chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days following vaccination: "My head started itching and I had difficulty breathing, numbness in my face and tongue, pain in my throat that felt like food stuck in my throat and dull pain throughout my chest." Three days following vaccination: patient went to the Emergency Department with raised red itchy rash all over body. ER administered Benadryl I.M. and advised patient to buy OTC Benadryl and continue taking. Treatment at the ER improved condition, but on day four following vaccination: rash was worse. On day five following vaccination: patient was examined at the clinic and received steroid cream, more Benadryl (Rx). Patient did not realize her Rx "Diphenhydramine" was the same as "Benadryl" and was taking both at the same time. On day six following vaccination: patient presented at the hospital ER again, "blacked out three times", and was put on a 6-day course of methylprednisolone (4 mg) tapering tablets starting with 6 tabs first day, one less tab each of the following 5 days. Patient was also advised to continue Benadryl and to start taking Pepsid to avoid stomach ulcers. As of today, patient has a follow-up appointment with the clinic for 9/15/08. Patient also c/o intermittent blurred vision and nerve-like pain in hands and feet, but did not indicate onset.
This spontaneous report was received from the patient's mother, referring to her son, a 17 year old male patient with asthma. The patient had none allergy or drug reactions. Concomitant therapies included XOLAIR. On an unknown date, the patient was vaccinated with GARDASIL 9 or with GARDASIL (dose, route of administration, lot number and expiration date were not reported) for prevention from human papillomavirus (HPV) for both. It could not be confirmed which one was administered. On an unknown date, after receiving the unspecified dose of the vaccine series, the patient developed Crohn's disease. It was reported in addition that, none laboratory diagnostics studies were performed, it was unknown whether treatment was given for the adverse event. At the reporting time, the outcome of the patient for Crohn's disease was unknown and the causality assessment between the suspect products and the event was unknown. Upon internal review the event of Crohn's disease was considered to be medically significant.
Soreness on my arm where I received the vaccine that started around 2h after the injection and got worse. My arm is swollen and painful now restricting the movements
body aches; nausea; headache; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunization. The patient's medical history reported as blood pressure high. The patient previously took the first dose of bnt162b2 (Lot number: EK5730) on 18Dec2020 for COVID-19 immunization. Concomitant medication included nifedipine extended release 60 mg, one time a day for blood pressure high from 20 years and continuing. On 08Jan2021, the patient experienced body aches, nausea, headache, fever and chills. The patient was neither admitted to hospital nor received treatment for the events. The patient was fine. On 09Jan2021, the outcome of the events was recovered.  Follow-up (03Feb2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on (03Feb2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer in response to Non-HCP letter sent that included: events, suspect product details and relevant medical history.
On Omnicef 1 wk prior to flu-resp sx's - on Levaquin day of, felt ok, no temp. PM-arm swollen, very hot to touch, tender, moving her arms. She felt area, school nurse practitioner saw Mon 10/5-9 cm area, red-reported to us on 10/8/09 area better by Wed 10/7-receive vaccine 10/2/09-no MD follow up-no other sx's reported.
On day 11 after my 1st vaccine my body joints ached like never before from my toes to my ears.  I am not 100% sure the pain level had gotten some what better or if the Aleve that I added to my daily meds for this joint pain, & the OxyContin I take on a daily basis for the past 18 years is masking it more.  It is making my hands feels so sore like I assume someone with Arthritis feels.  I also get nerve shooting pains in my thumbs & right arm.   My question is;  is this a reported side effect?  If yes, how long does it last & should I get the 2nd vaccine.
I received my second dose of the vaccination around 10:30 am, I felt great all day until I got home from work about 7:00 pm. I developed severe chills which escalated into a 102 fever, with body aches and fatigue by 11:30 pm. The next day I woke up and still had a 102 fever with body aches and fatigue. Throughout the day the fever has started to lower slowly to about 100.
Pain, redness at site immediately. 1 hour later noticed swelling and pain radiating to thumb, neck and scapula. Now pain is better but still feels tight. Took ibupofen 10/10/18 and 10/11/18.
Hives; Red and brown rash on chest; Fever; Nausea; Chils; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH (Red and brown rash on chest), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chils) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No specified medical history has been reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (Hives), RASH (Red and brown rash on chest), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chils). At the time of the report, URTICARIA (Hives), RASH (Red and brown rash on chest), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chils) outcome was unknown.            No concomitant medications provided. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up received on 07-May-2021. Patient initials was updated as Y-T from J-T On 14-Apr-2021: Follow-up received on 20-JUN-2021 and contains no new information.
