chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTERED VACCINE AT ROOM TEMPERATURE FOR 4 HOURS; VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 13:36 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUN-2021, the subject experienced administered vaccine at room temperature for 4 hours. On 14-JUN-2021, the subject experienced vaccine stored outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine at room temperature for 4 hours and vaccine stored outside of the recommended storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210630313.
Local swelling sight redness in leg at site of 4th injection. (otherwise well-no fever)
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (age not provided). Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  Approximately, on 26-JUL-2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered redness, swelling and soreness of her left breast and she was diagnosed with herpes zoster. As a direct and proximate result of her receipt of vaccination, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient outcome regarding shingles was unknown, and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX) and disabling.
Per F/U 7/5/02, autopsy DX: SIDS. The pt was last known alive by her mother at 06:45 on 5/12/02. She states she bottle-fed the pt 4 oz of Enfamil with Iron at 06:45. She also gave the pt Children's Tylenol (dosage unk). She states she fell asleep with the pt resting face up on her chest and wrapped in a receiving blanket. When she awoke at 11:15 and saw the pt's lips were blue, she yelled to her mother to call the hospital. At 11:16, the pt's grandmother iniated CPR. EMS responded and arrived at 11:19. The pt was without respirations or discernible heart beat. Pt was given oxygen via bag-valve mask and CPR was continued during transport. Arrived in ER at 11:24. At ER, advanced life support were iniated but unsuccessful. MD made the death decision at 11:47 hours. The pt's mother was present at the time of death. A low-grade temperature had been present since the immunizations. Final pathologic findings: scattered petechial hemorrhages of the lungs, heart and thymus.
Body started itching. Started from his palm of his hands and spreaded everywhere. Went to the ER.
This is 14 y/o female who received Menactra on 9/16/05 and two wk later had numbness of arm for 1 wk and now has resolved. The twin sister also had shot but no complaints.
DEVELOPED TINNITUS THE DAY AFTER RECEIVING THE 2ND VACCINE AND IT HAS NOT GONE AWAY.  IN FACT ITS GETTING WORSE.   I REPORTED THIS IMMEDIATELY AND NO ONE HAS EVER REACHED OUT
Parental consent form indicated patient's DOB was 05/15/2009 for both first and second doses. After calling insurance for rejected claim, insurance representative indicated they had 06/15/2009 as the DOB on file. Parent then confirmed DOB was 06/15/2009 and that they must have mistakenly wrote the wrong DOB on consent forms. Patient received both doses with no reported adverse events.
left arm became completely useless, weakness throughout entire arm, muscle at injection site wouldnt relax, shoulder/ arm muscles were sore about a week after arm began to function again
Injection site is swollen and red; Injection site is swollen and red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Injection site is swollen and red) and VACCINATION SITE ERYTHEMA (Injection site is swollen and red) 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 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site is swollen and red) and VACCINATION SITE ERYTHEMA (Injection site is swollen and red). At the time of the report, VACCINATION SITE SWELLING (Injection site is swollen and red) and VACCINATION SITE ERYTHEMA (Injection site is swollen and red) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Treatment information included antibiotic for injection site.
headache, fatigue & malaise since day of vaccine until cerebral hemorrhage on 4/18/21
left arm pain since vaccination 12/31/19.pain mostly just at night while sleeping. hurts more If puts left arm over chest; Information was received from Food and Drug Administration on 04-FEB-2022.  This spontaneous report was received from healthcare professional/staff member and refers to a 12-year-old female patient. Her chronic or long-standing health conditions included atrioventricular (AV) block first degree, chronic urinary tract infection (UTI), anisometropia, myopia, amblyopia of left eye, tuberculosis (TB) positive with treatment and being adopted at age 4.  On 31-DEC-2019 at 14:00, she was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered intramuscularly into left arm, lot # R025728, expiration date 18-JUN-2021 (dose was not reported) for prophylaxis. Vaccination facility was reported as doctor's office, urgent care or hospital. It was reported that the patient was not pregnant at the time of vaccination. On the same day (reported as "since vaccination"), the patient experienced left arm pain mostly just at night while sleeping. The patient stated that it hurt more if she puts left arm over chest. On 13-JAN-2020, the patient visited doctor or other healthcare professional office with her mom as a result of adverse event. Outcome of pain in left arm was unknown.  Causality assessment was not provided.  The agency considered report as non-serious.  Follow-up information was received from the registered nurse on 24-FEB-2022. The reporter stated that without the patient's name and date of birth they cannot provide any information. Additional information is not expected.
Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 (hiccups are not something that I normally get, if I do I only hiccup 3-4 times on average
Moderna COVID-19 vaccine EUA. Patient received COVID-19 vaccine booster dose on 4/6/2022. No symptoms or adverse events noted during administration and observation. No adverse events reported by the patient to date. On 5/4/2022, discovered the dose administered is past expiration or beyond-use date. Manufacturer contacted to report event and to obtain revaccination guidance.
Fever, headache, confusion, encephalopathy, hospitalized 5/28/21-6/1/21.
Pt recvd vax & complained of lingering pain at inj site. Exam by MD who noted 2-cm, non-tender lymph node left axilla.
behind ear lymph node soreness that she cannot hear well; behind ear lymph node soreness that she cannot hear well; bad stomach pain; slight headache; soreness L arm of injection; tenderness L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (bad stomach pain), HYPOACUSIS (behind ear lymph node soreness that she cannot hear well), VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection) and LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), PROGESTERONE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FLECAINIDE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection) and HEADACHE (slight headache). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (bad stomach pain). On an unknown date, the patient experienced HYPOACUSIS (behind ear lymph node soreness that she cannot hear well) and LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well). At the time of the report, ABDOMINAL PAIN UPPER (bad stomach pain), HYPOACUSIS (behind ear lymph node soreness that she cannot hear well), VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection), LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        .
left arm pain starting same day as vaccine. pain extends from shoulder to fingertips. patient says pain level is 9/10
I've experienced occasional shortness of breath. When this happens, I cough and cannot take a deep breath. I've never had asthma or bronchitis, but I've seen others with these issues and mine seems to resemble theirs when it occurs.
(R) upper arm red, swollen, painful, fever - PPV site (L) lower arm - PPD test that was not requested.
The experience is "like having nickels in your mouth,"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "The experience is "like having nickels in your mouth,"". Therapeutic measures were taken as a result of dysgeusia.  Additional information: The sensation came on within minutes of receiving his first dose of the Pfizer Covid-19 vaccination this past week. He tried to get rid of it with coffee, then mouthwash. Twenty-four hours later, the metal taste remained. "It's certainly not debilitating or anything like that," (Name), a contributor for (Organization Name), said. "But I do hope it goes away. I would like my coffee to taste normal."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200169519 Same reporter, different drugs/patients/events;US-PFIZER INC-202200169566 Same reporter, different drugs/patients/events
Stubbing chest pain for a couple times for 1 day, bloating and pain stomach and anxiety (in the morning of July 4th and a few hours in afternoon) Following day mild chest pain and anxiety ( July  5th late afternoon and night) July 6th in morning I went to Emergency room to get checked.
Shingles only vaccine on Tuesday. Wednesday was tired and rested. Went for a cabin outing on Thursday evening and noticed what she thought were big bites. Saturday the itching intensified but assumed it was still bug bites. Checked for spiders as nobody else reacted. Rash continued to spread at which point the patient followed up regarding the rash. The only place the bites are only located on the lower legs below the knees. Went back to the pharmacy who referred patient to have an exam. Dr. examined the patient and prescribed the treatment. Hydroxzine worked to allow the patient to rest from the itching. Since yesterday there are no new eruptions. Patient has isolated herself as not to risk spread of infection.
pt recvd vax;devel runny nose;small rash on nose on 29sep95;to hosp & dx w/ lymphocytic leukemia;exp leg pain,ha for several wks;bruising;fever;dec WBC count;dec hemoglobin;dec platelet count;hosp for next 28 days;relation to vax unk;
red dots in right legs appears on that evening, right leg hurt and can't  walk normally ~30 hours after short, and not getting better until now.  Will go to see doctor if symptoms last.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: El3248), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485), in right arm and on 16Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: shrimp" (unspecified if ongoing), notes: Known allergies: shrimp; "Known allergies: lobster" (unspecified if ongoing), notes: Known allergies: lobster, Ciprofloxacin. Concomitant medication(s) included: IMBRUVICA, start date: 09Dec2020, stop date: 07Jul2022. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin", notes: Known allergies: Ciprofloxacin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (13Jul2022) Negative; (16Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Second round of Paxlovid was given as AE treatment from 07Jul2022 to 11Jul2022. After testing negative on 13Jul2022, the patient tested positive on 16Jul because the patient was coughing and felt new head congestion. The patient received other medication in 2 weeks.
Caught COVID virus after being fully vaccinated. Fever, cough, congestion, no taste, no smell, can't breathe and shortness of breathe.
