chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; redness, pain, swelling, itching at site; malaise p/ dose 2; itching at site p/ dose 1;
This spontaneous report was received on 21-FEB-2017 from a pharmacist concerning a female patient. The female patient had no pertinent medical history, no concomitant medications and no drug reactions/allergies. The pharmacist reported that the female, at an unknown age, on an unknown date at an unspecified facility, received her first dose of MMRII (Dose, route of administration, site of administration, Lot number, and expiration date were not reported.) The pharmacist does not know if the female had experienced an adverse effect after she had received her first dose of MMRII. The pharmacist reported that on 21-FEB-2017, the female patient, presently aged 25 years old, not pregnant, received her booster dose of MMRII (Lot number L041457, expiration date 22-OCT-2017), subcutaneously left tricep region, and developed an area of redness the size of an adult hand at her injection site within a minute of the administration of the dose. The patient reported that the injection site felt warm, but the pharmacist did not think that the area felt any warmer than it had before the dose was injected. The pharmacist monitored the patient for approximately 5 minutes, and the area of redness began to improve. No laboratory studies performed. The patient left the pharmacy to go home independently in no apparent distress. [The therapy reason for use of MMRII was also reported as routine vaccination.] No treatment was given for the adverse experience. Outcome of the adverse experience reported patient as recovering. Additional information has been requested.
today 5-10-2021 patient presented to pharmacy with redness at injection site, about 5 inches in size, round, bumpy, warm to the touch, you could see where the needle went in (mark on skin), blotchy, painful, very itchy.  Patient said started 3 days after receiving vaccine.  Advised contact MD for follow up and put ice on it as well as take tylenol or ibuprofen.
Starting in 06/2021, I had issues with burning mouth syndrome where my tongue would have a "burning sensation". They are unsure of the cause. I had COVID in 01/2021 and other health issues. I'm still having issues to this day.
3NOV97 pt came to the clinic c/o hives & itching;hives noted on chest, shoulders, back & abd;instructed that areas must be covered while @ work, DPH, hydrocortisone cream & f/u w/MD if needed;
Discharge Provider: Private MD Primary Care Provider at Discharge: Private MD  Admission Date: 8/10/2022 Discharge Date:  8/14/2022 PRESENTING PROBLEM: Sickle cell crisis (HCC) [D57.00]; COVID-19 [U07.1]; Sickle cell pain crisis (HCC) [D57.00]. HOSPITAL COURSE: The patient is a 47-year-old female with a history sickle cell disease as well as chronic pain syndrome which is narcotic dependent, history of DVT/PE on anticoagulation with Pradaxa as well as depression and anxiety, who presented with an acute sickle cell pain crisis on 08/10/2022. Patient also had noted a sore throat, with headache, cough and myalgias beginning on 08/08 with a home COVID test being positive on 08/09. At the time of admission, the patient was without hypoxia. Given her symptoms she was not a candidate for remdesivir or dexamethasone. Patient was admitted to the hospital service for further treatment of for COVID infection and sickle cell pain crisis. During the patient's hospitalization her hemoglobin remained stable, without any need for transfusion. Patient was treated with half-normal saline. Patient was continued on her home dose of Hydrea as well as Oxbryta. Patient was also continued on her home regimen MSIR, fentanyl patch, Neurontin, Elavil and Flexeril. IV Dilaudid was added to regimen at a dose of 2-3 mg every 2 hours. Patient's COVID infection was treated symptomatically with Tessalon Perles, Mucinex, and guaifenesin. With supportive care the patient's cough and sore throat improved. Patient's sickle cell pain crisis also improved, with pain returning to a tolerable level. As patient was clinically stable, she was discharged to home on 08/14/2022.
Erythematous, very itchy rash that started on  right arm and spread to distal extremities.  Painful palms and soles that do not itch.  Hurts to walk.
Redness at injection site.  Redness has not gone away for about 8 days.
