chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurses mistakenly administered FLUZONE QUDRIVALENT to a patient instead of COVID vaccine with no adverse event; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of age Under 35 years old and unknown gender who was reported with nurses mistakenly administered influenza quadrival A-B vaccine [Fluzone QIV] to a patient instead of covid vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect influenza quadrival A-B vaccine suspension for injection at a dose of 0.5 ml once (expiry date and strength: unknown) lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the nurses mistakenly administered influenza quadrival A-B vaccine to a patient instead of covid vaccine with no adverse event (wrong product administered) (unknown latency) following the administration of vaccine.  Action taken was 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.
Rabies booster shots (2)- day 0=6/17/08, Day 3= 6/20/08 booster. Peripheral neuropathy- hands, feet, arms, legs-tingling and numbness commenced 6/28/08. Increased symptoms until about 7/17/08 when symptoms began to lessen. Currently minor numbness and tingling remaining.
Patient has signs and symptoms of celluitis or allergy in the arm. warmth, redness, spreading  started a few days before 10/8/21 and the vaccine was administered on 9/29/21
Healthy 18 yo female presented with 4 days of fever, chills, vomiting, diarrhea, headache., as well as mid-sternal chest pressure.  She had lab tests as indicated below that were consistent with a diagnosis of MIS-C. She was treated with IVIG and demonstrated significant improvement in symptoms following IVIG
Patient reported lightheadedness within 30 mins after vaccination. Patient denied any other symptoms. Patient was also noted to be hypertensive (BP=160/100) upon taking vital signs.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (therapy dates, route not reported). The reporter stated that on an unknown date the liquid shot out of the injection site on to her hands, while reconstituting vial of ZOSTAVAX (therapy dates, route, indication not reported). The nurse immediately washed her hands and had no side effects. A product quality complaint was filed to document vial pressure irregularity. The outcome of the event reported is unknown. Additional information has been requested.
ADMINISTERED VAXCHORA THAT WAS EXPIRED; PHARMACY STAFF WERE IN A HURRY AND GAVE EXPIRED VAXCHORA; This spontaneous case report (PVX2019-2893) was received from a pharmacist on 22-Nov-2019. It described an adult male consumer who was "administered expired Vaxchora" (PT: Expired product administered). It was reported that the "pharmacy staff were in a hurry and gave expired Vaxchora" (PT: Product dispensing error). The consumer received Vaxchora for an unknown indication.  Case report: The consumer was administered expired Vaxchora on 22-Nov-2019. It was reported that pharmacy intern were in a hurry and gave Vaxchora (lot# 7000015) that was expired in Oct 2019.  Action taken with Vaxchora with respect to the reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "administered expired Vaxchora" and  "pharmacy staff were in a hurry and gave expired Vaxchora" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "administered expired Vaxchora" and  "pharmacy staff were in a hurry and gave expired Vaxchora" was considered as not applicable.
Pain, redness, swelling, itching , and rash at injection site. Had similar reaction to varicella vaccine at 12mo.
Fever, twitching/vibrating legs, very out of it/spacey, site was sore and hard bump. Gave Tylenol.
Right after the shot I had diarrhea, was dehydrated and the ER kept me for several hours to hydrate me on the IV.  Then afterwards everything seemed  OK .  SO mid May I started bleeding very heavily. My menstrual cycle is very irregular and out of whack now. I literally bleed like all month and it hasn't gone back to normal. Then on memorial day I woke up with severe abdominal pain, I was very much in pain and went to the ER. They did a CT with contrast and they saw I had severe inflammation in my stomach and colon. They started giving me intravenous antibiotics and antibiotics to take at home for ten days. At home, I got another infection. I went to the ER again and it was diverticulosis and they gave me another antibiotic in which I had just finished a couple days ago so we will see. I also had Covid in March of 2020. Nobody can tell me why I had diverticulitis because I am vegan, I eat fiber all day and I am not overweight and there is not history of it in my family. All this happened post vaccination so I am not sure if it is worsened due to having Covid in March of 2020. I have also been to the GI DR as well as the ER. My menstrual cycles are completely ruined and that started after the vaccine actually but gradually got worse to where I could not stop the bleeding. I was warned not to take the vaccine due to my Covid in March of 2020 but I live in and didn't feel safe without it. I had surgery done on Thursday May 20, 2021 at to attempt to help my excessive menstrual bleeding. Dr did that, 212-517-9048 is his number. I have also been put on hormones because my menstrual cycle won't go back to normal. I am also on prescription famotidine 40MG for my stomach indefinitely. I also experienced irregular heart palpitations and I did see my Cardiologist and they didn't find anything abnormal, this was on 3/10/2021.