Patient describes fatigue when he awoke on 4/7/2015, which then lead to vomiting, and diarrhea in the evening hours. Patient proceeded to ER, received IV fluids & was discharged, ER doctor ruled out food poisoning according to patient's report.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-OCT-2008, the patient was inoculated with ZOSTAVAX by a physician for routine health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2016, the patient was treated at a hospital for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. The lawyer considered vaccination failure, immune system disorder, and herpes zoster to be disabling. Additional information has been requested.
Tension type headache; This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension type headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2UA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 08-Jan-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced TENSION HEADACHE (Tension type headache). At the time of the report, TENSION HEADACHE (Tension type headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included paracetamol and ibuprofen.  Company Comment - Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
Total fatigue, muscle aches, nausea, wooziness, headache  NOTE: I did not have this with the first vaccine, only with the second dose which was 32 days after my fourth Pfizer vaccine
Information has been received from a 46 year old female with allergies to sulfa and ATARAX and no pertinent medical history who on 30-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot# not provided) injection. There was no concomitant medication. On approximately 06-APR-2009 (about a weeks after getting the vaccine), the patient started experiencing a rash at the injection site that looked like shingles. On 06-APR-2009, about 2 days ago she started experiencing excruciating pain in the arm around the injection site. The rash was still there and it was painful and tingles. The dermatologist did not think it was shingles. There was no lab and diagnostic test performed. At the time of reporting, the patient did not recover from the events. No further information is available.
Red rash on right arm around area where shot was given. I told patient to take diphenhydramine 25mg Q6 hours and call Dr in AM if rash unresolved.
Sudden onset of muscle pain and spasms throughout body, esp legs, followed by intense headache and low grade fever (99.0 to 102.4) that has continued for 17 days now.  More recent symptoms are shooting pain  throughout body, intense backache and occasional irregular heartbeat.  Ongoing assessment and testing, no diagnosis yet but autoimmune disease is suspected.  Waiting on consult with rheumatologist.  I have been to urgent care twice and had one phone visit with MD.
Pt. came in for his 2nd Moderna dose and reported to the pharmacist that he has been experiencing a metallic taste in his mouth ever since getting his 1st  Moderna dose in May.  Pt. stated he is still experiencing  this side effect today.
pt had vax 10FEB93 AM; mom states aunt had pt around 1PM pt was very limp, poor response, generalized shaking, fever sl under 102 ax, irritable, cranky; mom states pt doing fine 12FEB93;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 26-JAN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, 0.5 ml, intramuscular. No adverse event was reported. Additional information has been requested.
pt c/o light headedness   vss b/p 116/78  64n18 99 % ra   monitored pt no other reactions
8 days after injection  the arm developed pain, swelling, redness, and was hot to the touch
A spontaneous non-serious report of "glassy looking eyes, red eyes, eye discharge and nasal congestion has been received from a consumer concerning a six year old female patient subsequent to FLUMIST.  Medical history and concomitant medications were not reported.  On 11-Dec-2008, the patient received FLUMIST.  Within 24 hours of administration, the patient developed nasal congestion which progressed to "glassy looking eyes", red eyes and discharge from eyes.  These symptoms were not associated with itching or burning of the eyes.  The patient's mother was going to take her to the doctor's office;  however, the symptoms began to clear on 14-Dec-2008 with no discharge and only mild redness of the eyes.  The events of "glassy looking eyes", red eyes, discharge and nasal congestion from eyes was recovering/resolving.
Woke up in mid July 2022 feeling like a house fell on me. Extreme fatigue felt feverish eyes burned. Lasted three months went to ER twice once in mid September once in mid October psych bc I was so sick it was making me feel hopeless. The debilitating fatigue has lasted until today and continues every morning I wake up. I cannot do my regular activities to keep up my house or self or pets. I am a widow of 13 years and have felt this deathly exhausted dialed down mentally as well. Can?t think to even clean out the litter box. I?ve been to specialists immunologists functional md holistic hair sample analysis gut map nothing even touches it. I?m going for infusions to see if high doses of vitamins and anti inflammatory work. Three infusions no changes whatever. This has changed my life so horribly that I have no life left in me. Barely can walk my dog. I have muscle weakness and slowness that I can?t walk up my indoor stairs without stopping.
Received Varicella vaccine on 07/21/06. On 07/29/06 developed a fever. On 07/30/06 developed a pin point red non-itchy rash from head to toe. Fever resolving with use of ibuprofen (recommended by  personal healthcare provider) but continues to have rash. Child normally sleeps through the night but woke up twice last night. Father denies any other symptoms,  no change in activity level. 5 year old brother, who did not receive any immunizations developed a fever on 07/30/06.