chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 19 year old female student who on an unspecified date was vaccinated with the first dose of Gardasil vaccine. On 05-OCT-2007(also reported as 08-OCT2007),  the patient was vaccinated with the second dose of Gardasil vaccine (lot # not reported). On 06-OCT-2007, the patient sought medical attention because she developed a warm raised eczema like rash on her face after receiving the second dose of vaccine. On 06-OCT-2007, she developed a pruritic rash on her cheeks. It was a vesicular rash with linear streaks on her cheeks and forehead. On 09-OCT-2007,  her cheeks felt warm to the the touch. She was treated with Benadryl, Keflex and Hydrocortisone 1% creme. On 12-OCT-2007, the patient was recovering. The patient was not planning on receiving her third dose. On an unspecified date the patient recovered. Additional information has been requested.
Imm Varicella (L) arm SQ given 4/27/11. Pt noticed red bump (Length 1 1/2 inches x 1in) Left - SQ area - of (L) arm today posterior c/o itching. No other adverse sx arm.
Primary Care Physician at Discharge: MD Hematologist/Oncologist: Dr. Admission Date: 2/17/2023 Discharge Date: 02/20/2023 Patient's Discharge Disposition:  Home in stable condition.  This is a 63 yo with a history of metastatic myxoid liposarcoma who presents to hospital on 2/17/23 for planned cycle 5 of Doxorubicin/Ifosfamide. He reports after the last chemo cycle he did get more fatigued than with previous cycles but that has since resolved. For his cycles he has been discharging prior to last inpatient doses of mesna and has a PO mesna script to take after discharge. He also self-injects Nyvepria. He has both mesna and nyvepria scripts already filled. He gets labs weekly and has standing orders there that are current. He usually follows up with staff or Dr. prior to his next cycle. Patient did tolerate chemotherapy but on 2/19 he woke up feeling very congested and reported other family members were sick at home. Film array was positive for covid-19. Given this finding and patient not feeling well discharge was delayed. He did receive IV mesna after his last ifosfamide instead of taking the PO at dc. He got 2 doses of IV remdesivir. He is afebrile and was feeling better on 2/20. He was given 1 unit of PRBC given mild anemia of 8.4. Discussed with Dr. and given he is feeling okay despite covid-19 infection will discharge home today. He can still do the self-inject Nyvepria later Monday evening or Tuesday evening. He will complete PO dex Days 4-6 of this cycle (has script at home). Given he will be in covid iso through 2/23 he will get labs drawn on Friday instead of Wednesday. We reviewed that if he has any worsening symptoms related to covid-19 infection he is to call our office. The patient is discharging home tonight in stable condition.
Per patient he was ill 11/1-2. Had no energy, felt like he had the flu. Said that he also had a separate GI illness going at the time but was sure that the side effects were due to the vaccine. Patient also stated that he had no issues with the HD vaccine last year. Patient is now fine. (11/3/18).
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 11-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Red, itchy spot (pea-sized) at injection site. Is still present on her upper arm but much less pronounced. No fever or discharge from site.
2 hours after vaccine, temp 102 for 4 hours. 24 hours after vaccine hives for 12 hours. Treatment Tylenol and Benadryl.
Proximally 24 hours post vaccine administration patient developed sudden onset lower back muscular pain radiating to the groin.
Started fever on Sunday 3/28/2021 till 4/2/2021. Also very tired/ could not do anytime.
soreness in the arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arms). At the time of the report, PAIN IN EXTREMITY (soreness in the arms) outcome was unknown.            No concomitant medications reported. No treatment reported   This case was linked to MOD-2021-423994 (Patient Link).   Reporter did not allow further contact
A dose was wasted due to a dull needle. A different vaccine was administered to the patient.
Systemic: Foot swollen, limping, calf pain for 4 days.  Foot hurting and limping has continued to be an issue.-Medium
At approximately 1:30 PM my throat area between roof of mouth and collar bones began to tighten and construct and swallowing became difficult. Throat felt compressed. I drank water delayed eating till 7:00PM, Symptoms and headache disappeared about 6:30PM, belching was a serious problem.
Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B and 041C21A) for COVID-19 vaccination.     It was unknown if the patient ever had COVID + test or diagnosis.  The patient had no Acute and Chronic illnesses at the time of vaccination.  It was unknown if the patient was given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the patient received dose from an expired vial of the Moderna Covid-19 Vaccine. This was the booster dose for the patient. The expiration date of the vaccine was 23-Mar-2022. The reporter was not aware if the patient was experiencing any symptoms after the administration of the vaccine.  The dose was administered after 30-day Use by date or after manufacturer date of expiry. The date the vial was initially stored in the refrigerator was unknown.  No treatment information was provided.   This case was linked to MOD-2022-537958 (Patient Link).
Patient developed a high, fluctuating fever for 2-4 days after the vaccine. Her highest temperature was 102 F, and she also developed some back pain. She visited the urgent care 4 days later to pickup medications for symptoms.
Light headed, dizzy (vertigo), vommitting.  Lasted 48 hours.
3/15/15 patient received a IPV on left thigh. Mother states next day it was 2x2 and raised. Thursday gave bath and tried to squeeze it. Friday it was 4x4 at daycare. Today 3/23/15 it is gone. The site was warm but there wasn't any pain.
Our clinic was contacted by the patients place of work and they stated she was feeling nauseous and sweating. I informed them of what signs to look for concerning anaphylaxis and when to call the ambulance. They called back 10 minutes later and stated that once I got off the phone the patient started saying her throat was feeling like it was closing so they contacted 911.
The pharmacist drew up a vial for Moderna Pediatric 6yr to 11yr instead of the Moderna Bivalent dosing. No adverse reactions.
I have a little bit of pain; My nose has like a little bit irritation and little bit asthma; My nose has like a little bit irritation and little bit asthma; This is a spontaneous report from a contactable consumer (patient reported for herself). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: E or FJ168), dose 1 via an unspecified route of administration on 11Jan2021 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune Auto immune condition, sjogren's syndrome from 2015 to an unknown date, fibromyalgia and covid-19 from Apr2020 to an unknown date. The patient was a respiratory therapist. Concomitant medication(s) included Ciclosporin (RESTASIS) taking for her eyes; Famotidine (PEPCID [FAMOTIDINE]); Albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) and Estradiol (ESTROGEN), all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Jan2021, after the first dose of vaccination, the patient experienced a little bit of pain, her nose had like a little bit irritation and little bit asthma, which the patient thought it was a weather. The patient underwent lab tests and procedures on an unspecified date in 2021 included blood electrolytes: unknown results, full blood count: unknown results, Hormone test: unknown results, absolute monocyte count: normal. The patient outcome of the events was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 54-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, chickenpox and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chickenpox and injection site erythema were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, chickenpox and injection site erythema to be related to SHINGRIX. Additional details were as follows: The age at vaccination was not reported but the patient could be 53 or 54 years old. The physician reported that the patient experienced chicken pox breakout all over the body along with redness and swelling at the injection site with an area of 5 to 10 inches in diameter. This case was linked with US2018143086, reported by the same reporter.
Severe left shoulder pain disabling use of left arm.  Facility contacted the next day, and was told the reaction was normal and to take ibuprofen to relieve pain.  I have had trouble with kidney function in the past taking ibuprofen and when I told the nurse that, she just said the pain would subside soon anyway and had no other pain relief recommendation.  It was 3 days later when the pain subsided just enough to be able to unholster and reholster my cell phone.  It's been over a week now and I still have pain in my left shoulder whenever attempting to use my arm to move or lift anything significant.  The muscles in my left shoulder have apparently been damaged and I suspect will take take several weeks of rehab.
Nauseous. Chills and fever of 99.5 starting at 7 pm. Vomited at 8 pm. Headache and difficulty sleeping. Tired and achy next day.