States at 1501 she received her Influenza vaccine and then went up to work.  States she was cleaning up in an OR room about 1510.  States her hearing was foggy, then she couldn't hear anything, co-workers said she looked white and then sat her down and brought her down to Employee Health.  Arrived in EHS about 1525 and states she has a headache and her arm hurts from the flu shot.  States she feels better but a little dizzy, states she can hear and see. Instructed to rest and lay down.  Employee took her blood sugar and it was 100.  BP was 98/60 in EHS.  By 4:00 PM states her arm hurts, denies headache or dizziness or vertigo. P Drda RN
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 24-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromyalgia and Sjogren's condition; right ankle became swollen; a prolonged episode of her fibromyalgia and Sjogren's condition; joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes); migraines; fatigue; multiple naps throughout the day; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41 Years, at single dose on 17Mar2021 (Lot number EN6207) for COVID-19 immunisation. Medical history included fibromyalgia, Sjogrens syndrome and lactose intolerant. Concomitant medications included gabapentin, ciclosporin (RESTASIS), cevimeline all taken for an unspecified indication and start and stop date were not reported. The patient previously took celecoxib and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, her joint was at a 2. Her right ankle became swollen. Usually, her ankles didn't swell. She also had four migraines during this time - she typically had migraines every two to three months. She experienced fatigue which caused me to take multiple naps throughout the day. She experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, she had brain fog for 2-3 days. Basically, the patient felt like she was having a prolonged episode of her fibromyalgia and Sjogren's condition. The symptoms were still persisting. The patient reported above events was non-serious. It was reported that the adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". And she received treatments for the adverse events including ace bandage for ankles and further monitoring. The patient was not diagnosed with COVID-19 prior to vaccination and she did not test for COVID-19 since the vaccination. Events outcome was not recovered.
Information has been received from a licensed practical nurse concerning an 18 year old female with gastrooesophageal reflux, depression and a penicillin allergy who on 26-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL (Lot # 658094/0524U). Concomitant therapy included LEXAPRO, SEASONALE and PROTONIX. Forty minutes after receiving the vaccination, the patient developed widespread hives and itching. The patient was evaluated in the local emergency room and was given intravenous steroid treatment. The patient was not admitted to the hospital. No laboratory or diagnostic tests were performed. The patient outcome was unknown. The licensed practical nurse considered the widespread hives and itching to be other important medical events. Additional information has been requested.
24 days post vax pt experienced chickenpox on her face and chest with approximately 15 lesions. Pt was afebrile.
Hives, SOB, and left arm (injection site) pain, swelling. Patient also received single dose PCE (erythromycin) which he has tolerated well in past.
pt recv vax & 2 hr later devel t104, irritability, lethargy; these sx all persisted in 4 days; On 4th day had a macular rash on trunk & full fontanelle; LP performed; on 5th day temp gone but still irritable & sleepy
About one week after my injection, I had severe cramping in left leg. On April 5th started with a couple of days with severe pain in tendons of right shoulder. The pain referred into the right neck and base of occiput. On April 7, 2021, I felt off then developed a severe, stabbing headache over my right eye referring back into the occiput.  Was not steady on my feet. Did not eat dinner, went to bed.  Felt tingling around my mouth, and my neck and shoulders were very tight.  I debated about going to the hospital, but decided against it.  Still have tightness on the right side of my neck into the occiput and right shoulder.
Day 6 swollen and painful arm pit on left arm - okay after 24 hours Day 7 injection site red, swollen and painful
2/25/05-3 seizures in 1 day and none since. All in 4 hrs. 1st one lasting 1 1/2 min. and 2nd 1 min. and 3rd 20-30 sec. Afebrile. Mother called  and was told to have VAERS done. 12/12/06 Received medical records from hospital which reveal patient admitted 2/25/05 & d/c to home 2/28/05.  Cough & congestion for approx 1 week prior to admit, then 3 days prior to admission started with severe watery diarrhea, low grade fever, decreased appetite & fussiness.  Fever max was 102.8.  Then on day of admit, patient awoke feeling better & taking fluids.  Then suddenly became limp & cyanotic for approx 1 min then had post ictal period.  Taken to local hospital where a generalized tonic clonic seizure with cyanosis was witnessed.  Patient was afebrile.  Labs at that hospital were WNL, CT of head reported as having low attenuation in left temporal lobe. Then transferred to medical center for further evaluation.  They read CT scan as WNL.  No seizure activity noted.  Neuro consulted by phone Final Dx: Afebrile seizures, new onset; gastroenteritis; & speech problems to be f/u with hearing screening.
Patient is experienced redness and warmness on the underside of the arm (in which the injection was given).  The reaction occurred the day after the injection.
Onset of severe pain in left (injection) arm (from above elbow to hand) and numbness in fingers; followed by difficulty breathing; severe flushing (head and upper thorax); fainting.
go through it it was awful; This case was reported by a consumer and described the occurrence of feels awful in a 93-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient received vaccine and felt awful. No other information was reported. This case has been linked with case US2021AMR073663, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073663:same reporter
8 of 25 employees recv vax & 1 of which was severe;pt had immed systemic rxn (tachycardia-pulse reg, cold sweats, inc BP to 138/100, SOB, extremity tingling;911 was called & pt taken to ER-tx & released;
Pt presented 3/22/2021 with 4 d hx of rash, consistent with significant zoster over left side of chest wall. Pt says pain began approx 4 hours after covid (moderna) vaccine, rash began the next day (approx 20 hours after covid vaccine). rash progressed over the next few days, is very painful and very widespread in the one left anterior chest wall dermatome.