Patient received the shot at 01:29 pm and a few minutes after around 01:32 pm the patient started to experience syncope and was sweating throughout his body. These symptoms lasted around 25 minutes. Paramedics came and took his blood pressure (reading 122/64 mmHg). Sweating stopped around 5 minutes after the vaccine. The patient requested to lie down for a few minutes due to his syncope.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Localized swelling and redness to injection site that occurred within minutes to hours of administration per mother.  On exam 2 days later, site w/swelling, pink, warm, pruritic.  Dx as allergy to vaccine.  Treated w/Benadryl and CAPHALCIN to prevent infection.
Swelling of affected admin site, right bicep. 5cm difference between biceps. 125 Solumedrol IM and 25mg Benadryl Q 6 hr. PO. Follow up in 24 hrs.
No adverse effect; Patient received an expired dose of VAQTA; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 04-JUN-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) injection (dose and frequency were not reported) (lot # R007388, expiry date: 27-MAY-2019) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
The day of started of with nausea. Then on the 23rd I had fever, sore throat, headache. On the 24th I got tested for Covid-19 and it came back positive.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID 19 Treatment". Paxlovid was taken as therapeutic measures from 21Sep2023 to 25Sep2023 as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300316245 Same reporter/patient; different drug/AE;
Pt recvd 3 doses of Engerix-B vax & did not seroconvert; Booster dose was administered; no tx was given;
Headache, Myalgia, Diarrhea, Fatigue Narrative:
Itching on arm injection given in started within one hour from receiving vaccine (10am), Pt woke at 1 am the next morning with hives on injection arm, hives were mainly from the elbow down with a few above the elbow.
My son was given the Hepatitis B vaccination 1 hours after he was born. Within 24 hours he began having seizures. He was transferred to another facility with an infant ICU. He has been placed on phenobarbital. - 3/16/06 Review of d/c summary confirms abnormal EEG and prescribing of phenobarbital to prevent further seizures. Review of medical record confirms convulsions in newborn.  - 4/27/06 Review of hospital birth record and transfer record confirms diagnosis of seizure and receipt of Hep B vaccine.
?Moderna COVID-19 Vaccine EUA? 1 week post vaccination and the injection site is inflamed, raised, and tender to touch. Margins were marked on the second day at approximately 10:00am on 1/17/2021 and by 8:30pm the margins expanded by approximately ¼ - ½ inch.
Pt said that on the day following the vaccine she felt very dizzy and kept blacking out.  Her husband said that she was also mumbling nonsensical things, and started drooling.  Today when she called, she had trouble with speaking and she is still drooling.   Client suspects that she might have had a stroke or a blood clot, but she have not gone to the doctor because she does not have health insurance.
Vaccine administered 7/13/07 at about 1PM administered IM R deltoid rather than SQ. Mom states at 8cm hard, red, tender swelling noted to R arm by 8am Sat 7/14/07. Couldn't really use R arm. Crying. By Sun am better much improved by today's visit 1:45 PM 7/16/07.
p/vax pt devel fever @ 3PM 103.0;3/21/99 vomiting & diarrhea;3/22/99 fever dropped to 101;child is active & playing;3/29/99 child was well;
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. On unspecified dates since 31-JUL-2015, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L009203, expiration date 17-MAR-2017, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient presented post rehab treatment for alcohol abuse, with a chief complaint of right lower quadrant abdominal pain and constipation for 2 days. He was found to be hypotensive, febrile  temperature 101.6°, hypoxic SpO2 91% in 4 L of oxygen. creatinine elevated at 4.2 and AST/ALT were elevated.  High sensitivity troponin was elevated at 843.8.  Patient was started on broad-spectrum antibiotics with Zosyn and Decadron. He was placed in the ICU, on NG Tube, due to bowl obstruction, and kidney injury. He was also was treated for  hyperkalemia hypophosphatemia, and obstructive uropathy due to urinary retention. on 1/14/22 due to prolonged agitation concerning for delirium and Neurology evaluated the patient and suggested patient possibly have toxic metabolic encephalopathy. Patient continued to improve, and was subsequently discharged on 1/17/22.
