chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RUNNING A LOW GRADE FEVER, 97.5. TO 97.8, A BURNING, ACHING PAIN IN ARM THAT HAS SPREAD TO BACK BETWEEN SHOULDER BLADES, LEFT UPPER ARM AND ACROSS CHEST. PAIN SOMETIMES IS UNBEARABLE. FATIGUE, BURNING EYES, HEADACHE. HAVE BEEN SLEEPING IN CHAIR BECAUSE THE PAIN CAUSES ME TO NOT BE ABLE TO LIE DOWN. HARD TO EXPLAIN THE PAIN, IT BURNS BUT ALSO HURTS, ACHES.
ADMINISTERED EARLIER THAN THE RECOMMENDED 21 DAY INTERVAL. DOSE ONE OF PFIZER/BIONTECH (LOT # FF2587) WAS ADMINISTERED TO PATIENT ON 09/01/2021 (LEFT ARM, DELTOID, IM).  PATIENT HAD NO ADVERSE REACTION. VAERS REPORT SUBMITTED TO RECORD EARLY VACCINATION.
Patient complained of pain at injection site. A lump formed. Over time a raised area progressed to neck. Patient applied heat and took ibuprofen.  Today the lump is now  retreated to original area of the injection site.
FLATULENCE; INSOMNIA; HALLUCINATION, VISUAL; FEELING HOT; HYPERSALIVATION; SKIN BURNING SENSATION; PALPITATIONS; HYPERHIDROSIS; VISUAL IMPAIRMENT; PAPULE; DISTURBANCE IN ATTENTION; NECK PAIN; IRRITABILITY; INCREASED APPETITE; ABDOMINAL PAIN; JOINT CLICKING; FATIGUE; A spontaneous report has been received from a pharmacist and a consumer via the regulatory authority concerning a 6 year old male patient.    No medical history was reported. No concomitant products were reported.    During Nov-2018, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) (batch number(s) KJ21501B) one dosage form ,x1, nasal.     During Mar-2019, the patient experienced flatulence (preferred term: Flatulence), insomnia (preferred term: Insomnia), hallucination, visual (preferred term: Hallucination, visual), feeling hot (preferred term: Feeling hot), hypersalivation (preferred term: Salivary hypersecretion), skin burning sensation (preferred term: Skin burning sensation), palpitations (preferred term: Palpitations), hyperhidrosis (preferred term: Hyperhidrosis), visual impairment (preferred term: Visual impairment), papule (preferred term: Papule), disturbance in attention (preferred term: Disturbance in attention), neck pain (preferred term: Neck pain), irritability (preferred term: Irritability), increased appetite (preferred term: Increased appetite), abdominal pain (preferred term: Abdominal pain), joint clicking (preferred term: Joint noise) and fatigue (preferred term: Fatigue).     The patient recovered with sequelae from the events of flatulence, insomnia, hallucination, visual, feeling hot, hypersalivation, skin burning sensation, palpitations, hyperhidrosis, visual impairment, papule, disturbance in attention, neck pain, irritability, increased appetite, abdominal pain, joint clicking and fatigue on an unspecified date.     The events were considered serious (disability) by the reporter.; Sender's Comments: This case concerns a 6-year old male patient with 16 serious events that are not listed in the company core data sheet of quadrivalent live attenuated influenza vaccine. Visual hallucination, irritability, disturbance in attention, insomnia could be in connection. However due to limited information on the exact event details, patient's relevant medical history, concurrent medical conditions, circumstances leading to the occurrence of the events, clinical course of the events, suspect drug indication and action taken with the suspect drug and clinical workup, concomitant medications, complete diagnostic workup, it is not possible to make a conclusive assessment of the causal relationship between events and suspect drug.
A week after the first dose, I experienced robotic hearing in my right ear. All sounds were doubled in that ear, and the pitch was lower in that ear. I was able to hear this using headphones. I did not having hearing loss at this point.  A week after the second dose, in addition to the hearing changes described above, I developed hearing loss suddenly in my right ear. The loss was obscured by sinus and nasal surgery that took place on 4/16/2021. The hearing loss was confirmed via audiology to be about a 40% loss in the low frequencies, and I was diagnosed with SSHL. I took a course of high dose steroids, and my hearing returned to normal in so far as hearing loss. The change in pitch and robotic sound remained. Unfortunately, the hearing loss fully regressed over the course of several weeks after completing the steroids.  An MRI confirmed that there is no tumor causing the loss.
Case number PHEH2014US022443, is an initial spontaneous report from a medical assistant received on 06 Nov 2014. This report refers to a 9-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly at a dose of 0.5 ml that was stored at a temperature of 31 F-47 F for two weeks from a multi dose vial on 01 Nov 2014. No adverse event reported.
