chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client come to health unit requesting a flu vaccine. Flu vaccine sheet reviewed with client for contraindications and clue vaccine was administered at 1400. Client stayed for 10 mins of observation in front lobby of health clinic. At 1409, RN went to check on client and client reported 5/10 sharp pain above left eye and that eye "felt sluggish." Client also reported SOB. Client was escorted to bed room and VS taken at 1410 BP 114/79 HR- 64 PO2- 99% on RA RR-21 and T-97.4 degrees F. Client then reported 4/10 chest tightness/pressure just below the top of the sternum. 1411 6L of O2 face mask was administered to client. 1412 cap refill and heart sounds assessed and lung clear. 1415 VS BP 106/71 HR- 62 PO2 99% on 6L O2 face mask RR-21 and A&O x4. Client continued to complain of SOB, chest pain and headache. 1418 EMS was initiated. 1423 VS BP 129/74 PO2 99% on 6L O2 face mask RR-20 HR-65. 1428 EMS arrived, report given and care transferred. EMS took client out for additional testing at 1437 and reported EKG clean. Client refused EMS transfer and RTW at 1455.
I started with a fever and chills shortly after,  fever broke and I had sweats. Tired, wiped out, achy muscles,  headache, lump, red, hot to the touch and painful injection site.  Moderately severe for 3 days.  A touch of nausea.   Yesterday and today I feel unwell,  blah. Achy, feverish and tired. I have taken Tylenol which does seem to help somewhat.  Hoping to feel better soon.   My arm feels better today
Two hours post vaccination:  tongue heaviness followed by metallic taste sensation, vomited once after this.  Four hours post vaccination:  nausea, bilateral forearm pain evolving to all over body aches and muscle cramping along with a pulsating headache.  Spiked a fever of 102 F that I treated with 500 mg of Tylenol.  Later took ibuprofen for body aches.  Had frequent urination along with unexplained crying.  The lowest the fever would measure for the next 24 hours was 100 F.  I was taking Tylenol and ibuprofen as directed on a regular basis.  On Thursday 1/21/2021 at 5:55 pm, I woke up drenched in sweat.  I felt weak yet improved.  Headache and back pain were less.  Showered and moved to the couch in living room attempting to watch TV.  Could not stay awake.  Woke up three hours later again drenched in sweat.  Showered and went to bed.  Slept through the night and woke up at 8 am with body aches, muscle cramping and nausea gone.  Night gown and sheets were damp with sweat. Lingering symptoms:  Skin from lips and inside my mouth appears to be sloughing off.  There are very tiny cuts on my bottom lip.  Left with mild headache I attribute to dehydration.  No longer nauseous although I have no appetite.
Info has been received from a pharmacist concerning a female friend who in 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Subsequently the pt developed a rash. About 2 weeks ago, the pt was vaccinated with a dose of flu vaccine and again developed a rash. The pt had also experienced a similar reaction to a steroid injection. The pt sought unspecified medical attention. Additional info has been requested.
patient received Bexsero expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comment: The health care professional reported that a dose of Bexsero was given to the patient and it was already expired. The reporter did not consent to follow up. Additional Supportive Information: The use of Bexsero dose which was already expired on 30th June 2022, which led to expired vaccine used.
Received vax on Thursday morning. Friday morning fever began and didn?t subside until Sunday morning. Headache persists daily. Wednesday morning I received my depoprovera shot (right arm). Wednesday evening began with dizziness causing nausea and vomiting. That subsided Saturday. Headache still persists. Both fever course and dizziness course were severe enough that I could not work. Headache can mostly be controlled with otc medications (mainly ibuprofen) to become manageable. Covid vax caused a large lump with swelling, pain, itching, and redness similar to previous covid vaccinations. Depo injection site was easily and largely bruised. This is not normal for my depo injections.
Severe itching @ 10:00 following day, hives, arm pits, soles of feet palms of hands   Treated with Benadryl. Symptoms gone by evening of second day following injection. No other symptoms since.  Concerned about second dose??????
pt states arm swollen, red & had raised bumps x 2 days; states today the area looks like a cigarette burn; states it itched alittle @ first but doesn't now; white w/small amount of pus;
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 022A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 23-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved.            Concomitant information use was not reported.
Next morning (1-29-21 Friday) after shot, was very tired feeling, as morning progressed got colder and colder (put on sweatshirt, jeans, socks, houseshoes and turned up heat).  by noon, took a tylenol 500mg and went to bed. Slept for 3 solid hrs. Ate a small lunch. After about an hour and half (5 pm) took another tylenol and went to bed again. Slept till after 8. Still felt tired , arm sore.  Upon taking a bath, removed shirt and saw my arm was red and swollen from shot area down till middle of arm. (did take a pic with phone). Took another Tylenol and went to bed, sleeping all night but discomfort on that arm when rolling over. Next morning swelling had progress till elbow and seemed to be traveling downward. Saturday morning, Did not take anymore Tylenol.  No worse pain/discomfort, in fact had a little more energy (took pic that evening).  By evening the redness again had traveled downward to middle forearm and became concerning as I thought it should be getting better. Still felt tired and not quite myself.  Loss of appetite, but still had sense of taste and smell. Sunday morning , still red and progressed a little further. Felt tired took a good nap.  Monday morning, still red but appears to be lessening and progression down arm stopped. Went to Pharmacist for her to look at and alert of possible side effects to other people being vacinated.  Tue. redness subsiding.
