chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received expired  Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) to be not related.    No concomitant medication was reported.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 year. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient given vaccine after BUD date.  The vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2022: Live follow-up received included- iNarrative updated. On 29-Nov-2022: Significant Follow-Up information received: Reporter, patient details added and dosage information, reporter causality updated.
blood pressure went up to 23-24 mmHg/blood pressure high; A spontaneous report was received from a 48 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his blood pressure went up to 23-24 mmHg/blood pressure increased.  The patient's medical history included bariatric surgery.  Concomitant medications included losartan.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that his blood pressure "went up to 23-24 mmHg" and he was hospitalized two times, one of the times was on 25 Jan 2021.  He reported that his blood pressure "does not go down" and that labs tests were being performed to determine the relationship with the vaccine.  AN electrocardiogram and radiography were normal.  On 25 Jan 2021, the patient was hospitalized due to high blood pressure which was 23-24 mm Hg. On 25-Jan-2021, the electrocardiogram and radiography findings were normal. The patient's blood pressure was 17-19 mm Hg at the time of this report.  The patient was worried because of the consequences of blood pressure high.  Losartan was changed to amlodipine as treatment for the event.  Action taken with mRNA-1273 in response to the event was  unknown.  The outcome of the event of blood pressure went up to 23-24 mmHg/blood pressure high was unknown; at the time of reporting, the patient said his blood pressure was "between 17-19 mmHg."; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed a complete circle similar to a shape of football below belly button which lasted for 2 days; Numerous headaches; Didn't feel good for about 5 days; This spontaneous case was reported by a patient and describes the occurrence of RASH (Developed a complete circle similar to a shape of football below belly button which lasted for 2 days), HEADACHE (Numerous headaches) and MALAISE (Didn't feel good for about 5 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00GM20A) for COVID-19 immunization.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (Developed a complete circle similar to a shape of football below belly button which lasted for 2 days), HEADACHE (Numerous headaches) and MALAISE (Didn't feel good for about 5 days). In February 2021, RASH (Developed a complete circle similar to a shape of football below belly button which lasted for 2 days), HEADACHE (Numerous headaches) and MALAISE (Didn't feel good for about 5 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
On 12-22-14 by 4 PM felt lightheaded, racing heart. Felt like she had a fever at 4 PM because she was hot. Took TYLENOL, went to bed at 7:30 PM. 12-23 - felt better. Also redness (hivelike) to left arm.
My Hashimotos is off the chart suddenly Im HYPERthyroid after being consistently HYPOthyroid for last 20 years; suffered a pounding headache for a few days; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 63-year-old female patient received bnt162b2 (Pfizer BioNtech), dose 1 via an unspecified route of administration, administered in arm right on 14May2021 09:15 (Batch/Lot Number: EW0175) as 1st dose, single for covid-19 immunisation. Patient received second dose of bnt162b2, via an unspecified route of administration, administered in arm right on 03Jun2021 09:15 (Batch/Lot Number: EW0178) for covid-19 immunisation. Medical history included Hashimotos thyroiditis, spinal arthritis, high cholesterol, vasovagal syncope, pacemaker, and hypothyroidism (Being consistently Hypothyroid for the last 20 year), and known allergies: acetylsalicylic acid (ASPIRIN), nickel, latex, chalk. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin, and Womens Multivitamin (patient received within 2 weeks of vaccination). Patient waited for the CDC to say its safe for autoimmune disorders. Got her 1st shot on 14May2021. Only suffered a pounding headache for a few days on May2021. Had her lab work done on 25May2021. Her Hashimotos was off the charts and suddenly she was hyperthyroid after being consistently hypothyroid for the last 20 years on 25May2021. Treatment received reported as medication adjustment, future titration as needed for hyperthyroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovered from event suffered a pounding headache for a few days. The outcome of other event was recovering. Serious reported as no.
The pt experienced a tonic-clonic seizure 2 minutes post vax, lasting a few seconds. The pt has no hx of seizure activity and no other contributing past medical hx. Additional information has been requested.
Death Narrative:  Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.
got the Shingrix vaccine and then had an episode of A-fib; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's comment: The reporter was the patient. The patient stated that he got the Shingrix vaccine and then had an episode of atrial fibrillation.  There was no information given as well concerning vaccine lot number or expiry date.  The patient did not consent to follow-up.  No healthcare professional for follow-up. The reporter had not given any demographics details or further information concerned to the adverse event.