Tingling down arm started within the first 15 minutes of vaccine being given (was given at 16:41), but no other side effects started until about 30 minutes later when I started feeling lightheaded. Started feeling hot and flushed around 18:15, and injection site feels very warm to the touch and muscle a bit tense.
Approx 10-12 hours after dose: injection site pain, swelling, headache, fever (temp max 99.5)
passed out, faint; Bad dry cough; fell and his head hit the concrete; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out, faint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G26-B21A and G17-C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Past medical history included, smoking for 30+ years and vaping for past two years.  The patient's past medical history included Ex-smoker. Concurrent medical conditions included Vapor cigarette smoker. Concomitant products included BENZTROPINE [BENZATROPINE], FLUOXETINE, TAMSULOSIN, CLONAZEPAM, AMLODIPINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out, faint) (seriousness criterion medically significant), COUGH (Bad dry cough) and FALL (fell and his head hit the concrete). On 12-May-2021, LOSS OF CONSCIOUSNESS (passed out, faint), COUGH (Bad dry cough) and FALL (fell and his head hit the concrete) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information included, an inhaler to help with the "lungs and stuff", cough syrup for a night was provided.  Very limited information regarding these events has been provided at this time. No follow up is possible.   This case was linked to MOD-2021-139015 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Lymph nodes in neck, jaw, under collar bone and in right breast swelled, caused pain on swallowing and tenderness to the touch, soreness on overuse of voice.
Reports left arm red, swollen at site. Entire arm tingling. Swelling of tongue, hard to swallow
A pregnant patient was administered with fluzone quadrivalent/no AE; It was unable to determine that how much vaccine that the patient had received/no AE; some of the product leaked out where the needle was connecting to the syringe/no AE; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer and other health care professional.  This case involves a female patient who was administered with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 0.5 ml prefilled syringe while she was pregnant (exposure during pregnancy) and during administration some of the product leaked out where the needle was connecting to the syringe (device leakage) and it was unable to determine that how much vaccine that the patient had received (under dose). It was also reported that they asked whether or not a second dose was safe in pregnancy  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   Gestation period was not reported.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (injection, suspension) (lot UT7058JA and expiry date 30-JUN-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of vaccine under dose (latency was on same day) and device leakage.  It was also the case vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  Relevant prenatal testing after exposure was not reported.  At the time of reporting, no adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy was not reported.  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 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.  Global PTC: 100073772 Investigation status: In process Issue status: In process Batch number: UT7058JA Sample Status: Not available
Suspected vaccination failure/Had both shingles vaccines, had shingles twice; Had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 18-Aug-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient had both shingles vaccines and now have had shingles twice. The patient was currently enduring it. The patient asked that anyone else has gotten shingles after getting vaccinated. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Dose administered to a 16 year old patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 16 year old patient) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 16 year old patient). On 19-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 16 year old patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received- Patient information and dose start date added
2 days after shot, pt called saying her arm was still sore/stiff she thought the shot was given too high on arm. Suggested ADVIL around the clock to help. On 10/19/12 pt came into warehouse & filled out incident report stating still having issues with arm pain.
A flu vaccine pt c/o sore throat 11-9-009. Pt c/o nose bleed 5 min in duration. Pt c/o headache 11/8/09 4 hr duration pt took EXCEDRIN. Pt c/o feeling achy, stomach, drowsy, dizzy & occasional hot flashes. Pt also has menses.
1300 received second moderna covid vaccine. Woke up about 3 am with severe arm pain. Then back to sleep at 0800 am temp 101.3 F, headache, body aches, injection site pain. Same symptoms the following day  until about 7 pm just much more mild.
Bad pain whole right arm, real bad pain in right hand-couldn't use it for the rest of day and next day.
Woke with stiff shoulders, slight headache. Took 2 aceteominophen, fever of 99.0°, headache eased but fever  rose to 99.5° F by 4:35 pm, took additional 2 acetominophen ; temp dropped to 97.5° F by 11:35 pm. No fever on awakening on Sunday 2/21 and none throughout day.
Vaccine left arm deltoid, massive black-blue swelling and pain from shoulder to wrist. Completely black-blue - whole arm. Unable to use arm and painful.
Pfizer-BioNTech COVID-19 Vaccine EUA I received the Pfizer vaccine a week ago from today and I believe I am having a mild allergic reaction to it. I have two very itchy bumps on each of my ankles, one under my right knee, and two on my left arm. The bumps formed almost immediately after getting the shot and was itching before I made it home. The bumps on my ankles are now larger than they were last week. The one under my knee just got there within the last few days. The itching has seem to have gotten worse because it woke me up out of my sleep over Monday night.
Headache, ErythemaMultiform, NauseaVomiting, chils, fatigue injection site pain/arm pain, swelling at injection site Narrative:  Other Relevant History:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Patient presented with a reddened, warm-to-the-touch injection site on 4/16/21. She was referred to seek medical attention, and she saw PAC on 4/16/21. The patient was prescribed dicloxacillin for suspected infection.