DEVELOPMENT OF RASH ON RIGHT ARM, TREATED AND SEEN AT URGENT CARE WITH PREDNISONE TAPER
SEVERE FLU LIKE SYMPTOMS THAT REQUIRED HOSPITALIZATION.  HE WAS TREATED AND RELEASED.
After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay in the observation area of the vaccine administration site for 10 additional minutes. At 12:00pm patient report throat itching "like chocking". Shock anaphylactic code (RR) was activated. At 12:03pm Epinephrine 0.3mg/1ml was administrated to the left thigh. Venous access was obtained and Solu-Cortef 200mg, Benadryl 50mg and O2 were administrated. Patient vital signs were blood glucose 121mg/dl, Oxygen Saturation 100%, BP 150/90 mmHg. Patient was transfer with the RR code team to the ER for observation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
his leg filled with fluid and stayed swollen for 3 weeks; his leg filled with fluid and stayed swollen for 3 weeks; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 dose 1 in Mar2021 for Covid-19 immunization and experienced INR was elevated at age 76 years old. On unspecified date the patient experienced his leg filled with fluid and stayed swollen for 3 weeks. Outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I started getting headaches, breast aches and both started swelling up, two lump in the left breast and one lump in the right breast. An then I started getting lightheaded. It is on an off. I never feel out, it felt like I would but then it would pass. It happens of and on. The headaches will last for a few hours and some days the headaches may last all day. I am a nonsmoker, nor do I drink. I worry about all this because of my brain surgeries and by me having stents in my head. I wasn't having any headaches at all before taking this vaccine. Nor with my breast swelling. I do have my yearly breast exams. Except for when COVID-19 hit.
No adverse event; which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead) and NO ADVERSE EVENT (No adverse event) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead).    No concomitant drug were reported.  On 26-Oct-2022, a patient came in for their 4th dose, which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead. No treatment drug were reported.
I had extreme pain at the injection site that afternoon that then included my arm from elbow to top of my shoulder.  That pain continued with the area very hot and difficult to lift my arm (which continued until Saturday, 1/30/21.)  After being asleep, I woke at about 10:50 pm, abruptly to racing heart beat, sense of tingling/numbness inside ears, feeling of swollen tongue (back of tongue) and then later feeling of tightness in throat. This was just less than 12 hours after my vaccination.   I sat upright sipping cold liquids for approx 2 hrs and sensations faded.   Next day I had headache, fatigue and felt extremely cold later in day for several hours. Occasional dizziness for the next 2 days with chills.
I was positive for the virus; UTI; This is a spontaneous report from a Pfizer-sponsored program, . A contactable consumer (patient) reported that a 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL8982; expiry: May2021), intramuscular on the left arm on 26Jan2021 (at the age of 70years) at single dose for covid-19 immunization. Medical history included high blood pressure and diabetic. Concomitant medications were unspecified. The patient was hospitalized on 04Feb2021 for a UTI and when she got into the hospital and they did the testing and they found that she was positive for the virus (in Feb2021). The patient was released on 06Feb2021 and she haven't had anything wrong, nothing and doctors were really surprised. When she was in the hospital, it was done on 04Feb2021 to the 06Feb2021, and every day, they took blood work for two days. The patient had her first vaccine on 26Jan2021 and due for her second vaccine tomorrow. She was wondering if she should go and get her next vaccine because she really wanted to, and her quarantine was up to Thursday. The patient was out of quarantine on 16Feb2021. The outcome of the events was unknown.
Contact  Dermatitis at site of injection and anterior part of abdomen (as alleged by PA)
Headache, Myalgia, Fever, NauseaVomiting,  chills  Narrative:  Onset of approximately 12 hours after vaccination -fever, chills, nausea, vomiting, body aches. employee took some OTC medication and employee  feels better but reports feeling fatigue. Felt much better on 1/10. 1/11 - all  symptoms resolved except mild lingering hadache.
Erythematous papular rash all over the body including scalp. Fever 102 F. Treated with Acetaminophen and Benadryl elixir.
The pt experienced skin numbness on both arms spreading out from the vax site. Approximately      4 x 4 inches. Numbness if from #2 and #3 in right and left arm.
Client stated that he received his first dose at back in May and does not recall if it was Housing for Health or the Fire Department. He only knows that he was told to come back for second dose at this location. Client information was checked both inand there was no record of him. Notified nurse manager,, and was directed to administer moderna. Client was notified of situation and client consented of moderna. Client had no reaction after 15 min of monitoring post vaccination.
