chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced hives in my right elbow within 2.5 hours of receiving the injection. Other areas of my body feel itchy.
Please read portal message below from bottom to top to see time course of symptoms/signs.  Message ( 09/29/20 (Tue Sep 29) 08:11 Am - Portal message You unfortunately had many side effects from the flu shot. It should subside over time. Over the counter meds to alleviate your symptoms is all that we can do at this point. I am glad your COVID test was negative.   ( 09/29/20 (Tue Sep 29) 08:05 Am - Portal message from) Hi, COVID-19 test came back negative. :) Temp remains elevated, between, 100-101F. Tylenol/ibuprofen bring it to 99-100F. Lethargy remains moderate, occasional headaches, but not as severe; cough is gradually increasing in frequency but not persistent/severe. It has been 11 days since I first started feeling ill. Hoping I'll turn the corner in the next few. Thanks,   ( 09/24/20 (Thr Sep 24) 10:54 Am - Portal message   You can go ahead and get a covid test to be sure. Urgent care can do that for you.  ( 09/24/20 (Thr Sep 24) 10:49 Am - Portal message from) Hey, Here we are 3 days later. My temp has been in the 99-100.0 range most of the last 3 days. I do not feel horrible, but I'm not well. Pain in back is better (1or2 out of 10); headaches less consistent but still bothersome (3-5 but not constant). The reason I write is that this is day 7 since my Friday morning flu shot, and my temp is going in the wrong direction. 100.2 a few hours ago. 100.3 a few minutes ago. Likely due to temp, overall fatigue, malaise, eyes burning a little. I will take some tylenol. My big question is whether I should do more/different. My temp is nearly at the point I need to report to UB as having COVID sx and then be mandated to get a COVID test (and be quarantined for 2 weeks - I'm not going anywhere now, but...). Should I just go ahead and do that? Thanks,    ( 09/21/20 (Mon Sep 21) 12:04 PM - Portal message  Sorry to hear. Symptomatic care for you. Some patients get more symptoms than others. You can continue to do what you have been.   ( 09/21/20 (Mon Sep 21) 11:36 Am - Portal message from) Hey, Within hours of getting my flu shot this past Friday, I began to have headaches. Pretty bad on Saturday (up to 6/10), forcing me to lay down for a couple of hours (which I don't normally do). Because they were worse when I bent over, I figured just sinuses and took Sudafed. Still going today though, and yesterday and today my lower back has been hurting (4/10). As my chart shows, my temp is typically 97.6-98F. However, it's been running between 98.6 and 99 over the past 2 days. Not a fever, but a bit higher than usual. Anyway, I'm not terribly concerned, but I wanted to check in and ask you if I should do anything other than continue with Sudafed and acet/ibuprofen - which seem somewhat helpful. Thanks,
Patient is a 84 y.o. male with a history of atrial fibrillation, CAD, hypertension, hyperlipidemia, CKD, metastatic carcinoid tumor that presented to the ED with weakness and loss of appetite. Patient states that for the past two weeks he has felt overall weak and fatigued. He has not had any falls or specific side to his weakness. He also has had a dry cough for several weeks. No fevers, chills, lightheadedness, palpitations, chest pain. States he has had shortness of breath for a long time, mainly with exertion, and it is not any worse now. He took a home COVID test 6 days ago which was positive. For the past couple of days he also has noted decreased appetite and subsequent decreased oral intake, has not been taking much fluids in. He is not nauseous, or has any belly pain. He otherwise feels well and has been taking all of his medications as prescribed.  In the ED, T 36.5, BP 112/63, HR 90, RR 24, SpO2 91% on room air. Quad test positive for COVID, negative for influenza A and B and RSV. CXR was negative for acute cardiopulmonary processes.  Patient was subsequently admitted to the hospital.
This was NOT an Adverse Event.  The vaccine was in freezer longer than 14 days.   The patient was advised to revaccinate per CDC.   Patient got Re-Vax 11/3/2021
Sore throat, swelling within 2 days of Flumist, persisted for weeks,then tinnitus.  Still having URI symptoms 1 month after Flumist.
On 25 February I began experiencing dizziness with severe headaches/migraines.  Symptoms intensified to where I was unable to walk without assistance and had to lay down with low lights due to severity of migraines.  Most severe timeframe of symptoms was between 21 March to 19 April.  Then symptoms began to improve, but not go away completely.  I still experience severe headaches and days of increased dizziness monthly.
pentacel was given subcutaneous this morning in error with no adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 months old male patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] was given subcutaneous this morning in error with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13), Hepatitis B Vaccine and rotavirus vaccine live reassort oral 5v (Rotateq) for immunisation.  On 14-Jun-2022, the patient received dose:1 of 0.5 ml total 1 day (once) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection, lot UJ648AAA expiry date: 25-Feb-2023 via subcutaneous route in the left thigh for immunization.  On 14-Jun-2022 the patient was given Pentacel subcutaneous this morning in error with no adverse event (incorrect route of product administration) (Latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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 guidelines. 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.