Itch at injection site on day ;, on day 6 developed a ~1.5 inch in diameter, red, raised area around injection site that was hard underneath and itchy
I had severe diarrhea within the first 12 hours and then did not have a bowel movement for 10 days. I gained 10 lbs in less than 30 days. Since the injection, my hair has fallen out in large amounts at a time, I was tired all of the time, always cold, blurred vision, and have struggled to have normal bowel movements.
w/in 2-3 hr pt devel total body rash, swollen neck gland, t107;fever brought down @ MD ofc but ran a lower fever & wasn't himself for several days;dx as vax rxn by MD:
Patient was given vaccines by RN, and was educated to remain on the table for 15 minutes.  Ten minutes later, patient reported to dad that he "wasn't feeling well" and fell headfirst from the table.  He was unresponsive for 5-10 seconds, sustained a lump to the center of his forehead, and scant bleeding in R nare. Persistent c/o headache and neck pain following the fall. Vitals were stable, patient was transported by EMS to Hospital ED for evaluation of head injury.
Information has been received from a Registered Nurse (R.N.) concerning a 62 year old female with migraine, fibromyalgia and allergy to PAXIL, NORVASC, ELAVIL who on 01-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 670386/0236AA; expiry on 17-MAY-2012). Concomitant therapy included KLONOPIN, atenolol, lisinopril-HCTZ (manufacturer unknown), PHENERGAN, multivitamin with calcium. On 02-APR-2011, the patient woke up with a headache that was still severe, joint and muscle pain especially on the left side of her body where ZOSTAVAX was administered, including pain in her left toe joints as well as her left elbow. In addition, she had a 6-inch by 2-inch red, raised rash at the injection site. No treatment was given for the adverse events. The re was no lab diagnostics performed. At the time of the report, the patient had not recovered from her adverse events. It was unknown if the patient sought medical attention. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L000610, expiry date: 31-JAN-2017; lot # L019297, expiry date: 18-AUG-2017; lot # M004116, expiry date: 12-OCT-2017). Medical assistant reported that the vaccine underwent temperature excursion at 54 degree Fahrenheit for 36 hours and 30 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
had slight temp; fussy/cranky; Administered an undiluted dose; Administered an undiluted dose; Administered an undiluted dose; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team, Program ID:.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose 2, single (Lot number: FL8695) at the age of 5 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, At 09:00, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot Number: FL2757), administration date: 25May2022, for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 17Jun2022, outcome "unknown" and all described as "Administered an undiluted dose"; FEELING ABNORMAL (non-serious) with onset 17Jun2022 at 17:06, outcome "recovering", described as "fussy/cranky"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 17Jun2022 at 17:06, outcome "recovering", described as "had slight temp". Therapeutic measures were not taken as a result of body temperature abnormal, feeling abnormal.  Additional information: The patient was administered with Pfizer Covid-19 vaccine, orange cap which was not diluted. The patient's mom was on site hanging out and before they leave, the reporter needed to know what kind of side effects to look out for this patient and if she will need the booster of Pfizer Covid-19 vaccine. An undiluted vaccine given (0.2 mL of undiluted 5 -11 year Pfizer preparation). The medication error affected the patient with clinical consequences slight temp and fussy/cranky that night but was not hospitalized. Prior vaccinations (within 4 weeks), relevant tests and specific relevant test for thromboembolic events with thrombocytopenia was none. The Pfizer product had a casual effect to the reported adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (17Jun2022): new information received from a contactable Other HCP includes: adverse event and reporter details.  Follow-up (03Aug2022): This is a spontaneous follow-up report from a contactable Other HCP. This Other HCP reported in response to HCP letter sent which included that: Updated information included: reporter physician information, patient information details, relevant medical history and historical vaccine details, suspect drug details, vaccination facility information, new events body temperature abnormal and feeling abnormal, onset date updated for at risk events and additional information were updated. No follow-up attempts are possible. No further information is expected.