THERE WAS AN RED, SCALLY SPOT AT THE INJECTION SITE. IT WAS ITCHY SO PATIENT THOUGH SHE TOOK BENADRYL. IT LASTED AROUND 1 WEEK TO DISAPPEAR.
rash from head to toe, rash on inside of palms, swelling hands, swelling face, increased heart rate
day of vaccine exhaustion in evening next day more tired and cold with what I was told was peticia / broken blood vesicles on left arm. (Not a rash but lots of red dots on left arm where injection was given). I am a woman who has completed menopause and has not had a period for 5 years and had heavy chunks of blood come out like a period 2 days after the shot with uncomfortable feelings in my stomach. I have also been cold to the point where I am staying under a heating blanket wearing a fleece jacket as well.
Sudden Cardiac Death by Myocarditis on 9/19/22. There were no symptoms prior to his death. He was a healthy young man who just completed his job.
pharmacist has reported that one of their pharmacy technicians administered two doses of the fluzone high dose to a patient with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 94-years-old male patient to whom pharmacy technicians administered two doses of the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Oct-2023, the patient received 2 dosage form (1.4 ml (0.7ml x 2 doses) Frequency: twice) of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (batch number: U8156CA; expiry date: 30-Jun-2024) via intramuscular route in Deltoid Muscle for immunization with no reported adverse event (extra dose administered) (same day latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, A pharmacist has reported that one of their pharmacy technicians administered two doses of the Fluzone High dose to a patient and would like to ask if we have any additional safety informational. AE symptoms: No symptoms  Action taken: not applicable.  At time of reporting, the outcome was Unknown 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.
Pt. c/o (R) arm shocking pain and it feels stiff and immobile. Thew up night she got the vaccines. Feels achey in chest and upper belly area. In exam (R) arm 10" diameter (L) arm 9.5 inch diameter. No redness on (R) arm. (L) arm small 25 cent area redness, blanches.
pt recv vax 11DEC96 & later on the same day pt exp a low grade fever, fatigue/lack of energy, gen achiness & malaise;
Mom called on 03/11/2005.  Patient was too ill to come to school with complaint of left arm and jaw pain.  Afebrile.  Taking Advil with minimal relief.  Also complaint of extreme exhaustion.  Phone private no, was told to seek er help if symptoms worsen.  Also dizzy.
States hives all over body, tight throat, swollen face and hands on 11/26/99.  11/30/99 f/u MD visit, swollen hands, hives.  Received Allegra and prednisone.
I noticed throughout the first month or two after getting each shot, I would get more migraine headache than I am having; the second booster/I always get a little chills and aches some days after; the second booster/I always get a little chills and aches some days after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; LIOTHYRONINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (Dose Number: Booster 1 [Dose 03], Lot no.: FH8027), for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Lot no.: EN6207), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Lot no.: EW0158), for Covid-19 Immunization.  The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "I noticed throughout the first month or two after getting each shot, I would get more migraine headache than I am having"; CHILLS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "the second booster/I always get a little chill and aches some days after". Therapeutic measures were taken as a result of migraine.  Additional information: Patient stated that patient just got second booster, the first two Pfizer and the third booster. patient noticed throughout the first month or two after getting each shot, patient would get more migraine headache than patient having. So, patient guessed finally, just got the booster, the second booster last Friday, 5 days ago and always get a little chill and aches some days after. It's just finally normal thought then sort of okay but then start getting headaches, they did go now for another month or two on and off and just wanted to report it. Patient stated typically they start like later in the afternoon and they usually have to take migraine medicine and then sometimes and patient wake up with it and take my migraine medicine and they will go away, when sleep in patient will be okay but then it will come back again that evening. So it happens for a couple of days in a row and then patient was fine for a while and then the same thing repeats and it goes usually a couple of days in a row and it's more so than patient would normally have my migraines. Patient took the medication Imitrex for Migraine.  No follow-up attempts are possible. No further information is expected.
Pt was very adamant about receiving the FluMist.  After pt received the FluMist, nurse noticed she was over 50 yr old.  Nurse advised pt that FluMist is against the protocols & may not be as effective as the shot for over 50 yr old people.    No adverse reactions known.
p/2nd shot pt devel reddness in arm that felt very warm; spoke w/ CDC said do skin test; skin test provided large hives & red patches w/in 24 hrs;
Patient told me on 10/2/19, that she went to the hospital the evening of the vaccination because she had fever & chills. She stated they sent her home. She stated she felt her fever & chills were related to the vaccination, but they couldn't be sure. I told her I thought we needed to report this to VAERS, but she did not want to, stating they couldn't be sure so she didn't want to report it. I left a message for her family Dr & called VAERS for guidance.
did not get the second dose after four months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second dose after four months) 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.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second dose after four months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second dose after four months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported. No concomitant medication was reported.
Spiking fevers to 103.9, 6 inches of erythema at inoculation site photo available.
Left arm edema running from ULA to LWRIST. Hematoma below injection site, toward bicep.