She received Gardasil 9 vaccine on 9/17/20, felt typical soreness in her left upper arm for the next 3 days, but on the 4th day, she developed "severe pain" in her left lateral upper arm. She is an avid athlete, but a few days prior to vaccination, she threw out her back and was taking a break from her usual work-out. On 9/21/20, she did lift a heavy desk up some stairs, and her severe pain started some time after this activity. She presented urgently to hospital on 9/26 and was advised to increase ibuprofen to 800mg PO TID with food.  The pain is located "right on the deltoid attachment and feels like stabbing into the bone," not like a muscle strain. The pain radiates down into her left fingers and she struggles to lift her left arm above 90 degrees. She feels the pain has stabilized now, but it's adversely affecting her life. Denies swelling, bruising, or erythema of left shoulder or upper arm, and there is no worsening of pain when she palpates the left upper arm. She can't lift weights or sleep through the night due to the pain. This lack of sleep "is frustrating as a grad student." It wakes her up around 5am despite taking Advil q6 hours and Acetaminophen qHS. The pain is the worst in the early mornings. Advil does reduce her pain, but doesn't eliminate it, and unfortunately, it's now upsetting her stomach.
pt c/o dizziness and headache. Pt. was made to lay down on gurney with lower leg extremities elevated.   Vitals monitored: BP 136/98  93P  18RR  o2 sat 99% RA  pt c/o of nausea pt was offered water and made to sit up to help with nausea.  vitals: advised resident to inform primary regarding symptoms after covid vaccine.   pt. stable with relief of symptoms noted and went home.  #23: dizziness on first covid vaccine. pt informed primary MD
I experienced left shoulder joint pain immediately after the vaccination was administered. Over the course of the day, the pain traveled up through my shoulder into the left side of my neck. My left arm became weak and it  was difficult to lift it above my head. The pain also traveled down my left arm into my left hand and became more intensely painful that night and the following day and a half.  My left hand became stiff and blood vessels ruptured in my left fingers. Three days out from time of vaccination pain is beginning to subside, but I?m still sore and am experiencing prickly pains in my left arm.
Information has been received from a physician concerning a "17 years old" male who on 28-SEP-2011 was vaccinated with a dose of GARDASIL intramuscularly (Lot#: 669796/0840AA, Exp. Date: unknown) along with a flu shot (unspecified medication) (manufacturer unknown). The patient complained about a headache and loss of vision in one eye about a week later (on 05-OCT-2011). The patient did not seek medical attention. No treatment was given. Therapy with GARDASIL continued. AE had been improved on therapy. At the time of the report, the patient had recovered with the date unknown. Follow up information was received from a licensed practical nurse concerning the patient reported that it wasn't until the patient came in for his second dose that the patient mentioned the adverse event. The patient simply stated he had a loss of vision in one eye about a week (on 05-OCT-2011) after the first dose of GARDASIL. There was no information as to which eye was affected, how long the event lasted, or to what level the vision was lost. Since the physician did not know about the event until later, no testing was done. The nurse did not know if the vision loss was disabling or life threatening, or if hospitalization was needed. The nurse also gave the patient's D.O.B. The patient had a concurrent condition of "anxiety with persistent worrying" and had been prescribed LEXAPRO. The nurse did not know if the patient was taking the LEXAPRO at the time of the event. A second dose was not administered. Upon internal review, loss of vision in one eye was determined to be an other important medical event. Additional information has been requested.
Janssen COVID-19 Vaccine EUA I had a slight headache the evening I received the shot.  I woke up feeling extremely tired, groggy.  Fog like and woozy, dizzy for several hours on March 9th, the day after I received the vaccine.  My side effects went away after about 36 hours.
This spontaneous report was received from a medical assistant and refers to a 69 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L018503 and expiration date 16-MAR-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administration error (patient did not experience any adverse reactions): Second dose given 15 days after first dose (Dose 1 = 05/03/2021, Dose 2 = 05/18/2021). I gave patient a dose of Pfizer today, 04/18/2022, which is considered the second dose since the second dose given on 05/18/2021 is void due to exceeding the 4-day grace period as described on the CDC website (below).
