chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient receieved stem cell transplant after receiving vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In November 2021, the patient experienced STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine). At the time of the report, STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered STEM CELL TRANSPLANT (Patient receieved stem cell transplant after receiving vaccine) to be not related.    Concomitant medication list was not provided. The reporter, a pharmacy intern, confirmed that the stem cell transplant was not related to the patient getting the primary doses. Treatment information was not provided.   This case was linked to MOD-2022-510119 (Patient Link).
Woke up in the middle of the night with heart racing and shortness of breath 6 days after 2nd shot.  Same thing happened after getting the first dose.  Exactly 6 days in the middle of the night for first dose.
This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable Caucasian Consumer reported for herself. A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on an unspecified date in 2015, about a year before this report, for pneumonia immunisation.   Medical history included ongoing high blood pressure, ongoing glucose tolerance impaired (pre-diabetic).  There were no concomitant medications. On an unspecified date the patient experienced itching at site of injection after the shot for about three weeks or something and now occasionally it still itches at that spot, she had little bumps at the side of injection where she itched with outcome of not recovered. The first three weeks when it was itching so bad, she took Prednisone and it did not even stop itching, it slowed it up but it did not stop it. As treatment of itching she have used the BENADRYL and everything which she had in her house to try to keep it away from itching so bad but she had all those little bumps under the skin.  She was still experiencing itching but it was not as bad and further added that it was severe for about 3 weeks and it was really bad and after that it was kind of flared up but then it was just came back. She added that itching was not gotten worst but it was just still there. No lab test performed. A Product Complaint was filed.
3am: awakened with mild to moderate pain at site of injection 6am: headache unlike any headache I've ever had (not a tension headache/not a migraine headache).  Difficult to describe 9am (with episode throughout the day until bedtime):  minor vertigo; minor nausea; loss of appetite  Adverse effects lasted only on day after the vaccination, Feb. 11, 2021;  and resolved by the following day (Feb. 12, 2021)
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 59.38 for dose administered on 29-Apr-2021. No concomitant medications were reported. Batch number 007C21A underwent temperature excursion on 29-Apr-2021 with temperature 33 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 29-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
I got shingles after 14 days of the 1st Moderna vaccine.  After 2 days I went to the doctor and they put me on Valacyclovil for 7 days.  I will complete all the pills on Thursday April 22.  The rash  and pain is subsiding.
Large red and warm area over deltoid area (4" X 2"). Area is painful and very itchy. Mild flu-like symptoms.
Started with overall bad body aches, fever sustained for 4 days, severe joint pain, headache and sore throat. All symptoms lasted for 4 days.
10/8/02 DTaP left deltoid given, MMR given in left arm SC given also. The next day, upper left arm (deltoid) became swollen and red measuring 2"x2". Per clinic physician, advised Tylenol, ice pack and Benadryl.
Dose administered after 30-day Use By Date; Patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.  It was reported that the vaccines placed in refrigerator on 13 Jan 2022, expiration date placed on vial was on 12 Feb 2022 and doses administered to patient on 17 Feb 2022.
Pt returned to office 10 mins after vaccines - Initially seemed to lose head control - then had tonic activity of upper extremities and eyes rolled back. She was pale & lips looked blue at the end of incident that lasted 10 seconds. No post ictal phase. No incontinence.
Pt administered Hep A at age 2 months no adverse side effects noted. Family present notified, Dr present notified no new orders. Encouraged family to seek tx if diff breathing or sx of concerns develop with understanding verbalized.
BLISTERS IN MOUTH AFTER 2ND MODERNA COVID 19 VACCINE STARTED AFTER A WEEK FROM GETTING THE VACCINE.  LASTED FOR ABOUT 8 MONTHS AND STILL GETTING OCCASSIONALY.  ALSO HAD DISCOLORATION ON MY LIPS WHICH KEPT GROWING.
Pt had rash on immunization arm went to md and pt was put on cephalexin 500mg four times daily as infection precaution.
