expiration date 24-JAN-2018) for prophylaxis. According to the reporter, VAQTA doses were exposed to the following temperatures excursions: 1 hour and 50 minutes between >0 degrees Celsius (C) and <2C, and 3 hours and 49 minutes between >0C and <2C. No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005576: US-009507513-1702USA005706:
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/7/2022 CHEST PAIN
Individual left a message 2/17/21 reporting that about day 5-6 he had erythema,warmness & itchiness around the injectyion site.   He also reported swelling in deltoid region that extended midway down his arm, but did not travel to the tricep area. He applied a topical steroid cream and triple antibiotic ointment to the area. As of today, the swelling, warmth and redness are improving. He was advised to contact PCP for follow up.
The patient was given Pfizer Bivalent Booster vaccine 4 days past beyond use date on 12/06/2022.  The patient was not able to be reachable and we are not able to gather any information on any symptoms, sings, time course, etc.
This case was reported by a pharmacist via out of hour services and described the occurrence of swelling arm in a 83-year-old female patient who received BOOSTRIX (batch number 9XJ5L, expiry date 14th October 2018) for prophylaxis. On 2nd June 2018, the patient received BOOSTRIX .5 ml. In June 2018, less than a week after receiving BOOSTRIX, the patient experienced swelling arm (serious criteria hospitalization), infection (serious criteria hospitalization) and erythema of extremities (serious criteria hospitalization). The patient was treated with antibiotics NOS. On an unknown date, the outcome of the swelling arm, infection and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm, infection and erythema of extremities to be related to BOOSTRIX. Additional information was received as follows: The patient came back into pharmacy on 9th June 2018, to report that she was hospitalized for 3 days after the administration of vaccine because of an infection in her arm. The patient's arm was swollen and red. The pharmacist reported that the patient's arm had a marking which used for measuring cellulitis. The patient was on antibiotics that was given in the hospital. The patient reported that the physician in the hospital told her that the infection didn't look like a normal reaction that would be caused by the BOOSTRIX. The contact details of the patient was provided. The pharmacist did not have the name of patient's physician.
Pt. c/o pain in (R) arm where injection was given. States it hurt when she received the shot. States it is difficult to raise (R) arm over her head. States it hurts to sleep.
Patient reports a red, itchy rash along  with swelling along her neck and left jawline.
After one month of time after the second dose, I had a seizure while driving. This was my first seizure, and i didn't realize what it was until the next seizure I had that was witnessed in front of someone a month later. I was not injured during seizure while i was driving thankfully. The second seizure was witnessed and lasted 4 minutes. I was picked up by the ambulance and taken to Emergency room, and then a couple days later I visited my HCP. He prescribed me Keppra and gave me a referral to a neurologist. I have had an EEG, MRI, CT, and blood work done. I'm not sure if the vaccination caused me to randomly develop epilepsy, but that was the only different factor in my life at the time. I have had 6 seizures since then. I have only gone to the ER twice for seizures. The rest I just manage at home if its not too long.  I still work and live my life, but i have to be cautious with certain activities that could be dangerous like driving, swimming, working. I had to sell my motorcycle due to my seizure risk. I have to take anti seizure medication every day for the rest of my life.  I have side effects from the medication like increased disturbed thoughts, unsteady gait, and fine tremor. If i don't take my medication, I will have a seizure. Two of my seizures were caused by a mishap with my anti seizure medication. I wanted answers so i started researching potential causes and then I saw a study of the two dose covid vaccination increasing the risk for developing epilepsy. I'm in nursing school and we are going over infectious disease and my teacher linked this form, so i decided to fill this out to possibly help with any research needed.
Underneath my ear and in front of my ear like a gland swollen; Huge lump in front of ear goes from middle of ear down to jaw where bottom of gland have pain; Huge lump in front of ear goes from middle of ear down to jaw where bottom of gland have pain; Pain in cheek; This is a spontaneous report from a contactable consumer or other non hcp.     A 55-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8729), dose 1 via an unspecified route of administration on 03Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included omeprazole (PRILOSEC). It was Reported, consumer stated, got my first vaccine on (03Apr2021) and after my first vaccine I had my, underneath my ear and in front of my ear, had like a gland that was swollen, so she thought like and it is said that you know that it's like normal that your gland swell. Gone for my second vaccine today actually had to leave right now had to drove for three hours and also had pain again and it's like a huge lump in front of my ear goes from the middle of my ear down to my jaw and where my jaw is like where your gland at the bottom of jaw there that's where the pain. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
I was very tired and had no energy when I had COVID-19. I had cough, sore throat, fever, and long-standing diarrhea. I was prescribed PAXLOVID, but I took it for only one day, because I thought that it was what was causing my diarrhea. I'm still in the process of getting over it, and it has already been two weeks. I took some ADVIL for the fever and MUCINEX for the congestion. They were pretty effective.