Woke with Fatigue, cold, swelling under Left axillae, wEakNEss, swElling in dEltoid area
.Swelling of left thigh from DTAP and right thigh MMR and PCV
The pt became purple, was gagging and progressed to the left arm shaking. Care-taker called 911, rescure breath given, his color improved. After shaking ceased, pt was lethargic and sleepy. Temp 101 deg. F.
8:33am EE states she feels flushed and heart racing.  BP 141/83 P-96 PO 100% Refused Benadryl.  Denies SOB, chest or throat tightness, no itchiness.   RN notified. 8:40am C/O warmth, no itchiness, no SOB, no tightness in chest or throat. BP 137/81 P-77 PO 100%. 8:50am 138/83 P-65 PO 98% abdomen with some light rash. 8:55am Benadryl 25mg given per RN 9:05am BP 129/87 P68 PO 100% c/o left eye feeling warm, no redness. 9:30am BP 127/84 P69 PO 100% denies heart racing, feels fine, Instructed to take Benadryl again if has reoccurrence and to call the Covid vaccine line or 911 if any resp distress.  EE states she understands. RN
LEFT ARM HAD LARGE INDURATION APPROXIMETLY 9.5CM WARM AND PAINFUL TO TOUCH. MEMBER REPORTS SEVERAL RED BLOTCHES ALL OVER HER BODY.
Pt recvd 2 doses of Engerix-B vax & following 1st dose devel h/a, nausea, inject site pain which resolved w/o tx; following 2nd dose devel same sx sz all were more severe; resolved w/o tx in 4 days;
chemical taste on tongue; stiff neck; felt a bit hot; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (chemical taste on tongue), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING HOT (felt a bit hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING HOT (felt a bit hot). On 30-Apr-2021, the patient experienced DYSGEUSIA (chemical taste on tongue). At the time of the report, DYSGEUSIA (chemical taste on tongue), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING HOT (felt a bit hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
The plunger on the FLUMIST didn't allow for 50/50 distribution in each nostril. FLUMIST sales rep notified and lot number shared.
Initial headache, followed by headache, fever and stiff neck. This was followed by 12 days of weakness and exhaustion. Some confusion.
Started w/ coughing to clear throat losing voice some trouble getting a full breath. About an hour later started w/ body aches, sore throat fever, stuffed nose. Pale and swelling under eyes. Took Benadryl and Ibuprofen. Felt mostly better the next day.
Two days after receiving the flu shot the patient developed pruritus on ankles (bilateral). Reaction spread to lower extremities, back and shoulders. Hyperpigmented marks on the abdomen. Excoriated marks noted. Patient has been self medication rash. Methylprednisolone 4mg as directed MG UD, hydroxyzine 25mg q6h MG UD, clobetasol apply sparingly to affected BID.
Started with hands and feet itching then started to get red and blotchy all over. Tongue started to swell. Given epinephrine 0.3mg  in left thigh and then monitored x 15 minutes. Redness and swelling of tongue went away.
15-20 min after vaccines- as leaving the building she had trouble breathing and stomach hurt-came back and was wheezing. EPI PEN, Jr. given. BENADRYL and Albuterol neb/O2 given. Pulse Ox was 90%-911 called and to ER.
Presented with shingles rash 2 days after administration of zoster vaccine. Shingles rash to right trunk.
Large red, warm, hard lump 2" x 3". Painful where SQ varicella vaccine was given. Occurred within 24 hrs of the inj. Pt seen about 20 hrs later. Applied cold compress, Ibuprofen, monitor for infection will see in 2 wks if not better.