A non-serious, spontaneous report of H1N1 administered to a 13-month-old, low grade temperature and mild cough was received from registered nurse concerning a 13-month-old male patient. The patient had no relevant medical history and was not taking any concomitant medication. On 20-Oct-2009 the patient received Influenza A (H1N1) 2009, Intranasal for an unspecified indication. The nurse reported that the vaccine was given by mistake. On 13-Nov-2009 the patient developed mild cough and low grade temperature of 99.7F. On the same day chest X-ray was done and found to be negative. On 15-Nov-2009 the symptoms of mild cough and low grade temperature were resolved. The outcome of the events was resolved. Additional information was received on 09-Nov-2009 and incorporated into the narrative: reporter's address. Additional information was received on 16-Nov-2009 and incorporated into the narrative: adverse events, AE onset, cessation date, outcome of AE, Lab test, medical history and concomitant medication.
PVC and tachycardia on ECG occurring within 30 minutes post injection. Metoprolol succinate ER 25 mg prescribed.  Patient remained 96-99% O2 with HR 100-106. Patient discharged home in stable condition.
Extreme pain up into her neck and shoulder couldn't sleep all night. Has to elevate arm above head for any relief. No swelling or redness. Feels it is more than normal reaction. Took ibuprofen I suggested ice. Pain level of 10.
102F fever, headache and joint pains about 14 hours after the shot. Headache better on day 2 but fever continued until I took Tylenol. Started to feel nauseous starting Day 2.
Same as my 1st Covid shot.    Very RED and hot,  had a knot , lot of swelling, hurt, sore and spread 7x5 inches.  Little fever and chills.
Patient came in for 3rd dose of Moderna, was administered Pfizer in error as dose 1 by nurse.
Patient received PNEUMOVAX shot and it was painful and arm felt heavy immediately, 5 hrs later she could hardly move it, pain radiated up to neck and down to fingers. She went to ER and then to PCP - given pain pills and muscle relaxers. Nurse practitioner ordered an x-ray. She still has pain in the arm, but seems to be getting better.
Sore arm at injection side. Feeling of swollen internal organs. Distended abdomen, stomach discomfort, intermittent nausea. Fatigue.
Patient is not sure if she had Moderna or Pfizer vaccine fatigue, headache, body aches "feels like" high blood pressure
Around 330 on 4/6, I started feeling bad and arrived home around 530pm and  had a slight Temperature (99) with hearing loss in both ears. But the right one had complete hearing loss. Thinking it would be a short term side effect, but realizing on Thursday am with was not, I called my physician office on Thursday and they called back on Thursday for a Friday 9am appt with the PA. She said it was sinus related , fluid in the ears was pushing the ear drum back and gave me a prescription for Fluticasone and to take my Zyretx and Sudafed. Call her in a week if symptoms did not away. On 4/12/21, I still have massive hearing loss and pain, so called a ENT for an appt and received a 1:15pm on the same day. This  was the first day I had balance issues.
This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 23-MAR-2017, the patient was vaccinated with an improperly stored VAQTA lot # M022924 and expiration date 24-JAN-2018 (strength, dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The reported storage temperature was 32 to 35 degrees Fahrenheit (F) for a time frame of 4 hours 2 minutes. There was no previous temperature excursion. No adverse effects were reported. There was no further information to report. No product quality complain (PQC) was involved. Additional information has been requested.
Redness/swelling/warmth at injection site about 20 degrees after vaccine. Also asthma flare - mild.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.
Swollen lymph nodes on left side of neck. Winded. Fatigue. Muscle or body aches. Headache.
I had fever from 10am to 10pm  between 99.3 to 104.5. Also I felt really tire, my arm hurt and I couldn?t lifted above my shoulder and a head pressure.  The 3 symptoms last around 12 to 14 hours. The next day I was perfectly fine. but  the pain in the arm still there.
Information has been received from a registered nurse concerning a 75 year old female with high blood pressure and a penicillin allergy who on 19-SEP-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot# 658083/0885U).  Concomitant drug therapy included LOTENSIN, hydrochlorothiazide, and PREMARIN.  On 20-SEP-2007 "24 hours after the vaccine," the patient developed a "silver dollar sized red ring at injection site" and swollen lymph nodes of the throat and under arm.  No medical attention was sought.  No labs or diagnostics studies were performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Premature Vascular Contractions (low pulse rates), atrial fibrillation after having been in sinus rhythm for several years
pt recvd vax & 9 hrs later  pt devel muscle aches; blood shot eyes & swollen eyes;
Patient received 2nd dose Pfizer Covid-19 vaccine on 3/2 then developed positive Covid-19 test on 3/23. Had fever but also confirmed E Coli bactremia.