28SEp93 phone call from pt took flu vax in rt arm 27SEP 830AM-arm became swollen, red, hot to touch w/pain; thinks had fever during the noc w/sweats;
Sat, Feb. 13, 2nd day after shot: during the afternoon arthritis pain intensified and Tylenol Extra Strength for Arthritis did not alleviate it, which it always has in the past. Later sometime in the middle of the night, I wasn't able to fall asleep as if I'd had a stimulant, and had intense arm pain where shot given, some nausea, some intestinal discomfort, intense pain at temples and behind eyes, overall "crappy" feeling.  Sun., Feb 14, 3rd day after shot: Pains/symptoms same as above with the addition of a low grade fever (99.9), chills, fatigue, no appetite. Tylenol didn't help. Was able to drift in and out of light sleep. Later in the day, fever and majority of symptoms suddenly "left",  gradually decreasing until I felt fine again by Sunday evening. No issues Monday, Feb. 15.
Patient complained to tech on a repeat trip to pharmacy for pain meds that vaccine administration caused prolonged pain.
Within 48 hours of vaccination the infant had inconsolable crying, refused to eat, and did not urinate nor soil diaper.
Low grade fever (100.8) Pain in lymph node regions (armpits, groin) Body aches Restlessness Loss of appetite Fatique
On 8/13/00, the infant developed a seizure. Seizures are considered "Medically Important." Still on Phenobarb, no siezures since 11/30/2000
VOMITING; This spontaneous report received from a patient concerned a female 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. The company is unable to follow-up to request batch/ lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Malaise, headaches, fevers 103 degrees, chills, myalgias. Lasted 4 full days. Treated with Tylenol and Ibuprofen and Rest.
Day p/immun feet turned pink w/small white patches - lasted for 3 days followed by aching in wrists & feet; pt cried a lot & scratched all over same evening as shot; APAP q 4 hrs given over 3 day period; 7OCT91 wrists continue to ache;
The worst pain I have ever had; My underarm lymph node swelled up to the size of a grapefruit; I felt like I was about to vomit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: Covid-19 vaccine (DOSE 1,SINGLE Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "The worst pain I have ever had"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "My underarm lymph node swelled up to the size of a grapefruit"; NAUSEA (non-serious), outcome "recovered", described as "I felt like I was about to vomit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, lymphadenopathy, nausea.  Additional clinical information: With this shot and with the last booster I had on 09Nov2021 my underarm lymph node swelled up to the size of a grapefruit and was the worst pain I have ever had. I happen to have a high tolerance for pain but this came in constant waves for 48 hours and every time it hit a 10 in pain I felt like I was about to vomit. I am hesitant to ever vaccinate again it was so horrible and I am pro vaccine. If COVID prior vaccination and If COVID tested post vaccination: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient had injection site rash 8 hours after was administered PNEUMOVAX23; This spontaneous report has been received from a pharmacist referring to a 69-year-old female patient. The patient's concurrent conditions, medical history and drug or allergy reactions were not reported. Concomitant therapies included atorvastatin, alendronate sodium, losartan and pantoprazole.       On 17-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route were not reported; lot # S002582, expiration reported as 10-AUG-2020) for prophylaxis.      On that date (after 8 ours was vaccinated the vaccine), the patient experienced injection site rash. The rash lasted 3 days. On 20-JUL-2019, the event resolved. There was no treatment given to the subject. No additional information provided. The reporter is requesting an investigation for the lot number the patient received. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Swollen Lymph nodes on left arm; Hot flashes; Achey; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:15 (Lot number: EN6205) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asa, reaction(s): "allergies", notes: Known allergies: ASA. Vaccination history included: Bnt162b2 (DOSE  1, Lot number: EN6207, Arm left, Time: 13:30), administration date: 01Mar2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "Headache". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Mar2021 11:00, outcome "not recovered", described as "Swollen Lymph nodes on left arm"; HOT FLUSH (non-serious) with onset 23Mar2021 11:00, outcome "recovering", described as "Hot flashes"; PAIN (non-serious) with onset 23Mar2021 11:00, outcome "recovering", described as "Achey". Therapeutic measures were not taken as a result of lymphadenopathy, hot flush, pain.  Additional information: No other vaccine in four weeks. No covid prior to vaccination. Not covid tested post vaccination. Headache 1st shot lasting 3 days. Second shot- swollen lymph nodes on left arm (injection site) onset: day 2 ongoing, hot flashes, and achey.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021359401 Same reporter/patient/vaccine, different dose/event
Started noticing a ringing in my ears that I believe started shortly after being vaccinated. This persisted for a couple months before I went to an ENT specialist to be checked out. I was diagnosed with Tinnitus. I do not know if this is directly related to the vaccine but I didn't have it prior to being vaccinated so I thought it best to report.