Information has been received from a physician concerning a patient's cousin who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported) 0.5ml, intramuscularly. On unspecified date after getting the vaccine her/his stomach became "upset". The patient sought unspecified medical attention. The outcome of the stomach became "upset" was unknown. The patient's cousin was not a patient at the doctor's patient. Attempts are being made to verify the existence of an identifiable patient and reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This is my fourth pregnancy and I was 27 weeks pregnant at time of my first dose of the vaccination. I have had no miscarriages. Non-painful Braxton-Hicks had been happening occasionally for about 3 months. The evening of my first dose they began to be more painful and consistent. This continued on and off for the 24 hour hour period after my first dose. They would eventually stop if I lay down to rest. Painful Braxton-Hicks have since stopped after that 24 hour period. Non-painful Braxton-Hicks have continued to come and go occasionally since then. I experienced none of these reactions after my second dose on 9/17.
Breakthrough case admission after 2 vaccines  Pfizer 3/25/21 Lot# ER8730;  Pfizer 4/20/21 Lot# Ew0170
Difficulty breathing, difficulty walking, dizzy, nausea. Called clinic to report and the nurse said it was "normal".
17 hours post administration - Pt presented w / 105 temperature, B knee edema +1, rash, tonic seizure, body aches, fever 101-103 and body aches lasted 3 days. 10/20/2009 received VAERS report , lab done 10/17/2009 and note from MD office stating that mother called MD office on 10/15/2009 to report that daughter, 1 day post vaccine, had sx of bilateral knee edema, fever of 105, rash, tonic seizure activity and arthralgias.
My daughter woke up at 2am  and I started feeling like I would throw up and I sat down and blacked out and fell into our shower and hit my head and shoulder my husband had to  shake me and wake me up and I also felt  like I would have diarrhea- ER said it was a vasovagal event
Headache; she has environmental allergies like pollen and has noticed, after the vaccines, they get severe; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was BNT162B2 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 18May2021 at 11:00 (at the age of 40 year) as dose 2, single for covid-19 immunization. Medical history included pollen allergy. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EWU175 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 29Apr2021 at 01:00 pm (at the age of 40 year) as dose 1, single for COVID-19 immunization and experienced Arm pain, Chills, really tired and really hungry the next day too which is not normal. On 18May2021, the headache started an hour after the second dose and lasted most of the day, until that evening. Patient took Tylenol, it was not a severe headache. The patient also explained that she has environmental allergies like pollen and has noticed, after the vaccines, they get severe on an unspecified date in 2021. They have stopped but there are times she feels they more severe now when she does get them, where they were light before the vaccines. The patient underwent lab tests and procedures which included weight with result 127-130 lbs. The outcome of event headache was recovered on an unspecified date in 2021 while for allergy aggravated was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116643 similar report from same reporter
Symptoms started with sporadic patches of hives that appeared and went away quickly. Hives were very itchy. After 4-5 days it progressed to raised red marks that appear anywhere skin has moderate pressure applied to (Dermatographia)- skin is constantly itchy globely unless antihistamine is taken. This started November 25th 2021 and is a continued daily occurrence with no noticeable improvement in symptoms. I do not have a primary physician so I did not seek out medical attention.
Patient was not of qualified age when receiving COVID 19 vaccine. Patient did not experience any adverse side effects during observation period. Patient did not report any adverse side effects after leaving facility.
It was a flu shot performed by staff (Hospital) and the next day my arm started hurting at the injection site and had severe swelling. The swelling went down after a few days but the pain kept increasing at the injection site. Within a week, I had severe pain down my right arm, numbness in my fingers and then reached a point where I could not move my arm above my head nor hold any weight. This has continued for a month. I have used TYLENOL and ice and heat to treat and get through the nights, but the pain is bad.