Day of vaccine at approximately 11:45AM I noticed that my entire throat area, and upper portion of my chest was really bright red so I took a dose of OTC benadryl and when it subsided I didn't think about it any further. After that day I was good for the following 4 or 5 days, and then woke up with tummy cramps and just did not feel good at all, I thought maybe I needed to eat something because I didn't eat with the previous nights bed time meds. About 30 minutes of still not feeling well I had watery stools immediately followed by vomiting, hot and cold flashes, and profusely sweating all over. The only comfort I could experience was when I slept. That all lasted about 36 hours and the crampy discomfort another 2 or 3 days passed that. I am now fine.
This spontaneous report was received from a back office lead referring to a 18-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a seizure about 5 to 10minutes after vaccine was administered. Full body seizure and patient slide down to the floor from the chair he was sitting. Seizure lasted about 30 seconds. We had the patient lie on the ground until ambulance arrived. Patient was able to answer questions and said he felt calm after seizure was over. Patient was able to walk and fully alert when ambulance arrived. Patient was taken to hospital by ambulance.
Episode of elbow pain 1 wk prior to vaccine administration. During the night approximately 11 hours after administration, developed a sharp pain in left elbow. Rated 9 on 1-10 scale. Pain subsided in 24 hrs. Follow up with PMD on 10-20-14 and PMD did not feel pain was related to Flu vaccine since she had prior. P.T. recommended. Pain returned and unable to move fingers. EMG 11-7-14.
This spontaneous report was received from a physician and refers to a 3-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-AUG-2018, the patient was inadvertently vaccinated with a third (extra) dose of VAQTA 25/0.5 (units not provided), intramuscularly, lot # N023953 with expiration date on 05-NOV-2018 (dose was not reported) for prophylaxis. No adverse effects were reported.
diagnosed with mononucleosis 3 weeks ago; feeling fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 21-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious) with onset Sep2022, outcome "unknown", described as "diagnosed with mononucleosis 3 weeks ago"; FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "feeling fatigued". Additional information: patient was diagnosed with mononucleosis 3 weeks from this report and they said it could take months before he is not feeling fatigued and all of those things.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This patient came in for dose two of this vaccine on (7/28/2023). After these vaccines were administered the RPh filling out the patient's vaccine card noticed the vaccines were administered too early (First dose was administered on 7/8/2023). The patient is aware and is going to return ~8/7/2023 when he should have been due for the 2nd dose of these vaccines.
Flu like symptoms, full body aches, 98.8 temp  Felt better 24 hours later having taken ibuprofen.
Headache, dizziness, sweating. Pt is better w/in 24 hours. Pt is a nurse.
Patient experienced peripheral edema with warmth and pain approximately 9 hours following vaccination. Patient was seen at urgent care and prescribed ibuprofen 800 mg by mouth three times a day. The following day, patient reported that edema had spread further down her arm with increased redness. She saw her primary care provider who initiated cephalexin 250 mg every 6 hours for 10 days.
Moderna 1/21/21 and 2/24/21. Positive on 1/23/22
Information has been received from a physician concerning a 15 year old female. The patient received her first dose of Gardasil and had no adverse reaction. On the week of 23-APR-2007 the patient was vaccinated with Gardasil second dose. Immediately after receiving her second dose, the patient's arm which received the injection began to hurt, the patient became dizzy and passed out. Her lips turned blue. Unspecified medical attention was sought. The patient was not given any other vaccines on the day she was given her second dose of Gardasil. Subsequently, the patient recovered from the arm pain, dizziness, passing out and lips turning blue. Additional information has been requested.
Patient was given only the diluent, the vaccine had not been added to the syringe.
Minor is not having any adverse reaction at this point. Minor received 2 doses of Covid bivalent in a period of 2 days difference.
This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262 and expiration date not provided), via an unspecified route of administration (left arm) second dose on 28Jan2021 11:00 at single dose for Covid-19 immunization. The patient's medical history included Seasonal allergies, allergic asthma, Allergies: Penicillin, and Allergies: Grapefruit. The patient was not pregnant at the time of vaccination. The patient's concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE). The patient's historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiration date not provided) first dose on 07Jan2021 left arm (age at the time of vaccination was 31-year-old) for Covid-19 immunization. On 29Jan2021 11:00, the patient experienced Swollen lymph nodes (left armpit). The patient did not received treatment for the event. The outcome of the event was not recovered.
