chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had random pain in my foot very acute pain in my right foot cc joint, lasting for 48 hours. One month later it was a recurrence of the same spot. I went to the urgent care for x rays but they came back ok, I was given prednisone for three days to help with inflammation and finally two days later I felt better. Two months later the pain came back but not as bad, I was scheduled a ultra sound which showed more inflammation. Early January I started to get pain in my thumb, I then went back to the doctor and they said it may be tendonitis. I have a follow up appointment on 3/21/22 to get a second a opinion as this is still a ongoing issue.
Agitated, no longer cared for appearance, would not wash hands, stared off into space, a non person, did not leave the house or have conversations any more. Diagnosed finally with Dementia on 11/29/09.  12/03/09 DC summary for DOS 09/05/09 - 09/08/09 Final DX: L finger cellulitis  Pt c/o swelling and pain of L index finger. On examination: Erythema of L finger and lymphatic streaking of forearm. Pt found to have osteoarthritis.  Tx: doxycycline.  Osteoarthritis of R index finger also noted. L finger improved. Pt discharged home.   12/03/09 Office F/U visit on 09/14/09: Cellulitis of L finger resolved. Vac lot # received.
a patient was administered an expired vaccine; This spontaneous report was received from a licensed vocational nurse (LVN), referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 06-APR-2022, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T024557, expiration date: 15-MAR-2022, dose, strength and route were not provided) for prophylaxis (expired product administered).
POSSIBLE COVID-19 REINFECTION; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced possible covid-19 reinfection, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and possible covid-19 reinfection was not reported. This report was non-serious.
p/vax pt became itchy, devel a rash on torso;rash is resolving;also joints began to ache especially rt thumb;also c/o sore throat;
Began feeling lightheaded, ears ringing, arms tingling, jaw tight. Lasted ten minutes before resolving.
1st pill taken a few hours felt aches in joints of hands and hips. Reports puffy hands and difficulty turning head. Discontinued taking
Having severe left arm pain which is affecting activates of daily living.  Site of injection is not red or swollen, but I cannot lift my arm or sleep on my left side without pain. I have been treating with acupuncture and advil.
A couple of hours after my HINI vaccine I began to be dizzy and I could feel my heart pounding fast when I went to bed that night.  The next day I was fine.
Patient received Flu injection in left anterior thigh. Left thigh to below knee is swollen to twice its normal size. Skin in effected area is blotchy red.
Pt forgot to get the second injection; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 10 months ago, on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient forgot to get the second injection of shingrix. The patient was now10 months late. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked should the patient take the series again or just get the second injection 10 months late. The reporter consented to follow up.
My arm was swollen and red with rash and it started around the site and then spread to my elbow. I took BENADRYL, and never got second vaccination.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 35-year-old patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD8448), at the age of 35, on Aug 30, 2021, single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing). Concomitant medication included lisinopril for hypertension. The patient had ocular discomfort (whenever patient laid down, felt lots of pressure behind eyeballs) and headache (pressure headache), with outcome of unknown. Therapeutic measures were taken as a result of ocular discomfort and  headache. Additional information: Treatment received: Ibuprofen and Tylenol. No other prior vaccination (4 weeks). No follow-up attempts possible. No further information expected.
Redness around injection site, approximately 3 inches in diameter. Patient also described pain near area.
Fainting and seizure like episode, dizziness, fainted, incontinence, muscle tension and contractions, and was unconscious for 2 mins after eyes were open.    Day 1 After vaccine: migraine, chills, possible fever. Day 2 after vaccine: I woke up feeling fine and then ended up fainting at work while walking out of the clinic. Was treated immediately with the Providers and wheeled down to the emergency room.   Treated with sodium chloride 0.9% Bolus   Diagnosis with vasovagal syncope because all other tests came back normal. The only change in routine in the last week was getting the vaccine.
Received Vaccination @1030Am.  PT felt faint and Clammy, 1037AM.  Staff lied PT down.  Pt was transferred to wheelchair, given water.  PT began to feel better.  Left @ 1105AM.
Body aches and pains, headache, chills, dizziness, shortness breadth,  skin extremely sensitive to touch all over
9/18- redness and swelling developed on left arm only. 9/20- reaction was managed with Benadryl but redness had spread down past the elbow of the left arm and across chest. Pt taken to local ER and given prednisone which cleared the reaction.
COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 25Sep2023 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "known allergies: Demerol", notes: known allergies: Demerol morphine; Morphine, reaction(s): "known allergies: morphine", notes: known allergies: Demerol morphine. The following information was reported: COVID-19 (non-serious) with onset Sep2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Additional information: The patient received Paxlovid from 25Sep2023 to 29Sep2023 for COVID 19 Treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Rx number reported as 801994.  It was reported that the vaccine was stored in freezer, one of two vials were taken out and placed in fridge each day as needed.  No treatment given to the patient.
Herpes Simplex Virus of the mouth started two weeks following my first dose. First outbreak of my life. Included painful blisters all over my bottom lip. Lasted for 10 days.
On 4/28/11 at approx 1;45 pm, patient came to clinic to receive her 2nd HPV GARDASIL shot. Administered shot to (L) deltoid with patient sitting in chair beside nurse's desk. Her mother was sitting next to patient. Approx. 3 minutes later, patient's head tilted back to wall and patient started to slump in chair. Arms bilaterally drew up to chin and patient voided her bladder. Nurse and mother on each side to stabilize her. We lowered patient gently to floor to elevate legs. Nurse called for assistance to nurse in hall to come help and check vital signs. Blood pressure on floor, 140/70, 3 minutes later escorted to exam table lying 120/70, then approx 15 minutes later prior to patient leaving clinic and sitting on exam table 118/70. After incident, patient's mom stated patient hadn't eaten and needed to urinate prior to coming into exam room.
Patient said a few days after receiving shot she developed a rash in the spot of injection.  It was not painful or itchy.  The rash has since subsided but a slight red area remains.  She said she has very sensitive skin, and it could have been the result of the alcohol used to cleanse prior to administration.  The area does appear to be what would have been swabbed.
Received flu shot without any issues at the time, experienced some expected soreness, however, it lasted more than 2 days. Upon that time, the pain was radiating down to her thumb and back and it was painful and numb for the patient. One week later, she went to the hospital.
I had very tender injection site, with stiff ness in the injection shoulder. The next day I had a steroid injection in both knees , the day after the steroid,  my injection site and shoulder were fine. Also I had the hot flashes and flushes. Possibly from steroid, or the vaccine, is the steroid masking the reaction to the vaccine? Will the steroid negate the effects of the vaccine on my immune system?
BACK PAIN IN SHOULDER BLADES/SEVERE KNEE PAIN; SEVERE FOOT PAIN; CHEST PAIN; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 17-APR-2021, the subject experienced chest pain. On an unspecified date, the subject experienced back pain in shoulder blades/severe knee pain, and severe foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pain in shoulder blades/severe knee pain, severe foot pain and chest pain was not reported. This report was non-serious.
Aseptic meningitis; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team. Other Case identifier(s): US-PFIZER INC-202200348390 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MENINGITIS ASEPTIC (medically significant), outcome "unknown", described as "Aseptic meningitis". The doctor doesn't think it was correlated, but reporter just wanted to cover all basis.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Meningitis aseptic  cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a female married patient who was vaccinated with a dose of varicella-zoster virus vaccine live (Merck). Subsequently the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 12/14/2006. Additional information has been received from a physician who reported that he diagnosed the patient with shingles. Her rash developed 72 hours post-vaccination. A scab was unearthed and a sample was sent to a lab; however, there was a mistake, and it was only tested for herpes simplex virus. There were no other samples to test. Additional information has been requested.
Patient administered Moderna booster after the use-by date of 2/10/2022.
Long QT syndrome; This spontaneous case was reported by a consumer and describes the occurrence of LONG QT SYNDROME (Long QT syndrome) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LONG QT SYNDROME (Long QT syndrome). At the time of the report, LONG QT SYNDROME (Long QT syndrome) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment drug information provided. No concomitant drug information provided.  Company comment- This case concerns an unknown age male subject with unknown relevant medical history, who experienced the unexpected event of LONG QT SYNDROME. The event occurred on an unknown date and there are no vaccination dates available. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Despite the event Long QT syndrome being automatically upgraded to serious as per IME list it was manually overridden according to provided narrative and medical judgement. Additional query was sent to obtain missing information and clarify details regarding this event.; Sender's Comments: This case concerns an unknown age male subject with unknown relevant medical history, who experienced the unexpected event of LONG QT SYNDROME. The event occurred on an unknown date and there are no vaccination dates available. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Despite the event Long QT syndrome being automatically upgraded to serious as per IME list it was manually overridden according to provided narrative and medical judgement. Additional query was sent to obtain missing information and clarify details regarding this event.