Within a few days of my second moderna covid vaccine, the surgical sites from the inguinal hernia surgery I had nearly two years prior started hurting again and feeling irritated. This lasted from nearly two months. I was examined by Dr. (my hernia surgeon) for a re-occurrence of the hernia, but the repairs were in place. After two months, the irritation went away. Nothing else changed in my normal routine, except for receiving the second covid vaccine, so I thought I should report this as an adverse event (possibly an inflammatory response kicked off by the second vaccine?).
Pain at injection site, patient rates pain a "6" on a scale of 0-10.  Injection was given IM rather than SC.
Patient was advised to wait 15 min after vaccine. Patient fainted twice and EMS was called
Arm very sore. 5:30pm. Fever began  8:30pm.  Fever at 100.6 at 9:00pm. Arm very sore. Large red, swollen, slightly hard bump about the size of a silver dollar over injection area and down the arm. 09/07/2013 9am.
5-3-07 - Received Adacel vaccine. 5-4-07 - pm right arm swollen, sore, tender to touch. 5-5-07 Right side of neck and right arm very sore with limited ROM.
MAN SUFFERS RARE SEVERE REACTION TO COVID-19 VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the subject experienced man suffers rare severe reaction to covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of man suffers rare severe reaction to covid-19 vaccine was not reported. This report was non-serious.
Moderna COVID-19 Vaccine EUA. Insomnia 12 hours after vaccine. headache 24 hours after the vaccine, progressed to body aches, fatigue, chills, fever 101.6  Resolved after 48 hours.  Red arm 6 inches by three inches started 24 hours after the vaccine, still there 36 hours after vaccine
Pfizer-BioNTech COVID-19 Vaccine EUA 2" diameter red and itchy area around injection site and 3" long by 1/4" wide red line from injection site to arm pit, that lasted 1 week. Also, 101 temp, some chills, light headache, upper teeth hurt (like in sinus infection) and tired that lasted 1 day.
I experienced colon tolerance with chills, cold feet and hands, racing heart and I am experiencing joint issues.
Heart beat increased to 100+ over a two-day period following the 2nd Covid shot.  Fatigue, mild fever also experienced for a day and a half following the day of the vaccination.  Then the frequency of my heart arrythmias increased.    My pulse readings on  my recording blood pressure cuff showed arrythmias every time I took my blood pressure for the entire month of April.  I reported this to my primary care doctor on April 30th and she sent me to provider  for an EKG, an echocardiogram, and a heart monitor test.
patient received first dose of GARDASIL in Oct 2014 and second dose October 2020; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in October 2014, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date in October 2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
I received my first dose of the Pfizer vaccine in January of 2021. The next day (or maybe two days later, I can't remember), I noticed that I had vaginal bleeding and I was not due for my period for another 2-3 weeks. Then, when I was supposed to my period, it was delayed by 9 days. My period always comes on time. A pharmacist I work with also had this same problem with spotting. After I received my second dose in late January, the same exact thing happened. Now, it is October 21,2021 and I just received my Pfizer booster vaccine on October 19. Yesterday, I noticed that I had the same vaginal bleeding which was very scary and extremely concerning. I don't know why this is something that happens only with the Pfizer vaccine, and I also don't now what would cause bleeding. It is especially concerning as I do eventually plan on becoming pregnant and don't know if this is something that would have an effect on my fertility. I though it was important to report this as I know other women I've read are experiencing this same concerning issue.
first dose > 35 days before second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose). In July 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose) had resolved.            No concomitant medication were reported no treatement of medication were reported
adacel was administered to three 65 year old and higher patients with no adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 years old male patient to whom Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 25-Sep-2023, the patient of 69 years old received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (lot U7905AA, Expiry date: 30-Oct-2025 with unknown strength) via intramuscular route in the deltoid nos (not otherwise specified) as immunization with no adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.   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 the 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.
Information has been received from a physician and a pharmacist concerning a 63 year old female consumer with no known drug allergies, diabetes, hypertension, Gastrooesophageal reflux disease and hyperlipidaemia who on 07-MAR-2008 was vaccinated SQ in the left deltoid with 0.65mL (also reported as 0.5mL) of zoster vaccine live (Oka/Merck) (lot # "01429U"). Concomitant therapy included PREVACID, AVAPRO, TOPROL XL TABLETS, ezetimibe (MSD), alendronate sodium (MSD), CRESTOR, ACTONEL, metformin, flaxseed, fish oil and aspirin. Subsequently, on 11-MAR-2008 the patient had shingles symptoms. She had a shingles-like rash with no vesicles. There are 3 patches which were red and raised on her left, mid-lower back near T-11. It was also reported as "the patient developed shingles." Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/MERCK vaccine strain. Follow-up information indicated that the patient developed 3 lesions along the T12 dermatome. The patient also developed pain (rated 3 on a scale of 0 to 10). It was also noted that there was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected and sent to the laboratory on 13-MAR-2008. The sample was taken from a lesion along the T12 dermatome location. The PCR results for the specimen taken from a lesion along the T12 dermatome location was an ADEQUATE SPECIMEN and identified the presence of WT VZV. Additional information has been requested.