Angioedema, UrticariaPruritus, "SWOLLEN, RED DELTOID, ITCHY Narrative:
11-12 day after injection developed red hard area no painful quarter size.  Resolved without  sequelae.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medication and drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not provided). The syringe used to draw up the GARDASIL from the vial and injection the patient "leaked" and the patient did not receive the full dose of GARDASIL. It was verified this was not a product quality complaint (PQC). No adverse effect was reported. The outcome of medical device complication was unknown. The relatedness between medical device complication and GARDASIL was not reported. Additional information has been requested.
Cannot hold anything on her stomach. Uncontrollable peeing and motion sickness. Bones are painful.
Mother reports redness and swelling from the elbow to the top of the shoulder. The area was hot to touch, "hard as a rock", and extremely painful required pain relievers. She reports the child had extreme lethargy/tiredness for the first 24 hours after the vaccine. She also had hives for 5 days. Mother treated the hives with Benadryl
Breathlessness and feeling slightly faint when doing strenuous exercise - don't get these anymore but it did happen a three of four times altogether (not in the last two months) when doing cardio. Separately: Mild chest pain/ache - mostly on right side but also on left side. These would randomly come and go. They have subsided over the last six months. I still get twangy kind of aches in my chest - that still lingers to this day.  My doctor thought it could be anxiety and/or that my fitness had gone down since COVID-19. I don't really agree with that last one.
I did not have an acute reaction immediately after the 1st or second shot. The adverse reaction followed hours after the second shot and have continued now for mover a month. Following the second shot, I had the normal, 2 day, in bed, flu-like symptoms only they were worse than a typical flu. Once the severity started to life, I was left with migraines every day for 1 month now. I have spoke to my primary care to try various medications that have not worked. I'm now scheduled to see a specialist on 4/30.
Dizzy, heat radiating, nausea, memory & speech problems, tingling, headache. This lasted till after 8PM 12/05/2012. Went to hospital and got a shot of Benadryl & a steroid shot.
Severe headache for 10 days. Muscle aches, joint aches, chills, and fever of 105 degrees for two days
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2013, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Seen in ER for local swelling, soreness at injection site (DTaP).  I saw him on 4/2 and he had slight bruise there and local reaction decreased.
A lot of pain in my right arm in my shoulder, elbow, wrist. Lots of aching pain and weakness like trying to pick things up is difficult arm felt really weak. Putting heat on different areas to try and help the pain. I've had RA for 20 years and you just have pain at different times for different reasons. At first, pain was there and I just dealt with them. I would put heat on them just to help with the pain. It just got to the point where, in early December, that I just didn't think it was normal and saw my rheumatologist early on Dec 6, instead of in January. She did some blood work but Didn't examine the arm really. She talked about changing medication, and she said that it would go away. So I continued taking Enbrel until the end December then switched to Humira. Holidays came along, but still just in a lot of pain, hard to sleep. By January, I remember she said I could take prednisone and I took a little bit of that. I reached out to both of my doctors, PCP and Rheumatologist. By January 10, I couldn't handle the pain anymore and got into my PCP on January 11, and she said because I was switching medications, I was transitioning and that that could be it. I emailed my Rheumatologist, and she mentioned the same thing with switching medication. She put me on a month long tapering of prednisone, and we need to wait and see for that. Prednisone has helped and I'm tapering, and it feels like it's coming back. Not sure if it's in relation to the vaccine, but it occurred after.
pt recv vax 11MAY98 & 13MAY98 pt devel swelling & tingling of lower lt leg;s/s worse, progressed up leg
Hallucinations in the last month or so, mostly when waking up after falling asleep during the day. Just occurred after getting the first shot and have happened sporadically over the last month or so.
Thought I felt fine, but lightheaded, dizzy upon leaving clinic, waited in my car for a while drove home with adult daughter passenger, still felt lightheaded and dizzy. About an hour later headache, body aches.  Injection site not bothersome. Came home, rested, still resting, still  feel ?off? continuing mild symptoms at 10 pm.
About 5 minutes after the shot my tongue went numb for about 40 minutes and then it started to tingle.