Shingles 2/11/2021 Treatment on 2/15, 2/19,3/01,2021
The patient is a 28yo with his of back pain, migraines and TBI from an mva in Feb. 2021. He called this am c/o pain in the upper back x 2 days after he received the first dose of the Pfizer vaccine on 9/14/21 @ about 1400. I called and spoke with the patient. He states he was very anxious prior to receiving the vaccine and even more anxious after the he went on internet to read about side effects of  the vaccines. He c/o of a pain between the shoulder blades which started  an hour after the vaccine administration. The pain is better with standing but worse when he sits or lays down.He also states he feels dizzy and has a headache but these sxs have not changed or gotten worse that what he had prior to receiving the vaccines. He also denies general malaise, chest or neck pain, sob, neck stiffness or rashes in the area of pain. He is able to move his head and neck and joints without difficulty. He also states the pain is gradually getting better, was 6/10. He currently has Tylenol and Flexeril at home.  He denies any other concerns.  Prior to contacting the patient, I had reviewed the Comirnaty package insert on the web from the  website. I counseled the patient about the documented adverse musculoskeletal effects of the vaccine in the literature, the mild severity of his symptoms and the expected  good prognosis.  I recommend topical application of cool compresses bid prn, start taking Tylenol Arthritis po otc bid prn pain and Flexeril po 10 mg an hour before bedtime today. The RN will f/u with him in 24 hours. ER precaution was given for progressing, spreading or sxs. F/u prn. He v/u
LMP 10/21/2021 patient came in for first trimester ultrasound on 12/30/2021 and 1/6/2022 interuterine preganacy, negative fetal heart tones on both ultrasounds consistent with miscarriage.
17 year old female patient was administered the 1st dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine). On 23-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Nurse declined that the patient had any side effects that she was aware of.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Reporter's address and additional hone number was added.
Experienced cranial nerve 3 palsy of the right eye; headache; double vision; nausea; Double vision, right eye fixed and turned outward; dilated pupil; droop of eyelid; inability to move eye past a certain position, difficulty focusing on close-up objects; inability to move eye past a certain position, difficulty focusing on close-up objects; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 06Aug2021 (Lot number: FC3180) at the age of 49 years as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRANIAL NERVE PALSIES MULTIPLE (medically significant) with onset 2021, outcome "unknown", described as "Experienced cranial nerve 3 palsy of the right eye"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown", described as "double vision"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; EYE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Double vision, right eye fixed and turned outward"; MYDRIASIS (non-serious) with onset 2021, outcome "unknown", described as "dilated pupil"; EYELID PTOSIS (non-serious) with onset 2021, outcome "unknown", described as "drop of eyelid"; EYE MOVEMENT DISORDER (non-serious), VISION BLURRED (non-serious) all with onset 2021, outcome "unknown" and all described as "inability to move eye past a certain position, difficulty focusing on close-up objects"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". It was reported that Description of Event:  Age 49. Experienced cranial nerve 3 palsy of the right eye. Symptoms included: initial onset came on with a headache, double vision and nausea. Double vision, right eye fixed and turned outward, dilated pupil, drop of eyelid, inability to move eye past a certain position, difficulty focusing on close-up objects, dizziness, nausea. She told me about this yesterday and said her eye doctor told her it was caused by the vaccine, so I am reporting it. Name of Product: COVID Vaccine Lot #FC3180 Pharmacy/Store 06Aug2021 Awareness Date: 06Dec2021 Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
12 year old received his covid booster about 1 month too soon.  He came with his family (4 including him), dates on form left blank.  We asked if it has been at least 5 months for all, and they said yes, and student gave vaccine.  We assumed his dates were same as his sister, which was filled out on her form.
Patient received 2 Fluarix Quad shots this flu season. 8/31/2023 and 11/20/2023