Employee states at 23:30 on 6/5/18 the day of the vaccination he became nauseated, vomited and had diarrhea. Reports he was chilling during the night. On 6/6/18 employee stayed home from work because he was still nauseated and had no energy. Today 6/7/18 employee came to Employee Health services reporting the symptoms from the past 2 days. Reports he has no energy today and his hands are achy. Reports he has eaten some yogurt and granola. T99.7 while in the clinic. Reports he has a history of migraines and he had a head ache yesterday but employee isn't sure whether it was a migraine or part of adverse reaction.
I was in the hospital on 02/26/23 for a procedure, I came home and was recovering nicely. On 03/05/23, I started having a runny nose that developed into a cough. I called my doctor; I was referred to their walk-in clinic. The doctor did a chest x-ray, she heard something in my chest when she listened through the stethoscope. The x-ray came back negative for pneumonia, I was prescribed an antibiotic doxycycline and benzonatate for the cough. I still have a small cough, but I am feeling.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history, who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine, IM into her deltoid. There was no concomitant medication. The patient fainted immediately after receiving the first dose of GARDASIL. She did get her color back within a few seconds after fainting and recovered soon after. The patient sought medical attention at the office. There were no lab or diagnostic studies performed. Additional information has been requested.
BODY ACHES; GOOFY SLEEP; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, goofy sleep, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, goofy sleep, and fever. This report was non-serious.
4:30 I had a bowel movement; colon felt funny on descending side; Had dinner around 6:30 pm and about 9:00 pm, I took vitamins and I started feeling queasy and nauseous. Laid there about an hour trying to keep food down. Decided I was still hungry and Had a hard boiled egg. But got nauseous again. Mouth started to water and I vomited everything that was in my stomach - intense vomiting. My intestines on left side after that was on fire- pain was so intense that my husband to ER (Emergency Room). They did a CAT scan - Colitis going on in there. They gave me morphine. The pain (on left side of intestine) continues for about another week but not as intensely as it was at first. I saw my GI Dr yesterday and colonoscopy and and EDG in March. I have pain meds that I was given and I have about four left and I am using them sparingly so I won't feel that pain anymore. So it is still there.
Hives, swelling to face and mouth, flushing. Increased heart rate and decreased BP.
11:30am Post vaccination reports light headed w/ feelings of palpitations and anxiety; initial vitals assessed P155 RR 16 BP 118/82 O2sat 99%; medical monitoring, po hydration and snack given; repeat P115. unchanged status, monitoring continued w/rest.  11:54 BP 125/82 P126; EMS dispatched for hospital transport for further evaluation / treatment.
children received FLUBLOK QUADRIVALENT, with no adverse event; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a  nurse.  This case involves 7 months old patient of unknown age, who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot: QFAA2056 and expiry date: 30-Jun-2021) children received flublok quadrivalent (product administered to patient of inappropriate age).   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 16-Dec-2020, the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Lot: QFAA2056 and expiry date: 30-Jun-2021) at a dose  of 0.5 ml, via unknown route at right thigh for prophylactic vaccination.  On 16-Dec-2020, (latency: unknown) children received FLQUADRIVALENT RECOMBINANT VACCINE  as their second doses in their influenza vaccine series (product administered to patient of inappropriate age). Their first doses were of Flulaval on 16-Nov-2020. She asked if their entire series needs to be repeated or just the second doses.  It was an actual medication error case due to Product administered to patient of inappropriate age.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Right arm (deltoid) swelling with pain-mid arm. 2 inches of swelling.
Left arm red, warm to touch, no soreness reported at this time. Describes a "knot" at injection site and a 3" by 2" area of redness that is warm to touch. This was noted on 1/20/2021 in the morning. The area became more red over the next few days and gradually became a light pink color although the knot remained. Patient believed site was healing. Woke at five am on 1/25/21 and noticed the area was again red and warm with a yellow "puss filled" area in the center. States this area looks like "ringworm". Reports has not seen a physician regarding this. Advised patient to make an appointment with her physician today for follow up.
Patient had positive COVID test at outside facility.  The facility told him he would have to leave, and after discussion with his wife, he came to ED where he was evaluated.  An initial oxygen sat was 88%.  He is therefore admitted. Oxygen then rapidly improved to then 95-100% x hours.  CTA chest shows no pneumonia or PE.