Information has been received from a physician concerning a 64 year old female patient with no known drug reactions/allergies who on 10-JUL-2008 was subcutaneously vaccinated in the left with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 659615/0162X). The physician reported that on 30-NOV-2009, the patient developed shingles. It was reported that the patient developed Zoster facial and in the eye area. No lab tests were performed. The patient was prescribed VALTREX, KEFLEX and topical medication (name and manufacturer unknown) for the treatment of shingles. It was noted that the patient was referred to an eye specialist. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the physician who reported that the patient was and had a weight of 162 pounds. It was reported that the patient had already had one previous dose of ZOSTAVAX (Merck) prior to the one administered on 10-JUL-2008. No illness at the time of vaccination. No rash occurred at the site of injection or elsewhere within 42 days of the vaccination, and there was no recent exposure chickenpox or herpes zoster. Physician confirmed that the patient developed zoster rash on the trigeminal nerve area (previously reported as "zoster facial" and "zoster eye area") on 27-NOV-2009 (previously reported as 30-NOV-2009). Clinical diagnosis was confirmed by ophthalmologist. No corneal lesions. On an unspecified date the patient recovered. The adverse events of zoster facial and zoster eye area were considered to be other important medical events by the physician. Additional information is expected.
Information has been received from a nurse practitioner concerning a 22 year old female who on an unspecified date was vaccinated with a first dose Gardasil (lot number unknown). Subsequently the patient developed genital warts. At the time of reporting it is unknown if the patient has recovered. Additional information was unavailable. Additional information has been requested.
Patient reported dizziness and a fainting episode the morning after her immunization. She knew she was getting dizzy and she attempted to get into her recliner, but fell into her recliner and injured her rib and possibly her 'tailbone'. She went to the Emergency Department  where she was examined and scans were taken of her ribs. She was determined to have 'bruised' ribs and sent home with advice to take ibuprofen and acetaminophen alternately every 4 hours for pain relief. She has been at home since this episode. We only found out about this adverse event this week when we called her to confirm her second immunization. She reported this fall to us and was reluctant to get the second shot. I reported the event to her provider, and now to you at VAERS.
Dizziness, Headache, Myalgia, NauseaVomiting, shortness of breath Narrative:
Patient was vaccinated with Smallpox on his left arm on 20 May 2009.  Pt's Smallpox blister 'popped' in his sleep the night of 30 May.  He noted that it leaked through the bandage, his T-shirt, and down his arm upon awakening.  The following day, 31 May, he noted a small lesion below his right nare.  He covered the lesion and sought his unit corpsman.  Then brought him to sick call on 1 June, where he was evaluated.  The lesion was a pustular Smallpox lesion and did not extend into the pt's nose.  The lesion was covered after bacitracin was applied.  Pt placed until lesion scabs over with daily site checks.
I have had headaches for years but the frequency has increased.  I was typically having headaches about 2/week but starting about 10 days after the second Moderna shot I'm have them 4-6 times a week.
Site: Bruising at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild, Additional Details: PAtient had transient fainting spell and later vomiting after recieveing the COVID bivalent booster, she was under the care of her parents who were both present and requested we not call EMS services.  She passed out but returned to consciouness within 1 minute.
Information has been received from a physician concerning a female who was vaccinated with a 0.5ml dose of GARDASIL and fainted. After the patient came to she fainted again. The patient seemed better when she was leaving the office however later that night she was still didn't feel well and she went to ER for medical attention. The tests showed that the patient had long QT. At the time if the report, the patient's outcome was unknown. Information has been received from a health professional concerning a 13 year old female with viral-wart on foot at the time of vaccination who on 07-JUL-2009 was vaccinated with the first 0.5ml dose of GARDASIL (lot#659437/1266U) in the left deltoid. On 07-JUL-2009 the patient experienced short episode syncope at 2:52pm. On 07-JUL-2009, the patient recovered. No further information is available.
Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and appetite loss. This lasted about 30 minutes. 36 hours after vaccine I experienced headache, swollen tender left lymph node above collarbone and elevated BP 167/90. This improved after taking Advil.
Pt received unnecessary COVID bivalent vaccine today. Pt received Pfizer Monovalent on 1/18/2022, 2/8/2022 and 7/27/2022. Pt received Pfizer Bivalnent on 12/1/2022 then received Moderna Bivalent today, 7/27/2023.