Patient got Pfizer 12+ on 03/09/22, patient came in  and told the pharmacist on duty he expirenced blood in the urine and diarrhea  on 03/10/22.
4 hours after the shot (8pm on 3/31/21) my arm started to become sore, by midnight my symptoms started heavy with Extreme chills, severe migraine/neck pain/joint pain/fever/sweating/puking
Measle like body rash /w malaise & arthralgias 10 days /p Rubella vax, lasted 4 days before resolution
This spontaneous report was received from 36 year old white male patient as part of market research program regarding himself. Concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, route of administration, anatomical location and lot number was unspecified by reporter). No concomitant medication was reported. On an unknown date, the patient got pneumonia only after having taken the PNEUMOVAX 23 (vaccination failure). The outcome of the event was unknown. The causal relationship between the events and PNEUMOVAX 23 was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
Wrong vaccine. Should have received 2nd dose of Pfizer and received 2nd dose of Moderna instead.
SORE ARM; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: not reported) dose was not reported, once a total administered on 27-MAR-2021 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 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, fatigue, and headache. This report was non-serious.
Received booster shot on 11/15/2021.  Four days after receiving the booster patient fell and hit his head on something.  He was transported by ambulance to the  hospital where he went into atrial fibrillation, which he was able to come out of on his own.
Cellulatis, inderation at injection site. Pt came in to be seen 11/08/09.
This spontaneous report was received from a registered nurse concerning to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date, the patients were vaccinated with one dose of M-M-R II diluted in sterile diluent for prophylaxis (the lot #, expiration date, route, frequency, strength, and dose were not provided). On an unspecified date, due to a local measles outbreak, the patients had a titers test which was negative. At the time of this report, the patients had not received the second vaccine dose yet. The outcome of the event and the causal relationship between the event and the vaccine were unknown. This is one of two reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008462.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out immediately after receiving vaccine. Woke up disoriented but became alert and aware within 2 minutes. Gave food and water and observed for 30 minutes.
Starting two days after shot was exhausted, taking naps every day which is highly unusual and has never happened to me after any vaccination. Six days after the vaccine I woke up with a medium level fever (101.5) and spent the next 24 hours unable to keep down food or even liquids. When I drank one gulp of water with Tylenol, I would vomit it back up. Six times in one day. Fever reduced to 100 by evening but still  feeling very unwell . Hopefully it subsides by tomorrow
High Fever, rash on injection site, joint aches, restless legs, restlessness
This spontaneous report was received from an 82-year-old female patient reporting on herself. The patient's concurrent conditions included Parkinson's disease which was treated with unspecified medication for that medical condition as concomitant therapies. There was no information regarding the patient's pertinent medical history and drug reactions or allergies. On an unspecified date, also reported as "4 years ago or more", the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (SC) (strength, dose, frequency, anatomical location, lot number, and expiration date were not reported), for prophylaxis reported as for prevention of shingles. On 24-FEB-2017, the patient felt like she had an earache along with itching. Subsequently, on 27-FEB-2017, the patient sought medical attention through a visit to a physician who diagnosed her with shingles on the ear and prescribed valacyclovir hydrochloride as treatment. The patient also reported that the Herpes zoster oticus had spread to her jaw. At the time of this report, the patient had not recovered from the event of Herpes zoster oticus. The causal relationship between the adverse event and the therapy with ZOSTAVAX was not provided. No product quality complaint was involved. Upon internal review, the event of Herpes zoster oticus was considered to be medically significant. Additional information is not expected as there was no information to contact the physician.
My left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (left arm). At the time of the report, PAIN IN EXTREMITY (left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. Patient reported that after receiving first dose his left arm was sore.   This case was linked to MOD-2021-327934, MOD-2021-327671 (Patient Link).
FRIDAY 1/22/21- 2:30pm headache started, 3pm started feeling really tired, by 6pm started feeling achy - arm was super warm to touch and hurt a lot, went to be early due to extreme exhaustion and malaise around 9pm Saturday - woke at 4am to extreme body aches - had to move to couch to stay sitting up to be able to sleep; all day felt horrible body aches, fever, chills (was super hot but also freezing at the same time), skin felt hot to touch- almost painful, extreme fatigue, joint pain - worst in knees and shoulders, hurt to walk, had a little cough, migraine (I'd rate pain around a 10/10) Saturday night into Sunday morning - woke several times drenched in sweat, got up to use bathroom, would be freezing to the point of shaking, then 30 mins later sweating under the covers but still so cold. Continued though out night. Sunday - same symptoms but less painful (rate it around a 9/10) - went to store to get groceries with husband around 8:30pm and almost passed out, super weak and felt like puking - not sure if it was just the mask making it hard to breathe. Monday - woke drenched in sweat but not as bad as over the weekend, still achy but not as bad, headache, arm is still super sore and enlarged, hot to touch, fatigue, malaise - but able to go to work (pain down to 6/10, so definitely better than before)