Patient experienced syncope after dose. Patient has a needle phobia (per patient) and has experienced this previously with other situations.
Tonsillitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONSILLITIS (Tonsillitis) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced TONSILLITIS (Tonsillitis). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) ongoing from 17-Feb-2021 for Tonsillitis, at an unspecified dose and frequency. At the time of the report, TONSILLITIS (Tonsillitis) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  The patient was additionally prescribed an unspecified antibacterial as treatment for the events. Treatment was not administered until approximately 8 hours after his second dose of mRNA-1273.
Report 2001025938-1 describes hair loss in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). The medical history included hysterectomy. Concurrent medications included conjugated estrogens, levothyroxine sodium, atorvastatin calcium, hydrochlorothiazide, atenolol, calcium, vitamin E and vitamin C. The vaccinee stated that she had no problems with previous vaccines of any kind. She developed seasonal allergies post-immunization.. On 10/3/01, the vaccinee received her 1st injection of Engerix-B. Subsequently, she experienced diffuse hair loss. This hair loss was an increase in her daily hair loss. The hair loss got better just before the vaccinee received her second injection of Engerix-B. On 10/31/01, the vaccinee received her second injection of Engerix B. the vaccinee stated that her hair loss worsened two weeks after receiving her second injection of Engerix B. The hair loss worsened for approximately one wek and then improved. On 5/21/02, the vaccinee received her third Engerix B injection. The status of the patient's hair loss after her third injection was unknown. The reporter stated that the hair loss was possibly related to Engerix B administration.
Headache, Arthralgia, Fever & Tachycardia Narrative:
Around April 11, 2021, 15 days after my second Moderna vaccination, I began experiencing tingling in the fingers on my left hand and a tightening sensation around my left bicep. The sensations worsened the morning of April 13th and I was told by my primary doctor?s office to go to the ER. The ER doctors ordered bloodwork, EKGs and I think a CT scan. They ruled out heart attack or issues related to the heart and sent me home. Symptoms remained about the same for the following week. On the morning of April 22nd, the symptoms worsened. The tightening sensations in my left bicep and tingling in my fingertips became stronger. Then I began to experience pain in my bicep that moved up to my shoulder/clavical area. I went to my primary doctor?s office. The NP thought that it was most likely related to a pinched nerve and ordered an x-ray of my neck. The x-ray showed some slight compression of the vertebra in the neck. My husband requested that I be checked for a blood clot. The NP ordered an ultrasound and I returned later that day to have it done. A blood clot was found in the subclavian vessel on the left shoulder/clavical area. I was immediately given Eliquis. Symptoms worsen over the weekend. I returned to the ER on April 24th. They ran more bloodwork, EKGs and a CT scan of my head and chest since I was feeling like I couldn?t breathe and had a bad headache. They were unable to compare the size and location of the clot to Ultrasound from the doctor?s office. The prescribed anxiety medicines. I returned to my primary doctor?s office on May 3, 2021, for a follow up appointment. They ran more bloodwork to check for COVID antigens and clotting factors and x-rayed my pelvic area since I have been experiencing significant pain in my tailbone. They have also ordered a CT scan of my lower abdomen to rule out other possible causes of the clot. I?m waiting to hear the results of the bloodwork and for the CT appointment to be scheduled.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing), CHEST PAIN (chest hurts when I cough) and PAIN (achy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event. Concomitant products included Osteo Bioflex, FISH OIL, Cinnamon pill and BIOTIN for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing) and CHEST PAIN (chest hurts when I cough). On 02-Mar-2021, the patient experienced PAIN (achy) and DYSPHONIA (voice is hoarse). At the time of the report, MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing), CHEST PAIN (chest hurts when I cough), PAIN (achy) and DYSPHONIA (voice is hoarse) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Dose 2- red area where the injection was. Hot to touch. Slightly itchy and raised
Pt devel hives & went to ER; recvd inject @ ER per mom;