Monovalent mRNA vaccine administered for a bivalent mRNA dose.  Patient was given the monovalent mRNA vaccine, as I was not aware at the time, that the EUA had been withdrawal by the FDA.  My supervisor received noticed on 05/01/2023 from Health Department with a link to the Department of Health and Human Services which announced updates to Covid-19 vaccines.  That the Bivalent Moderna & Pfizer BioNTec vaccines were to be used for all doses administered to those 6 months of age and older.  In the announcement, NO where did it state that this change had gone into effect the month prior. I was forwarded the email announcement  on 05/02/2023 and it was read on 05/03/2023 as soon as I returned to the clinic office from doing vaccinations I destroyed all remaining doses of our Pfizer monovalent mRNA FP7136 vaccine.   The patient suffered NO adverse affects and had NO adverse events following his vaccination.  This patient was notified on 05/19/2023 regarding the need to have his vaccine repeated with the updated Pfizer Bivalent vaccine and the patient agreed and was given the updated Pfizer Bivalent vaccine Lot GJ3270..  Patient tolerated well.
Information has been received from a consumer referring to her child, a 16 year old patient. The patient was a female to male transgender who received testosterone (manufacturer unknown). On unknown dates the patient  was vaccinated with two doses of GARDASIL (dose, route and lot # were unknown). The patient experienced "stomach pain" and "nausea" (date unspecified). The reporter stated that the second shot was "worse" (she did not clarify  how it was worse) than the first. The outcome of the events was unknown. Causality was not provided. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Leukaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imatinib, reaction(s): "Known allergies: Imatinib"; Epinephrine, reaction(s): "Known allergies: epinephrine"; Codeine, reaction(s): "Known allergies: Codeine"; Sulfur, reaction(s): "Known allergies: Sulfur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: Unknown. Paxlovid: Treatment start date= 04Dec2022, treatment stop date= 09Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Light headed and weak lasting for about 2 hours before going to sleep. Felt better the next morning.
Pt woke with varicella appearing rash less than 24 hours after receiving vaccine. Torso and back were covered and had some on arms and legs. No known exposure to varicella.
PATIENT FELT GROGGY; VACCINE VIAL KEPT IN THE FRIDGE FOR MORE THAN 6 HOURS OF BEING PUNCTURED; EXPIRED DOSE RECEIVED; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 24-JUL-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced expired dose received. On an unspecified date, the subject experienced subject felt groggy, and vaccine vial kept in the fridge for more than 6 hours of being punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired dose received, patient felt groggy and vaccine vial kept in the fridge for more than 6 hours of being punctured was not reported. This report was non-serious.
pt. vaccinated at a local outreach. vaccine provided based on database records at the time of vaccine. pt. presented without vaccine card. booster given too close to primary series. recommended interval was not met. pt. was vaccinated 2 days apart.
I felt great after my shot for several hours, then about 3:30pm I began to have a slight headache that became worse, then felt nauseous, then at 4:30pm I threw up for the first time. In the next 6 hours, I threw up 2-3 more times, the headache also became worse (7 on a 0-10 scale), I got chills and was sweating, and could not get out of bed. My arm was sore, but the other sx were so bad, I did not notice. By midnight I was a little better. I slept on and off for 18 hours, then by 2pm, I was good enough to get out of bed and take a shower. I slowly became better and better and today (Monday - 3 days later), I am fine and was able to run a few miles.
Patient developed rash 2 hours after vaccine while at home. They worsened x 12 hours and patient developed mild swelling on hands and feet. Denies difficulty breathing, swelling of mouth, difficulty swallowing, etc.  No medication given. Mother gave a tepid bath which improved rash.
Rabies 1 had palpitation episode x 60m; Rabies 2 had aching all over episode and sleepiness x 2 days. Vaccine given due to place of employment.
Felt mild sore throat and noticed that my mouth just did not feel right.  Looked with flashlight and saw lesions and white lines on both sides of my mouth.  Since I had a dentist appointment schedule for Tuesday (3/23/21), I called them and they said to keep the appointment and they would check it out.  The dentist examined me and the diagnosis was Lichen Planus.  They recommended that I report this since this is the first time this ever happened to me and the only thing I recall that was out of the ordinary was getting vaccinated.
Symptoms showed up as swollen lymph nodes on left side of neck and head (around ear) with swollen bumps running up the back of the scalp. These large bumps eventually split into a painful rash and scabbed over.
1DEC92 clinic reported pt was found dead that day & that shots had been given @ the clinic on the day a/;
Information has been received from a physician concerning a 2 month old male who was vaccinated with an oral first dose of Rotavirus Vaccine. Subsequently the pt experienced a blood stool and abdominal pain and had to be taken to the hospital. The duration of the hospital was not known. At the time of the report the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.