started throwing up; my arm was little bit sore; I started getting chills; This is a spontaneous report from a contactable consumer. A 70 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EN6207) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications included: LISINOPRIL; HYDROCHLOROTHIAZIDE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "my arm was little bit sore"; CHILLS (non-serious) with onset 21Mar2021, outcome "unknown", described as "I started getting chills"; VOMITING (non-serious), outcome "unknown", described as "started throwing up".  Additional information: Consumer stated, "Yesterday, I took the Pfizer shot about 1 o'clock and my arm was little bit sore but then mid night 1 o'clock in the morning or 1:30, I started getting chills and now I started throwing up. So, is that normal. When paraphrased the concern: Consumer stated, "Correct, like 12 hours later little bit more. 12 hours later started having chill then I threw up by 3 or 4 times." Consumer added, "Like the second shot going to be just that bad." Consumer stated, "I take about 6 to 7 pills." Consumer confirmed the vaccine dose as the first one.  No follow-up attempts are possible. No further information is expected.
This case was reported by a physician and described the occurrence of muscle spasm at injection in a 50-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 5 June 2008 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm. At an unspecified time after vaccination with BOOSTRIX, the subject experienced muscle spasms at injection. At the time of reporting the event was unresolved. Administration of BOOSTRIX to this subject was also considered to be a medication error as BOOSTRIX is not indicated for use in subjects over the age of 18 years.
Itching and red streak at injection site.  Two days after shot.  Feeling disoriented  and can't concentrate - one day after shot and still present.
This case was reported by a pharmacist and described the occurrence of nodule injection site in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included influenza vaccine; manufacturer unspecified; unknown; left arm given on 9 October 2012. On 9 October 2012 the subject received a dose of BOOSTRIX (unknown route, right arm). In October 2012, less than one week after vaccination with BOOSTRIX, the subject experienced nodule injection site and injection site pruritus. At the time of reporting, the events were unresolved. "The arm where BOOSTRIX was given developed a knot which had not gone away and it is now itching."
headaches; arm hurt a lot; I don't feel very well; My eyes are bothering me; This is a spontaneous report from a contactable consumer, reporting for herself.  A 65-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at 20:30 (at the age of 65 years old) as a single dose for COVID-19 vaccination. Medical history included being diabetic from an unspecified date. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced headaches, arm hurt a lot, don't feel very well, and her eyes are bothering her. The clinical outcome of headaches, arm hurt a lot, don't feel very well, and her eyes are bothering her was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Graves' disease (GD); Autoimmune Inflammatory Syndrome Induced by Adjuvants; This is a literature report.  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), 14 days after the suspect product(s) administration, outcome "recovering", described as "Graves' disease (GD)"; ASIA SYNDROME (medically significant), outcome "recovering", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: 0.01 uiU/mL; Thyroid stimulating immunoglobulin: 4.5; Thyroxine free: 3.3 ng/dL; Autoantibody test: positive. Therapeutic measures were taken as a result of basedow's disease, ASIA syndrome. Additional information: The patient developed tachycardia 14 days after the Pfizer vaccination. She responded well to methimazole 20 mg daily. The patient didn't had a personal or family history of thyroid disease. Our case series adds to the growing evidence for SARS-CoV-2 vaccine-induced Graves' disease (GD), suggesting the incidence may be higher than initially thought and may occur after the 1st, 2nd or booster doses. One potential mechanism is the Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA), which is likely triggered by the mRNA lipid nanoparticles present in the SARS-CoV-2 vaccine. Our patients all met criteria for ASIA with exposure to adjuvants, manifestations of autoimmune endocrine disorders, and positive autoantibodies. In our case series, patients had symptoms for weeks to months before their diagnosis of GD highlighting the importance of patient education regarding possible thyroid complications following vaccination to ensure prompt diagnosis and treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case a possible causal association between the reported event Graves' disease, Autoimmune/inflammatory syndrome induced by adjuvants and the suspect drug   BNT162B2 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 RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;
"50 cent" size swelling, eryhtrema at site. Itching/tender.