Recent J and J vaccine on may 14th  and then hospitalized on 5/31/21 till 6/7/21 with new onset rapid afib/new non ischemic cardiomyopathy ef 35%/ elevated inflammatory markers, new pleural effusions/sob-CTA chest neg for pulmonary embolism. , Pt did not have her vaccine card for her lot number. Reports her friend stole her card because she wasn't vaccinated and wanted it so she stole it but reports she has had the J and J on May 14th in her right arm. Pt was transferred to a larger teritary care hospital on 6/3 where she had cardiac cath  and was evaluated by the heart failure team and discharged home with home health care services on 6/7/21. Her cardiac catheterization revealed patent 2 vessel bypass grafts/non ischemic cardiomyopathy.  Cause for sudden cardiomyopathy and new atrial fibrillation unknown. discharged on amiodarone, entresto, demedex and eliquis.
Since receiving the Gardisil vaccination, patient has suffered frequent migraine headaches, bloodshot eyes, and extreme sensitivity to light. Within a week or two of the 3rd & final vaccination, eyes became extremely bloodshot. On 9/18/09, visit to NCAA team doctor for bloodshot eyes resulted in diagnosis of inflamed iris and two spots on the cornea. On 9/19/09, when patient woke up in the morning, was unable to see out of the left eye. Taken to emergency room and was diagnosed with corneal ulcer and bacterial infection. Has been referred to cornea specialists for treatment. Treatment for past 9 days has involved hourly eyedrops and/or ointments applied to the eye, 24 hours a day. Doctor now concerned about thinning of cells and the surface of the eye being broken as a result of the bacteria attacking the cornea. These events have had an adverse number of effects on her life in addition to the medical concerns.10/19/2009 received Opthalmologist records for dates 9/19 and 9/20/2009. Patient with c/o's decreased vision, eye pain. PE revealed discharge lt eye, Rx'd ABX eye gtts. DC
PATIENT HAD A SYNCOPE KIND OF REACTION. PATIENT DID NOT COMPLETELY PASS OUT BUT EYES WERE DILATED AND THROAT WAS HURTING IN THE BEGINNING. 911 WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL.
My face is swelled; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration (at the age of 84years) on 29Jan2021 at 09:00 at single dose for covid-19 immunisation and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included have a pacemaker. Concomitant medications were unspecified as stated, "I am taking lot of medication." The patient reported, "My face is swelled" on 29Jan2021. Consumer stated, "I got the Pfizer vaccine today and I looked in a mirror a couples of hours ago and my face is swelled. So, my question is should I take diphenhydramine hydrochloride or not? It got a little better but it is still swollen. I wonder if I took diphenhydramine hydrochloride would that be helpful. I am getting better." There was no treatment for the event. The action taken in response to the event for diphenhydramine hydrochloride was unknown. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 06-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pneumococcal polysaccharide vaccination at 3:00 pm, normal activity at gymnastics class 5:00 pm to 6:00 pm, arrived at school open house at 6:30 pm, may have gotten too warm walking around school, at 7:00 pm first squatted down and claimed she could not breath, within 5 minutes began vomiting violently for about 5 minutes, then appeared to be passing out and had a seizure, total event lasted approximately 15 to 20 minutes, ambulance arrived 7:23 pm
patient was given high-dose senior quadrivalent influenza vaccination instead of quadrivalent vaccination
I had side effects the day after the shot: severe vertigo; headache; muscle and joint pain; sore throat; slight fever; chills. A few days later I noticed a haze over my right eye (with the corneal transplant )  that did not go away. A few days after that I had eye pain and sensitivity to light. I sent an email to my doctor and they scheduled an appointment.
I had mild tinnitus before getting the Janssen COVID-19 Vaccine.  Around 10 hours after getting the shot, I started  having chills, fever and muscle aches. My tinnitus got really loud at the same time in both ears and has stayed loud. The rest of the symptoms cleared up after 48 hours. My tinnitus is still very loud and has not returned to pre-vaccine levels.
Itching started at injection site  on 3/18 with a raised red  area about  2" in diameter for another two days,
pt recvd vax; given apap & motrin;t 101; sz at 2:30;to med ctr;placed on ventilator until 9jan95
The vaccine site turned red, was very painful and was like a round knot that  grew from about 1 inch radius  to a  2.5 inch radius in two days.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic Reaction post vaccination) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic Reaction post vaccination). At the time of the report, HYPERSENSITIVITY (Allergic Reaction post vaccination) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter.
Myalgia, NauseaVomiting, chills, swollen neck and armpits, exhoustion Narrative: has been taking zofran rx for nausea and advil cold/sinus for allergic reaction(swelling).. Referred to PCP , agreed to plan
eye rolled back in head, t100-101 slept afterwards x 2; family hx of sz;