Patient developed big red bump/spot on arm which itches and diarrhea which started within a few hours along with achiness. The spot was still big and red several days later as well as upset stomach.
Fatigue, fever (100.4), tachycardia, lightheaded/near syncope, muscle aches
Information has been received from a physician and a nurse concerning an 8 year old male patient who in 2002, "sometime in 2002" was vaccinated with the first dose of VARIVAX (Merck) and the second dose of VARIVAX (Merck) (lot # 661659/1136X) in October, 2008.  On 12-AUG-2009 the patient developed a painful rash located on the left side of the front torso, on the knee, arms and legs.  The physician and nurse reported that the patient came into the office on 13-AUG-2009 and was prescribed acyclovir (manufacturer unknown) for the rash.  At the time of the report, the patient had not recovered.  Additional information has been requested.
down for 48 hours; really bad; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for 48 hours), FEELING ABNORMAL (really bad) and HEADACHE (headache) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (down for 48 hours), FEELING ABNORMAL (really bad) and HEADACHE (headache). At the time of the report, DEPRESSED MOOD (down for 48 hours), FEELING ABNORMAL (really bad) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD21-062901, US-MODERNATX, INC.-MOD-2021-082277 (E2B Linked Report).; Sender's Comments:  MOD21-062901: US-MODERNATX, INC.-MOD-2021-082277:Dose 1 events
Patient reports after observation from the clinic they were in the hospital cafeteria and they became dizzy and felt she was going to pass out and fell to the floor. She notes she was attend to by security and healthcare professionals within the cafeteria. Patient did not go to the hospital ED or come back to the clinic this day for further evaluation.
STIFFNESS IN THE JOINTS; LOWER BACK HURTS; MUSCLE ACHES, MUSCLE SORENESS; HEADACHES; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included arm hurting from a vaccine, and concurrent conditions included arthritis, headaches, penicillin allergy, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 18-JUN-2021 09:30:00 for prophylactic vaccination. Concomitant medications included paracetamol. On 18-JUN-2021, the subject experienced stiffness in the joints. On 18-JUN-2021, the subject experienced lower back hurts. On 18-JUN-2021, the subject experienced muscle aches, muscle soreness. On 18-JUN-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, muscle soreness, headaches, stiffness in the joints, and lower back hurts. This report was non-serious.
No adverse effect; Patient was inadvertently administered one expired dose of PROQUAD; This spontaneous report as received from a physician refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent (DILUENT MRK INJ).  On 16-APR-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # N028443, expiry date: 09-APR-2019) (dose and frequency were not reported) subcutaneous for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Itching sensation across body, no visible rash; Irritation on skin was present after physical scratching; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 37 years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks prior to the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 08:00, the patient had an itching sensation across the body with no visible rash but irritation on skin was present after physical scratching. The symptom emerged within 48 hours of vaccine and still persisted (at the time of reporting) but had become milder. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itching sensation across the body with no visible rash, irritation on skin present after physical scratching was resolved with lasting effects on an unspecified date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
12 hours after injection: chills, fever 101 F, headache, bone and body aches, nausea, severe stomach pain for about 3 hours, face and eyes hurt, swollen bags under eyes, fatigue.  Still having headaches 4 days later.
Information has been received from a RN concerning a 21 month old immunocompromised male who was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently the pt was hospitalized and died two weeks later (not further specified). A product quality complaint was not involved. Additional information was received from the RN who reported that the pt had a lot of problems. The pt was hospitalized until he was 20 months old with a diagnosis of extreme prematurity among other problems. The nurse did not know the cause of death but did indicate that high temperatures were involved. Additional information was received from a health professional at a pediatricians office who reported that the pt's demise had nothing to do with the vaccinations. The pt's experience was considered to be immediately life threatening and disabling by the RN. Additional information has been requested. Received Autopsy Report which revealed COD as acute bronchopneumonia, bronchopulmonary dysplasia, dilated cardiomyopathy & prematurity.
Received Hep A vaccine on 1/16/2008 at about 7:30-8p. Started itching et was found with hives 30min-1hr later. Was given Benadryl, slept, woke the next morning with swelling et redness around right eye, puffy. red face et hives. Given Benadryl et symptoms resolved.
Plaintiffs allege that as a result of vax on or p/20OCT88, pt died on 5FEB89; No addtl info is provided;