Lethargic; Vaccination site pain; Vaccination site warmth; Vaccination site erythema; Tired; Fever; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch) and FATIGUE (Tired) in a 66-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and PAIN (Aches All over). At the time of the report, LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch) and PYREXIA (Fever) had resolved and FATIGUE (Tired), CHILLS (Chills) and PAIN (Aches All over) had not resolved.            Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 and does not contains new information
Patient received flu shot around 11:40 am, that evening she experience bad lower back pain that radiated down both legs more so on right than left.  Patient states it took a couple of days for the back and leg pain to resolve.
Bilateral red swollen upper arm. painful and hot to touch, she has no fever. Large knot in left arm.
This spontaneous report has been received from a consumer regarding a 14 year and 364 day old female patient. The patient concurrent conditions, medical histories, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9. It was reported that it was unknown if the patient was supposed to be getting the three dose or two dose regimen of HPV vaccination series with GARDASIL 9. The consumer reports that the patient was late for her second dose of GARDASIL 9 if she was supposed to get the three dose series (Inappropriate schedule of drug administration). No adverse effects reported. No product quality compliant (PQC) was reported.
pt recvd vax & devel redness & induration @ the site of inject & lymphadenopathy in the groin; pt is being treated w/Zithromax;
The following morning I had a headache and nausea. I was fatigued for two days following and slept over 11 hours the second night. Upon the third day I felt fine.
HAS LOSS WEIGHT FROM 215LB TO 160LB; FELT MORE ENERGY, LOVE, POSITIVE, OVERWHELMED, HAPPY, LIKE ALL SYSTEMS WERE FIRING, HORMONAL PROBLEM GONE, BETTER MEMORY, LEARNING URGE, LIGHT, MORE PREDICTABLE MENSIS, MENOPAUSE SYMPTOMS GOT BETTER; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 215 pounds, and height was not reported. The patient's past medical history included: ovarian tube removal surgery, tubal pregnancy, nursing, post procedural complication, and hormone replacement therapy, and concurrent conditions included: hormonal problem, and non-functional ovary, and other pre-existing medical conditions included: patient had no known drug allergies. 10 to 15 years ago had to remove an ovarian tube, believes due to that surgery one of her ovaries was non functional. She stated that she was not taking any medications at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 19-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced felt more energy, love, positive, overwhelmed, happy, like all systems were firing, hormonal problem gone, better memory, learning urge, light, more predictable mensis, menopause symptoms got better. On an unspecified date, the patient experienced has loss weight from 215lb to 160lb. Laboratory data (dates unspecified) included: Weight 215 pounds, 160 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt more energy, love, positive, overwhelmed, happy, like all systems were firing, hormonal problem gone, better memory, learning urge, light, more predictable mensis, menopause symptoms got better and has loss weight from 215lb to 160lb was not reported. This report was non-serious.
Red, heat, swelling at site of injection, headache, generalized malaise and myalgia, back, neck, kidney, pain
Lightheadedness; Shaking really bad and was frozen; Shaking really bad and was frozen; Headache; Sore arm; Wasn't feeling good; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left arm on 21Feb2021 (age at vaccination 81 years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing essential tremors (started in her twenties), shoulder replacement; left shoulder two years ago and right shoulder ten years ago and mild Covid in Dec2020. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported, Expiration Date: 30May2021) via an unspecified route of administration, administered in right arm, on 31Jan2021 as DOSE 1, SINGLE, for COVID-19 immunisation The patient's concomitant medications were not reported. The patient reported that after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, she experienced some side effects. On 21Feb2021 22:30 she was shaking really bad, and was frozen She also had headache, sore arms. She also mentioned that on her card, she saw a sticker with the expiration date, 30Jun2021. The patient wanted to know if this was the expiration date for the vaccine, and if she needs to take another dose of the vaccine after the vaccine expires. She read all the information. She was fine until bedtime. She went to bed early because she was not feeling good. She woke at 10:30pm and was shaking so bad and was frozen. She keeps the heat at 70. She turned it up to 72 degrees and had two sweaters on and she was still cold. She guesses that was to be expected. She also had a headache and a sore arm. She was lightheaded this morning on 22Feb2021. She guesses that goes with it. Therapeutic measures were taken as a result of shaking really bad and was frozen. Outcome of the events Light-headedness recovered on 22Feb2021, event of not feeling good was unknown and other events was not recovered.  No follow-up attempts are possible. No further information is expected.